Detalle de la norma RE-44-1993-GMC
Resolución Nro. 44 Grupo Mercado Común
Organismo Grupo Mercado Común
Año 1993
Asunto Registro de los Productos Veterinarios
Detalle de la norma

 

Documento y Nro

Fecha

Publicado en:

Boletín/Of

Resolución n° 44

01/07/1993

Fecha:

 

 

 

Dependencia:

RE-44-1993-GMC

Tema:

MERCOSUR

Asunto:

SISTEMA DE CONVALIDACION DEL CERTIFICADO DE REGISTRO DE LOS PRODUCTOS VETERINARIOS

 

VISTO El Art 13 del Tratado de Asunción, el Art  10 de la Decision N¦ 4/91 del Consejo del Mercado Común y la Recomendación  No. 34 /93 del Subgrupo  de  Trabajo  Nro 3 “Normas Técnicas”

CONSIDERANDO:

Que  es  necesário la armonización de los reglamentos para  Registro  de  los  Productos Veterinarios  que  serán comercializados entre los países del MERCOSUR.                               

Que las normas que rigen esta actividad en los Estados Partes son en su principio comparables y armonizables  

Que es conveniente facilitar la circulación de Productos Veterinarios entre los países miembros cumpliendo con  las  más  estrictas  normas de calidad,  eficiencia  y seguridad.

EL GRUPO MERCADO COMUN RESUELVE:

Art 1º- Aprobar los siguientes documentos:

a)  SOLICITUD MERCOSUR DE INSCRIPCION PARA PRODUCTOS FARMACOLOGICOS  ANEXO I   

b)  SOLICITUD MERCOSUR DE INSCRIPCION PARA PRODUCTOS BIOLOGICOS  ANEXO II 

c)  SOLICITUD MERCOSUR DE INSCRIPCION PARA ALIMENTOS CON MEDICAMENTOS  ANEXO III      

d) NOMENCLADOR  ANEXO IV 

Art 2º- Los Estados Partes pondrán en vigencia las disposiciones legislativas, reglamentarias y administrativas necesarias para dar cumplimiento a la presente Resolución que entrará en vigor a partir del 1 de abril de 1994; así como también las siguientes Resoluciones anteriormente aprobadas por el Grupo Mercado Común    

1)  Res.  Nº 11/93. Marco Regulatorio para Productos Veterinarios  

2)  Res.    29/93.  Sistema  de  Convalidación  de Certificado  del Registro de Productos  Veterinarios con Normas Armonizadas en el MERCOSUR

 

LOGO MERCOSUR DEL ORGANISMO COMPETENTE   

 

SOLICITUD MERCOSUR DE INSCRIPCION para PRODUCTOS FARMACOLOGICOS

1.- Nombre comercial del producto:       

    (Marca)

2.- CLASIFICACION                                                            

    (uso oficial exclusivo)

 

3.- ESTABLECIMIENTO SOLICITANTE      

                                                                             

    3.1 - Nombre: .............................................

                                                                             

    3.2 - Domicilio: ..........................................    

                                                                              

    ...........................................................    

                                                                             

    3.3 - Número de habilitación oficial: ..................... 

                                                                             

    3.4 - Responsable técnico: ................................ 

                                                                             

    ...........................................................              

                                                                             

    3.4.1 - Profesión: ........................................ 

                                                                              

    3.4.2 - Matrícula no: .....................................  

                                                                             

    ...........................................................              

 

4.- ESTABLECIMIENTO ELABORADOR.  

                                                                              

    4.1 - Nombre: ...........................................   

                                                                             

    4.2 - Domicilio: ........................................     

                                                                           

    4.3 - Numero de habilitación oficial: ...................    

                                                                              

    4.4 - Responsable técnico: ..............................  

                                                                             

          ...................................................                

                                                                             

    4.4.1 - Profesión: ......................................          

                                                                             

    4.4.2 - Matrícula no: ...................................        

 

5. - ESTABLECIMIENTO IMPORTADOR (Productos de extra zona)

                                                                              

    5.1 - Nombre: ...........................................                

                                                                             

    5.2 - Domicilio: ........................................                

                                                                             

          ...................................................                

                                                                              

    5.3 - Numero de habilitación oficial: ...................

                                                                             

    5.4 - Responsable técnico: ..............................

                                                                             

    5.4.1 - Profesión: ......................................                

      

    5.4.2 - Matrícula no: ...................................     

                                                                             

    5.5 - Importado desde: ..................................  

                                                                             

    5.6 - Empresa colaboradora: ............................. 

                                                                             

    5.6.1 - Domicilio:.......................................   

                                                                              

          ...................................................  

 

6. - ESTABLECIMIENTO FRACCIONADOR

                                                                             

    6.1 - Nombre: ........................................... 

                                                                             

    6.2 - Domicilio: ........................................    

                                                                             

    6.3 - Numero de habilitación oficial: ................... 

                                                                              

    6.4 - Responsable técnico: ..............................  

                                                                             

    6.4.1 - Profesión: ...................................... 

                                                                              

    6.4.2 - Matricula no: ................................... 

                                                                             

 

7. - OBSERVACIONES

                                                                             

          ...................................................                 

                                                                             

          ...................................................                

                                                                              

          ...................................................                

                                                                             

          ...................................................                

                                                                              

          ...................................................                

                                                                             

          ...................................................                

                                                                             

          ...................................................                

                                                                              

          ...................................................                

                                                                             

          ...................................................                

                                                                             

          ...................................................                

                                                                              

          ...................................................                

 

8. - FORMA FARMACEUTICA Y DE PRESENTACION

Características del  envase, sistema de inviolabilidad y contenido del mismo. 

 

9.- FORMULA CUALICUANTITATIVA DE PRINCIPIOS ACTIVOS Y COMPONENTES DEL EXCIPIENTE

Se emplearán  las  denominaciones  comunes  recomendadas  por  los Organismos Internacionales  reconocidos cuando  existan, o  en  su defecto las  denominaciones comunes  usuales o  las denominaciones químicas.

Se expresarán  los componentes  en forma porcentual P/P, V/V, V/P, P/V o en U.I. o U con correspondencias en peso o volumen.

 

10. - MODO DE ELABORACION DEL PRODUCTO 

Describir resumidamente el proceso de fabricación. 

10.1 Para  productos en  forma de  soluciones se indicará el peso específico de  las sustancias  y para aquellas vehiculizadas en agua también debe indicarse el ph. final.

10.2 Para  productos constituidos por emulsiones suspensiones, se indicará la viscosidad y su peso específico.

10.3 Mencionar  los controles  de estabilidad  que demuestren las condiciones de  formulación originales  del producto  dentro del plazo de validez declarado.

 

11. - METODOS DE CONTROL

11.1 - Método Biológico

11.2 - Método Microbiológico       

11.3 - Método Químico            

11.4 - Método Físico        

11.5 - Método Físico-Químico 

 

Se indicará  y describirá  el método  empleado en  la  evaluación cualicuantitativa de  los  componentes,  de  la  formulación  del producto terminado.

Descripción de pruebas de eficacia biológica y/o farmacológica en un todo de acuerdo al inciso B del articulo 13 del MRPV.

 

12. - INDICACIONES DE USO 

12.1 - Principales y/o complementarios 

12.2 -Para  productos   antimicrobianos  y   antiparasitarios especificar los agentes etiológicos susceptibles

12.3 -  Especies animales a las que se destina, uso específico en instalaciones, equipos, etc.

 

13. - VIA Y FORMA DE ADMINISTRACION O APLICACION

Parenteral, oral  instalaciones, equipos,  instrumentales u otras de acuerdo al ART. 2 del MRPV.

 

14. - PREPARACION DEL PRODUCTO PARA SU CORRECTO USO

Premezcla, Soluciones, Preemulsiones, Suspensiones, u otras.

 

15.  -   DURACION  MAXIMA  DE  USO  DESPUES  DE  SU  RECONSTITUCION  O PREPARACION

 

16. - DOSIFICACION 

Indicar la  o las  cantidades del  o de  los  principios  activos expresadas en  unidades de  peso, volumen  y/o UI  por kg de peso  vivo en  aplicación preventiva,  o curativa  para las  diferentes especies y edades.

16.1 -  Indicar  la  o  las  dosis  del  producto  en  aplicación preventiva, o curativa por peso vivo según especies y edad

16.2 - Intervalo entre dosis.

16.3 - Duración del tratamiento 

16.4 - Margen de seguridad 

 

17. - FARMACOCINETICA DEL PRODUCTO - BIODISPONIBILIDAD 

Vías de  absorción, distribución, y eliminación de los principios activos y/o sus metabolitos.

 

18. - FARMACODINAMIA DEL PRODUCTO (Resumen)

 

19.  -   EFECTOS  COLATERALES   POSIBLES   (Locales   y/o   generales)  INCOMPATIBILIDADES Y ANTAGONISMOS FARMACOLOGICOS

19.1 Contraindicaciones  y limitaciones  de uso  (casos en que su administración puede dar lugar a efectos nocivos)

19.2 Precauciones que deben adoptarse antes, durante o después de su administración. 

 

20. - INTOXICACION Y SOBRE DOSIS EN LOS ANIMALES 

Síntomas, conducta de emergencia y antídotos

 

21. - INTOXICACION EN EL HOMBRE 

Se  indicará   tratamiento   y   antídoto,   datos   de   centros toxicológicos de referencia en el país.

 

22. - EFECTOS BIOLOGICOS NO DESEADOS

22.1 Se  declarará si  el  o  los  componentes  activos  en  las condiciones indicadas  de uso, no producen efectos adversos como  los  que  a  continuación  se  mencionan,  debiéndose  aportar,  si   existiera,  la  bibliografía  científica al respecto

a - Carcinógenos   

b - Teratógenos   

c - Mutágenos 

d - Resistencia en agentes patógenos   

e - Discrasias sanguíneas 

f - Neurotoxicidad  

g - Hipersensibilidad  

h - sobre la reproducción  

i - sobre la flora normal 

 

23. - CONTROLES SOBRE RESIDUOS MEDICAMENTOSOS

23.1 Datos  sobre Ingesta  Diaria Admisible (IDA) y Límite Máximo de Residuos (LMR) en tejidos (músculo, hígado, riñón, grasa) leche, huevos y miel.

23.2  Tiempo  que  debe  transcurrir  entre  el  último  día  del  tratamiento y el sacrificio del animal para consumo humano.

23.3  Tiempo  que  debe  transcurrir  entre  el  último  día  del tratamiento y  el destino de la leche, o huevos, o miel para consumo humano (con o sin manufactura previa).                     

23.4 Tratándose  de asociaciones  medicamentosas,  el  tiempo  de suspensión que  se declare  corresponderá al  del  principio activo cuyo periodo de restricción sea mayor.

 

24 - PRECAUCIONES GENERALES   

24.1 Indicar  la forma  adecuada de  almacenamiento, transporte y destrucción del  producto, como  así también  el  método  de eliminación de  los envases  que constituyan  un  factor  de riesgo para la Salud Pública, animal y el medio ambiente.

24.2 Cuando  el producto  sea para administrarse en raciones o en el  agua   de  bebida   deberá  indicarse: su  estabilidad  compatibilidad y/o tiempo de permanencia eficaz en la mezcla o en la solución.

 

25 - CAUSAS QUE PUEDEN HACER VARIAR LA CALIDAD DEL PRODUCTO 

Precipitaciones,  disociaciones,   disminución   o   pérdida   de  actividad de  los principios  activos, frío, calor, luz, humedad, compresión en estibas o depósitos.

 

26 - CONSERVACION CORRECTA DEL PRODUCTO

 

27 - VENCIMIENTO (Período de Validez)

 

28 - ETIQUETAS Y FOLLETOS 

Se adjuntarán  a la  presente los proyectos de impresos ajustados al Art. 19 del MRPV. 

 

POR LA  PRESENTE, EL ESTABLECIMIENTO SOLICITANTE DEL REGISTRO DE UN PRODUCTO FARMACOLOGICO, BIOLOGICO O ALIMENTO CON MEDICAMENTO, UNA VEZ OBTENIDO EL  CERTIFICADO QUE  AUTORIZA SU  USO Y  COMERCIALIZACION, SE COMPROMETE A  COMUNICAR AL ORGANISMO COMPETENTE (REGISTRANTE) LA FECHA DE LA PRIMERA SERIE ELABORADA O DE LA PRIMERA PARTIDA A SER IMPORTADA.

 

LOGO MERCOSUR DEL ORGANISMO  COMPETENTE                                    

 

SOLICITUD MERCOSUR DE INSCRIPCION para PRODUCTOS BIOLOGICOS

1.- Nombre comercial del producto: (Marca)  

1.1 - Indicaciones

 

2.- CLASIFICACION (uso oficial exclusivo) 

 

3.- ESTABLECIMIENTO SOLICITANTE         

 

3.1 - Nombre:..............................................              

                                                                             

3.2 - Domicilio:...........................................             

                                                                      

      .....................................................               

                                                                              

3.3 - Número de habilitación oficial:......................    

                                                                             

3.4 - Responsable técnico:.................................       

                                                                             

      .....................................................       

                       

     3.4.1 - Profesión:.....................................            

                                                                             

     3.4.2 - Matrícula no:..................................              

                                                                              

     .......................................................  

 

4.- ESTABLECIMIENTO ELABORADOR.

                                                                             

     4.1 - Nombre:..............................................

                                                                              

     4.2 - Domicilio:...........................................    

                                                                             

           .....................................................   

                                                                              

     4.3 - Número de habilitación oficial:......................

                                                                             

     4.4 - Responsable técnico:.................................

                                                                             

           .....................................................

                                                                             

     4.4.1 - Profesión:.........................................  

                                                                             

     4.4.2 - Matricula no:...................................... 

                                                                              

 

5. - ESTABLECIMIENTO IMPORTADOR (Productos de extra zona)

                                                                              

     5.1 - Nombre:..............................................           

                                                                             

     5.2 - Domicilio:...........................................             

                                                                             

           .....................................................             

                                                                             

     5.3 - Número de habilitación oficial:......................             

                                                                             

     5.4 - Responsable técnico:.................................             

                                                                             

           5.4.1 - Profesión:.........................................       

                                                                              

           5.4.2 - Matrícula no:......................................       

                                                                             

     5.5 - Importado desde:.....................................             

                                                                             

     5.6 - Empresa elaboradora:.................................             

                                                                              

           5.6.1 - Domicilio:.........................................       

                                                                             

                 .....................................................        

 

6. - ESTABLECIMIENTO FRACCIONADOR                      

                                                                              

     6.1 - Nombre:........................................... 

                                                                             

     6.2 - Domicilio:........................................ 

                                                                              

           .................................................. 

                                                                             

                                                                              

     6.3 - Número de habilitación oficial:................... 

                                                                             

     6.4 - Responsable técnico:.............................. 

                                                                              

           6.4.1 - Profesión:......................................

                                                                             

           6.4.2 - Matrícula no:...................................

                                                                             

 

7. - OBSERVACIONES                                   

                                                                             

      .....................................................                  

                                                                              

      .....................................................                  

                                                                             

      .....................................................                  

                                                                     

      .....................................................                  

                                                                             

      .....................................................                  

                                                                             

      .....................................................                  

                                                                              

      .....................................................                  

                                                                             

      .....................................................                  

                                                                             

 

8. - FORMA FARMACEUTICA Y DE PRESENTACION

Características del envase, sistema de inviolabilidad Y contenido del mismo

 

9. - DEFINICION DE LINEA BIOLOGICA 

Antígenos  vacunales,   sueros   terapéuticos,   reactivos   para diagnóstico, biotecnología e ingeniería genética, etc.

 

10. - FORMULA CUALICUANTITATIVA - CONSTITUCION BIOLOGICA Y QUIMICA            

Antígeno: identificación, cantidad/titulo; sueros: concentración en UI; inactivantes; conservadores; estabilizadores; emulsificantes u otras sustancias. 

 

11. - MODO DE ELABORACION DEL BIOLOGICO  

Describir resumidamente  el proceso de fabricación y el origen y caracterización de  la cepa  y el  test de  control de  la  cepa semilla

 

12. - CONTROLES SOBRE EL BIOLOGICO TERMINADO 

12.1 - Control de calidad y pureza 

a) pruebas biológicas (indicación de cepa)

b) pruebas fisicoquímicas

12.2 - Control de inocuidad 

a) tipo de pruebas y especie 

12.3 - Control de inactivación o modificación antigénica 

a) forma de inactivación 

b) método de modificación antigenica 

12.4 - Control de eficacia inmunológica y potencia

a) tipo de método y especies  

12.5 - Control de adyuvantes 

a) métodos químicos 

b) métodos fisicoquímicos  

c) métodos biológicos

 

13. - ESPECIES ANIMALES A LAS QUE SE DESTINA

 

14. - DOSIFICACION    

Indicar la o las cantidades del producto, expresadas en unidades de volumen  y/o UI  por animal o peso vivo (cuando corresponda),  en aplicación  preventiva y/o  curativa o  diagnóstico para  las diferentes especies,  edades,  sexo  y  categorías.  También  se deberá especificar el intervalo entre dosis.

 

15. - VIA DE ADMINISTRACION Y FORMA DE APLICACION

Parenteral, oral, dérmica, pulverización, escarificación, ocular, nasal u otras

 

16. - PREPARACION DEL PRODUCTO PARA SU USO CORRECTO

Soluciones, suspensiones u otras.

16.1 -  Para productos  administrados en  el agua  de bebida  se indicara su  estabilidad, compatibilidad  y el  tiempo de  permanencia eficaz en la solución. 

16.2 - Se indicará el tiempo máximo de utilización después de su  preparación o reconstitución.

 

17. - TIEMPO NECESARIO PARA CONFERIR INMUNIDAD Y DURACION DE LA MISMA        

 

18.  -   EFECTOS  COLATERALES   (locales  y/o   generales)   POSIBLES.

INCOMPATIBILIDADES Y ANTAGONISMOS.

18.1 - Contraindicaciones y limitaciones de uso (casos en que su administración puede dar lugar a efectos nocivos).

18.2 - Precauciones que deben adoptarse antes, durante o después de su administración.

 

19.  -  LIMITE MAXIMO Y MINIMO DE TEMPERATURA PARA SU CORRECTA CONSERVACION  

 

20. - VENCIMIENTO (tiempo de validez)  

 

21. - PRECAUCIONES GENERALES   

21.1 - Forma de conservación adecuada 

21.2 -  Forma y  método de  eliminación de  los  envases  cuando  constituyan un factor de riesgo

21.3 - Riesgo para la salud publica durante su manipulación

 

22. - ETIQUETAS Y FOLLETOS

Se adjuntará  a la presente los proyectos de impresos de acuerdo al Art. 19 del MRPV.

 

23. - TRABAJOS CIENTIFICOS Y/O MONOGRAFIAS

Se deberán  adjuntar los  trabajos científicos  y/o  monografías relacionadas con  el producto.  En los casos en que el Organismo Competente lo  requiera se  deberá  incluir  la  traducción  del  sumario y  las conclusiones  de dichos  trabajos  en  el  idioma  oficial respectivo                                                     

 

24. - LA PRESENTE TIENE CARACTER DE DECLARACION JURADA.

         ...........................           

            ............................                     

    Firma y aclaración del           

         Firma y aclaración del                       

  

 DIRECTOR TECNICO     

APODERADO DEL ESTABLECIMIENTO SOLICITANTE

 

POR LA  PRESENTE, EL ESTABLECIMIENTO SOLICITANTE DEL REGISTRO DE UN PRODUCTO FARMACOLOGICO,  BIOLOGICO O ALIMENTO CON MEDICAMENTO, UNA VEZ OBTENIDO EL CERTIFICADO QUE  AUTORIZA SU USO Y COMERCIALIZACION, SE COMPROMETE A  COMUNICAR AL ORGANISMO COMPETENTE (REGISTRANTE) LA FECHA  DE LA  PRIMERA SERIE A SER  ELABORADA O  DE LA  PRIMERA PARTIDA A SER IMPORTADA.

 

LOGO MERCOSUR DEL ORGANISMO  COMPETENTE 

 

SOLICITUD MERCOSUR DE INSCRIPCION para  ALIMENTOS CON MEDICAMENTOS                    

1.- Nombre comercial del producto: (Marca)  

2.- CLASIFICACION  (uso oficial exclusivo) 

3.- ESTABLECIMIENTO SOLICITANTE  

                                                                    

    3.1 - Nombre: ............................................. 

                                                                             

    3.2 - Domicilio: ..........................................

                                                                     

    ...........................................................

                                                                             

    3.3 - Número de habilitación oficial: .....................

                                                                              

    3.4 - Responsable técnico: ................................ 

                                                                             

    ........................................................... 

                                                                             

    3.4.1 - Profesión: ........................................

                                                                              

    3.4.2 - Matricula no: .....................................

                                                                        

    ...........................................................  

                                                                     

 

4.- ESTABLECIMIENTO ELABORADOR

                                                                              

    4.1 - Nombre: .............................................

                                                                             

    4.2 - Domicilio: .......................................... 

                                                                              

          .....................................................  

                                                                             

    4.3 - Numero de habilitación oficial: .....................  

                                                                             

    4.4 - Responsable técnico: ................................

                                                                             

    4.4.1 - Profesión: ........................................ 

                                                                             

    4.4.2 - Matrícula no: .....................................

 

5. - ESTABLECIMIENTO IMPORTADOR (Productos de extra zona)

                                                                             

      5.1 - Nombre: .............................................            

                                                                             

      5.2 - Domicilio: ..........................................            

                                                                              

      5.3 - Numero de habilitación oficial: .....................            

                                                                             

      5.4 - Responsable técnico: ................................            

                                                                             

            5.4.1 - Profesión: ........................................      

                                                                              

            5.4.2 - Matrícula no: .....................................      

                                                                             

      5.5 - Importado desde: ....................................            

                                                                             

      5.6 - Empresa elaboradora: ................................            

                                                                              

             5.6.1 - Domicilio: ........................................     

                                                                             

                     ...................................................     

 

6. - ESTABLECIMIENTO FRACCIONADOR

                                                                              

      6.1 - Nombre: ............................................. 

                                                                             

      6.2 - Domicilio: .......................................... 

                                                                             

      6.3 - Numero de habilitación oficial: ..................... 

                                                                             

      6.4 - Responsable técnico: ................................

                                                                             

             6.4.1 - Profesión: ........................................

                                                                              

             6.4.2 - Matrícula no: .....................................

 

7. - OBSERVACIONES                                  

                                                                             

              ...................................................            

                                                                              

              ...................................................            

                                                                             

              ...................................................             

                                                                             

              ...................................................            

                                                                             

              ...................................................            

                                                                             

              ...................................................            

                                                                              

              ...................................................            

                                                                             

              ...................................................            

                                                                             

              ...................................................            

                                                                              

              ...................................................            

                                                                             

 

8. - FORMA FARMACEUTICA Y DE PRESENTACION  

Características del envase, sistema de inviolabilidad y contenido del mismo.     

 

9. - FORMULA CUALICUANTITATIVA      

Expresada porcentualmente,  definir el  grado mínimo de pureza de cada uno de los principios activos.

 

10. - MODO DE ELABORACION DEL PRODUCTO

Describiéndolo resumidamente.

 

11. - METODOS DE CONTROL

11.1 Método Biológico 

11.2 Método Microbiológico

11.3 Método Químico

11.4 Método Físico

11.5 Método Físico-Químico

Que se  efectuará sobre  el producto terminado para verificar el contenido  cualicuantitavo   de  los   principios  activos,  con indicación de las técnicas utilizadas.      

Descripción de  pruebas de eficacia biológicas y farmacológicas, en un todo de acuerdo al inciso B del Articulo 13 del MRPV.

 

12. - INDICACIONES DE USO   

12.1 ESPECIES ANIMALES A LAS QUE SE DESTINA   

Especificando   las   categorías,   por   ejemplo:   pollos parrilleros,  gallinas   ponedoras,   bovinos   de   leche, terneros, lechones, cerdos adultos, etc.       

 

13. - DOSIFICACION  

Indicar la  o las  cantidades del  o de  los principios  activos expresadas en  unidades de  peso, volumen  y/o UI por kg de peso vivo aplicación  preventiva,  o  curativa  para  las  diferentes especies y categorías.                                            

13.1 Indicar  la ingesta  diaria promedio  necesaria  para  cada  especie y  categoría (ap  12.1),  que  asegure  la  acción  preventiva, y/o curativa del producto.     

 

14. - DURACION MINIMA Y MAXIMA DEL TRATAMIENTO  

 

15. - FARMACOCINETICA DEL PRODUCTO - BIODISPONIBILIDAD   

Vías  de   absorción,  distribución,  y  eliminación  y  de  los  principios activos y/o sus metabolitos.

 

16. - FARMACODINAMIA DEL PRODUCTO (Resumen) 

 

17. - EFECTOS COLATERALES POSIBLES - INCOMPATIBILIDADES Y ANTAGONISMOS FARMACOLOGICOS    

17.1  Contraindicaciones y limitaciones de uso (casos en que su administración puede dar lugar a efectos nocivos)  

17.2  Precauciones que deben adoptarse antes, durante o después de su administración.                                           

 

18. - INTOXICACION Y SOBREDOSIS EN LOS ANINALES 

Síntomas, conducta de emergencia y antídotos    

 

19. - EFECTOS BIOLOGICOS NO DESEADOS    

19.1 Se  declarará si  el  o  los  componentes  activos  en  las condiciones indicadas  de uso, no producen efectos adversos como  los  que  a  continuación  se  mencionan,  debiéndose  aportar,  si   existiera,  la  bibliografía  científica  al respecto.   

a - Carcinógenos         

b - Teratógenos  

c - Mutágenos  

d - Resistencia en agentes patógenos  

e - Discrasias sanguíneas  

f - Neurotoxicidad   

g - Hipersensibilidad   

h - Sobre la reproducción   

i - Sobre la flora normal 

 

20. - CONTROLES SOBRE RESIDUOS DE MEDICAMENTOS

20.1 Datos  sobre Ingesta Diaria Admisible (IDA) y Limite Máximo de Residuos  (LMR)  en  tejidos  (músculo,  hígado,  riñón, grasa) leche, huevos y miel.

20.2 Tiempo  que  debe  transcurrir  entre  el  último  día  del tratamiento y el sacrificio del animal para consumo humano. 

20.3 Tiempo  que  debe  transcurrir  entre  el  último  día  del  tratamiento y el destino de la leche, o huevos, o miel para consumo humano (con o sin manufactura previa).

20.4 Tratandose  de asociaciones  medicamentosas  el  tiempo  de suspensión que  se declare,  corresponderá al del principio activo cuyo periodo de restricción sea mayor.  

 

21 - PRECAUCIONES GENERALES  

21.1 Indicar  la forma  adecuada de almacenamiento, transporte y destrucción del  producto, como  así también  el método  de eliminación de  los envases  que constituyan  un factor  de riesgo para la Salud Pública, animal y el medio ambiente.         

 

22 - CAUSAS QUE PUEDEN HACER VARIAR LA CALIDAD DEL PRODUCTO 

Precipitaciones,  disociaciones,   disminución  o   pérdida   de  actividad de  los principios activos, frio, calor, luz, humedad, compresión en estibas o depósitos

 

23 - CONSERVACION CORRECTA DEL PRODUCTO 

 

24 - VENCIMIENTO (Periodo de Validez)   

 

25 - ETIQUETAS Y FOLLETOS   

Se adjuntarán  a la  presente los proyectos de impresos ajustados al Art. 19 del MRPV.

 

26 - TRABAJOS CIENTIFICOS Y/O MONOGRAFIAS    

Se deberán  adjuntar los  trabajos  científicos  y/o  monografías relacionadas con el producto.  

En los  casos en  que el  Organismo Competente  lo  requiera,  se  deberá incluir  la traducción  del sumario  y las conclusiones de dichos trabajos en el idioma oficial respectivo.                        

 

28. - LA PRESENTE TIENE CARACTER DE DECLARACION JURADA.  

       ............................                              ............................                  

   Firma y aclaración del                        Firma y aclaración del                     

    DIRECTOR TECNICO          APODERADO DEL ESTABLECIMIENTO 

                                                                    SOLICITANTE                           

 

POR LA PRESENTE, EL ESTABLECIMIENTO SOLICITANTE DEL REGISTRO DE UN PRODUCTO FARMACOLOGICO, BIOLOGICO O ALIMENTO CON MEDICAMENTO, UNA VEZ OBTENIDO EL CERTIFICADO QUE  AUTORIZA SU  USO Y  COMERCIALIZACION, SE COMPROMETE A COMUNICAR AL ORGANISMO COMPETENTE (REGISTRANTE) LA FECHA DE LA  PRIMERA SERIE A SER  ELABORADA O  DE LA  PRIMERA PARTIDA A SER IMPORTADA. 

A.   INMUNOLOGICOS                                      

    ------------------                                                       

                                                                              

    A.1  ANTIGENOS VACUNALES          

    ------------------------                                                 

                                                                             

** A.1.1                                                                      

   VACUNAS A VIRUS VIVO (A.1.1.1 - A.1.1.9)  

                                                                             

** A.1.2                                                                      

   VACUNAS A VIRUS INACTIVADOS (A.1.2.1 - A.1.2.13)    

                                                                             

** A.1.3                                                                     

   VACUNAS ANTlBACTERIANAS VIVAS (A.1.3.1 - A.1.3.3)   

                                                                             

** A.1.4                                                                     

   VACUNAS ANTIBACTERIANAS INACTIVADAS (A.1.4.1 - A.1.4.12)

                                                                             

** A.1.5                                                                     

   TOXOIDES                                                                   

 

   A.2 SUEROS TERAPEUTlCOS (A.2.1) 

   -------------------------------     

 

A.3 REACTIVOS PARA DIAGNOSTICO     

   ------------------------------                                            

                                                                             

** A.3.1                                                                      

   PRUEBAS IN VITRO (A.3.1.1 - A.3.1.6)   

                                                                             

** A.3.2                                                                      

   PRUEBAS HIPERSENSIBILlZADAS (A.3.2.1)          

 

A.4 BIOLOGICOS AVIARES (A.4.1 - A.4.12)

 

** A.5 DERIVADOS DE INGENIERIA GENETICA

 

B. FARMACOLOGICOS/NUTRICIONALES 

   -------------------------------                              

 

** B.1  ANTIBIOTICOS (B.1.1 - B.1.78)

 

** B.2  ANTIPARASITARIOS INTERNOS (B.2.1 - B.2.18)      

 

** B.3  ANTIPARASITARIOS EXTERNOS (B.3.1 - B.3.25)  

 

** B.4  ENDECTOCIDAS (B.4.1 - B.4.3)     

 

** B.5  ANTICOCCIDIOS (B.5.1 - B.5.15)  

 

** B.6  ANTISEPTICOS - DESINFECTANTES (B.6.1 - B.6.8)  

 

** B.7  VITAMINAS (B.7.1 - B.7.13)     

 

** B.8  PROMOTORES DE CRECIMIENTO (B.8.1 - B.8.12)  

 

** B.9  ANABOLICOS (B.9.1 - B.9.5)

 

** B.10   MINERALES (B.10.1 - B.10.14)      

 

** B.11 ANTI-INFLAMATORIOS    

   B.11.1 CORTICOIDES (B.11.1.1 - B.11.1.5)

   B.11.2 NO CORTICOIDES (B.11.2.1 - B.11.2.6)

 

** B.12  ANTIHISTAMINICOS (B.12.1 - B.12.2)        

 

** B.13  ANTIDIARREICOS Y ANTIESPASMODICO (B.13.1 - B.13.5)

 

** B.14  ANESTESICOS Y ANALGESICOS (B.14.1 - B.14.17)

 

** B.15  CARMINATlVOS (B.15.1 - B.15.6)   

 

** B.16  DIURETICOS (B.16.1 - B.16.2)        

 

** B.17  HORMONALES (B.17.1 - B.17.9) 

 

B. FARMACOLOGICOS

----------------- 

 

** B.18  QUIMIOTERAPICOS

   B.18.1 SULFAMIDICOS (B.18.1.1 - B.18.1.13)

   B.18.2 NO SULFAMIDICOS (B.18.2.1 - B.18.2.10) 

 

** B.19  BRONCODILATADORES (B.19.1 - B.19.7) 

 

** B.20  PURGANTES (B.20.1)

 

** B.21  CARDIOTONICOS (B.21.1)          

 

** B.22  RECONSTITUYENTES ORGANICOS Y HEMATINICOS (B.22.1 - B.22.6) 

 

** B.23  INYECTABLES MEDIO INTERNO (MlNERALES) (B.23.1 - B.23.5)

 

** B.24  ADITIVOS (B.24.1 - B.24.8)

 

** B.25 AMINAOACIDOS (B.25.1 - B.25.3)

 

** B.26  NEURO-ESTIMULANTES (B.26.1 - B.26.4)

 

** B.27  ANTIOXIDANTES (B.27.1 - 8.27.2)

 

** B.28  REVULSIVOS (B.28.1 - B.28.3)

 

PRODUCTO INDIVIDUAL  

-------------------  

   A. INMUNOLOGICOS

   ----------------   

   A.1     ANTIGENOS VACUNALES

   -----------------------  

   A.1.1   VACUNAS A "VIRUS VIVO"

   ----------------------------

 

** A.1.1.1                              

   * Parvovirosis Canina                  

 

 ** A.1.1.2                                          

   * Moquillo y Hepatitis Canina             

                                                

   ** A.1.1.3                              

   * Peste Porcina Clásica          

                                       

   ** A.1.1.4                                               

   * Rabia Canina                              

                                 

   ** A.1.1.4.1                                                               

   * Rabia Bovina 

                                                                             

   ** A.1.1.4.2      

   * Rabia Zorros   

                                                                              

   ** A.1.1.5        

   * Panleucopenia Felina (1)    

                                                                             

   ** A.1.1.6    

   * Ectima Contagioso    

                                                                              

   ** A.1.1.7         

   * I.B.R. (Rinotraqueitis Infecciosa Bovina)

                                                                             

   ** A.1.1.8                             

   * D.V.B. (Diarrea Viral Bovina)  

                                                                             

   ** A.1.1.9                   

   * P.I.B. (Parainfluenza Bovina)

                                                                              

 (1) DICE NOMENCLADOR LEUCOSIS FELINA. 

                                                                             

 

PRODUCTO INDIVIDUAL                               

-------------------                                          

   A.        INMUNOLOGICOS                             

   ----------------                                                           

   A.1      ANTIGENOS VACUNALES                 

   -----------------------                                                   

   A.1.2   VACUNAS A "VIRUS INACTIVADOS" 

   -----------------------------------                           

                                                                             

   ** A.1.2.1                                                                

   * Antiaftosa                                                               

                                                                             

   ** A.1.2.2                                                                

   * I.B.R. (Rinotraqueitis Infecciosa Bovina)    

                                                                             

   ** A.1.2.3                                                                

   * D.V.B. (Diarrea Viral Bovina)                      

                                                                             

   ** A.1.2.4                                                                

   * P.I.U. (Parainfluenza Bovina)                         

                                                                              

   ** A.1.2.5                                                                

   * Rota Virus Bovino                                      

                                                                              

   ** A.1.2.6                                                                

   * Encefalomielitis Equina              

                                                                             

   ** A.1.2.7                                                                

   * Influenza Equina                                                        

                                                                             

   ** A.1.2.8     \                                                          

   * P.V.P. (Parvo Virus Porcino)             

                                                                             

   ** A.1.2.9                                                                 

   * Antirrabica Canina                                                      

                                                                             

   ** A.1.2.9.1                                                               

   * Antirrabica Bovina                           

                                                                             

   ** A.1.2.10                                                               

   * Aujeszky                                                                

                                                                             

   ** A.1.2.11                                                               

   * Parvovirosis Canina                       

                                                                             

   ** A.1.2.12                                                               

   * Moquillo - Hepatitis Canina (Inactivada)  

                                                                             

   ** A.1.2.13                                                               

   * Peste Porcina (Cristal Violeta)               

                                                                              

 

PRODUCTO INDIVIDUAL                   

-------------------                                                           

   A. INMUNOLOGICOS               

   ----------------                                                          

   A.1 ANTIGENOS VACUNALES     

   -----------------------                                                    

   A.1.3 VACUNAS ANTIBACTERIANAS VIVAS  

   -----------------------------------                                       

                                                                             

   ** A.1.3.1                                                                

   * Anticarbunclosa                                                         

                                                                             

   ** A.1.3.2                                                                 

   * Antibrucelica Bovina                                                    

                                                                             

   ** A.1.3.3                                                                 

   * Tifosis Aviar                                                           

 

PRODUCTO INDIVIDUAL 

-------------------                                                          

   A.         INMUNOLOGICOS                                        

   ----------------                                                          

   A.1       ANTIGENOS VACUNALES    

   -----------------------                                                   

   A.1.4    VACUNAS ANTIBACTERIANAS INACTlVAS 

   ----------------------------------------                                  

                                                                              

   ** A.1.4.1                                                                

   * Antileptospira                                                          

                                                                              

   ** A.1.4.2                                                                

   * Clostridiales                                                           

                                                                              

   ** A.1.4.2.1                                                              

   * Clostridium chauvoei                                                    

                                                                              

   ** A.1.4.2.2                                                              

   * Clostridium novyl (Tipo 3)                                              

                                                                              

   ** A.1.4.2.3                                                              

   * Clostridium perfringens (welchii C y D)

                                                                             

   ** A.1.4.2.4                                                              

   * Clostridium tetani (Toxoide)                                            

                                                                             

   ** A.1.4.2.5                                                               

   * Clostridium botulinum (C y D)                                           

                                                                             

   ** A.1.4.2.6                                                               

   * Clostridium haemoliticum                                                

                                                                             

                                                                              

   ** A.1.4.2.7                                                              

   * Clostridium septicum                                                    

                                                                              

   ** A.1.4.3                                                                

   * Queratoconjuntivitis (Moraxella)                                        

                                                                              

   ** A.1.4.4                                                                

   * Rinitis Atrófica                                                        

                                                                              

   ** A.1.4.5                                                                

   * Escherichia coli                                                        

                                                                             

   ** A.1.4.6                                                                

   * Foot Rot (U. nodosus)                                                   

                                                                             

   ** A.1.4.7                                                                

   * Pasteurella - haemolitica/multocida                                     

                                                                             

   ** A.1.4.8                                                                

   * Streptococcus equi                                                      

                                                                             

   ** A.1.4.9                                                                 

   * Vibriosis (V. foetus) CAMPYLOBACTER

                                                                             

   ** A.1.4.10                                                                

   * Antipiojenas (ESTAFILOCOCCUS-ESTREPTOCOCCUS)

                                                                             

   ** A.1.4.11                                                               

   * Epidimititis ovina                                                       

                                                                             

   ** A.1.4.12                                                               

   * Antimastitica                                                            

                                                                             

 

PRODUCTO INDIVIDUAL   

-------------------              

A. INMUNOLOGICOS       

   ----------------         

   A.2 SUEROS TERAPEUTICOS         

   -----------------------     

                                

   ** A.2.1   

   * Antitoxina Tetanica 

 

PRODUCTO INDIVIDUAL                     

-------------------               

   A. INMUNOLOGICOS   

   ----------------                     

   A.3 REACTIVOS PARA DIAGNOSTICO

   ------------------------------       

   A.3.1 PRUEBAS IN VITRO

   ----------------------    

                                                  

   ** A.3.1.1               

   * Antigeno Pullorum     

                                  

   ** A.3.1.2             

   * Antigenos Brucelicos 

                                    

   ** A.3.1.2.1          

   * Wright (Prueba lenta)    

                                      

   ** A.3.1.2.2                           

   * Huddleson (Prueba en Placa)

                                      

   ** A.3.1.2.3

   * Ring Test   

                                                                              

   ** A.3.1.2.4      

   * Prueba de Tamiz (BPA)                  

                                 

   ** A.3.1.2.5         

   * Prueba del Rivanol 

                                 

   ** A.3.1.2.6       

   * Prueba Rosa de Bengala                          

                                                                             

   ** A.3.1.2.7      

   * Prueba para Brucella ovis   

                                                                              

   ** A.3.1.2.8    

   * Prueba para Brucella Suis    

                                    

   ** A.3.1.3          

   * Antigeno de Coggins      

                                                                              

   ** A.3.1.4       

   * Antigeno Mycoplasma (Gallinarum)

                                                                             

   ** A.3.1.5       

   * Reactivo California Mastitis Test

                                                                             

   ** A.3.1.6    

   * Leucosis   

                                                                             

 

PRODUCTO INDIVIDUAL            

-------------------                   

   A. INMUNOLOGICOS          

   ----------------                                                          

   A.3 REACTIVOS PARA DIAGNOSTICO         

   ------------------------------                                            

   A.3.2 PRUEBAS HIPERSENSIBILIZADAS    

   ---------------------------------   

                                                  

   ** A.3.2.1           

   * Tuberculina (P.P.D.)

 

PRODUCTO INDIVIDUAL. 

-------------------         

   A.   INMUNOLOGlCOS   

   ----------------                                

   A.4 BIOLOGICOS AVIARES 

   ----------------------       

 

 ** A.4.1                                                                   

   * Viruela Aviar    

                                                                             

   ** A.4.2                                  

   * Laringo-Traqueitis (Virus Vivo)     

                                                                              

   ** A.4.3.1                           

   * Vacuna Newcastle (Virus Inactivado)

                                                                             

   ** A.4.3.2      

   * Vacuna Newcastle (Virus Vivo) 

                                                                             

   ** A.4.4.1             

   * Bronquitis Infecciosa (Vacuna Inactivada) 

                                                                              

   ** A.4.4.2                                                                

   * Bronquitis Infecciosa (Vacuna Virus Vivo) 

                                                                              

   ** A.4.5.                                                                 

   * Enfermedad de Marek (Virus Vivo)  

                                                                             

   ** A.4.6.1                                                                 

   * Enfermedad de Gumboro (Vacuna Inactivada)

                                                                             

   ** A.4.6.2                                                                 

   * Enfermedad de Gumboro (Vacuna Virus Vivo)

                                                                             

   ** A.4.7.1                                                                

   * Encefalomielitis Aviar (Virus Vivo)

                                                                             

   ** A.4.7.2                                                                

   * Encefalomielitis Aviar (Vacuna Inactivada)

                                                                              

   ** A.4.8                                                                  

   * E.D.S. (EGG DROP SYNDROME)

                                                                             

   ** A.4.9                                                                  

   * Coriza Aviar  

                                                                             

   ** A.4.10                                                                  

   * Nicoplasma Gallisepticum 

                                                                             

   ** A.4.11                                                                 

   * Nicoplasma Synoviae (Virus Vivo) 

                                                                              

   ** A.4.12                                                                 

   * Reovirus 

                                                                              

                                                                             

 

PRODUCTO INDIVIDUAL                                                           

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                          

                                                                             

   ** B.1.1                                                                  

   * Amikacin (sintesis quimica) Steptocccus aureus 

                                                                             

   ** B.1.2                                                                  

   * Amphotericin B (fermentación) Saccharomyces cerevisiae

                                                                              

   ** B.1.3                                                                  

   * Ampicilin (penicilina derivado) Microccocus Luteus 

                                                                              

   ** B.1.4                                                                  

   * Amoxicillin    

                                                                             

   ** B.1.5                                                                   

   * Aztreonam (sintesis quimica) 

                                                                             

   ** B.1.6                                                                  

   * Bacitracin (fermentación) Microccocus Luteus

                                                                             

   ** B.1.7                                                                  

   * Bleomycin (fermentación) Mycobacterium smegmatis 

                                                                             

   ** B.1.8                                                                  

   * Candicin (fermentación) Saccharomyces cerevisieae

                                                                             

   ** B.1.9                                                                  

   *  Capreomycin  (fermentación)  Klebsiella  pneumoniae  -  Bacillus  subtilis      

                                                                             

   ** B.1.10                                                                 

   * Carbenicillin Pseudomonas aeruginosa  

                                                                              

   ** B.1.11                                                                 

   * Cephalexin (fermentación) Staphyloccucus aureus 

                                                                              

   ** B.1.11.1                                                               

   * Cephalosporin (fermentación) Staphyloccucus aureus 

                                                                             

   ** B.1.11.2                                                               

   * Cephapirin (fermentación) Staphyloccucus aureus   

                                                                             

   ** B.1.11.3                                                                

   * Cephalothin (fermentación) Staphyloccucus aureus 

                                                                             

   ** B.1.11.4                                                                

   * Cephradine (fermentación) Staphyloccucus aureus  

                                                                             

   ** B.1.12                                                                 

   * Cefonicid (sintesis quimica)                                            

                                                                             

   ** B.1.13                                                                 

   * Cefoperazone (sintesis quimica)                                         

                                                                             

   ** B.1.14                                                                 

   * Ceftriaxone (sintesis quimica)                                          

                                                                             

   ** B.1.15                                                                 

   * Cloranphenicol - Escherichia coli                                       

                                                                             

   ** B.1.16                                                                 

   * Chlortetracycline (fermentación) Staphyloccucus aureus 

                                                                             

   ** B.1.17                                                                 

   * Clindamicine (sintesis quimica) Micrococcus luteus 

                                                                             

   ** B.1.18                                                                 

   * Clavulanic acid (sintesis quimica)                                       

                                                                             

   ** B.1.19                                                                 

   * Cloxacilin (penicilina derivado) Staphyloccocus aureus 

                                                                              

   ** B.1.20                                                                 

   * Colistin (fermentación) Bordatella Bronchiseptica 

                                                                              

   ** B.1.21.1                                                               

   Colistin Sulfomethate Na. (fermentación) Bordatella 

   Bronchiseptica                                                             

                                                                             

   ** B.1.21                                                                 

   * Cycloserine (fermentación) Staphyloccocus aureus

                                                                              

   ** B.1.22                                                                 

   * Cyclosporine                                                            

                                                                              

   ** B.1.23                                                                 

   * Dactinomycin (fermentación) Bacillus subtilis                           

                                                                              

   ** B.1.24                                                                 

   * Daunorubicin (fermentación)                                             

                                                                              

   ** B.1.25                                                                 

   *  Demeclocycline   (clorotetracycline   derivado)   Staphyloccocus 

   aureus/Staphyloccocus cereus                                               

                                                                             

   ** B.1.26                                                                 

   * Dicloxacilin (penicilina derivado) Staphyloccocus aureus                

                                                                             

   ** B.1.27                                                                 

   *    Dihydrostreptomicin     (streptomycin    derivado)    Bacillus  

   subtilis/Klebsiella pneumoniae                                            

                                                                             

   ** B.1.28                                                                 

   * Doxicycline Staphyloccocus aureus                                       

                                                                             

   ** B.1.29                                                                 

   * Doxorubicin (fermentación)                                              

                                                                             

   ** B.1.30                                                                 

   * Erithromycin (fermentación) Microccocus luteus/Bacillus pumilus  

                                                                             

   ** B.1.31                                                                 

   * Framycetin Bacillus pumilus                                             

                                                                             

   ** B.1.32                                                                 

   *  Gentamicine   fermentación   Staphyloccocus   epidermis/Bacillus

   pumilus                                                                   

                                                                             

   ** B.1.33                                                                  

   * Gramicidin (fermentación) Streptoccocus faecium   

                                                                             

   ** B.1.34                                                                  

   * Griseofulvin (fermentación)                                             

                                                                             

   ** B.1.35                                                                 

   * Imipenem (sintesis química)                                             

                                                                             

   ** B.1.36                                                                 

   * Kanamycln (fermentación) Staphyloccocus aureus/Bacillus subtilis

                                                                             

   ** B.1.37                                                                 

   * Lincomycin (fermentación) Staphyloccocus aureus 

                                                                             

   ** B.1.38                                                                 

   * Lymeciclyne Bacillus pumilus                                             

                                                                             

   ** B.1.39                                                                 

   * Methacycline Staphyloccocus aureus                                       

                                                                             

   ** B.1.40                                                                 

   * Methicilin (penicilina derivado) Staphyloccocus aureus

                                                                             

   ** B.1.41                                                                 

   * Minocycline Staphyloccocus aureus                                       

                                                                              

   ** B.1.42                                                                 

   * Mitomycin (fermentación) Bacillus subtilis   

                                                                              

   ** B.1.43                                                                 

   * Moxalactam (sintesis quimica)                                           

                                                                              

   ** B.1.44                                                                 

   * Nafcilin (penicliina derivado) Staphyloccocus aureus  

                                                                             

   ** B.1.45                                                                 

   * Natamycin (fermentación) Saccharomyces cerevisiae  

                                                                             

   ** B.1.46                                                                  

   * Neomycin (fermentación) Staphyloccocus epidermis

                                                                             

   ** B.1.47                                                                  

   * Netilmicin (sinomicin derivado) Staphyloccocus epidermis  

                                                                             

   ** B.1.48                                                                 

   * Novobiocin (fermentación) Staphyloccocus epidermis          

                                                                             

   ** B.1.49                                                                 

   * Nystatin (fermentación) Saccharomyces cerevisae  

                                                                             

   ** B.1.50                                                                 

   * Oleandomycin (fermentación)                                              

                                                                             

   ** B.1.51                                                                 

   * Oxacylin (penicilina derivado) Staphyloccocus aureus 

                                                                              

   ** B.1.52                                                                 

   *  Oxitetracycline  (fermentación)  Staphyloccocus  aureus/bacillus 

   pumilus                                                                    

                                                                             

   ** B.1.53                                                                 

   * Paromomycin (fermentación) Staphyloccocus epidermis

                                                                             

   ** B.1.54                                                                 

   * Penicilin G (fermentación) Staphyloccocus aureus 

                                                                              

   ** B.1.55                                                                 

   * Plicamycin (fermentación) Staphyloccocus aureus  

                                                                              

                                                                             

   ** B.1.56                                                                 

   * Polimyxin B Bordetella bronchiseptica                                    

                                                                             

   ** B.1.57                                                                 

   * Rifampin Bacillus subtilis                                               

                                                                             

   ** B.1.58                                                                 

   * Rifamycin (fermentación) Staphyloccocus saprophyticus  

                                                                             

   ** B.1.59                                                                 

   * Rolitetraciclyne Staphyloccocus epidermis                               

                                                                              

   ** B.1.60                                                                 

   * Sisomicin (fermentación) Staphyloccocus epidermis                       

                                                                              

   ** B.1.61                                                                 

   *   Spectinomycin    (fermentación)   Escherichia   coli/Klebsiella 

   aerogenes                                                                  

                                                                             

   **     B.1.62      Streptomycin      (fermentación)      Klebsiella 

   pneumoniae/Bacillus subtilis                                               

                                                                             

   ** B.1.63                                                                 

   *    Tetracycline     (tetracycline    derivado)     Staphiloccocus 

   aureus/Bacillus pumilus                                                   

                                                                             

   ** B.1.64                                                                 

   * Ticarcillin Psedomonas aeruginosa        

                                                                             

   ** B.1.65                                                                 

   Tobramycin (fermentación) Staphyloccocus aureus/Bacillus pumilus

                                                                             

   ** B.1.66                                                                 

   * Troleandomycin (oleandomycine derivado) Klebsiella pneumoniae 

                                                                             

   ** B.1.67                                                                 

   * Tyrotricyn (fermentación)                                                

                                                                             

   ** B.1.68                                                                 

   * Vancomycin (fermentación) Bacillus subtilis                              

                                                                             

   ** B.1.69                                                                 

   * Vidarabine (sintesis quimica)                                            

                                                                             

   ** B.1.70                                                                 

   * Viomycin Klebsiella pneumoniae                                           

                                                                             

   ** B.1.71                                                                 

   * Spiramicinum                                                            

                                                                             

   ** B.1.72                                                                 

   * Josamicina                                                              

                                                                              

   ** B.1.73                                                                 

   * Dinamotilin                                                             

                                                                              

   ** B.1.74                                                                 

   * Cephecetril                                                             

                                                                              

   ** B.1.75                                                                 

   * Apramicina                                                              

                                                                              

   ** B.1.76                                                                 

   * Pathocefi                                                               

                                                                              

   ** B.1.77                                                                 

   * Leocilina                                                               

                                                                              

   ** B.1.78                                                                 

   * Tiamulina                                                               

                                                                              

                                                                             

 

PRODUCTO INDIVIDUAL           

-------------------                                                           

   B.    FARMACOLOGICOS                  

   -----------------                                                         

   B.2 ANTIPARASITARIOS INTERNOS   

   -----------------------------                                              

                                                                             

   ** B.2.1                                                                  

   * Piperazina                                                               

                                                                             

   ** B.2.2                                                                  

   * Benzimidazoles                                                           

                                                                             

   ** B.2.2.1                                                                

   * Dimetidazole                                                             

                                                                             

   ** B.2.2.2                                                                

   * Triclabendazole                                                         

                                                                             

   ** B.2.2.3                                                                

   * Tiabendazole                                                            

                                                                              

   ** B.2.2.4                                                                

   * Oxibendazole                                                            

                                                                              

   ** B.2.2.5                                                                

   * Mebendazole                                                             

                                                                              

   ** B.2.2.6                                                                

   * Oxfendazole                                                             

                                                                              

   ** B.2.2.7                                                                

   * Febendazole/Febendazole                                                 

                                                                              

   ** B.2.2.8                                                                

   * Albendazole                                                             

                                                                              

   ** 8.2.2.9                                                                

   * Flubendazole                                                            

                                                                              

   ** B.2.3                                                                  

   * Febantel                                                                

                                                                             

   ** B.2.4                                                                  

   * Levamisol                                                               

                                                                             

   ** B.2.5                                                                  

   * Dipropionato de Imidocarb                                               

                                                                             

   ** B.2.6                                                                   

   * Rafoxanide                                                              

                                                                             

   ** B.2.7                                                                   

   * Praziquantel                                                            

                                                                             

   ** B.2.8                                                                   

   * Closantel                                                               

                                                                             

   ** B.2.9                                                                   

   * Nitroscanate                                                            

                                                                             

   ** B.2.10                                                                  

   * Tetramisole                                                             

                                                                             

   ** B.2.11                                                                  

   * Pamoato De Pirantel                                                     

                                                                             

   ** B.2.12                                                                  

   * Disofenol                                                               

                                                                             

   ** B.2.13                                                                 

   * Triclorfon                                                              

                                                                             

   ** B.2.14                                                                 

   * Epsiprantel                                                             

                                                                             

   ** B.2.15                                                                 

   * Clorsulon                                                               

                                                                             

   ** B.2.16                                                                 

   * Netobimin                                                                

                                                                             

   ** B.2.17                                                                 

   * Nitroxinil                                                               

                                                                             

   B.2.18                                                                    

   * Naftonato de sodio                                                       

                                                                             

 

PRODUCTO INDIVIDUAL

-------------------                                                          

   B. FARMACOLOGICOS         

   -----------------                                                          

   B.3 ANTIPARASITARIOS EXTERNOS   

   -----------------------------                                             

                                                                             

   ** B.3.1                                                                   

   * Pirimifosetil                                                           

                                                                             

   ** B.3.2                                                                   

   * Cialotrina                                                              

                                                                             

   ** B.3.3                                                                   

   * Closantel                                                               

                                                                             

   ** B.3.4                                                                   

   * Lindane                                                                 

                                                                             

   ** B.3.5                                                                  

   * Amitraz                                                                 

                                                                             

   ** B.3.6                                                                  

   * D.D.V.P.                                                                

                                                                             

   ** B.3.7                                                                  

   * Dimpilato (Diazinon)                                                    

                                                                             

   ** B.3.8                                                                  

   * Deltametrina                                                            

                                                                             

   ** B.3.9                                                                  

   * Flumetrina                                                               

                                                                             

   ** B.3.10                                                                 

   * Cumafos                                                                  

                                                                             

   ** B.3.11                                                                 

   * Foxin                                                                    

                                                                             

   ** B.3.12                                                                 

   * Clorpirifos - Clorpirifos metil (B.3.12.1)                               

                                                                             

   ** 8.3.13                                                                 

   * Propoxur                                                                 

                                                                             

   ** B.3.14                                                                 

   * Clorfenvinfos                                                            

                                                                             

   ** B.3.15                                                                 

   * Cipermetrina                                                            

                                                                             

   ** B.3.16                                                                 

   * Alfametrina                                                             

                                                                              

   ** B.3.17                                                                 

   * Alfacipermetrina                                                        

                                                                              

   ** B.3.18                                                                 

   * Etion                                                                   

                                                                              

   ** B.3.19                                                                 

   * Azametiphos                                                             

                                                                              

   ** B.3.20                                                                 

   * Permetrina                                                              

                                                                              

   ** B.3.21                                                                 

   * Fenitrothion                                                            

                                                                              

   ** B.3.22                                                                 

   * Cimiazole                                                               

                                                                              

   ** B.3.23                                                                 

   * Cyromazina                                                              

                                                                             

   ** B.3.24                                                                 

   * Cypotrina                                                               

                                                                             

   ** B.3.25                                                                 

   * Tetrafenvinfos                                                           

                                                                             

 

   PRODUCTO INDIVIDUAL                      

                                                                              

   B. FARMACOLOGICOS                             

                                                      

   B.4 ENDECTOCIDAS                       

                                                    

   ** B.4.1                                                                   

   * Moxidectin                                  

                                                                             

   ** B.4.2                                              

   * Ivermectina                                

                                                                 

   ** B.4.3                                                                  

   * Abamectina                                         

                                                                             

 

PRODUCTO INDIVIDUAL    

-------------------                                                           

   B. FARMACOLOGICOS  

   -----------------                                                         

   B.5 ANTICOCCIDIOS    

   -----------------                        

   B.5.1                                                                      

   * Nicarbazina        

                                                                             

   ** B.5.2                                                                   

   * Robenidina               

                                                                             

   ** B.5.3         

   * Naduramicina                   

                                                                              

   ** B.5.4                                                                  

   * Salinomicina                       

                                              

   ** B.5.5                                                                   

   * Monensina                            

                                                                             

   ** B.5.6                                                                  

   * Narasina + Nicarbazina                 

                                                                     

   ** B.5.7                                          

   * Amprolium                                                               

                                                   

   B.5.7.1                                                                   

   * Amprolium + Etopabato            

                                                                             

   ** B.5.8                                                                   

   * Clinacox                           

                                                                             

   ** B.5.9                                                                   

   * Lasalocid sodico               

                                                                             

   ** B.5.10                                                                 

   * Toltrazudil                

                                                                             

   ** B.5.11                                                                 

   * D.O.T                         

                                                                              

   ** B.5.12                                                                 

   * E.S.B.3                           

                                                                             

   ** B.5.13                                                                 

   * Halolofuginona                

                                                                             

   ** B.5.14                                                                  

   * Cyxgro                

                                                                             

   ** B.5.15       

   * Cycarb                                                                  

                                                                              

 

PRODUCTO INDIVIDUAL                                                           

-------------------                                                          

   B. FARMACOLOGlCOS                                                         

   -----------------                                                          

   B.6 ANTISEPTICOS - DESINFECTANTES            

   ---------------------------------                                         

                                                                             

   ** B.6.1                                                                   

   * Cresilico y Derivados                                                   

   * BP 85 A.14                                                              

                                                                              

   ** B.6.2                                                                  

   * Base Amonio Cuaternario y Derivados                                     

                                                                              

   ** B.6.3                                                                  

   * Cloruro de bensalconio                                                  

                                                                              

   ** B.6.4                                                                  

   * Cloro activo y derivados                                                

                                                                              

   ** B.6.5                                                                  

   * Diodoforos (Iodopovidona)                                               

                                                                              

   ** B.6.6                                                                  

   * Dodecil Benzeno - Sulfonico (Activos Anionicos)                         

                                                                             

 

PRODUCTO INDIVIDUAL  

-------------------                                                          

   B. FARMACOLOGICOS

   -----------------                                                         

   B.7 VITAMINAS                                                             

   -------------                                                             

                                                                              

   ** B.7.1                                                                  

   * Vitamina A                                                              

                                                                              

   ** B.7.2                                                                  

   * Vitamina D3                                                             

                                                                              

   ** B.7.3                                                                  

   * Vitamina B1 (Tiamina)                                                   

                                                                               

   ** B.7.4                                                                  

   * Vitamina B2 (Rlboflavina)                                               

                                                                              

   ** B.7.5                                                                  

   * Vitamina B6 (Piridoxina)                                                

                                                                              

   ** B.7.6                                                                  

   * Vitamina B12 (Cianocobalamina)                                          

                                                                              

   ** B.7.7                                                                  

   * Biotina                                                                 

                                                                             

   ** B.7.8                                                                  

   * Acido Folico

 

   **B.7.9

   * Ácido Nicotínico (Niacinamina)

 

   **B.7.10

   * Pantotenato de Calcio

 

   **B.7.11

   *  Acido Ascorbico

 

   **B.7.12

   *  Vitamina E (a Tocoferol)

 

   **B.7.13

   *  Viatamina K (Menadiona)

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.8 PROMOTORES DE CRECIMIENTO                                             

   -----------------------------                                             

                                                                              

   ** B.8.1                                                                  

   * Avilamicina                                                             

                                                                              

   ** B.8.2                                                                  

   * Avoparcina                                                              

                                                                              

   ** B.8.3                                                                  

   * Virginiamicina                                                          

                                                                              

   ** B.8.4                                                                  

   * Rosarxone (Acido-3-Nitro)                                               

                                                                              

   ** B.8.5                                                                  

   * Bacitracina-zinc Bacitracina (Ver B.1.6 Antibioticos)                   

                                                                              

   ** B.8.6                                                                  

   * Olaquindox                                                              

                                                                              

   ** B.8.7                                                                  

   * Nitrovin                                                                

                                                                             

   ** B.8.8                                                                  

   * Halquinol                                                               

                                                                             

   ** B.8.9                                                                  

   * Lasalocide                                                              

                                                                             

   ** B.8.10                                                                  

   * Artacin                                                                 

                                                                             

   ** B.8.11                                                                  

   * Bambeermicina (Flavomicina)                                             

                                                                             

   ** B.8.12                                                                  

   * Enramicina                                                              

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B.   FARMACOLOGICOS                                                         

   -----------------                                                         

   B.9 ANABOLICOS                                                            

   --------------                                                            

   ** B.9.1                                                                   

   * Boldenona                                                               

                                                                             

   ** B.9.2                                                                   

   * Nandrolona                                                              

                                                                             

   ** B.9.3                                                                   

   * Trenbolona                                                              

                                                                             

   ** B.9.4                                                                   

   * Zeranol                                                                 

                                                                             

   ** B.9.5                                                                   

   * Stanozolol

 

PRODUCTO INDIVIDUAL

---------------------------------

   B.        FARMACOLOGICOS

   -------------------------------------

   B.10    MINERALES

   -------------------------------------

 

   **B.10.1

   *  Carbonato de Calcio

 

   **B.10.2

   *  Iodato de Calcio

 

   **B.10.3

   *  Sales de Hierro (Sulfato Ferroso)

 

   **B.10.4

   *  Selenito de Sodio

 

   **B.10.5

   *  Fosfatos Tricalcicos - bicalcico

 

   **B.10.6

   *  Oxido de Cobre

 

   **B.10.7

   *  Oxido de Zinc

 

   **B.10.8

   *  Oxido de Magnesio y Sales de Magnesio

 

                                                                   

   ** B.10.9                                                                 

   ** Oxido de Manganeso y Sales de Manganeso                                 

                                                                             

   ** B.10.10                                                                

   * Cloruro de Cobalto y Sales de Cobalto                                    

                                                                             

   ** B.10.11                                                                

   * Sales de Molibdeno                                                       

                                                                             

   ** B.10.12                                                                

   * Fosfato Disodico                                                        

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                           

   B.         FARMACOLOGICOS                                                         

   -----------------                                                         

   B.11     ANTI-INFLAMATORIOS                                                    

   -----------------------                                                   

   B.11.1  CORTICOIDES                                                        

   ------------------                                                         

                                                                             

   ** B.11.1.1                                                               

   * Betametasona                                                             

                                                                             

   ** B.11.1.2                                                               

   * Dexametasona (a) - Isinicotinato (b)                                     

                                                                             

   ** B.11.1.3                                                               

   * Prednisolona                                                            

                                                                             

   ** B.11.1.4                                                               

   * Flumetasona                                                             

                                                                              

   ** B.11.1.5                                                               

   * Triamcinolona                                                           

                                                                              

                                                                             

                                                                             

                                                                              

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                          

   -----------------                                                         

   B.11 ANTI-INFLAMATORIOS                                                   

   -----------------------                                                    

   B.11.2 NO CORTICOIDES                                                     

   ---------------------                                                     

                                                                              

   ** B.11.2.1                                                               

   * Acido Salicilico y Derivados                                            

                                                                              

   ** B.11.2.2                                                               

   * Fenilbutasona                                                           

                                                                             

   ** B.11.2.3                                                               

   * Flunixin                                                                

                                                                             

   ** B.11.2.4                                                               

   * Dimetilsulfoxido                                                        

                                                                             

   * B.11.2.5                                                                 

   * Benzydamina                                                             

                                                                             

   ** B.11.2.6                                                                

   * Fenil-dimetil-Piraxolona                                                

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                           

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.12 ANTI-HISTAMINICOS                                                    

   ----------------------                                                    

                                                                             

   ** B.12.1                                                                 

   * Difenhidramina                                                          

                                                                             

   ** B.12.2                                                                 

   * Clorfeniramina Maleato                                                  

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.13 ANTI-DIARREICOS Y ANTI-ESPASMODICOS                                  

   ----------------------------------------                                  

                                                                             

   ** B.13.1                                                                  

   * Benzetimida                                                             

                                                                             

   ** B.13.2                                                                  

   * Loperamida                                                              

                                                                             

   ** B.13.3                                                                  

   * Subnitrato de Bismuto                                                   

 

PRODUCTO INDIVIDUAL                                                           

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                          

   B.14 ANALGESICOS - ANESTESICOS                                            

   ------------------------------                                            

                                                                              

   ** B.14.1                                                                 

   * Ketamina Clorhidrato                                                    

                                                                              

   ** B.14.2                                                                 

   * Lidocaina                                                               

                                                                              

   ** B.14.3                                                                 

   * Procaina                                                                

                                                                              

   ** B.14.4                                                                 

   * Derivados Promacinicos (Acepromacina)                                   

                                                                             

   ** B.14.5                                                                 

   * Azaperona                                                               

                                                                             

   ** B.14.6                                                                 

   * Detomida                                                                

                                                                             

   ** B.14.7                                                                  

   * Diazepan                                                                

                                                                             

   ** B.14.8                                                                  

   * Benzodiazepina                                                          

                                                                             

   ** B.14.9                                                                  

   * Derivados del Acido Barbiturico                                         

                                                                             

   ** B.14.10                                                                 

   * Meprobamato                                                             

                                                                             

   ** B.14.11                                                                 

   * Clozoxazone                                                             

                                                                             

   ** B.14.12                                                                 

   * Xilocaina                                                               

                                                                             

   ** B.14.13                                                                

   * Xilacina                                                                

                                                                             

   ** B.14.14                                                                

   * Detomidina                                                              

                                                                             

   ** B.14.15                                                                

   * Benzocaina                                                              

                                                                             

   ** B.14.16                                                                

   * Tiopental Sodico                                                         

                                                                             

   ** B.14.17                                                                

   * Novalgina (Fenil-Dimetil-Pirazolona) (Ver 11.2.6)                       

                                                                             

 

PRODUCTO INUIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                          

   -----------------                                                         

   B.15 CARMINATIVOS                                                         

   -----------------                                                          

                                                                             

   ** B.15.1                                                                 

   * Dimetilpolisiloxano                                                      

                                                                             

   ** B.15.2                                                                 

   * Poloxaleno                                                              

                                                                             

   ** B.15.3                                                                 

   * Simeticona                                                              

                                                                                    

   ** B.15.4                                                                 

   * Xilidino Dihidrotiacino                                                 

                                                                              

   ** B.15.5                                                                 

   * Caolin                                                                  

                                                                              

   ** B.15.6                                                                 

   * Pectina                                                                 

                                                                              

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.16 DIURETICOS                                                           

   ---------------                                                           

                                                                             

   ** B.16.1                                                                  

   * Furosemida                                                              

                                                                             

   ** B.16.2                                                                  

   * Hidroclorotiazida                                                       

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

B. FARMACOLOGICOS                                                            

-----------------                                                             

B.17 HORMONALES                                                              

---------------                                                              

                                                                              

   ** B.17.1                                                                 

   * Testosterona                                                            

                                                                              

   ** B.17.2                                                                 

   * Estradiol y Derivados                                                   

                                                                              

   ** B.17.3                                                                 

   * F.S.H.                                                                  

                                                                              

   ** B.17.4                                                                 

   * Oxitocina                                                               

                                                                              

   ** B.17.5                                                                 

   * Acetato de Medroxiprogesterona                                          

                                                                             

   ** B.17.6                                                                 

   * Prostaglandina F 2 alfa                                                 

                                                                             

   ** B.17.7                                                                 

   * Somatotropina Bovina y Suina                                            

                                                                             

   ** B.17.8                                                                  

   * Gonadotropina a.Serica - b.Corionica                                    

                                                                             

   ** B.17.9                                                                  

   * G.N.R.H. (Liberador Gonadotropina)                                      

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.18 QUIMIOTERAPICOS                                                      

   --------------------                                                      

   B.18.1 SULFAMIDICOS                                                       

   -------------------                                                       

                                                                             

   ** B.18.1.1                                                                

   * Sulfacloropiridazina                                                    

                                                                             

   ** B.18.1.2                                                                

   * Sulfacloropirazina                                                      

                                                                             

   ** B.18.1.3                                                                

   * Sulfadiazina                                                            

                                                                             

   ** B.18.1.4                                                                

   * Sulfaquinoxalina                                                        

                                                                             

   ** B.18.1.5                                                                

   * Sulfametazina                                                           

                                                                             

   ** B.18.1.6                                                                

   * Sulfatiazol                                                             

                                                                             

   ** B.18.1.7                                                               

   * Ftalilsulfatiazol                                                       

                                                                             

   ** B.18.1.8                                                               

   * Sulfadoxina                                                             

                                                                             

   ** B.18.1.9                                                               

   * Sulfametoxazole                                                         

                                                                             

   ** B.18.1.10                                                              

   * Sulfaquanidina                                                          

                                                                             

   ** B.18.1.11                                                              

   * Sulfamerazina                                                           

                                                                             

   ** B.18.1.12                                                              

   * Sulfanilamida                                                           

                                                                             

   ** B.18.1.13                                                              

   * Sulfacetamida                                                            

                                                                             

                                                                             

                                                                              

                                                                             

                                                                             

PRODUCTO INDIVIDUAL                                                           

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                          

   B.18 QUIMIOTERAPICOS                                                      

   --------------------                                                      

   B.18.2 NO SULFAMIDICOS                                                     

   ----------------------                                                    

                                                                             

   ** B.18.2.1                                                                

   * Dimetridazole                                                           

                                                                             

   ** B.18.2.2                                                               

   * Furaltadona                                                             

                                                                             

   ** B.18.2.3                                                               

   * Furasolidona                                                            

                                                                             

   ** B.18.2.4                                                               

   * Nitrofurazona                                                           

                                                                             

   ** B.18.2.5                                                               

   * Quinolonas                                                               

                                                                             

   ** B.18.2.5.1                                                             

   * Acido oxonilico                                                          

                                                                             

   ** B.18.2.5.2                                                             

   * Danofloxina                                                              

                                                                             

   ** B.18.2.5.3                                                             

   * Enrofloxacina                                                            

                                                                             

   ** B.18.2.6                                                               

   * Etidio Bromuro (Homidio)                                                 

                                                                             

   ** B.18.2.7                                                               

   * Trimetropin                                                              

                                                                             

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.19 BRONCODlLATADORES                                                    

   ----------------------                                                    

                                                                             

   ** B.19.1                                                                 

   * Clenbuterol                                                             

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.20 PURGANTES                                                            

   --------------                                                            

                                                                              

   ** B.20.1                                                                 

   * Dantrona                                                                

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.21 CARDIOTONICOS                                                        

   ------------------                                                        

                                                                             

   ** B.21.1                                                                 

   * Cafeina                                                                  

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                           

   B.       FARMACOLOGICOS                                                         

   -----------------                                                         

   B.22   RECONSTITUYENTES ORGANICOS Y HEMATINICOS                             

   ---------------------------------------------                             

                                                                             

   ** B.22.1                                                                  

   * Ferrodextrano (Ferro - Gluconato)                                       

                                                                             

   ** B.22.2                                                                  

   * (a)  Extracto conc.  hígado inyectable  (b) Extracto  hígado sol.       

   oral                                                                      

                                                                              

   ** B.22.3                                                                 

   * Dextrosa Inyectable                                                     

                                                                              

   ** B.22.4                                                                 

   * Citrato de hierro amoniacal                                             

                                                                              

   ** B.22.5                                                                 

   * Sulfato de cobre (Ver B.10.6 Sales Minerales)                           

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                           

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.23 INYECTABLES MEDIO INTERNO - (MINERALES)                               

   --------------------------------------------                              

                                                                             

   ** B.23.1                                                                 

   * Calcio Borogluconato                                                    

                                                                             

   ** B.23.2                                                                 

   * Calcio Gluconato                                                        

                                                                             

   ** B.23.3                                                                 

   * Cloruro de Magnesio                                                     

                                                                             

   ** B.23.4                                                                 

   * Fosforo elemental                                                       

 

PRODUCTO INDIVIDUAL                                                           

-------------------                                                          

   B. FARMACOLOGICOS                                                         

   -----------------                                                         

   B.24 ADITIVOS                                                             

   -------------                                                             

                                                                             

   ** B.24.1                                                                 

   * Apoester (Apocarotenie Ester)                                           

                                                                             

   ** B.24.2                                                                  

   * Cantaxantina                                                            

                                                                             

   ** B.24.3                                                                  

   * Citranaxantina                                                          

                                                                             

   ** B.24.4                                                                  

   * Propilenglicol                                                          

                                                                             

   ** B.24.5                                                                  

   * Xilol                                                                   

                                                                             

   ** B.24.6                                                                  

   * Dodecil Benceno Sulfonico                                               

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B.      FARMACOLOGICOS                                                          

   -----------------                                                         

   B.25  AMINOACIDOS                                                          

   ----------------                                                           

                                                                             

   ** B.25.1                                                                 

   * Lisina                                                                   

                                                                             

   ** B.25.2                                                                 

   * Metionina                                                                

                                                                             

   ** B.25.3                                                                 

   * Triptofano                                                              

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                           

   B.      FARMACOLOGICOS                                                         

   -----------------                                                         

   B.26 NEURO-ESTIMULANTES                                                   

   -----------------------                                                   

                                                                             

   ** B.26.1                                                                 

   * Atropina Sulfato                                                        

                                                                             

   ** B.26.2                                                                 

   * Alcaloides de la Belladona                                              

                                                                             

   ** B.26.3                                                                 

   * Pilocarpina                                                             

                                                                             

   ** B.26.4                                                                 

   * Hioscinamina Sulfato                                                    

                                                                             

                                                                             

 

PRODUCTO INDIVIDUAL                                                          

-------------------                                                          

   B.     FARMACOLOGICOS                                                         

   -----------------                                                         

   B.27 ANTIOXIDANTES                                                        

   ------------------                                                        

                                                                             

   ** B.27.1                                                                 

   * B.H.T.                                                                   

                                                                             

   ** B.27.2                                                                 

   * Etoxiquina                                                               

 

 

Esta norma modifica/complem./relac./deroga a:
Relación Norma Detalle
Complementa RE-11-1993-GMC Compl Productos Veterinarios.
Complementa RE-29-1993-GMC Compl Productos Veterinarios.