Hiperton

Información principal

  • Denominación comercial:
  • Hiperton
  • Dosis:
  • 50,0 mg/g
  • formulario farmacéutico:
  • Ungüento oftálmico
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.


    Solicitar el prospecto de información al público.

Localización

  • Disponible en:
  • Hiperton
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m14224s01
  • última actualización:
  • 09-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

Hiperton®

DCI

(Cloruro de sodio)

Forma farmacéutica:

Ungüento oftálmico

Fortaleza:

50,0 mg/g

Presentación:

Estuche por un tubo de AL con 5 g.

Titular del Registro Sanitario, país:

Laboratorios Grin S.A. de C.V., México.

Fabricante, país:

Laboratorios Grin S.A. de C.V., México.

Número de Registro Sanitario:

M-14-224-S01

Fecha de Inscripción:

12 de noviembre de 2014

Composición:

Cada g contiene:

Cloruro de sodio*

*Se incrementa en un 5 %

50,0 mg

Metilparabeno 1,0 mg

Propilparabeno 0,1 mg

Lanolina anhidra 150,0 mg

Parafina líquida cbp 1,0 g

Plazo de validez:

24 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C.

Indicaciones terapéuticas:

Como coadyuvante en el tratamiento del edema corneal

Contraindicaciones:

Hipersensibilidad a los componentes de la formula

Precauciones:

No hay estudios adecuados para valorar su potencial en carcinogénesis, mutagénesis y

efectos sobre la fertilidad

Advertencias especiales y precauciones de uso:

La sobredosificación puede favorecer la aparición de los efectos secundarios

Efectos indeseables:

IFA

Efectos Indeseables

Cloruro de Sodio

No se han reportado

Excipientes

Efectos Indeseables

Metilparabeno

Puede

causar

irritación,

efectos

crónicos

información reportada, dosis letal en rata LD50 (oral,

rata) = 960 mg/Kg, es un producto poco toxico.

Propilparabeno

Puede

causar

irritación

lagrimeo

ocular,

efectos

crónicos:

puede

presentar

conjuntivitis

exposición prolongada. Dermatitis de contacto alérgica

con enrojecimiento e inflamación de los parpados ha

ocurrido ocasionalmente de la aplicación de productos

que contienen parabeno en áreas alrededor de los

ojos. Ensayo de ingestión en ratas (1600 mg/Kg/día)

ha producido retardo en el crecimiento. Soluciones al

0.03

producido

malestar

irritación

mucosa intestinal.

Lanolina Anhidra

No se conocen efectos secundarios

Parafina Líquida

Piel:

Ligeramente

irritante,

considera

toxico,

resultados específicos sintomáticos no disponible.

Observaciones: Es importante mencionar que las cantidades utilizadas de los excipientes en

nuestra formulación no está excediendo las cantidades de los límites permitidos.

Posología y método de administración:

Una pequeña cantidad de 1 a 5 veces al día

Interacción con otros productos medicinales y otras formas de interacción:

Ninguna

Uso en Embarazo y lactancia:

No se tienen estudios bien controlados del uso de cloruro de sodio en mujeres embarazadas

y lactantes, aunque la droga no se absorbe sistemáticamente se recomienda precaución

cuando se use en estas condiciones.

Efectos sobre la conducción de vehículos/maquinarias:

No se han reportado

Sobredosis:

Puede favorecer la aparición de efectos secundarios

Propiedades farmacodinámicas:

Produce

deshidratación

epitelio

corneal

debido

redistribución

líquido

intercelular por ósmosis.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

agentes

hiperosmóticos

tópicos

absorben

sistémicamente,

objetivo

favorecer el movimiento de líquido de la córnea hacia la película lagrimal hiperosmolar y

eliminarlo a través del mecanismo de flujo normal.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

No requiere de uso, manipulación y/o destrucción especial debido a las características

fisicoquímicas y biológicas de la fórmula, el sobrante se desecha.

Fecha de aprobación/ revisión del texto: 12 de noviembre de 2014.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

    Solicitar el prospecto de información al público.



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