SALES DE REHIDRATACIÓN ORAL

Información principal

  • Denominación comercial:
  • SALES DE REHIDRATACIÓN ORAL
  • formulario farmacéutico:
  • Polvo para solución oral
  • 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.


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Localización

  • Disponible en:
  • SALES DE REHIDRATACIÓN ORAL
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m14074a07
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERISTICAS DEL PRODUCTO

Nombre del producto:

SALES DE REHIDRATACIÓN ORAL

Forma farmacéutica:

Polvo para solución oral

Fortaleza:

Presentación:

Sobre de AL-Poliéster-PE con 26,505 g.

Titular del Registro Sanitario, país:

EMPRESA LABORATORIO FARMACÉUTICO ORIENTE,

SANTIAGO DE CUBA, CUBA.

Fabricante, país:

EMPRESA LABORATORIO FARMACÉUTICO ORIENTE,

ESTABLECIMIENTO PLANTA 1 TABLETAS Y POLVOS,

SANTIAGO DE CUBA, CUBA.

Número de Registro Sanitario:

M-14-074-A07

Fecha de Inscripción:

13 de mayo de 2014

Composición:

Cada sobre contiene:

Dextrosa anhidra

Cloruro de sodio

Cloruro de potasio

Citrato de sodio dihidratado

19,000 g

3,325 g

1,425 g

2,755 g

Plazo de validez:

24 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 ºC. Protéjase de la luz

y la humedad.

Indicaciones terapéuticas:

Prevención y tratamiento de la deshidratación leve y moderada por enfermedad diarreica aguda

de origen infeccioso y no infeccioso.

Contraindicaciones:

Deshidratación

severa

acidosis

metabólica,

recién

nacidos

pretérminos,

vómitos

incontrolables, obstrucción intestinal, íleo paralítico, perforación intestinal, hemorragia digestiva

alta, shock, convulsiones.

Precauciones:

Mala absorción de glucosa: exacerbación o persistencia de la diarrea. Alteración de la función

renal.

Advertencias especiales y precauciones de uso:

Consultar al médico si la diarrea no mejora luego de un día o dos de tratamiento. No usar la

solución después de 24 horas de preparadas. Los desequilibrios severos de electrólitos requieren

administración parenteral. Descontinuar su administración cuando se restablece la ingesta del

alimento.

Efectos indeseables:

Ocasionales: vómitos leves al inicio del tratamiento en ese caso esperar 10 min y continuar con la

administración gradualmente.

Raras: hipernatremia, hipopotasemia y sobrehidratación.

Posología y modo de administración:

Adultos:

Rehidratación:

ajustada

acuerdo

libre

demanda,

tolerancia,

respuesta

tratamiento.

Deshidratación leve: 50 mL/ kg en 4-6 h.

Deshidratación moderada: 100 mL/kg en 6 h.

Deshidratación severa: tratamiento intravenoso Fase de mantenimiento: (una vez hidratado).

Diarrea continua leve o moderada: 100 a 200 mL/kg/d hasta que cese la diarrea. Diarrea continua

severa: 15 mL/kg/h hasta que cese la diarrea, máximo 1000 mL/h. En caso de no mejorar

considerar el tratamiento intravenoso.

Niños:

Rehidratación: ajustada de acuerdo con libre demanda, tolerancia, sed y respuesta al tratamiento.

Deshidratación leve o moderada: en las primeras 4 h, entre 50 a 100 mL/kg. En caso de no

mejorar considerar el tratamiento i.v. Fase de mantenimiento: una vez hidratado, por cada

episodio diarreico administrar un volumen equivalente de la solución.

Menores de 2 años: 50 a 100 mL, de 2 a 10 años: 100 a 200 mL.

Interacciones con otros productos medicinales y otras formas de interacción:

No se han descrito.

Uso en Embarazo y lactancia:

Embarazo: no se reportan riesgos.

Lactancia materna: amamantar entre una dosis y otra.

Efectos sobre la conducción de vehículos / maquinarias:

No hay reportes.

Sobredosis:

La sobredosis de electrolitos puede ocasionar vómitos, diarreas, trastornos cardiovasculares. Si la

ingesta es reciente, se recomienda inducir el vómito y/o lavado gástrico; evaluación de la función

cardiovascular y la determinación de los niveles de electrólitos

Propiedades farmacodinámicas:

Proporcionan los electrólitos necesarios para mantener el equilibrio ácido – base. Las SRO-

Citrato, además de ser más estables, corrigen la acidosis al mismo nivel que las de bicarbonato, y

pueden reducir el número de deposiciones diarreicas, especialmente en diarreas graves.

Este efecto se debe probablemente a la acción directa del citrato trisódico de aumentar la

absorción intestinal de sodio y agua. La glucosa facilita la absorción de sodio en el intestino

delgado. El sodio y el potasio son necesarios para reemplazar las pérdidas corporales de iones

esenciales durante la diarrea.

El citrato corrige la acidosis que sucede como resultado de la diarrea y la deshidratación además

aumenta la absorción de sodio en el intestino delgado.

Propiedades farmacocinéticas (absorción, distribución, biotransformación, eliminación):

Su osmolaridad y concentración proporcional de glucosa y sodio promueven la óptima absorción

de agua y electrólitos. El citrato favorece esta absorción así como la incorporación de potasio a la

célula.

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

Deseche el resto que pueda quedar. No hierva la solución, ni le añada azúcar. No administrar

otros líquidos que contengan electrolitos: leche, jugos.

Fecha de aprobación/revisión del texto: 30 de noviembre de 2017.

  • 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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29-8-2018

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29-8-2018

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28-8-2018

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23-8-2018

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10-8-2018

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28-6-2018

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7-6-2018

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6-6-2018

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24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

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23-5-2018

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit

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23-5-2018

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FDA - U.S. Food and Drug Administration

22-5-2018

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

FDA is taking safety actions regarding over-the-counter benzocaine oral drug products and prescription local anesthetics.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

17-2-2014

Danish Pharmacovigilance Update 19 December 2013

Danish Pharmacovigilance Update 19 December 2013

In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.

Danish Medicines Agency

20-7-2018

Bayer to stop #Essure sales in the U.S.  https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

FDA - U.S. Food and Drug Administration

5-12-2017

Rabitec (IDT Biologika GmbH)

Rabitec (IDT Biologika GmbH)

Rabitec (Active substance: Rabies vaccine (live, oral) for foxes and raccoon dogs) - New authorisation - Commission Decision (2017)1365 of Tue, 05 Dec 2017 European Medicines Agency (EMA) procedure number: EMEA/V/C/4387

Europe -DG Health and Food Safety