Viro - Grip

Información principal

  • Denominación comercial:
  • Viro - Grip
  • formulario farmacéutico:
  • Jarabe
  • 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:
  • Viro - Grip
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 05417d3
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

Viro - Grip®

Forma farmacéutica:

Jarabe

Fortaleza:

-

Presentación:

Estuche por un frasco de PET ámbar con 120 mL .

Titular del Registro Sanitario, país:

LABORATORIOS VIJOSA, S.A. DE C.V., ANTIGUO

CUSCATLÁN, EL SALVADOR.

Fabricante, país:

LABORATORIOS VIJOSA, S.A. DE C.V., ANTIGUO

CUSCATLÁN, EL SALVADOR.

Número de Registro Sanitario:

054-17D3

Fecha de Inscripción:

13 de julio de 2017.

Composición:

Cada 5mL contiene:

Acetaminofén

Bromhidrato de dextrometorfano

Maleato de clorfeniramina

Clorhidrato de fenilefrina

Sacarosa

Propilenglicol

150 mg

5 mg

0,67 mg

2,5 mg

898,112 mg

1,325 mL

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30°C.

Indicaciones terapéuticas:

Está indicado

para el alivio

los síntomas de: resfriado, catarro,

gripe,

rinitis

alérgica, sinusitis; y los síntomas tales como flujo y congestión nasal, estornudos,

ardor de garganta, tos, fiebre, dolor de cabeza y cuerpo.

Contraindicaciones:

Hipersensibilidad a algunos de los componentes de la formula. Pacientes con historial de

asma

enfermedades

respiratorias

crónicas,

problemas

renales

hepáticos.

Está

contraindicado el consumo simultáneo de alcohol o depresores del sistema nervioso central.

Contiene sacarosa, no administrar en pacientes con intolerancia hereditaria a la fructosa,

mala absorción a la glucosa o galactosa o deficiencia de sacarasa isomaltasa.

Precauciones:

No exceda la dosis recomendada. En caso de problemas cardíacos, presión alta, trastornos

de la tiroides, diabetes, problemas de próstata o glaucoma, embarazo, lactancia, consulte a

su médico.

Descontinúe su uso y consulte a su médico si los síntomas persisten por más de 5 días en

niños o 7 días en adultos, consultar si la fiebre continúa por más de tres días.

Advertencias especiales y precauciones de uso:

Descontinúe su uso y consulte a su médico si los síntomas persisten por más de 5 días en

niños o 7 días en adultos, consultar si la fiebre continúa por más de tres días. Contiene

propilenglicol, puede producir síntomas parecidos a los del alcohol.

Efectos indeseables:

Ingerido a las dosis indicadas, es prácticamente libre de efectos secundarios.

Posología y método de administración:

No exceder 4 dosis en 24 horas; o según prescripción médica,

Adultos y niños de 12 años o más: Tomar 1 ½ - 2 cucharadas (22.5 – 30.0 mL) cada 6 a 8

horas.

Niños de 6 – 12 años: Tomar 2 – 3 cucharaditas (10 – 15 mL) cada 6- 8 horas.

Niños de 2 – 6 años: Tomar 1 – 1 ½ cucharaditas (5 – 7.5 mL) cada 6 a 8 horas.

Interacción con otros productos medicinales y otras formas de interacción:

Consulte a su médico para determinar el uso de este producto si está bajo tratamiento con:

Bloqueantes beta-adrenérgicos, fenilpropanolamina, antihipertensivos, glucósidos digitálicos

o levodopa. Evitar el uso simultáneo con inhibidores de la monoamino oxidasa (IMAO).

Uso en Embarazo y lactancia:

Embarazo: Precaución a causa del feto o el recién nacido, especialmente con dosis altas y/

o uso a largo plazo.

Lactancia: Los antihistamínicos pueden producir excitación o irritabilidad en el lactante.

Efectos sobre la conducción de vehículos/maquinarias:

Evitar conducir o manejar maquinarias peligrosas.

Sobredosis:

Para el tratamiento de la sobredosis es aconsejable vaciar el estómago mediante la

inducción de la emesis o por lavado gástrico.

Propiedades farmacodinámicas:

CETAMINOFÉN

. Como Analgésico, puede actuar inhibiendo la síntesis de prostaglandinas a

nivel del SNC y en menor grado bloqueando la generación del impulso doloroso a nivel

periférico. La acción periférica puede deberse también a la inhibición de la síntesis de

prostaglandinas o a la inhibición de la síntesis o de la acción de otras sustancias que

sensibilizan los nociceptores ante estímulos mecánicos o químicos.

Como

Antipirético,

produce

antipiresis

actuando

nivel

central

sobre

centro

hipotalámico regulador de la temperatura para producir una vasodilatación periférica que da

lugar a un aumento de flujo de sangre en la piel, de sudoración y de pérdida de calor. La

acción a nivel central probablemente está relacionada con la inhibición de la síntesis de

prostaglandinas en el hipotálamo.

EXTROMETORFANO

Como Antitusivo, suprime el reflejo de la tos por acción directa

sobre el centro bulbar de la tos.

LORFENIRAMINA

ALEATO

. Como Antihistamínico, que se utiliza en el tratamiento de la

alergia actúan compitiendo con la histamina por los receptores H

en las células efectoras.

De esta manera evitan, pero no revierten, las respuestas mediadas únicamente por la

histamina. Además, las acciones anticolinérgicas de la mayoría de los antihistamínicos

producen un efecto secante sobre la mucosa nasal.

Fenilefrina HCl: La fenilefrina es una amina simpaticomimética de acción directa; actúa

sobre los receptores alfa adrenérgicos de las arteriolas de la mucosa nasal y produce

vasoconstricción, lo que ocasiona una disminución de la congestión nasal.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

CETAMINOFEN

La absorción por vía oral es rápida y casi completa, puede disminuir si se ingiere después

de una comida rica en hidratos de carbono.

Distribución, en leche materna: se han registrado concentraciones máximas de 10 a 15 mcg

por mL (de 66.2 – 99.3 micromoles/l) al cabo de 1 a dos horas de la ingestin por parte de la

madre de una dosis única de 650 mg. La vida media de la leche materna es de 1.35 – 3.5

horas.

Metabolismo: Aproximadamente de un 90- 95 % se metaboliza en el hígado, principalmente

por conjugación con ácido glucoronico, ácido sulfúrico y cisteína. Un metabolismo intermedio

que puede acumularse en caso de sobredosificación debido a que las rutas metabólicas

principales se saturan.

Dextrometorfano HBr. Su biotransformación, es hepática. El comienzo de la acción, es

usualmente antes de media hora. La duración de la acción, es hasta de 6 horas. Su

eliminación, es principalmente renal (se excreta como dextrometorfano inalterado). La vida

media es de 1 a 4 horas no varía en situaciones de insuficiencia renal, pero puede

prolongarse en caso de sobredosis aguda, en algunos tipos de enfermedades hepáticas y

en los ancianos y neonatos; puede ser algo más corta en niños.

Clorfeniramina Maleato: Se absorben bien tras la administración oral o parenteral. Unión a

proteínas

%¸su

biotransformación

hepática;

renal

pequeña

proporción, su concentración máxima la alcanza en un tiempo de 2 – 6 horas, su efecto

máximo lo alcanza las 6 horas, la eliminación es de 14 a 25 horas.

Fenilefrina HCl: Su Biotransformación es gastrointestinal y hepática, la duración de la acción

es de 30 minutos a cuatro horas.

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

producto:

No procede.

Fecha de aprobación/ revisión del texto: 13 de julio 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.



  • Los documentos en otros idiomas están disponibles aquí

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8-10-2018

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2-10-2018

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18-9-2018

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14-9-2018

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11-9-2018

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11-9-2018

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29-8-2018

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29-8-2018

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14-8-2018

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6-7-2018

Revocation of S-classification status for certain
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30-5-2018

Climate change and health

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25-10-2018

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2-10-2018

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11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

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This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

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22-8-2018

Gripovac 3 (Merial)

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Gripovac 3 (Active substance: Not available) - Centralised - Withdrawal - Commission Decision (2018)5633 of Wed, 22 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency