FERCAYL

Información principal

  • Denominación comercial:
  • FERCAYL
  • Dosis:
  • 0,5 mL/mL
  • formulario farmacéutico:
  • inyección IM, IV
  • 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:
  • FERCAYL
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m11155b03-fercayl
  • última actualización:
  • 09-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

FERCAYL®

(Hierro dextrano)

Forma farmacéutica:

inyección IM, IV

Fortaleza:

0,5 mL/mL

Presentación:

Estuche por 5 ó 10 ampolletas de vidrio

ámbar con 1 ó 2 mL cada una.

Titular del Registro Sanitario, país:

HEMO-DIAGNOSTICA S. R. L., Guidonia,

Italia.

Fabricante, país:

LABORATOIRES STEROP, Bruselas,

Bélgica.

Número de Registro Sanitario:

M-11-155-B03

Fecha de Inscripción:

23 de septiembre de 2011

Composición:

Cada mL contiene:

Solución de hierro dextrano 10%

0,50 mL

Cloruro de sodio

Fenol

Agua para inyección

Plazo de validez:

48 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C.

Indicaciones:

FERCAYL

está

indicado

tratamiento

deficiencia

hierro

para

siguientes

indicaciones:

Intolerancia probada para las soluciones de hierro de administración oral.

Cuando existe necesidad clínica de un suministro rápido de hierro para su acumulación.

Cuando se ha confirmado que después de la administración oral de hierro la terapéutica no ha sido

efectiva.

El diagnóstico de una deficiencia de hierro se debe basar en pruebas de laboratorios adecuadas

(por ejemplo: ferritina sérica, hierro sérico, saturación de transferrina y células rojas hipocrómicas).

Contraindicaciones:

Si usted es hipersensible (alérgico) al hierro dextrana o a uno de los componentes de la solución

para inyección FERCAYL 100 mg/2ml.

Si tiene historia de asma, eczema u otra alergia tópica, no debe ser tratado con inyecciones

intramusculares. Si tiene o alguna vez ha tenido insuficiencia hepática grave, cirrosis hepática

descompensada o hepatitis.

Si tiene o ha tenido problemas renales (insuficiencia renal).

En el caso de anemia (= falta de hierro en sangre) provocada por otra causa que no sea por

deficiencia de hierro.

Pacientes extrahospitalatios.

Si tiene artritis reumatoide con signos y síntomas de inflamación activa.

Si tiene sobrecarga de hierro o ha interrumpido el uso de hierro (por ejemplo hemocromatosis,

hemosiderosis).

Precauciones:

Ver Advertencias.

Advertencias especiales y precauciones de uso:

FERCAYL solamente es utilizado en hospitales y bajo estricta supervisión médica. El inicio de la

administración de soluciones de hierro dextrana requiere de un acceso inmediato a los equipos de

resucitación en el caso de un evento de reacción anafiláctica.

No utilizar alcohol para limpiar o desinfectar la piel antes de la inyección.

Evitar la infiltración debajo de la piel. Preferiblemente utilizar la técnica de inyección en Z

(desplazamiento lateral de la piel antes de la inyección) y no masajear el sitio de inyección.

Posibles

reacciones

anafilácticas

pueden

ocurrir

durante

tratamiento

pacientes

extrahospitalarios. Por esta razón, una prueba de inyección de 0.5 ml (= 25 mg de hierro) se debe

administrar el primer día y el paciente debe ser monitorizado estrictamente por aproximadamente 1

hora antes de administrar el resto de la dosis. Se deben tener disponibles epinefrina (= adrenalina),

antihistamínicos y corticoides para tratar con situaciones de emergencia. Dado que las reacciones

pueden demorar en aparecer, los pacientes deben ser monitorizados por 1 o 2 días.

La solución no se debe utilizar si no está clara.

Generalmente, si la administración es muy rápida o prolongada existen riesgo de irritación,

necrosis en el sitio de la inyección o tromboflebitis. El riesgo de tromboflebitis se puede reducir

cambiando el sitio de la inyección cada 24 horas.

Efectos indeseables:

Como con todos los medicamentos, la solución para inyección FERCAYL 100 mg/2ml puede

desencadenar efectos adversos.

Los síntomas de hipersensibilidad inmediata se caracterizan por urticaria, rash en la piel, prurito,

escalofríos

caso

reacción

anafiláctica

grave

aparecen

síntomas

como

dificultad

respiratoria, hipotensión (presión arterial baja) e incluso shock cardiovascular (colapso); estos

signos y síntomas pueden ocurrir en minutos durante la inyección. En estos casos se debe

inmediatamente suspender la inyección de FERCAYL.

Los síntomas de hipersensibilidad tardía se caracterizan por dolores articulares (artralgia) y dolores

musculares (mialgia) así como fiebre de origen desconocido; este dolor puede ocurrir varias horas o

varios días después de la inyección y pueden ser tratados con analgésicos simples. En pacientes

que padecen poliartritis, los síntomas articulares pueden exacerbarse.

Locales: los efectos indeseables se caracterizan por dolor y pigmentación persistente en el sitio de

la inyección y tromboflebitis.

Pueden ocurrir los siguientes síntomas gastrointestinales: náusea, vómito y sabor metálico en la

boca.

Los siguientes efectos cardiovasculares pueden ocurrir: rubor (enrojecimiento), caída de la presión

arterial (hipotensión), pulso anormalmente rápido (taquicardia) y decaimiento.

Los otros efectos adversos más importantes incluyen: cefalea, malestar, hormigueo pasajero

(parestesia pasajera), vértigo, dificultad respiratoria (disnea) y trastornos en los ganglios linfáticos

(linfadenopatía).

Las inyecciones intramusculares han sido vinculadas con la aparición de sarcoma después de un

largo período de latencia.

Posología y método de administración:

Por cualquier vía de administración, antes de la administración de la primera dosis a un nuevo

paciente, debe administrarse una pequeña dosis.

Si no surge ninguna reacción indeseable durante los 60 minutos siguientes, puede administrarse la

dosis remanente.

La dosis total de Fercayl se determina a partir de su índice de hierro (hemoglobina) en sangre y su

peso. La dosis individual se estima en base a cáculos realizados por su médico. La dosis usual

recomendada es de 100 a 200 mg de hierro, correspondiente a 2-4 ml de Fercayl, dos o tres veces

a la semana, de acuerdo con el déficit de hierro.

Interacción con otros productos medicinales y otras formas de interacción:

Se debe evitar la administración oral concomitante de preparaciones a base de hierro debido a que

aumenta

riesgo

sobredosis.

debe

evitar

administración

hierro

durante

transfusiones de sangre.

Uso en Embarazo y lactancia:

Por favor consulte a su médico o farmacéutico antes de administrar este medicamento.

No existe información concerniente a la presencia de FERCAYL en la leche materna.

Efectos sobre la conducciòn de vehìculos/maquinarias:

No presenta.

Sobredosis:

La administración de FERCAYL no provoca intoxicación aguda. Sin embargo, un exceso en los

niveles de dosis que se requieren para restablecer los niveles de hemoglobina y la acumulación de

hierro pueden provocar niveles elevados de hierro en sangre. Por esta razón, se deben realizar

pruebas de sangre en el laboratorio con regularidad.

Antídoto: si es necesario administrar con goteo intravenoso lento o intramuscular la deferoxamina.

Propiedades farmacodinámicas:

Ver Farmacodinamia.

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

La mayor parte de las inyecciones intramusculares de hierro dextrana se absorben dentro de las 72

horas; la mayoría del hierro remanente es absorbido en las siguientes 3 a 4 semanas.

Varios estudios han dado valores de vida media que varían dentro de un rango de 5 horas (hierro

dextrana circulante) a más de 20 horas (hierro total, tanto circulante como enlazado). Estos valores

de vida media no representan el aclaramiento de hierro del cuerpo. El hierro no se elimina

fácilmente del cuerpo y su acumulación puede ser tóxica.

Cantidades insignificantes de hierro se pierden a través de las vías urinaria y alimentaria después

de la administración de hierro dextrana. Estudios in vitro han demostrado que la eliminación del

hierro dextrana mediante diálisis es insignificante.

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

No presenta.

Fecha de aprobación/ revisión del texto: 31 de marzo 2015.

  • 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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