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EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION

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About the medicine

How to use EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introducción

Prospecto: Información para elpaciente

Eptifibatida Accord 0,75 mg/ml solución para perfusiónEFG

eptifibatida

Lea todo el prospecto detenidamente antes de empezar a usar este medicamento, porque contiene información importante para usted.

  • Conserve este prospecto ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico, farmacéutico del hospital o enfermero.
  • Si experimenta efectos adversos, consulte a su médico, farmacéutico del hospital o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Eptifibatida Accord y para qué se utiliza
  2. Qué necesita saber antes de que le administren Eptifibatida Accord
  3. Cómo usar Eptifibatida Accord
  4. Posibles efectos adversos
  5. Conservación de Eptifibatida Accord
  6. Contenido del envase e información adicional

1. Qué es Eptifibatida Accord y para qué se utiliza

Eptifibatida Accord es un inhibidor de la agregación plaquetaria. Esto significa que ayuda a prevenir la formación de coágulos sanguíneos.

Se utiliza en adultos con manifestación de insuficiencia coronaria grave definida como dolor torácico espontáneo y reciente con alteraciones electrocardiográficas o cambios biológicos. Se administra normalmente junto con aspirina y heparina no fraccionada.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de que le administren Eptifibatida Accord

No deben administrarle Eptifibatida Accord:

  • si es alérgico a la eptifibatida o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).
  • si ha presentado recientemente una hemorragia de origen gástrico, intestinal, vesical o de otro órgano, por ejemplo, si se ha observado de forma anormal sangre en las heces o la orina (excepto la hemorragia menstrual) en los últimos 30 días.
  • si ha padecido un accidente cerebrovascular dentro de los 30 días previos o cualquier accidente cerebrovascular hemorrágico (además, asegúrese de que su médico sepa si ha padecido alguna vez un accidente cerebrovascular).
  • si ha padecido un tumor cerebral o un proceso que afecte a los vasos sanguíneos del cerebro.
  • si ha sido sometido a una operación importante o ha padecido una lesión grave durante las 6 semanas previas.
  • si presenta o ha presentado problemas de hemorragias.
  • si presenta o ha presentado problemas de la coagulación sanguínea o un recuento de plaquetas bajo.
  • si presenta o ha presentado hipertensión grave (tensión arterial alta).
  • si presenta o ha presentado problemas hepáticos o renales graves.
  • si ha sido tratado con otro medicamento del mismo tipo que Eptifibatida Accord.

Si ha presentado alguna de las situaciones anteriores, comuníquelo a su médico. Si tuviera alguna pregunta, consulte a su médico, farmacéutico del hospital o enfermero.

Advertencias y precauciones:

  • Eptifibatida Accord solamente se recomienda para su uso en pacientes adultos, hospitalizados en unidades de cuidados coronarios.
  • Eptifibatida Accord no debe emplearse en niños o adolescentes menores de 18 años.
  • Antes y durante su tratamiento con Eptifibatida Accord, se analizarán muestras de su sangre como una medida de seguridad para limitar la posibilidad de hemorragia inesperada.
  • Durante la utilización de Eptifibatida Accord, usted será observado cuidadosamente en busca de signos de hemorragia inusual o inesperada.

Hable con su médico o farmacéutico o enfermera del hospital antes de usar Eptifibatida Accord.

Uso de Eptifibatida Accord con otros medicamentos

Para evitar la posibilidad de interacciones con otros medicamentos informe a su médico, farmacéutico del hospital o enfermero si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta.

Especialmente:

  • diluyentes sanguíneos (anticoagulantes orales) o
  • fármacos que evitan la formación de coágulos sanguíneos, tales como warfarina, dipiridamol, ticlopidina, aspirina (excepto aquellos que pudiera recibir como parte del tratamiento con Eptifibatida Accord).

Embarazo y lactancia

El uso de Eptifibatida Accord no está normalmente recomendado durante el embarazo. Indíquele a su médico si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada. Su médico valorará si los beneficios del tratamiento con Eptifibatida Accord para usted compensan los posibles riesgos para su bebé.

Si está dando el pecho a un bebé, la lactancia deberá interrumpirse durante el período de tratamiento.

3. Cómo usar Eptifibatida Accord

Eptifibatida Accord se administra en vena mediante inyección directa seguida de una perfusión (solución gota a gota). La dosis administrada se basa en su peso. La dosis recomendada es de 180 microgramos/kg administrados en un bolo (inyección intravenosa rápida), seguido de una perfusión (solución gota a gota) de 2,0 microgramos/kg/minuto durante un máximo de 72 horas. Si tiene una enfermedad del riñón, la dosis para perfusión puede reducirse a 1,0 microgramo/kg/minuto.

Si se practica una intervención coronaria percutánea durante el tratamiento con Eptifibatida Accord, la solución intravenosa podría continuarse durante un máximo de 96 horas.

Usted también deberá recibir algunas dosis de ácido acetilsalicílico (aspirina) y heparina (si no está contraindicado en su caso).

Si tiene cualquier otra duda sobre el uso de este producto, pregunte a su médico, farmacéutico del hospital o enfermero.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Posibles efectos adversos

Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

Efectos adversos muy frecuentes

Estos pueden afectar a más de 1 de cada 10 personas

  • hemorragia menor o mayor (por ejemplo sangre en la orina, en las heces, vómito con sangre o sangrado por la cirugía)
  • anemia (descenso en el número de células rojas o hematíes de la sangre).

Efectos adversos frecuentes

Estos pueden afectar hasta 1 de cada 10 personas

  • inflamación de una vena.

Efectos adversos poco frecuentes

Estos pueden afectar hasta 1 de cada 100 personas

  • descenso del número de plaquetas (células de la sangre que son necesarias para su coagulación)
  • disminución del flujo de sangre al cerebro.

Efectos adversos muy raros

Estos pueden afectar hasta 1 de cada 10.000 personas

  • sangrado grave (por ejemplo, sangrado en el interior del abdomen, el cerebro o los pulmones).
  • sangrado con desenlace fatal
  • disminución grave del número de plaquetas (células de la sangre que son necesarias para su coagulación)
  • erupción cutánea (tales como habones o ronchas)
  • reacción alérgica grave y repentina.

Si aprecia cualquier signo de hemorragia, dígaselo inmediatamente a su médico, farmacéutico del hospital o enfermero. Muy raramente, la hemorragia ha llegado a ser grave e incluso mortal. Las medidas de seguridad para evitar que esto ocurra incluyen análisis de sangre y un control minucioso de los profesionales sanitarios que le cuidan.

Si muestra los síntomas de una reacción alérgica grave o ronchas cutáneas, dígaselo inmediatamente a su médico, farmacéutico del hospital o enfermero.

Otros efectos que pueden aparecer en pacientes que necesitan este tipo de tratamiento incluyen aquellos relacionados con la condición para la que está siendo tratado, como latidos rápidos o irregulares del corazón, baja presión sanguínea, shock o paro cardiaco.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico de hospital o enfermero, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto.

También puede comunicarlos directamente a través del sistema nacional de notificación incluido en el Apéndice V. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Eptifibatida Accord

Mantener este medicamento fuera de la vista y del alcance de los niños.

No utilice este medicamento después de la fecha de caducidad (CAD) que aparece en el embalaje exterior y en el vial después de (CAD). La fecha de caducidad es el último día del mes que se indica.

Conservar en nevera (entre 2ºC y 8ºC).

Conservar el vial en el embalaje exterior para protegerlo de la luz. No obstante, durante la administración de la solución de Eptifibatida Accord no se precisa protección frente a la luz.

Antes de su empleo, se debe examinar el contenido del vial.

No utilice Eptifibatida Accord si se observan partículas o un cambio de color.

Una vez abierto, se debe tirar el medicamento no utilizado.

Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.

6. Contenido del envase e información adicional

Composición de Eptifibatida Accord

  • El principio activo es eptifibatida.
  • Eptifibatida Accord 0,75 ml: Cada ml de solución para perfusión contiene 0,75 mg de eptifibatida. Un vial de 100 ml de solución para perfusión contiene 75 mg de eptifibatida.
  • Los demás componentes son ácido cítrico monohidrato, hidróxido de sodio y agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Eptifibatida Accord 0,75 mg/ml solución para perfusión: vial de 100 ml, envase con un vial.

Eptifibatida Accord 0,75 mg/ml: La solución transparente, incolora está contenida en un vial de vidrio de 100 ml, cerrado con un tapón de goma de butilo y cierre de aluminio de apertura flip-off.

Titular de la autorización de comercialización y responsable de la fabricación

Titular de la autorización de comercialización:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona, España

Responsable de la fabricación:

Accord Healthcare Limited

Sage House

319, Pinner Road, Harrow

Middlesex HA1 4HF

Reino Unido

Wessling Hungary Kft

Fòti ùt 56, Budapest 1047,

Hungría

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Polonia

Fecha de la última revisión de este prospecto:

La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos: http://www.ema.europa.eu/

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Frequently Asked Questions

Is a prescription required for EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION?
EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION?
The active ingredient in EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION is eptifibatide. This information helps identify medicines with the same composition but different brand names.
Who manufactures EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION?
EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to EPTIFIBATIDE ACCORD 0.75 mg/mL SOLUTION FOR INFUSION?
Other medicines with the same active substance (eptifibatide) include EPTIFIBATIDE ACCORD 2 mg/ml INJECTABLE SOLUTION, INTEGRILIN 0.75 mg/ml SOLUTION FOR INFUSION, INTEGRILIN 2 mg/ml INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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