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PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION

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About the medicine

How to use PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION

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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 el usuario

Pulmozyme 2.500 U/2,5 ml solución para inhalación por nebulizador

Dornasa alfa

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

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su médico o farmaceútico.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas, aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.
  • Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

Contenido del prospecto

  1. Qué es Pulmozyme y para qué se utiliza
  2. Qué necesita saber antes de empezar a usar Pulmozyme
  3. Cómo usar Pulmozyme
  4. Posibles efectos adversos
  5. Conservación de Pulmozyme
  6. Contenido del envase e información adicional

1. Qué es Pulmozyme y para qué se utiliza

Pulmozyme es un medicamento que contiene dornasa alfa, que es una versión humanizada de la proteína que se encuentra en nuestro cuerpo denominada “DNasa”.

Pulmozyme está indicado en el tratamiento de la fibrosis quística para ayudar a disolver las secreciones viscosas que se producen en los pulmones en adultos y niños mayores de 5 años. Pulmozyme se aspira (inhalación) utilizando un nebulizador (ver sección 3: Como usar Pulmozyme). Durante el tratamiento con Pulmozyme normalmente podrá seguir con otros medicamentos que esté usando para el tratamiento de la fibrosis quística (ver “Uso de Pulmozyme con otros medicamentos” en sección 2).

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de empezar a usar Pulmozyme

No use Pulmozyme:

  • Si es alérgico a la dornasa alfa o a cualquiera de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico o farmaceútico antes de empezar a usar Pulmozyme.

Niños

No se recomienda usar Pulmozyme en niños menores de 5 años. Antes de usar Pulmozyme, confirme con su médico o farmacéutico si ha sido recetado para un niño menor de 5 años.

Uso de Pulmozyme con otros medicamentos

Comunique a su médico o farmacéutico si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento. Esto incluye medicamentos que compre sin receta médica y medicamentos a base de plantas. Pulmozyme puede alterar el mecanismo de acción de otros medicamentos, así como otros medicamentos pueden alterar el funcionamiento de Pulmozyme.

Los tratamientos habituales para la fibrosis quística (como antibióticos, enzimas pancreáticos, broncodilatadores, y analgésicos) pueden seguir usándose junto con Pulmozyme. Si no está seguro, consulte a su médico o farmacéutico antes de usar Pulmozyme.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico antes de utilizar este medicamento.

Conducción y uso de máquinas

No es probable que Pulmozyme afecte su capacidad para conducir o manejar máquinas.

3. Cómo usar Pulmozyme

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. Pulmozyme se aspira (inhalación) utilizando un nebulizador (ver sección “Qué nebulizador usar”). En caso de duda, consulte de nuevo a su médico.

Continúe con su tratamiento de fisioterapia torácica cuando esté usando Pulmozyme.

Adultos y niños de 5 años o más

  • Use Pulmozyme cada día.
  • La dosis recomendada es una ampolla al día, para inhalación usando el nebulizador.
  • Si es mayor de 21 años, su médico puede indicarle que use una ampolla dos veces al día.

Niños menores de 5 años

Pulmozyme no se recomienda en niños menores de 5 años.

Qué nebulizador usar:

  • Use un nebulizador como:
  • El Hudson T Up-draft II/Pulmo-Aide, el Airlife Misty/Pulmo-Aide, el Respirgard/Pulmo-Aide personalizado o el AcornII/Pulmo-Aide.
  • Pulmozyme se puede utilizar también con un sistema nebulizador reutilizable, como el Pari LL/Inhalierboy, el Pari LC/Inhalierboy o Master, Aiolos/2 Aiolos, el Side Stream/CR50 o MobilAire o Porta-Neb
  • Se puede utilizar el nebulizador Pari eFlow Rapid, un nebulizador electrónico de uso general que utiliza tecnología de membrana vibratoria. El nebulizador Pari eFlow Rapid se debe limpiar según las instrucciones del fabricante. Además se recomienda usar el accesorio de limpieza Pari EasyCare después de cada siete usos.
  • Los nebulizadores ultrasónicos no pueden ser usadoscon Pulmozyme ya que pueden hacer que Pulmozyme no funcione adecuadamente.

Lea detenidamente y siga las instrucciones del fabricante para el uso de cada nebulizador.

Hable con su médico, ya que él puede indicarle que nebulizadores pueden usarse con Pulmozyme.

Cómo usar Pulmozyme con nebulizador:

Cuando tenga el nebulizador listo para ser usado con Pulmozyme, por favor tenga en cuenta los siguientes puntos:

  • No mezcle Pulmozyme con otros líquidos o medicamentos en el nebulizador.
  • No use ninguna porción sobrante, éstas deben siempre desecharse.
  • Si su nebulizador es reutilizable, recuerde limpiarlo después de usarlo. Siga las instrucciones de los fabricantes del compresor y nebulizador para el uso y mantenimiento de estos equipos.
  • Si alguien usa Pulmozyme por error, contacte con su médico inmediatamente.

Para usar el nebulizador

  • Asegúrese de que el nebulizador está limpio antes de usarlo.
  • Rompa la parte superior de una ampolla de Pulmozyme.
  • Vierta el contenido completo de la ampolla en la cámara del nebulizador.
  • Siga las instrucciones de uso del nebulizador e inhale inmediatamente Pulmozyme.

Si usa más Pulmozyme del que debe

Si usa más Pulmozyme del que debiera, informe inmediatamente a su médico.

Si olvidó usar Pulmozyme

  • Si olvidó tomar una dosis, tómela en el momento en que se acuerde.
  • Si está próxima la siguiente dosis, sáltese la dosis olvidada.
  • No tome una dosis doble para compensar las dosis olvidadas.

Si interrumpe el tratamiento con Pulmozyme

Si interrumpe el tratamiento con Pulmozyme puede que los síntomas del pecho empeoren. Contacte con su médico si quiere interrumpir el tratamiento con Pulmozyme.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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. Los efectos adversos de Pulmozyme son raros. Estos afectan a menos de 1 entre 1.000.

Estos efectos adversos incluyen:

  • Dolor en el pecho.
  • Fiebre.
  • Trastornos de la digestión (indigestión)
  • Alteración de la voz incluyendo ronquera o pérdida de la voz.
  • Dolor de garganta.
  • Dificultad para respirar.
  • Moqueo o nariz taponada y estornudos (rinitis).
  • Irritación en los ojos (conjuntivitis). Estos signos incluyen enrojecimiento, picor y secreción de líquido.
  • Erupción cutánea que puede tener nódulos y producir picor (habones).
  • En el comienzo del tratamiento con dornasa alfa, la función pulmonar puede disminuir, así como aumentar las secreciones mucosas. Esto generalmente mejora a medida que pasa el tiempo.

Si considera que alguno de los efectos adversos que sufre es grave o si aprecia cualquier efecto adverso no mencionado en este prospecto, consulte a su médico o farmacéutico.

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

5. Conservación de Pulmozyme

  • Pulmozyme ampollas se debe conservar en nevera (entre 2ºC y 8ºC), en el embalaje original, para protegerlo de la luz.
  • Se puede utilizar la ampolla aunque haya estado fuera de la nevera durante un periodo breve de tiempo y sometido a altas temperaturas (siempre y cuando sea la primera vez que la ampolla se deja fuera de la nevera y durante un máximo de 24 horas a temperaturas de hasta 30ºC).
  • Mantener este medicamento fuera de la vista y del alcance de los niños.
  • No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de (CAD). La fecha de caducidad es el último día del mes que se indica. No tire el sobrante de las ampollas, llévelo a su farmacia para que ellos puedan encárgarse de su eliminación. Conserve el líquido sobrante sólo si su médico se lo dice.
  • Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el punto SIGRE de la farmacia. 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 Pulmozyme

  • El principio activo es dornasa alfa. También es conocido como desoxirribonucleasa 1 o rhDnasa. Cada 2,5 ml (mililitros) de solución contienen 2.500 Unidades (o 2,5 miligramos) de dornasa alfa.
  • Los demás componentes son cloruro de sodio, cloruro de calcio dihidratado y agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Pulmozyme solución para inhalación por nebulizador se presenta en ampollas de plástico transparente. Las ampollas contienen 2,5 ml de solución. La solución es transparente, de incolora a ligeramente amarillenta.

Pulmozyme está disponible en envases de cartón que contienen 6 ó 30 ampollas. Puede que solamente estén comercializados algunos tamaños de envases

Titular de la autorización de comercialización

Roche Farma, S.A.

C/ Ribera del Loira, nº 50,

28042 Madrid

Responsable de la fabricación

Roche Pharma AG

Emil-Barell-St. 1

D-79639 Grenzach-Wyhlen

Este prospecto ha sido aprobado en noviembre 2015

La información detallada y actualizada de este medicamento está disponible en la página Web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)http://www.aemps.gob.es/

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Frequently Asked Questions

Is a prescription required for PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION 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 PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
The active ingredient in PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION is dornase alfa (desoxyribonuclease). This information helps identify medicines with the same composition but different brand names.
Who manufactures PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION is manufactured by Roche Farma S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION 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 PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION 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 PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION?
Other medicines with the same active substance (dornase alfa (desoxyribonuclease)) include ACETYLCYSTEINE ABEX 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE ALTER 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS. 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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