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SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION

Translated with AI

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

Synagis 50 mg/0.,5ml solución inyectable

Synagis 100 mg/1 ml solución inyectable

Principio activo: palivizumab

Lea todo el prospecto detenidamente antes de que su hijo reciba este medicamento, porque contiene información importante para usted y para su hijo

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico o farmacéutico.
  • Si considera que alguno de los efectos adversos que sufre es grave o si aprecia cualquier efecto adverso no mencionado en este prospecto, informe a su médico o farmacéutico. Ver sección 4.

Contenido delprospecto:

  1. Qué es Synagis y para qué se utiliza
  2. Qué necesita saber antes de que se le administre Synagis a su hijo
  3. Cómo se administrará Synagis a su hijo
  4. Posibles efectos adversos
  5. Conservación de Synagis
  6. Contenido del envase e información adicional

1. Qué es Synagis y para qué se utiliza

Synagis contiene como principio activo un anticuerpo monoclonal llamado palivizumab, que actúa específicamente contra el virus respiratorio sincitial (VRS).

Su hijo tiene un alto riesgo de contraer una infección por el virus respiratorio sincitial.

Los niños que son más susceptibles a contraer una enfermedad grave por el VRS (niños de alto riesgo) incluyen bebés nacidos prematuramente a las 35 semanas de gestación o antes) o bebés con determinados problemas de corazón o pulmón.

Synagis es un medicamento que se utiliza para proteger a su hijo frente a esta grave enfermedad provocada por el VRS.

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 que se le administre Synagis a su hijo

Su hijo no debe recibir Synagis

Si es alérgico a palivizumab o a cualquiera de los demás componentes de este medicamento (enumerados en la sección 6). Los signos y síntomas de una reacción alérgica grave pueden incluir:

  • sarpullido grave, urticaria o picor en la piel
  • hinchazón de labios, lengua y cara
  • cierre de garganta, dificultad para tragar
  • color azulado en la piel, labios o debajo de las uñas
  • debilidad o flojedad muscular
  • caída de la presión sanguínea
  • pérdida de consciencia

Advertencias y precauciones

Tenga especial cuidado con Synagis

  • si su hijo se encuentra enfermo, informe a su médico, ya que puede ser necesario retrasar la administración de Synagis.
  • si su hijo tiene cualquier problema de coagulación, ya que Synagis se inyecta normalmente en el muslo.

Otros medicamentos y Synagis

No se ha observado que Synagis interaccione con otros medicamentos. Sin embargo, antes de la administración de Synagis, informe a su médico o farmacéutico de todos los medicamentos que está tomando su hijo.

3. Cómo se administrará Synagis a su hijo

¿Con qué frecuencia se administrará Synagisa su hijo?

Synagis se debe administrar en dosis de 15 mg/kg del peso corporal, una vez al mes durante el tiempo que exista riesgo de infección por VRS. Para la mejor protección de su hijo, es necesario seguir las instrucciones del médico sobre cuando recibir las siguientes dosis de Synagis.

Si su hijo se somete a una operación cardiaca (intervención quirúrgica con circulación extracorpórea), se le administrará una dosis adicional de Synagis después de la operación quirúrgica. En lo sucesivo se continuará con el programa inicial de inyección.

¿Cómo recibirá Synagissu hijo?

Synagis se debe administrar a su hijo mediante inyección en el músculo, normalmente en la parte externa del muslo.

¿Qué debe hacer si no se le ha administrado una dosis de Synagis?

Si se ha saltado una dosis, debe hablar lo antes posible con el médico de su hijo. Cada inyección de Synagis puede proteger a su hijo alrededor de un mes antes de que se necesite otra dosis.

Siga exactamente las instrucciones de administración indicadas por su médico o farmacéutico. En caso de duda sobre cómo se administrará este medicamento a su hijo, consulte 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 tener efectos adversos, aunque no todas las personas los sufran.

Synagis puede producir efectos adversos graves incluyendo:

  • reacciones alérgicas graves (tales reacciones pueden ser potencialmente mortales o mortales (ver “Su hijo no debe recibir Synagis” para consultar la lista de signos y síntomas).
  • contusiones inusuales o grupos de pequeñas manchas rojas en la piel.

Llame a su médico o busque ayuda médica inmediatamente si su hijo presenta alguno de los efectos adversos graves incluidos arriba después de recibir una dosis de Synagis.

Efectos adversos adicionales

Muy frecuentes (al menos 1 de cada 10 pacientes):

  • sarpullido
  • fiebre

Frecuentes (entre 1 y 10 de cada 100 pacientes):

  • dolor, enrojecimiento o hinchazón en el punto de inyección
  • pausas en la respiración u otras dificultades respiratorias

Poco frecuentes (menos de 1 de cada 100 pacientes):

  • convulsiones
  • urticaria

Comunicación de efectos adversos

Si su hijo experimenta cualquier tipo de efecto adverso, consulte a su médico, incluso si se trata de 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 Synagis

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 la etiqueta después de “CAD” La fecha de caducidad es el último día del mes que se indica.

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

No congelar.

Conservar el vial en el envase original para protegerlo de la luz.

6. Contenido del envase e información adicional

Composición de Synagis

  • El principio activo es palivizumab, un ml de Synagis solución inyectable contiene 100 mg de palivizumab.
  • Cada vial de 0,5 ml contiene 50 mg de palivizumab.
  • Cada vial de 1 ml contiene 100 mg de palivizumab.
  • Los demás componentes son histidina, glicina y agua para preparaciones inyectables.

Aspecto del producto y contenido del envase

Synagis solución inyectable es una solución transparente y ligeramente opalescente y está disponible en viales de 0,5 ml o 1 ml.

Tamaño de envase de 1.

Titular de la autorización de comercialización

AstraZeneca AB

SE 151 85 Södertälje

Suecia

Responsable de la fabricación

AbbVie S.r.l.

04011 Campoverde di Aprilia (LT)

Italia

Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:

België/Belgique/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

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??????????? ???????? ????

Te?.: +359 2 44 55 000

Luxembourg/Luxemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Ceská republika

AstraZeneca Czech Republic s.r.o

Tel: +420 222 807 111

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

Deutschland

AstraZeneca GmbH

Tel: +49 40 809034100

Nederland

AstraZeneca BV

Tel: 31 85 808 9900

Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Ελλ?δα

AstraZeneca A.E.

Τηλ: +30 2 106871500

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Italia

AstraZeneca S.p.A.

Tel: +39 02 00704500

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Κ?προς

Αλ?κτωρ Φαρµακευτικ? Λτδ

Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

United Kingdom(Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836?836

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

------------------------------[perforación para separar de la información al paciente]-------------------

Esta información está destinada únicamente a médicos o profesionales del sector sanitario:

Instrucciones para la administración

Con objeto de mejorar la trazabilidad de los medicamentos biológicos, el nombre y el número de lote del medicamento administrado deben estar claramente registrados.

Palivizumab no debe mezclarse con ningún medicamento o disolvente.

Tanto el vial de 0,5 ml como el vial del 1 ml contienen un sobrellenado para permitir la retirada de 50 mg o 100 mg respectivamente.

No diluya el producto.

No agitar el vial.

Para administrar, eliminar la parte de la lengüeta de la tapa del vial y limpiar el tapón con etanol 70% o equivalente. Introduzca la aguja en el vial y extraiga a la jeringa el volumen apropiado de solución. Palivizumab solución inyectable no contiene conservantes, es para un único uso y debe administrarse inmediatamente tras extraer la dosis a la jeringa.

La eliminación del medicamento no utilizado y de todos los materiales que hayan estado en contacto con él se realizará de acuerdo con las normativas locales.

Palivizumab se administra una vez al mes por vía intramuscular, preferiblemente en la cara anterolateral del muslo. El músculo glúteo no se debe utilizar habitualmente como un punto de inyección debido al riesgo de lesión en el nervio ciático. La inyección debe administrarse utilizando una técnica aséptica clásica. Los volúmenes de inyección superiores a 1 ml deben administrarse en dosis divididas.

Cuando use palivizumab 100 mg/1 ml, el volumen de palivizumab (expresado en ml) que debe ser administrado una vez al mes = (peso del paciente en kg) multiplicado por 0,15.

Por ejemplo, el cálculo para un bebé que pesa 3 kg:

(3 x 0,15) ml = 0,45 ml de palivizumab por mes.

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Discuss questions about SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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General medicine 7 years exp.

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Family medicine 13 years exp.

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Frequently Asked Questions

Is a prescription required for SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION?
SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION 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 SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION?
The active ingredient in SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION is palivizumab. This information helps identify medicines with the same composition but different brand names.
Who manufactures SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION?
SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION is manufactured by Astrazeneca Ab. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION 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 SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION 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 SYNAGIS 50 mg/0.5 ml INJECTABLE SOLUTION?
Other medicines with the same active substance (palivizumab) include SYNAGIS 100 mg/1 ml INJECTABLE SOLUTION, BEYFORTUS 100 mg injectable solution in pre-filled syringe, BEYFORTUS 50 mg Injectable Solution in Pre-filled Syringe. 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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