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title: TEST PURPOSES ONLY - Flucelvax

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Prospecto: información para el usuario

 

 

 

Flucelvax Tetra - suspensión inyectable en jeringa precargada

Vacuna contra la gripe (antígeno de superficie, inactivado, preparada en cultivos celulares)

 

 

Lea todo el prospecto detenidamente antes de empezar a recibir 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 o enfermero.

-              Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

 

 

" } }, { "title" : "What is in this leaflet", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "Contenido del prospecto" }, "text" : { "status" : "additional", "div" : "

Contenido del prospecto

 

1.    Qué es Flucelvax Tetra y para qué se utiliza

2.    Qué necesita saber antes de empezar a recibir Flucelvax Tetra

3.    Cómo se administra Flucelvax Tetra

4.    Posibles efectos adversos

5.    Conservación de Flucelvax Tetra

6.    Contenido del envase e información adicional

" } }, { "title" : "1. What Flucelvax is and what it is used for", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "1. Qué es Flucelvax Tetra y para qué se utiliza" }, "text" : { "status" : "additional", "div" : "

 

Flucelvax Tetra es una vacuna contra la gripe. Flucelvax Tetra se prepara en cultivos celulares y, por lo tanto, no contiene huevo.

Cuando una persona recibe la vacuna, el sistema inmunitario (el sistema de defensa natural del organismo) producirá su propia protección frente al virus de la gripe. Ninguno de los componentes de la vacuna puede causar la gripe.

 

Flucelvax Tetra se usa para prevenir la gripe en adultos y niños a partir de los 2 años de edad.

 

La vacuna va dirigida a cuatro cepas del virus de la gripe siguiendo las recomendaciones de la Organización Mundial de la Salud para la campaña 2023/2024.

" } }, { "title" : "2. What you need to know before you take Flucelvax", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "2. Qué necesita saber antes de empezar a recibir Flucelvax Tetra" }, "text" : { "status" : "additional", "div" : "

 

No debe recibir Flucelvax Tetra:

Si es alérgico a:

 

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de empezar a recibir Flucelvax Tetra.

 

ANTES DE vacunarse

 

Como ocurre con todas las vacunas, Flucelvax Tetra puede no proteger completamente a todas las personas que son vacunadas.

 

Otros medicamentos y Flucelvax Tetra

Informe a su médico o enfermero si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta, o si ha recibido recientemente alguna otra vacuna.

 

Flucelvax Tetra se puede administrar al mismo tiempo que otras vacunas.

 

Embarazo y lactancia

Embarazo:

Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico. Las vacunas antigripales se pueden administrar en cualquier trimestre del embarazo.

 

Lactancia:

El uso de Flucelvax Tetra durante la lactancia no ha sido estudiado. Flucelvax Tetra se puede administrar durante la lactancia.

 

Conducción y uso de máquinas

La influencia de Flucelvax Tetra sobre la capacidad para conducir y utilizar máquinas es nula o insignificante.

 

Flucelvax Tetra contiene cloruro de sodio y cloruro de potasio

Esta vacuna contiene menos de 1 mmol de sodio (23 mg) por dosis; esto es, esencialmente “exento de sodio”.

Esta vacuna contiene potasio, menos de 1 mmol (39 mg) por dosis; esto es, esencialmente “exento de potasio”.

" } }, { "title" : "3. How to take Flucelvax", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "3. Cómo se administra Flucelvax Tetra" }, "text" : { "status" : "additional", "div" : "

 

Su médico o enfermero le administrará Flucelvax Tetra en forma de inyección en el músculo de la parte superior del brazo (músculo deltoides).

 

Adultos y niños a partir de 2 años de edad:

 

Una dosis de 0,5 ml

 

Si su hijo es menor de 9 años y nunca ha sido vacunado contra la gripe, se le debe administrar una segunda dosis después, de al menos, 4 semanas.

 

" } }, { "title" : "4. Possible side effects", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "4. Posibles efectos adversos" }, "text" : { "status" : "additional", "div" : "

 

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

Los siguientes efectos adversos se han notificado durante los ensayos clínicos y durante el uso general:

 

Efectos adversos muy graves

Consulte inmediatamente con su médico o acuda al servicio de urgencias del hospital más cercano si presenta el siguiente efecto adverso – puede necesitar urgentemente atención médica u hospitalización:

 

•              Dificultad para respirar, mareos, pulso débil y rápido junto con erupción cutánea, que son los síntomas de una reacción anafiláctica (una reacción alérgica muy grave)

 

Efectos adversos graves

Informe inmediatamente a su médico si presenta cualquiera de los efectos adversos siguientes – puede necesitar atención médica:

 

 

Efectos adversos leves

Muy frecuentes (pueden afectar a más de 1 de cada 10 personas):

En los pacientes de edad avanzada fueron frecuentes el endurecimiento o la hinchazón en el lugar de la inyección, el dolor de cabeza, el dolor muscular y la fatiga.

Los cardenales en el lugar de la inyección fueron frecuentes en adultos, ancianos y niños de 9 a < 18 años.

El dolor de cabeza fue frecuente en ancianos.

La pérdida de apetito fue frecuente en adultos, ancianos y niños de 9 a < 18 años.

 

Frecuentes (pueden afectar hasta 1 de cada 10 personas):

Los vómitos fueron poco frecuentes en los pacientes de edad avanzada

La fiebre fue infrecuente en adultos y ancianos

 

Frecuencia no conocida (no puede estimarse a partir de los datos disponibles):

 

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su profesional sanitario, 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 en www.notificaRAM.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

" } }, { "title" : "5. How to store Flucelvax", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "5. Conservación de Flucelvax Tetra" }, "text" : { "status" : "additional", "div" : "

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

 

Conservar en nevera (entre 2 °C y 8 °C). No congelar.

Mantener la jeringa precargada en el embalaje exterior para protegerla de la luz.

 

No utilice esta vacuna después de la fecha de caducidad que aparece en la etiqueta y en la caja después de EXP/CAD. La fecha de caducidad es el último día del mes que se indica.

 

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.

 

" } }, { "title" : "6. Contents of the pack and other information", "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/rmswi/", "code" : "100000155538" }], "text" : "6. Contenido del envase e información adicional" }, "text" : { "status" : "additional", "div" : "

 

Composición de Flucelvax Tetra

 

 

Cepa similar a A/Wisconsin/67/2022 (H1N1)pdm09 (A/Georgia/12/2022 CVR-167)

15 microgramos HA**

Cepa similar a A/Darwin/6/2021 (H3N2) (A/Darwin/11/2021, wild type)

15 microgramos HA**

Cepa similar a B/Austria/1359417/2021 (Singapore/WUH4618/2021, wild type) 15 microgramos HA**

Cepa similar a B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type)

15 microgramos HA**

 

por dosis de 0,5 ml

……………………………………….

*              propagadas en células Madin Darby Canine Kidney (MDCK) (se trata de un cultivo celular especial en el que crece el virus de la gripe)

** hemaglutinina

 

Esta vacuna cumple con la recomendación de la Organización Mundial de la Salud (OMS) (hemisferio norte) y con la recomendación de la UE para la CAMPAÑA 2023/2024.

 

 

Aspecto del producto y contenido del envase

 

Flucelvax Tetra es una suspensión inyectable en jeringa precargada (jeringa lista para usar). Flucelvax Tetra es una suspensión de transparente a ligeramente opalescente.

Cada jeringa individual contiene 0,5 ml de suspensión inyectable.

Flucelvax Tetra está disponible en envases de 1 jeringa precargada con o sin aguja o 10 jeringas

precargadas con o sin agujas.

Puede que solamente estén comercializados algunos tamaños de envases.

 

Titular de la autorización de comercialización y responsable de la fabricación

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

Países Bajos

 

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

 

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

 

Fecha de la última revisión de este prospecto: 07/2023

 

 

Otras fuentes de información

 

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

 

------------------------------------------------------------------------------------------------------------- Esta información está destinada únicamente a profesionales del sector sanitario:

 

Debe estar siempre fácilmente disponible el tratamiento médico y la supervisión apropiados en caso de un episodio anafiláctico, que puede aparecer raramente después de administrar la vacuna.

 

Agitar antes de usar. Después de agitar, el aspecto normal de la vacuna es una suspensión de transparente a ligeramente opalescente.

 

Se debe inspeccionar visualmente la vacuna en busca de partículas extrañas o cambios de color antes de la administración. Si se observan partículas extrañas y/o cualquier variación del aspecto físico, no administre la vacuna.

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Profile: ManufacturedItemDefinition (ePI)

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