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TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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About the medicine

How to use TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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 paciente

Trumenba suspensión inyectable en jeringa precargada

vacuna frente al meningococo del grupo B

(recombinante, adsorbida)

Lea todo el prospecto detenidamente antes de que usted o su hijo reciba esta vacuna, porque contiene información importante para usted o su hijo.

  • Conserve este prospecto, ya que puede tener que volver a leerlo.
  • Si tiene alguna duda, consulte a su médico, farmacéutico o enfermero.
  • Esta vacuna se le ha recetado solamente a usted o a su hijo.
  • 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.

Contenido del prospecto

  1. Qué es Trumenba y para qué se utiliza
  2. Qué necesita saber antes de que usted o su hijo reciban Trumenba
  3. Cómo se administra Trumenba
  4. Posibles efectos adversos
  5. Conservación de Trumenba
  6. Contenido del envase e información adicional

1. Qué es Trumenba y para qué se utiliza

Trumenba es una vacuna para prevenir la enfermedad meningocócica invasiva, causada por Neisseria meningitidisdel serogrupo B, para su uso en personas de 10 años de edad y mayores. Este tipo de bacteria puede causar infecciones graves y algunas veces mortales, tales como meningitis (inflamación del revestimiento del cerebro y la médula espinal) y sepsis (infección de la sangre).

La vacuna contiene 2 componentes importantes de la superficie de las bacterias.

La vacuna actúa ayudando al cuerpo a producir anticuerpos (defensas naturales del organismo) que le protegen a usted o a su hijo frente a esta enfermedad.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. Qué necesita saber antes de que usted o su hijo reciban Trumenba

No se debe administrar Trumenba

  • si usted o su hijo es alérgico al principio activo o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de la vacunación con Trumenba. Informe a su médico, farmacéutico o enfermero si usted o su hijo:

  • Padece una infección grave con fiebre alta. En este caso la vacunación se pospondrá. La presencia de una infección menor, como un resfriado, no es motivo para aplazar la vacunación, pero hable primero con su médico.
  • Tiene problemas de sangrados o le salen cardenales con facilidad.
  • Tiene un sistema inmunitario debilitado que puede impedir que usted o su hijo obtenga un beneficio completo de Trumenba.
  • Ha tenido algún problema después de una dosis de Trumenba, como una reacción alérgica o dificultades para respirar.

Pueden producirse desmayos, sensación de debilidad u otras reacciones asociadas con el estrés como respuesta a cualquier inyección con aguja. Informe a su médico, farmacéutico o enfermero si ha tenido este tipo de reacción anteriormente.

Otros medicamentos y Trumenba

Informe a su médico, farmacéutico o enfermero si usted o su hijo están utilizando, han utilizado recientemente o pudieran tener que utilizar cualquier otro medicamento o si se les ha administrado recientemente otra vacuna.

Trumenba puede administrarse a la vez que cualquiera de los siguientes componentes de la vacuna: tétanos, difteria y tosferina (pertussis), virus de la poliomielitis y del papiloma, y los serogrupos meningocócicos A, C, W e Y.

No se ha estudiado la administración de Trumenba con vacunas diferentes a las incluidas arriba.

Si recibe más de una vacuna de forma simultánea, es importante que use diferentes zonas de inyección.

Si toma medicamentos que afectan a su sistema inmunológico (como radioterapia, corticosteroides o algunos tipos de quimioterapia para el cáncer), puede que no obtenga un beneficio completo de Trumenba.

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 que se le administre Trumenba. Puede que su médico le siga recomendando la administración de Trumenba si tiene riesgo de exposición a una infección meningocócica.

Conducción y uso de máquinas

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

Sin embargo, algunos de los efectos adversos mencionados en la sección 4 “Posibles efectos adversos” pueden afectarle temporalmente. Si esto ocurre, espere hasta que los efectos desaparezcan antes de conducir o utilizar máquinas.

Trumenba contiene polisorbato80

Esta vacuna contiene 0,018 mg de polisorbato 80 por dosis. Los polisorbatos pueden causar reacciones alérgicas. Informe a su médico si usted o su hijo tienen cualquier alergia conocida.

Trumenba contiene sodio

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

3. Cómo se administra Trumenba

Trumenba le será administrado a usted o a su hijo por un médico, farmacéutico o enfermero. Se le inyectará en un músculo en la parte superior del brazo.

Es importante que siga las instrucciones del médico, farmacéutico o enfermero para que usted o su hijo completen la serie de inyecciones.

Personas de 10 años de edad y mayores

  • A usted o a su hijo se les administrarán 2 inyecciones de la vacuna, administrándose la segunda inyección 6 meses después de la primera;

o

  • A usted o a su hijo se les administrarán 2 inyecciones de la vacuna con un intervalo de al menos 1 mes, y una tercera inyección al menos 4 meses después de la segunda.
  • Usted o su hijo podrían recibir una dosis de recuerdo.
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4. Posibles efectos adversos

Al igual que todas las vacunas, esta vacuna puede producir efectos adversos, aunque no todas las personas los sufran.

Al administrar Trumenba a usted o a su hijo, se pueden presentar los siguientes efectos adversos:

Muyfrecuentes(pueden afectar a más de 1 de cada 10 personas)

  • Enrojecimiento, hinchazón y dolor en la zona de inyección
  • Dolor de cabeza
  • Diarrea
  • Náuseas
  • Dolor en los músculos
  • Dolor en las articulaciones
  • Escalofríos
  • Fatiga

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

  • Vómitos
  • Fiebre ≥ 38°C

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

  • Reacciones alérgicas

Comunicación de efectos adversos

Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico 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 Trumenba

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 y en el envase después de EXP. La fecha de caducidad es el último día del mes que se indica.

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

Las jeringas se deben guardar en la nevera horizontalmente para minimizar el tiempo de re-dispersión.

No congelar.

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 Trumenba

Una dosis (0,5 ml) contiene:

Principios activos:

fHbp de la subfamilia A de Neisseria meningitidisdel serogrupo B1,2,3 60 microgramos

fHbp de la subfamilia B de Neisseria meningitidisdel serogrupo B1,2,3 60 microgramos

1 fHbp lipidada recombinante (proteína de unión al factor H)

2 producida en células de Escherichiacolimediante tecnología de ADN recombinante

3 adsorbida en fosfato de aluminio (0,25 miligramos de aluminio por dosis)

Otros componentes:

Cloruro de sodio (ver sección 2 “Trumenba contiene sodio”), histidina, agua para preparaciones inyectables, fosfato de aluminio y polisorbato 80 (E433, ver sección 2 Trumenba contiene polisorbato80).

Aspecto de Trumenba y contenido del envase

Trumenba es una suspensión inyectable blanca, en jeringa precargada.

Tamaños de envases de 1, 5 y 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

Titular de la autorización de comercialización:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Bélgica

Fabricante responsable de la liberación de los

lotes:

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Bélgica

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

België/Belgique/Belgien Luxembourg/Luxemburg

Pfizer S.A./N.V.

Tél/Tel: + 32 (0)2 554 62 11

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel: +370 52 51 4000

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??????? ?????????? ????, ????

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Te?.: +359 2 970 4333

Magyarország

Pfizer Kft

Tel: +36 1 488 3700

Ceská republika

Pfizer, spol. s r.o.

Tel: + 420 283 004 111

Malta

Vivian Corporation Ltd.

Tel: + 35621 344610

Danmark

Pfizer ApS

Tlf.: + 45 44 201 100

Nederland

Pfizer BV

Tel: +31 (0)800 63 34 636

Deutschland

Pfizer Pharma GmbH

Tel: + 49 (0)30 550055-51000

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel.: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H

Tel: + 43 (0)1 521 15-0

Ελλ?δα

Pfizer Ελλ?ς A.E.

Τηλ.: +30 210 6785 800

Polska

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

España

Pfizer, S.L.

Tel+34914909900

Portugal

Laboratórios Pfizer, Lda.

Tel: (+351) 21 423 55 00

France

Pfizer

Tél +33 1 58 07 34 40

România

Pfizer Romania S.R.L

Tel: +40 (0) 21 207 28 00

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

Slovenija

Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s podrocja farmacevtske dejavnosti,

Ljubljana

Tel.: + 386 (0)1 52 11 400

Ireland

Pfizer Healthcare Ireland Unlimited Company

Tel: 1800 633 363 (toll free)

+44 (0)1304 616161

Slovenská republika

Pfizer Luxembourg SARL,

organizacná zložka

Tel: + 421 2 3355 5500

Ísland

Icepharma hf

Simi: + 354 540 8000

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Italia

Pfizer s.r.l

Tel: +39 06 33 18 21

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Κ?προς

Pfizer Ελλ?ς Α.Ε. (Cyprus Branch)

Tηλ: +357 22 817690

Latvija

Pfizer Luxembourg SARL filiale Latvija

Tel.: + 371 670 35 775

Fecha de la última revisión de este prospecto: 04/2025.

Otras fuentes de información

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

En la página web de la Agencia Europea de Medicamentos puede encontrarse este prospecto en todas las lenguas de la Unión Europea/Espacio Económico Europeo.

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Esta información está destinada únicamente a profesionales sanitarios:

Durante el almacenamiento, se puede observar un depósito blanco y un sobrenadante transparente.

Inspeccione la vacuna visualmente por si hubiera partículas y decoloración antes de la administración. En caso de que se observe alguna partícula extraña y/o variación de aspecto físico, no administre la vacuna.

Agite bien antes de usar para obtener una suspensión blanca homogénea.

Trumenba es únicamente para uso por vía intramuscular. No administrar por vía intravascular o subcutánea.

Trumenba no debe mezclarse con otras vacunas en la misma jeringa.

Cuando se administre a la vez que otras vacunas, Trumenba debe administrarse en una zona de inyección separada.

La eliminación del medicamento no utilizado y de todos los materiales que hayan estado en contacto con él se realizará de acuerdo con la normativa local.

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General medicine 21 years exp.

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Frequently Asked Questions

Is a prescription required for TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE 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 TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
The active ingredient in TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE is meningococcus B, multicomponent vaccine. This information helps identify medicines with the same composition but different brand names.
Who manufactures TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE is manufactured by Pfizer Europe Ma Eeig. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE 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 TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE 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 TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
Other medicines with the same active substance (meningococcus B, multicomponent vaccine) include BEXSERO Injectable Suspension in Pre-filled Syringe, BEXSERO Injectable Suspension in Pre-filled Syringe, MENQUADFI 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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