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CAPVAXIVE Injectable Solution in Pre-filled Syringe

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About the medicine

How to use CAPVAXIVE Injectable Solution in Pre-filled Syringe

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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

CAPVAXIVE solución inyectable en jeringa precargada

Vacuna antineumocócica polisacárida conjugada (21-valente)

Este medicamento está sujeto a seguimiento adicional, lo que agilizará la detección de nueva información sobre su seguridad. Puede contribuir comunicando los efectos adversos que pudiera usted tener. La parte final de la sección 4 incluye información sobre cómo comunicar estos efectos adversos.

Lea todo el prospecto detenidamente antes de recibir esta vacuna, porque contiene informaciónimportante para usted.

  • 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, y no debe dársela a otras personas.
  • 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 CAPVAXIVE y para qué se utiliza
  2. Qué necesita saber antes de recibir CAPVAXIVE
  3. Cómo se administra CAPVAXIVE
  4. Posibles efectos adversos
  5. Conservación de CAPVAXIVE
  6. Contenido del envase e información adicional

1. Qué es CAPVAXIVE y para qué se utiliza

CAPVAXIVE es una vacuna antineumocócica que se administra a:

  • personas a partir de 18años de edadpara ayudarles a protegerse frente a enfermedades causadas por una bacteria llamada Streptococcus pneumoniaeo neumococo. Estas enfermedades incluyen: infección pulmonar (neumonía), inflamación del cerebro y la médula espinal (meningitis) e infección en la sangre (bacteriemia).

La vacuna actúa ayudando al cuerpo a producir sus propios anticuerpos, que le protegen frente a estas enfermedades.

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 recibir CAPVAXIVE

No debe recibir CAPVAXIVE:

  • si es alérgico a los principios activos, incluido el toxoide diftérico, o a alguno de los demás componentes de esta vacuna (incluidos en la sección 6).

Advertencias y precauciones

Consulte a su médico, farmacéutico o enfermero antes de recibir CAPVAXIVE si:

  • Tiene fiebre alta o una infección grave. En estos casos, la vacunación puede tener que posponerse hasta que se haya recuperado. Sin embargo, una fiebre o infección leve (por ejemplo, un resfriado) no es una razón para retrasar la vacunación.
  • Tiene problemas de sangrado, se hace moretones fácilmente o está tomando medicamentos para prevenir coágulos sanguíneos.
  • Tiene ansiedad relacionada con las inyecciones o alguna vez se ha desmayado después de alguna inyección.
  • Tiene el sistema inmunitario debilitado (lo que implica que el cuerpo es menos capaz de combatir las infecciones) o si está tomando determinados medicamentos que pueden debilitar el sistema inmunitario.

Como cualquier vacuna, CAPVAXIVE puede no proteger completamente a todas las personas vacunadas.

Niños y adolescentes

CAPVAXIVE no se ha estudiado en niños y adolescentes menores de 18 años de edad.

Otros medicamentos/vacunas y CAPVAXIVE

CAPVAXIVE se puede administrar al mismo tiempo que la vacuna de la gripe (vacuna de la gripe inactivada).

Informe a su médico, farmacéutico o enfermero si:

  • Está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.
  • Ha recibido recientemente o tiene previsto recibir cualquier otra vacuna.

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, farmacéutico o enfermero antes de recibir esta vacuna.

Conducción y uso de máquinas

La influencia de CAPVAXIVE sobre la capacidad para conducir y utilizar máquinas es nula o insignificante. Sin embargo, algunos de los efectos mencionados en la sección 4 “Posibles efectos adversos” pueden afectar temporalmente a la capacidad para conducir o utilizar máquinas.

CAPVAXIVE contiene sodio

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

CAPVAXIVE contiene polisorbato20

Este medicamento contiene 0,5 mg de polisorbato 20 en cada dosis de 0,5 ml de solución inyectable. Los polisorbatos pueden causar reacciones alérgicas. Informe a su médico si tiene alguna alergia conocida.

3. Cómo se administra CAPVAXIVE

Informe a su médico, farmacéutico o enfermero si ha recibido previamente una vacuna antineumocócica.

Adultos

Debe recibir 1 inyección (1 dosis de 0,5 ml).

Su médico o enfermero le administrará la vacuna en el músculo superior del brazo.

Si tiene cualquier otra duda sobre el uso de CAPVAXIVE, pregunte a su médico, farmacéutico 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 todas las vacunas, CAPVAXIVE puede producir efectos adversos, aunque no todas las personas los sufran.

Efectos adversos graves

Raros (pueden afectar hasta a 1 de cada 1 000 personas):

CAPVAXIVE puede causar reacciones alérgicas (hipersensibilidad), incluyendo contracción excesiva de los músculos de las vías respiratorias que causa dificultad para respirar (broncoespasmo). Busque atención médica de inmediato si tiene síntomas de una reacción alérgica, que pueden ser:

  • Silbidos al respirar o dificultad para respirar
  • Hinchazón de la cara, labios o lengua
  • Habones urticariales
  • Erupción

Otros efectos adversos

Se han observado los siguientes efectos adversos después del uso de CAPVAXIVE:

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

  • Dolores de cabeza
  • Dolor en el lugar de inyección
  • Sensación de cansancio

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

  • Dolores musculares (muy frecuentes en personas de 18 a 49 años de edad)
  • Enrojecimiento o hinchazón en el lugar de inyección (muy frecuentes en personas de 18 a 49 años de edad)
  • Fiebre

Poco frecuentes(pueden afectar hasta a 1 de cada 100 personas):

  • Hinchazón de los ganglios linfáticos
  • Mareo
  • Ganas de vomitar (náuseas)
  • Diarrea
  • Vómitos
  • Dolor de articulaciones
  • Picor en el lugar de inyección
  • Escalofríos
  • Moratones en el lugar de inyección

Estos efectos secundarios son generalmente leves o moderados y duran poco tiempo.

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 CAPVAXIVE

Mantener esta vacuna fuera de la vista y del alcance de los niños.

No utilice esta vacuna después de la fecha de caducidad que aparece en la caja y en la etiqueta de la jeringa después de CAD.

La fecha de caducidad es el último día del mes que se indica.

Conservar en nevera (entre 2 °C y 8 °C). No congelar. Mantener la jeringa precargada en el embalaje exterior para protegerla de la luz.

CAPVAXIVE se debe administrar lo antes posible una vez que está fuera de la nevera. Sin embargo, en circunstancias en las que CAPVAXIVE se mantenga temporalmente fuera de la nevera, la vacuna es estable a temperaturas de hasta 25 °C durante 96 horas. Al final de este período, CAPVAXIVE se debe utilizar o desechar. Esta información está destinada a orientar a los profesionales sanitarios solo en caso de desviaciones temporales de la temperatura.

6. Contenido del envase e información adicional

Composición de CAPVAXIVE

Los principios activos son:

  • Polisacáridos de los tipos neumocócicos 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B des-O-acetilado, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F y 35B (4 microgramos de cada tipo)

Cada polisacárido está unido a una proteína transportadora (CRM197). Los polisacáridos y la proteína transportadora no están vivos y no provocan la enfermedad.

Una dosis (0,5 ml) contiene aproximadamente 65 microgramos de proteína transportadora.

Los demás componentes son cloruro de sodio (NaCl), histidina, polisorbato 20 (E 432), ácido clorhídrico (HCl; para ajustar el pH) y agua para preparaciones inyectables. Para obtener más información sobre el polisorbato 20 (E 432), ver sección 2.

Aspecto del producto y contenido del envase

CAPVAXIVE es una solución inyectable (inyección) incolora, entre transparente y opalescente, que se presenta en una jeringa precargada de dosis única (0,5 ml). CAPVAXIVE se presenta en tamaños de envase de 1 o 10 jeringas precargadas, sin agujas, con 1 aguja separada o con 2 agujas separadas por jeringa precargada.

Puede que solamente estén comercializados algunos tamaños de envases.

Titular de la autorización de comercialización y responsable de la fabricación

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Países Bajos.

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

België/Belgique/Belgien

MSD Belgium

Tél/Tel: +32(0)27766211

[email protected]

Lietuva

UAB Merck Sharp & DohmeTel. +370 5 2780 [email protected]

Texto en idioma búlgaro que incluye nombre de empresa, dirección y datos de contacto como teléfono y correo electrónico

Luxembourg/Luxemburg

MSD Belgium

Tél/Tel: +32 (0) 27766211

[email protected]

Ceská republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

[email protected]

Magyarország

MSD Pharma Hungary Kft.

Tel.: + 36.1.888.5300

[email protected]

Danmark

MSD Danmark ApS

Tlf.: +45 4482 4000

[email protected]

Malta

Merck Sharp & Dohme Cyprus Limited.Tel: 8007 4433 (+356 99917558)

[email protected]

Deutschland

MSD Sharp & Dohme GmbH

Tel.: +49 (0) 89 20 300 4500

[email protected]

Nederland

Merck Sharp & Dohme B.V.

Tel: 0800 9999000

(+31 23 5153153)

[email protected]

Eesti

Merck Sharp & Dohme OÜ

Tel: +372 614 4200

[email protected]

Norge

MSD (Norge) AS

Tlf: +47 32 20 73 00

[email protected]

Ελλ?δα

MSD Α.Φ.Ε.Ε.

Τηλ: +30 210 98 97 300

[email protected]

Österreich

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

[email protected]

España

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

[email protected]

Polska

MSD Polska Sp. z o.o.Tel.: +48 22 549 51 00

[email protected]

France

MSD FranceTél: +33 (0)1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

[email protected]

Hrvatska

Merck Sharp & Dohme d.o.o.Tel: +385 1 66 11 333

[email protected]

România

Merck Sharp & Dohme Romania S.R.L

Tel: + 4021 529 29 00

[email protected]

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700

[email protected]

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.Tel: +386 1 520 4201

[email protected]

Ísland

Vistor ehf.

Sími: + 354 535 7000

Slovenská republika

Merck Sharp & Dohme, s. r. o.Tel: +421 2 58282010

[email protected]

Italia

MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911)

[email protected]

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

[email protected]

Κ?προς

Merck Sharp & Dohme Cyprus LimitedΤηλ: 800 00 673 (+357 22866700)

[email protected]

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvija

SIA Merck Sharp & Dohme LatvijaTel.: +371 [email protected]

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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.

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Esta información está destinada únicamente a profesionales sanitarios:

  • La vacuna se debe utilizar tal y como se suministra.
  • Inspeccionar visualmente la solución para detectar partículas y decoloración antes de la administración. Desechar la vacuna si detecta partículas presentes y/o si parece decolorada.
  • Fije una aguja con conexión Luer Lock girando en el sentido de las agujas del reloj hasta que la aguja encaje de forma segura en la jeringa.
  • CAPVAXIVE solo se debe administrar mediante inyección intramuscular. Esta vacuna se debe administrar preferiblemente en el músculo deltoides del brazo en adultos, con precaución para evitar la inyección en o cerca de los nervios y vasos sanguíneos.

CAPVAXIVE se puede administrar al mismo tiempo que la vacuna tetravalente frente a la gripe (virión fraccionado, inactivado) en adultos. Las diferentes vacunas inyectables siempre se deben administrar en distintos lugares de inyección.

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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Frequently Asked Questions

Is a prescription required for CAPVAXIVE Injectable Solution in Pre-filled Syringe?

CAPVAXIVE Injectable Solution 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 CAPVAXIVE Injectable Solution in Pre-filled Syringe?

The active ingredient in CAPVAXIVE Injectable Solution in Pre-filled Syringe is pneumococcus, purified polysaccharides antigen conjugated. This information helps identify medicines with the same composition but different brand names.

Who manufactures CAPVAXIVE Injectable Solution in Pre-filled Syringe?

CAPVAXIVE Injectable Solution in Pre-filled Syringe is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of CAPVAXIVE Injectable Solution 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 CAPVAXIVE Injectable Solution 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.

How to buy CAPVAXIVE Injectable Solution in Pre-filled Syringe in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy CAPVAXIVE Injectable Solution in Pre-filled Syringe in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to CAPVAXIVE Injectable Solution in Pre-filled Syringe?

Other medicines with the same active substance (pneumococcus, purified polysaccharides antigen conjugated) include PREVENAR 13 INJECTABLE SUSPENSION, PREVENAR 13 INJECTABLE SUSPENSION, PREVENAR 20 INJECTABLE SUSPENSION 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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