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HBVAXPRO 10 micrograms INJECTABLE SUSPENSION

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About the medicine

How to use HBVAXPRO 10 micrograms INJECTABLE SUSPENSION

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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

HBVAXPRO 10 microgramos, suspensión inyectable

Vacuna antihepatitis B (DNA recombinante)

Lea todo el prospecto detenidamente antes de que usted sea vacunado, 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.

Contenido del prospecto

  1. Qué es HBVAXPRO 10 microgramos y para qué se utiliza
  2. Qué necesita saber antes de recibir HBVAXPRO 10 microgramos
  3. Cómo se administra HBVAXPRO 10 microgramos
  4. Posibles efectos adversos
  5. Conservación de HBVAXPRO 10 microgramos
  6. Contenido del envase e información adicional

1. Qué es HBVAXPRO 10 microgramos y para qué se utiliza

Esta vacuna está indicada para la inmunización activa frente a la infección por el virus de la hepatitis B causada por todos los subtipos conocidos, en individuos a partir de 16 años de edad considerados en riesgo de exposición al virus de la hepatitis B.

Se puede esperar que mediante la inmunización con HBVAXPRO también se prevenga la hepatitis D, dado que la hepatitis D no se presenta en ausencia de infección de hepatitis B.

La vacuna no previene las infecciones causadas por otros agentes como la hepatitis A, hepatitis C y hepatitis E, ni por otros patógenos que se sabe que infectan al hígado.

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 HBVAXPRO 10 microgramos

No use HBVAXPRO 10 microgramos

  • si usted es alérgico al antígeno de superficie del virus de la hepatitis B o a alguno de los demás componentes de HBVAXPRO (ver sección 6).
  • si padece una enfermedad grave con fiebre.

Advertencias y precauciones

Puede producir reacciones alérgicas graves porque contiene goma de látex en el envase. Consulte a su médico, farmacéutico o enfermero antes de recibir HBVAXPRO 10 microgramos.

Otras vacunas y HBVAXPRO 10 microgramos

HBVAXPRO se puede administrar al mismo tiempo que la inmunoglobulina antihepatitis B, en lugares de inyección diferentes.

HBVAXPRO se puede utilizar para completar un ciclo de inmunización primaria o como dosis de refuerzo en personas que hayan recibido previamente otra vacuna antihepatitis B.

HBVAXPRO se puede administrar al mismo tiempo que otras vacunas, utilizando lugares de inyección y jeringas diferentes.

Informe a su médico, farmacéutico o enfermero si usted está tomando o ha tomado recientemente cualquier otro medicamento, incluso los adquiridos sin receta.

Embarazo y lactancia

Se debe prestar atención en la prescripción de la vacuna a mujeres embarazadas ó mujeres en periodo de lactancia.

Consulte a su médico, farmacéutico o enfermero antes de utilizar cualquier medicamento.

Conducción y uso de máquinas

HBVAXPRO se espera que no tenga influencia o tenga una influencia insignificante sobre la capacidad para conducir y utilizar máquinas.

HBVAXPRO 10 microgramos contiene sodio: este medicamento contiene menos de 23 mg de sodio (1 mmol) por dosis; esto es, esencialmente “exento de sodio”.

3. Cómo se administra HBVAXPRO 10 microgramos

Dosis

La dosis recomendada por cada inyección (1 ml) es de 10 microgramos en individuos a partir de 16 años de edad.

Un ciclo de vacunación deberá incluir al menos tres inyecciones.

Se pueden recomendar dos pautas de vacunación:

  • dos inyecciones con un intervalo de un mes seguido de una tercera inyección 6 meses después de la primera administración (0, 1, 6 meses).
  • si se requiere una inmunidad rápida: tres inyecciones con un intervalo de un mes y una cuarta dosis 1 año después (0, 1, 2, 12 meses).

En caso de exposición reciente al virus de la hepatitis B, se puede administrar la primera dosis de HBVAXPRO junto con la dosis adecuada de inmunoglobulina.

Algunas pautas de vacunación local incluyen actualmente la recomendación de una dosis de refuerzo. Su médico, farmacéutico o enfermero le informará si debe recibir una dosis de refuerzo.

HBVAXPRO 10 microgramos no está indicado en personas menores de 16 años de edad.

La dosis apropiada para la administración a individuos desde el nacimiento hasta los 15 años de edad es HBVAXPRO 5 microgramos.

Forma de administración

El vial se deberá agitar bien hasta que se obtenga una suspensión blanquecina ligeramente opaca. El médico o enfermero administrará la vacuna mediante inyección en el músculo. El lugar preferido para la inyección en adultos y adolescentes es el músculo de la parte superior del brazo.

Esta vacuna nunca debe administrarse en un vaso sanguíneo.

Excepcionalmente, se puede administrar la vacuna por vía subcutánea en pacientes con trombocitopenia (disminución de las plaquetas de la sangre) o en personas con riesgo de hemorragia.

Si olvidó una dosis de HBVAXPRO 10 microgramos

Si olvida una inyección prevista, consulte a su médico, farmacéutico o enfermero. Su médico o enfermero decidirá cuándo administrar la dosis olvidada.

Si tuviera alguna pregunta adicional acerca del uso de este producto, consulte con 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 todos los medicamentos, esta vacuna puede producir efectos adversos, aunque no todas las personas los sufran.

Como ocurre con otras vacunas antihepatitis B, en muchos casos, no se ha establecido la relación causal de los efectos adversos con la vacuna.

Los efectos adversos más frecuentemente observados son reacciones en el lugar de inyección: molestias, enrojecimiento e induración.

Otros efectos adversos notificados muy raramente son:

  • Bajo nivel de plaquetas, Enfermedad del ganglio linfático
  • Reacciones alérgicas
  • Trastornos del sistema nervioso como Hormigueo, Parálisis facial, Inflamaciones de los nervios incluyendo Síndrome de Guillain-Barré, Inflamación del nervio óptico que provoca alteraciones en la visión, Inflamación del cerebro, Exarcebación de esclerosis múltiple, Esclerosis múltiple, Convulsiones, Dolor de cabeza, Mareo y Desmayo
  • Presión arterial baja, Inflamación de los vasos sanguíneos
  • Síntomas parecidos al asma
  • Vómitos, Náuseas, Diarrea, Dolor abdominal
  • Reacciones cutáneas como Eczema, Erupción, Picor, Habones y Formación de ampollas en la piel, Pérdida de cabello
  • Dolor de las articulaciones, Artritis, Dolor muscular, Dolor en una extremidad
  • Fatiga, Fiebre, Enfermedad indefinida, Síntomas parecidos a la gripe
  • Elevación de las enzimas hepáticas
  • Inflamación de los ojos que causa dolor y enrojecimiento

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 HBVAXPRO 10 microgramos

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 etiqueta.

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

No congelar.

Conservar en el embalaje original para protegerlo de la luz.

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 HBVAXPRO 10 microgramos

El principio activo es:

Antígeno de superficie del virus de la hepatitis B, recombinante (HBsAg)*……..10 microgramos

Adsorbido en sulfato hidroxifosfato de aluminio amorfo (0,50 miligramos Al+)#

  • producido en levadura Saccharomyces cerevisiae (cepa 2150-2-3) mediante tecnología recombinante de DNA.

# El sulfato hidroxifosfato de aluminio amorfo se incluye en esta vacuna como un adsorbente. Los adsorbentes son sustancias incluidas en ciertas vacunas para acelerar, mejorar y/o prolongar los efectos protectores de la vacuna.

Los demás componentes son cloruro de sodio (NaCl), borato de sodio y agua para preparaciones inyectables.

Aspecto del producto y contenido del envase de HBVAXPRO 10 microgramos

HBVAXPRO 10 microgramos es una suspensión inyectable en un vial. Tamaños de envase de 1 y 10 viales.

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 esta vacuna 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 & Dohme

Tel.: +370.5.2780.247

[email protected]

Texto en idioma búlgaro con nombre de empresa Мерк Шарп и Доум България ЕООД y número telefónico +359 2 819 3737

[email protected]

Luxembourg/Luxemburg

MSD Belgium

Tél/Tel: +32(0)27766211

[email protected]

Ceskárepublika

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: 0800 673 673 673 (+49 (0) 89 4561 0)

[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]

Ελλáδα

MSD Α.Φ.Β.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 France

Tél: +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 hf.

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 Limited

Τηλ: 800 00 673 (+357 22866700)

[email protected]

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

[email protected]

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: +371.67364.224

[email protected]

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

[email protected]

Este prospecto ha sido aprobado en

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 tnicamente a médicos o profesionales del sector sanitario:

Instrucciones

Se debe realizar una inspección visual de la vacuna para detectar la posible aparición de cualquier partícula extraña y/o aspecto físico extraño del contenido antes de la administración. El vial se debe agitar bien hasta que se obtenga una suspensión blanquecina ligeramente opaca.

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Get HBVAXPRO 10 micrograms INJECTABLE SUSPENSION Prescription Online

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Frequently Asked Questions

Is a prescription required for HBVAXPRO 10 micrograms INJECTABLE SUSPENSION?

HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION?

The active ingredient in HBVAXPRO 10 micrograms INJECTABLE SUSPENSION is hepatitis B, purified antigen. This information helps identify medicines with the same composition but different brand names.

Who manufactures HBVAXPRO 10 micrograms INJECTABLE SUSPENSION?

HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION 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 HBVAXPRO 10 micrograms INJECTABLE SUSPENSION?

Other medicines with the same active substance (hepatitis B, purified antigen) include ENGERIX-B 20 micrograms/1 ml, PRE-FILLED SYRINGE SUSPENSION FOR INJECTION, ENGERIX-B JUNIOR 10 micrograms/0.5 ml, PRE-FILLED SYRINGE SUSPENSION, FENDRIX, INJECTABLE SUSPENSION. 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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