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HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION

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About the medicine

How to use HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION

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

HBVAXPRO5microgramos, suspensión inyectable en jeringa precargada

Vacuna antihepatitis B (DNA recombinante)

Lea todo el prospecto detenidamente antes de que usted o su hijo 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 usted o su hijo 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 5 microgramos y para qué se utiliza
  2. Qué necesita saber antes de que usted o su hijo reciban HBVAXPRO 5 microgramos
  3. Cómo se administra HBVAXPRO 5 microgramos
  4. Posibles efectos adversos
  5. Conservación de HBVAXPRO 5 microgramos
  6. Contenido del envase e información adicional

1. Qué es HBVAXPRO 5 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 desde el nacimiento hasta los 15 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 que usted o su hijo reciban HBVAXPRO 5 microgramos

No use HBVAXPRO5microgramos

  • si usted o su hijo 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 usted o su hijo 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 que usted o su hijo reciban HBVAXPRO 5 microgramos.

Otras vacunas y HBVAXPRO5microgramos

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 algunas otras vacunas, utilizando lugares de inyección y jeringas diferentes.

Informe a su médico, farmacéutico o enfermero si usted o su hijo 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 o 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.

HBVAXPRO5microgramos 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 5 microgramos

Dosis

La dosis recomendada por cada inyección (0,5 ml) es de 5 microgramos en individuos desde el nacimiento hasta los 15 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 una 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 medico, farmacéutico o enfermero le informará si debe recibir una dosis de refuerzo.

Forma de administración

El médico o enfermero administrará la vacuna mediante inyección en el músculo. El lugar preferido para la inyección en recién nacidos y lactantes es la parte superior del muslo. El lugar preferido para la inyección en los niños mayores 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 usted o su hijo olvidó una dosis de HBVAXPRO5microgramos

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

Si usted o su hijo 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

En niños nacidos muy prematuramente (a las 28 semanas de gestación o antes) se pueden producir intervalos entre respiraciones más largos de lo normal durante los 2 ó 3 días siguientes a la vacunación.

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 5 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 HBVAXPRO5microgramos

  • El principio activo es:

Antígeno de superficie del virus de la hepatitis B, recombinante (HBsAg)* ......... 5 microgramos Adsorbido en sulfato hidroxifosfato de aluminio amorfo (0,25 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 deHBVAXPRO5microgramos

HBVAXPRO 5 microgramos es una suspensión inyectable en una jeringa.

Tamaños de envase de 1, 10, 20 y 50 jeringas precargadas sin aguja ó con 2 agujas separadas.

Tamaños de envase de 1 y 10 jeringas precargadas con 1 aguja separada.

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/BelgienMSD BelgiumTél/Tel: +32(0)[email protected]

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

Texto en idioma búlgaro con información de contacto de Merck Sharp y Dohme Bulgaria, incluyendo teléfono e email

Luxembourg/LuxemburgMSD BelgiumTél/Tel: +32 (0) [email protected]

Ceská republika

Merck Sharp & Dohme s.r.o.Tel.: +420 233 010 [email protected]

Magyarország

MSD Pharma Hungary Kft.Tel.: + [email protected]

DanmarkMSD Danmark ApSTlf.: +45 4482 [email protected]

MaltaMerck Sharp & Dohme Cyprus Limited.Tel: 8007 4433 (+356 99917558)[email protected]

DeutschlandMSD Sharp & Dohme GmbHTel.: +49 (0) 89 20 300 [email protected]

NederlandMerck Sharp & Dohme B.V.Tel: 0800 9999000 (+31 23 5153153)[email protected]

EestiMerck Sharp & Dohme OÜTel: +372 614 [email protected]

NorgeMSD (Norge) ASTlf: +47 32 20 73 [email protected]

Ελλ?δαMSD Α.Φ.Ε.Ε.Τηλ: +30 210 98 97 [email protected]

ÖsterreichMerck Sharp & Dohme Ges.m.b.H.Tel: +43 (0) 1 26 [email protected]

EspañaMerck Sharp & Dohme de España, S.A.Tel: +34 91 321 06 [email protected]

PolskaMSD Polska Sp. z o.o.Tel.: +48 22 549 51 [email protected]

FranceMSD FranceTél: +33 (0)1 80 46 40 40

PortugalMerck Sharp & Dohme, LdaTel: +351 21 [email protected]

HrvatskaMerck Sharp & Dohme d.o.o.Tel: +385 1 66 11 [email protected]

RomâniaMerck Sharp & Dohme Romania S.R.LTel: + 4021 529 29 [email protected]

IrelandMerck Sharp & Dohme Ireland (Human Health) LimitedTel: +353 (0)1 [email protected]

SlovenijaMerck Sharp & Dohme, inovativna zdravila d.o.o.Tel: +386 1 520 [email protected]

ÍslandVistor ehf.Sími: + 354 535 7000

Slovenská republikaMerck Sharp & Dohme, s. r. o.Tel: +421 2 [email protected]

ItaliaMSD Italia S.r.l.Tel: 800 23 99 89 (+39 06 361911)[email protected]

Suomi/FinlandMSD Finland OyPuh/Tel: +358 (0)9 804 [email protected]

Κ?προςMerck Sharp & Dohme Cyprus LimitedΤηλ: 800 00 673 (+357 22866700)[email protected]

SverigeMerck Sharp & Dohme (Sweden) ABTel: +46 77 [email protected]

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

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: https://www.ema.europa.eu.

Esta información está destinada únicamente 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. La jeringa se debe agitar bien hasta que se obtenga una suspensión blanquecina ligeramente opaca.

La aguja se fija girándola en la dirección de las agujas del reloj hasta que encaje de forma segura en la jeringa.

Online doctors for HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION

Discuss questions about HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Frequently Asked Questions

Is a prescription required for HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION?
HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE 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 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION?
The active ingredient in HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION is hepatitis B, purified antigen. This information helps identify medicines with the same composition but different brand names.
Who manufactures HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION?
HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE 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 5 micrograms, PRE-FILLED SYRINGE 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 5 micrograms, PRE-FILLED SYRINGE 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.
What are the alternatives to HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE 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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