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HBVAXPRO 40 micrograms INJECTABLE SUSPENSION

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About the medicine

How to use HBVAXPRO 40 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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Introduction

Package Leaflet: Information for the user

HBVAXPRO40micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

Read all of this leaflet carefully before you are vaccinated because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

  1. What is HBVAXPRO 40 micrograms and what is it used for
  2. What you need to know before you receive HBVAXPRO 40 micrograms
  3. How HBVAXPRO 40 micrograms is administered
  4. Possible side effects
  5. Storage of HBVAXPRO 40 micrograms
  6. Contents of the pack and further information

1. What is HBVAXPRO 40 micrograms and what is it used for

This vaccine is indicated for active immunization against hepatitis B virus infection caused by all known subtypes, in adult patients on pre-dialysis and dialysis.

It can be expected that immunization with HBVAXPRO will also prevent hepatitis D, since hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

The vaccine does not prevent infections caused by other agents such as hepatitis A, hepatitis C, and hepatitis E, or by other pathogens known to infect the liver.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you receive HBVAXPRO 40 micrograms

Do not use HBVAXPRO40micrograms

  • if you are allergic to the hepatitis B surface antigen or to any of the other components of HBVAXPRO (see section 6).
  • if you have a severe illness with fever.

Warnings and precautions

May cause severe allergic reactions because it contains latex in the packaging.

Consult your doctor, pharmacist, or nurse before receiving HBVAXPRO 40 micrograms.

Other vaccines and HBVAXPRO40micrograms

HBVAXPRO can be administered at the same time as hepatitis B immunoglobulin, in different injection sites.

HBVAXPRO can be used to complete a primary immunization cycle or as a booster dose in individuals who have previously received another hepatitis B vaccine.

HBVAXPRO can be administered at the same time as other vaccines, using different injection sites and syringes.

Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy and lactation

Caution should be exercised when prescribing the vaccine to pregnant or breastfeeding women.

Consult your doctor, pharmacist, or nurse before using any medicine.

Driving and using machines

HBVAXPRO is expected to have no influence or negligible influence on the ability to drive and use machines.

HBVAXPRO40microgramscontains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.

3. How HBVAXPRO 40 micrograms is administered

Dose

The recommended dose per injection (1 ml) is 40 micrograms in adult patients on pre-dialysis and dialysis.

A vaccination cycle should include at least three injections.

The schedule used is two injections with a one-month interval followed by a third injection six months after the first administration (0, 1, 6 months).

A booster dose should be considered in these vaccinated individuals if the level of antibodies against the hepatitis B surface antigen is less than 10 IU/l.

Method of administration

The vial should be shaken well until a slightly opaque white suspension is obtained.

The doctor or nurse will administer the vaccine by injection into the muscle. The preferred site for injection in adults is the muscle of the upper arm.

This vaccine should never be administered into a blood vessel.

Exceptionally, the vaccine can be administered subcutaneously in patients with thrombocytopenia (decreased blood platelets) or in individuals at risk of bleeding.

If you miss a dose of HBVAXPRO 40 micrograms

If you miss a scheduled injection, consult your doctor, pharmacist, or nurse. Your doctor or nurse will decide when to administer the missed dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

As with other hepatitis B vaccines, in many cases, a causal relationship between the side effects and the vaccine has not been established.

The most frequently observed side effects are injection site reactions: pain, redness, and induration.

Other side effects reported very rarely are:

  • Low platelet count, Lymph node disease
  • Allergic reactions
  • Nervous system disorders such as Tingling, Facial paralysis, Inflammation of the nerves including Guillain-Barré syndrome, Optic neuritis causing vision disturbances, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizures, Headache, Dizziness, and Fainting
  • Low blood pressure, Inflammation of blood vessels
  • Symptoms similar to asthma
  • Vomiting, Nausea, Diarrhea, Abdominal pain
  • Skin reactions such as Eczema, Rash, Itching, Hives, and Blistering of the skin, Hair loss
  • Joint pain, Arthritis, Muscle pain, Pain in a limb
  • Fatigue, Fever, Undiagnosed illness, Flu-like symptoms
  • Elevation of liver enzymes
  • Inflammation of the eyes causing pain and redness

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HBVAXPRO 40 micrograms

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the label.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of HBVAXPRO40micrograms

The active substance is:

Recombinant hepatitis B surface antigen (HBsAg)* …..... 40 micrograms Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.50 milligrams Al+)

  • produced in yeast Saccharomyces cerevisiae (strain 2150-2-3) using recombinant DNA technology.

The aluminum hydroxyphosphate sulfate is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

The other ingredients are sodium chloride, sodium borate, and water for injections.

Appearance and pack size of HBVAXPRO40micrograms

HBVAXPRO 40 micrograms is a suspension for injection in a vial.

Pack size of 1 vial.

Marketing authorisation holder and manufacturer

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

For further information on this vaccine, please contact the local representative of the marketing authorisation holder.

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

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

Text in Bulgarian language with contact information of Merck Sharp and Dohme Bulgaria, including phone and email

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

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

MagyarországMSD 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]

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Instructions

A visual inspection of the vaccine should be performed to detect any possible appearance of foreign particles and/or abnormal physical appearance of the contents before administration. The vial should be shaken well until a slightly opaque white suspension is obtained.

Online doctors for HBVAXPRO 40 micrograms INJECTABLE SUSPENSION

Discuss questions about HBVAXPRO 40 micrograms INJECTABLE SUSPENSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Gastroenterology – Digestive health:
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General internal medicine and preventive care:
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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  • Chronic conditions: diabetes, thyroid disorders.
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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
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  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
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Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for HBVAXPRO 40 micrograms INJECTABLE SUSPENSION?
HBVAXPRO 40 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 40 micrograms INJECTABLE SUSPENSION?
The active ingredient in HBVAXPRO 40 micrograms INJECTABLE SUSPENSION is hepatitis B, purified antigen. This information helps identify medicines with the same composition but different brand names.
Who manufactures HBVAXPRO 40 micrograms INJECTABLE SUSPENSION?
HBVAXPRO 40 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 40 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 40 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.
What are the alternatives to HBVAXPRO 40 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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