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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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Doctor

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:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
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.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
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  • eFAST and critical care transthoracic echocardiography
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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

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.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
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  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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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:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

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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€70
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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:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
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  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
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Doctor

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:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

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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€50

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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