Prospecto: information for the user

HBVAXPRO40micrograms, injectable suspension

Anti-hepatitis B vaccine(DNA recombinant)

Read this prospectus carefully before you are vaccinated, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section4.

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

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

3.How HBVAXPRO 40 micrograms is administered

4.Possible adverse effects

5.Storage of HBVAXPRO 40 micrograms

6.Contents of the package and additional information

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

It is expected that through immunization with HBVAXPRO, hepatitis D will also be prevented, 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, nor by other pathogens known to infect the liver.

Do not use HBVAXPRO40micrograms

• if you are allergic to the hepatitis B surface antigen or to any of the other components of HBVAXPRO (see section6).
• if you have a severe illness with fever.

Warnings and precautions

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

Consult your doctor, pharmacist, or nurse before receiving HBVAXPRO40micrograms.

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.

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

Pregnancy and breastfeeding

Care should be taken in the prescription of the vaccine to pregnant women or women in the lactation period.

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

Driving and operating machinery

HBVAXPRO is expected to have no influence or insignificant influence on the ability to drive and operate machinery.

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

Dose

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

A vaccination cycle should include at least three injections.

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

Consideration should be given to the administration of a booster dose in these vaccinated individuals if the level of antibodies against the hepatitis B virus surface antigen is less than 10UI/l.

Administration form

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

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

This vaccine should never be administered into a blood vessel.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia (decreased platelet count) or in individuals at risk of hemorrhage.

If a dose of HBVAXPRO 40micrograms is missed

If a scheduled injection is missed, consult a doctor, pharmacist, or nurse. The doctor or nurse will decide when to administer the missed dose.

For any additional questions about the use of this product, consult a doctor, pharmacist, or nurse.

Like all medications, this vaccine may produce adverse effects, although not all people may experience them.

As occurs with other hepatitis B vaccines, in many cases, no causal relationship of adverse effects with the vaccine has been established.

The most frequently observed adverse effects are reactions at the injection site: discomfort, redness, and induration.

Other adverse effects reported very rarely are:

• Low platelet count,Lymph node disease
• Allergic reactions
• Nervous system disorders such as Tingling, Facial paralysis, Inflammations of the nerves including Guillain-Barré Syndrome, Optic nerve inflammation causing vision disturbances, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Convulsions, Headache, Dizziness, and Syncope
• Low blood pressure, Vascular inflammation
• Symptoms similar to asthma
• Vomiting, Nausea, Diarrhea, Abdominal pain
• Dermatological reactions such as Eczema, Rash, Itching, Hives, and Blister formation on the skin, Hair loss
• Joint pain, Arthritis, Muscle pain, Pain in a limb
• Fatigue, Fever, Indefinite illness, Symptoms similar to the flu
• Elevation of liver enzymes
• Eye inflammation causing pain and redness

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the label.

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

Do not freeze.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

HBVAXPRO Composition40micrograms

The active ingredient is:

Surface antigen of hepatitis B virus, recombinant (HBsAg)* …..... 40micrograms Adsorbed on amorphous aluminium hydroxiphosphate sulfate (0.50milligrams Al+)#

* produced in yeastSaccharomyces cerevisiae(strain2150‑2‑3) by DNA recombinant technology.

#The amorphous aluminium hydroxiphosphate sulfate is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.

The other components are sodium chloride(NaCl), sodium borate and water for injection.

Appearance of the product and contents of theHBVAXPRO40micrograms

HBVAXPRO40micrograms is a suspension for injection in a vial.

Container size of 1vial.

Marketing Authorization Holder and Responsible Manufacturer

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

For more information about this vaccine, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

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

This information is intended solely for healthcare professionals:

Instructions

Perform a visual inspection of the vaccine to detect any possible appearance of foreign particles and/or unusual physical appearance of the content before administration. The vialshould be shaken well until a white, slightly opaque suspension is obtained.