Prospect: information for the user

HBVAXPRO10micrograms, pre-filled syringe injectable suspension

Anti-hepatitis B vaccine(DNA recombinant)

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

-Keep this prospect, as you may need to read it again.

-If you have any questions, 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 prospect. See section4.

1.What is HBVAXPRO 10 micrograms and for what it is used

2.What you need to know before receiving HBVAXPRO 10 micrograms

3.How HBVAXPRO 10 micrograms is administered

4.Possible adverse effects

5.Storage of HBVAXPRO 10 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 individuals aged 16 years or older who are considered at risk of exposure to the hepatitis B virus.

It is expected that through immunization with HBVAXPRO, hepatitis D infection will also be prevented, since hepatitis D 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 HBVAXPRO10micrograms

• 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 HBVAXPRO10micrograms.

Other vaccines and HBVAXPRO10micrograms

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 have a negligible influence on the ability to drive and operate machinery.

HBVAXPRO10micrograms contains sodium:this medication contains less than 23mg of sodium (1mmol) per dose; this is essentially “sodium-free”.

Dose

The recommended dose per injection (1 ml) is 10 micrograms in individuals 16 years of age or older.

A vaccination cycle should include at least three injections.

Two vaccination schedules may be recommended:

• two injections with a one-month interval followed by a third injection 6 months after the first administration (0, 1, 6 months).
• if rapid immunity is required: three injections with a one-month interval and a fourth dose 1 year after (0, 1, 2, 12 months).

In case of recent exposure to the hepatitis B virus, the first dose of HBVAXPRO may be administered along with the appropriate dose of immunoglobulin.

Some local vaccination schedules currently include the recommendation of a booster dose. Your doctor, pharmacist, or nurse will inform you if you should receive a booster dose.

HBVAXPRO 10 micrograms is not indicated in individuals under 16 years of age. The appropriate dose for administration to individuals from birth to 15 years of age is HBVAXPRO 5 micrograms.

Administration form

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

This vaccine should never be administered into a vein.

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

If you forgot a dose of HBVAXPRO 10 micrograms

If you forget 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 additional questions about the use of this product, consult with your doctor, pharmacist, or nurse.

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

As occurs with other hepatitis B vaccines, in many cases, the causal relationship of adverse effects with the vaccine has not 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
• Neurological 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 Blistering of 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
• Inflammation of the eyes 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 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 empty containers and unused medicines. This will help protect the environment.

HBVAXPRO Composition10micrograms

The active ingredient is:

Surface antigen of hepatitis B virus, recombinant (HBsAg)* .....10micrograms Adsorbed on amorphous aluminium hydroxiphosphate sulfate (0.50milligrams Al+)#

* produced in yeastSaccharomyces cerevisiae(strain2150‑2‑3) by recombinant DNA 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 theHBVAXPRO10micrograms

HBVAXPRO10micrograms is a suspension for injection in a pre-filled syringe.

Container sizes of 1, 10 and 20pre-filled syringes with two separate needles.

Container sizes of 1 and 10pre-filled syringes without a needle, or with 1separate needle.

Only some container sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

For further information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.

Last update of the summary of product characteristics:

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

This information is intended for healthcare professionals only:

Instructions

Inspect the vaccine visually for any particulate matter or foreign particles before administration. The syringeshould be shaken well until a white, slightly opaque suspension is obtained.

The needle is fixed by turning it in the direction of the clock until it securely locks into the syringe.