Prospect: information for the user

HBVAXPRO5micrograms, pre-filled syringe injection

Anti-hepatitis B vaccine (DNA recombinant)

Read this prospect carefully before you or your child is 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 or your child 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 5 micrograms and for what it is used

2.What you need to know before you or your child receive HBVAXPRO 5 micrograms

3.How HBVAXPRO 5 micrograms is administered

4.Possible adverse effects

5.Storage of HBVAXPRO 5 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 from birth to 15 years of age considered at risk of exposure to the hepatitis B virus.

It can be expected that through immunization with HBVAXPRO, hepatitis D 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 HBVAXPRO5micrograms

• if you or your child is allergic to the hepatitis B virus surface antigen or to any of the other components of HBVAXPRO (see section6).
• if you or your child has 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 you or your child receive HBVAXPRO5micrograms.

Other vaccines and HBVAXPRO5micrograms

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

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

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

Inform your doctor, pharmacist, or nurse if you or your child is taking or has recently taken any other medication, including those purchased without a prescription.

Pregnancy and breastfeeding

Caution should be exercised 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.

HBVAXPRO5micrograms contains sodium:this medication contains less than 23mg of sodium (1mmol) per dose; this is essentially “sodium-free”.

Dose

The recommended dose for each injection (0.5 ml) is 5 micrograms in individuals from birth to 15 years of age.

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, a 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.

Administration form

The doctor or nurse will administer the vaccine by injection into the muscle. The preferred site for injection in newborns and infants is the upper thigh. The preferred site for injection in older children and adolescents 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 you or your child forget a dose of HBVAXPRO 5 micrograms

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

If you or your child 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 may experience them.

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

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, Seizures, Headache, Dizziness, and Fainting
• Low blood pressure, Vascular inflammation
• Symptoms similar to asthma
• Vomiting, Nausea, Diarrhea, Abdominal pain
• Dermatological reactions such as Eczema, Rash, Itching, Hives, and Blistering on the skin, Hair loss
• Joint pain, Arthritis, Muscle pain, Pain in a limb
• Fatigue, Fever, Undetermined illness, Symptoms similar to the flu
• Elevation of liver enzymes
• Inflammation of the eyes causing pain and redness

In very premature babies (born at 28 weeks of gestation or earlier), longer-than-normal intervals between breaths may occur during the 2 to 3 days following vaccination.

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 the national 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.

Composition of HBVAXPRO5micrograms

• The active principle is:

Surface antigen of hepatitis B virus, recombinant (HBsAg)* ......... 5micrograms Adsorbed on amorphous aluminium hydroxide phosphate (0.25milligrams Al+)#

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

#The amorphous aluminium hydroxide phosphate 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 the HBVAXPRO5micrograms

HBVAXPRO5micrograms is a suspension for injection in a syringe.

Container sizes of 1, 10, 20 and 50syringes pre-filled without needle or with 2separate needles.

Container sizes of 1 and 10syringes pre-filled with 1separate needle.

Only some container sizes may be commercially available.

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 solely for healthcare professionals:

Instructions

Inspect the vaccine visually for the presence of 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 fits into the syringe.