HBVAXPRO 5 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

HBVAXPRO5micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (recombinant DNA)

Read all of this leaflet carefully before you or your child 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 or your child 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 5 micrograms and what is it used for
2. What you need to know before you or your child receive HBVAXPRO 5 micrograms
3. How HBVAXPRO 5 micrograms is administered
4. Possible side effects
5. Storage of HBVAXPRO 5 micrograms
6. Contents of the pack and further information

1. What is HBVAXPRO 5 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 individuals from birth to 15 years of age considered at risk of exposure to hepatitis B virus.

It can be expected that immunization with HBVAXPRO will also prevent hepatitis D, 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, or by other pathogens known to infect the liver.

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

Do not use HBVAXPRO5micrograms

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

Warnings and precautions

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

Consult your doctor, pharmacist or nurse before you or your child receive HBVAXPRO 5 micrograms.

Other vaccines and HBVAXPRO5micrograms

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 some other vaccines, using different injection sites and syringes.

Tell your doctor, pharmacist or nurse if you or your child 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.

HBVAXPRO5micrograms contains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; i.e., it is essentially "sodium-free".

3. How HBVAXPRO 5 micrograms is administered

Dose

The recommended dose per 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 can 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 later (0, 1, 2, 12 months).

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

Some local vaccination schedules currently recommend a booster dose. Your doctor, pharmacist or nurse will inform you if you need a booster dose.

Method of administration

The doctor or nurse will administer the vaccine by injection into the muscle. The preferred injection site in newborns and infants is the upper part of the thigh. The preferred injection site in older children and adolescents 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 or your child miss a dose of HBVAXPRO5micrograms

If you or your child miss 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 further questions about the use of this product, ask your doctor, pharmacist or nurse.

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 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, nerve inflammation including Guillain-Barré syndrome, optic nerve inflammation causing vision problems, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, seizures, headache, dizziness, and fainting
• Low blood pressure, blood vessel inflammation
• 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, undefined disease, flu-like symptoms
• Elevation of liver enzymes
• Eye inflammation causing pain and redness

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

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 through 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 5 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 HBVAXPRO5micrograms

• The active substance is:

Hepatitis B surface antigen, recombinant (HBsAg)* ..... 5 micrograms Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.25 milligrams Al+)

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

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

Appearance and packaging ofHBVAXPRO5micrograms

HBVAXPRO 5 micrograms is a suspension for injection in a pre-filled syringe.

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

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

Not all pack 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, contact the local representative of the marketing authorisation holder.

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

The needle is fixed by twisting it in the direction of the clock hands until it is securely attached to the syringe.