HBVAXPRO 10 micrograms, PRE-FILLED SYRINGE INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

HBVAXPRO10micrograms, suspension for injection in a pre-filled syringe

Hepatitis B vaccine (recombinant DNA)

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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is HBVAXPRO 10 micrograms and what is it used for
2. What you need to know before you are given HBVAXPRO 10 micrograms
3. How HBVAXPRO 10 micrograms is given
4. Possible side effects
5. Storage of HBVAXPRO 10 micrograms
6. Contents of the pack and further information

1. What is HBVAXPRO 10 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 16 years of age considered to be at risk of exposure to the 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 are given HBVAXPRO 10 micrograms

Do not use HBVAXPRO10micrograms

• 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.

Talk to your doctor, pharmacist or nurse before you are given HBVAXPRO 10 micrograms.

Other vaccines and HBVAXPRO10micrograms

HBVAXPRO can be given 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 given 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 breastfeeding

Caution should be exercised when prescribing the vaccine to pregnant or breastfeeding women.

Talk to your doctor, pharmacist or nurse before using any medicine.

Driving and using machines

HBVAXPRO is not expected to have a significant effect on the ability to drive and use machines.

HBVAXPRO10micrograms contains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

3. How HBVAXPRO 10 micrograms is given

Dose

The recommended dose per injection (1 ml) is 10 micrograms in individuals from 16 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 the event of recent exposure to the hepatitis B virus, the first dose of HBVAXPRO can be given at the same time as 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.

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.

Method of administration

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

This vaccine should never be given into a blood vessel.

Exceptionally, the vaccine can be given subcutaneously in patients with thrombocytopenia (low blood platelet count) or in individuals at risk of bleeding.

If you miss a dose of HBVAXPRO10micrograms

If you miss a planned injection, talk to your doctor, pharmacist or nurse. Your doctor or nurse will decide when to give the missed dose.

If you have any further questions on 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 reactions at the injection site: discomfort, 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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 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 10 micrograms

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is 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 HBVAXPRO10micrograms

The active substance is:

Recombinant hepatitis B surface antigen (HBsAg)* .....10 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 other ingredients are sodium chloride (NaCl), sodium borate, and water for injections.

Appearance and packaging ofHBVAXPRO10micrograms

HBVAXPRO 10 micrograms is a suspension for injection in a pre-filled syringe.

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

Pack sizes of 1 and 10 pre-filled syringes without a needle, or with one 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 on this vaccine, please 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 potential 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 attached by twisting it in a clockwise direction until it is securely locked onto the syringe.