Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (recombinant DNA)

Read this entire leaflet carefully before you are vaccinated, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What HBVAXPRO 10 micrograms is and what it is used for
2. What you need to know before receiving HBVAXPRO 10 micrograms
3. How HBVAXPRO 10 micrograms is administered
4. Possible adverse effects
5. How to store HBVAXPRO 10 micrograms
6. Contents of the pack and other information

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

This vaccine is indicated for active immunization against infection caused by the hepatitis B virus, including all known subtypes, in individuals aged 16 years and older who are considered at risk of exposure to the hepatitis B virus.

Prevention of hepatitis D can also be expected through immunization with HBVAXPRO, 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.

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

Do not use HBVAXPRO 10 micrograms

• 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

Severe allergic reactions may occur because the container contains latex rubber.

Talk to your doctor, pharmacist, or nurse before receiving HBVAXPRO 10 micrograms.

Other vaccines and HBVAXPRO 10 micrograms

HBVAXPRO may be administered simultaneously with hepatitis B immunoglobulin, provided different injection sites are used.

HBVAXPRO may be used to complete a primary vaccination course or as a booster dose in individuals who have previously received another hepatitis B vaccine.

HBVAXPRO may be administered at the same time as other vaccines, using separate injection sites and separate 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 women or women who are breastfeeding.

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

Driving and using machines

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

HBVAXPRO 10 micrograms contains sodium: this medicine contains less than 23 mg of sodium (1 mmol) per dose; essentially, it is "sodium-free".

3. How HBVAXPRO 10 micrograms is administered

Dosage

The recommended dose for each 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 may be recommended:

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

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

Some local vaccination guidelines currently recommend a booster dose. Your doctor, pharmacist, or nurse will inform you whether you should receive a booster dose.

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

Method of administration

The vaccine will be administered by your doctor or nurse as an injection into the muscle. The preferred injection site in adults and adolescents is the muscle of the upper arm.

This vaccine must never be given into a blood vessel.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia (reduced blood platelets) or in individuals at risk of bleeding.

If you forget a dose of HBVAXPRO 10 micrograms

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

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

As with other hepatitis B vaccines, a causal relationship between the vaccine and the adverse effects has not been established in many cases.

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

Other very rare adverse effects reported include:

• Low platelet count, Lymph node disease
• Allergic reactions
• Disorders of the nervous system such as tingling, facial paralysis, nerve inflammations including Guillain-Barré syndrome, optic neuritis causing vision disturbances, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, seizures, headache, dizziness, and fainting
• Low blood pressure, inflammation of blood vessels
• Asthma-like symptoms
• Vomiting, nausea, diarrhea, abdominal pain
• Skin reactions such as eczema, rash, itching, hives, blistering of the skin, hair loss
• Joint pain, arthritis, muscle pain, limb pain
• Fatigue, fever, malaise, flu-like symptoms
• Elevated liver enzymes
• Eye inflammation causing pain and redness

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the label.

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

Do not freeze.

Keep 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of HBVAXPRO 10 micrograms

The active substance is:

Hepatitis B surface antigen, recombinant (HBsAg)* 10 micrograms
Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligrams Al+)#

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

Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

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

Appearance of the product and contents of the pack of HBVAXPRO 10 micrograms

HBVAXPRO 10 micrograms is an injectable suspension in a 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 needles, or with one separate needle.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Further information on this vaccine is available from the local representative of the Marketing Authorization Holder.

Date of the most recent review 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 for medical or healthcare professionals only:

Instructions

A visual inspection of the vaccine should be performed to check for the presence of any foreign particles and/or unusual physical appearance of the contents before administration. The syringe should be shaken well until a slightly opaque, whitish suspension is obtained.

The needle is attached by screwing it clockwise until it is securely fastened to the syringe.