Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HBVAXPRO 5 micrograms, injectable suspension in pre-filled syringe

Hepatitis B vaccine (recombinant DNA)

Read this entire leaflet carefully before you or your child is vaccinated, as 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 or your child experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What HBVAXPRO 5 micrograms is and what it is 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. How to store HBVAXPRO 5 micrograms
6. Contents of the pack and other information

1. What HBVAXPRO 5 micrograms is and what it is used for

This vaccine is indicated for active immunization against hepatitis B virus infection caused by all known subtypes, in individuals from birth up to 15 years of age who are considered at risk of exposure to the hepatitis B virus.

Prevention of hepatitis D can also be expected through immunization with HBVAXPRO, given that 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 you or your child receive HBVAXPRO 5 micrograms

Do not use HBVAXPRO 5 micrograms

• if you or your child are allergic to the 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

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

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

Other vaccines and HBVAXPRO 5 micrograms

HBVAXPRO can be administered at the same time as hepatitis B immunoglobulin, using different injection sites.

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

HBVAXPRO can be administered simultaneously with certain other vaccines, using different injection sites and syringes.

Inform 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 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 to have a negligible effect on the ability to drive and use machines.

HBVAXPRO 5 micrograms contains sodium: this medicine contains less than 23 mg of sodium (1 mmol) per dose; essentially "sodium-free".

3. How HBVAXPRO 5 micrograms is administered

Dosage

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

A vaccination course 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 given 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, a first dose of HBVAXPRO may be administered together with the appropriate dose of immunoglobulin.

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

Method of administration

The vaccine will be administered by your doctor or nurse as an 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 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 (low blood platelet count) or in individuals at risk of bleeding.

If you or your child misses a dose of HBVAXPRO 5 micrograms

If you or your child misses a scheduled injection, consult your doctor, pharmacist, or nurse. Your doctor or nurse will decide when the missed dose should be given.

If you or your child has any further questions about the use of this product, please 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, in many cases a causal relationship between the adverse effects and 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 very rarely reported include:

• Low platelet count, Lymph node disease
• Allergic reactions
• Nervous system disorders such as Tingling, Facial paralysis, Nerve inflammation 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, and Blistering of the skin, Hair loss
• Joint pain, Arthritis, Muscle pain, Limb pain
• Fatigue, Fever, Malaise, Flu-like symptoms
• Increased liver enzymes
• Eye inflammation causing pain and redness

In infants born very prematurely (at 28 weeks of gestation or earlier), episodes of prolonged intervals between breaths may occur during the 2 to 3 days following vaccination.

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 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.

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 containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of HBVAXPRO 5 micrograms

The active substance is:

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

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

Amorphous hydroxyphosphosulfate aluminum 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 5 micrograms

HBVAXPRO 5 micrograms is an injectable suspension in a syringe.

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

Pack sizes of 1 and 10 pre-filled syringes with 1 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

More information about this vaccine can be requested 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 healthcare professionals only:

Instructions

A visual inspection of the vaccine should be performed to detect any foreign particulate matter and/or unusual physical appearance of the contents prior to administration. The syringe should be shaken well until a slightly opaque, whitish suspension is obtained.

Attach the needle by rotating it clockwise until it is securely fixed to the syringe.