HBVAXPRO 5 micrograms INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

Read all of this leaflet carefully before you or your child is 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 it is 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 receives 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 receives HBVAXPRO 5 micrograms

Do not use HBVAXPRO 5 micrograms

Warnings and precautions

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

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

Other vaccines and HBVAXPRO 5 micrograms

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 needles.

Tell your doctor, pharmacist, or nurse if you or your child is taking or has 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 or negligible influence 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; this 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 six months after the first administration (0, 1, 6 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 vial should be shaken well until a slightly opaque white suspension is obtained. Once the vial is pierced, the withdrawn vaccine should be administered immediately and the vial discarded.

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 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 to administer the missed dose.

If you or your child has 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 the 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, Inflammation of the nerves including Guillain-Barré syndrome, Optic neuritis causing vision problems, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizures, Headache, Dizziness, and Fainting
• Low blood pressure, Inflammation of blood vessels
• 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, Illness, Flu-like symptoms
• Elevated liver enzymes
• Inflammation of the eyes causing pain and redness

In children born very prematurely (at 28 weeks of gestation or earlier), longer pauses between breaths than normal 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 it is 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 HBVAXPRO 5 micrograms

-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 adjuvant is included in this vaccine to accelerate, enhance, and/or prolong the protective effects of the vaccine.

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

Appearance and pack size of HBVAXPRO 5 micrograms

HBVAXPRO 5 micrograms is a suspension for injection in a vial. Pack sizes of 1 and 10 vials without syringe/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.

This leaflet was approved on

Detailed information on this medicine is available on the European Medicines Agency website: http://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 particles and/or abnormal physical appearance of the contents before administration. The vial should be shaken well until a slightly opaque white suspension is obtained.