HBVAXPRO 10 micrograms INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the User

HBVAXPRO 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

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, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What HBVAXPRO 10 micrograms is and what it is 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 other information

1. What HBVAXPRO 10 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 16 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 are given HBVAXPRO 10 micrograms

Do not use HBVAXPRO 10 micrograms

• if you are allergic to 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

It can cause severe allergic reactions because it contains latex in the packaging. Consult your doctor, pharmacist or nurse before receiving HBVAXPRO 10 micrograms.

Other vaccines and HBVAXPRO 10 micrograms

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 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 not expected to have a significant 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; 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 six 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 one year later (0, 1, 2, 12 months).

In the event of recent exposure to hepatitis B virus, the first dose of HBVAXPRO can be given 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.

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 vial should be shaken well until a slightly opaque white suspension is obtained. The doctor or nurse will administer 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 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 miss 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 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 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, Inflammations of the nerves 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
• 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, Undiagnosed illness, Flu-like symptoms
• Elevation of liver enzymes
• Inflammation of the eyes causing pain and redness

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 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 other information

Composition of HBVAXPRO 10 micrograms

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 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 packaging of HBVAXPRO 10 micrograms

HBVAXPRO 10 micrograms is a suspension for injection in a vial. Pack sizes of 1 and 10 vials.

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, please 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 unusual physical appearance of the contents before administration. The vial should be shaken well until a slightly opaque white suspension is obtained.