HBVAXPRO 40 micrograms INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the user

HBVAXPRO40micrograms, 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 package leaflet

1. What is HBVAXPRO 40 micrograms and what is it used for
2. What you need to know before you receive HBVAXPRO 40 micrograms
3. How HBVAXPRO 40 micrograms is administered
4. Possible side effects
5. Storage of HBVAXPRO 40 micrograms
6. Contents of the pack and further information

1. What is HBVAXPRO 40 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 adult patients on pre-dialysis and dialysis.

It can be expected that immunization with HBVAXPRO will also prevent hepatitis D, since hepatitis D (caused by the delta agent) 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 receive HBVAXPRO 40 micrograms

Do not use HBVAXPRO40micrograms

• 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.

Consult your doctor, pharmacist, or nurse before receiving HBVAXPRO 40 micrograms.

Other vaccines and HBVAXPRO40micrograms

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 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 expected to have no influence or negligible influence on the ability to drive and use machines.

HBVAXPRO40microgramscontains sodium:this medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.

3. How HBVAXPRO 40 micrograms is administered

Dose

The recommended dose per injection (1 ml) is 40 micrograms in adult patients on pre-dialysis and dialysis.

A vaccination cycle should include at least three injections.

The schedule used is two injections with a one-month interval followed by a third injection six months after the first administration (0, 1, 6 months).

A booster dose should be considered in these vaccinated individuals if the level of antibodies against the hepatitis B surface antigen is less than 10 IU/l.

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 site for injection in adults 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 40 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 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 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 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 40 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 HBVAXPRO40micrograms

The active substance is:

Recombinant hepatitis B surface antigen (HBsAg)* …..... 40 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 aluminum hydroxyphosphate sulfate is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

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

Appearance and pack size of HBVAXPRO40micrograms

HBVAXPRO 40 micrograms is a suspension for injection in a vial.

Pack size of 1 vial.

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 possible appearance of 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.