Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HBVAXPRO 40 micrograms, injectable suspension

Hepatitis B vaccine (recombinant DNA)

Read all of this leaflet carefully before you are vaccinated, as it contains important information for you.

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

Contents of the leaflet

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

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

Prevention of hepatitis D can also be expected through immunization with HBVAXPRO, 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 receiving HBVAXPRO 40 micrograms

Do not use HBVAXPRO 40 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 40 micrograms.

Other vaccines and HBVAXPRO 40 micrograms

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

HBVAXPRO may be used to complete a primary immunization cycle 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 40 micrograms contains sodium: this medicine contains less than 23 mg of sodium (1 mmol) per dose; that is, essentially "sodium-free".

3. How HBVAXPRO 40 micrograms is administered

Dosage

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

A vaccination cycle must include at least three injections.

The schedule used consists of two injections given one month apart, followed by a third injection at 6 months after the first dose (0, 1, 6 months).

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

Method of administration

The vial should be shaken well until a slightly opaque, whitish suspension is obtained.

The vaccine will be administered by a doctor or nurse as an intramuscular injection. The preferred site for injection in adults is the muscle of the upper arm.

This vaccine must never be administered into a blood vessel.

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

If you missed a dose of HBVAXPRO 40 micrograms

If you missed 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, 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 are:

• Low platelet count, Lymph node disease
• Allergic reactions
• Nervous system disorders such as paraesthesia, facial paralysis, nerve inflammation including Guillain-Barré syndrome, optic neuritis causing visual disturbances, encephalitis, exacerbation of multiple sclerosis, multiple sclerosis, seizures, headache, dizziness, and fainting
• Low blood pressure, inflammation of blood vessels
• Asthma-like symptoms
• Vomiting, nausea, diarrhoea, 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, influenza-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 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.

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. Package contents and other information

Composition of HBVAXPRO 40 micrograms

The active substance is:

Hepatitis B surface antigen, recombinant (HBsAg)*......40 micrograms
Adsorbed on amorphous hydroxyphosphosulfate aluminum (0.50 milligrams Al+)#

• produced in yeast Saccharomyces cerevisiae (strain 2150-2-3) by 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 medicinal product and contents of the container of HBVAXPRO 40 micrograms

HBVAXPRO 40 micrograms is an injectable suspension in a vial.

Pack size: 1 vial.

Marketing Authorization Holder and Manufacturer

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

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

Date of the most recent review of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Instructions

The vaccine should be visually inspected for the presence of any foreign particles and/or unusual physical appearance of the contents prior to administration. The vial should be shaken well until a slightly opaque, whitish suspension is obtained.