The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53095/0025.
HBVAXPRO® 10 micrograms suspension for injection in pre-filled syringe
Hepatitis B vaccine (recombinant DNA)
1. What HBVAXPRO 10 micrograms is and what it is used for
2. What do you need to know before you receive HBVAXPRO 10 micrograms
3. How HBVAXPRO 10 micrograms is given
4. Possible side effects
5. How to store HBVAXPRO 10 micrograms
6. Contents of the pack and other information
This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis B virus.
It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D does not occur in the absence of hepatitis B infection.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
The container of this vaccine contains latex rubber. Latex rubber may cause severe allergic reactions.
Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 10 micrograms.
HBVAXPRO can be administered at the same time as with hepatitis B immunoglobulin, at a separate injection site.
HBVAXPRO can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.
HBVAXPRO can be administered at the same time as with other vaccines, using separate sites and syringes.
Tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Caution should be exercised when prescribing the vaccine to pregnant or breast-feeding women.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
HBVAXPRO 10 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
The recommended dose for each injection (1 mL) is 10 micrograms for individuals 16 years of age or more.
A course of vaccination should include at least three injections.
Two immunisation schedules can be recommended:
In case of a recent exposure to the hepatitis B virus, a first dose of HBVAXPRO together with the appropriate dose of immunoglobulin can be given.
Some local vaccination schedules currently include recommendations for a booster dose. Your doctor, pharmacist or nurse will inform you if a booster dose should be given.
For individuals less than 16 years of age, HBVAXPRO 10 micrograms is not recommended. The appropriate strength for administration to individuals from birth to 15 years of age is HBVAXPRO 5 micrograms.
The doctor or nurse will give the vaccine as an injection into muscle. The upper arm muscle is the preferred site for injection in adults and adolescents.
This vaccine should never be given into a blood vessel.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia (diminution of blood platelets) or to persons at risk of haemorrhage.
If you miss a scheduled injection, talk to your doctor, pharmacist or nurse. Your doctor or nurse will decide when to give the missed dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
As with other hepatitis B vaccines, in many instances, the causal relationship of side effects to the vaccine has not been established.
The most common side effects seen are injection-site reactions: soreness, redness and hardening.
Other side effects are reported very rarely:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is:
Hepatitis B virus surface antigen, recombinant (HBsAg) * ................... 10 micrograms
Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)#
* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
# Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant. Adsorbants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other ingredients are sodium chloride (NaCl), borax and water for injections.
HBVAXPRO 10 micrograms is a suspension for injection in a syringe.
Pack sizes of 1, 10 and 20 pre-filled syringes with 2 separate needles.
Pack sizes of 1 and 10 pre-filled syringes without needle, or with 1 separate needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
For any information about this vaccine, please contact:
This leaflet was last revised in October 2023.