Patient Leaflet Updated 15-Nov-2023 | Merck Sharp & Dohme (UK) Limited
HBVAXPRO 5mcg
HBVAXPRO® 5 micrograms suspension for injection in pre-filled syringe
Hepatitis B vaccine (recombinant DNA)
1. What HBVAXPRO 5 micrograms is and what it is used for
2. What you need to know before you or your child receive HBVAXPRO 5 micrograms
3. How HBVAXPRO 5 micrograms is given
4. Possible side effects
5. How to store HBVAXPRO 5 micrograms
6. Content 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 from birth through 15 years of age 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 or your child receive HBVAXPRO 5 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 may be administered at the same time as with some other vaccines, using separate sites and syringes.
Tell your doctor, pharmacist or nurse if you or your child is taking or has 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 5 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 (0.5 mL) is 5 micrograms for individuals from birth through 15 years of age.
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.
The doctor or nurse will give the vaccine as an injection into muscle. The upper side of the thigh is the preferred site for injection in neonates and infants. The upper arm muscle is the preferred site for injection in children 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 or your child 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 or your child 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:
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
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) * ................... 5 micrograms
Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 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 5 micrograms is a suspension for injection in a syringe.
Pack sizes of 1, 10, 20 and 50 pre-filled syringes without needle or with 2 separate needles,
Pack sizes of 1 and 10 pre-filled syringes with 1 separate needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
For any information about this vaccine, please contact:
This leaflet was last revised in October 2023.
120 Moorgate, London, EC2M 6UR, UK
+44 (0)208 154 8000
+44 (0)2081548001
