patient information leaflet hbvaxpro 5mcg

PACKAGE LEAFLET: INFORMATION FOR THE USER

HBVAXPRO 5 micrograms/0.5 ml, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

Read all of this leaflet carefully before your child is vaccinated.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What HBVAXPRO 5 micrograms/0.5 ml is and what it is used for
2. Before you use HBVAXPRO 5 micrograms/0.5 ml
3. How to use HBVAXPRO 5 micrograms/0.5 ml
4. Possible side effects
5. How to store HBVAXPRO 5 micrograms/0.5 ml
6. Further information

1. WHAT IS HBVAXPRO 5 micrograms/0.5 ml AND WHAT IT IS USED FOR

This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (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.

2. BEFORE YOU USE HBVAXPRO 5 micrograms/0.5 ml

Do not use HBVAXPRO 5 micrograms/0.5 ml:

if your child is allergic (hypersensitive) to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO (see section 6.)
if your child has a severe febrile illness

Using other vaccines:

This vaccine can be administered simultaneously with hepatitis B immunoglobulin, at a separate injection site.

This vaccine can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.

This vaccine may be administered concomitantly with some other vaccines, using separate sites and syringes.

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription.

3. HOW TO USE HBVAXPRO 5 micrograms/0.5 ml

Posology:

The recommended dose for each injection (0.5 ml) is 5 micrograms for children and adolescents (birth through 15 years of age).

A course of vaccination should include at least three injections.

Two immunisation schedules can be recommended:

two injections with an interval of one month followed by a third injection 6 months after the first administration (0,1,6 months).
three injections with an interval of one month and a fourth dose 1 year later, if a rapid immunity is requested (0,1,2,12 months).

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 or pharmacist will inform you if a booster dose should be given.

Method of administration:

It should be well shaken until a slightly opaque white suspension is obtained.

The needle is attached by twisting in clockwise direction, until the needle fits securely on the syringe.

The doctor 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 vein.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia (diminution of blood platelets) or to persons at risk of haemorrhage.

If you forget one dose of HBVAXPRO 5 micrograms/0.5 ml:

If you miss a scheduled injection, your doctor will decide when to give the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, HBVAXPRO 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.

HBVAXPRO is generally well tolerated.

The most common side effects seen are injection-site reactions: soreness, redness and hardening.

Other side effects are reported very rarely: low platelet count, lymph node disease, allergic reactions, nervous system disorders such as pins and needles, facial paralysis, nerve inflammations including Guillain-Barre Syndrome, inflammation of the nerve of the eye that leads to impaired vision, brain inflammation, exacerbation of multiple sclerosis, multiple sclerosis, convulsions, headache, dizziness and fainting, low blood pressure, blood vessel inflammation, asthma-like symptoms, vomiting, nausea, diarrhoea, abdominal pain, skin reactions such as eczema, rash, hair loss, itching, hives and skin blistering, joint pain, arthritis, muscle pain, pain in extremity, fatigue, fever, vague illness, flu-like symptoms and elevations of liver enzymes.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HBVAXPRO 5 micrograms/0.5 ml

Keep out of the reach and sight of children.

Do not use HBVAXPRO after the expiry date which is stated on the label.

Store in a refrigerator (2 °C – 8 °C)

Do not freeze

6. FURTHER INFORMATION

What HBVAXPRO 5 micrograms/0.5 ml contains

The active substance is, for one dose of 0.5 ml:

Hepatitis B virus surface antigen, recombinant (HBsAg) * 5.00 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced from recombinant strain of the yeast Saccharomyces cerevisiae (strain 2150-2-3)

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

Medicine: hbvaxpro 5mcg