AMBIRIX Suspension for injection Ref.[49680] Active ingredients: Hepatitis A, inactivated vaccine Hepatitis B, purified antigen

Posology

Dosage

A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.

Primary vaccination schedule

The standard primary course of vaccination consists of two doses, the first administered at the elected date and the second between 6 and 12 months after the first dose.

The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.

Booster dose

In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given. The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.

Long-term antibody persistence data following vaccination with Ambirix are available up to 15 years after vaccination (see section 5.1).

The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines. General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.

Hepatitis B

The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established. However some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.

For some categories of subjects at risk of exposure to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥10 mIU/ml is maintained.

Hepatitis A

It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory. Guidelines for boosting are based on the assumption that antibodies are required for protection.

Paediatric population

The safety and efficacy of Ambirix in children aged less than 1 year have not been established.

No data are available.

Method of administration

Ambirix is for intramuscular injection, usually into the deltoid muscle. However the anterolateral thigh may be used in very young subjects if preferred.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).

Cases of overdose with GlaxoSmithKline’s combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance. Adverse reactions reported following overdosage were similar to those reported with normal vaccine administration.

3 years.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package, in order to protect from light.

1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).

Pack sizes of 1 and 10 pre-filled syringes with or without needles and pack size of 50 pre-filled syringes without needles.

Not all pack sizes may be marketed.

Upon storage, a fine white deposit with a clear colourless layer above may be observed.

The vaccine should be re-suspended before use. When re-suspended, the vaccine will have a uniform hazy white appearance.

Re-suspension of the vaccine to obtain a uniform hazy white suspension

The vaccine should be re-suspended following the steps below.

• Hold the syringe upright in a closed hand.
• Shake the syringe by tipping it upside down and back again.
• Repeat this action vigorously for at least 15 seconds.
• Inspect the vaccine again:
  • If the vaccine appears as a uniform hazy white suspension, it is ready to use – the appearance should not be clear.
  • If the vaccine still does not appear as a uniform hazy white suspension – tip upside down and back again for at least another 15 seconds – then inspect again.

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, do not administer the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.