AVAXIM Suspension for injection in a prefilled syringe Ref.[28228] Active ingredients: Hepatitis A, inactivated vaccine

Posology

The recommended dosage for subjects from 16 years of age is 0.5 ml.

The initial protection is obtained after one single injection.

In order to obtain a long-term protection against infections caused by the Hepatitis A virus, in adolescents from 16 years of age and in adults, a second dose (booster) should be administered, preferably between 6 and 12 months after the first vaccination and can be administered up to 36 months after the first vaccination (see section 5.1). It is estimated that anti-VHA antibodies persist several years (beyond 10 years) after the second dose (booster).

This vaccine can also be administered as a booster dose of the hepatitis A vaccination in subjects from 16 years of age who received a first injection with the combined typhoid fever (Vi purified polysaccharide) and hepatitis A (inactivated) vaccine between 6 and 36 months earlier.

Paediatric population

Not applicable.

Method of administration

• This vaccine must be administered by the intramuscular route (IM). The recommended injection site is the deltoid region.
• In exceptional cases, the vaccine may be administered by the subcutaneous route in patients with thrombocytopenia or in patients at risk of haemorrhage.
• The vaccine should not be administered into the buttocks because of the varying amount of fat tissue in this region, that may contribute to variability in effectiveness of the vaccine.
• Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
• Do not inject by the intradermal route.
• See section 6.6 for the instructions on preparation.

A few cases of overdose have been reported with AVAXIM 160 U, with no specific undesirable effects.

3 years.

Store in a refrigerator (2°C-8°C).

Do not freeze.

If frozen, the vaccine should be discarded.

Keep in the original packaging, protected from light.

0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), and an attached needle. Box of 1, 5, 10 or 20.

0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), without needle. Box of 1 or 10.

0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), with 1 or 2 separate needles. Box of 1 or 10.

All pack sizes may not be marketed.

Shake before injection, until a homogenous suspension is obtained.

For the syringes without attached needles, the separate needle should be fitted firmly to the syringe, rotating it by one quarter turn.

The vaccine must be visually inspected before administration to verify the absence of foreign particles.

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