AVAXIM VACCINE [SIN10611P]

Product Info

AVAXIM VACCINE

[SIN10611P]

4.1 Therapeutic indications

This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents from 16 years of age and in adults.

This vaccine should be administered in accordance with official recommendations.

4.2 Posology and method of administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It is estimated that anti-VHA antibodies persist several years (beyond 10 years) after the second dose (booster). This recommendation is based on mathematical modelling with persistence data available for 3–5 years.

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.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients or to neomycin (that may be present as traces in each dose due to its use during the manufacturing process).

• Hypersensitivity following a previous injection of this vaccine.

• Vaccination should be postponed in case of severe acute febrile illness.