Posology : מינונים

4.2   Posology and method of administration

Posology
Havrix 720 Junior - Children/adolescents (1-15 years):
Primary immunisation consists of a single dose given intramuscularly. This provides anti-HAV antibodies for at least one year.

This vaccine confers protection against hepatitis A within two to four weeks.

In order to obtain more persistent immunity, for at least 10 years, a booster dose is recommended between 6 and 12 months after primary immunisation.

Booster vaccination delayed up to 3 years after the primary dose induces similar antibody levels as a booster dose administered within the recommended time interval.

Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course (see section 5.1).

Havrix 720 Junior can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine.

In the event of a subject being exposed to a high risk of contracting hepatitis A within two weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.

Havrix 1440 - Adults (16 years and over):
Primary immunisation consists of a single dose given intramuscularly. This provides anti-HAV antibodies for at least one year.

This vaccine confers protection against hepatitis A within 2-4 weeks.

In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation.

Although a booster should be given within 6–12 months of the initial vaccination, it has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels to subjects given a booster within the recommended time period. Subjects given a booster up to 5 years after initial vaccination can also show a satisfactory antibody response, but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.

It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination.

Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course (see section 5.1).

The results described above should be considered to apply only to immunocompetent adults.

Havrix 1440 can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine.

In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose, human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.
Method of administration
The vaccine should be injected intramuscularly in the deltoid region or into the antero-lateral part of the thigh in young children. The vaccine should not be administered in the gluteal region.

The vaccine should never be administered intravascularly.

The vaccine should not be administered subcutaneously/intradermally since administration by these routes may result in a less than optimal anti-HAV antibody response. In subjects with a bleeding disorder who are at risk of haemorrhage following intramuscular injection (e.g. haemophiliacs), this vaccine may be administered by deep subcutaneous injection as per local guidance. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.