HBVAXPRO Suspension for injection Ref.[9864] Active ingredients: Hepatitis B, purified antigen

Posology

Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection:

Primary vaccination

A course of vaccination should include at least three injections.

Two primary immunisation schedules can be recommended:

0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.

0, 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.

It is recommended that the vaccine be administered in the schedules indicated. Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.

Booster

Immunocompetent vaccinees

The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established. However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.

Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)

In vaccinees with an impaired immune system, administration of additional doses of vaccine should be considered if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) is less than 10 IU/l.

Revaccination of nonresponders

When persons who do not respond to the primary vaccine series are revaccinated, 15-25% produce an adequate antibody response after one additional dose and 30-50 % after three additional doses. However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended. Revaccination should be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.

Special dosage recommendations

Dosage recommendation for neonates of mothers who are hepatitis B virus carriers:

• At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
• The first dose of the vaccine should be given within 7 days of birth and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.
• Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.

Dosage recommendation for known or presumed exposure to hepatitis B virus (e.g. needlestick with contaminated needle):

• Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
• The first dose of the vaccine should be given within 7 days of exposure and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.
• Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if necessary, (i.e. according to the serologic status of the patient) for short and long term protection.
• In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule. The accelerated schedule including the 12 month booster dose can be proposed.

Method of administration

This vaccine should be administered intramuscularly.

The anterolateral thigh is the preferred site for injection in neonates and infants. The deltoid muscle is the preferred site for injection in children and adolescents.

Do not inject intravascularly.

Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia or bleeding disorders.

Precautions to be taken before handling or administering the product: see section 6.6.

There have been reports of administration of higher than recommended doses of HBVAXPRO. In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.

3 years.

Store in a refrigerator (2°C–8°C).

Do not freeze. Store in the original package in order to protect from light.

HBVAXPRO should be administered as soon as possible after being removed from refrigeration. HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours. Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours. These are not, however, recommendations for storage.

0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps. Pack size of 1, 10.

0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps with an empty sterile injection syringe with needle. Pack size of 1.

Not all pack sizes may be marketed.

The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered. Before use, the vial should be well shaken.

Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.

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