Active Ingredient: Hepatitis B, purified antigen
Hepatitis B vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.
The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with hepatitis B vaccine as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intramuscular, 0.5 milliliters hepatitis B, purified antigen, once monthly, 2 doses in total, over the duration of 6 months. Afterwards, intramuscular, 0.5 milliliters hepatitis B, purified antigen, one dose.
Regimen B: Intramuscular, 0.5 milliliters hepatitis B, purified antigen, once monthly, 3 doses in total, over the duration of 12 months. Afterwards, intramuscular, 0.5 milliliters hepatitis B, purified antigen, one dose.
Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection.
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.
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.
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.
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.
Dosage recommendation for neonates of mothers who are hepatitis B virus carriers:
Dosage recommendation for known or presumed exposure to hepatitis B virus (e.g. needlestick with contaminated needle):
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.
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