Active Ingredient: Hepatitis A, inactivated vaccine
The hepatitis A vaccine is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intramuscular, 50 international units hepatitis A, inactivated vaccine, one dose, over the duration of 6 to 18 months. Afterwards, intramuscular, 50 international units hepatitis A, inactivated vaccine, one dose.
The vaccination series consists of one primary dose and one booster dose given according to the following schedule:
Primary dose:
Adults 18 years of age and older should receive a single 1.0 mL (50U) dose of vaccine at an elected date.
Booster dose:
Adults 18 years of age and older who received a primary dose should receive a booster dose of 1.0 mL (50U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 6 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years.
A booster dose may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines.
It should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered intradermally since administration by this route may result in a less than optimal response.
For individuals with bleeding disorders who are at risk of haemorrhage following intramuscular injection (e.g. haemophiliacs), this vaccine may be administered subcutaneously.
For:
Intramuscular, 25 international units hepatitis A, inactivated vaccine, one dose. Afterwards, intramuscular, 25 international units hepatitis A, inactivated vaccine, one dose.
The vaccination series consists of one primary dose and one booster dose given according to the following schedule:
Primary dose:
Children and adolescents aged 12 months to 17 years of age should receive a single 0.5 mL (25 U) dose of vaccine at an elected date.
Safety and effectiveness in infants <12 months of age have not been established.
Booster dose:
Individuals who received a primary dose at 12 months to 17 years of age should receive a booster dose of 0.5 mL (25 U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 10 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years.
A booster dose may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines as shown by data for adults, 18 to 83 years of age; no such data are available for the 25 U/0.5 mL presentation.
The vaccine should be injected INTRAMUSCULARLY. The deltoid muscle is the preferred site for injection. The anterolateral thigh region may be used in infants if the deltoid muscle is not sufficiently developed. The vaccine should not be administered subcutaneously or intradermally since administration by these routes may result in a less than optimal antibody response.
For individuals with bleeding disorders who are at risk of haemorrhage following intramuscular injection (e.g., haemophiliacs) other measures can be taken such as intramuscular administration of the vaccine after anti-haemophilia or other similar therapy, or applying pressure. This vaccine may be administered subcutaneously to these subjects.
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