Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure: Adults: 2000 IU every 15 days.
For the long term treatment the dosage should be aimed to the maintenance of the serum level of anti HBsAg antibodies above 100 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.
Paediatric population: There are no available data regarding the efficacy in paediatric population.
Immunoprophylaxis of hepatitis B: Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: at least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24-72 hours.
Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion following vaccination.
Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30-100 IU/kg. The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
Method of administration: IMMUNOHBs should be administered via the intramuscular route.
If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
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