Prevention of Hepatitis B in Case of Accidental Exposure in Non-Immunised Subjects (Including Persons Whose Vaccination is Incomplete or Status Unknown): 12 IU/kg bodyweight (bw), at least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably within 72 hrs.
Immunoprophylaxis of Hepatitis B in Haemodialysed Patients: 8-12 IU/kg bw (maximal 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 bw (normally 1 mL). 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 bw to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 MIU/mL.
Administration: Human hepatitis B immunoglobulin should be administered via the IM route.
Do not use solutions which are cloudy or contain residues (deposits/particles).
Hepatitis B Immunoglobulin P Behring is a ready-to-use solution and should be administered at body temperature.
If comparatively large volumes are required it is advisable to administer them in divided fractions. This applies in the case of doses >2 mL for children up to 20 kg bw and doses >5 mL for persons >20 kg bw.
In case of simultaneous prophylaxis the immunoglobulin and the vaccine should be administered at contralateral sites of the body.
In the presence of a severe coagulation disorder, in the case of which IM injections are contraindicated, Hepatitis B Immunoglobulin P Behring may also be given SC. Afterwards, the injection site should be compressed with a swab.
However, it should be noted that there are no clinical efficacy data to support administration by the SC route.