Venbig Dosage/Direction for Use

Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure: In adults: 10,000 IU on the day of transplantation, peri-operatively; then 2,000-10,000 IU/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.
Paediatric population: Posology must be adjusted according to body surface area, on the basis of 10,000 IU/1.73 m².
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. In the clinical practice the intramuscular route is preferred whenever repeated administration is required to achieve seroconversion after 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: VENBIG must be infused intravenously at an initial rate of 0.46-0.92 ml/kg/h (for example, for a patient of 65 kg at 10-20 drops/minute) for 20-30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 1.85 ml/kg/hr (for example, for a patient of 65 kg at 40 drops/minute) for the remainder of the infusion.
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.