Niuliva Solution For Infusion 250 I.U./ml

INJECTION, SOLUTION

**Posology and method of administration** _Posology_ **Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure during the maintenance phase in non replicator patients**: In adults: 2,000 – 10,000 international units/month to maintain antibody levels above 100 – 150 international units/l in HBV-DNA negative patients. **Immunoprophylaxis of hepatitis B**: - Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 international units, 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 international units/kg with a maximum of 500 international units, 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 international units/kg. The antihepatitis B immunoglobulin administration may 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 on the same day as human antihepatitis B immunoglobulin, however in different sites. In subjects who did not show an immune response (no measurable antihepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 international units to adults and 8 international units/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 milli-international units/ml. _Method of administration_ Niuliva® should be infused intravenously at a maximum initial rate of 0.02 ml/kg/min for the first 10 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.04 ml/kg/min. Therefore, generally, the administration of 5,000 international units will be performed in less than 15 minutes. In the case that there are no adverse reactions, the maximum initial rate of the following infusions will also be of 0.02 ml/kg/min and, if well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min. In general, the time for administration of 5,000 international units will be less than 10 minutes.