Neohepatect CP (Hepatect CP)
Solution for infusion
The solution is clear or slightly opalescent.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human hepatitis B immunoglobulinHuman protein 50 g/l of which at least 96 % is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml.
Each vial of 2 ml contains: 100 IU
Each vial of 10 ml contains: 500 IU
Each vial of 40 ml contains: 2000 IU
Each vial of 100 ml contains: 5000 IU
Distribution of IgG subclasses:
IgG2: 35 %
IgG3: 3 %
IgG4: 3 %
IgA max 2,000 micrograms/ml.
Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.
Immunoprophylaxis of hepatitis B
In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).
In haemodialysed patients, until vaccination has become effective.In the newborn of a hepatitis B virus carrier-mother.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
For more information: Swedish Medical Products Agency: