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Human Hepatitis B Immunoglobulin 180IU/1ml
NAME OF THE MEDICINE
ImmunoHBs
Human Hepatitis B Immunoglobulin 180 IU/ml Solution for injection for intramuscular use vial of 180 IU/ml
COMPOSITION
Human hepatitis B immunoglobulin
|
IMMUNOHBs 180 IU/ml |
|
|
Human proteins |
100-180 g/l |
|
of which human immunoglobulin (IgG) at least to |
90% |
|
antibodies to HBs antigen (anti – HBs) not less than |
180 IU/ml 180 IU in 1 ml vial 540 IU in 3 ml vial |
Excipients:
The medicinal product contains 3.9 mg sodium per ml
INDICATIONS
- 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.
PRESENTATION
Carton box containing:
one neutral, transparent, type I glass vial with elastomer stopper suitable for perforation, or one pre-filled syringe in neutral glass with attached needle and plunger made of halobutyl.
Vial with 1 ml of solution containing 180 IU
MANUFACTURER
Production from Fraction II and Batch Release
KEDRION S.P.A
S.S 7 Bis Km 19,5 – 80029 Sant’Antimo Naples – Italy
Production up to Fraction II and determination of pyrogens on finished product
KEDRION S.P.A
Bolognana Gallicano – 55027 Lucca – Italy
Read the package insert carefully before use.
For any more information, please consult your doctor