Country: Singapúr
Tungumál: enska
Heimild: HSA (Health Sciences Authority)
Human Hepatitis B Immunoglobulin in 50mg/ml human plasma protein (IgG ≥ 96%)
GRIFOLS ASIA PACIFIC PTE. LTD.
J06BB04
50 iu/ml
INFUSION, SOLUTION
Human Hepatitis B Immunoglobulin in 50mg/ml human plasma protein (IgG ≥ 96%) 50 iu/ml
INTRAVENOUS
Prescription Only
Biotest AG
ACTIVE
2014-10-24
184678 001 PACKAGE LEAFLET 1. NAME OF THE MEDICINAL PRODUCT Hepatect ® CP 50 IU/ml; solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. Human protein 50 g/l of which at least 96 % is IgG, with a content of anti- bodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml One vial of 2 ml contains: 100 IU One vial of 10 ml contains: 500 IU One vial of 40 ml contains: 2000 IU One vial of 100 ml contains: 5000 IU Distribution of IgG subclasses: IgG1: 59% IgG2: 35 % IgG3: 3 % IgG4: 3 % IgA max 2 mg/ml. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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 per- sons whose vaccination is incomplete or status unknown). 184.678.001.indd 1 17.05.13 08:19 - 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY PREVENTION OF HEPATITIS B RE-INFECTION AFTER LIVER TRANSPLANTATION FOR HEPATITIS B IN- DUCED LIVER FAILURE: In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40- 200 ml)/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. In Lestu allt skjalið
Hepatect CP 1/7 12 / 2019 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Hepatect CP 50 IU/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. Human 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 One vial of 2 ml contains: 100 IU One vial of 10 ml contains: 500 IU One vial of 40 ml contains: 2000 IU One vial of 100 ml contains: 5000 IU Distribution of IgG subclasses (approx..values): IgG1: 59% IgG2: 35 % IgG3: 3 % IgG4: 3 % The maximum IgA content is 2,000 micrograms /ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion The solution is clear or slightly opalescent and colourless to pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. Hepatect CP 2/7 12 / 2019 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY 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 2000-10 000 IU (40-200 ml)/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. In children: Posology should be adjusted according to body surface area, on the basis of 10 000 IU/1.73 m 2 . IMMUNOPROPHYLAXIS OF HEPATITIS B: - Preve Lestu allt skjalið