Country: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
Human Hepatitis B Immunoglobulin in 150g/l human plasma protein (IgG ≥ 96%)
ESHCOL PHARMACEUTICAL GROUP SINGAPORE PTE LTD
J06BB04
500 iu/ml
INJECTION
Human Hepatitis B Immunoglobulin in 150g/l human plasma protein (IgG ≥ 96%) 500 iu/ml
SUBCUTANEOUS
Prescription Only
Vetter Pharma-Fertigung GmbH Co. KG (filling, packing and labelling)
ACTIVE
2014-10-24
ACTIVE SUBSTANCE Human hepatitis B immunoglobulin for subcutaneous adminis- tration COMPOSITION One pre-filled syringe of 1ml contains Human hepatitis B immuno- globulin 500 IU. Human protein 150 mg/ml of which at least 96% is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml. Distribution of IgG subclasses: IgG1: 59%, IgG2: 35%, IgG3: 3%, IgG4: 3% IgA content max. 6,000 micrograms/ml. Excipients: Glycine, water for injections PHARMACEUTICAL FORM AND PRESENTATIONS Solution for injection in pre-filled syringe Pack size of five syringes in a blistered pack. PHARMACOTHERAPEUTIC GROUP Specific immunoglobulins, ATC code: J06BB04 NAME AND ADDRESS OF MANUFACTURER Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Ger- many INDICATIONS Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA nega- tive patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure. Zutectra is indicated in adults only. The concomitant use of adequate virostatic agents should be con- sidered, if appropriate, as standard of hepatitis B re-infection proph- ylaxis. POSOLOGY AND METHOD OF ADMINISTRATION Posology In HBV-DNA negative adults ≥ 6 months after liver transplantation: - patients with bodyweight < 75 kg: 500 IU (1 ml)/week - patients with bodyweight ≥ 75 kg: 1,000 IU (2 times 1 ml)/week Package Leaflet 500 IU solution for injection in pre-filled syringe Prior to the initiation of subcutaneous treatment with Zutectra, anti-HBs serum levels should be stabilized with an adequate in- travenous hepatitis B immunoglobulin to levels at or above 300- 500 IU/l. The first Zutectra dose should be administered approxi- mately 14-21 days after the last intravenous dose at stabilized anti- HBs serum levels i Aqra d-dokument sħiħ
Package Leaflet ZUTECTRA® 500 IU solution for injection in pre-filled syringe ACTIVE SUBSTANCE Human hepatitis B immunoglobulin for subcutaneous administration COMPOSITION One pre-filled syringe of 1ml contains Human hepatitis B immunoglobulin 500 IU. Human protein 150 mg/ml of which at least 96% is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml. Distribution of IgG subclasses: IgG1: 59%, IgG2: 35%, IgG3: 3%, IgG4: 3% The maximum IgA content is 6,000 micrograms/ml. Excipients: Glycine, water for injections PHARMACEUTICAL FORM AND PRESENTATIONS Solution for injection in pre-filled syringe Pack size of five syringes in a blistered pack. PHARMACOTHERAPEUTIC GROUP Specific immunoglobulins, ATC code: J06BB04 NAME AND ADDRESS OF MANUFACTURER Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany INDICATIONS Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re- infection prophylaxis. POSOLOGY AND METHOD OF ADMINISTRATION Posology In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels. Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilized with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing. Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients. The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 Aqra d-dokument sħiħ