Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Human Antithrombin
GRIFOLS ASIA PACIFIC PTE. LTD.
B01AB02
1000 I.U. per 20ml
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Human Antithrombin 1000 I.U. per 20ml
INTRAVENOUS
Prescription Only
INSTITUTO GRIFOLS, S.A. (manufacturer for lyophilisate)
ACTIVE
2009-08-06
Human antithrombin QUALITATIVE AND QUANTITATIVE COMPOSITION Human antithrombin. Anbinex ® is presented as a lyophilised powder containing nominally 500 I.U. or 1000 I.U. human plasma-derived antithrombin per vial. The product contains approximately 500 I.U./10 ml or 1000 I.U./20 ml human plasma-derived antithrombin when reconstituted with 10 ml or 20 ml of water for injections. The potency (I.U.) is determined using the European Pharmacopoeial chromogenic assay. The specific activity of Anbinex ® is at least 5 I.U./mg protein. For a full list of excipients, see section "List of excipients". PHARMACEUTICAL FORM Powder and solvent for solution for infusion. Vial containing a white, hygroscopic, friable solid or powder and a syringe pre-filled with water for injections. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS - Patients with congenital deficiency: a) Prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations (especially during surgery or during the peri-partum period), in association with heparin if indicated. b) Prevention of progression of deep vein thrombosis and thromboembolism in association with heparin as indicated. POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with deficiency of antithrombin. Posology In congenital deficiency, dosage should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment. The number of units of antithrombin administered is expressed in International Units (I.U.), which are related to the current WHO standard for antithrombin. Anti Prečítajte si celý dokument
Human antithrombin QUALITATIVE AND QUANTITATIVE COMPOSITION Human antithrombin. Anbinex ® is presented as a lyophilised powder containing nominally 500 I.U. or 1000 I.U. human plasma-derived antithrombin per vial. The product contains approximately 500 I.U./10 ml or 1000 I.U./20 ml human plasma-derived antithrombin when reconstituted with 10 ml or 20 ml of water for injections. The potency (I.U.) is determined using the European Pharmacopoeial chromogenic assay. The specific activity of Anbinex ® is at least 5 I.U./mg protein. For a full list of excipients, see section "List of excipients". PHARMACEUTICAL FORM Powder and solvent for solution for infusion. Vial containing a white, hygroscopic, friable solid or powder and a syringe pre-filled with water for injections. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS - Patients with congenital deficiency: a) Prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations (especially during surgery or during the peri-partum period), in association with heparin if indicated. b) Prevention of progression of deep vein thrombosis and thromboembolism in association with heparin as indicated. POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with deficiency of antithrombin. Posology In congenital deficiency, dosage should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment. The number of units of antithrombin administered is expressed in International Units (I.U.), which are related to the current WHO standard for antithrombin. Antithrombin activity plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for antithrombin in plasma). One International Unit (I.U.) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal Prečítajte si celý dokument