Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
HUMAN BLOOD COAGULATION FACTOR VIII
GRIFOLS ASIA PACIFIC PTE. LTD.
B02BD02
250 iu/vial
INJECTION, POWDER, FOR SOLUTION
HUMAN BLOOD COAGULATION FACTOR VIII 250 iu/vial
INTRAVENOUS
Prescription Only
BIOTEST AG
ACTIVE
1998-11-11
184091 002 INSTRUCTIONS FOR USE HAEMOCTIN® SDH 250 / HAEMOCTIN® SDH 500 Powder and solvent for solution for injection ACTIVE SUBSTANCE Human plasma derived coagulation factor VIII COMPOSITION One vial of Haemoctin® SDH 250 / Haemoctin® SDH 500 contains 250 IU / 500 IU human plasma derived coagulation factor VIII when reconstituted with either 5 ml or 10 ml of water for injections. Haemoctin® SDH 250 / Haemoctin® SDH 500 contains approximately 50 IU/ml human coagulation factor VIII. The potency (IU) is determined using the European Pharmacopoeia chro- mogenic factor VIII coagulation assay. The specific activity of Haemoctin® SDH 250 / Haemoctin® SDH 500 is approximately 100 IU/mg protein. Excipients (powder): glycine, sodium chloride, sodium citrate, calcium chloride Solvent: water for injections PHARMACEUTICAL FORM Powder and solvent for solution for injection PACK SIZES Haemoctin® SDH 250 Powder and solvent for solution for injection Each pack contains: one vial with powder (250 IU) one vial with 5 ml water for injections one disposable syringe one transfer system with integral filter one butterfly cannula Haemoctin® SDH 500 Powder and solvent for solution for injection Each pack contains: one vial with powder (500 IU) one vial with 10 ml water for injections one disposable syringe one transfer system with integral filter one butterfly cannula 184.091.002.indd 1 30.03.2011 8:18:39 Uhr INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This product may be used in the management of acquired factor VIII deficiency. This preparation does not contain von Willebrand factor in pharmacologically effec- tive quantities and is therefore not indicated in von Willebrand‘s disease. DOSAGE AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experien Διαβάστε το πλήρες έγγραφο
1 Instructions for use HAEMOCTIN SDH 250 HAEMOCTIN SDH 500 HAEMOCTIN SDH 1000 ACTIVE SUBSTANCE Human plasma derived coagulation factor VIII COMPOSITION One vial contains nominally 250, 500 or 1000 IU human plasma derived coagulation factor VIII. Haemoctin SDH 250 contains approximately 250 IU (50 IU/ml) human coagulation factor VIII after reconstitution. Haemoctin SDH 500 contains approximately 500 IU (100 IU/ml) human coagulation factor VIII after reconstitution. Haemoctin SDH 1000 contains approximately 1000 IU (200 IU/ml) human coagulation factor VIII after reconstitution. The potency (IU) is determined using the European Pharmacopoeia chromogenic factor VIII coagulation assay. The specific activity of Haemoctin SDH is approximately 100 IU/mg protein. Produced from the plasma of human donors. Excipient with known effect: One vial contains up to 32.2 mg sodium (1.4 mmol). List of excipients Powder: glycine, sodium chloride, sodium citrate, calcium chloride Solvent: water for injections PHARMACEUTICAL FORM Powder and solvent for solution for injection White powder and clear, colourless solvent for solution for injection. 1 package Haemoctin SDH contains: 1 vial (20ml), of glass type 1 acc. to Ph. Eur., with powder Freeze-drying stoppers, of chlorobutyl, type 1 acc. to Ph. Eur. 1 vial, glass type 1 acc. to Ph. Eur., with 5 ml solvent Injection stoppers, of bromobutyl, type 1 acc. to Ph. Eur. The pack also contains: 1 disposable syringe (5ml), 1 transfer system with integral filter, 1 butterfly cannula. INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). This product may be used in the management of acquired factor VIII deficiency. This preparation does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand's disease. DOSAGE AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. Biotest’s logo Διαβάστε το πλήρες έγγραφο