Страна: Израиль
Язык: английский
Источник: Ministry of Health
FACTOR VIII (HUMAN)
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
B02BD02
POWDER FOR SOLUTION FOR INJECTION
FACTOR VIII (HUMAN) 1000 IU/VIAL
I.V
Required
GRIFOLS THERAPEUTICS LLC., USA
COAGULATION FACTOR VIII
COAGULATION FACTOR VIII
For the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII . Koate-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.
2015-02-28
1 PRESCRIBING INFORMATION KOATE ® -DVI 250/500/1000 Factor VIII (Human) 250/500/1000 IU/vial Powder for solution for injection For intravenous use after reconstitution only. 1 THERAPEUTIC INDICATIONS Koate-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koate-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia. 2 DOSAGE AND ADMINISTRATION Each vial of Koate-DVI is labeled with the actual Factor VIII potency in international units (IU). The reconstituted product must be administered intravenously by either direct syringe injection or drip infusion. The product must be administered within 3 hours after reconstitution. GENERAL APPROACH TO TREATMENT AND ASSESSMENT OF TREATMENT EFFICACY The dosages described below are presented as general guidance. It should be emphasized that the dosage of Koate-DVI required for hemostasis must be individualized according to the needs of the patient, the severity of the deficiency, the severity of the hemorrhage, the presence of inhibitors, and the factor VIII level desired. It is often critical to follow the course of therapy with factor VIII level assays. The clinical effect of Koate-DVI is the most important element in evaluating the effectiveness of treatment. It may be necessary to administer more Koate-DVI than would be estimated in order to attain satisfactory clinical results. If the calculated dose fails to attain the expected factor VIII levels, or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating inhibitor in the patient should be suspected. Its presence should be substantiated and the inhibitor level quantitated by appropriate laboratory tests. When an inhibitor is present, the dosage requirement for Antihemophilic Factor (Human) is extr Прочитать полный документ