国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
moroctocog alfa
Pfizer Europe MA EEIG
B02BD02
moroctocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.,
Revision: 40
Authorised
1999-04-13
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa. ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa. ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa. ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctoco 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa. ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa. ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa. ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctoco 阅读完整的文件