국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
Nonacog alfa
Pfizer Europe MA EEIG
B02BD04
nonacog alfa
Antihemorrhagics
Hemophilia B
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).,
Revision: 42
Authorised
1997-08-27
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa. BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU non 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa. BeneFIX 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU non 전체 문서 읽기