BeneFIX
Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Informace pro uživatele
(PIL)
17-10-2022
Charakteristika produktu
(SPC)
17-10-2022
Veřejná zpráva o hodnocení
(PAR)
30-10-2015
Aktivní složka:
Nonacog alfa
Dostupné s:
Pfizer Europe MA EEIG
ATC kód:
B02BD04
INN (Mezinárodní Name):
nonacog alfa
Terapeutické skupiny:
Antihemorrhagics
Terapeutické oblasti:
Hemophilia B
Terapeutické indikace:
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).,
Přehled produktů:
Revision: 42
Stav Autorizace:
Authorised
Datum autorizace:
1997-08-27
Informace pro uživatele
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
Přečtěte si celý dokument
Charakteristika produktu
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
Přečtěte si celý dokument
