BeneFIX
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-10-2022
Charakterystyka produktu
(SPC)
17-10-2022
Sprawozdanie z oceny publicznego
(PAR)
30-10-2015
Składnik aktywny:
Nonacog alfa
Dostępny od:
Pfizer Europe MA EEIG
Kod ATC:
B02BD04
INN (International Nazwa):
nonacog alfa
Grupa terapeutyczna:
Antihemorrhagics
Dziedzina terapeutyczna:
Hemophilia B
Wskazania:
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).,
Podsumowanie produktu:
Revision: 42
Status autoryzacji:
Authorised
Data autoryzacji:
1997-08-27
Ulotka dla pacjenta
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
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Charakterystyka 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
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