NOVOEIGHT 250 IU

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

TUROCTOCOG ALFA

Disponível em:

NOVO NORDISK LTD, ISRAEL

Código ATC:

B02BD02

Forma farmacêutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composição:

TUROCTOCOG ALFA 250 IU / 4 ML

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

NOVO NORDISK A/S, DENMARK

Área terapêutica:

COAGULATION FACTOR VIII

Indicações terapêuticas:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).NovoEight can be used for all age groups.

Data de autorização:

2015-09-21

Características técnicas

1
The content of this leaflet was approved by the Ministry of Health in
September 2015 and updated
according to the guidelines of the Ministry of Health in January 2019
1.
NAME OF THE MEDICINAL PRODUCT
NovoEight 250 IU powder and solvent for solution for injection
NovoEight 500 IU powder and solvent for solution for injection
NovoEight 1000 IU powder and solvent for solution for injection
NovoEight 1500 IU powder and solvent for solution for injection
NovoEight 2000 IU powder and solvent for solution for injection
NovoEight 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoEight 250 IU powder and solvent for solution for injection.
Each powder vial contains nominally 250 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 62.5 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 500 IU powder and solvent for solution for injection.
Each powder vial contains nominally 500 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 125 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 1000 IU powder and solvent for solution for injection.
Each powder vial contains nominally 1000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 250 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 1500 IU powder and solvent for solution for injection.
Each powder vial contains nominally 1500 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 375 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog alfa.
NovoEight 2000 IU powder and solvent for solution for injection.
Each powder vial contains nominally 2000 IU human coagulation factor
VIII (rDNA), turoctocog alfa.
After reconstitution NovoEight contains approximately 500 IU/ml of
human coagulation factor VIII
(rDNA), turoctocog