NOVOEIGHT 250 IU

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

TUROCTOCOG ALFA

Tilgængelig fra:

NOVO NORDISK LTD, ISRAEL

ATC-kode:

B02BD02

Lægemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammensætning:

TUROCTOCOG ALFA 250 IU / 4 ML

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

NOVO NORDISK A/S, DENMARK

Terapeutisk område:

COAGULATION FACTOR VIII

Terapeutiske indikationer:

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

Autorisation dato:

2015-09-21

Produktets egenskaber

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