ADVATE 1000 IU

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

Disponível em:

TAKEDA ISRAEL LTD

Código ATC:

B02BD02

Forma farmacêutica:

POWDER FOR SOLUTION FOR INJECTION

Composição:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 1000 IU/VIAL

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

BAXTER AG, AUSTRIA

Grupo terapêutico:

COAGULATION FACTOR VIII

Área terapêutica:

COAGULATION FACTOR VIII

Indicações terapêuticas:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Data de autorização:

2018-09-30

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ADVATE 250 IU powder and solvent for solution for injection.
ADVATE 500 IU powder and solvent for solution for injection.
ADVATE 1000 IU powder and solvent for solution for injection.
ADVATE 1500 IU powder and solvent for solution for injection.
ADVATE 2000 IU powder and solvent for solution for injection.
ADVATE 3000 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_ADVATE 250 IU powder and solvent for solution for injection. _
Each vial contains nominally 250 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 50 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
_ADVATE 500 IU powder and solvent for solution for injection. _
Each vial contains nominally 500 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 100 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
_ADVATE 1000 IU powder and solvent for solution for injection. _
Each vial contains nominally 1000 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 200 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
_ADVATE 1500 IU powder and solvent for solution for injection. _
Each vial contains nominally 1500 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 300 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
_ADVATE 2000 IU powder and solvent for solution for injection. _
Each vial contains nominally 2000 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 400 IU per ml of human coagulation factor VIII
(rDNA), octocog alfa after
reconstitution.
_ADVATE 3000 IU powder and solvent for solution for injection. _
Each vial contains nominally 3000 IU human coagulation factor VIII
(rDNA), octocog alfa. ADVATE
contains approximately 600 IU per ml