ADVATE 1000 IU

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

Доступно од:

TAKEDA ISRAEL LTD

АТЦ код:

B02BD02

Фармацеутски облик:

POWDER FOR SOLUTION FOR INJECTION

Састав:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 1000 IU/VIAL

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

BAXTER AG, AUSTRIA

Терапеутска група:

COAGULATION FACTOR VIII

Терапеутска област:

COAGULATION FACTOR VIII

Терапеутске индикације:

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

Датум одобрења:

2018-09-30

Карактеристике производа

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