ADVATE 1000 IU

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

Verfügbar ab:

TAKEDA ISRAEL LTD

ATC-Code:

B02BD02

Darreichungsform:

POWDER FOR SOLUTION FOR INJECTION

Zusammensetzung:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 1000 IU/VIAL

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

BAXTER AG, AUSTRIA

Therapiegruppe:

COAGULATION FACTOR VIII

Therapiebereich:

COAGULATION FACTOR VIII

Anwendungsgebiete:

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

Berechtigungsdatum:

2018-09-30

Fachinformation

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