ADVATE 500 IU

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

זמין מ:

TAKEDA ISRAEL LTD

קוד ATC:

B02BD02

טופס פרצבטיות:

POWDER FOR SOLUTION FOR INJECTION

הרכב:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 500 IU/VIAL

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

BAXTER AG, AUSTRIA

קבוצה תרפויטית:

COAGULATION FACTOR VIII

איזור תרפויטי:

COAGULATION FACTOR VIII

סממני תרפויטית:

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

תאריך אישור:

2018-09-30

מאפייני מוצר

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