ADVATE 500 IU
Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
Caracteristicilor produsului
(SPC)
25-10-2023
Raport public de evaluare
(PAR)
06-03-2023
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Trimite cerere.
Trimite cerere.
Ingredient activ:
OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)
Disponibil de la:
TAKEDA ISRAEL LTD
Codul ATC:
B02BD02
Forma farmaceutică:
POWDER FOR SOLUTION FOR INJECTION
Compoziție:
OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 500 IU/VIAL
Calea de administrare:
I.V
Tip de prescriptie medicala:
Required
Produs de:
BAXTER AG, AUSTRIA
Grupul Terapeutică:
COAGULATION FACTOR VIII
Zonă Terapeutică:
COAGULATION FACTOR VIII
Indicații terapeutice:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Data de autorizare:
2018-09-30
Caracteristicilor produsului
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
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