ADVATE 500 IU

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Ciri produk Ciri produk (SPC)
25-10-2023
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
06-03-2023

Bahan aktif:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

Boleh didapati daripada:

TAKEDA ISRAEL LTD

Kod ATC:

B02BD02

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INJECTION

Komposisi:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 500 IU/VIAL

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

BAXTER AG, AUSTRIA

Kumpulan terapeutik:

COAGULATION FACTOR VIII

Kawasan terapeutik:

COAGULATION FACTOR VIII

Tanda-tanda terapeutik:

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

Tarikh kebenaran:

2018-09-30

Ciri produk

                                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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