ADVATE 1000 IU

국가: 이스라엘

언어: 영어

출처: Ministry of Health

지금 구매하세요

제품 특성 요약 제품 특성 요약 (SPC)
25-10-2023
공공 평가 보고서 공공 평가 보고서 (PAR)
06-03-2023

유효 성분:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT)

제공처:

TAKEDA ISRAEL LTD

ATC 코드:

B02BD02

약제 형태:

POWDER FOR SOLUTION FOR INJECTION

구성:

OCTOCOG ALFA (ANTIHEMOPHILIC FACTOR RECOMBINANT) 1000 IU/VIAL

관리 경로:

I.V

처방전 유형:

Required

Manufactured by:

BAXTER AG, AUSTRIA

치료 그룹:

COAGULATION FACTOR VIII

치료 영역:

COAGULATION FACTOR VIII

치료 징후:

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

승인 날짜:

2018-09-30

제품 특성 요약

                                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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