FLUDARABINE PHOSPHATE INJECTION SOLUTION
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
14-01-2017
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유효 성분:
FLUDARABINE PHOSPHATE
제공처:
FRESENIUS KABI CANADA LTD
ATC 코드:
L01BB05
INN (국제 이름):
FLUDARABINE
복용량:
25MG
약제 형태:
SOLUTION
구성:
FLUDARABINE PHOSPHATE 25MG
관리 경로:
INTRAVENOUS
패키지 단위:
2ML
처방전 유형:
Prescription
치료 영역:
ANTINEOPLASTIC AGENTS
제품 요약:
Active ingredient group (AIG) number: 0123842003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2015-06-04
제품 특성 요약
PRODUCT MONOGRAPH
PR
FLUDARABINE PHOSPHATE INJECTION
25 mg/mL
USP
PR
FLUDARABINE PHOSPHATE FOR INJECTION
50 mg/vial
USP
Antineoplastic
FRESENIUS KABI CANADA LTD.
Date of Revision:
45 Vogell Rd, Suite 200
January 9, 2017
Richmond Hill, ON, L4B 3P6
Control No. 201501
_ _
Fludarabine Liq-PM-ENG-v2.0-Proposed PM_ _
_Page 2 of 57 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHARMACOLOGY
...........................
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