PEMETREXED POWDER FOR SOLUTION
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
07-06-2016
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유효 성분:
PEMETREXED (PEMETREXED DISODIUM)
제공처:
APOTEX INC
ATC 코드:
L01BA04
INN (국제 이름):
PEMETREXED
복용량:
100MG
약제 형태:
POWDER FOR SOLUTION
구성:
PEMETREXED (PEMETREXED DISODIUM) 100MG
관리 경로:
INTRAVENOUS
패키지 단위:
10ML/50ML
처방전 유형:
Prescription
치료 영역:
ANTINEOPLASTIC AGENTS
제품 요약:
Active ingredient group (AIG) number: 0150104002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2016-06-03
제품 특성 요약
_PEMETREXED Product Monograph_
Page 1 of 66
PRODUCT MONOGRAPH
Pr
PEMETREXED
PEMETREXED DISODIUM FOR INJECTION
100 MG OR 500 MG PEMETREXED PER VIAL
STERILE LYOPHILIZED POWDER
ANTINEOPLASTIC AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
June 01, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 180839
_PEMETREXED Product Monograph_
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3
SUMMARY PRODUCT INFORMATION .................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE REACTIONS
........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................19
DOSAGE AND ADMINISTRATION
......................................................................................20
OVERDOSAGE
....................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
......................................................................26
STORAGE AND STABILITY
................................................................................................28
SPECIAL HANDLING INSTRUCTIONS
................................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................28
PART II: SCIENTIFIC INFORMATION .................................................................................30
PHARMACEUTICAL INFORMATION
..................................................................................30
CLINICAL TRIALS
........................................................
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