ENTERIC COATED ASA DAILY LOW DOSE TABLET (DELAYED-RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
13-03-2017
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유효 성분:
ACETYLSALICYLIC ACID
제공처:
PHARMASCIENCE INC
ATC 코드:
B01AC06
INN (국제 이름):
ACETYLSALICYLIC ACID
복용량:
81MG
약제 형태:
TABLET (DELAYED-RELEASE)
구성:
ACETYLSALICYLIC ACID 81MG
관리 경로:
ORAL
패키지 단위:
7/30/120/150/180/255/300/360/365/500/1000
처방전 유형:
OTC
치료 영역:
SALICYLATES
제품 요약:
Active ingredient group (AIG) number: 0101169013; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2017-10-21
제품 특성 요약
PRODUCT MONOGRAPH
ENTERIC COATED ASA DAILY LOW DOSE
Acetylsalicylic Acid Delayed-release Tablets, USP
81 mg
Analgesic, anti-inflammatory, antipyretic and
Platelet aggregation inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
DATE OF REVISION:
March 08, 2017
SUBMISSION CONTROL NUMBER: 199017
_ENTERIC COATED ASA DAILY LOW DOSE Product Monograph _
_Page 2 of 38_
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
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II : SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................1
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