ENTERIC COATED DAILY LOW DOSE ASA 81 MG TABLET (DELAYED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ACETYLSALICYLIC ACID

제공처:

VITA HEALTH PRODUCTS 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:

30/120/180/300

처방전 유형:

OTC

치료 영역:

SALICYLATES

제품 요약:

Active ingredient group (AIG) number: 0101169013; AHFS:

승인 상태:

APPROVED

승인 날짜:

2011-02-17

제품 특성 요약

ASA 81 mg Page 1 of 46
PRODUCT MONOGRAPH
ASA 81 MG
Acetylsalicylic Acid Delayed Release Tablets
81 mg
USP
Platelet aggregation inhibitor
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, MB
Canada R2J 3W2
Control Number: 261087
Date of Preparation:
February 3, 2011
Date of Revision :
March 23, 2022
ASA 81 mg Page 2 of 46
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
.....................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.....................................................................................
14
CLINICAL TRIALS
..............