ENTERIC COATED ASA DAILY LOW DOSE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-03-2017
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Active ingredient:
ACETYLSALICYLIC ACID
Available from:
PHARMASCIENCE INC
ATC code:
B01AC06
INN (International Name):
ACETYLSALICYLIC ACID
Dosage:
81MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
ACETYLSALICYLIC ACID 81MG
Administration route:
ORAL
Units in package:
7/30/120/150/180/255/300/360/365/500/1000
Prescription type:
OTC
Therapeutic area:
SALICYLATES
Product summary:
Active ingredient group (AIG) number: 0101169013; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-10-21
Summary of Product characteristics
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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