देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
ACETYLSALICYLIC ACID
PHARMASCIENCE INC
B01AC06
ACETYLSALICYLIC ACID
81MG
TABLET (DELAYED-RELEASE)
ACETYLSALICYLIC ACID 81MG
ORAL
120
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169013; AHFS:
APPROVED
2001-11-30
PRODUCT MONOGRAPH ASA 81 MG Acetylsalicylic Acid Delayed-release Tablets USP 81 mg ASA DAILY LOW DOSE Acetylsalicylic Acid Tablets USP 81 mg Platelet aggregation inhibitor PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Quebec H4P 2T4 DATE OF REVISION: March 14, 2022 www.pharmascience.com SUBMISSION CONTROL NUMBER: 261509, 261543 Page 2 of 42 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................3 INDICATIONS AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................4 WARNINGS AND PRECAUTIONS .............................................................................5 ADVERSE REACTIONS..............................................................................................7 DRUG INTERACTIONS ..............................................................................................8 DOSAGE AND ADMINISTRATION ......................................................................... 10 OVERDOSAGE ......................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY......................................................... 11 STORAGE AND STABILITY .................................................................................... 13 SPECIAL HANDLING INSTRUCTIONS ................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 13 PART II : SCIENTIFIC INFORMATION ......................................................................... 15 PHARMACEUTICAL INFORMATION ..................................................................... 15 CLINICAL TRIALS ........................................................................................... पूरा दस्तावेज़ पढ़ें