Država: Kanada
Jezik: angleščina
Source: Health Canada
ACETYLSALICYLIC ACID
PHARMASCIENCE INC
B01AC06
ACETYLSALICYLIC ACID
81MG
TABLET (DELAYED-RELEASE)
ACETYLSALICYLIC ACID 81MG
ORAL
500/1000
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169013; AHFS:
APPROVED
2009-08-07
PRODUCT MONOGRAPH PRAXIS ASA EC 81 MG DAILY LOW DOSE Acetylsalicylic Acid Delayed-release Tablets USP 81 mg Platelet aggregation inhibitor PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 DATE OF REVISION: March 30, 2022 www.pharmascience.com SUBMISSION CONTROL NUMBER: 262153 _Product Monograph - PRAXIS ASA EC 81 mg Daily Low Dose _ _ _ _ _ _ _ _Page 2 of 39 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................3 INDICATIONS AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................3 WARNINGS AND PRECAUTIONS .............................................................................4 ADVERSE REACTIONS..............................................................................................6 DRUG INTERACTIONS ..............................................................................................7 DOSAGE AND ADMINISTRATION ...........................................................................9 OVERDOSAGE ......................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY......................................................... 11 STORAGE AND STABILITY .................................................................................... 12 SPECIAL HANDLING INSTRUCTIONS ................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 13 PART II : SCIENTIFIC INFORMATION ......................................................................... 14 PHARMACEUTICAL INFORMATION ..................................................................... 14 CLINICAL TRIALS .......................................................... Preberite celoten dokument