Ország: Kanada
Nyelv: angol
Forrás: Health Canada
APIXABAN
LABORATOIRE RIVA INC.
B01AF02
APIXABAN
5MG
TABLET
APIXABAN 5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0153051002; AHFS:
APPROVED
2022-10-05
_RIVA APIXABAN - Product Monograph _ _Page 1 of 77_ PRODUCT MONOGRAPH PR RIVA APIXABAN Apixaban Tablets 2.5 mg and 5 mg Anticoagulant LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.labriva.com Submission Control No.: 268218 DATE OF INITIAL APPROVAL: FEB 25, 2022 DATE OF REVISION: OCT 4, 2022 _RIVA APIXABAN - Product Monograph _ _Page 2 of 77_ 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 ................................................................................................. 11 DRUG INTERACTIONS ................................................................................................. 19 DOSAGE AND ADMINISTRATION ............................................................................. 24 OVERDOSAGE ............................................................................................................... 30 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 32 STORAGE AND STABILITY ......................................................................................... 36 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 36 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 37 PART II: SCIENTIFIC INFORMATION ............................................................................... 38 PHARMACEUTICAL INFORMATION ......................................................................... 38 CLINICAL TRIALS .......... Olvassa el a teljes dokumentumot