Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
APIXABAN
BRISTOL-MYERS SQUIBB CANADA
B01AF02
APIXABAN
5MG
TABLET
APIXABAN 5MG
ORAL
10/60/180/500
Prescription
Direct Factor Xa Inhibitors
Active ingredient group (AIG) number: 0153051002; AHFS:
APPROVED
2012-12-05
_Pr_ _ELIQUIS (apixaban) Product Monograph _ _Page 1 of 83_ PRODUCT MONOGRAPH Pr ELIQUIS ® apixaban tablets 2.5 mg and 5 mg Anticoagulant Pfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Bristol-Myers Squibb Canada Co. Montreal, Canada H4S 0A4 www.bmscanada.ca Date of Initial Approval: 13 December 2011 Date of Revision: 07 October 2019 Registered trademark of Bristol-Myers Squibb Company used under license by Bristol-Myers Squibb Canada Co. Submission Control No: 229267 _Pr_ _ELIQUIS (apixaban) Product Monograph _ _Page 2 of 83_ 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 ................................................................................................. 10 DOSAGE AND ADMINISTRATION ............................................................................. 26 OVERDOSAGE ................................................................................................................ 33 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 34 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 39 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 39 PART II: SCIENTIFIC INFORMATION .............................................................................. 41 PHARMACEUTICAL INFORMATION ......................................................................... 41 CLINICAL TRIALS ........................................................ Přečtěte si celý dokument