Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
APIXABAN
NATCO PHARMA (CANADA) INC
B01AF02
APIXABAN
5MG
TABLET
APIXABAN 5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0153051002; AHFS:
APPROVED
2022-09-20
IMPORTANT: PLEASE READ _Pr_ _NAT-APIXABAN (apixaban) Product Monograph_ _Page 1 of 80 _ _ _ PRODUCT MONOGRAPH PR NAT-APIXABAN Apixaban Tablets 2.5 mg and 5 mg Anticoagulant Natco Pharma (Canada) Inc. Date of Revision: 2000 Argentia Road, Plaza 1, Suite 200 June 18, 2022 Mississauga ON L5N 1P7 Submission Control No: 260519 _Pr_ _NAT-APIXABAN Product Monograph_ _Page 2 of 80 _ _ _ 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 DRUG INTERACTIONS ................................................................................................. 20 DOSAGE AND ADMINISTRATION ............................................................................. 25 OVERDOSAGE ............................................................................................................... 32 ACTION AND CLINICAL PHARMACOLOGY ............................................................33 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 38 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 38 PART II: SCIENTIFIC INFORMATION .............................................................................. 39 PHARMACEUTICAL INFORMATION ........................................................................ 39 CLINICAL TRIALS ......................................................................................................... 40 DETAILED PH Aqra d-dokument sħiħ