Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
RIVAROXABAN
PHARMASCIENCE INC
B01AF01
RIVAROXABAN
20MG
TABLET
RIVAROXABAN 20MG
ORAL
100
Prescription
Direct Factor Xa Inhibitors
Active ingredient group (AIG) number: 0152487003; AHFS:
CANCELLED PRE MARKET
2021-11-18
PRODUCT MONOGRAPH PR PMSC-RIVAROXABAN Rivaroxaban Tablets Tablets 2.5 mg, 10 mg, 15 mg and 20 mg Rivaroxaban Granules for Oral Suspension Granules for oral suspension, 1mg/mL when reconstituted Anticoagulant (ATC Classification: B01AF01) PHARMASCIENCE INC. 6111 Royalmount Ave. Suite 100 Montreal, Canada H4P 2T4 www.pharmascience.com Submission Control No: 250929 Date of Revision: May 10, 2021 _ _ _pmsc-RIVAROXABAN_ _Product Monograph Page 2 of 120 _ TABLE OF CONTENTS TABLE OF CONTENTS ...................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 30 DOSAGE AND ADMINISTRATION ..................................................................................... 35 OVERDOSAGE ....................................................................................................................... 46 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 48 STORAGE AND STABILITY ................................................................................................. 58 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 58 PART II : SCIENTIFIC INFORMATION ........... Přečtěte si celý dokument