País: Canadá
Idioma: francés
Fuente: Health Canada
Rivaroxaban; Rivaroxaban
BAYER INC
B01AF01
RIVAROXABAN
15MG; 20MG
Trousse
Rivaroxaban 15MG; Rivaroxaban 20MG
Orale
100
Prescription
Direct Factor Xa Inhibitors
Numéro de groupe d'ingrédients actifs (GIA) :0256950001; AHFS:
ANNULÉ APRÈS COMMERCIALISATION
2018-12-01
_XARELTO_ _Product Monograph Page 1 of 97_ PRODUCT MONOGRAPH PR XARELTO ® rivaroxaban tablets 2.5 mg, 10 mg, 15 mg and 20 mg Anticoagulant (ATC Classification: B01AF01) Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6 Canada http://www.bayer.ca Date of Revision: September 13, 2018 Submission Control No: 211611 2018, Bayer Inc. ® TM see www.bayer.ca/tm-mc All other trademarks are the property of their respective owners. _XARELTO_ _Product Monograph Page 2 of 97_ 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 .........................................................................................................26 DOSAGE AND ADMINISTRATION.....................................................................................30 OVERDOSAGE .......................................................................................................................36 ACTION AND CLINICAL PHARMACOLOGY ...................................................................38 STORAGE AND STABILITY.................................................................................................45 DOSAGE FORMS, COMPOSITION AND PACKAGING 1 ...................................................45 PART II : SCIENTIFIC INFORMATION ..........................................................................47 PHARMACEUTICAL INFORMATION.......................... Leer el documento completo