País: Canadá
Idioma: inglés
Fuente: Health Canada
RIVAROXABAN
BAYER INC
B01AF01
RIVAROXABAN
2.5MG
TABLET
RIVAROXABAN 2.5MG
ORAL
14/100
Prescription
Direct Factor Xa Inhibitors
Active ingredient group (AIG) number: 0152487004; AHFS:
APPROVED
2018-09-14
_XARELTO (rivaroxaban tablets; rivaroxaban granules for oral suspension) _ _Page 1 of 119_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR XARELTO® Rivaroxaban tablets Tablets 2.5 mg, 10 mg, 15 mg and 20 mg, Oral Rivaroxaban granules for oral suspension Granules for oral suspension, 1mg/mL when reconstituted, Oral Anticoagulant (ATC Classification: B01AF01) Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6 http://www.bayer.ca Date of Initial Authorization: SEP 15, 2008 Date of Revision: MAR 27, 2024 Submission Control Number: 280484 © 2024, Bayer Inc. ® TM see www.bayer.ca/tm-mc _XARELTO (rivaroxaban tablets; rivaroxaban granules for oral suspension) _ _Page 2 of 119_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution 04/2023 7 WARNINGS AND PRECAUTIONS, Anticoagulant-Related Nephropathy 03/2024 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ..................................................................................................... 2 TABLE OF CONTENTS ....................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .............................................................................. 4 1 INDICATIONS ................................................................................................................................ 4 1.1 Pediatrics ..................................................................................................................................... 4 1.2 Geriatrics ..................................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................... Leer el documento completo