Kraj: Kanada
Język: angielski
Źródło: Health Canada
RIVAROXABAN
LABORATOIRE RIVA INC.
B01AF01
RIVAROXABAN
2.5MG
TABLET
RIVAROXABAN 2.5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152487004; AHFS:
APPROVED
2023-11-01
_Page 1 of 111_ _RIVA RIVAROXABAN (rivaroxaban)_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RIVA RIVAROXABAN Rivaroxaban Tablets Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral House standard Anticoagulant (ATC Classification: B01AF01) LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.labriva.com Submission Control Number: 276851 Date of Initial Authorization: AUG 25, 2023 _RIVA RIVAROXABAN (rivaroxaban) _ _ _ _Page 2 of 111_ RECENT MAJOR LABEL CHANGES N/A 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 ................................................................................. 5 4.1 Dosing Considerations .............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 7 4.4 Administration ........................................................................................................ 11 4.5 Missed Dose .............................................................................. Przeczytaj cały dokument