Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
RIVAROXABAN
PRO DOC LIMITEE
B01AF01
RIVAROXABAN
2.5MG
TABLET
RIVAROXABAN 2.5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152487004; AHFS:
APPROVED
2023-11-01
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PRO-RIVAROXABAN Rivaroxaban Tablets Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg, Oral House standard Anticoagulant (ATC Classification: B01AF01) PRO DOC LTÉE 2925, boul. Industriel Laval, Québec H7L 3W9 Submission Control Number: 276861 Date of Initial Authorization: AUG 30, 2023 _PRO-RIVAROXABAN _ _ _ _Page 2 of 119_ 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 ....................................................................................................................................... 5 1.2 Geriatrics ....................................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................................5 4 DOSAGE AND ADMINISTRATION ...................................................................................................6 4.1 Dosing Considerations ................................................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment .............................................................................. 8 4.4 Administration ............................................................................................................................. 13 4. Přečtěte si celý dokument