PRO-RIVAROXABAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RIVAROXABAN

Boleh didapati daripada:

PRO DOC LIMITEE

Kod ATC:

B01AF01

INN (Nama Antarabangsa):

RIVAROXABAN

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

RIVAROXABAN 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0152487004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2023-11-01

Ciri produk

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.