XARELTO TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RIVAROXABAN

Sẵn có từ:

BAYER INC

Mã ATC:

B01AF01

INN (Tên quốc tế):

RIVAROXABAN

Liều dùng:

2.5MG

Dạng dược phẩm:

TABLET

Thành phần:

RIVAROXABAN 2.5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

14/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

Direct Factor Xa Inhibitors

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-09-14

Đặc tính sản phẩm

_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
...................................................................