APO-LEFLUNOMIDE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

LEFLUNOMIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

L04AK01

INN (Tên quốc tế):

LEFLUNOMIDE

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

LEFLUNOMIDE 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0140182001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2004-09-08

Đặc tính sản phẩm

_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_ Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEFLUNOMIDE
Leflunomide Tablets
Tablets, 10 mg and 20 mg, Oral
Apotex Standard
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
September 8, 2004
Date of Revision:
July 24, 2023
Submission Control Number: 272007
_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2023
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
......................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................ 5
4.4
Administration
.............................................................................................................
6
4.5
Missed Dose
.................................................................................................................
6
5