APO-RASAGILINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RASAGILINE (RASAGILINE MESYLATE)

Sẵn có từ:

APOTEX INC

Mã ATC:

N04BD02

INN (Tên quốc tế):

RASAGILINE

Liều dùng:

0.5MG

Dạng dược phẩm:

TABLET

Thành phần:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MONOAMINE OXIDASE B INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0151662001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-01-11

Đặc tính sản phẩm

_APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RASAGILINE
Rasagiline Mesylate Tablets
Tablets, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral
Antiparkinson Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 11, 2016
Date of Revision:
SEP 22, 2023
Submission Control Number: 274257
_APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
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
................................................................. 5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
.............................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.4
Administration
..................................................