APO-CYCLOBENZAPRINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CYCLOBENZAPRINE HYDROCHLORIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

M03BX08

INN (Tên quốc tế):

CYCLOBENZAPRINE

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0112363001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2021-06-17

Đặc tính sản phẩm

Page 1 of 19
PRODUCT MONOGRAPH
INCLUDING CONSUMER INFORMATION
PR APO-CYCLOBENZAPRINE
Cyclobenzaprine Hydrochloride Tablets USP
10 mg
SKELETAL MUSCLE RELAXANT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JUNE 16, 2021
TORONTO, ONTARIO
M9L 1T9
Submission Control No: 252375
Page 2 of 19
_ _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
.................................................................................................
6
DRUG INTERACTIONS
..................................................................................................
7
DOSAGE AND ADMINISTRATION
..................................................................................
7
OVERDOSAGE
.............................................................................................................
8
ACTIONS AND CLINICAL PHARMACOLOGY
.................................................................. 9
STORAGE AND STABILITY
...........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 10
PART II: SCIENTIFIC INFORMATION
............................................................................
11
PHARMACEUTICAL INFORMATION
..............................................................................
11
CLINICAL TRIALS
......................................................................................................
112
DETAILED PHARMACOLOGY
........................................