APO-GLIMEPIRIDE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

GLIMEPIRIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

A10BB12

INN (Tên quốc tế):

GLIMEPIRIDE

Liều dùng:

4MG

Dạng dược phẩm:

TABLET

Thành phần:

GLIMEPIRIDE 4MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SULFONYLUREAS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0146247003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2007-05-16

Đặc tính sản phẩm

Page 1 of 51
PRODUCT MONOGRAPH
PR
APO-GLIMEPIRIDE
GLIMEPIRIDE TABLETS USP
1 MG, 2 MG AND 4 MG
ORAL HYPOGLYCEMIC (SULFONYLUREA)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
CANADA M9L 1T9
_ _
_ _
SUBMISSION CONTROL NO.: 219952
Page 2 of 51
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLINICAL TRIALS
...............................................................................................................
25
DETAILED PHARMACOLOGY
..