GLUCOPHAGE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

METFORMIN HYDROCHLORIDE

Sẵn có từ:

SANOFI-AVENTIS CANADA INC

Mã ATC:

A10BA02

INN (Tên quốc tế):

METFORMIN

Liều dùng:

1000MG

Dạng dược phẩm:

TABLET

Thành phần:

METFORMIN HYDROCHLORIDE 1000MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/60/100/120/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BIGUANIDES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0101773003; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-06-28

Đặc tính sản phẩm

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_Page 1 of 35_
PRODUCT MONOGRAPH
GLUCOPHAGE
®
Metformin Hydrochloride Tablets
Manufacturer’s standard
500 mg, 850 mg, and 1000 mg tablets
Oral Antihyperglycemic Agent
sanofi-aventis Canada Inc.
Date of Revision:
2150 St. Elzear Blvd. West
September 10, 2015
Laval, Quebec H7L 4A8
Submission Control No.:156892
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_Page 2 of 35_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
6
ADVERSE
REACTIONS
.........................................................................................................
12
DRUG
INTERACTIONS
.........................................................................................................
14
DOSAGE
AND
ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
18
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
18
STORAGE
AND
STABILITY
.................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION
.................................................................................
21
CLINICAL
TRIALS
...........................................