GLUCOPHAGE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

METFORMIN HYDROCHLORIDE

から入手可能:

SANOFI-AVENTIS CANADA INC

ATCコード:

A10BA02

INN（国際名）:

METFORMIN

投薬量:

1000MG

医薬品形態:

TABLET

構図:

METFORMIN HYDROCHLORIDE 1000MG

投与経路:

ORAL

パッケージ内のユニット:

30/60/100/120/500

処方タイプ:

Prescription

治療領域:

BIGUANIDES

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2017-06-28

製品の特徴

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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
...........................................