GLUCOPHAGE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
14-09-2015
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유효 성분:
METFORMIN HYDROCHLORIDE
제공처:
SANOFI-AVENTIS CANADA INC
ATC 코드:
A10BA02
INN (International Name):
METFORMIN
복용량:
1000MG
약제 형태:
TABLET
구성:
METFORMIN HYDROCHLORIDE 1000MG
관리 경로:
ORAL
패키지 단위:
30/60/100/120/500
처방전 유형:
Prescription
치료 영역:
BIGUANIDES
제품 요약:
Active ingredient group (AIG) number: 0101773003; AHFS:
승인 상태:
CANCELLED PRE MARKET
승인 날짜:
2017-06-28
제품 특성 요약
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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
...........................................
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