GLUCOPHAGE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

METFORMIN HYDROCHLORIDE

থেকে পাওয়া:

SANOFI-AVENTIS CANADA INC

এটিসি কোড:

A10BA02

INN (আন্তর্জাতিক নাম):

METFORMIN

ডোজ:

1000MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

METFORMIN HYDROCHLORIDE 1000MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30/60/100/120/500

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

BIGUANIDES

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED PRE MARKET

অনুমোদন তারিখ:

2017-06-28

পণ্য বৈশিষ্ট্য

_ _
_ _
_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
_ _
_ _
_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
...........................................