GLUCOPHAGE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
14-09-2015
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
METFORMIN HYDROCHLORIDE
Fáanlegur frá:
SANOFI-AVENTIS CANADA INC
ATC númer:
A10BA02
INN (Alþjóðlegt nafn):
METFORMIN
Skammtar:
1000MG
Lyfjaform:
TABLET
Samsetning:
METFORMIN HYDROCHLORIDE 1000MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/60/100/120/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
BIGUANIDES
Vörulýsing:
Active ingredient group (AIG) number: 0101773003; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2017-06-28
Vara einkenni
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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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