GLUCOPHAGE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
02-03-2018
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Aktiva substanser:
METFORMIN HYDROCHLORIDE
Tillgänglig från:
SANOFI-AVENTIS CANADA INC
ATC-kod:
A10BA02
INN (International namn):
METFORMIN
Dos:
850MG
Läkemedelsform:
TABLET
Sammansättning:
METFORMIN HYDROCHLORIDE 850MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
BIGUANIDES
Produktsammanfattning:
Active ingredient group (AIG) number: 0101773002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2006-05-12
Produktens egenskaper
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_Page 1 of 39_
PRODUCT MONOGRAPH
Pr
GLUCOPHAGE
®
Metformin Hydrochloride Tablets
Manufacturer’s standard
500 mg, 850 mg
Oral Antihyperglycemic Agent
®
Registered trade mark of Merck Santé. Used under licence
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval (Québec) H7V 0A3
Date of revision :
March 2, 2018
Submission Control No.: 211582
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_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION................................................................................
3
INDICATIONS
AND
CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
13
DRUG
INTERACTIONS
.........................................................................................................
15
DOSAGE
AND
ADMINISTRATION
.....................................................................................
18
OVERDOSAGE........................................................................................................................
20
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
21
STORAGE
AND
STABILITY
.................................................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION
.................................................................................
23
CLINICAL
TRIALS
..
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