GLUCOPHAGE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

METFORMIN HYDROCHLORIDE

Commercializzato da:

SANOFI-AVENTIS CANADA INC

Codice ATC:

A10BA02

INN (Nome Internazionale):

METFORMIN

Dosaggio:

500MG

Forma farmaceutica:

TABLET

Composizione:

METFORMIN HYDROCHLORIDE 500MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

BIGUANIDES

Dettagli prodotto:

Active ingredient group (AIG) number: 0101773001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2006-05-12

Scheda tecnica

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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
..