AVA-METFORMIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

METFORMIN HYDROCHLORIDE

Verfügbar ab:

AVANSTRA INC

ATC-Code:

A10BA02

INN (Internationale Bezeichnung):

METFORMIN

Dosierung:

500MG

Darreichungsform:

TABLET

Zusammensetzung:

METFORMIN HYDROCHLORIDE 500MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/500

Verschreibungstyp:

Prescription

Therapiebereich:

BIGUANIDES

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2014-08-21

Fachinformation

_ _
_Product Monograph _
_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
AVA-METFORMIN
metformin hydrochloride tablets
House standard
500 and 850 mg
Oral antihyperglycemic agent
Avanstra Inc.
10761 – 25th NE
Suite 110, Building “B”
Calgary, Alberta
T2C 3C2
Canada
Date of Preparation:
February 21, 2011
Submission Control No: 145186
_ _
_Product Monograph _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG
INTERACTIONS...................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE.................................................................................................................15
ACTION AND CLINICAL
PHARMACOLOGY.............................................................16
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................17
PART II: SCIENTIFIC
INFORMATION................................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHA