NTP-METFORMIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

METFORMIN HYDROCHLORIDE

Verfügbar ab:

NT PHARMA CANADA LTD

ATC-Code:

A10BA02

INN (Internationale Bezeichnung):

METFORMIN

Dosierung:

500MG

Darreichungsform:

TABLET

Zusammensetzung:

METFORMIN HYDROCHLORIDE 500MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100/360/500

Verschreibungstyp:

Prescription

Therapiebereich:

BIGUANIDES

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2017-03-16

Fachinformation

_ _
_Product Monograph _
_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
NTP-METFORMIN
metformin hydrochloride tablets
House standard
500 and 850 mg
Oral antihyperglycemic agent
NT PHARMA CANADA LTD.
5691 MAIN STREET
STOUFFVILLE, ONTARIO
CANADA, L4A 1H5
Date of Preparation:
January 6, 2011
Submission Control No: 143949
_ _
_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 PHARMACOLOGY
........