EUGLUCON TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GLYBURIDE

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

A10BB01

INN (Internationale Bezeichnung):

GLIBENCLAMIDE

Dosierung:

5MG

Darreichungsform:

TABLET

Zusammensetzung:

GLYBURIDE 5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/100/300/500

Verschreibungstyp:

Prescription

Therapiebereich:

SULFONYLUREAS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108708001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

1997-06-06

Fachinformation

_ _
_Product Monograph – EUGLUCON_
_®_
_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
EUGLUCON
®
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
May 02, 2011
SUBMISSION CONTROL NO.: 138840
EUGLUCON
®
is a registered trademark used under license by Pharmascience Inc.
_ _
_Product Monograph – EUGLUCON_
_®_
_ _
_Page 2 of 30_
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....................................................................................................8
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................15
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND
STABILITY..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL
INFORMATION..........................................................................21
CLINICAL
TRIALS............................