DIABETA TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GLYBURIDE

Verfügbar ab:

SANOFI-AVENTIS CANADA INC

ATC-Code:

A10BB01

INN (Internationale Bezeichnung):

GLIBENCLAMIDE

Dosierung:

2.5MG

Darreichungsform:

TABLET

Zusammensetzung:

GLYBURIDE 2.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30

Verschreibungstyp:

Prescription

Therapiebereich:

SULFONYLUREAS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108708002; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2020-05-07

Fachinformation

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_Page 1 of 27_
PRODUCT MONOGRAPH
PR
DIASSETA
®
Glyburide_ _
Manufacturer’s Standard
2.5 and 5 mg Tablets
Oral Hypoglycemic - Sulfonylurea
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec
H7V 0A3
Date of Revision:
November 23, 2016
Submission Control No.: 197357
_ _
_Page 2 of 27_
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
...................................................................................................
10
DOSAGE AND ADMINISTRATION
...............................................................................
15
OVERDOSAGE
.................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 17
STORAGE AND STABILITY
...........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 18
PART II: SCIENTIFIC INFORMATION
.................................................................................
20
PHARMACEUTICAL INFORMATION
...........................................................................
20
CLINICAL TRIALS
...........................................................................................................
21
DETAILED PHARMACOLOGY
.................