SANDOZ GLYBURIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-05-2017
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Active ingredient:
GLYBURIDE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
A10BB01
INN (International Name):
GLIBENCLAMIDE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
GLYBURIDE 2.5MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0108708002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-08-01
Summary of Product characteristics
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_Sandoz Glyburide _
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PRODUCT MONOGRAPH
PR
SANDOZ GLYBURIDE
Glyburide
Manufacturer’s Standard
2.5 mg and 5 mg Tablets
Oral Hypoglycemic - Sulfonylurea
Sandoz Canada Inc. Date of Revision:
145 Jules-Léger
May 11, 2017
Boucherville, Quebec
J4B 7K8
Submission Control No.: 204488
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_Sandoz Glyburide _
_Page 2 of 26_
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
.............................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 16
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
.........................................................................................................
19
DETAILED PHARMACOLOGY
...............
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