PRO-GLYBURIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-06-2013
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Active ingredient:
GLYBURIDE
Available from:
PRO DOC LIMITEE
ATC code:
A10BB01
INN (International Name):
GLIBENCLAMIDE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
GLYBURIDE 5MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
SULFONYLUREAS
Product summary:
Active ingredient group (AIG) number: 0108708001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-07-04
Summary of Product characteristics
_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
PRO-GLYBURIDE
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
DATE OF REVISION:
June 6, 2013
Submission Control No.: 164951
_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARM
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