APO-REPAGLINIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-06-2016
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Active ingredient:
REPAGLINIDE
Available from:
APOTEX INC
ATC code:
A10BX02
INN (International Name):
REPAGLINIDE
Dosage:
0.5MG
Pharmaceutical form:
TABLET
Composition:
REPAGLINIDE 0.5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MEGLITINIDES
Product summary:
Active ingredient group (AIG) number: 0137035001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-09-09
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
APO-REPAGLINIDE
Repaglinide Tablets USP
0.5 mg, 1 mg and 2 mg
Oral antidiabetic Agent
APOTEX INC.
Date of Revision:
150 Signet Drive
April 29, 2016
Toronto, Ontario
M9L 1T9
Control No: 187867
_APO-REPAGLINIDE – Product Monograph_
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
......................................................................................
16
OVERDOSAGE
........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL
TRIALS..................................................................................................................
22
DETAILED PHARMACOLOGY
........................................................................................
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