ACT REPAGLINIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-04-2020
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Active ingredient:
REPAGLINIDE
Available from:
TEVA CANADA LIMITED
ATC code:
A10BX02
INN (International Name):
REPAGLINIDE
Dosage:
0.5MG
Pharmaceutical form:
TABLET
Composition:
REPAGLINIDE 0.5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MEGLITINIDES
Product summary:
Active ingredient group (AIG) number: 0137035001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-06-05
Summary of Product characteristics
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_Page 1 of 39_
PRODUCT MONOGRAPH
Pr
ACT REPAGLINIDE
Repaglinide Tablets, USP
0.5 mg, 1 mg, and 2 mg
Oral Antidiabetic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No.: 237126
Date of Revision:
April 3, 2020
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_Page 2 of 39_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
..........................................................................
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