JAMP REPAGLINIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-06-2018
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Active ingredient:
REPAGLINIDE
Available from:
JAMP PHARMA CORPORATION
ATC code:
A10BX02
INN (International Name):
REPAGLINIDE
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
REPAGLINIDE 2MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MEGLITINIDES
Product summary:
Active ingredient group (AIG) number: 0137035003; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-07-26
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
JAMP REPAGLINIDE
Repaglinide Tablets, House Standard
0.5 mg, 1 mg and 2 mg
Oral Antidiabetic Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Submission Control No: 216463
Date of Revision:
June 27, 2018
_JAMP REPAGLINIDE Product Monograph _
_Page 2 of 41_
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
.............................................................................
15
OVERDOSAGE................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
.........................................................................................................
22
DETAILED PHARMACOLOGY
....................................................
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