SANDOZ REPAGLINIDE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
16-08-2018
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Aktiva substanser:
REPAGLINIDE
Tillgänglig från:
SANDOZ CANADA INCORPORATED
ATC-kod:
A10BX02
INN (International namn):
REPAGLINIDE
Dos:
0.5MG
Läkemedelsform:
TABLET
Sammansättning:
REPAGLINIDE 0.5MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
MEGLITINIDES
Produktsammanfattning:
Active ingredient group (AIG) number: 0137035001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2010-09-27
Produktens egenskaper
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_Sandoz Repaglinide _
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PRODUCT MONOGRAPH
PR
SANDOZ REPAGLINIDE
(Repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Oral Antidiabetic Agent
Manufacturer's Standard
Sandoz Canada Inc.
110 de Lauzon
Boucherville, QC
J4B 1E6
Date of Revision:
August 16, 2018
Submission Control No: 218326
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_Sandoz Repaglinide _
_Page 2 of 43_
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
.................................................................................................
11
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
.........................................................................................................
23
DETAILED PHARMACOLOGY
....................
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