SANDOZ REPAGLINIDE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

REPAGLINIDE

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

A10BX02

DCI (Dénomination commune internationale):

REPAGLINIDE

Dosage:

0.5MG

forme pharmaceutique:

TABLET

Composition:

REPAGLINIDE 0.5MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MEGLITINIDES

Descriptif du produit:

Active ingredient group (AIG) number: 0137035001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2010-09-27

Résumé des caractéristiques du produit

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_Sandoz Repaglinide _
_Page 1 of 43_
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
....................