ACT REPAGLINIDE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

REPAGLINIDE

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

A10BX02

DCI (Dénomination commune internationale):

REPAGLINIDE

Dosage:

2MG

forme pharmaceutique:

TABLET

Composition:

REPAGLINIDE 2MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MEGLITINIDES

Descriptif du produit:

Active ingredient group (AIG) number: 0137035003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-06-05

Résumé des caractéristiques du produit

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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
..........................................................................