ACT REPAGLINIDE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

REPAGLINIDE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

A10BX02

INN (International Name):

REPAGLINIDE

Dosering :

1MG

Legemiddelform:

TABLET

Sammensetning:

REPAGLINIDE 1MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

MEGLITINIDES

Produkt oppsummering:

Active ingredient group (AIG) number: 0137035002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-06-05

Preparatomtale

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