ACT REPAGLINIDE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

REPAGLINIDE

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

A10BX02

INN (Mezinárodní Name):

REPAGLINIDE

Dávkování:

1MG

Léková forma:

TABLET

Složení:

REPAGLINIDE 1MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

MEGLITINIDES

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2014-06-05

Charakteristika produktu

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