SANDOZ REPAGLINIDE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

REPAGLINIDE

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

A10BX02

INN (Међународно име):

REPAGLINIDE

Дозирање:

0.5MG

Фармацеутски облик:

TABLET

Састав:

REPAGLINIDE 0.5MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

MEGLITINIDES

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2010-09-27

Карактеристике производа

_ _
_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
_ _
_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
....................