SANDOZ REPAGLINIDE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

REPAGLINIDE

Disponibbli minn:

SANDOZ CANADA INCORPORATED

Kodiċi ATC:

A10BX02

INN (Isem Internazzjonali):

REPAGLINIDE

Dożaġġ:

0.5MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

REPAGLINIDE 0.5MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MEGLITINIDES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2010-09-27

Karatteristiċi tal-prodott

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