SANDOZ REPAGLINIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

REPAGLINIDE

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

A10BX02

SNN (starptautisko nepatentēto nosaukumu):

REPAGLINIDE

Deva:

0.5MG

Zāļu forma:

TABLET

Kompozīcija:

REPAGLINIDE 0.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

MEGLITINIDES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-09-27

Produkta apraksts

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