APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
27-12-2019

Aktiv ingrediens:

GLICLAZIDE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

A10BB09

INN (International Name):

GLICLAZIDE

Dosering :

30MG

Legemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensetning:

GLICLAZIDE 30MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

SULFONYLUREAS

Produkt oppsummering:

Active ingredient group (AIG) number: 0119934002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2008-06-04

Preparatomtale

                                PRODUCT MONOGRAPH
Pr
APO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
December 27, 2019
TORONTO ONTARIO
M9L 1T9
CONTROL NO: 233440
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
............................................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
15
OVERDOSAGE
.........................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
17
STORAGE AND STABILITY
..................................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCI
                                
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