MINT-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

GLICLAZIDE

Disponible des:

MINT PHARMACEUTICALS INC

Codi ATC:

A10BB09

Designació comuna internacional (DCI):

GLICLAZIDE

Dosis:

60MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

GLICLAZIDE 60MG

Vía de administración:

ORAL

Unidades en paquete:

30/60

tipo de receta:

Prescription

Área terapéutica:

SULFONYLUREAS

Resumen del producto:

Active ingredient group (AIG) number: 0119934003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2015-04-07

Fitxa tècnica

_ Page 1 of 41 _
PRODUCT MONOGRAPH
PR
MINT-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea
Oral antidiabetic agent
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Submission Control No: 234824
Date of Revision:
February 21, 2020
_ Page 2 of 41 _
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
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 22
PART II: SCIENTIFIC INFORMATION .......................................................................................
23
PHARMACEUTICAL INFORMATION
...............