MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

GLICLAZIDE

Disponível em:

MYLAN PHARMACEUTICALS ULC

Código ATC:

A10BB09

DCI (Denominação Comum Internacional):

GLICLAZIDE

Dosagem:

30MG

Forma farmacêutica:

TABLET (EXTENDED-RELEASE)

Composição:

GLICLAZIDE 30MG

Via de administração:

ORAL

Unidades em pacote:

60/100

Tipo de prescrição:

Prescription

Área terapêutica:

SULFONYLUREAS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2015-03-17

Características técnicas

_MYLAN-GLICLAZIDE MR (Gliclazide) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-GLICLAZIDE MR
Gliclazide
Modified Release Tablets
30 mg
Modified Release Breakable Tablets
60 mg
Hypoglycemic sulfonylurea
Oral antidiabetic agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
MAR 17, 2015
Date of Revision:
MAR 08, 2024
Submission Control No. 280151
_MYLAN-GLICLAZIDE MR (Gliclazide) _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
Not Applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORISATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................................
2
TABLE OF CONTENTS
............................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics (< 18 years of age)
................................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................................
4
4.1
Dosing Considerations
..........................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.....................................................................
5
4.4
Administration
...........................................................