MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

GLICLAZIDE

Saatavilla:

MYLAN PHARMACEUTICALS ULC

ATC-koodi:

A10BB09

INN (Kansainvälinen yleisnimi):

GLICLAZIDE

Annos:

30MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

GLICLAZIDE 30MG

Antoreitti:

ORAL

Kpl paketissa:

60/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SULFONYLUREAS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-03-17

Valmisteyhteenveto

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