GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

GLICLAZIDE

Saadav alates:

SANIS HEALTH INC

ATC kood:

A10BB09

INN (Rahvusvaheline Nimetus):

GLICLAZIDE

Annus:

60MG

Ravimvorm:

TABLET (EXTENDED-RELEASE)

Koostis:

GLICLAZIDE 60MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2022-01-28

Toote omadused

_Product Monograph - GLICLAZIDE MR (Gliclazide) _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR GLICLAZIDE MR
Gliclazide
Modified-release tablets 30 mg
Modified-release breakable tablets 60 mg
Hypoglycemic sulfonylurea
Oral antidiabetic agent
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
January 27, 2022
Date of Revision:
MAR 27, 2024
Submission Control Number: 280770
_Product Monograph - GLICLAZIDE MR (Gliclazide) _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
Non Applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION 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
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
........................