MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GLICLAZIDE

Pieejams no:

MYLAN PHARMACEUTICALS ULC

ATĶ kods:

A10BB09

SNN (starptautisko nepatentēto nosaukumu):

GLICLAZIDE

Deva:

30MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

GLICLAZIDE 30MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

60/100

Receptes veids:

Prescription

Ārstniecības joma:

SULFONYLUREAS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-03-17

Produkta apraksts

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