MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

GLICLAZIDE

Доступна с:

MYLAN PHARMACEUTICALS ULC

код АТС:

A10BB09

ИНН (Международная Имя):

GLICLAZIDE

дозировка:

30MG

Фармацевтическая форма:

TABLET (EXTENDED-RELEASE)

состав:

GLICLAZIDE 30MG

Администрация маршрут:

ORAL

Штук в упаковке:

60/100

Тип рецепта:

Prescription

Терапевтические области:

SULFONYLUREAS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2015-03-17

Характеристики продукта

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