MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

GLICLAZIDE

可用日期:

MYLAN PHARMACEUTICALS ULC

ATC代码:

A10BB09

INN（国际名称）:

GLICLAZIDE

剂量:

30MG

药物剂型:

TABLET (EXTENDED-RELEASE)

组成:

GLICLAZIDE 30MG

给药途径:

ORAL

每包单位数:

60/100

处方类型:

Prescription

治疗领域:

SULFONYLUREAS

產品總結:

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

授权状态:

APPROVED

授权日期:

2015-03-17

产品特点

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