MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

GLICLAZIDE

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

A10BB09

INN（国際名）:

GLICLAZIDE

投薬量:

30MG

医薬品形態:

TABLET (EXTENDED-RELEASE)

構図:

GLICLAZIDE 30MG

投与経路:

ORAL

パッケージ内のユニット:

60/100

処方タイプ:

Prescription

治療領域:

SULFONYLUREAS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2015-03-17

製品の特徴

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