MYLAN-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GLICLAZIDE

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

A10BB09

INN (International Name):

GLICLAZIDE

복용량:

30MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

GLICLAZIDE 30MG

관리 경로:

ORAL

패키지 단위:

60/100

처방전 유형:

Prescription

치료 영역:

SULFONYLUREAS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2015-03-17

제품 특성 요약

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