APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GLICLAZIDE

제공처:

APOTEX INC

ATC 코드:

A10BB09

INN (International Name):

GLICLAZIDE

복용량:

30MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

GLICLAZIDE 30MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SULFONYLUREAS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2008-06-04

제품 특성 요약

PRODUCT MONOGRAPH
Pr
APO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
December 27, 2019
TORONTO ONTARIO
M9L 1T9
CONTROL NO: 233440
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
15
OVERDOSAGE
.........................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
17
STORAGE AND STABILITY
..................................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCI