APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
27-12-2019

有效成分:

GLICLAZIDE

可用日期:

APOTEX INC

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:

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:

2008-06-04

产品特点

                                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
                                
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