PMS-GLIMEPIRIDE TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
20-02-2014
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有效成分:
GLIMEPIRIDE
可用日期:
PHARMASCIENCE INC
ATC代码:
A10BB12
INN（国际名称）:
GLIMEPIRIDE
剂量:
4MG
药物剂型:
TABLET
组成:
GLIMEPIRIDE 4MG
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: 0146247003; AHFS:
授权状态:
CANCELLED PRE MARKET
授权日期:
2016-10-28
产品特点
PRODUCT MONOGRAPH
PR
PMS-GLIMEPIRIDE
Glimepiride Tablets, House Standard
1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
February 12, 2014
www.pharmascience.com
Submission Control No: 167575
_pms-GLIMEPIRIDE Product Monograph _
_Page 2 of 48_
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
..................................................................................................
11
DOSAGE
AND
ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................. 17
STORAGE
AND
STABILITY
..........................................................................................
20
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .............................................. 21
PART II: SCIENTIFIC INFORMATION
...................................................................................
22
PHARMACEUTICAL
INFORMATION
..........................................................................
22
CLINICAL
TRIALS
..........................................................................................................
23
DETAILED
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