TEVA-REPAGLINIDE TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
31-03-2011
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有效成分:
REPAGLINIDE
可用日期:
TEVA CANADA LIMITED
ATC代码:
A10BX02
INN（国际名称）:
REPAGLINIDE
剂量:
1MG
药物剂型:
TABLET
组成:
REPAGLINIDE 1MG
给药途径:
ORAL
每包单位数:
100
处方类型:
Prescription
治疗领域:
MEGLITINIDES
產品總結:
Active ingredient group (AIG) number: 0137035002; AHFS:
授权状态:
CANCELLED PRE MARKET
授权日期:
2021-07-29
产品特点
PRODUCT MONOGRAPH
PR
TEVA-REPAGLINIDE
(repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Teva Standard
Oral Antidiabetic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 31, 2011
Toronto, Ontario
M1B 2K9
Control # 133231
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................
4
ADVERSE
REACTIONS.............................................................................................
7
DRUG INTERACTIONS
...........................................................................................
10
DOSAGE AND
ADMINISTRATION.......................................................................
14
OVERDOSAGE
.........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 15
STORAGE AND
STABILITY...................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL
INFORMATION...................................................................
20
CLINICAL
TRIALS.................................................................................................
201
DETAILED
PHARMACOLOGY..............................................................................
24
TOXICOLOGY
..........................................................................................................
27
REFERENCES
.....................................................................................
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