PMS-GALANTAMINE TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
12-10-2016
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有效成分:
GALANTAMINE (GALANTAMINE HYDROBROMIDE)
可用日期:
PHARMASCIENCE INC
ATC代码:
N06DA04
INN（国际名称）:
GALANTAMINE
剂量:
4MG
药物剂型:
TABLET
组成:
GALANTAMINE (GALANTAMINE HYDROBROMIDE) 4MG
给药途径:
ORAL
每包单位数:
100
处方类型:
Prescription
治疗领域:
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
產品總結:
Active ingredient group (AIG) number: 0144660001; AHFS:
授权状态:
APPROVED
授权日期:
2010-01-26
产品特点
Page 1 of 53
PRODUCT MONOGRAPH
Pr
PMS-GALANTAMINE
galantamine hydrobromide tablets
4 mg, 8 mg and 12 mg galantamine base
Cholinesterase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite #100
Montreal, Quebec
H4P 2T4
Control #
106278
Date of Preparation:
January 22, 2010
Page 2 of 53
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
.........................................................................................14
DOSAGE AND ADMINISTRATION
.....................................................................16
OVERDOSAGE
.......................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
...................................................19
STORAGE AND STABILITY
................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................24
PART II SCIENTIFIC INFORMATION
........................................................................25
PHARMACEUTICAL INFORMATION
................................................................25
CLINICAL TRIALS
.................................................................................................26
DETAILED PHARMACOLOGY
............................................................................34
TOXICOLOGY
........................................................................................................35
REFEREN
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