OXEZE TURBUHALER POWDER
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
23-04-2018
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有效成分:
FORMOTEROL FUMARATE DIHYDRATE
可用日期:
ASTRAZENECA CANADA INC
ATC代码:
R03AC13
INN（国际名称）:
FORMOTEROL
剂量:
6MCG
药物剂型:
POWDER
组成:
FORMOTEROL FUMARATE DIHYDRATE 6MCG
给药途径:
INHALATION
每包单位数:
60 DOSES
处方类型:
Prescription
治疗领域:
SELECTIVE BETA 2-ADRENERGIC AGONISTS
產品總結:
Active ingredient group (AIG) number: 0152345004; AHFS:
授权状态:
APPROVED
授权日期:
2000-02-01
产品特点
COPYRIGHT 2000-2018 ASTRAZENECA CANADA INC.
Page 1 of 33
PRODUCT MONOGRAPH OXEZE
® TURBUHALER
®
(formoterol fumarate dihydrate)
6 mcg/dose
and
12 mcg/dose
Dry Powder for Oral Inhalation
Bronchodilator
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
April 23, 2018
Submission Control No: 213703
OXEZE
®
and TURBUHALER
®
are registered trademarks of AstraZeneca AB, used under
license by AstraZeneca Canada Inc.
COPYRIGHT 2000-2018 ASTRAZENECA CANADA INC.
Page 2 of 33
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
...............................................................................................
10
DOSAGE AND ADMINISTRATION
...........................................................................
10
OVERDOSAGE
..............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 13
STORAGE AND STABILITY
.......................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 14
PART II: SCIENTIFIC INFORMATION
......................................................................
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