SEREVENT (25MCG/ACTUATION) METERED-DOSE AEROSOL

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

SALMETEROL (SALMETEROL XINAFOATE)

可用日期:

GLAXOSMITHKLINE INC

ATC代码:

R03AC12

INN（国际名称）:

SALMETEROL

剂量:

25MCG

药物剂型:

METERED-DOSE AEROSOL

组成:

SALMETEROL (SALMETEROL XINAFOATE) 25MCG

给药途径:

INHALATION

每包单位数:

60/120 DOSES

处方类型:

Prescription

治疗领域:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

產品總結:

Active ingredient group (AIG) number: 0126960001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2006-07-12

产品特点

_DCTM/201/540/2006-03-01-131-pm-pristine-serevent.doc _
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_Page 1 of 50_
PRODUCT MONOGRAPH
Pr
SEREVENT
®
salmeterol xinafoate inhalation aerosol
25 mcg salmeterol (as the xinafoate salt)/metered dose
Pr
SEREVENT
®
DISKHALER
®
Disk
salmeterol xinafoate dry powder for inhalation
50 mcg salmeterol (as the xinafoate salt)/blister
Pr
SEREVENT
®
DISKUS
®
salmeterol xinafoate dry powder for inhalation
50 mcg salmeterol (as the xinafoate salt)/blister
Bronchodilator
(β
2
-adrenergic stimulant)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.gsk.ca
Date of Preparation:
August 27, 2001
Date of Revision:
March 2, 2006
Submission Control No: 102588
_©_
_ 2006 GlaxoSmithKline Inc. All Rights Reserved_
_ _
_®_
_SEREVENT, DISKHALER and DISKUS are registered trademarks, used under
license by GlaxoSmithKline Inc. _
_DCTM/201/540/2006-03-01-131-pm-pristine-serevent.doc _
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_Page 2 of 50_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20