SEREVENT (25MCG/ACTUATION) METERED-DOSE AEROSOL

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SALMETEROL (SALMETEROL XINAFOATE)

Предлага се от:

GLAXOSMITHKLINE INC

АТС код:

R03AC12

INN (Международно Name):

SALMETEROL

дозиране:

25MCG

Лекарствена форма:

METERED-DOSE AEROSOL

Композиция:

SALMETEROL (SALMETEROL XINAFOATE) 25MCG

Начин на приложение:

INHALATION

Броя в опаковка:

60/120 DOSES

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2006-07-12

Данни за продукта

_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