SEREVENT DISKHALER DISK (50MCG/DOSE) POWDER

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

SALMETEROL (SALMETEROL XINAFOATE)

Доступна с:

GLAXOSMITHKLINE INC

код АТС:

R03AC12

ИНН (Международная Имя):

SALMETEROL

дозировка:

50MCG

Фармацевтическая форма:

POWDER

состав:

SALMETEROL (SALMETEROL XINAFOATE) 50MCG

Администрация маршрут:

INHALATION

Штук в упаковке:

15X4 BLISTER DISKS

Тип рецепта:

Prescription

Терапевтические области:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Обзор продуктов:

Active ingredient group (AIG) number: 0126960002; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2017-09-20

Характеристики продукта

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_Page 1 of 50_
PRODUCT MONOGRAPH
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
(beta
2
-adrenergic stimulant)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.gsk.ca
Date of Revision:
July 9, 2014
Submission Control No: 173662
_©_
_ 2014 GlaxoSmithKline Inc. All Rights Reserved_
_ _
_®_
_SEREVENT, DISKHALER and DISKUS are registered trademarks, used under
license by GlaxoSmithKline Inc. _
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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
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
.