VENTODISK 400MCG POWDER

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SALBUTAMOL (SALBUTAMOL SULFATE)

제공처:

GLAXOSMITHKLINE INC

ATC 코드:

R03AC02

INN (국제 이름):

SALBUTAMOL

복용량:

400MCG

약제 형태:

POWDER

구성:

SALBUTAMOL (SALBUTAMOL SULFATE) 400MCG

관리 경로:

INHALATION

패키지 단위:

120 DOSES

처방전 유형:

Prescription

치료 영역:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

제품 요약:

Active ingredient group (AIG) number: 0108887004; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2007-04-03

제품 특성 요약

_DCTM/120/635/2007-01-26/131-pristine-ventodisk-&-ventolin.doc _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
PR
VENTODISK
®
salbutamol sulphate Powder for Inhalation
200 and 400 mcg
and
PR
VENTODISK
®
DISKHALER
®
inhalation device for use with
PR
VENTODISK
® DISKS
PR
VENTOLIN
®
RESPIRATOR SOLUTION
salbutamol sulphate solution
5 mg/mL
PR
VENTOLIN NEBULES
®
P.F.
salbutamol sulphate solution
2.5 mg/2.5 mL, 5.0 mg/2.5 mL ampoules
Bronchodilator
(beta
2
-adrenergic stimulant)
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
February 1, 2007
Submission Control No: 109343
_2007 GlaxoSmithKline Inc. All rights reserved. _
_®_
_VENTOLIN, VENTOLIN NEBULES, VENTODISK and DISKHALER are registered
trademarks, used under license _
_by GlaxoSmithKline Inc. _
_DCTM/120/635/2007-01-26/131-pristine-ventodisk-&-ventolin.doc _
_ _
_Page 2 of 42_
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
....................................................................................................9
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND
STABILITY............................