VENTODISK 200MCG POWDER

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SALBUTAMOL (SALBUTAMOL SULFATE)

Dostępny od:

GLAXOSMITHKLINE INC

Kod ATC:

R03AC02

INN (International Nazwa):

SALBUTAMOL

Dawkowanie:

200MCG

Forma farmaceutyczna:

POWDER

Skład:

SALBUTAMOL (SALBUTAMOL SULFATE) 200MCG

Droga podania:

INHALATION

Sztuk w opakowaniu:

8 BLISTERS/DISC;15 DISCS

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108887005; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2007-04-03

Charakterystyka produktu

_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............................