Страна: Канада
Език: английски
Източник: Health Canada
SALBUTAMOL (SALBUTAMOL SULFATE)
GLAXOSMITHKLINE INC
R03AC02
SALBUTAMOL
200MCG
POWDER
SALBUTAMOL (SALBUTAMOL SULFATE) 200MCG
INHALATION
8 BLISTERS/DISC;15 DISCS
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0108887005; AHFS:
CANCELLED POST MARKET
2007-04-03
_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............................ Прочетете целия документ