FLOVENT DISKUS POWDER
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-08-2014
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Active ingredient:
FLUTICASONE PROPIONATE
Available from:
GLAXOSMITHKLINE INC
ATC code:
R03BA05
INN (International Name):
FLUTICASONE
Dosage:
50MCG
Pharmaceutical form:
POWDER
Composition:
FLUTICASONE PROPIONATE 50MCG
Administration route:
INHALATION
Units in package:
60 DOSES
Prescription type:
Prescription
Therapeutic area:
ADRENALS
Product summary:
Active ingredient group (AIG) number: 0124685001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2015-10-09
Summary of Product characteristics
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PRODUCT MONOGRAPH
PR
FLOVENT
® HFA
fluticasone propionate inhalation aerosol
50, 125, and 250 mcg/metered dose
PR
FLOVENT
® DISKUS
®
fluticasone propionate powder for inhalation
50, 100, 250, and 500 mcg/blister
Corticosteroid for Oral Inhalation
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.gsk.ca
Date of Revision: July 29, 2014
Submission Control No: 174022
_©_
_2014. GlaxoSmithKline Inc. All rights reserved. _
_®_
_FLOVENT, DISKUS and BABYHALER are registered trademarks, used under
license by GlaxoSmithKline Inc. _
_®_
_AEROCHAMBER PLUS is a registered trademark of Trudell Medical
International _
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_Page 2 of 49_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................19
SPECIAL HANDLING INSTRUCTI
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