FLOVENT DISKUS POWDER

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FLUTICASONE PROPIONATE

Disponibil de la:

GLAXOSMITHKLINE INC

Codul ATC:

R03BA05

INN (nume internaţional):

FLUTICASONE

Dozare:

50MCG

Forma farmaceutică:

POWDER

Compoziție:

FLUTICASONE PROPIONATE 50MCG

Calea de administrare:

INHALATION

Unități în pachet:

60 DOSES

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ADRENALS

Rezumat produs:

Active ingredient group (AIG) number: 0124685001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-10-09

Caracteristicilor produsului

_2014-07-29/131-pristine-english-Flovent.doc _
_ _
_ _
_Page 1 of 49_
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 _
_2014-07-29/131-pristine-english-Flovent.doc _
_ _
_ _
_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