FLOVENT DISKUS POWDER

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

FLUTICASONE PROPIONATE

Disponível em:

GLAXOSMITHKLINE INC

Código ATC:

R03BA05

DCI (Denominação Comum Internacional):

FLUTICASONE

Dosagem:

50MCG

Forma farmacêutica:

POWDER

Composição:

FLUTICASONE PROPIONATE 50MCG

Via de administração:

INHALATION

Unidades em pacote:

60 DOSES

Tipo de prescrição:

Prescription

Área terapêutica:

ADRENALS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2015-10-09

Características técnicas

_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