FLOVENT DISKUS POWDER

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FLUTICASONE PROPIONATE

Διαθέσιμο από:

GLAXOSMITHKLINE INC

Φαρμακολογική κατηγορία (ATC):

R03BA05

INN (Διεθνής Όνομα):

FLUTICASONE

Δοσολογία:

50MCG

Φαρμακοτεχνική μορφή:

POWDER

Σύνθεση:

FLUTICASONE PROPIONATE 50MCG

Οδός χορήγησης:

INHALATION

Μονάδες σε πακέτο:

60 DOSES

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ADRENALS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-10-09

Αρχείο Π.Χ.Π.

_2014-07-29/131-pristine-english-Flovent.doc _
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_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 _
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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