ARNUITY ELLIPTA POWDER

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FLUTICASONE FUROATE

Prieinama:

GLAXOSMITHKLINE INC

ATC kodas:

R03BA09

INN (Tarptautinis Pavadinimas):

FLUTICASONE FUROATE

Dozė:

100MCG

Vaisto forma:

POWDER

Sudėtis:

FLUTICASONE FUROATE 100MCG

Vartojimo būdas:

INHALATION

Vienetai pakuotėje:

14 BLISTERS/30 BLISTERS

Recepto tipas:

Prescription

Gydymo sritis:

CORTICOSTEROIDS

Produkto santrauka:

Active ingredient group (AIG) number: 0152271002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2015-09-21

Prekės savybės

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_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ARNUITY ELLIPTA
fluticasone furoate dry powder for oral inhalation
Powder, 100 mcg or 200 mcg, per oral inhalation
Inhaled corticosteroid
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, ON
L5R 4H1
Canada
Date of Initial Authorization:
September 21, 2015
Date of Revision:
September 15, 2023
Submission Control No: 274458
_©_
_2023 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_ _
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_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.................................