BREO ELLIPTA POWDER

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

VILANTEROL (VILANTEROL TRIFENATATE); FLUTICASONE FUROATE

Disponible desde:

GLAXOSMITHKLINE INC

Código ATC:

R03AK10

Designación común internacional (DCI):

VILANTEROL AND FLUTICASONE FUROATE

Dosis:

25MCG; 100MCG

formulario farmacéutico:

POWDER

Composición:

VILANTEROL (VILANTEROL TRIFENATATE) 25MCG; FLUTICASONE FUROATE 100MCG

Vía de administración:

INHALATION

Unidades en paquete:

14/30 DOSES

tipo de receta:

Prescription

Área terapéutica:

ADRENALS

Resumen del producto:

Active ingredient group (AIG) number: 0254450003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-07-03

Ficha técnica

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_Page 1 of 74_
PRODUCT MONOGRAPH
PR
BREO ELLIPTA
fluticasone furoate/vilanterol (as trifenatate) dry powder for oral
inhalation
100 mcg/25 mcg
200 mcg/25 mcg
Inhaled Corticosteroid (ICS) and Bronchodilator
(Long-Acting Beta
2
-Adrenergic Agonist (LABA)) Combination for Oral Inhalation
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
January 7, 2019
Submission Control No: 213290
_©_
_2018 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 74_
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND
PRECAUTIONS................................................................................
5
ADVERSE REACTIONS
..............................................................................................
14
DRUG INTERACTIONS
..............................................................................................
23
DOSAGE AND ADMINISTRATION
............................................................................
26
OVERDOSAGE............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.......................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
......................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 39
PART II: SCIENTIFIC
INFORMATION.....................