Breo™ Ellipta®

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Fluticasone furoate 200ug;  ; Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg;  

Tersedia dari:

GlaxoSmithKline NZ Limited

INN (Nama Internasional):

Fluticasone furoate 200 µg

Dosis:

200mcg/25mcg

Bentuk farmasi:

Powder for inhalation

Komposisi:

Active: Fluticasone furoate 200ug   Vilanterol trifenatate 40ug equivalent to vilanterol 25 mcg   Excipient: Lactose monohydrate Magnesium stearate

Jenis Resep:

Prescription

Diproduksi oleh:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

Indikasi Terapi:

Indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.

Ringkasan produk:

Package - Contents - Shelf Life: Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 14 dose units - 24 months from date of manufacture stored at or below 30°C protect from moisture 1 months opened stored at or below 30°C protect from moisture - Inhaler, metered, Plastic with dose counter, inside a sealed aluminium foil tray with desiccant - 30 dose units - 24 months from date of manufacture stored at or below 30°C protect from moisture 1 months opened stored at or below 30°C protect from moisture

Tanggal Otorisasi:

2012-08-27

Selebaran informasi

BREO ELLIPTA
1
BREO
ELLIPTA
_Fluticasone furoate 100 or 200 micrograms and vilanterol (as
trifenatate) 25 micrograms per inhalation _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using BREO
ELLIPTA.
This leaflet answers some common
questions about BREO ELLIPTA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BREO
ELLIPTA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BREO ELLIPTA
IS USED FOR
BREO ELLIPTA is used to treat
asthma and chronic obstructive
pulmonary disease (COPD). To use
BREO ELLIPTA, you breathe it into
your lungs through your mouth using
the ELLIPTA inhaler.
Asthma is when the muscles
surrounding the smaller airways
become tight (bronchoconstriction),
swollen and irritated (inflammation).
Symptoms come and go and include
shortness of breath, wheezing, chest
tightness and cough.
COPD is a long-term condition that
slowly gets worse. Symptoms
include shortness of breath, cough,
chest discomfort and coughing up
mucus. BREO ELLIPTA has been
shown to reduce flare-ups of COPD
symptoms.
BREO ELLIPTA contains two active
ingredients: fluticasone furoate and
vilanterol trifenatate.
Fluticasone furoate belongs to a
group of medicines called
_corticosteroids_
, often simply called
_steroids_
. Corticosteroids are used to
reduce inflammation. They reduce
the swelling and irritation in the
small air passages in the lungs and
can ease breathing problems.
Corticosteroids also help to prevent
attacks of asthma.
Vilanterol trifenatate belongs to a
group of medicines called
_bronchodilators_
. It relaxes the
muscles of the small air passages in
the lungs. This helps to open the
airways and makes it easier for air to
get in and ou

Karakteristik produk

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BREO ELLIPTA fluticasone furoate (100 micrograms or 200
micrograms)/vilanterol (as
trifenatate) (25 micrograms), powder for inhalation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_BREO ELLIPTA 100 micrograms/25 micrograms:_ Each single inhalation
provides a
delivered dose (the dose leaving the mouthpiece) of 92 micrograms of
fluticasone furoate
and 22 micrograms of vilanterol (as trifenatate). This corresponds to
a pre-dispensed dose
of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol
(as trifenatate).
_BREO ELLIPTA 200 micrograms/25 micrograms:_ Each single inhalation
provides a
delivered dose (the dose leaving the mouthpiece) of 184 micrograms of
fluticasone furoate
and 22 micrograms of vilanterol (as trifenatate). This corresponds to
a pre-dispensed dose
of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol
(as trifenatate).
Excipients with known effect:
Each delivered dose contains approximately 25 mg of lactose (as
monohydrate).
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Powder for inhalation.
White powder in a light grey inhaler (Ellipta) with a pale blue
mouthpiece cover and a dose
counter.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Asthma
BREO ELLIPTA is indicated for the regular treatment of asthma in
adults and adolescents
aged 12 years and older where use of a combination product
(long-acting beta
2
-agonist
and inhaled corticosteroid) is appropriate.
Chronic Obstructive Pulmonary Disease (COPD)
BREO ELLIPTA is indicated for symptomatic treatment of adult patients
with COPD with a
FEV
1
< 70% predicted normal (post-bronchodilator) in patients with an
exacerbation
history.
2
4.2.
DOSAGE AND METHOD OF ADMINISTRATION
DOSE
Asthma
_Adults and adolescents aged 12 years and over _
One inhalation of BREO ELLIPTA 100/25 micrograms once daily
or
One inhalation of BREO ELLIPTA 200/25 micrograms once daily
Patients usually experience an improvement in lung function within 15
minut