TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate 100 ug / umeclidinium (as bromide) 62.5 ug / vilanterol (as trifenatate) 25 ug powder for inhalation

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

vilanterol trifenatate, Quantity: 40 microgram (Equivalent: vilanterol, Qty 25 microgram); umeclidinium bromide, Quantity: 74.2 microgram (Equivalent: umeclidinium, Qty 62.5 microgram); fluticasone furoate, Quantity: 100 microgram

Disponible depuis:

GlaxoSmithKline Australia Pty Ltd

forme pharmaceutique:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate

Mode d'administration:

Inhalation

Unités en paquet:

14 blisters (sample pack), 30 blisters

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Asthma,TRELEGY ELLIPTA is indicated for the maintenance treatment of asthma in adult patients who are not adequately controlled with a combination of inhaled corticosteroid and a long-acting beta2-agonist.,COPD,TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe COPD who require treatment with LAMA+LABA+ICS.,TRELEGY ELLIPTA is not indicated for the initiation of therapy in COPD.

Descriptif du produit:

Visual Identification: A plastic inhaler with a light grey body and a beige mouthpiece cover containing two strips of blister each containing a white powder; Container Type: Inhaler - dry powder; Container Material: Other plastic laminate/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statut de autorisation:

Registered

Date de l'autorisation:

2018-01-16

Notice patient

TRELEGY ELLIPTA
100/62.5/25 AND
200/62.5/25
_Fluticasone furoate 100 or 200 micrograms, umeclidinium (as bromide)
62.5 micrograms and vilanterol_
_(as trifenatate) 25 micrograms per inhalation_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using TRELEGY
ELLIPTA.
This leaflet answers some common
questions about TRELEGY
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 TRELEGY
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 TRELEGY
ELLIPTA IS USED FOR
TRELEGY ELLIPTA is a dry
powder inhaler. When you breathe in
using the inhaler, the medicine is
deposited into the lungs. TRELEGY
ELLIPTA is used to treat asthma or
chronic obstructive pulmonary
disease (COPD).
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.
TRELEGY ELLIPTA contains three
active ingredients: fluticasone
furoate, umeclidinium (as bromide)
and vilanterol (as trifenatate).
Fluticasone furoate belongs to a
group of medicines called
corticosteroids, often simply called
steroids. They are not 'anabolic
steroids' which are the steroids
sometimes misused by athletes.
Corticosteroids are used to reduce
inflammation. They reduce the
swelling and irritation in the small air
passages in the lungs and so ease
breathing problems.
Umeclidinium and vilanterol belong
to a group of medicines called
bronchodilators. They work together
to help open the airways and make it

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
TRELEGY ELLIPTA 100/62.5/25 AND 200/62.5/25 (FLUTICASONE
FUROATE/UMECLIDINIUM [AS BROMIDE]/VILANTEROL [AS TRIFENATATE])
POWDER FOR INHALATION
1
NAME OF THE MEDICINE
Fluticasone furoate/umeclidinium (as bromide)/vilanterol (as
trifenatate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each foil strip contains regularly distributed blisters with one strip
containing either
100 micrograms or 200 micrograms of fluticasone furoate and the other
strip containing
62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms
umeclidinium [as bromide])
and 25 micrograms of vilanterol (as trifenatate).
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece of the
inhaler) containing 92 micrograms fluticasone furoate, 55 micrograms
umeclidinium
(equivalent to 65 micrograms umeclidinium [as bromide]) and 22
micrograms vilanterol (as
trifenatate) OR 184 micrograms fluticasone furoate, 55 micrograms
umeclidinium (equivalent
to 65 micrograms umeclidinium [as bromide]) and 22 micrograms
vilanterol (as trifenatate).
Excipients with known effect
Lactose monohydrate (which contains milk protein).
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 beige mouthpiece
cover and a dose
counter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
TRELEGY ELLIPTA is indicated for the maintenance treatment of asthma
in adult patients
who are not adequately controlled with a combination of inhaled
corticosteroid and a long-
acting beta2-agonist.
COPD
TRELEGY ELLIPTA is indicated for the maintenance treatment of adults
with moderate to
severe COPD who require treatment with LAMA+LABA+ICS.
TRELEGY ELLIPTA is not indicated for the initiation of therapy in
COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
Patients can be changed from their existing inhalers to TRELEGY
ELLIPTA at the next dose.
HOWEVER, IT IS IMPORTANT THAT PATIENTS DO NOT TAKE OTHER LONG-ACTING
BETA
2
-RECE