Trelegy Ellipta 100/62.5/25

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Fluticasone furoate 100ug;  ; Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation);  ; Vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base);  

可用日期:

GlaxoSmithKline NZ Limited

药物剂型:

Powder for inhalation

组成:

Active: Fluticasone furoate 100ug   Umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg (free cation)   Vilanterol trifenatate 40ug equivalent to 25 mcg of vilanterol (free base)   Excipient: Lactose monohydrate Magnesium stearate

处方类型:

Prescription

疗效迹象:

TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with a long-acting muscarinic receptor antagonist (LAMA) + long-acting beta2-receptor agonist (LABA) + inhaled corticosteroid (ICS). TRELEGY ELLIPTA should not be used for the initiation of COPD treatment.

產品總結:

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

授权日期:

2018-02-21

资料单张

TRELEGY ELLIPTA
1
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 _
NEW ZEALAND 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
t

产品特点

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate (100
micrograms)/umeclidinium (as
bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25
micrograms), powder for
inhalation.
TRELEGY ELLIPTA 200/62.5/25 fluticasone furoate (200
micrograms)/umeclidinium (as
bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25
micrograms), powder for
inhalation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
Each pre-dispensed dose contains either 100 micrograms fluticasone
furoate,
62.5 micrograms umeclidinium (equivalent to 74.2 micrograms
umeclidinium bromide) and
25 micrograms vilanterol (as trifenatate) or 200 micrograms
fluticasone furoate,
62.5 micrograms umeclidinium (equivalent to 74.2 micrograms
umeclidinium bromide) and
25 micrograms vilanterol (as trifenatate).
Excipient with known effect:
Each delivered dose contains approximately 25 milligrams 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 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 beta
2
-agonist.
2
COPD
TRELEGY ELLIPTA is indicated for the maintenance treatment of adults
with moderate to
severe chronic obstructive pulmonary disease (COPD) who require
treatment with a long-
acting muscarinic receptor