TRELEGY ELLIPTA 92 55 22 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUTICASONE FUROATE; UMECLIDINIUM AS BROMIDE; VILANTEROL AS TRIFENATATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

R03AL08

Pharmaceutical form:

POWDER FOR INHALATION PRE-DISPENSED

Composition:

VILANTEROL AS TRIFENATATE 22 MCG/INH; UMECLIDINIUM AS BROMIDE 55 MCG/INH; FLUTICASONE FUROATE 92 MCG/INH

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

GLAXOSMITHKLINE TRADING SERVICES LIMITED

Therapeutic area:

VILANTEROL, UMECLIDINIUM BROMIDE AND FLUTICASONE FUROATE

Therapeutic indications:

AsthmaTrelegy Ellipta 92/55/22 mcg is indicated for the maintenance treatment of asthma in patients aged 18 years and older.Trelegy Ellipta 92/55/22 mcg should be prescribed for patients who are not adequately controlled on maintenance asthma medication, such as an ICS/LABA.Important Limitations of Use:Trelegy Ellipta 92/55/22 mcg is NOT indicated for the relief of acute asthma.COPD (Chronic Obstructive Pulmonary Disease)Trelegy Ellipta 92/55/22 mcg is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.

Authorization date:

2023-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physicians prescription only
TRELEGY ELLIPTA 92/55/22 MCG,
POWDER FOR INHALATION
PRE-DISPENSED
Each dose released from the Ellipta inhaler contains:
92
mcg
fluticasone
furoate/55
mcg
umeclidinium
(equivalent
to
65
mcg
umeclidinium bromide)/22 mcg vilanterol (as trifenatate).
TRELEGY ELLIPTA 184/55/22 MCG,
POWDER FOR INHALATION
PRE-DISPENSED
Each dose released from the Ellipta inhaler contains:
184 mcg fluticasone furoate/55 mcg umeclidinium (equivalent to 65 mcg
umeclidinium bromide)/22 mcg vilanterol (as trifenatate).
For a list of the inactive and allergenic ingredients, see section 2
–
Important
information about some of the ingredients in the medicine and section
6 –
Additional information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
ASTHMA
Trelegy Ellipta 92/55/22 mcg and Trelegy Ellipta 184/55/22 mcg are
intended
for the maintenance treatment of asthma in patients aged 18 years and
older,
who are not adequately controlled on
maintenance asthma medication, such as
a combination treatment with an inhaled corticosteroid and a
long-acting beta
agonist bronchodilator.
Trelegy Ellipta 92/55/22 mcg and Trelegy Ellipta 184/55/22 mcg are not
intended for the relief of acute asthma.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Trelegy Ellipta 92/55/22 mcg is intended for a maintenance treatment
in adult
patients
with
moderate
to
severe
chronic
obstructive
pulmonary
disease
(COPD), who are not adequately treated by a combination of an inhaled
corticosteroid and a long-acting beta agonist bronchodilator or
combination
treatment with a lo

Summary of Product characteristics

1
Trelegy Ellipta 92/55/22 mcg
Trelegy Ellipta 184/55/22 mcg
1.
NAME OF THE MEDICINAL PRODUCT
Trelegy Ellipta 92/55/22 mcg
, inhalation powder, pre-dispensed
Trelegy Ellipta 184/55/22 mcg
, inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trelegy Ellipta 92/55/22 mcg
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 92 micrograms
fluticasone furoate, 65 micrograms umeclidinium bromide (equivalent to
55 micrograms umeclidinium) and
22 micrograms vilanterol (as trifenatate). This corresponds to a
pre-dispensed dose of 100 micrograms
fluticasone furoate, 74.2 micrograms umeclidinium bromide (equivalent
to 62.5 micrograms umeclidinium
free cation) and 40 micrograms vilanterol trifenatate (equivalent to
25 micrograms vilanterol free base).
Trelegy Ellipta 184/55/22 mcg
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 184 micrograms
fluticasone furoate, 65 micrograms umeclidinium bromide (equivalent to
55 micrograms umeclidinium) and
22 micrograms vilanterol (as trifenatate). This corresponds to a
pre-dispensed dose of 200 micrograms
fluticasone furoate, 74.2 micrograms umeclidinium bromide (equivalent
to 62.5 micrograms umeclidinium
free cation) and 40 micrograms vilanterol trifenatate (equivalent to
25 micrograms vilanterol free base).
Excipient with known effect
Each delivered dose contains approximately 25 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder).
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 92/55/22 mcg and Trelegy Ellipta 184/55/22 mcg are
indicated for the maintenance treatment
of asthma in patients aged 18 years and older. Trelegy Ellipta
92/55/22 mcg and Trelegy Ellipta 184/55/22
mcg should be prescribed for patients who are not adequately
controlled on maintenance asthma medi