RELVAR ELLIPTA 18422 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUTICASONE FUROATE; VILANTEROL AS TRIFENATATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

R01AD12

Pharmaceutical form:

POWDER FOR INHALATION

Composition:

VILANTEROL AS TRIFENATATE 22 MCG; FLUTICASONE FUROATE 184 MCG

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

GLAXO OPERATIONS UK LIMITED ( TRADING AS GLAXO WELLCOME OPERATIONS)

Therapeutic area:

FLUTICASONE FUROATE

Therapeutic indications:

AsthmaRelvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonists.• patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.

Authorization date:

2019-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician s prescription only
Relvar Ellipta 92/22 mcg, powder for inhalation
Each dose released from the Ellipta inhaler contains:
92 mcg Fluticasone furoate/22 mcg Vilanterol (as trifenatate).
Relvar Ellipta 184/22 mcg, powder for inhalation
Each dose released from the Ellipta inhaler contains:
184 mcg Fluticasone furoate/22 mcg Vilanterol (as trifenatate).
For the list of the inactive and allergenic ingredients in the
medicine, 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?
Relvar Ellipta contains two active substances: fluticasone furoate and
vilanterol.
Two different strengths of Relvar Ellipta are available: fluticasone
furoate 92
micrograms/vilanterol
22
micrograms
and
fluticasone
furoate
184 micrograms/vilanterol 22 micrograms.
The 92/22 mcg strength is used for the regular treatment of chronic
obstructive
pulmonary disease (COPD) in adults, and asthma in adults and
adolescents
aged 12 years and older.
The 184/22 mcg strength is used to treat asthma in adults and
adolescents
aged 12 years and older.
The
184/22 mcg
strength
is
not
approved
for
the
treatment
of
chronic
obstructive pulmonary disease (COPD).
Relvar Ellipta should be used every day and not only when you have
breathing
problems or other symptoms of COPD and asthma. It should not be used
to
relieve a sudden attack of breathlessness or wheezing. If you get this
sort of
attack, you must use a quick-acting inhaler (such as salbutamol). If
you do not
hav

Summary of Product characteristics

1
RELVAR ELLIPTA 92/22 MCG
RELVAR ELLIPTA 184/22 MCG
1.
NAME OF THE MEDICINAL PRODU CT
RELVAR ELLIPTA 92/22 MCG.
RELVAR ELLIPTA 184/22 MCG.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Relvar Ellipta 92/22 mcg: 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).
Relvar Ellipta 184/22 mcg: 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).
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.
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
Relvar Ellipta 92/22 mcg and Relvar Ellipta 184/22 mcg is indicated
for the regular treatment of asthma in
adults and adolescents aged 12 years and older where use of a
combination medicinal product (long-acting
beta
2
-agonist and inhaled corticosteroid) is appropriate:
•
patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short acting
beta
2
-agonists.
•
patients already adequately controlled on both inhaled corticosteroid
and long-acting beta
2
-agonist.
COPD (Chronic Obstructive Pulmonary Disease)
Relvar Ellipta 92/22 mcg is indicated for the symptomatic treatment of
adults with COPD with a FEV
1
<70%
predicted normal (post-bronchodilator) with an exacerbation history
despite regular bronchodilator therapy.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Asthma _
Patients with asthma should b