Relvar Ellipta powder for inhalation

Country: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

fluticasone (fluticasone furoate), vilanterol

Доступно од:

Glaxo Operations UK Ltd

АТЦ код:

R03AK10

INN (Међународно име):

fluticasone (fluticasone furoate), vilanterol

Дозирање:

200mcg/dose+ 25mcg/dose

Фармацеутски облик:

powder for inhalation

Јединице у пакету:

powder in strip (60/2x30/ dose) in plastic inhaler

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2016-02-26

Карактеристике производа

Relvar Ellipta 92 micrograms/22 micrograms inhalation powder,
pre-
dispensed
Summary
of
Product
Characteristics
1. Name of the medicinal
product
Relvar
Ellipta 92 micrograms/22
micrograms
inhalation
powder,
pre-dispensed
2. Qualitative and quantitative
composition
Each single inhalation
provides
a delivered
dose (the dose leaving the mouthpiece)
of
92 micrograms
of
f1uticasone furoate
and 22 micrograms
of
vilanterol
(as
trifenatate).This
corresponds
to a pre-dispensed
dose of
100 micrograms
of
f1uticasone
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.
3. Pharmaceutical
form
Inhalation
powder,
pre-dispensed
(Inhalation
powder).
White powder
in a light
grey inhaler
with a yellow mouthpiece
cover
and a dose counter.
4. Clinical
particulars
4.1 Therapeutic
indications
Asthma
Relvar
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--aqonist
and inhaled corticosteroid)
is appropriate:
• patients
not
adequately
controlled
with inhaled corticosteroids
and 'as needed'
inhaled
short
acting beta--aqonlsts
..
CO PO (Chronic
Obstructive
Pulmonary
Disease)
Relvar
Ellipta 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.
4.2 Posology
and method
of
administration
Posology
_Asthma_
_Adults_
_and adolescents_
_aged_
12
years
_and over_
One inhalation of
Relvar
Ellipta_ 92/22_ micrograms
once daily.
Patients
usually experience
an improvement
in lung function
within
15 minutes
of
inhaling Relvar
Ellipta.
However,
the patient
should
be informed that
regular
daily usage is necessary
to
maintain
control
of
asthma
symptoms
and that
use should be continued
even when
asymptomatic.
If symptoms
arise in the period between