INCRUSE ELLIPTA 55 MCG

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

UMECLIDINIUM AS BROMIDE

Mevcut itibaren:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kodu:

R03BB07

Farmasötik formu:

POWDER FOR INHALATION

Kompozisyon:

UMECLIDINIUM AS BROMIDE 55 MCG

Uygulama yolu:

INHALATION

Reçete türü:

Required

Tarafından üretildi:

GLAXO OPERATIONS UK LIMITED ( TRADING AS GLAXO WELLCOME OPERATIONS)

Terapötik alanı:

UMECLIDINIUM BROMIDE

Terapötik endikasyonlar:

INCRUSE is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Yetkilendirme tarihi:

2020-01-31

Bilgilendirme broşürü

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
INCRUSE ELLIPTA 55 MCG, INHALATION POWDER
Each dose released from the Incruse Ellipta inhaler contains 55
micrograms
of
the
active
ingredient,
Umeclidinium
(equivalent
to
65
micrograms
of
umeclidinium bromide).
For
the
list
of
the
inactive
and
allergenic
ingredients,
see
section
2
-
“Important information about some of the ingredients of the
medicine” and
section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains
concise
information
about
the
medicine.
If
you
have
further
questions, refer to the physician or the 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?
Incruse Ellipta contains the active substance umeclidinium.
This medicine is used to treat
chronic obstructive pulmonary disease
(COPD)
in adults. COPD is a long-term condition in which the airways and air
sacs in
the
lungs
gradually
become
blocked
or
damaged,
leading
to
breathing
difficulties
that
slowly
get
worse.
Tightening
of
the
muscles
around
the
airways narrows the airways and restricts the flow of air, thereby
adding to
breathing difficulties.
This medicine blocks the tightening of these muscles, making it easier
for air
to get in and out of the lungs. When used regularly, it can help
control your
breathing difficulties and reduce the effects of COPD on your everyday
life.
INCRUSE
ELLIPTA
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 reliever
inhaler (such
as salbutamol).
If you do not have a quick-acting inhaler, contact your physician.
THERAPEUTIC GROUP: anticholinergic.
Incruse Ellipta belongs to a group of medicines called
bronchodilators.
2. BEFORE USING THE MEDICINE
DO NOT

Ürün özellikleri

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1.
NAME OF THE MEDICINAL PRODUCT
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece of the inhaler) of
55 micrograms umeclidinium (equivalent to 65 micrograms of
umeclidinium bromide) This corresponds to a
pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2
micrograms umeclidinium bromide.
Excipient with known effect:
Each delivered dose contains approximately 12.5 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 grey inhaler (Ellipta) with a light green mouthpiece
cover and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Incruse Ellipta is indicated as a maintenance bronchodilator treatment
to relieve symptoms in adult patients
with chronic obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The recommended dose is one inhalation of umeclidinium bromide once
daily.
Incruse Ellipta should be administered each day at the same time of
the day to maintain bronchodilation.
The maximum dose is one inhalation of umeclidinium bromide once daily.
_Special populations _
Elderly
No dose adjustment is required in patients 65 years of age or older
(see section 5.2).
Renal impairment
No dose adjustment is required in patients with renal impairment (see
section 5.2).
Hepatic impairment
No dose adjustment is required in patients with mild or moderate
hepatic impairment. Incruse Ellipta has not
been studied in patients with severe hepatic impairment and should be
used with caution (see section 5.2).
_Paediatric population _
There is no relevant use of Incruse Ellipta in the paediatric
population (under 18 years of age) for the
indication of COPD.
_ _
Method of administration
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2
For inhalation use only.
The following instructions for the 30 dose inhaler (30 day supply)