Lifsar Pulmojet

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

SALMETEROL, FLUTICASONE PROPIONATE

Mevcut itibaren:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC kodu:

R03AK06

INN (International Adı):

SALMETEROL 50 µg FLUTICASONE PROPIONATE 500 µg

Farmasötik formu:

INHALATION POWDER

Kompozisyon:

SALMETEROL 50 µg FLUTICASONE PROPIONATE 500 µg

Reçete türü:

POM

Terapötik alanı:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2015-07-21

Bilgilendirme broşürü

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIFSAR PULMOJET 50 MICROGRAM / 500 MICROGRAM PER METERED DOSE
INHALATION POWDER
Salmeterol / fluticasone propionate
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START
USING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lifsar PulmoJet is and what it is used for
2.
What you need to know before you use Lifsar PulmoJet
3.
How to use Lifsar PulmoJet
4.
Possible side effects
5.
How to store Lifsar PulmoJet
6.
Contents of the pack and other information
1. WHAT LIFSAR PULMOJET IS AND WHAT IT IS USED FOR
Lifsar
PulmoJet
is
an
inhaler
that
contains
two
active
ingredients,
salmeterol
and
fluticasone
propionate.
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay open.
This makes it easier for air to get in and out. The effects last for
at least 12 hours.
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
The doctor has prescribed this medicine to help to prevent breathing
problems associated with Chronic
Obstructive Pulmonary Disease (COPD). Lifsar PulmoJet reduces the
number of flare ups of symptoms
related to COPD.
You must use Lifsar PulmoJet every day, as prescribed by
your doctor. This will ensure that
the medicine works properly in controlling these symptoms.
Page 2 of 12
LIFSAR
PULMOJET
HELPS
TO
STOP
BREATHLESSNESS
AND
WHEEZINESS
COMING
ON.
HOWEVER,
LIFSAR
PULMOJET SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OF WHEEZING. IF THIS
HAPPENS
YOU
NEED
TO
USE
A
FAST-ACTING
“RELIEVER”
(�

Ürün özellikleri

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lifsar PulmoJet 50 microgram / 500 microgram per metered dose
Inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
single
inhalation
provides
a
delivered
dose
(the
dose
leaving
the
mouthpiece)
of 45 micrograms
of
salmeterol
(as
salmeterol
xinafoate)
and
465 micrograms
of fluticasone
propionate. This corresponds to a metered dose of 50 micrograms of
salmeterol (as salmeterol
xinafoate) and 500 micrograms of fluticasone propionate.
Excipient with known effect: contains up to 7 milligrams of lactose
monohydrate per metered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
The
inhaler
contains
white
powder.
The
inhaler
body
is
grey
and
white
with
a
grey
base
and mouthpiece, a white cover and a purple or grey bottom lid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lifsar PulmoJet is indicated for the symptomatic treatment of adults
with Chronic Obstructive
Pulmonary
Disease
(COPD)
with
a
FEV
1
< 60%
predicted
normal
(pre-bronchodilator)
and a history
of
repeated
exacerbations
and
who
have
significant
symptoms
despite
regular
bronchodilator therapy.
Lifsar PulmoJet is intended for use by adults 18 years of age and
older only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Route of administration; inhalation use._ _
Patients should be made aware that Lifsar PulmoJet must be used
regularly, every day for optimum
benefit, even when asymptomatic.
Page 2 of 14
LIFSAR
PULMOJET
IS
AVAILABLE
IN
THE
STRENGTH
OF
50 MICROGRAMS
OF
SALMETEROL
AND 500 MICROGRAMS OF FLUTICASONE PROPIONATE PER METERED DOSE ONLY.
RECOMMENDED DOSES
Adults:
One inhalation of 50 micrograms salmeterol and 500 micrograms
fluticasone propionate twice
daily.
Special patient groups
There is no need to adjust the dose in elderly patients or in those
with renal impairment. There are
no data available for use of Lifsar PulmoJet in patients with hepatic
impairment.
Paediatric population
Lifsar PulmoJet is NOT fo