FLIXOTIDE NEBULES 2 mg/2ml Nebuliser Suspension

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

FLUTICASONE PROPIONATE

Mevcut itibaren:

PCO Manufacturing

ATC kodu:

R03BA05

INN (International Adı):

FLUTICASONE PROPIONATE

Doz:

2 mg/2ml

Farmasötik formu:

Nebuliser Suspension

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Glucocorticoids

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-11-20

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE
® NEBULES
® 0.5 MG/2ML
NEBULISER SUSPENSION
FLIXOTIDE
® NEBULES
® 2 MG/2ML
NEBULISER SUSPENSION
(fluticasone propionate)
_ _
_The name of this product imported from Italy is Flixotide 500mcg/2ml
_
_sospensione da nebulizzare. _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse or
pharmacist.

This medicine has been prescribed for you. 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, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet.
See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Flixotide is and what it is used for
2.
What you need to know before you use Flixotide
3.
How to use Flixotide
4.
Possible side effects
5.
How to store Flixotide
6.
Contents of the pack and other information
1.
WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR
Flixotide contains a medicine called fluticasone propionate which
belongs to a group of medicines called corticosteroids (a group of
synthetic hormones, often just called steroids). Flixotide works by
reducing swelling and irritation in the lungs. It has an
anti-inflammatory
action. Only a very small dose is needed as it is inhaled straight to
the
lungs.
Flixotide helps to prevent and treat asthma attacks in adults and
children
over 16 years of age who need regular treatment. This is why it is
sometimes called a ‘preventer’. It needs to be used regularly,
every day.
Flixotide also helps treat asthma attacks in children 4 years of age
and
over.
Flixotide will not help treat sudden asthma attacks where you feel
breathless.

A different medicine is used for treating sudden attacks (called a
‘reliever’).

If you have more than one medicine, be careful not to confuse
them.
2.
WHAT YOU NE

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Nebules 2mg/2ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nebule contains 2mg Fluticasone propionate in 2ml suspension.
Each ml of suspension contains 1mg Fluticasone propionate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser Suspension (Nebuliser liquid)
_Product imported from Greece and Romania:_
White, opaque suspension
4 CLINICAL PARTICULARS
As per PA1077/044/017
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/044/017
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polysorbate 20
Sorbitan monolaurate
Monosodium phosphate dihydrate
Dibasic sodium phosphate
Sodium Chloride
Water for Injection
6.2 INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products
except these mentioned in section 6.6.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
Once Nebules have been removed from their foil flow wrap pack, they
should be used within 28 days.
Opened Nebules should be used immediately.
If diluted with sodium chloride injection, use immediately (see
section 4.2 of PA1077/044/016 and section 6.6)
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
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