Flixotide Nebules 0.5 mg/ 2ml Nebuliser Suspension

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Fluticasone propionate

可用日期:

GlaxoSmithKline (Ireland) Limited

ATC代码:

R03BA; R03BA05

INN（国际名称）:

Fluticasone propionate

剂量:

0.5  mg/2ml

药物剂型:

Nebuliser suspension

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Glucocorticoids; fluticasone

授权状态:

Not marketed

授权日期:

1999-02-05

资料单张

Reason for Update: Type 1A variation to remove Barnard Castle as Batch
Release Site (no impact to
PIL artwork)
Market: IE
Agency Approval Date: N/A T1A
Text Date: 15
th
February 2021
Text Issue and Draft No.: Issue 10 draft 1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE NEBULES 0.5 MG/2 ML NEBULISER SUSPENSION
FLIXOTIDE NEBULES 2 MG/2 ML NEBULISER SUSPENSION
(fluticasone propionate)
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
‘r

产品特点

Health Products Regulatory Authority
08 October 2019
CRN009D3C
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Nebules 0.5 mg/ 2ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nebule contains 0.5mg Fluticasone propionate in a 2ml suspension.
Each ml of suspension contains 0.25mg Fluticasone propionate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nebuliser Suspension (Nebuliser Liquid)
A white, opaque suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults and adolescents over 16 years of age:

Prophylactic management in severe asthma (patients requiring high dose
inhaled or oral corticosteroid therapy).

Treatment of acute exacerbations of asthma.
Children and adolescents from 4 to 16 years of age:

Treatment of acute exacerbations of asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Flixotide Nebules should be administered as an aerosol produced by a
jet nebuliser, as directed by a physician.
As drug
delivery can be affected by a wide range of criteria, please refer to
the directions recommended by the manufacturer of the
nebuliser equipment.
Fluticasone propionate for nebulisation should not be injected.
Use of Flixotide Nebules with ultrasonic nebulisers is not generally
recommended.
Fluticasone propionate for nebulisation is intended for oral
inhalation, and use of a mouthpiece is recommended.
If use of a
face mask is necessary, nasal inhalation may occur.
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone propionate and that it should be
taken regularly even when they are asymptomatic.
Maximal improvement in asthma may be achieved within 4 to 7 days of
starting treatment.
However, fluticasone propionate has been shown to have a therapeutic
effect as soon as 24 hours after
starting treatment for patients who have not previously received
inhaled steroids.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they