Flixotide

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Fluticasone propionate 125ug;  

から入手可能:

GlaxoSmithKline NZ Limited

INN（国際名）:

Fluticasone propionate 125 µg

投薬量:

125 mcg/dose

医薬品形態:

Aerosol inhaler, metered dose

構図:

Active: Fluticasone propionate 125ug   Excipient: Norflurane

パッケージ内のユニット:

Inhaler, metered, (not marketed), 60 dose units

クラス:

Prescription

処方タイプ:

Prescription

製:

Glaxo Wellcome Manufacturing Pte Ltd

適応症:

Fluticasone propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (see dosage instructions) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.

製品概要:

Package - Contents - Shelf Life: Inhaler, metered, - 60 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat - Inhaler, metered, sample pack - 120 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat - Inhaler, metered, - 120 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat

承認日:

1970-01-01

情報リーフレット

1
FLIXOTIDE
INHALER
_Fluticasone propionate (CFC-Free) Inhaler 50, 125 or 250 _
_micrograms _
_per actuation _
_ _
CONSUMER MEDICINE INFORMATION
Please read this leaflet carefully before you start using FLIXOTIDE
(CFC-free) Inhaler.
WHAT IS IN THIS
LEAFLET?
This leaflet answers some
common questions about
FLIXOTIDE Inhaler. It does
not contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
FLIXOTIDE Inhaler against
the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT FLIXOTIDE
INHALERS (‘PUFFERS’)
ARE USED FOR
You may know your Inhaler
better as a ‘puffer’.
FLIXOTIDE puffers contain a
medicine called fluticasone
propionate. This medicine
belongs to a group of
medicines known as
corticosteroids, frequently
called ‘steroids’. They are not
‘anabolic steroids’ which are
the steroids sometimes misused
by athletes.
Your FLIXOTIDE puffer
provides a measured amount of
steroid for you to breathe into
your lungs. By using your
FLIXOTIDE puffer regularly
every day, the medicine
reduces the swelling and
irritation in the walls of the
small air passages in your
lungs. Your FLIXOTIDE
puffer contains the type of
asthma medicine known as a
‘preventer’. It does not give
immediate relief from an
asthma attack and may take up
to a week to start to work. If
your shortness of breath or
wheeze does not get better
after 7 days, tell your doctor.
When used every day, your
FLIXOTIDE puffer helps to
ease breathing problems and
prevent asthma attacks.
This medicine is only one part
of a general plan to help you
manage your asthma. You
should discuss this plan with
your doctor. You may also be
using a ‘reliever puffer’. Keep
using it according to your
doctor’s advice. Ask your
doctor to check your treatment
regularly.
A

製品の特徴

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
FLIXOTIDE Inhaler (CFC-Free) 50 micrograms/dose, aerosol inhaler,
metered dose.
FLIXOTIDE Inhaler (CFC-Free) 125 micrograms/dose, aerosol inhaler,
metered
dose.
FLIXOTIDE Inhaler (CFC-Free) 250 micrograms/dose, aerosol inhaler,
metered
dose.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION _ _
FLIXOTIDE 50 Inhaler is a pressurised metered-dose inhaler which
delivers 50 mcg
of fluticasone propionate per actuation into the mouthpiece of a
specially designed
actuator.
FLIXOTIDE 125 Inhaler is a pressurised metered-dose inhaler which
delivers
125 mcg of fluticasone propionate per actuation into the mouthpiece of
a specially
designed actuator.
FLIXOTIDE 250 Inhaler is a pressurised metered-dose inhaler which
delivers
250 mcg of fluticasone propionate per actuation.
For full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM _ _
Aerosol inhaler, metered dose.
The canisters are fitted into plastic actuators incorporating an
atomising orifice and
fitted with dustcaps.
4.
CLINICAL PARTICULARS _ _
4.1
THERAPEUTIC INDICATIONS
FLIXOTIDE is indicated in adults and children aged from 1 year and
above for
prophylactic treatment of asthma.
Fluticasone propionate has a marked anti-inflammatory effect in the
lungs.
It reduces symptoms and exacerbations of asthma in patients previously
treated with
bronchodilator alone or with other prophylactic therapy.
Severe asthma requires regular medical assessment as death may occur.
Patients
with severe asthma have constant symptoms and frequent exacerbations,
with
limited physical capacity, and PEF values below 60% predicted at
baseline with
greater than 30% variability, usually not returning entirely to normal
after a
bronchodilator. These patients will require high dose inhaled (see
dosage
2
instructions) or oral corticosteroid therapy. Sudden worsening of
symptoms may
require increased corticosteroid dosage which should be administered
under urgent
medical supervision.
Adults:
_Prophylactic management in: _
-
Mild asthma (PE