AXOTIDE ACCUHALER fluticasone propionate 250 micrograms powder for inhalation blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

fluticasone propionate, Quantity: 20 mg/g

Предлага се от:

GlaxoSmithKline Australia Pty Ltd

INN (Международно Name):

fluticasone propionate

Лекарствена форма:

Inhalation, powder for

Композиция:

Excipient Ingredients: lactose monohydrate

Начин на приложение:

Inhalation

Броя в опаковка:

60 blisters

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

For use in the prophylactic management of asthma in adults and children over 4 years of age.

Каталог на резюме:

Visual Identification: A white powder contained in two-tone orange, circular device in moulded plastic, approx 8.5cm in diameter and approximately 3cm high, with a dose counter indicating 28 or 60 doses.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2016-03-11

Листовка

AXOTIDE
®
ACCUHALER
®
,
AXOTIDE
® JUNIOR
ACCUHALER
®
_Fluticasone propionate_
CONSUMER MEDICINE INFORMATION
Please read this leaflet carefully before you start Axotide Accuhaler
or Axotide Junior Accuhaler. (simply called Axotide
Accuhaler in this document.)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Axotide Accuhaler.
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 Axotide
Accuhaler 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 AXOTIDE
ACCUHALER IS USED FOR
Axotide Accuhaler contains 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 Axotide Accuhaler provides a
measured amount of steroid for you
to breathe into your lungs. By using
your Axotide Accuhaler regularly
every day, the medicine reduces the
swelling and irritation in the walls of
the small air passages in your lungs.
Your Axotide Accuhaler 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 Axotide
Accuhaler 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.
Ask your doctor if you have any
questions about why Axo

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION
AXOTIDE (FLUTICASONE PROPIONATE) (CFC-FREE) INHALER, JUNIOR
(CFC-FREE) INHALER, ACCUHALER AND JUNIOR ACCUHALER
1
NAME OF THE MEDICINE
Fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AXOTIDE ACCUHALER is a moulded plastic device containing a foil strip
with regularly
placed blisters each containing a mixture of microfine fluticasone
propionate (100
micrograms, 250 micrograms or 500 micrograms) and larger particle size
lactose
monohydrate
AXOTIDE INHALEr contains a pressurised inhalation suspension,
delivering either 50, 125 or
250 micrograms of fluticasone propionate per inhalation.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
AXOTIDE ACCUHALER also contains the excipient lactose monohydrate
(which contains
milk protein).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AXOTIDE ACCUHALER: Powder for inhalation_ _
AXOTIDE INHALEr: Pressurised inhalation
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in the prophylactic management of asthma in adults and
children of ages 1 year and
older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Fluticasone propionate has a marked anti-inflammatory effect in the
lungs. It reduces
symptoms and exacerbations of asthma in patients receiving either no
prophylactic
treatment or other available anti-asthma therapy.
AXOTIDE ACCUHALER IS ADMINISTERED VIA THE INHALED ROUTE ONLY.
AXOTIDE INHALER is administered via the inhaled route only. It is
intended that each
prescribed dose is given by a minimum of 2 inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer
may be used with AXOTIDE Inhaler.
2
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. The
onset of therapeutic effect is within 4 to 7 days.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or
they need more inhalations than us