ALVESCO ciclesonide 80 micrograms per actuation aerosol can

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

ciclesonide, Quantity: 100 microgram

Commercializzato da:

Chiesi Australia Pty Ltd

Forma farmaceutica:

Inhalation, pressurised

Composizione:

Excipient Ingredients: norflurane; ethanol

Via di somministrazione:

Inhalation

Confezione:

60 metered doses, 120 metered doses

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Alvesco is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older.

Dettagli prodotto:

Visual Identification: A colourless solution in an aluminium canister with a metering valve.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2004-02-24

Foglio illustrativo

ALVESCO AU CMI v2.0
1
ALVESCO
®
_ciclesonide _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALVESCO.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALVESCO IS
USED FOR
ALVESCO is inhaled into the lungs
for the treatment of asthma. Asthma
is a disease where the lining of the
lungs becomes inflamed (red and
swollen), making it difficult to
breathe.
ALVESCO contains a medicine
called ciclesonide, which belongs to
a family of medicines called
corticosteroids.
ALVESCO metered dose inhalers
deliver a measured amount of
ciclesonide, which acts directly on
your air passages to reduce
inflammation and help keep the air
passages open. In doing so, this
medication helps to improve your
condition and to prevent asthma
attacks from occurring. It is a
preventer and needs to be taken
regularly.
ALVESCO will NOT give you
immediate relief of wheezing or
breathlessness during sudden, severe
or continuous asthma attacks. In this
situation you should use a quick
acting reliever inhaler, which
contains a different medicine, a so-
called bronchodilator.
Your doctor may prescribe
ALVESCO to replace corticosteroid
tablets, which will mean that you
need to take both medicines for a
short period of time. It is important to
foll

Scheda tecnica

ALVESCO AU PI v 2.0
1 of 16
AUSTRALIAN PRODUCT INFORMATION
ALVESCO
®
(CICLESONIDE) PRESSURISED METERED DOSE INHALER (PMDI)
1
NAME OF THE MEDICINE
ciclesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALVESCO is available in the following strengths:

ALVESCO 80: 80 micrograms ciclesonide per actuation

ALVESCO 160: 160 micrograms ciclesonide per actuation
_Excipient(s) with known effect:_ ethanol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Inhalation, pressurised.
The drug is dissolved in a non-halogenated solution and delivered via
a pMDI, resulting in an extra
fine aerosol. The main particle fraction ranges from 1.1 microns to
2.1 microns, which ensures high
lung deposition (>50% of the ex-actuator dose), and less deposition in
the oropharynx than
marketed suspension formulations of other ICS.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALVESCO is indicated as prophylactic treatment of asthma in adults,
adolescents and in children
6 years of age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
ALVESCO is for oral inhalation use only.
Symptoms start to improve with ALVESCO within 24 hours of treatment.
However, due to its
prophylactic nature, ALVESCO should be taken regularly even when
patients are asymptomatic.
DOSING RECOMMENDATION FOR CHILDREN (6-11 YEARS)
The recommended dose of ALVESCO for children is 80 micrograms or 160
micrograms once daily.
ALVESCO can be administered as 1 or 2 puffs once daily either in the
morning or evening. The use
of a spacer is recommended for children 6-11 years (see _Method of
administration_ ). The dose
should be adjusted to the lowest dose at which effective control of
asthma is maintained.
ALVESCO AU PI v 2.0
2 of 16
DOSING RECOMMENDATION FOR ADULTS AND ADOLESCENTS AGED 12 YEARS AND
OLDER
The recommended dose range is 80 to 320 micrograms per day in adult
and adolescent patients. In
certain circumstances the dosage may be increased in adults (see
_Adult Patients - Higher doses in _
_certain circumstances_ below). Pa