TILADE CFC-FREE INHALER nedocromil sodium 2mg/actuation metered dose aerosol can

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

nedocromil sodium

Mevcut itibaren:

Sanofi-Aventis Australia Pty Ltd

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

TILADE
® CFC-FREE
INHALER
_nedocromil sodium_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tilade CFC-Free
Inhaler.
It does not contain all the information
that is known about Tilade CFC-Free
Inhaler. 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 Tilade CFC-
Free Inhaler against the benefits they
expect 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 TILADE CFC-FREE
INHALER IS USED FOR
Tilade CFC-Free Inhaler is inhaled
into the lungs for the preventive
treatment of mild to moderate
asthma.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to an
allergy to house dust mites, pollens,
smoke, air-borne pollution or other
irritants.
Tilade CFC-Free Inhaler is used to
prevent bronchial asthma due to
allergy, exercise, cold air or irritants,
in both adults and children over two
years of age.
Tilade CFC-Free Inhaler works by
reducing the inflammation of the
airways which occurs in asthma.
With regular use, Tilade CFC-Free
Inhaler will help prevent asthma
symptoms from occurring.
Tilade CFC-Free Inhaler will not
relieve the symptoms of an asthma
attack once the attack has started.
YOU SHOULD FOLLOW YOUR DOCTOR'S
ADVICE AND PRESCRIBED TREATMENT TO
GET RELIEF FROM A SUDDEN ASTHMA
ATTACK.
Your doctor may have prescribed
Tilade CFC-Free Inhaler for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TILADE CFC-
FREE INHALER HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with
a doctor's prescription.
There is no evidence that Tilade
CFC-Free Inhaler is addictive.
This product contains HFA-227, a
non-ozone depleting propellant gas,
which has been introduced as a
replacement for the environmentally
damaging chlorofluoro

Ürün özellikleri

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AUSTRALIAN PRODUCT INFORMATION – TILADE CFC FREE
(NEDOCROMIL SODIUM)
1
NAME OF THE MEDICINE
Nedocromil sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation contains nedocromil sodium 2 mg. Menthol flavoured.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pressurised inhalation.
Tilade CFC-Free contains nedocromil sodium as a suspension in a
non-CFC propellant.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tilade CFC-Free is indicated for the prophylactic treatment of mild to
moderate persistent
asthma in adults and frequent episodic asthma in children aged over
two years, and for the
prevention of bronchospasm provoked by exercise, cold air, inhaled
allergens, atmospheric
pollutants and other irritants.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN OVER 2 YEARS OF AGE:
The recommended initial dosage is two actuations (each yielding 2 mg
of nedocromil
sodium) four times daily. Some patients who have demonstrated a good
response to therapy
and whose asthma is stable may be able to reduce the dose to two
actuations twice daily.
This may take more than one week of regular use.
The efficacy of Tilade CFC-Free in children under 2 years of age has
not been established.
Tilade CFC-Free, in a single dose of two actuations (4 mg) a few
minutes before exposure,
affords protection for several hours against bronchospasm provoked by
exercise, cold air,
inhaled allergens, atmospheric pollutants and other irritants.
Most patients will benefit from the consistent use of a spacer device
with their metered dose
inhaler (MDI or puffer), particularly those with poor inhaler
technique. Use of a spacer will
tilade-ccdsv5-piv2-24jul20
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also decrease the amount of drug deposited in the mouth and back of
the throat, and therefore,
reduce the incidence of local side effects such as mouth and throat
irritation and hoarse voice.
In those people using a spacer, a change in formulation of the drug