Tilade CFC-free

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nedocromil sodium 1.4085%{relative} (2 mg/dose);  

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Nedocromil sodium 1.4085% w/w (2 mg/dose)

Dosage:

2 mg/dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Nedocromil sodium 1.4085%{relative} (2 mg/dose)   Excipient: Apaflurane Macrogol 600 Menthol Povidone

Units in package:

Inhaler, metered, 1 x 112 metered doses in 19 mL, 112 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aventis Pharma Ltd - Holmes Chapel

Therapeutic indications:

Tilade CFC-free is indicated in the treatment of bronchial asthma (whether extrinsic or intrinsic in nature, and including asthmatic bronchitis, late onset asthma, exercise induced asthma, and bronchospasm provoked by a variety of stimuli such as cold air, inhaled allergens, atmospheric pollutants and other irritants). Tilade CFC-free is intended for regular prophylactic treatment and not for symptomatic relief. In the management of asthma, Tilade CFC-free improves pulmonary function, reduces the frequency and severity of attacks and reduces bronchospasm, cough and bronchial hyper-responsiveness. In patients already receiving treatment for their asthma, Tilade CFC-free can be given in addition to all existing therapies and will in many cases provide added therapeutic benefit. Having established this benefit of Tilade CFC-free, it may be possible to gradually reduce or eliminate concomitant therapy.

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, 19 mL - 112 dose units - 2 years from date of manufacture stored at or below 30°C

Authorization date:

1998-05-27

Patient Information leaflet

Tilade
®
1
TILADE
®
_CFC-FREE INHALER (TIE-LAID) _
_nedocromil sodium (ned-oh-crow-mill so-dee-u m) _
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. 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 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
IS USED FOR
Tilade CFC-Free 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 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 works by reducing
the inflammation of the airways
which occurs in asthma.
With regular use, Tilade CFC-Free
will help prevent asthma symptoms
from occurring.
Tilade CFC-Free 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 for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TILADE CFC-
FREE HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
There is no evidence that Tilade
CFC-Free is addictive.
This product contains HFA-227, a
non-ozone depleting propellant gas,
which has been introduced as a
replacement for the environmentally
damaging chlorofluorocarbons
(CFC's). This product

Summary of Product characteristics

New Zealand Data Sheet
21-Sep-2018
Tilade CFC-free - nedocromil sodium
Property of the Sanofi group - strictly confidential
Tilade-ccdsv4-dsv4-21sep18
Page 1
DATA SHEET
1
TILADE CFC-FREE 2 MG AEROSOL INHALER, METERED DOSE
Tilade CFC-free 2 mg aerosol inhaler, metered dose.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nedocromil sodium 1.4085% w/w.
Each canister provides at least 112 actuations each containing 2 mg of
nedocromil sodium ex-
valve and 1.9 mg ex-standard actuator.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tilade CFC-free is presented as a metered dose inhaler containing
nedocromil sodium as a
suspension in the new, non - CFC propellant HFA-227.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tilade CFC-free is indicated in the treatment of bronchial asthma
(whether extrinsic or intrinsic in
nature, and including asthmatic bronchitis, late onset asthma,
exercise induced asthma, and
bronchospasm provoked by a variety of stimuli such as cold air,
inhaled allergens, atmospheric
pollutants and other irritants). Tilade CFC-free is intended for
regular prophylactic treatment and
not for symptomatic relief.
In the management of asthma, Tilade CFC-free improves pulmonary
function, reduces the
frequency and severity of attacks and reduces bronchospasm, cough and
bronchial hyper-
responsiveness.
In patients already receiving treatment for their asthma, Tilade
CFC-free can be given in addition
to all existing therapies and will in many cases provide added
therapeutic benefit. Having
established this benefit of Tilade CFC-free, it may be possible to
gradually reduce or eliminate
concomitant therapy.
New Zealand Data Sheet
21-Sep-2018
Tilade CFC-free - nedocromil sodium
Property of the Sanofi group - strictly confidential
Tilade-ccdsv4-dsv4-21sep18
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS, INCLUDING THE ELDERLY AND CHILDREN OVER 2 YEARS OF AGE: _
The recommended dosage is two actuations 2 to 4 times a day; the
dosage to be adjusted within
this range according to the