Floair

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluticasone propionate 0.125mg

Available from:

REX Medical Ltd

INN (International Name):

Fluticasone propionate 0.125 mg

Dosage:

0.125 mg/dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Fluticasone propionate 0.125mg Excipient: Ethanol Lecithin Norflurane

Units in package:

Inhaler, metered, Aluminium aerosol can with metered dose valve and actuator, 120 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

Floair Inhaler is indicated for the long-term prevention of bronchospasm in adults or children with mild, moderate or severe asthma. Floair Inhaler is also indicated for adults and children with severe asthma dependent on oral corticosteroids for symptom control. Introduction of Floair Inhaler may allow the requirement for oral corticosteroids to be reduced or eliminated over time. Floair Inhaler is NOT indicated for the treatment of acute asthma symptoms, for which a fast acting inhaled bronchodilator (e.g. salbutamol) should be used.

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, Aluminium aerosol can with metered dose valve and actuator - 120 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze. Protect from direct sunlight.

Authorization date:

2006-07-31

Patient Information leaflet

FLOAIR INHALER
CONSUMER MEDICINE INFORMATION
FLUTICASONE PROPIONATE
50 mcg, 125 mcg, 250 mcg suspension for inhalation
120 ACTUATIONS
WHAT IS IN THIS LEAFLET
The information enclosed answers several general questions about your
Floair
Inhaler. This leaflet does not include all the accessible information
on Floair Inhaler.
All medication has benefits and risks. Your doctor will have
considered the risks of
you using Floair Inhaler against the benefits expected. Discuss with
your doctor or
pharmacist any concerns you may have.
This leaflet was last updated on the date at the end of this leaflet.
Keep this information with the medicine and refer to this leaflet if
you have any
queries.
Floair Inhaler is one component of your asthma plan to help control
and manage
your condition. Your asthma plan should be checked by your doctor on a
regular
basis. Discuss any concerns about your plan with your doctor.
WHAT YOUR FLOAIR INHALER IS USED FOR
Floair Inhaler contains Fluticasone propionate, a steroid that
prevents asthma
attacks.
The corticosteroids in your Floair Inhaler are not the same as
anabolic steroids that
have been known to have been exploited by sports people. The
anti-inflammatory
effect in your medication is due to the corticosteroids.
Each Floair Inhaler delivers either 50 mcg, 125 mcg or 250 mcg of
Fluticasone
propionate per actuation (or dose). Your Floair Inhaler contains 120
actuations.
This inhaler may have a body or cap colour that is different to your
previous inhaler.
This does not affect the way it works.
Each Floair Inhaler also contains the propellant HFA-134a, less than
0.002g ethanol,
and less than 0.00005mg soy lecithin per actuation.
Floair Inhaler does not contain any chlorofluorocarbon (CFC)
propellants. It does
contain a non-CFC propellant, known as HFA-134a. If you have
previously used
another inhaler, you might notice that the spray from Floair Inhaler
tastes or feels
different in your mouth, or that the inhaler sounds different when
sprayed. This does
not affect the way your inhaler works

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Floair Inhaler – with dose counter
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone propionate (equivalent to 50, 125 or 250 micrograms per
metered actuation).
Pressurised metered-dose inhaler (pMDI)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Floair Inhaler with a dose counter is a pressurised metered-dose
inhaler that delivers
fluticasone propionate equivalent to 50 micrograms per actuation into
a specifically designed
actuator.
Floair Inhaler with a dose counter is a pressurised metered-dose
inhaler that delivers
fluticasone propionate equivalent to 125 micrograms per actuation into
a specifically designed
actuator.
Floair Inhaler with a dose counter is a pressurised metered-dose
inhaler that delivers
fluticasone propionate equivalent to 250 micrograms per actuation into
a specifically designed
actuator.
Floair Inhaler consists of a pressurised aluminium canister filled
with fluticasone propionate
suspended in the non-CFC HFA-134a propellant (norflurane). The
aluminium canister has a
metering valve fitted within a plastic actuator. A dose counter is
incorporated into the actuator,
which shows how many actuations of medicine remain in the canister.
One Floair Inhaler
delivers 120 actuations of medicine. The actuator is fitted with a
plastic dust cap.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Floair Inhaler is indicated for the long-term prevention of
bronchospasm in adults or children
with mild, moderate or severe asthma.
Floair Inhaler is also indicated for adults or children with severe
asthma dependent on oral
corticosteroids for symptom control. Introduction of Floair Inhaler
may allow the requirement
for oral corticosteroids to be reduced or eliminated over time.
FLOAIR INHALER IS NOT INDICATED FOR THE TREATMENT OF ACUTE ASTHMA
SYMPTOMS, FOR WHICH
A FAST-ACTING INHALED BRONCHODILATOR (E.G. SALBUTAMOL) SHOULD BE USED.
Asthma:
Floair inhaler results in an anti-inflammatory effect within the lung
tissue.
In individuals treate