Rexair

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fluticasone propionate 0.125mg; Salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol

Available from:

REX Medical Ltd

INN (International Name):

Fluticasone propionate 0.125 mg

Dosage:

0.125mg/0.025mg per dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Fluticasone propionate 0.125mg Salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol 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:

Reversible Obstructive Airways Disease (ROAD): Indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. This may include: · Patients on effective maintenance doses of long-acting beta-agonists and inhaled corticosteroids. · Patients who are symptomatic on current inhaled corticosteroid therapy. · Patients who are symptomatic on as needed short-acting beta agonists, as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroid alone.

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, Aluminium aerosol uncoated can with dose-counter in the 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. - 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:

2006-07-28

Patient Information leaflet

REXAIR INHALER
CONSUMER MEDICINE INFORMATION
FLUTICASONE PROPIONATE AND SALMETEROL (AS XINAFOATE)
50 mcg/25 mcg, 125 mcg/25 mcg, 250 mcg/25 mcg suspension for
inhalation
120 ACTUATIONS
WHAT IS IN THIS LEAFLET
The information enclosed answers several general questions about your
Rexair
Inhaler. This leaflet does not include all the accessible information
on Rexair Inhaler.
All medication has benefits and risks. Your doctor will have
considered the risks of
you using Rexair 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.
Rexair Inhaler is only available by prescription.
WHAT YOUR REXAIR INHALER IS USED FOR
Rexair Inhaler contains Fluticasone propionate which is a steroid and
Salmeterol (as
xinafoate) which opens the airways.
The corticosteroids in your Rexair 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.
Salmeterol is a bronchodilator which opens the airways in your lungs.
Salmeterol
provides support for up to twelve hours.
Each Rexair Inhaler delivers either 50 mcg of fluticasone propionate
and 25 mcg of
salmeterol (as salmeterol xinafoate); 125 mcg of fluticasone
propionate and 25 mcg
of salmeterol (as xinafoate); or 250 mcg of fluticasone propionate and
25 mcg of
salmeterol (as salmeterol xinafoate) per actuation (or dose). Your
Rexair 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 Rexair Inhaler also contains the propellant HFA-134a, less than
0.002g
ethanol, and less than 0.00006mg soy lecithin per actuation.
Rexair Inhaler does not contain any chlorofluorocarbon (CFC)
propellants. It does
contain a non-CFC propellant, known as HFA-134a. If yo

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Rexair Inhaler – with dose counter
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone
propionate/Salmeterol
xinafoate
(equivalent
to
50mcg/25mcg,
125mcg/25mcg or 250mcg/25mcg per metered actuation).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rexair Inhaler 50mcg/25mcg is a pressurised metered-dose inhaler that
delivers 50
mcg of fluticasone propionate and 25 mcg of salmeterol (as salmeterol
xinafoate) per
actuation into a specifically designed actuator. Each canister
supplies 120 actuations.
Rexair Inhaler 25mcg/125mcg is a pressurised metered-dose inhaler that
delivers 125
mcg of fluticasone propionate and 25 mcg of salmeterol (as salmeterol
xinafoate) per
actuation into a specifically designed actuator. Each canister
supplies 120 actuations.
Rexair Inhaler 25mcg/250mcg is a pressurised metered-dose inhaler that
delivers 250
mcg of fluticasone propionate and 25 mcg of salmeterol (as salmeterol
xinafoate) per
actuation into a specifically designed actuator. Each canister
supplies 120 actuations.
Rexair Inhaler consists of a pressurised aluminium canister filled
with a suspension of
salmeterol xinafoate and fluticasone propionate in a non-CFC
propellant HFA-134a
(norflurane). The aluminium canister has a metering valve within a
plastic actuator
incorporating an atomising orifice. The actuator is fitted with a
plastic dust cap.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ROAD)
Rexair Inhaler is indicated for reversible obstructive airways disease
(ROAD), or the
regular therapy of asthma in children and adults, where a combination
(inhaled
corticosteroid and bronchodilator) is appropriate.
This could also include:
•
Patients on successful inhaled corticosteroid maintenance treatment of
and
long-acting β (beta) agonists administered in separate inhalers.
•
Patients whose current corticosteroid inhalation therapy is not well
controlled.
•
Patients who are inadequately controlled on "as requi