FOSTAIR 200/6 beclometasone dipropionate 200 microgram and formoterol fumarate dihydrate 6 microgram pressurised inhalation solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

beclometasone dipropionate, Quantity: 200 microgram; formoterol fumarate dihydrate, Quantity: 6 microgram

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane; ethanol absolute; hydrochloric acid

Administration route:

Inhalation

Units in package:

Each pressurised container provides 120 actuations. Pack size is 1 x 120 actuations or 2 x 120 actuations

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma FOSTAIR is indicated in adults (18 years and older) in the treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or - patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA). (See section 4.2 DOSE AND METHOD OF ADMINISTRATION for treatment approaches).

Product summary:

Visual Identification: An aluminium canister with metering valve and light purplish-red polypropylene actuator with a dark green cap and a dose counter or dose indicator; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: PP/Al; Container Life Time: 17 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-08-05

Patient Information leaflet

FOSTAIR CMI V3.0
1
FOSTAIR
®
100/6 AND 200/6
_Beclometasone dipropionate 100 or 200 micrograms and formoterol
(eformoterol) fumarate dihydrate _
_6 micrograms pressurised inhalation solution _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
FOSTAIR.
It does not contain all the available
information. 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 being given this
medicine against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FOSTAIR IS
USED FOR
FOSTAIR is a pressurised metered
dose inhaler containing two active
substances which are inhaled through
your mouth and delivered directly
into your lungs.
The two active substances are
beclometasone dipropionate and
formoterol (eformoterol) fumarate
dihydrate.
Beclometasone dipropionate is a
corticosteroid, a medicine used to
treat swelling and irritation in your
lungs.
Formoterol (eformoterol) fumarate
dihydrate is a long-acting
bronchodilator, a medicine which
relaxes the muscles in your airways
and helps you to breathe more easily.
Together these two active substances
make breathing easier, by providing
relief from symptoms such as
shortness of breath, wheezing and
cough in patients with asthma or
Chronic Obstructive Pulmonary
Diseases (COPD). They can also help
to prevent the symptoms of asthma.
ASTHMA
FOSTAIR used for the treatment of
asthma in adult patients in whom:
•
asthma is not adequately
controlled by using inhaled
corticosteroids and “as needed”
short-acting bronchodilators or
•
asthma is responding well to
treatment with both
corticosteroids and long-acting
bronchodilators.
COPD (FOSTAIR 100/6 ONLY)
FOSTAIR 100/6 can also be used to
treat the symptoms of severe COPD
in adult patients. COPD is a long-
term disease of the a

Summary of Product characteristics

FOSTAIR PI v6.0
1
AUSTRALIAN PRODUCT INFORMATION - FOSTAIR
(BECLOMETASONE DIPROPIONATE AND FORMOTEROL
(EFORMOTEROL) FUMARATE DIHYDRATE) PRESSURISED INHALATION
SOLUTION
1.
NAME OF THE MEDICINE
Beclometasone dipropionate and formoterol (eformoterol) fumarate
dihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOSTAIR is a pressurised metered dose inhaler (pMDI).
FOSTAIR 100/6
Each metered dose (the dose leaving the valve) contains 100 micrograms
of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate.
Each delivered dose (the dose leaving the mouthpiece) contains 84.6
micrograms of
beclometasone dipropionate and 5.0 micrograms of formoterol fumarate
dihydrate.
FOSTAIR 200/6
Each metered dose (the dose leaving the valve) contains 200 micrograms
of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate.
Each delivered dose (the dose leaving the mouthpiece) contains 177.7
micrograms of
beclometasone dipropionate and 5.1 micrograms of formoterol fumarate
dihydrate.
Excipient with known effect: ethanol absolute.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Pressurised inhalation solution.
Colourless to yellowish solution.
The inhalation solution is contained in a pressurised aluminium
container sealed with a metering
valve. The canister is inserted into a polypropylene plastic actuator
which incorporates a
mouthpiece and is fitted with a plastic protective cap. The actuator
is light purplish-red with a
dark purplish-red cap (FOSTAIR 100/6) or dark green cap (FOSTAIR
200/6). The actuator has
a dose counter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
FOSTAIR is indicated in adults (18 years and older) in the treatment
of asthma where use of a
combination product (inhaled corticosteroid and long-acting beta
2
-agonist) is appropriate:
FOSTAIR PI v6.0
2
-
patients not adequately controlled with inhaled corticosteroids (ICS)
and 'as needed' inhaled
rapid-acting beta
2
-agonist or
-
patients already adequately contro