FOSTAIR 100/6 beclometasone dipropionate 100 microgram and formoterol fumarate dihydrate 6 microgram pressurised inhalation solution

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

beclometasone dipropionate, Quantity: 100 microgram; formoterol fumarate dihydrate, Quantity: 6 microgram

Tilgængelig fra:

Chiesi Australia Pty Ltd

Lægemiddelform:

Inhalation, pressurised

Sammensætning:

Excipient Ingredients: norflurane; ethanol absolute; hydrochloric acid

Indgivelsesvej:

Inhalation

Enheder i pakken:

1 x 120 actuations 1 x180 actuations 2 x120 actuations

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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). COPD (FOSTAIR 100/6 only) Symptomatic treatment of adults with severe COPD (FEV1 less than 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Produkt oversigt:

Visual Identification: An aluminium canister with metering valve and light purplish-red polypropylene actuator with a dark purplish-red 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

Autorisation status:

Registered

Autorisation dato:

2020-02-12

Indlægsseddel

FOSTAIR AU CMI v2.0
1
FOSTAIR
®
_Beclomethasone dipropionate and formoterol (eformoterol) fumarate
dihydrate _
_(100/6 micrograms per spray) 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 of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. 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, YOU
MAY NEED TO READ IT
AGAIN.
WHAT
FOSTAIR IS
USED FOR
FOSTAIR is an 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, redness
or pain.in your lungs.
Formoterol 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 COPD
and also help to prevent the
symptoms of asthma.
Asthma
FOSTAIR is indicated in the
treatment of asthma in adult
patients (18 years and older) 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 can also be used to
treat the symptoms of severe
chronic obstructive pulmonary
disease (COPD) in adult
patients. COPD is a long-term
disease of the airways in the
lungs which is primarily
caused by cigarette smoking.
ASK YOUR

Produktets egenskaber

FOSTAIR Product Information
FOSTAIR AU PI v4.0
1
AUSTRALIAN PRODUCT INFORMATION - FOSTAIR 100/6
(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). Each metered
dose (ex-valve) contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate
dihydrate.
This
is
equivalent
to
a
delivered
dose
(ex-actuator)
of
84.6
micrograms
of
beclometasone
dipropionate and 5.0 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. 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:
-
patients not adequately controlled with inhaled corticosteroids (ICS)
and 'as needed' inhaled
rapid-acting beta
2
-agonist or
-
patients already adequately controlled on both ICS and long-acting
beta
2
-agonists (LABA).
(see section 4.2 DOSE AND METHOD OF ADMINISTRATION for treatment
approaches).
COPD
Symptomatic treatment of adults with severe COPD (FEV
1
< 50% predicted normal) and a history
of repeated exacerbations, who have significant symptoms despite
regular therapy with long-acting
bronchodilators.
4.2 DOSE AND METHOD OF ADMINISTRATION
FOSTAIR is