ATECTURA BREEZHALER 125/260 indacaterol (as acetate)/mometasone furoate 125/260 microgram powder for inhalation in hard capsule with inhaler

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

indacaterol acetate, Quantity: 173 microgram (Equivalent: indacaterol, Qty 150 microgram); mometasone furoate, Quantity: 320 microgram

Disponibbli minn:

Novartis Pharmaceuticals Australia Pty Ltd

Għamla farmaċewtika:

Capsule, hard

Kompożizzjoni:

Excipient Ingredients: lactose monohydrate

Rotta amministrattiva:

Inhalation

Unitajiet fil-pakkett:

10 capsules + 1 inhaler (sample and commercial packs), 30 capsules + 1 inhaler

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Atectura Breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:,- patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists or,- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists

Sommarju tal-prodott:

Visual Identification: Natural transparent capsules containing a white to practically white powder, with the product code 'IM150-320' printed in black above two black bars on the body and a logo printed in black and surrounded by two black bars on the cap; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2020-07-21

Fuljett ta 'informazzjoni

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems .
ATECTURA
®
BREEZHALER
®
125/62.5, 125/127.5,
125/260 MICROGRAMS
_Indacaterol (as acetate)/ mometasone furoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ATECTURA
BREEZHALER.
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 taking ATECTURA
BREEZHALER against the benefits
they expect it will have for you.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU
Those updates may contain important
information about the medicine and
its use of which you should be aware.
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 ATECTURA
BREEZHALER IS USED FOR
Your doctor has prescribed this
medicine to treat asthma in adults
and adolescents 12 years of age and
older.
Asthma is a serious, long-term lung
disease where the muscles
surrounding the smaller airways
become tight (bronchoconstriction),
swollen and irritated (inflammation).
Symptoms come and go, and include
shortness of breath, wheezing, chest
tightness and cough.
Atectura capsules for inhalation
contains two active substances called
indacaterol and mometasone furoate.
Indacaterol belong to a group of
medicines called bronchodilators.
They relax the muscles of the small
airways in the lungs. This helps to
open the

Karatteristiċi tal-prodott

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
ATECTURA
® BREEZHALER
®
(INDACATEROL/MOMETASONE FUROATE)
POWDER FOR INHALATION IN HARD CAPSULE
1
NAME OF THE MEDICINE
Indacaterol/mometasone furoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atectura Breezhaler 125/62.5 micrograms, inhalation powder, hard
capsules
Atectura Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Atectura
Breezhaler inhalation device to permit oral inhalation of the contents
of the capsule shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol and 80 micrograms of mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) is equivalent to 125
micrograms indacaterol, and 62.5 micrograms mometasone furoate.
Atectura Breezhaler 125/127.5 micrograms, inhalation powder, hard
capsules
Atectura Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Atectura
Breezhaler inhalation device to permit oral inhalation of the contents
of the capsule shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol and 160 micrograms of mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) is equivalent to 125
micrograms indacaterol, and 127.5 micrograms mometasone furoate.
Atectura Breezhaler 125/260 micrograms, inhalation powder, hard
capsules
Atectura Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Atectura
Breezhaler inhalation device to permit oral inhalation of the contents
of the capsule shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol and 320 micrograms of mometasone furoate.
The del