ENERZAIR BREEZHALER 114/46/136 indacaterol/glycopyrronium/mometasone furoate 114/46/136 microgram powder for inhalation in capsule with inhaler

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

indacaterol acetate, Quantity: 173 microgram (Equivalent: indacaterol, Qty 150 microgram); mometasone furoate, Quantity: 160 microgram; glycopyrronium bromide, Quantity: 63 microgram (Equivalent: glycopyrronium, Qty 50 microgram)

Beschikbaar vanaf:

Novartis Pharmaceuticals Australia Pty Ltd

farmaceutische vorm:

Capsule, hard

Samenstelling:

Excipient Ingredients: lactose monohydrate; magnesium stearate

Toedieningsweg:

Inhalation

Eenheden in pakket:

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

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Product samenvatting:

Visual Identification: Transparent capsules with green cap containing a white to practically white powder. Body printed with black 'IM150-50-160' above 2 bars & logo on 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 30 degrees Celsius; Container Closure: Child resistant closure

Autorisatie-status:

Registered

Autorisatie datum:

2020-10-20

Bijsluiter

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 .
ENERZAIR
®
BREEZHALER
®
114/46/68, 114/46/136
MICROGRAMS
_Indacaterol (as acetate)/ glycopyrronium (as bromide)/ mometasone
furoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ENERZAIR
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 ENERZAIR
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 ENERZAIR
BREEZHALER IS USED FOR
Your doctor has prescribed this
medicine to treat asthma in adults.
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.
Enerzair capsules for inhalation
contains three active substances
called indacaterol, glycopyrronium
and mometasone furoate.
Indacaterol and glycopyrronium
belong to a group of medicines called
bronchodilators. They relax the
muscles of the small airways in the
lungs. This

Productkenmerken

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
ENERZAIR
® BREEZHALER
®
(INDACATEROL/GLYCOPYRRONIUM/MOMETASONE FUROATE)
POWDER FOR INHALATION IN HARD CAPSULE
1
NAME OF THE MEDICINE
Indacaterol/glycopyrronium/mometasone furoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enerzair Breezhaler 114/46/68 micrograms, inhalation powder, hard
capsule
Enerzair Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Enerzair
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, 63 micrograms of glycopyrronium bromide (glycopyrrolate)
equivalent to 50 micrograms
glycopyrronium and 80 micrograms mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/68 micrograms is
equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium, and 68 micrograms
mometasone furoate.
Enerzair Breezhaler 114/46/136 micrograms, inhalation powder, hard
capsule
Enerzair Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Enerzair
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, 63 micrograms of glycopyrronium bromide (glycopyrrolate)
equivalent to 50 micrograms
glycopyrronium and 160 micrograms mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/136 micrograms
is equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium, and 136 micrograms
mometasone furoate.
EXCIPIENTS WITH KNOWN EFFECT
Each capsule contains approximately 25 mg lactose (as monohyd