ONBREZ BREEZHALER indacaterol maleate 150 microgram hard capsule for inhalation

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

indacaterol maleate, Quantity: 194 microgram (Equivalent: indacaterol, Qty 150 microgram)

Dostupné z:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Medzinárodný Name):

Indacaterol maleate

Forma lieku:

Capsule, hard

Zloženie:

Excipient Ingredients: Gelatin; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Spôsob podávania:

Inhalation

Počet v balení:

60 capsules + 2 Breezhalers, 10 capsules + 1 Breezhaler, 30 capsules + 1 Breezhaler

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

ONBREZ BREEZHALER is a long-acting beta2-agonist indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (COPD).

Prehľad produktov:

Visual Identification: Colourless capsule, marked in black with Novartis logo and "IDL 150"; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2010-08-03

Príbalový leták

ONBREZ
®
BREEZHALER
®
CAPSULES FOR INHALATION
_Indacaterol maleate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Onbrez Breezhaler.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
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.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Onbrez
Breezhaler against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ONBREZ
BREEZHALER IS USED FOR
Onbrez capsules are for the treatment
of chronic obstructive pulmonary
disease, also called COPD. COPD is
a serious lung condition that can
cause difficulty in breathing, and
constant coughing. Symptoms of
COPD include shortness of breath,
cough, chest discomfort and
coughing up phlegm.
Onbrez capsules for inhalation
belong to a group of medicines called
bronchodilators. These medicines are
used to keep the air passages in the
lungs open and make breathing
easier.
Onbrez capsules make breathing
easier by opening the small air
passages in the lungs and helping
them to remain relaxed and open.
Onbrez is a long acting
bronchodilator. Each dose of Onbrez
will keep your air passages open and
relieve chest tightness and wheezing
for 24 hours.
Onbrez capsules for inhalation
contain the active ingredient,
indacaterol maleate in a capsule
form.
The capsules are for oral inhalation
only. The powder from the capsule is
inhaled (breathed into the lungs),

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION – ONBREZ
® BREEZHALER
®
(INDACATEROL MALEATE) HARD CAPSULE FOR INHALATION
1
NAME OF THE MEDICINE
indacaterol maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONBREZ

hard capsules are for oral inhalation only. ONBREZ

is also supplied with a BREEZHALER

inhalation device to permit oral inhalation of the contents of the
capsule shell.
150 MICROGRAMS
Each capsule contains 194

g indacaterol maleate equivalent to 150

g indacaterol.
The delivered dose (the dose that leaves the mouthpiece of the
BREEZHALER

device) is equivalent
to 120

g indacaterol.
300 MICROGRAMS
Each capsule contains 389

g indacaterol maleate equivalent to 300

g indacaterol.
The delivered dose (the dose that leaves the mouthpiece of the
BREEZHALER

device) is equivalent
to 240

g indacaterol.
EXCIPIENTS: lactose monohydrate and gelatin.
3
PHARMACEUTICAL FORM
Hard capsule containing powder for oral inhalation.
150 MICROGRAMS
Black product code “IDL 150” printed above and black company logo
printed under black bar on
clear colourless hard capsule.
300 MICROGRAMS
Blue product code “IDL 300” printed above and blue company logo
printed under blue bar on clear
colourless hard capsule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ONBREZ

BREEZHALER

is a long-acting β2-agonist indicated for long-term, once-daily,
maintenance
bronchodilator treatment of airflow limitation in patients with
chronic obstructive pulmonary disease.
(See Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical Trials)
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage
_Adults with COPD _
The recommended and usual dosage of ONBREZ

BREEZHALER

is the once-daily inhalation of the
content of one 150

g ONBREZ

capsule using the BREEZHALER

inhaler. The dosage should only be
increased on medical advice.
Once-daily inhalation of the content of one 300

g ONBREZ

capsule, using the BREEZHALER

inhaler,
has only been shown to provide additional clinical benefit to some
patien