Onbrez Breezhaler

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Indacaterol maleate 0.389mg;  ;  ;  

Dostupné s:

Novartis New Zealand Ltd

INN (Mezinárodní Name):

Indacaterol maleate 0.389 mg

Dávkování:

300 mcg

Léková forma:

Powder filled inhalation capsule

Složení:

Active: Indacaterol maleate 0.389mg       Excipient: Gelatin Lactose monohydrate Opacode

Jednotky v balení:

Blister pack, Sample pack PA/Al/PVC/Al blister sheet with inhaler printed carton, 10 dose units

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Ringaskiddy Novartis Limited

Terapeutické indikace:

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.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, Sample pack PA/Al/PVC/Al blister sheet with inhaler printed carton - 10 capsules - 30 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/AL/PVC/Al blister sheet with inhaler in printed carton - 30 capsules - 30 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PA/Al/PVC/Al blister sheet with 2 inhalers in printed carton - 60 capsules - 30 months from date of manufacture stored at or below 30°C protect from moisture

Datum autorizace:

2010-10-19

Informace pro uživatele

ONBREZ
®
BREEZHALER
®
1
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

Charakteristika produktu

NEW ZEALAND DATA SHEET
Page 1 of 18
1
PRODUCT NAME
ONBREZ

BREEZHALER

150 microgram inhalation powder, hard capsules
ONBREZ

BREEZHALER

150 microgram inhalation powder, hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ONBREZ

hard capsules is supplied with a BREEZHALER

inhalation device.
150 microgram inhalation powder hard capsules
Each capsule contains 194 microgram indacaterol maleate equivalent to
150 microgram indacaterol.
The delivered dose leaving the mouthpiece of the BREEZHALER

device is equivalent to 120 microgram
indacaterol.
300 microgram inhalation powder hard capsules
Each capsule contains 389 microgram indacaterol maleate equivalent to
300 microgram indacaterol.
The delivered dose leaving the mouthpiece of the BREEZHALER

device is equivalent to 240 microgram
indacaterol.
Excipients:
Lactose monohydrate and gelatin
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Inhalation powder, hard capsule.
150 microgram: Black product code “IDL 150” printed above and
black company logo printed under
black bar on clear colourless hard capsule.
300 microgram: 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
THERAPEUTIC 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).
NEW ZEALAND DATA SHEET
Page 2 of 18
4.2
DOSE 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 microgram ONBREZ

capsule using the BREEZHALER

inhaler. The dosage should
only be increased on medical advice.
Once-daily inhalation of the content of one 300 microgram ONBREZ

capsule, using the BREEZHALER

inhaler, has only been shown to provide additional clinical benefit to
s