Onbrez Breezhaler
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
23-09-2021
Produktets egenskaber
(SPC)
23-09-2021
Offentlige vurderingsrapport
(PAR)
12-10-2017
Aktiv bestanddel:
indacaterol maleate
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
R03AC18
INN (International Name):
indacaterol
Terapeutisk gruppe:
Drugs for obstructive airway diseases,
Terapeutisk område:
Pulmonary Disease, Chronic Obstructive
Terapeutiske indikationer:
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Produkt oversigt:
Revision: 17
Autorisation status:
Authorised
Autorisation dato:
2009-11-29
Indlægsseddel
55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONBREZ BREEZHALER 150 MICROGRAM INHALATION POWDER, HARD CAPSULES
ONBREZ BREEZHALER 300 MICROGRAM INHALATION POWDER, HARD CAPSULES
indacaterol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Onbrez Breezhaler is and what it is used for
2.
What you need to know before you use Onbrez Breezhaler
3.
How to use Onbrez Breezhaler
4.
Possible side effects
5.
How to store Onbrez Breezhaler
6.
Contents of the pack and other information
1.
WHAT ONBREZ BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ONBREZ BREEZHALER IS
Onbrez Breezhaler contains the active substance indacaterol which
belongs to a group of medicines
called bronchodilators. When you inhale it, it relaxes the muscles in
the walls of the small air passages
in the lungs. This helps open up the airways, making it easier to get
air in and out.
WHAT ONBREZ BREEZHALER IS USED FOR
Onbrez Breezhaler is used to make breathing easier for adult patients
who have breathing difficulties
due to a lung disease called chronic obstructive pulmonary disease
(COPD). In COPD the muscles
around the airways tighten. This makes breathing difficult. This
medicine relaxes these muscles in the
lungs, making it easier for air to get in and out of the lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ONBREZ BREEZHALER
DO NOT USE ONBREZ BREEZHALER
-
if you are allergic to indacaterol or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist befor
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains indacaterol maleate equivalent to 150 microgram
indacaterol.
The delivered dose leaving the mouthpiece of the inhaler is
indacaterol maleate equivalent to
120 microgram indacaterol.
Excipient with known effect
Each capsule contains 24.8 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Transparent (uncoloured) capsules containing a white powder, with
“IDL 150” printed in black above
a black bar and company logo (
) printed in black below the black bar.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onbrez Breezhaler is indicated for maintenance bronchodilator
treatment of airflow obstruction in
adult patients with chronic obstructive pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is the inhalation of the content of one 150
microgram capsule once a day,
using the Onbrez Breezhaler inhaler. The dose should only be increased
on medical advice.
The inhalation of the content of one 300 microgram capsule once a day,
using the Onbrez Breezhaler
inhaler has been shown to provide additional clinical benefit with
regard to breathlessness, particularly
for patients with severe COPD. The maximum dose is 300 microgram once
daily.
Onbrez Breezhaler should be administered at the same time of the day
each day.
If a dose is missed the next dose should be taken at the usual time
the next day.
_Special populations _
_Elderly population_
Maximum plasma concentration and overall systemic exposure increase
with age but no dose
adjustment is required in elderly patients.
_Hepatic impairment _
No dose adjustment is required for patients with mild and moderate
hepatic impairment. There are no
data available for use of Onbrez Breezhaler in patients with severe
hepatic impairment.
3
_Renal impairment _
No do
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