ONBREZ BREEZHALER 150MCG INHALATION POWDER HARD CAPSULE

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

INDACATEROL

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

INDACATEROL

Unit dalam pakej:

30Capsule Capsules

Dikeluarkan oleh:

NOVARTIS FARMACEUTICA S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ONBREZ
® BREEZHALER
®
Indacaterol maleate
(
150 microgram and 300 microgram)
_ _
1
WHAT IS IN THIS LEAFLET
1.
WHAT ONBREZ BREEZHALER IS USED
FOR
2.
HOW ONBREZ BREEZHALER WORKS
3.
BEFORE YOU USE ONBREZ
BREEZHALER
4.
HOW TO USE ONBREZ BREEZHALER
5.
WHILE YOU ARE USING ONBREZ
BREEZHALER
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF ONBREZ
BREEZHALER
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT ONBREZ BREEZHALER IS USED FOR
Onbrez Breezhaler
_ _
contains an active
substance called indacaterol. This
medicine
_ _
belongs to a group of
medicines called bronchodilators.
When you inhale it, it helps you
breathe more easily.
You use it with a device called an
inhaler (only use the Onbrez
Breezhaler
_ _
inhaler contained in this
pack). In this pack, you will find an
inhaler and capsules (in blister strips)
that contain the medicine as inhalation
powder. The Onbrez Breezhaler
_ _
inhaler enables you to inhale the
medicine contained in a capsule.
Onbrez Breezhaler is used to make
breathing easier for people who have
breathing difficulties due to a lung
disease called chronic obstructive
pulmonary disease (COPD).
Regular, once a day, use of Onbrez
Breezhaler
_ _
will help to minimise the
effects of the disease on your everyday
life.
HOW ONBREZ BREEZHALER WORKS
Onbrez Breezhaler
_ _
relaxes the muscles
in the walls of the small air passages in
the lungs. This helps open up the
airways, making it easier for air to get
in and out.
If you have any questions about how
Onbrez Breezhaler
_ _
_ _
works or why it
has been prescribed for you, ask your
doctor.
BEFORE YOU USE ONBREZ BREEZHALER
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
_When you must not use it _
•
If you have ever had an unusual or
allergic reaction to indacaterol or
to any other ingredients of this
product listed at the end of this
leaflet.
•
If either of these apply to

Ciri produk

Novartis
Page 2
Malaysia Package Insert
27-Jul-2020
Onbrez Breezhaler
ONBREZ
® BREEZHALER
®
Long-acting beta
2
-adrenergic agonist.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Inhalation powder, hard capsules.
150 microgram: Black product code “IDL 150” printed above and
black company logo printed
under black bar on yellowish transparent (uncolored) capsule.
300 microgram: Blue product code “IDL 300” printed above and blue
company logo printed
under blue bar on yellowish transparent (uncolored) capsule.
ACTIVE SUBSTANCE
150 MICROGRAM INHALATION POWDER HARD CAPSULES
Each capsule contains 194 microgram indacaterol maleate equivalent to
150 microgram
indacaterol.
The delivered dose (the dose that leaves the mouthpiece of the Onbrez
Breezhaler inhaler) 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 (the dose that leaves the mouthpiece of the Onbrez
Breezhaler inhaler) is
equivalent to 240 microgram indacaterol.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Lactose monohydrate and gelatin.
INDICATIONS
Onbrez Breezhaler is a long-acting beta
2
-agonist indicated for maintenance bronchodilator
treatment of airflow obstruction in adult patients with chronic
obstructive pulmonary disease
(COPD).
Novartis
Page 3
Malaysia Package Insert
27-Jul-2020
Onbrez Breezhaler
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ADULTS
_ _
The recommended dosage of Onbrez Breezhaler is the once-daily
inhalation of the content of
one 150 microgram capsule using the Onbrez Breezhaler inhaler. The
dosage should only be
increased on medical advice.
Once-daily inhalation of the content of one 300 microgram capsule,
using the Onbrez
Breezhaler inhaler, has been shown to provide additional clinical
benefit to some patients, e.g.
with regard to breathlessness, particularly for patients with severe
COPD. The maximum dose
is