Enerzair Breezhaler (Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate) 150/50/160mcg Inhalation Powder Hard Capsule

国: マレーシア

言語: 英語

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

有効成分:

GLYCOPYRRONIUM BROMIDE; MOMETASONE FUROATE; INDACATEROL ACETATE

から入手可能:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国際名）:

GLYCOPYRRONIUM BROMIDE; MOMETASONE FUROATE; INDACATEROL ACETATE

パッケージ内のユニット:

10 Capsules and 1 Inhaler Units; 30 Capsules and 1 inhaler Units

製:

NOVARTIS PHARMA STEIN AG

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ENERZAIR
® BREEZHALER
® INHALATION POWDER HARD CAPSULES
Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate
(150/50/160 micrograms)
_________________________________________________________________________________________
1 WHAT IS IN THIS LEAFLET
1. What Enerzair Breezhaler is used
for
2. How Enerzair Breezhaler works
3. Before you use Enerzair
Breezhaler
4. How to use Enerzair Breezhaler
5. While you are using it
6. Side effects
7. Storage and Disposal of Enerzair
Breezhaler
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Instructions for use of Enerzair
Breezhaler Inhaler.
WHAT ENERZAIR BREEZHALER IS USED
FOR
Enerzair Breezhaler is used regularly
as treatment for asthma in adults.
Asthma is a serious, long-term lung
disease where the muscles around the
smaller airways become tight
(bronchoconstriction) and inflamed.
Symptoms come and go and include
shortness of breath, wheezing, chest
tightness and cough.
You should use Enerzair Breezhaler
every day and not only when you
have breathing problems or other
symptoms of asthma. This will ensure
that it controls your asthma properly.
Do not use this medicine to relieve a
sudden attack of breathlessness or
wheezing.
If you have any questions about how
Enerzair Breezhaler works or why
this medicine has been prescribed for
you, ask your doctor.
HOW ENERZAIR BREEZHALER WORKS
Enerzair Breezhaler contains three
active substances:
•
indacaterol
•
glycopyrronium
•
mometasone furoate
Indacaterol and glycopyrronium
belong to a group of medicines called
bronchodilators. They work in
different ways to relax the muscles of
the small airways in the lungs. This
helps to open the airways and makes
it easier for air to get in and out of the
lungs. When they are taken regularly,
they help the small airways to remain
open.
Mometasone furoate belongs to a
group of medicines called
corticosteroids (or steroids).
Corticosteroids reduce the swelling
and irritation (

製品の特徴

Novartis
Page 2
Malaysia Package Leaflet
05-Mar-2020 Corr.10-Jun-2020
Enerzair Breezhaler
1.
NAME OF THE MEDICINAL PRODUCT
Enerzair
Breezhaler
150
micrograms/50
micrograms/160
micrograms
inhalation
powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mcg of indacaterol (as acetate), 63 mcg of
glycopyrronium
bromide equivalent to 50 mcg of glycopyrronium and 160 mcg of
mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 114 mcg of
indacaterol (as acetate), 58 mcg of glycopyrronium bromide equivalent
to 46 mcg of
glycopyrronium and 136 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains 25 mg of lactose monohydrate. For the full list
of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Capsules with green transparent cap and uncoloured transparent body
containing a white
powder, with the product code “IGM150-50-160” printed in black
above two black bars on the
body and with the product logo printed in black and surrounded by a
black bar on the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enerzair Breezhaler is indicated as a maintenance treatment of asthma
in adult patients not
adequately controlled with a maintenance combination of a long-acting
beta
2
-agonist and a high
dose of an inhaled corticosteroid who experienced one or more asthma
exacerbations in the
previous year.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one capsule to be inhaled once daily.
The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily.
Treatment should be administered at the same time of the day each day.
It can be administered
irrespective of the time of the day. If a dose is missed, it should be
taken as soon as possible.
Patients should be instructed not to take more than one dose in a day.
_Special populations _
_Elderly population _
No dose adjustment is required in elderly patients (65 years of age or
older)