Enerzair Breezhaler powder for inhalation, capsules hard

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

indacaterol (indacaterol acetate), glycopyrronium bromide, mometasone fuora

থেকে পাওয়া:

Siegfried Barbera S.L.

এটিসি কোড:

R03AL12

INN (আন্তর্জাতিক নাম):

indacaterol (indacaterol acetate), glycopyrronium bromide, mometasone fuora

ডোজ:

150mcg+ 50mcg+ 160mcg

ফার্মাসিউটিকাল ফর্ম:

powder for inhalation, capsules hard

প্যাকেজ ইউনিট:

(30/3x10/) in blister and inhaler

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2022-05-11

তথ্য লিফলেট

ENERZAIR BREEZHALER 150/50/160 MICROGRAMS INHALATION POWDER, HARD
CAPSULES
indacaterol/glycopyrronium/mometasone furoate
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 any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Enerzair Breezhaler is and what it is used for
2.
What you need to know before you use Enerzair Breezhaler
3.
How to use Enerzair Breezhaler
4.
Possible side effects
5.
How to store Enerzair Breezhaler
6.
Contents of the pack and other information
Instructions for use of Enerzair Breezhaler inhaler
1.
WHAT ENERZAIR BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ENERZAIR BREEZHALER IS AND HOW IT 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 (inflammation) in the small airways
in the lungs and so gradually ease
breathing problems. Corticosteroids also help to prevent attacks of
asthma.
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 ti

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enerzair Breezhaler 150/50/160 mcg 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) (see section 5.2).
_Renal impairment_
No dose adjustment is required in patients wit