Atectura Breezhaler inhalation powder, capsules hard

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

indacaterol (indacaterol acetate), mometasone fuorat

Saatavilla:

Siegfried Barbera S.L.

ATC-koodi:

R03AK14

INN (Kansainvälinen yleisnimi):

indacaterol (indacaterol acetate), mometasone fuorat

Annos:

150mcg+ 320mcg

Lääkemuoto:

inhalation powder, capsules hard

Kpl paketissa:

(30/3x10/) in blister and inhaler

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2022-06-10

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ATECTURA BREEZHALER 150 MICROGRAMS/320 MICROGRAMS INHALATION POWDER,
HARD CAPSULES
indacaterol/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 Atectura Breezhaler is and what it is used for
2.
What you need to know before you use Atectura Breezhaler
3.
How to use Atectura Breezhaler
4.
Possible side effects
5.
How to store Atectura Breezhaler
6.
Contents of the pack and other information
Instructions for use of Atectura Breezhaler inhaler
1.
WHAT ATECTURA BREEZHALER_ _IS AND WHAT IT IS USED FOR
WHAT ATECTURA BREEZHALER_ _IS AND HOW IT WORKS
Atectura Breezhaler
_ _
contains two active substances called indacaterol and mometasone
furoate.
Indacaterol belongs to a group of medicines called bronchodilators. It
relaxes 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 it is taken regularly, it helps 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 ATECTURA BREEZHALER IS USED FOR
Atectura Breezhaler is used regularly as treatment for asthma in
adults and adolescents (12 years of
age and older).
Asthma is a serious, long-term lung disease where the muscles
surroun

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder,
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 260 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains approximately 25 mg of lactose monohydrate/
lactose hydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powder, with the
product code “IM150-320”
printed in black above two black bars on the body and with the product
logo printed in black and
surrounded by two black bars on the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atectura Breezhaler is indicated as a maintenance treatment of asthma
in adults and adolescents
12 years of age and older not adequately controlled with inhaled
corticosteroids and inhaled
short-acting beta
2
-agonists.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 years and over_
The recommended dose is one capsule to be inhaled once daily.
Patients should be given the strength containing the appropriate
mometasone furoate dosage for the
severity of their disease and should be regularly reassessed by a
healthcare professional.
The maximum recommended dose is 125 mcg/260 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.
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