Onbrez Breezhaler

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
23-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
23-09-2021
Public Assessment Report Public Assessment Report (PAR)
12-10-2017

Active ingredient:

indakateroolmaleaat

Available from:

Novartis Europharm Limited 

ATC code:

R03AC18

INN (International Name):

indacaterol

Therapeutic group:

Ravimid hingamisteede obstruktiivsete haiguste,

Therapeutic area:

Kopsuhaigus, Krooniline Obstruktiivne

Therapeutic indications:

Onbrez Breezhaler on näidustatud kroonilise obstruktiivse kopsuhaigusega täiskasvanud patsientide õhuvoolu obstruktsiooni bronhodilataatorite hoolduseks.

Product summary:

Revision: 17

Authorization status:

Volitatud

Authorization date:

2009-11-29

Patient Information leaflet

                                54
B. PAKENDI INFOLEHT
55
PAKENDI INFOLEHT: TEAVE KASUTAJALE
ONBREZ BREEZHALER 150 MIKROGRAMMI INHALEERITAV PULBER KÕVAKAPSLITES
ONBREZ BREEZHALER 300 MIKROGRAMMI INHALEERITAV PULBER KÕVAKAPSLITES
indakaterool
_(indacaterolum)_
ENNE RAVIMI KASUTAMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti
või apteekriga. Kõrvaltoime
võib olla ka selline, mida selles infolehes ei ole nimetatud. Vt
lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Onbrez Breezhaler ja milleks seda kasutatakse
2.
Mida on vaja teada enne Onbrez Breezhaleri kasutamist
3.
Kuidas Onbrez Breezhalerit kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Onbrez Breezhalerit säilitada
6.
Pakendi sisu ja muu taeve
1.
MIS RAVIM ON ONBREZ BREEZHALER JA MILLEKS SEDA KASUTATAKSE
MIS RAVIM ON ONBREZ BREEZHALER
Onbrez Breezhaler sisaldab toimeainena indakaterooli, mis kuulub
bronhodilataatoriteks ehk
bronhilõõgastiteks nimetatud ravimite rühma. Ravimi sissehingamisel
lõõgastuvad lihased väikeste
hingamisteede seintes. See aitab avada hingamisteed, muutes sisse- ja
väljahingamise kergemaks.
MILLEKS ONBREZ BREEZHALERIT KASUTATAKSE
Onbrez Breezhalerit kasutatakse hingamise kergemaks muutmiseks
kroonilisest obstruktiivsest
kopsuhaigusest (KOK) tingitud hingamisraskustega täiskasvanutel. KOKi
korral on lihased
hingamisteede ümber pinguldunud. See muudab hingamise raskeks. See
ravim aitab kopsudes lihaseid
lõõgastada, kergendades õhu liikumist kopsudesse ja kopsudest
välja.
2.
MIDA ON VAJA TEADA ENNE ONBREZ BREEZHALERI KASUTAMIST
ONBREZ BREEZHALERIT EI TOHI KASUTADA
-
kui olete indakaterooli või selle ravimi mis tahes koostisosade
(loetletud lõigus 6) suhtes
allergiline.
HOIATUSED JA ETTEVAATUSAB
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Onbrez Breezhaler 150 mikrogrammi inhaleeritav pulber kõvakapslites
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Iga kapsel sisaldab indakateroolmaleaati koguses, mis vastab 150
mikrogrammile indakateroolile
(
_indacaterolum_
).
Inhalaatori huulikust väljastatakse 120 mikrogrammile indakateroolile
vastav indakateroolmaleaadi
annus.
Teadaolevat toimet omav abiaine
Iga kapsel sisaldab 24,8 mg laktoosi.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Inhalatsioonipulber kõvakapslis
Valget pulbrit sisaldavad läbipaistvad (värvitud) kapslid, millele
on mustas kirjas trükitud „IDL 150“
musta joone kohale ja firma logo (
) musta joone alla.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Onbrez Breezhaler on näidustatud bronhe lõõgastavaks
säilitusraviks hingamisteede obstruktsiooni
korral kroonilise obstruktiivse kopsuhaigusega (KOK) täiskasvanud
patsientidel.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Annustamine
Soovitatavaks annuseks on ühe 150-mikrogrammise kapsli sisu
inhalatsioon üks kord päevas Onbrez
Breezhaler inhalaatorist. Annust tohib suurendada ainult arsti
ettekirjutusel.
Ühe 300-mikrogrammise kapsli sisu inhaleerimisel üks kord päevas
Onbrez Breezhaler inhalaatorist
on saadud täiendavat kliinilist kasu hingelduse leevendamisel, eriti
raske KOKiga patsientidel.
Maksimaalne annus on 300 mikrogrammi üks kord päevas.
Onbrez Breezhalerit tuleb kasutada iga päev samal ajal.
Kui annus jääb manustamata, tuleb järgmine annus manustada
järgmisel päeval tavalisel ajal.
_Patsientide erirühmad _
_Eakad_
Maksimaalne plasmakontsentratsioon ja üldine süsteemne ekspositsioon
suurenevad vanuse kasvades,
kuid eakatel patsientidel ei ole vaja annust muuta.
3
_Maksakahjustus _
Kerge ja mõõduka maksakahjustusega patsientidel ei ole vaja annust
muuta. Puuduvad andmed
Onbrez Breezhaleri kasutamise kohta raske maksakahjustusega
patsientidel.
_Neerukahjustus _
Neerukahjustusega patsientidel ei ole vaja annust muuta.
_Lapsed _
Puudub Onbrez Breez
                                
                                Read the complete document

Similar products

Active ingredient indakateroolmaleaat

indakateroolmaleaat

ATC code R03AC18

R03AC18

Marketed by Novartis Europharm Limited 

Novartis Europharm Limited 

INN (International Name) indacaterol

indacaterol

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Summary of Product characteristics Summary of Product characteristics Bulgarian 23-09-2021
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Public Assessment Report Public Assessment Report Danish 12-10-2017
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Summary of Product characteristics Summary of Product characteristics German 23-09-2021
Public Assessment Report Public Assessment Report German 12-10-2017
Patient Information leaflet Patient Information leaflet Greek 23-09-2021
Summary of Product characteristics Summary of Product characteristics Greek 23-09-2021
Public Assessment Report Public Assessment Report Greek 12-10-2017
Patient Information leaflet Patient Information leaflet English 23-09-2021
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Public Assessment Report Public Assessment Report English 12-10-2017
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Public Assessment Report Public Assessment Report French 12-10-2017
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Public Assessment Report Public Assessment Report Croatian 12-10-2017

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