Onbrez Breezhaler

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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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:

indakaterol maleat

Available from:

Novartis Europharm Limited 

ATC code:

R03AC18

INN (International Name):

indacaterol

Therapeutic group:

Zdravila za obstruktivne pljučne bolezni,

Therapeutic area:

Pljučna bolezen, kronična obstruktivna bolezen

Therapeutic indications:

Zdravilo Onbrez Breezhaler je indicirano za vzdrževanje bronhodilatatorja pri obtoku zračnega toka pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo.

Product summary:

Revision: 17

Authorization status:

Pooblaščeni

Authorization date:

2009-11-29

Patient Information leaflet

                                39
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30 °C.
Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred
vlago in vzemite iz ovojnine
šele tik pred uporabo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Irska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/09/593/001
10 kapsul + 1 inhalatorr
EU/1/09/593/002
30 kapsul + 1 inhalator
13.
ŠTEVILKA SERIJE
_ _
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Onbrez Breezhaler 150
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
40
PODATKI NA ZUNANJI OVOJNINI
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z "BLUE BOX" PODATKI)
1.
IME ZDRAVILA
Onbrez Breezhaler 150 mikrogramov prašek za inhaliranje, trde kapsule
indakaterol
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 150
mikrogramom indakaterola.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje laktozo (za več podatkov glejte Navodilo za uporabo) in
želatino.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
prašek za inhaliranje, trde kapsule
Skupno pakiranje: 60 kapsul (2 pakiranji po 30 kapsul in 1 inhalator).
Skupno pakiranje: 90 kapsul (3 pakiranja po 30 kapsul in 1 inhalator).
Skupno pakiranje: 300 kapsul (30 pakiranj po 10 kapsul in 1
inhalator).
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
_ _
Kapsul ne smete pogoltniti.
Uporabljajte samo s priloženim inhalatorjem.
Pred uporabo preberite priloženo navodilo!
za inhaliranje
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
41
9.
POSE
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Onbrez Breezhaler 150 mikrogramov prašek za inhaliranje, trde kapsule
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 150
mikrogramom indakaterola.
Odmerek indakaterolijevega maleata, ki pride skozi ustnik inhalatorja,
ustreza 120 mikrogramom
indakaterola.
Pomožna(e) snov(i) z znanim učinkom:
Ena kapsula vsebuje 24,8 mg laktoze.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
prašek za inhaliranje, trde kapsule
Prosojne (neobarvane) kapsule, ki vsebujejo bel prašek in imajo črno
tiskano oznako "IDL 150" nad
črno črto in črno tiskan zaščitni znak družbe (
) pod črno črto.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Onbrez Breezhaler je indicirano za vzdrževalno
brohodilatatorno zdravljenje obstrukcije
dihalnih poti pri odraslih bolnikih s kronično obstruktivno pljučno
boleznijo (KOPB).
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočeni odmerek je inhalacija vsebine ene 150-mikrogramske
kapsule enkrat na dan z uporabo
inhalatorja Onbrez Breezhaler. Odmerek je mogoče zvišati samo po
nasvetu zdravnika.
Pokazalo se je, da inhalacija vsebine ene 300-mikrogramske kapsule
enkrat na dan z uporabo
inhalatorja Onbrez Breezhaler še dodatno klinično koristi pri
zadihanosti zlasti bolnikom s hudo
KOPB. Najvišji odmerek je 300 mikrogramov enkrat dnevno.
Zdravilo Onbrez Breezhaler je treba jemati vsak dan ob istem času.
V primeru izpuščenega odmerka je treba naslednji odmerek vzeti
naslednji dan ob običajnem času.
_Posebne skupine bolnikov _
_Starejši ljudje_
S starostjo se zviša najvišja koncentracija v plazmi in poveča
sistemska izpostavljenost zdravilu,
vendar prilagajanje odmerjanja pri starejših bolnikih ni potrebno.
_ _
_Okvara jeter _
Pri bolnikih z blago in zmerno okvaro jeter prilagajanje odmerjanja ni
potrebno. O uporabi zdravila
Onbrez Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih
podatkov.
3
_Okvara ledvic _
                                
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Similar products

Active ingredient indakaterol maleat

indakaterol maleat

ATC code R03AC18

R03AC18

Marketed by Novartis Europharm Limited 

Novartis Europharm Limited 

INN (International Name) indacaterol

indacaterol

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