Hirobriz Breezhaler

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
08-09-2021
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:

Lijekovi za opstruktivne plućne bolesti dišnih putova,

Therapeutic area:

Plućna bolest, kronična opstruktivna

Therapeutic indications:

Hirobriz Breezhaler je indiciran za liječenje bronhodilatatora kod opstrukcije protoka zraka kod odraslih osoba s kroničnom opstruktivnom plućnom bolesti.

Product summary:

Revision: 18

Authorization status:

odobren

Authorization date:

2009-11-30

Patient Information leaflet

                                52
B. UPUTA O LIJEKU
53
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
HIROBRIZ BREEZHALER 150 MIKROGRAMA PRAŠAK INHALATA, TVRDE KAPSULE
HIROBRIZ BREEZHALER 300 MIKROGRAMA PRAŠAK INHALATA, TVRDE KAPSULE
indakaterol
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA
VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
-
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Hirobriz Breezhaler i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Hirobriz
Breezhaler
3.
Kako primjenjivati Hirobriz Breezhaler
4.
Moguće nuspojave
5.
Kako čuvati Hirobriz Breezhaler
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE HIROBRIZ BREEZHALER I ZA ŠTO SE KORISTI
ŠTO JE HIROBRIZ BREEZHALER
Hirobriz Breezhaler sadrži djelatnu tvar indakaterol koja pripada
skupini lijekova koji se nazivaju
bronhodilatatori. Kada ga udahnete, on opušta mišiće u stijenkama
dišnih puteva u plućima. To
pomaže otvaranju dišnih puteva, olakšavajući ulazak i izlazak
zraka.
ZA ŠTO SE KORISTI HIROBRIZ BREEZHALER
Hirobriz Breezhaler se koristi da bi se olakšalo disanje u odraslih
bolesnika koji imaju poteškoće s
disanjem zbog plućne bolesti koja se zove kronična opstruktivna
plućna bolest (KOPB). U KOPB-u se
mišići oko dišnih puteva stežu. Ovo uzrokuje otežano disanje.
Ovaj lijek opušta te mišiće u plućima,
omogućava lakši protok zraka u i iz pluća.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMJENJIVATI HIROBRIZ
BREEZHALER
NEMOJTE PRIMJENJIVATI HIROBRIZ BREEZHALER
-
ako ste alergični na indakaterol ili neki drugi sastojak ovog lijeka
(naveden u dijelu 6.).
UP
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Hirobriz Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka kapsula sadrži 150 mikrograma indakaterola u obliku
indakaterolmaleata.
Doza indakaterolmaleata koja izlazi iz nastavka za usta inhalatora
odgovara 120 mikrograma
indakaterola.
Pomoćna tvar s poznatim učinkom
Svaka kapsula sadrži 24,8 mg laktoze.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak inhalata, tvrda kapsula
Prozirne (bezbojne) kapsule koje sadrže bijeli prašak, s crnom
oznakom „IDL 150“ otisnutom iznad
crne crte te crnim logom proizvođača (
) otisnutim ispod crne crte.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Hirobriz Breezhaler je indiciran za terapiju održavanja
bronhodilatacije kod opstrukcije dišnih puteva
u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti
(KOPB).
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza je udisanje sadržaja jedne kapsule od 150
mikrograma jedanput na dan uz pomoć
Hirobriz Breezhaler inhalatora. Doza se smije povećati samo prema
liječničkoj preporuci.
Dokazano je da udisanje sadržaja kapsule od 300 mikrograma jedanput
na dan uz pomoć Hirobriz
Breezhaler inhalatora omogućava dodatnu kliničku korist s obzirom na
dispneju, osobito u bolesnika s
teškim KOPB-om. Najveća doza je 300 mikrograma jedanput na dan.
Hirobriz Breezhaler treba primjenjivati svakog dana u isto vrijeme.
U slučaju propuštene doze, sljedeću dozu treba uzeti sljedećeg
dana u isto vrijeme.
_Posebne populacije _
_Starija populacija_
Najveća koncentracija u plazmi i ukupna sistemska izloženost raste s
dobi, ali nije potrebno
prilagođavati dozu u starijih bolesnika.
_ _
_Oštećenje jetre _
Nije potrebno prilagođavanje doze u bolesnika s blagim i umjerenim
oštećenjem jetre. Nema podataka
o primjeni Hirobriz Breezhalera u bolesnika s teškim oštećenjem
jetre.
3
_Oštećenje bubrega _
Nije potrebno prilagođavanje doze u bolesnika s oštećenjem 
                                
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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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