Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2022
Public Assessment Report Public Assessment Report (PAR)
06-09-2019

Active ingredient:

formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

R03AL09

INN (International Name):

beclometasone, formoterol

Therapeutic group:

Lijekovi za opstruktivne plućne bolesti dišnih putova,

Therapeutic area:

Plućna bolest, kronična opstruktivna

Therapeutic indications:

Terapija održavanja u odraslih bolesnika s umjerenim do teške kronične opstruktivne plućne bolesti (KOPB) koji se adekvatno liječe kombinacijom inhalacijski kortikosteroid i dugodjelujući beta2-agonist (za učinak na simptome kontrole i prevenciji egzacerbacije vidjeti dio 5.

Product summary:

Revision: 4

Authorization status:

odobren

Authorization date:

2018-04-23

Patient Information leaflet

                                33
B. UPUTA O LIJEKU
34
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
RIARIFY 87 MIKROGRAMA/5 MIKROGRAMA/9 MIKROGRAMA STLAČENI INHALAT,
OTOPINA
beklometazondipropionat/formoterolfumarat dihidrat/glikopironij
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 Riarify i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Riarify
3.
Kako primjenjivati Riarify
4.
Moguće nuspojave
5.
Kako čuvati Riarify
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE RIARIFY I ZA ŠTO SE KORISTI
Riarify je lijek za olakšavanje disanja koji sadrži tri djelatne
tvari:
•
beklometazondipropionat,
•
formoterolfumarat dihidrat i
•
glikopironij.
Beklometazondipropionat pripada skupini lijekova koji se nazivaju
kortikosteroidi i djeluju tako što
smanjuju oticanje i nadraženost u plućima.
Formoterol i glikopironij su lijekovi koji se nazivaju dugodjelujući
bronhodilatatori. Oni na različite
načine opuštaju mišiće dišnih puteva, tako ih proširuju te Vam
omogućuju da lakše dišete.
Redovito liječenje pomoću ove tri djelatne tvari pomaže olakšati i
spriječiti simptome poput
nedostatka zraka, piskanja pri disanju i kašlja u odraslih bolesnika
s kroničnom opstruktivnom
plućnom bolešću (KOPB-om). Riarify može smanjiti egzacerbacije
(razbuktavanje) simptoma KOPB-
a. KOPB je ozbiljna dugotrajna bolest u kojoj dolazi do začepljenja
dišnih puteva i oštećenja zračnih
vrećica u plućima, a to dovodi do otežanog disanja.
2.
ŠTO MORATE ZNATI PR
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Riarify 87 mikrograma/5 mikrograma/9 mikrograma stlačeni inhalat,
otopina
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna isporučena doza (doza koja izađe iz nastavka za usta) sadrži
87 mikrograma
beklometazondipropionata, 5 mikrograma formoterolfumarat dihidrata i 9
mikrograma glikopironija (u
obliku 11 mikrograma glikopironijevog bromida).
Jedna odmjerena doza (doza koja izađe iz ventila) sadrži 100
mikrograma beklometazondipropionata,
6 mikrograma formoterolfumarat dihidrata i 10 mikrograma glikopironija
(u obliku 12,5 mikrograma
glikopironijevog bromida).
Pomoćna tvar s poznatim učinkom
Riarify sadrži 8856 mg etanola po potisku.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Stlačeni inhalat, otopina (stlačeni inhalat)
Bezbojna do žućkasta otopina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Terapija održavanja u odraslih bolesnika s umjerenom do teškom
kroničnom opstruktivnom plućnom
bolešću (KOPB) koji nisu odgovarajuće liječeni kombinacijom
inhalacijskog kortikosteroida i
dugodjelujućeg beta-2 agonista ili kombinacijom dugodjelujućeg
beta-2 agonista i dugodjelujućeg
muskarinskog antagonista (za učinke na kontrolu simptoma i
sprječavanje egzacerbacija vidjeti
dio 5.1).
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Preporučena doza je dva udaha dvaput na dan.
Maksimalna doza je dva udaha dvaput na dan.
Posebne populacije
_ _
_Starije osobe _
Nije potrebna prilagodba doze u starijih bolesnika (u dobi od 65
godina i starijih).
_ _
_Oštećenje funkcije bubrega _
Riarify se može primjenjivati u preporučenoj dozi u bolesnika s
blagim (brzina glomerularne filtracije
[GFR] ≥ 50 do < 80 ml/min/1,73 m
2
) do umjerenim (GFR ≥ 30 do < 50 ml/min/1,73 m
2
) oštećenjem
funkcije bubrega. Primjena u bolesnika s teškim oštećenjem funkcije
bubrega (GFR
< 30 ml/min/1,73 m
2
) ili u bolesnika u završnom stadiju bubrežne bolesti (GFR < 15
ml/min/1,73 m
2
)
3
kojima je potrebna dijaliza, osobito ako je pove
                                
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Similar products

Active ingredient formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate

formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate

ATC code R03AL09

R03AL09

Marketed by Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici S.p.A.

INN (International Name) beclometasone, formoterol

beclometasone, formoterol

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Patient Information leaflet Patient Information leaflet Bulgarian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-12-2022
Public Assessment Report Public Assessment Report Bulgarian 06-09-2019
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Public Assessment Report Public Assessment Report Spanish 06-09-2019
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Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)