Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
08-12-2021
Download Summary of Product characteristics (SPC)
08-12-2021
Download Public Assessment Report (PAR)
01-01-1970

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V. 

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol fumarate dihydrate

Therapeutic group:

Lijekovi za opstruktivne plućne bolesti dišnih putova,

Therapeutic area:

Asthma; Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Budesonid / Formoterol Teva Pharma B. je indiciran u odrasloj dobi od 18 godina i stariji. AsthmaBudesonide/Формотерола Tewa Pharma B. navodi u redovnom liječenju astme, gdje je upotreba kombinacije (inhalacijskim kortikosteroidima i trajno djeluju β2 адренорецепторов) preporuča:-kod bolesnika adekvatno ne prati ингаляционными kortikosteroidima i "po potrebi" udahnuti короткодействующих β2 адреномиметиков. ili-kod pacijenata već adekvatno prati na oba inhalacijskim kortikosteroidima i trajno djeluju β2 адреномиметиков. COPDSymptomatic liječenje bolesnika s KOPB, kotor принудили выдыхательный tome u 1 drugom (FEV1) .

Product summary:

Revision: 2

Authorization status:

odobren

Authorization date:

2020-04-03

Patient Information leaflet

                                48
B. UPUTA O LIJEKU
49
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
BUDEZONID/FORMOTEROL TEVA PHARMA B.V. 160 MIKROGRAMA/4,5 MIKROGRAMA
PRAŠAK INHALATA
budezonid/formoterolfumarat dihidrat
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, ljekarniku ili
medicinskoj sestri.
-
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, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte dio
4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Budezonid/Formoterol Teva Pharma B.V. i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati
Budezonid/Formoterol Teva Pharma B.V.
3.
Kako primjenjivati Budezonid/Formoterol Teva Pharma B.V.
4.
Moguće nuspojave
5.
Kako čuvati Budezonid/Formoterol Teva Pharma B.V.
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE BUDEZONID/FORMOTEROL TEVA PHARMA B.V. I ZA ŠTO SE KORISTI
Budezonid/Formoterol Teva Pharma B.V. sadrži dvije različite
djelatne tvari: budezonid i
formoterolfumarat dihidrat.
•
Budezonid pripada skupini lijekova pod nazivom „kortikosteroidi”,
poznati i kao „steroidi”.
Djeluje smanjenjem i sprječavanjem oticanja i upale u vašim plućima
i pomaže Vam da lakše
dišete.
•
Formoterolfumarat dihidrat pripada skupini lijekova pod nazivom
„dugodjelujući agonisti β
2
-
adrenoceptora” ili „bronhodilatatori”. Djeluje opuštanjem
mišića Vaših dišnih puteva. To će
pomoći da se otvore dišni putevi i olakšati Vam disanje.
PRIMJENA LIJEKA BUDEZONID/FORMOTEROL TEVA PHARMA B.V. INDICIRANA JE
SAMO ZA ODRASLE U DOBI
OD 18 I VIŠE GODINA.
BUDEZONID/FORMOTEROL TEVA PHARMA B.V. NIJE INDICIRAN ZA PRIMJENU U
DJECE S NAVRŠENIH 12
GODINA I MLAĐU NI
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Budezonid/Formoterol Teva Pharma B.V. 160 mikrograma/4,5 mikrograma
prašak inhalata
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna primijenjena doza (doza koja izlazi iz nastavka za usta
inhalatora Spiromax) sadrži 160
mikrograma budezonida i 4,5 mikrograma formoterolfumarat dihidrata.
To odgovara odmjerenoj dozi od 200 mikrograma budezonida i 6
mikrograma formoterolfumarat
dihidrata.
Pomoćna(e) tvar(i) s poznatim učinkom:
Jedna doza sadrži oko 5 miligrama laktoze (u obliku hidrata).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak inhalata.
Bijeli prašak.
Bijeli inhalator s poluprozirnim poklopcem nastavka za usta boje
crvenog vina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Budezonid/Formoterol Teva Pharma B.V. indiciran je samo u odraslih u
dobi od 18 godina iviše.
Astma
_ _
Budezonid/Formoterol Teva Pharma B.V. indiciran je u redovitom
liječenju astme kad je primjereno
kombinirano liječenje (inhalacijskim kortikosteroidom i
dugodjelujućim agonistima ß
2
-adrenergičkih
receptora):
- u bolesnika u kojih astma nije zadovoljavajuće kontrolirana
inhalacijskim kortikosteroidima i prema
potrebi primijenjenim inhalacijskim kratkodjelujućim agonistima ß
2
-adrenergičkih receptora
ili
- u bolesnika u kojih je astma već zadovoljavajuće kontrolirana
primjenom i inhalacijskih
kortikosteroida i dugodjelujućih agonista ß
2
-adrenergičkih receptora.
KOPB
_ _
Simptomatsko liječenje bolesnika s KOPB-om s forsiranim
ekspiracijskim volumenom tijekom
1. sekunde (FEV
1
) < 70% od predviđene normale (nakon primjene bronhodilatatora) i
anamnezom
ponavljanih egzacerbacija, koji imaju značajne simptome unatoč
redovnoj terapiji bronhodilatatorima
dugog djelovanja.
3
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_Astma _
_ _
Budezonid/Formoterol Teva Pharma B.V. nije namijenjen za početno
zbrinjavanje astme.
Budezonid/Formoterol Teva Pharma B.V. nije odgovarajuće liječenje za
odraslog bolesnika koji ima
samo blagi obli
                                
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Active ingredient Budesonide, formoterol fumarate dihydrate

Budesonide, formoterol fumarate dihydrate

ATC code R03AK07

R03AK07

Marketed by Teva Pharma B.V. 

Teva Pharma B.V. 

INN (International Name) budesonide, formoterol fumarate dihydrate

budesonide, formoterol fumarate dihydrate

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Patient Information leaflet Patient Information leaflet Bulgarian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-12-2021
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Spanish 08-12-2021
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 08-12-2021
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Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 08-12-2021
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Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 08-12-2021
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 08-12-2021
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 08-12-2021
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Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 08-12-2021
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Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 08-12-2021
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