Vylaer Spiromax

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
15-07-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
15-07-2016
Public Assessment Report Public Assessment Report (PAR)
05-12-2014

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol

Therapeutic group:

Lijekovi za opstruktivne plućne bolesti dišnih putova,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Vylaer Spiromax je indiciran u odrasloj dobi od 18 i više godina. AsthmaVylaer Spiromax drugačije u redovnom liječenju astme, gdje je upotreba kombinacije (inhalacijskim kortikosteroidima i trajno djeluju β2 адренорецепторов) prikladno:u bolesnika adekvatno ne prati ингаляционными kortikosteroidima i "po potrebi" udahnuti короткодействующих β2 адреномиметиков. Орин pacijenata već adekvatno prati na oba inhalacijskim kortikosteroidima i trajno djeluju β2 адреномиметиков. COPDSymptomatic liječenje bolesnika s teškim KOPB (ОФВ1 < 50%, predviđa normalno) i ponovljenim vrhunac, koji imaju značajne simptome, unatoč regularnu terapiju s длинн-djeluje bronhodilatatora.

Product summary:

Revision: 3

Authorization status:

povučen

Authorization date:

2014-11-19

Patient Information leaflet

                                42
B. UPUTA O LIJEKU
Lijek koji više nije odobren
43
UPUTA O LIJEKU: INFORMACIJA ZA BOLESNIKA
VYLAER SPIROMAX 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 svom 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 nuspojavu koja nije navedena u ovoj
uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Vylaer Spiromax i za što se koristi (stranica 3)
2.
Što morate znati prije nego počnete primjenjivati Vylaer Spiromax
(stranica 5)
3.
Kako primjenjivati Vylaer Spiromax (stranica 9)
4.
Moguće nuspojave (stranica 18)
5.
Kako čuvati Vylaer Spiromax (stranica 21)
6.
Sadržaj pakiranja i druge informacije (stranica 22)
1.
ŠTO JE VYLAER SPIROMAX I ZA ŠTO SE KORISTI
Vylaer Spiromax 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 beta2-
adrenoceptora” ili „bronhodilatatori”. Djeluje opuštanjem
mišića Vaših dišnih puteva. To će
pomoći da se otvore dišni putevi i olakšati Vam disanje.
PRIMJENA LIJEKA VYLAER SPIROMAX INDICIRANA JE SAMO ZA ODRASLE U DOBI
OD 18 I VIŠE GODINA.
VYLAER SPIROMAX NIJE INDICIRAN ZA PRIMJENU U DJECE S NAVRŠENIH 12
GODINA I MLAĐU NITI ZA
ADOLESCENTE U DOBI OD 13 DO 17 GODINA
.
Liječnik Vam je propisao ovaj lijek za lije
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Vylaer Spiromax 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
Vylaer Spiromax indiciran je samo u odraslih u dobi od 18 godina i
više.
Astma
_ _
Vylaer Spiromax je indiciran 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″ 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 teškom KOPB (FEV
1
< 50% od predviđene normale) i
anamnezom ponavljanih egzacerbacija, koji imaju značajne simptome
unatoč redovnoj terapiji
bronhodilatatorima dugog djelovanja.
4.2
DOZIRANJE I NAČIN PRIMJENE
Vylaer Spiromax indiciran je samo u odraslih u dobi od 18 godina i
više.
Vylaer Spiromax nije indiciran za primjenu u djece, u dobi od 12
godina i mlađe, niti za adolescente u
dobi od 13 do 17 godina.
Lijek koji više nije odobren
3
Doziranje
_Astma _
_ _
Vylaer Spiromax nije namijenjen za početno zbrinjavanje astme.
Vylaer Spiromax nije odgovarajuće 
                                
                                Read the complete document

Similar products

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

budesonide, formoterol

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Patient Information leaflet Patient Information leaflet Bulgarian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Bulgarian 15-07-2016
Public Assessment Report Public Assessment Report Bulgarian 05-12-2014
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Summary of Product characteristics Summary of Product characteristics Spanish 15-07-2016
Public Assessment Report Public Assessment Report Spanish 05-12-2014
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