Vylaer Spiromax

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

Buy It Now

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:

Zdravila za obstruktivne pljučne bolezni,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Zdravilo Vylaer Spiromax je indicirano pri odraslih, starejših od 18 let in starejših. AsthmaVylaer Spiromax je navedena v redno zdravljenje astme, kjer je uporaba kombinacije (pri vdihavanju kortikosteroidi in dolgo delujoči β2 adrenergični agonist) je ustrezno:pri bolnikih, ki ni ustrezno nadzorovana z vdihavajo kortikosteroide in "kot je treba" pri vdihavanju kratko delujoči β2 adrenergični agonisti. orin bolnikih, ki so že ustrezno nadzorovan na obeh vdihavajo kortikosteroide in dolgo delujoči β2 adrenergični agonisti. COPDSymptomatic zdravljenje bolnikov s hudo KOPB (FEV1 < 50% predvidenih normalno) in zgodovina ponovi exacerbations, ki so pomembne simptome kljub redne terapije z dolgotrajnim delovanjem bronchodilators.

Product summary:

Revision: 3

Authorization status:

Umaknjeno

Authorization date:

2014-11-19

Patient Information leaflet

                                35
STRANSKA PLOSKEV: SAMO ZA UPORABO PRI ODRASLIH, STARIH 18 IN VEČ LET.
NI ZA UPORABO PRI OTROCIH
ALI MLADOSTNIKIH, MLAJŠIH OD 18 LET.
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
Izdelek je treba porabiti v 6 mesecih po odstranitvi ovoja iz folije.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25 °C. Po odstranitvi ovoja iz folije
naj bo pokrovček ustnika zaprt.
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
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/14/949/001
EU/1/14/949/003
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
Vylaer Spiromax 160 mcg/4,5 mcg
Zdravilo nima več dovoljenja za promet
36
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
FOLIJA
1.
IME ZDRAVILA IN POT(I) UPORABE
Vylaer Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
BUDEZONID/FORMOTEROLIJEV FUMARAT DIHIDRAT
za inhaliranje
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Vsebuje 1 inhalator.
6.
DRUGI PODATKI
Po odstranitvi ovoja iz folije naj bo pokrovček ustnika zaprt,
zdravilo pa porabite v 6 mesecih po
odstranitvi ovoja iz folije.
Teva Pharma B.V.
Zdravilo nima več dovoljenja za promet
37
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
INHALATOR
1.
IME ZDRAVILA IN POT(I) UPORABE
Vylaer Spiromax 160 mcg/4,5 mcg prašek za inhaliranje
BUDEZONID/FORMOTEROLIJEV FUMARAT DIHIDRAT
za inhaliranje
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
120 odmerkov
6.
DRUGI PODATKI
ZAČETEK
Teva Pharma B.V.
Zdravilo nima več dovoljenja za pr
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima več dovoljenja za promet
2
1.
IME ZDRAVILA
Vylaer Spiromax 160 mikrogramov/4,5 mikrogramov prašek za inhaliranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje
160 mikrogramov budezonida
in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
To je enakovredno odmerjenemu odmerku 200 mikrogramov budezonida in 6
mikrogramov
formoterolijevega fumarata dihidrata.
Pomožne snovi z znanim učinkom:
En odmerek vsebuje približno 5 miligramov laktoze (v obliki
monohidrata).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
prašek za inhaliranje
bel prašek
bel inhalator s polprozornim vinsko rdečim pokrovčkom ustnika
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Vylaer Spiromax je indicirano izključno pri odraslih, starih
18 let in več.
Astma
_ _
Zdravilo Vylaer Spiromax je indicirano za redno zdravljenje astme v
primerih, ko je primerna
kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči
agonist adrenergičnih receptorjev β
2
):
–
pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z
inhalacijskimi
kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti
adrenergičnih receptorjev β
2,
ki so
predpisani za uporabo po potrebi;
ali
–
pri bolnikih, pri katerih bolezen že ustrezno nadzorujemo tako z
inhalacijskimi kortikosteroidi
kot z dolgodelujočimi agonisti adrenergičnih receptorjev β
2
.
KOPB
Simptomatsko zdravljenje bolnikov s hudo obliko KOPB (FEV
1
< 50 % predvidenega normalnega
FEV
1
) in s ponavljajočimi se poslabšanji v anamnezi, pri katerih se
kljub zdravljenju z
dolgodelujočimi bronhodilatatorji pojavljajo znatni simptomi.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo Vylaer Spiromax je indicirano izključno pri odraslih, starih
18 let in več.
Zdravilo Vylaer Spiromax ni indicirano za uporabo pri otrocih, starih
12 let ali manj, ali mladostnikih,
starih od 13 do 17 let.
Zdravilo nima več dovoljenja za 
                                
                                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

Documents in other languages

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
Patient Information leaflet Patient Information leaflet Spanish 15-07-2016
Summary of Product characteristics Summary of Product characteristics Spanish 15-07-2016
Public Assessment Report Public Assessment Report Spanish 05-12-2014
Patient Information leaflet Patient Information leaflet Czech 15-07-2016
Summary of Product characteristics Summary of Product characteristics Czech 15-07-2016
Public Assessment Report Public Assessment Report Czech 05-12-2014
Patient Information leaflet Patient Information leaflet Danish 15-07-2016
Summary of Product characteristics Summary of Product characteristics Danish 15-07-2016
Public Assessment Report Public Assessment Report Danish 05-12-2014
Patient Information leaflet Patient Information leaflet German 15-07-2016
Summary of Product characteristics Summary of Product characteristics German 15-07-2016
Public Assessment Report Public Assessment Report German 05-12-2014
Patient Information leaflet Patient Information leaflet Estonian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Estonian 15-07-2016
Public Assessment Report Public Assessment Report Estonian 05-12-2014
Patient Information leaflet Patient Information leaflet Greek 15-07-2016
Summary of Product characteristics Summary of Product characteristics Greek 15-07-2016
Public Assessment Report Public Assessment Report Greek 05-12-2014
Patient Information leaflet Patient Information leaflet English 15-07-2016
Summary of Product characteristics Summary of Product characteristics English 15-07-2016
Public Assessment Report Public Assessment Report English 05-12-2014
Patient Information leaflet Patient Information leaflet French 15-07-2016
Summary of Product characteristics Summary of Product characteristics French 15-07-2016
Public Assessment Report Public Assessment Report French 05-12-2014
Patient Information leaflet Patient Information leaflet Italian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Italian 15-07-2016
Public Assessment Report Public Assessment Report Italian 05-12-2014
Patient Information leaflet Patient Information leaflet Latvian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Latvian 15-07-2016
Public Assessment Report Public Assessment Report Latvian 05-12-2014
Patient Information leaflet Patient Information leaflet Lithuanian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Lithuanian 15-07-2016
Public Assessment Report Public Assessment Report Lithuanian 05-12-2014
Patient Information leaflet Patient Information leaflet Hungarian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Hungarian 15-07-2016
Public Assessment Report Public Assessment Report Hungarian 05-12-2014
Patient Information leaflet Patient Information leaflet Maltese 15-07-2016
Summary of Product characteristics Summary of Product characteristics Maltese 15-07-2016
Public Assessment Report Public Assessment Report Maltese 05-12-2014
Patient Information leaflet Patient Information leaflet Dutch 15-07-2016
Summary of Product characteristics Summary of Product characteristics Dutch 15-07-2016
Public Assessment Report Public Assessment Report Dutch 05-12-2014
Patient Information leaflet Patient Information leaflet Polish 15-07-2016
Summary of Product characteristics Summary of Product characteristics Polish 15-07-2016
Public Assessment Report Public Assessment Report Polish 05-12-2014
Patient Information leaflet Patient Information leaflet Portuguese 15-07-2016
Summary of Product characteristics Summary of Product characteristics Portuguese 15-07-2016
Public Assessment Report Public Assessment Report Portuguese 05-12-2014
Patient Information leaflet Patient Information leaflet Romanian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Romanian 15-07-2016
Public Assessment Report Public Assessment Report Romanian 05-12-2014
Patient Information leaflet Patient Information leaflet Slovak 15-07-2016
Summary of Product characteristics Summary of Product characteristics Slovak 15-07-2016
Public Assessment Report Public Assessment Report Slovak 05-12-2014
Patient Information leaflet Patient Information leaflet Finnish 15-07-2016
Summary of Product characteristics Summary of Product characteristics Finnish 15-07-2016
Public Assessment Report Public Assessment Report Finnish 05-12-2014
Patient Information leaflet Patient Information leaflet Swedish 15-07-2016
Summary of Product characteristics Summary of Product characteristics Swedish 15-07-2016
Public Assessment Report Public Assessment Report Swedish 05-12-2014
Patient Information leaflet Patient Information leaflet Norwegian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Norwegian 15-07-2016
Patient Information leaflet Patient Information leaflet Icelandic 15-07-2016
Summary of Product characteristics Summary of Product characteristics Icelandic 15-07-2016
Patient Information leaflet Patient Information leaflet Croatian 15-07-2016
Summary of Product characteristics Summary of Product characteristics Croatian 15-07-2016
Public Assessment Report Public Assessment Report Croatian 05-12-2014

Search alerts related to this product

Alerts Vylaer Spiromax Budesonide, formoterol fumarate dihydrate

Vylaer Spiromax Budesonide, formoterol fumarate dihydrate

View documents history

Documents history Documents history

Vylaer Spiromax