Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
30-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
30-01-2017
Public Assessment Report Public Assessment Report (PAR)
30-01-2017

Active ingredient:

Budesonide, formoterol

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol fumarate dihydrate

Therapeutic group:

Zdravila za obstruktivne pljučne bolezni,

Therapeutic area:

Astma

Therapeutic indications:

Budezonid / Formoterol Teva Pharma B. je indiciran pri odraslih, starih samo 18 let ali več. AsthmaBudesonide/Formoterol Teva Pharma B. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists. in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Product summary:

Revision: 1

Authorization status:

Umaknjeno

Authorization date:

2014-11-19

Patient Information leaflet

                                36
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., Computerweg 10, 3542 DR Utrecht, Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/14/950/001
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
Budezonid/formoterol Teva Pharma B.V. 160 mcg/4,5 mcg
Zdravilo nima več dovoljenja za promet
37
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
FOLIJA
1.
IME ZDRAVILA IN POT(I) UPORABE
Budezonid/formoterol Teva Pharma B.V. 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
38
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
INHALATOR
1.
IME ZDRAVILA IN POT(I) UPORABE
Budezonid/formoterol Teva Pharma B.V. 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 promet
39
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Budezonid/formoterol
                                
                                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
Budezonid/formoterol Teva Pharma B.V. 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 Budezonid/formoterol Teva Pharma B.V. je indicirano
izključno pri odraslih, starih 18 let in
več.
Astma
_ _
Zdravilo Budezonid/formoterol Teva Pharma B.V. 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
.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo Budezonid/formoterol Teva Pharma B.V. je indicirano
izključno pri odraslih, starih 18 let in
več.
Zdravilo Budezonid/formoterol Teva Pharma B.V. ni indicirano za
uporabo pri otrocih, starih 12 let ali
manj, ali mladostnikih, starih od 13 do 17 let.
Zdravilo nima več dovoljenja za promet
3
Odmerjanje
_Astma _
_ _
Zdravilo Budezonid/formoterol Teva Pharma B.V. ni primerno za začetno
zdravljenje astme.
Zdravljenje z zdra
                                
                                Read the complete document

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Active ingredient Budesonide, formoterol

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ATC code R03AK07

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Marketed by Teva Pharma B.V.

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INN (International Name) budesonide, formoterol fumarate dihydrate

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