natgillin/translations-raw huggingface dataset:
Overall, the greatest effects on the early asthmatic response were seen with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms or vilanterol 22 micrograms alone. 
V celoti so največje učinke na zgodnji astmatični odziv zabeležili s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 92 mikrogrami FF ali 22 mikrogrami vilanterola, uporabljenih samih.
EXP In use shelf-life: 6 weeks. 
EXP: Rok uporabnosti po prvem odprtju: 6 tednov.
For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22. 
Za hudo pljučnico je bilo ustrezno število pljučnic na 1000 bolnik-let 33,6, 35,5 in 7,6, za resno pljučnico pa je bilo ustrezno število pljučnic na 1000 bolnik-let 35,1 s FF/VI 184/22, 42,9 s FF/VI 92/22 in 12,1 z VI 22.
There was no effect of race on pharmacokinetic parameter estimates of vilanterol in subjects with COPD. 
Pri preiskovancih s KOPB rasa ni vplivala na ocene farmakokinetičnih parametrov vilanterola.
Always use this medicine exactly as your doctor has told you to. 
Zelo pomembno je, da to zdravilo uporabljate vsak dan, kot vam je naročil zdravnik.
Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta. 
Med uporabo simpatikomimetičnih zdravil, vključno z zdravilom Relvar Ellipta, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kakršne so supraventrikularna tahikardija in ekstrasistole.
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street 
Glaxo Operations UK Ltd. (posluje kot Glaxo Wellcome Operations) Priory Street
The pharmacokinetics of fluticasone furoate/vilanterol in patients less than 12 years of age has not been studied. 
Farmakokinetika zdravila Relvar Ellipta pri bolnikih, mlajših od 12 let, ni raziskana.
At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively. 
Ob presejanju je bil povprečni FEV1 pred bronhodilatatorjem v HZC112206 42,6 % predvidenega in povprečna reverzibilnost 15,9 % napovedane, v
Hold the inhaler away from your mouth and breathe out as far as is comfortable. 
Bolnik naj drži inhalator odmaknjen od ust in izdihne čim bolj globoko, a ne toliko, da bi bilo neprijetno.
• patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. 
• bolniki, ki imajo bolezen ustrezno urejeno ob uporabi inhalacijskih kortikosteroidov in dolgodelujočih agonistov adrenergičnih receptorjev beta2.
The risk of the cardiovascular composite event with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.93; 95% CI: 0.75 to 1.14), fluticasone furoate (HR 1.03; 95% CI: 0.83 to 1.28) or vilanterol (HR 0.94; 95% CI: 0.76 to 1.16). 
Tveganje za sestavljeni kardiovaskularni dogodek se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO 0,93, 95 % IZ: 0,75 do 1,14), flutikazonfuroata (RO 1,03, 95 % IZ: 0,83 do 1,28) ali vilanterola (RO 0,94, 95 % IZ: 0,76 do 1,16).
SUMMIT was a multi-centre, randomised, double-blind study evaluating the effect on survival of fluticasone furoate/vilanterol 92/22 micrograms compared with placebo in 16,485 subjects. 
Študije, ki so trajale več kot 1 leto Študija SUMMIT je bila multicentrična, randomizirana dvojno slepa študija, ki je pri 16.485 bolnikih ocenjevala vpliv kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov v primerjavi s placebom na preživetje.
Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary. 
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med 24-tedenskim zdravljenjem glede na izhodišče je bil sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 
HZA106829 je trajala 24 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 184/22 mikrogramov
Put the mouthpiece between your lips and close your lips firmly around it. 
• Ustnik namestite čvrsto med ustnici.
It is packaged in a foil laminate tray with a peelable foil lid. 
Nahaja se v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
Both fluticasone furoate and vilanterol have a low association with red blood cells. 
Tako flutikazonfuroat kot vilanterol imata nizko povezanost z eritrociti.
HZC102970 and HZC102871 integrated 
HZC102970 in HZC102871 skupaj vilanterol (n = 409)
At the 24-week time point FF and FP increased trough FEV1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo. 
za 146 ml (95 % IZ od 36 do 257 ml, p = 0,009) in FP za 145 ml (95 % IZ od 33 do 257 ml, p = 0,011) v primerjavi s placebom.
Use this medicine for as long as your doctor recommends. 
Zdravilo Relvar Ellipta uporabljajte toliko časa, kot vam svetuje vaš zdravnik.
Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats. 
Niti flutikazonfuroat niti vilanterolijev trifenatat pri podganah nista imela neželenih učinkov na plodnost,
In subjects with COPD estimates of fluticasone furoate AUC(0-24) for East Asian, Japanese and South East Asian subjects (13-14% subjects) were on average 23% to 30% higher compared with Caucasian subjects. 
Pri KOPB je bila ocenjena AUC(0-24) flutikazonfuroata za preiskovance iz vzhodne Azije, Japonske in jugovzhodne Azije (13-14 % preiskovancev) v povprečju za 23 do 30 % večja kot pri belcih.
Mortality risk with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.88; 95% CI: 0.74 to 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 to 1.15; p=0.681) or vilanterol (HR 0.91; 95% CI: 0.77 to 1.09; p=0.299). 
Tveganje umrljivosti se s kombinacijo flutikazonfuroat/vilanterol ni značilno razlikovalo od placeba (RO [razmerje ogroženosti] 0,88, 95 % IZ: 0,74 do 1,04, p = 0,137), flutikazonfuroata (RO 0,96, 95 % IZ: 0,81 do 1,15, p = 0,681) ali vilanterola (RO 0,91, 95 % IZ: 0,77 do 1,09, p = 0,299).
However, fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. 
Vendar je treba pri bolnikih s hudo kardiovaskularno boleznijo ali motnjami srčnega ritma, hipertiroidizmom, nekorigirano hipokaliemijo ali pri bolnikih, ki so nagnjeni k nizkim vrednostim kalija v serumu, flutikazonfuroat/vilanterol uporabljati previdno.
When given subcutaneously there were no effects at exposures 84-times greater than those at the maximum recommended human dose, based on AUC. 
Med subkutano uporabo ob izpostavljenostih, 84-krat večjih od izpostavljenosti (na podlagi AUC) med uporabo največjega priporočenega odmerka za človeka,
Following repeat dosing of fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (up to three-fold as measured by AUC(0-24)) in subjects with hepatic impairment (Child-Pugh A, B or C) compared with healthy subjects. 
Po ponavljajočem se odmerjanju flutikazonfuroata/vilanterola 7 dni se je sistemska izpostavljenost flutikazonfuroatu pri preiskovancih z okvaro jeter (Child-Pugh A, B in C) povečala (do trikrat, merjeno z
A randomised, double-blind, parallel group, 24 week study (201378) was conducted to demonstrate noninferiority (using a margin of -100 mL for trough FEV1) of fluticasone furoate/vilanterol 92/22 once daily to salmeterol/FP 50/250 twice daily in adults and adolescents whose asthma was well controlled following 4 weeks of treatment with open-label salmeterol/FP 50/250 twice daily (N=1504). 
Randomizirano, dvojno slepo 24-tedensko študijo vzporednih skupin (201378) so izvedli za ugotavljanje neinferiornosti (z uporabo meje -100 mL za najnižji FEV1) kombinacije flutikazonfuroat/vilanterol 92/22 mikrogramov enkrat na dan v primerjavi s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan pri odraslih in mladostnikih, ki so imeli astmo dobro urejeno po 4 tednih zdravljenja (po shemi odprtega načrta zdravljenja) s kombinacijo salmeterol/FP 50/250 mikrogramov dvakrat na dan (N = 1504).
• voice disorders 
• motnje glasu,
In an integrated analysis of HZC102970 and HZC102871 at week 52, an improvement was seen when comparing the fluticasone furoate/vilanterol 92/22 micrograms versus vilanterol 22 micrograms in adjusted mean trough FEV1 (42 mL 95% CI: 19, 64mL, p<0.001). 
Integrirana analiza HZC102970 in HZC102871 52. teden je pokazala izboljšanje korigiranega povprečnega najmanjšega FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov v primerjavi z 22 mikrogrami vilanterola (42 ml, 95 % IZ: 19, 64 ml, p < 0,001).
Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms. 
Na voljo sta dve različni jakosti zdravila Relvar Ellipta: flutikazonfuroat 92 mikrogramov/vilanterol 22 mikrogramov in flutikazonfuroat 184 mikrogramov/vilanterol 22 mikrogramov.
Gender, weight and BMI 
Spol, telesna masa in ITM
Change from Baseline in Percentage of Rescue-Free 24-hour Periods Treatment difference 
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila glede na izhodišče Razlika zdravljenj
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria. 
Bolezni imunskega sistema preobčutliivostne reakcije, vključno z anafilakso, angioedemom,
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use. 
Če je zdravilo shranjeno v hladilniku, je treba inhalator vsaj eno uro pred uporabo pustiti zunaj, da se ogreje na sobno temperaturo.
Improvements were also seen in this subgroup at week 52 when comparing the fluticasone furoate/vilanterol 92/22 micrograms vs. vilanterol 22 micrograms in adjusted mean trough FEV1 (44 mL 95% CI: 15, 73mL, (p=0.003)). 
Izboljšanje so v tej podskupini zabeležili tudi 52. teden, ko so primerjali korigirani povprečni najnižji FEV1 s flutikazonfuroatom/vilanterolom 92/22 mikrogramov in z 22 mikrogrami vilanterola (44 ml, 95 % IZ: 15, 73 ml, (p = 0,003))
The European Medicines Agency has waived the obligation to submit the results of studies with Relvar Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use). 
Ellipta za vse skupine pediatrične populacije pri KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group. 
V integrirani analizi dveh repliciranih enoletnih študij pri zmerni do hudi KOPB (povprečni predvideni FEV1 po bronhodilatatorju ob presejanju 45 %, standardni odklon 13 %) s poslabšanjem v predhodnem letu (n = 3255) je bilo število pljučnic na 1000 bolnik-let v skupini s FF/VI 184/22 97,9, v skupini s FF/VI 92/22 85,7 in v skupini z VI 22 42,3.
Pack sizes of 14 or 30 dose Inhalers. 
Velikost pakiranja je inhalator s 14 ali 30 odmerki.
The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 micrograms was 0.755 (95% CI 0.603, 0.945). 
Razmerje deležev poslabšanj z flutikazonfuroatom/vilanterolom 92/22 mikrogramov in s FF 92 mikrogramov je bilo 0,755 (95 % IZ 0,603, 0,945).
This leaflet 
Opazovani dogodek
• infection of the nose sinuses or throat 
• srbenje nosu, izcedek iz nosu ali zamašen nos,
For trough FEV1 subjects in the fluticasone furoate/vilanterol group achieved a LS mean change from baseline of 281 mL and subjects in the salmeterol/FP group a change of 300 mL; (the difference in adjusted mean of -19 mL (95%CI:-0.073, 0.034) was not statistically significant (p=0.485). 
Kar zadeva najnižji FEV1, so preiskovanci v skupini s flutikazonfuroatom/vilanterolom dosegli povprečno spremembo (po metodi NK) glede na izhodišče 281 ml in v skupini s salmeterolom/FP spremembo 300 ml (razlika v korigiranem povprečju 19 ml (95 % IZ: -0,073, 0,034) ni bila statistično značilna (p = 0,485)).
Pneumonia in patients with COPD 
Pljučnica pri bolnikih s KOPB
Change from baseline in the percentage of rescue-free 24 hour periods during treatment was a powered secondary endpoint. 
Sprememba odstotka 24-urnih obdobij brez rešilnega zdravila med zdravljenjem je bila sekundarni opazovani dogodek, za ugotavljanje katerega je bila določena moč.
• awareness of heart beat (palpitations) 
• neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije),
Following oral administration, vilanterol was eliminated mainly by metabolism followed by excretion of metabolites in urine and faeces approximately 70% and 30% of the radioactive dose respectively in a human radiolabel study conducted by the oral route. 
V študiji radioaktivno označenega, peroralno uporabljenega zdravila pri človeku se je vilanterol odstranil predvsem s presnovo, ki ji je sledilo izločanje presnovkov: približno 70 % radioaktivnega odmerka v urinu in približno 30 % v blatu.
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road, 
Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Harmire Road,
There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females). 
Populacijska farmakokinetična analiza podatkov 856 preiskovancev z astmo (500 žensk) in 1091
You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it. 
Inhalatorja ni potrebno posebej pripraviti za uporabo, niti ko zdravilo Relvar Ellipta uporabite prvič.
• Rinse your mouth with water after you have used the inhaler, do not swallow. 
• Po uporabi inhalatorja si usta splaknite z vodo, vode ne pogoltnite.
This represents a 25% reduction in the rate of severe asthma exacerbations for subjects treated with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms(p=0.014). 
To pomeni 25 % zmanjšanje deleža hudih poslabšanj astme pri preiskovancih, zdravljenih z flutikazonfuroatom/vilanterolom 92/22 mikrogramov, v primerjavi s prejemniki FF 92 mikrogramov (p = 0,014).
Rinsing your mouth out with water immediately after using Relvar Ellipta may help stop this side effect developing. 
Nastanek tega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Relvar Ellipta.
The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT). 
(HZC112206, HZC112207), dve 1-letni (HZC102970, HZC102871) in eno več kot 1 leto trajajočo študijo (SUMMIT).To so bile randomizirane kontrolirane študije pri bolnikih s klinično diagnozo KOPB.
The absolute bioavailability for fluticasone furoate and vilanterol when administered by inhalation as fluticasone furoate/vilanterol was on average 15.2% and 27.3%, respectively. 
Absolutna biološka uporabnost za flutikazonfuorat in vilanterol v obliki inhaliranega flutikazonfuroata/vilanterola je bila v povprečju 15,2 % (za prvega) in 27,3 % (za drugega).
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
Fluticasone furoate/vilanterol 
Tako flutikazonfuroat/vilanterol
Take it back to a pharmacist for advice. 
Bolnik naj ga nese k farmacevtu in se posvetuje z njim.
In-use shelf-life after opening the tray: 6 weeks. 
Rok uporabnosti po prvem odprtju embalaže: 6 tednov.
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street, 
Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations), Priory Street,
Relvar Ellipta contains lactose 
Zdravilo Relvar Ellipta vsebuje laktozo.
Don't use this medicine if you are pregnant unless your doctor tells you that you can. 
Če ste noseči, tega zdravila ne uporabljajte, razen če vam je tako svetoval zdravnik.
The oral bioavailability of both fluticasone furoate and vilanterol was low, on average 1.26% and <2%, respectively. 
Peroralna biološka uporabnost obeh učinkovin je bila majhna (v povprečju flutikazonfuroat 1,26 % in vilanterol
Multipack of 3 x 30 dose Inhalers. 
Pakiranje z več inhalatorji - 3 x 30 odmerkov.
At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo. 
Na 168. dan je flutikazonfuroat/vilanterol 92/22 mikrogramov povečal korigirani povprečni uteženi povprečni FEV1 v obdobju 0-4 ure za 193 ml (95 % IZ:156, 230 ml, p < 0,001) in vilanterol za 145 ml (95 % IZ: 108, 181 ml, p < 0,001) v primerjavi s placebom.
Asthma Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: 
Zdravilo Relvar Ellipta je indicirano za redno zdravljenje astme pri odraslih in mladostnikih, starih 12 let ali več, za katere je primerna uporaba kombiniranega zdravila (dolgodelujočega agonista adrenergičnih receptorjev beta2 in inhalacijskega kortikosteroida): • bolniki, ki bolezni nimajo ustrezno urejene ob uporabi inhalacijskih kortikosteroidov in inhalacijskih kratkodelujočih agonistov adrenergičnih receptorjev beta2 ''po potrebi'';
Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017). 
Flutikazonfuroat/vilanterol 92/22 mikrogramov je povečal najnižji FEV1 v primerjavi z vilanterolom za 46 ml (95 % IZ: 8, 83 ml, p =
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids. 
Bolniki z okvaro jeter imajo lahko večje tveganje za sistemske neželene učinke kortikosteroidov.
Infection of the lung 
Okužba pljuč
Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82). 
44 % bolnikov v skupini s flutikazonfuroatom/vilanterolom 92/22 mikrogramov je imelo na koncu zdravljenja dobro urejeno bolezen (ACQ7 ≤ 0,75); v skupini z 92 mikrogrami FF je bilo takšnih 36 % (p < 0,001, 95 % IZ od 1,23 do 1,82).
How to use Relvar Ellipta 
Kako uporabljati zdravilo Relvar Ellipta
There was no decrease in the extent of in vitro plasma protein binding in subjects with renal or hepatic impairment. 
Vezava na plazemske beljakovine in vitro se pri preiskovancih z okvaro ledvic ali jeter ni zmanjšala.
You can also report side effects directly via the national reporting system listed in Appendix V . 
da poročajo o kateremkoli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
In peripheral blood mononuclear cells from subjects with COPD, a larger anti-inflammatory effect was seen in the presence of the combination of fluticasone furoate/vilanterol compared with fluticasone furoate alone at concentrations achieved with clinical doses. 
KOPB je bil protivnetni učinek ob koncentracijah, doseženih s kliničnimi odmerki, večji v prisotnosti kombinacije flutikazonfuroat/vilanterol kot samega flutikazonfuroata.
Posology 
Študija
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IMETNIK DOVOLJENJA ZA PROMET
HZC112207 evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=204] and fluticasone furoate/vilanterol 184/22 micrograms [n=205] compared with FF 92 micrograms [n=204], FF 184 micrograms [n=203] and vilanterol 22 micrograms [n=203] and placebo [n = 205], all administered once daily. 
Študija HZC112207 je ocenila učinkovitost flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 204] in flutikazonfuroata/vilanterola 184/22 mikrogramov [n = 205] v primerjavi s FF 92 mikrogramov [n = 204], FF 184 mikrogramov [n = 203], vilanterolom 22 mikrogramov [n = 203] in placebom [n = 205]; vsi so bili uporabljeni enkrat na dan.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
HZA106827 was 12 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 92/22 micrograms [n=201] and FF 92 micrograms [n=205]) compared with placebo [n=203], all administered once daily. 
Študija HZA106827 je trajala 12 tednov in je ocenila učinkovitost flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 201] in 92 mikrogramov FF [n = 205] v primerjavi s placebom [n = 203], vseh uporabljenih enkrat na dan.
By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S poročanjem o neželenih učinkih lahko prispevate k boljši obveščenosti glede varnosti tega zdravila.
Three phase III randomised, double-blind studies (HZA106827, HZA106829 and HZA106837) of different durations evaluated the safety and efficacy of fluticasone furoate/vilanterol in adult and adolescent patients with persistent asthma. 
Varnost in učinkovitost flutikazonfuroata/vilanterola pri odraslih in mladostnikih s perzistentno astmo so ocenili v treh randomiziranih, dvojno slepih študijah III. faze (HZA106827, HZA106829 in HZA106837), ki so trajale različno dolgo.
METHOD AND ROUTE(S) OF ADMINISTRATION ONCE DAILY 
POSTOPEK IN POT(I) UPORABE ZDRAVILA ENKRAT NA DAN Pred uporabo preberite priloženo navodilo!
If the inhaler cover is opened and closed without inhaling the medicine, the dose will be lost. 
Pred začetkom uporabe naj bolnik prebere ta navodila Če se pokrovček inhalatorja odpre in zapre, ne da bi bilo zdravilo vdihnjeno, bo odmerek zdravila izgubljen.
HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily. 
Študija HZC112206 je ocenila učinkovitost flutikazonfuroata/vilanterola 46/22 mikrogramov [n = 206] in flutikazonfuroata/vilanterola 92/22 mikrogramov [n = 206] v primerjavi s FF 92 mikrogramov [n = 206], vilanterolom 22 mikrogramov [n = 205] in placebom [n = 207]; vsi so bili uporabljeni enkrat na dan.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 184/22 micrograms 
VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI) 184/22 mikrogramov
These may affect up to 1 in 1,000 people: 
Ti se lahko pojavijo pri največ 1 od 100 bolnikov:
In use shelf-life: 6 weeks Discard by: 
Rok uporabnosti po prvem odprtju: 6 tednov Zavrzite do:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 92/22 micrograms 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PAKIRANJE Z ENIM INHALATORJEM) 92/22 mikrogramov
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 92/22 micrograms 
VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI) 92/22 mikrogramov