FrancophonIA/ELRC3.0 huggingface dataset:
English: Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849
Slovenian: Sími: + 46 (0) 8 5057 1849
English: ↔ Cmin 1.18 (1.06, 1.31) Cobicistat ↔ Cmax 0.96 (0.92, 1.00)
Slovenian: ↔ Cmax 1,00 (0,86; 1,16) ↔ AUC 0,96 (0,89; 1,03)
English: Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Slovenian: Tel: + 46 (0) 8 5057 1849
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and/or OATP1B3.
Slovenian: OATP1B3 lahko vpliva na porazdelitev tenofoviralafenamida v telesu.
English: Do not take Vemlidy with other medicines containing:
Slovenian: Zdravila, ki se uporabljajo za zdravljenje okužb s hepatitisom B Zdravila Vemlidy ne smete jemati z drugimi zdravili, ki vsebujejo:
English: ↔ Cmin 1.01 (0.95, 1.09) Voxilaprevir ↔ Cmax 0.96 (0.84, 1.11)
Slovenian: ↔ Cmax 1,05 (0,96; 1,16) ↔ AUC 1,01 (0,94; 1,07) ↔ Cmin 1,01 (0,95; 1,09)
English: Contents of the pack and other information What Vemlidy contains
Slovenian: Kaj vsebuje zdravilo Vemlidy
English: ↔ Cmin 1.02 (0.98, 1.07) Sofosbuvir ↔ Cmax 0.96 (0.89, 1.04)
Slovenian: ↔ Cmax 0,98 (0,89; 1,07) ↔ AUC 0,99 (0,96; 1,01) ↔ Cmin 1,00 (0,96; 1,04)
English: ↔ Cmin 0.97 (0.82, 1.15) Cobicistat ↔ Cmax 1.06 (1.00, 1.12)
Slovenian: ↔ Cmax 0,95 (0,86; 1,05) ↔ AUC 1,01 (0,97; 1,06)
English: Tenofovir ↑ Cmax 2.42 (1.98, 2.95)
Slovenian: ↑ Cmax 1,77 (1,28; 2,44) ↑ AUC 1,91 (1,55; 2,35)
English: • painful and frequent urination (may be signs of a urinary tract infection)
Slovenian: • boleče in pogosto uriniranje (to je lahko znak okužbe sečil),
English: The first time you use Elebrato Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Slovenian: Ko prvič uporabite zdravilo Elebrato Ellipta, vam ni treba preverjati, ali inhalator deluje pravilno; inhalator vsebuje predhodno odmerjene odmerke in je pripravljen za takojšnjo uporabo.
English: Don't use Elebrato Ellipta if you already use these medicines.
Slovenian: Ne uporabljajte zdravila Elebrato Ellipta, če že uporabljate ta zdravila.
English: Administration of Elebrato Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Slovenian: Uporaba zdravila Elebrato Ellipta pri nosečnicah pride v poštev le, če pričakovana korist za mater upravičuje morebitno tveganje za plod.
English: Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Slovenian: Zdravilo Elebrato Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB.
English: Because you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Slovenian: Ker uporabljate to zdravilo za KOPB, imate morda večje tveganje za okužbo pljuč, imenovano pljučnica.
English: Elebrato Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Slovenian: Zdravila Elebrato Ellipta se ne sme uporabljati pri bolnikih z astmo, ker v tej populaciji bolnikov ni raziskano.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Elebrato Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Elebrato Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation.
Slovenian: Bolniki ne smejo končati zdravljenja z zdravilom Elebrato Ellipta brez zdravniškega nadzora, ker se lahko simptomi po prenehanju zdravljenja ponovijo.
English: Tabulated summary of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies.
Slovenian: Povzetek neželenih učinkov v preglednici Ugotovljene varnostne značilnosti zdravila Elebrato Ellipta temeljijo na treh kliničnih študijah III. faze.
English: There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Slovenian: Ni kliničnih podatkov, ki bi potrjevali uporabo zdravila Elebrato Ellipta za zdravljenje akutnega bronhospazma ali akutnega poslabšanja KOPB (tj. za rešilno zdravljenje).
English: Population PK analyses for FF/UMEC/VI were conducted using a combined PK dataset from three phase III studies in 821 COPD subjects.
Slovenian: Populacijske farmakokinetične analize FF/UMEC/VI so izvedli s kombiniranim naborom farmakokinetičnih podatkov iz treh študij III. faze pri 821 preiskovancih s KOPB.
English: The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Slovenian: Najpogosteje zabeleženi neželeni učinki med uporabo zdravila Elebrato Ellipta so bili nazofaringitis (7 %), glavobol (5 %) in okužba zgornjih dihal (2 %).
English: Significant reductions were observed over all other timepoints for UMEC/VI (p<0.001) and for the all but two of the of timepoints for FF/VI (p≤0.021).
Slovenian: Značilno zmanjšanje je bilo opaženo na vseh drugih časovnih točkah za UMEC/VI (p < 0,001) in na vseh časovnih točkah razen dveh za FF/VI (p ≤ 0,021).
English: The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose') and magnesium stearate.
Slovenian: Pomožni snovi sta laktoza monohidrat (glejte poglavje 2 pod naslovom "Zdravilo Elebrato Ellipta vsebuje laktozo") in magnezijev stearat.
English: Elebrato Ellipta is for inhalation use only.
Slovenian: Zdravilo Elebrato Ellipta je namenjeno samo za inhalacijsko uporabo.
English: The recommended and maximum dose is one inhalation of Elebrato Ellipta 92/55/22 micrograms once daily, at the same time each day.
Slovenian: Priporočeni in največji odmerek je ena inhalacija zdravila Elebrato Ellipta 92/55/22 mikrogramov enkrat na dan, vsak dan ob istem času.
English: Caution should be exercised when Elebrato Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Slovenian: Previdnost je potrebna, če se zdravilo Elebrato Ellipta uporablja z drugimi zdravili, ki lahko prav tako povzročijo hipokaliemijo (glejte poglavje 4.5).
English: The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Slovenian: Sestavini flutikazonfuroat/vilanterol zdravila Elebrato Ellipta so ocenili pri bolnikih z vsemi stopnjami okvare jeter (Child-Pugh A, B in C).
English: Upon initiation of treatment with Elebrato Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Po uvedbi zdravljenja z zdravilom Elebrato Ellipta je treba sladkornim bolnikom natančneje kontrolirati glukozo v plazmi.
English: Genotoxicity and carcinogenicity
Slovenian: Genotoksičnost in kancerogenost Flutikazonfuroat
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta.
Slovenian: Če jemljete katero od teh zdravil, vas bo zdravnik morda natančno nadzoroval, kajti ta zdravila lahko povečajo neželene učinke zdravila Elebrato Ellipta.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Elebrato Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Slovenian: Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma z ozkim zakotjem; naročiti jim je treba, da morajo v primeru takšnih znakov ali simptomov nemudoma prenehati uporabljati zdravilo Elebrato Ellipta in se posvetovati z zdravnikom.
English: Once the tray is opened Elebrato Ellipta is ready to use.
Slovenian: Ko je embalaža odprta, je zdravilo Elebrato Ellipta pripravljeno za uporabo.
English: This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs.
Slovenian: Zdravilo Elebrato Ellipta sprosti te mišice v pljučih, zmanjša oteklost in draženje v malih dihalnih poteh ter olajša vstopanje zraka v pljuča in njegovo izstopanje iz pljuč.
English: It is very important that you use Elebrato Ellipta every day, as instructed by your doctor.
Slovenian: Zdravilo Elebrato Ellipta uporabljajte redno Zelo pomembno je, da zdravilo Elebrato Ellipta uporabljate vsak dan, kot vam je naročil zdravnik.
English: What Elebrato Ellipta is and what it is used for 2.
Slovenian: Kaj je zdravilo Elebrato Ellipta in za kaj ga uporabljamo 2.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta and budesonide/formoterol arms was equal at 2%.
Slovenian: V podskupini 430 bolnikov, zdravljenih do 52 tednov, je bila pojavnost pljučnic tako v skupini z zdravilom Elebrato Ellipta kot v skupini s kombinacijo budezonid/formoterol enaka in je znašala 2 %.
English: Patients with moderate to severe hepatic impairment receiving Elebrato Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Slovenian: Bolnike z zmerno do hudo okvaro jeter, ki prejemajo zdravilo Elebrato Ellipta, je treba nadzorovati glede sistemskih neželenih učinkov, povezanih s kortikosteroidi (glejte poglavje 5.2).
English: If you use more Elebrato Ellipta than you should
Slovenian: Če ste uporabili večji odmerek zdravila Elebrato Ellipta, kot bi smeli
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation).
Slovenian: V inhalacijskih študijah pri kuncih je vilanterol povzročil podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke, sternebralna fuzija in fleksura/malrotacija udov).
English: Vilanterol was not teratogenic in rats.
Slovenian: Vilanterol Vilanterol pri podganah ni bil teratogen.
English: The efficacy of Elebrato Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Slovenian: Učinkovitost zdravila Elebrato Ellipta (92/55/22 mikrogramov) enkrat na dan so ovrednotili na bolnikih s klinično diagnozo KOPB v dveh z zdravilno učinkovino kontroliranih študijah in v eni študiji neinferiornosti.
English: The incidence of pneumonia with Elebrato Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Slovenian: Pojavnost pljučnice z zdravilom Elebrato Ellipta je primerljiva tisti, ki so jo opažali v skupini s kombinacijo flutikazonfuroat/vilanterol (FF/VI) 100/25 kliničnih študij FF/VI pri KOPB.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Elebrato Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Slovenian: Pljučnica, ki je zahtevala sprejem v bolnišnico, se je v obdobju do 24 tednov pojavila pri 1 % prejemnikov zdravila Elebrato Ellipta in pri < 1 % prejemnikov kombinacije budezonid/formoterol.
English: There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Slovenian: V pediatrični populaciji (mlajši od 18 let) zdravilo Elebrato Ellipta nima relevantne uporabe za indikacijo KOPB.
English: Treatment difference (95% CI) Comparison with BUD/FOR
Slovenian: Razlika med zdravljenji (95% IZ) Primerjava zdravila Elebrato s FF/VI
English: In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Slovenian: Če se KOPB med zdravljenjem z zdravilom Elebrato Ellipta poslabša, je treba znova oceniti tako bolnika kot shemo zdravljenja KOPB.
English: Elebrato Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Slovenian: Zdravilo Elebrato Ellipta je treba uporabljati previdno pri bolnikih s konvulzivnimi motnjami ali tirotoksikozo in pri bolnikih, ki so nenavadno odzivni na agoniste adrenergičnih receptorjev beta2.
English: In FULFIL, Elebrato Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Slovenian: V študiji FULFILje zdravilo Elebrato Ellipta izboljšalo dnevne simptome KOPB, ocenjene z E-RS: celotna ocena KOPB, v primerjavi z BUD/FOR (zmanjšanje izhodiščne vrednosti za ≥ 2 enoti).
English: What you need to know before you use Elebrato Ellipta 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Elebrato Ellipta 3.
English: Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Elebrato Ellipta je indicirano za vzdrževalno zdravljenje odraslih bolnikov z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), ki niso zadostno zdravljeni s kombinacijo inhalacijskega kortikosteroida in dolgodelujočega agonista adrenergičnih receptorjev β2 ali s kombinacijo dolgodelujočega agonista adrenergičnih receptorjev β2 in dolgodelujočega antagonista muskarinskih receptorjev (za učinke na obvladanje simptomov in preprečevanje poslabšanj glejte poglavje 5.1).
English: INFORMATION IN BRAILLE elebrato ellipta
Slovenian: PODATKI V BRAILLOVI PISAVI elebrato ellipta
English: Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Slovenian: Zdravila Elebrato Ellipta se ne sme uporabljati za ublažitev nenadnega napada težkega ali piskajočega dihanja.
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Elebrato Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Slovenian: Pljučnica s smrtnim izidom se je pojavila pri 12 od 4151 bolnikov (3,5 na 1000 bolnik-let), ki so prejemali zdravilo Elebrato Ellipta, pri 5 od 4134 bolnikov (1,7 na 1000 bolnik-let), ki so prejemali kombinacijo flutikazonfuroat/vilanterol in pri 5 od 2070 bolnikov (2,9 na 1000 bolnik-let), ki so prejemali kombinacijo umeklidinij/vilanterol.
English: In FULFIL, bronchodilatory effects with Elebrato Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Slovenian: Pljučna funkcija V študiji FULFIL so bili bronhodilatacijski učinki zdravila Elebrato Ellipta opazni že prvi dan zdravljenja in so se ohranili med 24-tedenskim obdobjem zdravljenja (povprečna sprememba FEV1 od izhodišča je bila 1. dan od 90 do 222 ml in 24. teden od 160 do 339 ml).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use,
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za inhaliranje
English: Therefore, Elebrato Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Slovenian: Zato je treba zdravilo Elebrato Ellipta previdno uporabljati pri bolnikih, ki imajo kakšno nestabilno ali življenjsko ogrožujočo kardiovaskularno bolezen.
English: Treatment with Elebrato Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Slovenian: Zdravljenje z zdravilom Elebrato Ellipta je značilno zmanjšalo letni delež hudih poslabšanj za 34 % v primerjavi z UMEC/VI (95 % IZ: 22, 44; p < 0,001).
English: Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Slovenian: Klinično pomembna medsebojna delovanja z zdravili zaradi flutikazonfuroata/umeklidinja/vilanterola v kliničnih odmerkih niso verjetna, ker je koncentracija v plazmi po inhaliranju nizka.
English: Elebrato Ellipta (N = 4,151
Slovenian: Zdravilo Elebrato Ellipta (N = 4,15
English: In Study 200812, Elebrato Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Slovenian: V študiji 200812 je bilo zdravilo Elebrato Ellipta neinferiorno v primerjavi s sočasno uporabljeno kombinacijo dveh inhalatorjev FF/VI+UMEC, kar zadeva izboljšanje najnižjega FEV1 od izhodišča do 24.
English: Other medicines and Elebrato Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Your Elebrato Ellipta inhaler carton contains
Slovenian: Škatla vašega inhalatorja Elebrato Ellipta vsebuje
English: Eye problems during treatment with Elebrato Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Elebrato Ellipta:
Slovenian: Težave z očmi med zdravljenjem z zdravilom Elebrato Ellipta Če se vam med zdravljenjem z zdravilom Elebrato Ellipta pojavijo bolečine ali nelagodje v očesu, prehodno zamegljen vid, odsevi okrog stvari ali obarvane slike ter pordele oči:
English: In IMPACT, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
Slovenian: V študiji IMPACT je zdravilo Elebrato Ellipta značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila (dogodki na dan) v vsakem 4-tedenskem obdobju kot FF/VI in UMEC/VI.
English: What you need to know before you use Elebrato Ellipta
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Elebrato Ellipta
English: Elebrato Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Slovenian: Zdravilo Elebrato Ellipta je treba uporabljati previdno pri bolnikih s pljučno tuberkulozo in pri bolnikih s kroničnimi ali nezdravljenimi okužbami.
English: In IMPACT, Elebrato Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Slovenian: V študiji IMPACT je zdravilo Elebrato Ellipta značilno izboljšalo (p < 0,001) pljučno funkcijo v primerjavi s kombinacijo FF/VI in UMEC/VI v obdobju 52 tednov (glejte Preglednico 2).
English: In IMPACT, Elebrato Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1).
Slovenian: V študiji IMPACT je zdravilo Elebrato Ellipta podaljšalo čas do prvega zmernega ali hudega poslabšanja in značilno zmanjšalo (p < 0,001) tveganje za zmerno ali hudo poslabšanje, merjeno s časom do prvega poslabšanja, tako v primerjavi s FF/VI (14,8 %; 95 % IZ: 9,3, 19,9) kot z UMEC/VI (16,0 %; 95% IZ: 9,4, 22,1).
English: Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: Za kaj uporabljamo zdravilo Elebrato Ellipta Zdravilo Elebrato Ellipta uporabljamo za zdravljenje kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Slovenian: Zdravilo Elebrato Ellipta vsebuje tri zdravilne učinkovine: flutikazonfuroat, umeklidinij in vilanterol.
English: Talk to your doctor before using Elebrato Ellipta - if you have asthma (Don't use Elebrato Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Slovenian: Pred začetkom uporabe zdravila Elebrato Ellipta se posvetujte z zdravnikom: - če imate astmo (zdravila Elebrato Ellipta ne uporabljajte za zdravljenje astme), - če imate težave s srcem ali visok krvni tlak, - če imate težave z jetri, - če imate pljučno tuberkulozo (TB) ali kakšne dolgotrajne ali nezdravljene okužbe,
English: The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Slovenian: Srčna elektrofiziologija Učinka kombinacije flutikazonfuroat/umeklidinij/vilanterol na interval QT niso ocenili v podrobni študiji QT
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Elebrato Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Slovenian: Študija IMPACT (CTT116855) je bila 52 tednov trajajoča študija (N = 10355), v kateri so primerjali zdravilo Elebrato Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation.
Slovenian: Po večkratnem odmerjanju inhalirane kombinacije flutikazonfuroat/vilanterol je bilo stanje dinamičnega ravnovesja doseženo v 6 dneh; kopičenje je bilo do 1,6-kratno.
English: In FULFIL, based upon data up to 24 weeks, Elebrato Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Slovenian: V študiji FULFIL je zdravilo Elebrato Ellipta na podlagi podatkov do 24 tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
English: Co-administration of Elebrato Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Slovenian: Druge dolgodelujoče antimuskarinske učinkovine in dolgodelujoči agonisti adrenergičnih receptorjev beta2 Sočasna uporaba zdravila Elebrato Ellipta z drugimi dolgodelujočimi muskarinskimi antagonisti ali dolgodelujočimi agonisti adrenergičnih receptorjev beta2 ni raziskana in ni priporočljiva, ker lahko poveča neželene učinke (glejte poglavji 4.8 in 4.9).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
Slovenian: ZUNANJA OVOJNINA (SAMO POSAMIČNA PAKIRANJA)
English: In FULFIL, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Slovenian: V študiji FULFIL je zdravilo Elebrato Ellipta med 1. in 24. tednom značilno bolj zmanjšalo (p < 0,001) uporabo rešilnega zdravila kot BUD/FOR (razlika med zdravljenjema: -0,2 dogodka na dan; 95 % IZ: -0,3,