FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Trelegy Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Slovenian: Študija 200812 je bila 24 tednov trajajoča študija neinferiornosti (N = 1055), v kateri so primerjali zdravilo Trelegy Ellipta (92/55/22 mikrogramov) s sočasno uporabljeno kombinacijo FF/VI (92/22 mikrogramov) + UMEC (55 mikrogramov) enkrat na dan kot zdravljenje z več inhalatorji pri bolnikih z anamnezo zmernih ali hudih poslabšanj v 12 mesecih pred vstopom v študijo.
English: When given subcutaneously there were no effects at exposures 62-fold the human clinical exposure at a daily dose of 22 micrograms, based on AUC.
Slovenian: Subkutano dajanje ni povzročilo učinkov ob izpostavljenostih, ki so bile na podlagi AUC 62-kratnik klinične izpostavljenosti pri človeku med uporabo dnevnega odmerka 22 mikrogramov.
English: How to store Trelegy Ellipta 6.
Slovenian: Shranjevanje zdravila Trelegy Ellipta 6.
English: 2 years Shelf-life after opening the tray: 6 weeks
Slovenian: Rok uporabnosti po prvem odprtju: 6 tednov.
English: Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Slovenian: Povprečni volumen porazdelitve vilanterola po intravenski uporabi je bil pri zdravih prostovoljcih v stanju dinamičnega ravnovesja 165 litrov.
English: Open the cover when ready to take a dose.
Slovenian: Pokrovček odprite šele, ko ste pripravljeni, da vzamete odmerek.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/17/1236/001
English: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women.
Slovenian: Podatkov o uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri nosečnicah je malo.
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: No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
Slovenian: V kliničnih študijah zdravila Trelegy Ellipta med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov hipokaliemije.
English: The tray contains a desiccant sachet, to reduce moisture in the packaging.
Slovenian: Pladenj vsebuje vrečko s sušilom za zmanjšanje vlažnosti v pakiranju.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44
Slovenian: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: In IMPACT, over 52 weeks, Trelegy Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Slovenian: V študiji IMPACT je zdravilo Trelegy Ellipta v 52 tednih značilno zmanjšalo (p < 0,001) letni delež zmernih ali hudih poslabšanj za 15 % (95 % IZ: 10, 20) v primerjavi s FF/VI (delež; 0,91 v primerjavi z 1,07 dogodkov na bolnik-leto) in za 25 % (95 % IZ: 19, 30) v primerjavi z UMEC/VI (delež; 0,91 v primerjavi z 1,21 dogodkov na bolnik-leto).
English: Talk to your doctor before using Trelegy Ellipta - if you have asthma (Don't use Trelegy 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: - če imate astmo (zdravila Trelegy 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 primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Slovenian: Primarne poti presnove umeklidinija so oksidativne (hidroksilacija, O-dealkilacija) in nato konjugacijske (glukuronidacija itn.).
English: This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Slovenian: To ustreza odmerjenemu odmerku 100 mikrogramov flutikazonfuroata, 74,2 mikrograma umeklidinijevega bromida, kar je enakovredno 62,5 mikrograma umeklidinija in 25 mikrogramov vilanterola (kot trifenatata).
English: Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po intravenski uporabi flutikazonfuroata pri zdravih prostovoljcih je bil 661 litrov.
English: After inhalation, patients should rinse their mouth with water without swallowing.
Slovenian: Po uporabi inhalatorja si mora usta splakniti z vodo, vode ne sme pogoltniti.
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Trelegy Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Slovenian: Tudi v študiji IMPACT je bil delež odzivnih bolnikov značilno večji (p < 0,001) pri zdravilu Trelegy Ellipta (36 %) v primerjavi s FF/VI (29 %; RO 1,36; 95 % IZ: 1,19, 1,55) in UMEC/VI (30 %; OR 1,33; 95 % IZ: 1,13, 1,57).
English: Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Slovenian: Zdravilo Trelegy Ellipta je treba uporabljati previdno pri bolnikih z glavkomom z ozkim zakotjem ali retenco urina.
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Slovenian: IME ZDRAVILA Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Trelegy Ellipta - these could be symptoms of a lung infection:
Slovenian: Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Trelegy Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
English: Multipack of 90 (3 packs of 30) dose inhalers.
Slovenian: Skupno pakiranje z 90 (3 pakiranja po 30) odmerki.
English: No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the subset of 210 subjects exposed for up to 52 weeks.
Slovenian: S centralnim odčitanjem EKG 911 preiskovancev s KOPB, ki so bili izpostavljeni kombinaciji flutikazonfuroat/umeklidinij/vilanterol do 24 tednov, in podskupine 210 preiskovancev, ki so bili izpostavljeni do 52 tednov, niso ugotovili klinično pomembnih učinkov na interval QTc.
English: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Slovenian: Delež odzivnih bolnikov je bil med 21. in 24. tednom značilno večji (p < 0,001) pri zdravljenih z zdravilom Trelegy Ellipta v primerjavi z BUD/FOR (47 % v primerjavi s 37 %; RO 1,59; 95 % IZ: 1,30, 1,94).
English: The second study included safety data from 527 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 24 weeks (study 200812).
Slovenian: Druga študija je obsegala podatke o varnosti, zbrane pri 527 bolnikih s KOPB, ki so prejemali kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov in 528 bolnikih s KOPB, ki so prejemali kombinacijo flutikazonfuroat/vilanterol 92/22 mikrogramov in umeklidinij 55 mikrogramov enkrat na dan do 24 tednov (študija 200812).
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Trelegy Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Slovenian: V študiji FULFIL je bil delež bolnikov, ki so bili odzivni po TDI (opredeljeno kot vsaj 1 enota) značilno večji (p < 0,001) pri zdravilu Trelegy Ellipta v primerjavi z BUD/FOR (61 % v primerjavi z 51 %; RO 1,61; 95 % IZ: 1,33, 1,95).
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Slovenian: V študiji z radioaktivno označenim vilanterolom pri človeku so se plazemske presnovne značilnosti po peroralni uporabi skladale z obsežno presnovo prvega prehoda.
English: Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Slovenian: Povprečni volumen porazdelitve umeklidinija po intravenski uporabi je bil pri zdravih prostovoljcih 86 litrov.
English: There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
Slovenian: Pri podganah in miših se pojavnost tumorjev ni povečala med izpostavljenostjo, ki je bila na podlagi AUC 0,9-kratnik (podgane) ali 22-kratnik (miši) klinične izpostavljenosti vilanterolu pri človeku med uporabo dnevnega odmerka 22 mikrogramov.
English: b) How to inhale the medicinal product
Slovenian: b) Kako vdihniti zdravilo
English: Don't use Trelegy Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na flutikazonfuroat, umeklidinij, vilanterol ali katero koli sestavino tega zdravila
English: One fatal case of pneumonia was reported in a patient who received Trelegy Ellipta.
Slovenian: Med bolniki, ki so prejemali zdravilo Trelegy Ellipta, je bil zabeležen en primer pljučnice s smrtnim izidom.
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,
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Slovenian: Študije in vitro so pokazale, da se vilanterol presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
English: In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Slovenian: Študije in vitro so pokazale, da se flutikazonfuroat presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1236/003
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: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Klinično pomembna medsebojna delovanja z zdravili zaradi flutikazonfuroata/umeklidinja/vilanterola v kliničnih odmerkih niso verjetna, ker je koncentracija v plazmi po inhaliranju nizka.
English: How to use Trelegy Ellipta
Slovenian: Kako uporabljati zdravilo Trelegy Ellipta
English: Trelegy Ellipta
Slovenian: Zdravilo Trelegy Ellipta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
Slovenian: NALEPKA NA SKUPNEM PAKIRANJU (Z MODRIM OKENCEM - PAKIRANJE Z VEČ INHALATORJI)
English: Comparison
Slovenian: Odmerjanje
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Slovenian: Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax flutikazonfuroata pojavila po 15 minutah.
English: The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment.
Slovenian: Učinkov kombinacije flutikazonfuroat/umeklidinij/vilanterol niso ocenili pri bolnikih z okvaro ledvic.
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Slovenian: Študije in vitro so pokazale, da se umeklidinij presnavlja predvsem s citokromom P450 2D6 (CYP2D6) in da je substrat prenašalca P-gp.
English: What Trelegy Ellipta is and what it is used for
Slovenian: Kaj je zdravilo Trelegy Ellipta in za kaj ga uporabljamo Kaj je zdravilo Trelegy Ellipta
English: It is packaged in a foil laminate tray with a peelable foil lid.
Slovenian: Inhalator se nahaja v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
English: 1 inhaler of 30 doses
Slovenian: 1 inhalator s 14 odmerki 1 inhalator s 30 odmerki
English: A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor).
Slovenian: Pri zdravih preiskovancih so izvedli študijo s ponavljajočimi se odmerki kombinacije flutikazonfuroata/vilanterola (184/22 mikrogramov)
English: Lung Function
Slovenian: Pljučna funkcija
English: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.
Slovenian: Učinki na srce in ožilje Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, vključno z umeklidinijem in vilanterolom, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kot sta atrijska fibrilacija in tahikardija.
English: Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect.
Slovenian: Nastanek tega neželenega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Trelegy
English: In FULFIL, bronchodilatory effects with Trelegy 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: V študiji FULFIL so bili bronhodilatacijski učinki zdravila Trelegy Ellipta opazni že prvi dan zdravljenja in so se ohranili med 24-tedenskim obdobjem zdravljenja (povprečna sprememba FEV1 od izhodišča je bila 1.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Slovenian: Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax vilanterola pojavila po 7 minutah.
English: What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Slovenian: Zdravilne učinkovine so flutikazonfuroat, umeklidinijev bromid in vilanterol.
English: Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Slovenian: Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 52 tednih a
English: Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Slovenian: Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 24 tednih a
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Slovenian: Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax umeklidinija pojavila po 5 minutah.
English: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Slovenian: Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
English: Do not open the tray until you are ready to inhale a dose of your medicine.
Slovenian: Ne odpirajte embalaže, dokler niste pripravljeni za vdihanje odmerka zdravila.
English: In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Slovenian: Nočna prebujanja V študiji IMPACT je zdravilo Trelegy Ellipta statistično značilno bolj zmanjšalo povprečno število nočnih prebujanj zaradi KOPB kot FF/VI (-0,05; 95 % IZ: -0,08, -0,01; p = 0,005) ali UMEC/VI (-0,10; 95 % IZ:
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Slovenian: Umeklidinij ni bil genotoksičen v standardni skupini študij in ni bil kancerogen v študijah vseživljenjskega vdihavanja pri miših ali podganah ob izpostavljenostih, ki so na podlagi AUC ≥ 20-kratnik (miši) ali
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Slovenian: V študiji IMPACT je bil delež bolnikov, ki so bili po 52. tednih opredeljeni kot odzivni glede na CAT značilno večji (p < 0,001) med prejemniki zdravila Trelegy Ellipta (42 %) kot med prejemniki FF/VI (37 %; RO 1,24; 95 % IZ: 1,14, 1,36) in UMEC/VI (36 %; RO 1,28; 95 % IZ: 1,15,
English: In FULFIL, based upon data up to 24 weeks, Trelegy Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Slovenian: tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
English: • infection of the upper airways
Slovenian: • okužba zgornjih dihal,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Trelegy Ellipta 92 /55 /22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum za inhaliranje
English: • Don't shake the inhaler at any time.
Slovenian: • Inhalatorja nikoli ne smete stresati.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler:
Slovenian: Če se vam takoj po uporabi inhalatorja Trelegy Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: Exacerbations
Slovenian: Poslabšanja
English: Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Slovenian: Če se pojavi paradoksni bronhospazem, je treba zdravljenje z zdravilom Trelegy Ellipta nemudoma prenehati.
English: Tell your doctor as soon as possible if you develop any of these symptoms.
Slovenian: Če se vam pojavi kateri od teh simptomov, o tem čim prej obvestite zdravnika.
English: Inhalation powder, pre-dispensed (inhalation powder).
Slovenian: FARMACEVTSKA OBLIKA Prašek za inhaliranje, odmerjeni (prašek za inhaliranje).
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Slovenian: Trelegy Ellipta 92/55/22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum
English: Write the “Discard by” date on the inhaler label and the carton in the space provided.
Slovenian: V predvideni prostor na nalepki in škatli inhalatorja vpišite datum "Zavrzite do".
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali medicinsko sestro.
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Slovenian: a) Priprava odmerka Pokrovček naj bolnik odpre šele, ko je pripravljen, da uporabi odmerek.
English: A higher percentage of patients receiving Trelegy Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001).
Slovenian: V študiji IMPACT se je v 52. tednu celotna ocena po SGRQ klinično pomembno izboljšala pri višjem odstotku bolnikov, ki so prejemali zdravilo Trelegy Ellipta, v primerjavi s tistimi, ki so prejemali kombinaciji FF/VI in UMEC/VI (42 %, 34 % in 34 %), RO v primerjavi s kombinacijo FF/VI (1,41; 95 % IZ: 1,29, 1,55) in RO v primerjavi s kombinacijo UMEC/VI (1,41; 95 % IZ: 1,26, 1,57).
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Slovenian: Trelegy Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
English: Umeclidinium
Slovenian: Umeklidinij
English: The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL).
Slovenian: Prva študija je obsegala podatke o varnosti, zbrane pri 911 bolnikih s KOPB, ki so do 24 tednov prejemali kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan; 210 od teh bolnikov je kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan prejemalo do 52 tednov.
English: There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
Slovenian: Pri preiskovancih s KOPB rasa ni vplivala na farmakokinetične parametre umeklidinija ali vilanterola.
English: The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT).
Slovenian: Tretja študija je obsegala podatke o varnosti, zbrane pri 4151 bolnikih s KOPB, ki so prejemali flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan do 52 tednov.