FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: U ispitivanju IMPACT, Trelegy Ellipta je tijekom 52 tjedna značajno smanjio (p < 0,001) godišnju stopu umjerenih/teških egzacerbacija za 15% (95% CI: 10; 20) u odnosu na FF/VI (stopa: 0,91 naspram 1,07 događaja po bolesnik-godini) te za 25% (95% CI: 19; 30) u odnosu na UMEK/VI (stopa: 0,91 naspram 1,21 događaj po bolesnik-godini).
English: Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days with up to 1.6-fold accumulation
Croatian: Nakon inhalacije ponovljenih doza flutikazonfuroata/vilanterola, stanje dinamičke ravnoteže postignuto je unutar 6 dana, s kumulacijom do 1,6 puta.
English: • faster heart beat
Croatian: • ubrzani otkucaji srca
English: If you stop using Trelegy Ellipta
Croatian: Ako prestanete primjenjivati Trelegy Ellipta
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Trelegy Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Croatian: Ispitivanje FULFIL (CTT116853) bilo je 24-tjedno ispitivanje (N = 1810) koje je u jednoj podskupini ispitanika (n = 430) bilo produženo do 52 tjedna i u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao se s budezonidom/formoterolom u dozi od 400/12 mikrograma (BUD/FOR) primijenjenim dvaput na dan.
English: If you forget to use Trelegy Ellipta
Croatian: Ako ste zaboravili primijeniti Trelegy Ellipta
English: Elderly patients
Croatian: Posebne populacije Stariji bolesnici
English: The “Discard by” date is 6 weeks from the date of opening the tray.
Croatian: Datum kada lijek treba baciti je 6 tjedana nakon datuma otvaranja podloška.
English: In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Croatian: U 52-tjednom ispitivanju koje je obuhvatilo ukupno 10 355 bolesnika s KOPB-om i umjerenim ili teškim egzacerbacijama unutar proteklih 12 mjeseci (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 46% predviđene vrijednosti; standardno odstupanje: 15%) (ispitivanje CTT116855), incidencija pneumonije iznosila je 8% (317 bolesnika) uz Trelegy Ellipta (n = 4151), 7% (292 ispitanika) uz flutikazonfuroat/vilanterol (n = 4134) te 5% (97 ispitanika) uz umeklidinij/vilanterol (n = 2070).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Astma
English: FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
Croatian: FEV1 (forced expiratory volume in 1 second) = forsirani izdisajni volumen u 1 sekundi; l = litra; LS (least squares) = metoda najmanjih kvadrata; SE (standard error) = standardna pogreška, N = broj bolesnika u populaciji predviđenoj za liječenje; CI (confidence interval) = interval pouzdanosti.
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).
Croatian: Ispitivanje IMPACT (CTT116855) bilo je 52-tjedno ispitivanje (N = 10 355) u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom u dozi od 92/22 mikrograma (FF/VI) i umeklidinijem/vilanterolom u dozi od 55/22 mikrograma (UMEK/VI).
English: Supraventricular tachyarrhythmia Tachycardia
Croatian: Srčani poremećaji supraventrikularna tahiaritmija tahikardija fibrilacija atrija manje često
English: Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Croatian: Najniža vrijednost FEV1 (l) u 52. tjednu, srednja vrijednost promjene (LS) od početne vrijednosti
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).
Croatian: Udio bolesnika s odgovorom tijekom razdoblja od 21. do 24. tjedna bio je značajno veći (p < 0,001) uz Trelegy Ellipta nego uz BUD/FOR (47% odnosno 37%; OR 1,59; 95% CI: 1,30; 1,94).
English: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids.
Croatian: U bolesnika s KOPB-om koji su primali inhalacijske kortikosteroide zabilježeno je povećanje incidencije pneumonije, uključujući pneumoniju koja je zahtijevala hospitalizaciju.
English: ONCE DAILY
Croatian: Za inhaliranje, JEDANPUT NA DAN
English: Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Croatian: Najniža vrijednost FEV1 (l) u 24. tjednu, srednja vrijednost promjene (LS) od početne vrijednosti (SE)a
English: Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Croatian: Sistemske razine (Cmax i AUC u stanju dinamičke ravnoteže) flutikazonfuroata, umeklidinija i vilanterola nakon primjene kombinacije FF/UMEK/VI u jednom inhalatoru (trojna kombinacija) bile su unutar raspona razina opaženih nakon primjene kombinacije FF/VI + UMEK dvama inhalatorima,
English: In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Croatian: Evaluating Respiratory Symptoms in COPD, E-RS:COPD) u odnosu na BUD/FOR (smanjenje početnog rezultata za ≥ 2 jedinice).
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Croatian: Kada se inhalator prvi puta izvadi iz zatvorenog podloška, nalazi se u 'zatvorenom' položaju.
English: Trelegy Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Croatian: Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s glaukomom uskog kuta ili retencijom mokraće.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44
Croatian: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres.
Croatian: Nakon intravenske primjene umeklidinija u zdravih ispitanika, srednja vrijednost volumena distribucije iznosila je 86 litara.
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol.
Croatian: Međutim, provedena su ispitivanja s flutikazonfuroatom/vilanterolom te umeklidinijem/vilanterolom.
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).
Croatian: U ispitivanju FULFIL, udio bolesnika koji su postigli odgovor prema TDI rezultatu (koji se definirao kao najmanje 1 jedinica) bio je značajno veći (p < 0,001) uz Trelegy Ellipta nego uz BUD/FOR (61% naspram 51%; OR 1,61; 95% CI: 1,33; 1,95).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1236/001
English: Do not open the tray until you are ready to inhale a dose of your medicine.
Croatian: Nemojte otvarati podložak dok ne budete spremni inhalirati dozu lijeka.
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).
Croatian: U drugom su se ispitivanju podaci o sigurnosti prikupljali u 527 bolesnika s KOPB-om koji su primali flutikazonfuroat/umeklidinij/vilanterol (92/55/22 mikrograma) i 528 bolesnika s KOPB-om koji su primali flutikazonfuroat/vilanterol (92/22 mikrograma) + umeklidinij (55 mikrograma) jedanput na dan tijekom najviše 24 tjedna (ispitivanje 200812).
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.
Croatian: Kod supkutane primjene nisu primijećeni učinci pri izloženosti 62 puta većoj od kliničke izloženosti u ljudi nakon primjene dnevne doze od 22 mikrograma, što je utvrđeno na temelju AUC-a.
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.
Croatian: Buđenje noću U ispitivanju IMPACT, Trelegy Ellipta statistički je značajno smanjio srednju vrijednost broja buđenja noću zbog KOPB-a u odnosu na FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) i UMEK/VI (-0,10; 95% CI: -0,14; -0,05; p < 0,001) između 49. i 52. tjedna.
English: Vilanterol had no adverse effect on preor post-natal development in rats.
Croatian: Vilanterol nije imao štetnih učinaka na prenatalni ni postnatalni razvoj štakora.
English: The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler.
Croatian: Upute za uporabu inhalatora korak po korak prikazane u nastavku odnose se i na inhalator s 30 doza (terapija za 30 dana) i na inhalator s 14 doza (terapija za 14 dana).
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: NAZIV LIJEKA Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani
English: Warnings and precautions
Croatian: (naveden u dijelu 6.) Upozorenja i mjere opreza
English: Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Croatian: St. George's Respiratory Questionnaire, SGRQ]) i u ispitivanju FULFIL (24. tjedan) u usporedbi s kombinacijom BUD/FOR (-2,2 jedinice; 95% CI: -3,5; -1,0) i u ispitivanju IMPACT (52. tjedan) u usporedbi s kombinacijom FF/VI (-1,8 jedinica; 95% CI: -2,4; -1,1) i UMEK/VI (-1,8 jedinica; 95% CI: -2,6; -1,0).
English: Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA).
Croatian: Flutikazonfuroat/umeklidinij/vilanterol je kombinacija inhalacijskog sintetičkog kortikosteroida, dugodjelujućeg antagonista muskarinskih receptora (engl. long-acting muscarinic receptor antagonist,
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).
Croatian: U trećem su se ispitivanju podaci o sigurnosti prikupljali u 4151 bolesnika s KOPB-om koji je primao flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo dva aktivna usporedna lijeka (ispitivanje CTT116855, IMPACT).
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.
Croatian: 911 ispitanika s KOPB-om izloženih flutikazonfuroatu/umeklidiniju/vilanterolu do 24 tjedna niti u podskupini od 210 ispitanika koji su toj kombinaciji bili izloženi do 52 tjedna.
English: No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure.
Croatian: Nisu opažene klinički važne razlike u sistemskoj izloženosti flutikazonfuroatu, umeklidiniju ili vilanterolu koje bi zahtijevale prilagodbu doze na temelju rase, spola ili tjelesne težine.
English: There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Trelegy Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
English: In IMPACT, Trelegy 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).
Croatian: U ispitivanju IMPACT, Trelegy Ellipta produljio je vrijeme do prve umjerene/teške egzacerbacije te je značajno smanjio (p < 0,001) rizik od umjerene/teške egzacerbacije, mjeren vremenom do prve egzacerbacije, i u odnosu na FF/VI (14,8%; 95% CI: 9,3; 19,9) i u odnosu na UMEK/VI (16,0%;
English: The tray contains a desiccant sachet, to reduce moisture in the packaging.
Croatian: Podložak sadrži vrećicu sa sredstvom za sušenje, koje služi za smanjivanje količine vlage u pakiranju.
English: The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Croatian: Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
English: There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD.
Croatian: Rasa ispitanika nije utjecala na farmakokinetičke parametre umeklidinija ili vilanterola u ispitanika s KOPB-om.
English: The dose counter will appear completely red if the cover is opened again.
Croatian: Ako se poklopac ponovno otvori, brojač doza će postati potpuno crven.
English: Wait to open the cover until you are ready to take your dose.
Croatian: Otvorite poklopac tek onda kada ste spremni uzeti dozu.
English: Multipack of 90 (3 packs of 30) dose inhalers.
Croatian: Višestruko pakiranje: inhalatori s 90 (3 pakiranja s 30) doza.
English: Symptom Relief
Croatian: Ublažavanje simptoma
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).
Croatian: - ako ste alergični na flutikazonfuroat, umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka
English: However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Croatian: Međutim, u majčinu su mlijeku otkriveni drugi kortikosteroidi, muskarinski antagonisti i beta2-adrenergički agonisti.
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).
Croatian: U prvom su se ispitivanju podaci o sigurnosti prikupljali u 911 bolesnika s KOPB-om koji su primali flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 24 tjedna, od kojih je njih 210 primalo flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo aktivan usporedni lijek (ispitivanje CTT116853, FULFIL).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1236/003
English: Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Croatian: Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
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).
Croatian: FEV1 u odnosu na početnu vrijednost iznosila je 90 - 222 ml prvog dana te 160 - 339 ml u 24. tjednu).
English: What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Croatian: Djelatne tvari su flutikazonfuroat, umeklidinijev bromid i vilanterol.
English: Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists.
Croatian: Farmakološki i toksikološki učinci zabilježeni kod primjene flutikazonfuroata, umeklidinija ili vilanterola u nekliničkim ispitivanjima bili su oni koji se tipično povezuju s glukokortikoidima,
English: NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Croatian: Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes.
Croatian: Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, vilanterol je dosegnuo Cmax nakon 7 minuta.
English: The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Croatian: Vrećicu sa sredstvom za sušenje treba baciti; njezin se sadržaj ne smije otvoriti,
English: At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI.
Croatian: Razlika između liječenja u razdoblju od 49. do 52. tjedna iznosila je -0,28 (95% CI: -0,37; -0,19) u odnosu na FF/VI te -0,30 (95% CI: -0,41; -0,19) u odnosu na UMEK/VI.
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.
Croatian: Ispitivanja in vitro pokazala su da se flutikazonfuroat prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
Croatian: CYP2D6 niti pri primjeni flutikazonfuroata/umeklidinija/vilanterola u bolesnika s genetski nedostatnom aktivnošću CYP2D6 (spori metabolizatori).
English: In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
Croatian: Ispitivanja in vitro pokazala su da se vilanterol prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
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.
Croatian: Nakon primjene antagonista muskarinskih receptora i simpatomimetika, uključujući umeklidinij i vilanterol, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes.
Croatian: Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, flutikazonfuroat je dosegnuo Cmax nakon 15 minuta.
English: Comparison Trelegy vs. UMEC/VI
Croatian: Trelegy u odnosu na UMEK/VI
English: Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna isporučena doza sadrži 92 mikrograma flutikazonfuroata, 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida) i 22 mikrograma vilanterola (u obliku trifenatata).
English: The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment.
Croatian: Učinak flutikazonfuroata/umeklidinija/vilanterola nije se ocjenjivao u ispitanika s oštećenjem jetrene funkcije.
English: What Trelegy Ellipta is used for
Croatian: Za što se Trelegy Ellipta koristi
English: How to store Trelegy Ellipta
Croatian: Kako primjenjivati Trelegy Ellipta
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).
Croatian: FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) i UMEK/VI (30%; OR 1,33; 95% CI: 1,13; 1,57).
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter.
Croatian: Ispitivanja in vitro pokazala su da se umeklidinij prvenstveno metabolizira posredstvom izoenzima 2D6 citokroma P450 (CYP2D6) i da je supstrat prijenosnika P-gp-a.
English: Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Croatian: Uputa o lijeku: Informacije za bolesnika Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
English: Use of Rescue Medication
Croatian: NAČIN PRIMJENE LIJEKA
English: What Trelegy Ellipta is
Croatian: Što je Trelegy Ellipta
English: 4) Close the inhaler and rinse your mouth
Croatian: 4) Zatvorite inhalator i isperite usta • Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
English: PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed.
Croatian: Prašak inhalata, dozirani.
English: c) Close the inhaler and rinse your mouth
Croatian: c) Zatvorite inhalator i isperite usta Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
English: Dry mouth
Croatian: Sredstvo za sušenje
English: The “Discard by” date should be written on the inhaler label and carton in the space provided.
Croatian: Datum kada lijek treba baciti treba napisati na za to predviđeno mjesto na naljepnici inhalatora i kutiji.
English: Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes.
Croatian: Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, umeklidinij je dosegnuo Cmax nakon 5 minuta.
English: The tray contains a desiccant sachet, to reduce moisture.
Croatian: Podložak sadrži vrećicu sa sredstvom za sušenje radi smanjivanja vlage.