FrancophonIA/ELRC3.0 huggingface dataset:
English: The apparent plasma elimination half-life of fluticasone furoate following inhaled administration of fluticasone furoate/vilanterol was, on average, 24 hours.
Croatian: Prividno poluvrijeme eliminacije flutikazonfuroata iz plazme nakon inhalacijske primjene flutikazonfuroata/vilanterola u prosjeku je iznosilo 24 sata.
English: Plasma clearance following intravenous administration was 65.4 litres/hour.
Croatian: Klirens iz plazme nakon intravenske primjene iznosio je 65,4 litre/sat.
English: Umeclidinium has not been evaluated in patients with severe hepatic impairment.
Croatian: Umeklidinij se nije ispitivao u bolesnika s teškim oštećenjem jetrene funkcije.
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).
Croatian: U ispitivanjima inhalacijske primjene na kunićima vilanterol je izazvao učinke slične učincima zabilježenima kod ostalih beta2-adrenergičkih agonista (rascjep nepca, otvorene vjeđe, spojeni segmenti prsne kosti te fleksura/malrotacija ekstremiteta).
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).
Croatian: Značajna smanjenja u odnosu na kombinaciju UMEK/VI opažena su i u svim ostalim vremenskim točkama (p < 0,001), dok su u odnosu na kombinaciju FF/VI opažena u svim vremenskim točkama osim dvije (p ≤ 0,021).
English: No effect of verapamil was observed on umeclidinium or vilanterol Cmax.
Croatian: Nije primijećen učinak verapamila na Cmax umeklidinija ni vilanterola.
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Croatian: Izlučivanje srodnih tvari lijeka u feces nakon intravenske primjene ukazivalo je na izlučivanje u žuč.
English: The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler.
Croatian: Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode, ali nemojte izdisati u inhalator.
English: The incidence of pneumonia with Trelegy Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Croatian: Incidencija pneumonije kod primjene lijeka Trelegy Ellipta usporediva je s onom primijećenom u skupini liječenoj flutikazonfuroatom/vilanterolom (FF/VI) u dozi od 100/25 mikrograma u kliničkim ispitivanjima primjene kombinacije FF/VI kod KOPB-a.
English: Administration of combined fluticasone furoate, umeclidinium and vilanterol to dogs did not result in any significant new toxicity or any major exacerbation of expected findings associated with fluticasone furoate, umeclidinium or vilanterol alone.
Croatian: Primjena kombinacije flutikazonfuroata, umeklidinija i vilanterola u pasa nije dovela do značajne nove toksičnosti ni većih pogoršanja očekivanih nalaza povezanih s primjenom samo flutikazonfuroata,
English: Trelegy Ellipta contains lactose
Croatian: Trelegy Ellipta sadrži laktozu
English: Fluticasone furoate is a corticosteroid with potent anti-inflammatory activity.
Croatian: Flutikazonfuroat Flutikazonfuroat je kortikosteroid s jakim protuupalnim djelovanjem.
English: The effects of haemodialysis have not been studied.
Croatian: Nisu se ispitivali učinci hemodijalize.
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 45% and 65% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Croatian: Pri probiru je srednja vrijednost FEV1 nakon primjene bronhodilatatora iznosila 45% predviđene vrijednosti, a 65% bolesnika prijavilo je jednu ili više umjerenih/teških egzacerbacija unutar proteklih godinu dana.
English: In Study 200812, Trelegy 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.
Croatian: U ispitivanju 200812, Trelegy Ellipta bio je neinferioran flutikazonfuroatu/vilanterolu (FF/VI) + umeklidiniju (UMEK), primijenjenima istodobno dvama inhalatorima, s obzirom na poboljšanje najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna.
English: Fluticasone furoate has a low association with red blood cells.
Croatian: Flutikazonfuroat se u maloj mjeri vezuje za crvene krvne stanice.
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Trelegy 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.
Croatian: Pneumonija sa smrtnim ishodom zabilježena je u 12 od 4151 bolesnika (3,5 na 1000 bolesnik-godina) koji je primjenjivao Trelegy Ellipta, 5 od 4134 bolesnika (1,7 na 1000 bolesnik-godina) koja su primjenjivala flutikazonfuroat/vilanterol te 5 od 2070 bolesnika (2,9 na 1000 bolesnik-godina) koji su primjenjivali umeklidinij/vilanterol.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 14 doza
English: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni flutikazonfuroata/umeklidinija/vilanterola u trudnica.
English: Patients with moderate to severe hepatic impairment receiving Trelegy Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Croatian: Bolesnike s umjerenim do teškim oštećenjem jetrene funkcije koji se liječe lijekom Trelegy Ellipta treba nadzirati zbog mogućih sistemskih nuspojava kortikosteroida (vidjeti dio 5.2).
English: At screening, the mean post-bronchodilator percent predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe exacerbation in the past year.
Croatian: Pri probiru je srednja vrijednost FEV1 nakon primjene bronhodilatatora iznosila 46% predviđene vrijednosti, a 99% bolesnika prijavilo je jednu ili više umjerenih/teških egzacerbacija unutar proteklih godinu dana.
English: Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Croatian: Reproduktivna toksičnost Flutikazonfuroat, umeklidinij i vilanterol nisu imali štetnih učinaka na plodnost mužjaka i ženki štakora.
English: In vitro plasma protein binding in human plasma was on average 89%.
Croatian: Stupanj vezivanja za proteine u ljudskoj plazmi in vitro u prosjeku je iznosio 89%.
English: Pack sizes of 14 or 30 dose inhalers.
Croatian: Veličine pakiranja: inhalatori s 14 ili 30 doza.
English: Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058).
Croatian: Transitional Dyspnoea Index, TDI) u 24. tjednu ispitivanja FULFIL i 52. tjednu ispitivanja IMPACT (podskupina bolesnika, n = 5058).
English: The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.
Croatian: Upute u nastavku koje opisuju uporabu inhalatora Ellipta s 30 doza (terapija za 30 dana) odnose se i na inhalator Ellipta s 14 doza (terapija za 14 dana).
English: There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.
Croatian: Nema podataka o učincima flutikazonfuroata/umeklidinija/vilanterola na plodnost u ljudi.
English: Inhalation powder, pre-dispensed (inhalation powder).
Croatian: OBLIK Prašak inhalata, dozirani (prašak inhalata).
English: • Rinse your mouth with water after you have used the inhaler, do not swallow.
Croatian: • Isperite usta vodom nakon korištenja inhalatora, ali nemojte progutati vodu.
English: Therefore, Trelegy Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Croatian: Stoga Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s nestabilnom ili po život opasnom kardiovaskularnom bolešću.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Croatian: Klirens vilanterola iz plazme nakon intravenske primjene iznosio je 108 litara/sat.
English: Write the date that the inhaler should be discarded on the label and carton in the space provided.
Croatian: Napišite datum kada inhalator treba baciti na za to predviđeno mjesto na naljepnici i kutiji.
English: The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Croatian: Učinci dobi na farmakokinetiku flutikazonfuroata, umeklidinija i vilanterola ocjenjivali su se u populacijskoj farmakokinetičkoj analizi.
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation.
Croatian: Nakon inhalacije ponovljenih doza umeklidinija, stanje dinamičke ravnoteže postignuto je unutar 7 - 10 dana, s kumulacijom 1,5 - 2 puta.
English: Trelegy Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Croatian: Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika s neuobičajeno dobrim odgovorom na beta2-adrenergičke agoniste.
English: • Don't shake the inhaler at any time.
Croatian: • Ni u jednom trenu nemojte tresti inhalator.
English: Fluticasone furoate had no adverse effect on pre- or post-natal development in rats.
Croatian: Flutikazonfuroat nije imao štetnih učinaka na prenatalni ni postnatalni razvoj štakora.
English: In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Trelegy Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Croatian: Među ukupno 1810 bolesnika s uznapredovalim KOPB-om (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 45% predviđene vrijednosti; standardno odstupanje: 13%), od kojih je njih 65% doživjelo umjerenu/tešku egzacerbaciju KOPB-a unutar godinu dana prije uključivanja u ispitivanje (ispitivanje CTT116853), prijavljena je viša incidencija događaja pneumonije tijekom najviše 24 tjedna u bolesnika koji su primali Trelegy Ellipta (20 bolesnika, 2%) nego u onih koji su primali budezonid/formoterol (7 bolesnika, < 1%).
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Croatian: U ispitivanju provedenom u ljudi uz primjenu radioaktivno označenog lijeka, metabolički profili u plazmi nakon peroralne primjene vilanterola bili su u skladu s opsežnim metabolizmom prvog prolaza.
English: There were no effects on development in rats at exposures 6.6fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC.
Croatian: Nisu primijećeni učinci na razvoj štakora pri razinama izloženosti 6,6 puta većima od kliničke izloženosti u ljudi nakon primjene dnevne doze od 92 mikrograma, što je utvrđeno na temelju AUC-a.
English: Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in rats or mice at exposures of 1.4- or 2.9-fold, respectively, those seen in humans at a daily dose of 92 micrograms fluticasone furoate, based on AUC.
Croatian: Flutikazonfuroat se nije pokazao genotoksičnim u standardnom skupu ispitivanja niti kancerogenim u ispitivanjima cjeloživotne inhalacije na štakorima ili miševima pri razinama izloženosti 1,4 odnosno 2,9 puta većima od onih koje se postižu u ljudi nakon primjene dnevne doze flutikazonfuroata od
English: The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a thorough QT (TQT) study.
Croatian: Učinak flutikazonfuroata/umeklidinija/vilanterola na QT interval nije se ocjenjivao u temeljitom ispitivanju učinaka na QT interval.
English: Treatment with Trelegy Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Croatian: Liječenje lijekom Trelegy Ellipta značajno je smanjilo godišnju stopu teških egzacerbacija za 34% u odnosu na UMEK/VI (95% CI: 22; 44; p < 0,001).
English: No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose.
Croatian: kliničkim ispitivanjima nisu primijećeni klinički značajni učinci na razinu glukoze u plazmi kod primjene flutikazonfuroata/umeklidinija/vilanterola u preporučenoj terapijskoj dozi.
English: Multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available.
Croatian: Dostupna su i višestruka pakiranja s 90 (3 inhalatora s 30) doza (terapija za 90 dana).
English: This breath should be held in for as long as possible (at least 3-4 seconds).
Croatian: (najmanje 3 - 4 sekunde).
English: All three studies were multicentre, randomised, double-blind studies that required patients to be symptomatic with a COPD Assessment Test (CAT) score ≥10 and on daily maintenance treatment for their COPD for at least three months prior to study entry.
Croatian: COPD Assessment Test, CAT) ≥ 10 te su morali svakodnevno primjenjivati terapiju održavanja za KOPB tijekom najmanje tri mjeseca prije uključivanja u ispitivanje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY)
Croatian: MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE)
English: Rinse your mouth with water after you have used the inhaler, do not swallow.
Croatian: Isperite usta vodom nakon korištenja inhalatora, ali nemojte progutati vodu.
English: Lung Function
Croatian: Plućna funkcija
English: The most frequently reported adverse reactions with Trelegy Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Croatian: Najčešće prijavljene nuspojave kod primjene lijeka Trelegy Ellipta bile su nazofaringitis (7%),
English: An approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax.
Croatian: Pri primjeni 16 puta veće doze primijećeno je povećanje AUC-a umeklidinija za približno 1,3 puta, dok na Cmax umeklidinija nije bilo učinka.
English: Trelegy Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Trelegy Ellipta ne smije se primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: In FULFIL, Trelegy Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Croatian: U ispitivanju FULFIL, Trelegy Ellipta značajno je smanjio rizik od umjerene/teške egzacerbacije u odnosu na BUD/FOR tijekom 24 tjedna (33%; 95% CI: 12; 48; p = 0,004).
English: In IMPACT, Trelegy Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Croatian: U ispitivanju IMPACT, Trelegy Ellipta značajno je poboljšao (p < 0,001) plućnu funkciju u usporedbi s kombinacijama FF/VI i UMEK/VI tijekom 52-tjednog razdoblja (vidjeti Tablicu 2).
English: The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Croatian: Nastavak za usta možete očistiti suhom maramicom prije zatvaranja poklopca.
English: • infection of the nose, sinuses or throat
Croatian: • infekcija nosa, sinusa ili grla • infekcija gornjih dišnih putova
English: At study entry, the most common COPD medications reported in the FULFIL and IMPACT studies were ICS +LABA+LAMA (28%, 34% respectively), ICS+LABA (29%, 26% respectively), LAMA+LABA (10%, 8% respectively) and LAMA (9%, 7% respectively).
Croatian: IKS+LABA+LAMA (28% odnosno 34%), IKS+LABA (29% odnosno 26%), LAMA+LABA (10% odnosno 8% ) i LAMA (9% odnosno 7%).
English: What Trelegy Ellipta is and what it is used for
Croatian: Što je Trelegy Ellipta i za što se koristi
English: Trelegy Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Croatian: Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s tuberkulozom pluća te u bolesnika s kroničnim ili neliječenim infekcijama.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Croatian: S obzirom na opseg tih promjena, ne očekuje se klinički značajna interakcija pri istodobnoj primjeni flutikazonfuroata/umeklidinija/vilanterola s inhibitorima P-gp-a.
English: The Ellipta inhaler consists of a light grey body, beige mouthpiece cover and a dose counter, packed into a foil laminate tray containing a desiccant sachet.
Croatian: Inhalator Ellipta sastoji se od svijetlosivog tijela, bež poklopca nastavka za usne i brojača doza, a zapakiran je u podložak od višeslojne folije koji sadrži vrećicu sa sredstvom za sušenje.
English: Dose counter
Croatian: Brojač doza
English: Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients.
Croatian: Hiperglikemija Agonisti beta2-adrenergičkih receptora mogu izazvati prolaznu hiperglikemiju u nekih bolesnika.
English: TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI.
Croatian: Temeljita ispitivanja učinaka na QT interval provedena s flutikazonfuroatom/vilanterolom (FF/VI) i umeklidinijem/vilanterolom (UMEK/VI) nisu pokazala klinički značajne učinke na QT interval pri kliničkim dozama flutikazonfuroata, umeklidinija i vilanterola.
English: Don't use this medicine if you are breastfeeding unless your doctor tells you that you can.
Croatian: Ne smijete primjenjivati ovaj lijek ako dojite, osim ako Vam to ne kaže liječnik.
English: Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at steady state of 661 litres.
Croatian: Nakon intravenske primjene flutikazonfuroata u zdravih dobrovoljaca, srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže iznosila je 661 litru.
English: Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Croatian: Nakon intravenske primjene vilanterola u zdravih dobrovoljaca, srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže iznosila je 165 litara.
English: medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems ketoconazole or itraconazole, to treat fungal infections clarithromycin or telithromycin, to treat bacterial infections ritonavir or cobicistat, to treat HIV infection medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets)
Croatian: - ketokonazol ili itrakonazol, koji se koriste za liječenje gljivičnih infekcija - klaritromicin ili telitromicin, koji se koriste za liječenje bakterijskih infekcija - ritonavir ili kobicistat, koji se koriste za liječenje HIV infekcije - lijekove koji smanjuju količinu kalija u krvi, poput nekih diuretika (tableta za izmokravanje) - druge dugodjelujuće lijekove slične ovom lijeku koji se koriste za liječenje dišnih tegoba, npr.
English: In FULFIL, Trelegy 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).
Croatian: U ispitivanju FULFIL, Trelegy Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma između 1. i 24. tjedna u odnosu na BUD/FOR (razlika između liječenja: -0,2 primjene na dan; 95% CI: -0,3; -0,1).
English: It should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Ne smije se primjenjivati za ublažavanje simptoma u slučaju naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: Co-administration of Trelegy 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).
Croatian: Drugi dugodjelujući antimuskarinici i dugodjelujući beta2-adrenergički agonisti Istodobna primjena lijeka Trelegy Ellipta s drugim dugodjelujućim muskarinskim antagonistima ili dugodjelujućim beta2-adrenergičkim agonistima nije se ispitivala te se ne preporučuje jer može potencirati nuspojave (vidjeti dijelove 4.8 i 4.9).
English: In IMPACT, treatment with Trelegy Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Croatian: U ispitivanju IMPACT, liječenje lijekom Trelegy Ellipta smanjilo je godišnju stopu teških egzacerbacija (tj. onih koje su zahtijevale hospitalizaciju ili imale smrtni ishod) za 13% u odnosu na FF/VI (95% CI: -1; 24; p = 0,064).
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).
Croatian: To odgovara odmjerenoj dozi od 100 mikrograma flutikazonfuroata, 74,2 mikrograma umeklidinijeva bromida, što odgovara količini od 62,5 mikrograma umeklidinija, i 25 mikrograma vilanterola (u obliku trifenatata).
English: Your Trelegy Ellipta inhaler carton contains
Croatian: Vaša kutija s Trelegy Ellipta inhalatorom sadrži
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use,
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Trelegy Ellipta is for inhalation use only.
Croatian: Način primjene Trelegy Ellipta namijenjen je isključivo za inhaliranje.
English: INFORMATION IN BRAILLE trelegy ellipta
Croatian: 16. PODACI NA BRAILLEOVOM PISMU trelegy ellipta
English: In IMPACT, Trelegy 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.
Croatian: U ispitivanju IMPACT, Trelegy Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma (broj primjena na dan) u svakom 4-tjednom razdoblju u odnosu na FF/VI i UMEK/VI.
English: There have been reports of increases in blood glucose levels in diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol and this should be considered when prescribing to patients with a history of diabetes mellitus.
Croatian: U bolesnika sa šećernom bolešću liječenih flutikazonfuroatom/umeklidinijem/vilanterolom prijavljene su povišene razine glukoze u krvi pa to treba uzeti u obzir pri propisivanju lijeka bolesnicima koji imaju šećernu bolest u anamnezi.
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.
Croatian: Prema podacima prikupljenima do 24. tjedna u ispitivanju FULFIL, Trelegy Ellipta je značajno smanjio (p = 0,002) godišnju stopu umjerenih/teških egzacerbacija za 35% (95% CI: 14; 51) u odnosu na BUD/FOR.
English: Lung function endpoint in FULFIL
Croatian: Tablica 1. Plućna funkcija kao mjera ishoda u ispitivanju FULFIL
English: Visual disturbance may be reported with systemic and topical corticosteroid use.
Croatian: Kod primjene sistemskih i topikalnih kortikosteroida mogu se javiti smetnje vida.