FrancophonIA/ELRC3.0 huggingface dataset:
English: Trelegy Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Croatian: Trelegy Ellipta sadrži tri djelatne tvari koje se zovu flutikazonfuroat, umeklidinij i vilanterol.
English: Table 2 - Lung function endpoint in IMPACT
Croatian: Tablica 2 - Plućna funkcija kao mjera ishoda u ispitivanju IMPACT
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Croatian: Bolesnicima treba savjetovati da ne otvaraju podložak sve dok ne budu spremni za inhaliranje doze lijeka.
English: Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Croatian: Povećane razine cikličkog AMP-a uzrokuju opuštanje glatkih mišića bronha te inhibiraju otpuštanje medijatora reakcija neposredne preosjetljivosti iz stanica, osobito iz mastocita.
English: The primary metabolic route for fluticasone furoate is hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Croatian: Primarni metabolički put za flutikazonfuroat je hidroliza skupine S-fluorometil karbotioata, kojom nastaju metaboliti sa značajno smanjenim kortikosteroidnim djelovanjem.
English: Tabulated summary of adverse reactions The safety profile of Trelegy Ellipta is based on three phase III clinical studies.
Croatian: Sigurnosni profil lijeka Trelegy Ellipta temelji se na trima kliničkim ispitivanjima faze III.
English: Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.
Croatian: Nisu provedena klinička farmakološka ispitivanja nekog određenog inhibitora P-gp-a i flutikazonfuroata.
English: Vilanterol has a low association with red blood cells.
Croatian: Vilanterol se u maloj mjeri vezuje za crvene krvne stanice.
English: Population PK analyses for FF/UMEC/VI were conducted using a combined PK dataset from three phase III studies in 821 COPD subjects.
Croatian: Populacijske farmakokinetičke analize za FF/UMEK/VI provedene su na temelju objedinjenih podataka o farmakokinetici prikupljenih u trima ispitivanjima faze III u 821 ispitanika s KOPB-om.
English: Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Croatian: Vilanterol se prvenstveno eliminirao metabolizmom, nakon čega je uslijedilo izlučivanje metabolita u mokraću i feces.
English: Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines) involved in inflammation.
Croatian: Pokazalo se da kortikosteroidi imaju širok spektar djelovanja na više tipova stanica (npr. na eozinofile, makrofage, limfocite) i medijatore upale (npr. na citokine i kemokine).
English: The fluticasone furoate/vilanterol component of Trelegy Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Croatian: Kombinacija flutikazonfuroat/vilanterol, sadržana u lijeku Trelegy Ellipta, ocjenjivala se u bolesnika sa svim stupnjevima oštećenja jetrene funkcije (Child-Pugh stadij A, B ili C).
English: In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Croatian: U slučaju pogoršanja KOPB-a tijekom liječenja lijekom Trelegy Ellipta potrebno je ponovno ocijeniti stanje bolesnika i režim liječenja KOPB-a.
English: If you use more Trelegy Ellipta than you should
Croatian: Ako primijenite više lijeka Trelegy Ellipta nego što ste trebali
English: If you are breast-feeding, you must check with your doctor before you use Trelegy Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego što primijenite Trelegy Ellipta.
English: Vilanterol was not teratogenic in rats.
Croatian: Vilanterol Vilanterol nije bio teratogen u štakora.
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:
Croatian: Upala pluća (infekcija pluća) u bolesnika s KOPB-om (česta nuspojava) Obavijestite svog liječnika ako se pri primjeni lijeka Trelegy Ellipta pojavi bilo koja od sljedećih nuspojava - možda se radi o simptomima infekcije pluća:
English: The absolute bioavailability of fluticasone furoate when administrated as fluticasone furoate/vilanterol by inhalation was 15.2%, primarily due to absorption of the inhaled portion of the dose delivered to the lung, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost flutikazonfuroata nakon inhalacijske primjene flutikazonfuroata/vilanterola iznosila je 15,2%, prvenstveno zbog apsorpcije inhaliranog dijela doze lijeka isporučenog u pluća, pri čemu je udio oralne apsorpcije bio zanemariv.
English: Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Croatian: Primjena flutikazonfuroata/umeklidinija/vilanterola može uzrokovati paradoksalni bronhospazam praćen nastupom piskanja pri disanju i nedostatka zraka odmah nakon primjene, što može biti opasno po život.
English: Patients with moderate hepatic impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC).
Croatian: Bolesnici s umjerenim oštećenjem jetrene funkcije nisu pokazivali dokaze povećane sistemske izloženosti umeklidiniju ni vilanterolu (Cmax i AUC).
English: 1 inhaler of 14 doses
Croatian: 1 inhalator s 14 doza
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA OMOTU (S PLAVIM OKVIROM - VIŠESTRUKO PAKIRANJE)
English: There is no specific treatment for an overdose with Trelegy Ellipta.
Croatian: Nema specifične terapije za predoziranje lijekom Trelegy Ellipta.
English: Umeclidinium was not teratogenic in rats or rabbits.
Croatian: Umeklidinij nije bio teratogen u štakora ni kunića.
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose was excreted in faeces and approximately 22% of the administered radiolabelled dose was excreted in urine.
Croatian: Nakon intravenske primjene, približno 58% primijenjene radioaktivno označene doze izlučilo se u feces, dok se približno 22% primijenjene radioaktivno označene doze izlučilo u mokraću.
English: The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
Croatian: Inhalator sadrži dvije blister trake od višeslojne aluminijske folije s ukupno 14 ili 30 doza (terapija za 14 ili 30 dana).
English: Do not open until ready to inhale.
Croatian: Ne otvarati dok niste spremni za inhaliranje.
English: An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC.
Croatian: Primijećeno je povećanje AUC-a umeklidinija za približno 1,4 puta, dok na AUC vilanterola nije bilo učinka.
English: Discard by:
Croatian: Baciti do:
English: In COPD the muscles around the airways tighten, making breathing difficult.
Croatian: U bolesnika s KOPB-om mišići oko dišnih putova se stežu, što otežava disanje.
English: However, these higher systemic exposures remain below the threshold for FF-induced reduction of serum and urine cortisol and are not considered clinically relevant.
Croatian: Međutim, te povećane razine sistemske izloženosti ispod su granične vrijednosti za smanjenje razine kortizola u serumu i mokraći inducirano flutikazonfuroatom, pa se ne smatraju klinički važnima.
English: See ‘Step-by-step instructions' in this leaflet for full information.
Croatian: Za više informacija pročitajte 'Upute korak po korak' u ovoj uputi.
English: 14 doses 30 doses
Croatian: 30 doza
English: The primary metabolic routes for vilanterol are O-dealkylation to a range of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity.
Croatian: Primarni metabolički putovi za vilanterol su O-dealkilacija, kojom nastaje niz metabolita sa značajno smanjenim agonističkim djelovanjem na beta1- i beta2-adrenergičke receptore.
English: Urinary excretion accounted for approximately 2 % of the intravenously administered dose.
Croatian: Kroz mokraću se izlučilo približno 2% intravenski primijenjene doze.
English: For fluticasone furoate, patients with moderate hepatic impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients with severe hepatic impairment received half the dose (FF 92 micrograms).
Croatian: U bolesnika s umjerenim oštećenjem jetrene funkcije zabilježena je do tri puta veća sistemska izloženost flutikazonfuroatu (FF u dozi od 184 mikrograma), pa su bolesnici s teškim oštećenjem jetrene funkcije dobivali samo pola doze (FF u dozi od 92 mikrograma).
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Croatian: Poluvrijeme eliminacije nakon intravenske primjene u prosjeku je iznosilo 15,1 sat.
English: If you open the cover after this, the dose counter will change from half red to completely red.
Croatian: Ako nakon toga otvorite poklopac, brojač doza više neće biti napola crven nego potpuno crven.
English: The patient should be assessed and alternative therapy instituted if necessary.
Croatian: Treba ocijeniti bolesnikovo stanje i po potrebi uvesti neku drugu terapiju.
English: What you need to know before you use Trelegy Ellipta
Croatian: Što morate znati prije nego počnete primjenjivati Trelegy Ellipta
English: The efficacy of Trelegy 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.
Croatian: Djelotvornost lijeka Trelegy Ellipta (92/55/22 mikrograma) primijenjenog jedanput na dan ocjenjivala se u bolesnika s kliničkom dijagnozom KOPB-a u dvama aktivnim lijekom kontroliranim ispitivanjima i jednom ispitivanju neinferiornosti.
English: These include:
Croatian: Ti lijekovi uključuju:
English: Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Trelegy Ellipta treba primjenjivati uz oprez u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
English: Trelegy 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).
Croatian: 4.1 Terapijske indikacije Trelegy Ellipta indiciran je kao terapija održavanja u odraslih bolesnika s umjerenom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB) koji nisu adekvatno liječeni kombinacijom inhalacijskog kortikosteroida i dugodjelujućeg β2-agonista ili kombinacijom dugodjelujućeg β2-agonista i dugodjelujućeg antagonista muskarinskih receptora (za učinke na kontrolu simptoma i prevenciju egzacerbacija vidjeti dio 5.1).
English: Following oral administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces.
Croatian: Nakon peroralne primjene radioaktivno označenog vilanterola, 70% radioaktivno označene doze izlučilo se u mokraću, a 30% u feces.
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Croatian: Farmakokinetika umeklidinija u stanju dinamičke ravnoteže ocijenjena je u zdravih dobrovoljaca koji nemaju CYP2D6 (spori metabolizatori).
English: Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Croatian: Umeklidinij je supstrat citokroma P450 2D6 (CYP2D6).
English: Eye problems during treatment with Trelegy 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 Trelegy Ellipta:
Croatian: Ako se tijekom liječenja lijekom Trelegy Ellipta pojave bol ili nelagoda u oku, privremeno zamagljenje vida, odbljesak ili krugovi duginih boja pred očima, kao i crvenilo očiju:
English: Slide the cover down fully until a “click” is heard.
Croatian: Povucite poklopac prema dolje skroz do kraja, sve dok ne čujete 'klik'.
English: The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol.
Croatian: Povećanje izloženosti flutikazonfuroatu bilo je povezano sa smanjenjem ponderirane srednje vrijednosti 24-satnog kortizola u serumu za 27%.
English: Use Trelegy Ellipta regularly
Croatian: Primjenjujte Trelegy Ellipta redovito
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics including triple combinations with corticosteroids, ATC code: R03AL08.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, adrenergici u kombinaciji s antikolinergicima, uključujući trojne kombinacije s kortikosteroidima; ATK oznaka:
English: Upon initiation of treatment with Trelegy Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon uvođenja liječenja lijekom Trelegy Ellipta potrebno je pobliže nadzirati razine glukoze u plazmi u bolesnika sa šećernom bolešću.
English: Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Croatian: Svaki blister u jednoj traci sadrži flutikazonfuroat, a u drugoj umeklidinij (u obliku bromida) i vilanterol (u obliku trifenatata).
English: Step-by-step instructions
Croatian: Upute za primjenu korak po korak
English: Visual disturbance
Croatian: Smetnje vida
English: There was no significant increase in systemic exposure to vilanterol.
Croatian: Sistemska izloženost vilanterolu nije se značajno povećala.
English: For further instructions on handling the device, see section 6.6.
Croatian: Za dodatne upute o rukovanju inhalatorom vidjeti dio 6.6.
English: When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled route from a single inhaler in healthy subjects, the pharmacokinetics of each component were similar to those observed when each active substance was administered either as fluticasone furoate/vilanterol combination or as an umeclidinium/vilanterol combination or umeclidinium monotherapy.
Croatian: Kada su zdravi ispitanici inhalacijom primjenjivali kombinaciju flutikazonfuroata, umeklidinija i vilanterola u jednom inhalatoru, farmakokinetika svake sastavnice bila je slična onoj opaženoj kada se svaka od tih djelatnih tvari primjenjivala kao kombinacija flutikazonfuroat/vilanterol, kao kombinacija umeklidinij/vilanterol ili kao monoterapija umeklidinijem.
English: In vitro plasma protein binding in human plasma of fluticasone furoate was high, on average >99.6%.
Croatian: Stupanj vezivanja flutikazonfuroata za proteine u ljudskoj plazmi in vitro bio je visok te je u prosjeku iznosio > 99,6%.
English: Trelegy Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Croatian: Trelegy Ellipta značajno je poboljšao (p < 0,001) plućnu funkciju (definirano srednjom vrijednošću promjene najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna) (vidjeti Tablicu 1), a to se poboljšanje održalo u podskupini bolesnika koji su nastavili liječenje do 52. tjedna.
English: Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours.
Croatian: Poluvrijeme eliminacije vilanterola iz plazme nakon inhalacijske primjene tijekom 10 dana u prosjeku je iznosilo 11 sati.
English: If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use.
Croatian: Ako se inhalator čuva u hladnjaku, treba pričekati najmanje jedan sat prije primjene da se ugrije na sobnu temperaturu.
English: Other medicines and Trelegy Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Following oral inhalation, umeclidinium and vilanterol act locally on airways to produce bronchodilation by separate mechanisms and fluticasone furoate reduces inflammation.
Croatian: Nakon oralne inhalacije, umeklidinij i vilanterol djeluju lokalno u dišnim putovima i zasebnim mehanizmima djelovanja uzrokuju bronhodilataciju, dok flutikazonfuroat smanjuje upalu.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Croatian: Kada ste spremni upotrijebiti inhalator, odlijepite poklopac kako biste otvorili podložak.
English: Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids.
Croatian: Flutikazonfuroat pripada skupini lijekova koji se zovu kortikosteroidi ili skraćeno steroidi.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised (see section 4.4).
Croatian: Istodobno liječenje drugim lijekovima koji uzrokuju hipokalijemiju, kao što su derivati metilksantina, steroidi ili diuretici koji ne štede kalij, može potencirati mogući hipokalijemijski učinak beta2-adrenergičkih agonista pa je potreban oprez (vidjeti dio 4.4).
English: Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala na utjecaj flutikazonfuroata, umeklidinija ni vilanterola na plodnost muškaraca ili žena (vidjeti dio 5.3).
English: The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were also evaluated in the population pharmacokinetic analysis.
Croatian: Učinci rase, spola i tjelesne težine na farmakokinetiku flutikazonfuroata, umeklidinija i vilanterola također su se ocjenjivali u populacijskoj farmakokinetičkoj analizi.
English: Following oral administration, 92% of the administered radiolabelled dose was excreted primarily in faeces.
Croatian: Nakon peroralne primjene, 92% primijenjene radioaktivno označene doze prvenstveno se izlučilo u feces.
English: It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se flutikazonfuroat, umeklidinij, vilanterol ili njihovi metaboliti u majčino mlijeko.
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.
Croatian: Klinički značajne interakcije posredovane flutikazonfuroatom/umeklidinijem/vilanterolom u kliničkim dozama ne smatraju se vjerojatnima zbog malih koncentracija lijeka u plazmi nakon inhaliranja doze.
English: Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4.
Croatian: I flutikazonfuroat i vilanterol brzo se uklanjaju ekstenzivnim metabolizmom prvog prolaska kroz jetru, u kojem posreduje enzim CYP3A4.
English: FF/VI
Croatian: UMEK/VI
English: Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Croatian: Flutikazonfuroat/umeklidinij/vilanterol ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: However, studies have been conducted with fluticasone furoate/vilanterol and umeclidinium/vilanterol that showed no evidence of an increase in systemic exposure to fluticasone furoate, umeclidinium or vilanterol.
Croatian: Međutim, provedena su ispitivanja s flutikazonfuroatom/vilanterolom i umeklidinijem/vilanterolom, u kojima nisu pronađeni dokazi povećane sistemske izloženosti flutikazonfuroatu, umeklidiniju ni vilanterolu.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Trelegy Ellipta and budesonide/formoterol arms was equal at 2%.
Croatian: U podskupini od 430 bolesnika liječenih tijekom najviše 52 tjedna, prijavljena incidencija događaja pneumonije bila je jednaka u skupini liječenoj lijekom Trelegy Ellipta i u onoj koja je primala budezonid/formoterol (2%).
English: Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state.
Croatian: Umeklidinij Poluvrijeme eliminacije umeklidinija iz plazme nakon inhalacijske primjene tijekom 10 dana u prosjeku je iznosilo 19 sati, pri čemu se u stanju dinamičke ravnoteže 3 - 4% djelatne tvari izlučilo u mokraću u neizmijenjenom obliku.
English: Consistent with findings for other beta2 agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and rat pituitary gland.
Croatian: Sukladno nalazima za druge beta2-agoniste, vilanteroltrifenatat je u ispitivanjima cjeloživotne inhalacije imao proliferativne učinke na reproduktivni sustav ženki štakora i miševa te na hipofizu u štakora.
English: 3) Inhale your medicine
Croatian: 3) Inhalirajte lijek
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA INHALATORU
English: Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively.
Croatian: Istodobna primjena povećala je srednju vrijednost AUC(0-24) i Cmax flutikazonfuroata za 36% odnosno 33%.
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA).
Croatian: Vilanterol je dugodjelujući selektivni agonist beta2-adrenergičkih receptora (LABA).
English: Each inhaler contains either 14 or 30 doses (14 or 30 day supply).
Croatian: Jedan inhalator sadrži 14 ili 30 doza (terapija za 14 ili 30 dana).
English: 2 years Shelf-life after opening the tray: 6 weeks
Croatian: Rok valjanosti nakon otvaranja podloška: 6 tjedana
English: Where adverse reaction frequencies differed between studies, the higher frequency is reported below.
Croatian: Ako je učestalost nuspojava u tim ispitivanjima bila različita, u nastavku je navedena veća zabilježena učestalost.
English: The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost inhaliranog umeklidinija u prosjeku je iznosila 13%, pri čemu je udio oralne apsorpcije bio zanemariv.
English: 1 inhaler of 30 doses
Croatian: 1 inhalator s 30 doza
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively.
Croatian: Istodobna primjena povećala je srednju vrijednost AUC(0-t) i Cmax vilanterola za 65% odnosno 22%.
English: White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter.
Croatian: Bijeli prašak u svijetlosivom inhalatoru (Ellipta) s bež poklopcem nastavka za usta i brojačem doza.
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Croatian: Agonisti beta2-adrenergičkih receptora mogu u nekih bolesnika izazvati značajnu hipokalijemiju, koja može uzrokovati kardiovaskularne nuspojave.
English: Don't block the air vent with your fingers.
Croatian: Nemojte prstima blokirati otvor za zrak.