FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland.
Croatian: Sukladno nalazima za druge beta2-adrenergičke agoniste, vilanteroltrifenatat je u ispitivanjima cjeloživotne inhalacije imao proliferativne učinke na reproduktivni sustav u ženki štakora i miša te na hipofizu u štakora.
English: A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo controlled clinical study and in two of the three 24-week active-controlled studies.
Croatian: Viša doza umeklidinija/vilanterola (113/22 mikrograma) također je ispitana u jednom 24-tjednom placebom kontroliranom ispitivanju te u dvama od triju 24-tjednih ispitivanja kontroliranih aktivnim
English: The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost inhaliranog umeklidinija u prosjeku je iznosila 13% doze, pri čemu je udio oralne apsorpcije bio zanemariv.
English: Multipack: 90 (3 packs of 30) doses
Croatian: Višestruko pakiranje: 90 (3 inhalatora s 30) doza
English: If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek medical advice.
Croatian: Ako dođe do piskanja pri disanju ili ako ostanete bez zraka, primijenite brzodjelujući inhalacijski lijek (npr. salbutamol), a zatim zatražite savjet liječnika.
English: To use ANORO ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Croatian: ANORO ELLIPTA se primjenjuje tako da ga udahnete kroz usta u pluća uz pomoć ELLIPTA inhalatora.
English: If you stop using ANORO ELLIPTA
Croatian: Ako prestanete primjenjivati ANORO ELLIPTA
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).
Croatian: Vilanterol je dugodjelujući selektivni agonist beta2-adrenergičkih receptora (beta2-adrenergički agonist).
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (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 ga treba primjenjivati uz oprez (vidjeti dio 4.4).
English: The increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method).
Croatian: Povećana izloženost vilanterolu nije bila povezana s povećanjem sistemskih učinaka beta-adrenergičkih agonista na frekvenciju otkucaja srca, razinu kalija u krvi niti QT-interval
English: • decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Croatian: • povišenje izmjerenog očnog tlaka • slabljenje vida ili bol u očima zbog povišenog tlaka (mogući znaci glaukoma).
English: Umeclidinium plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in urine at steady-state.
Croatian: Poluvrijeme eliminacije umeklidinija iz plazme nakon inhalacijske primjene tijekom 10 dana u prosjeku je iznosilo 19 sati u zdravih dobrovoljaca, pri čemu se u stanju dinamičke ravnoteže 3-4% doze izlučilo mokraćom u neizmijenjenu obliku.
English: Plasma clearance of vilanterol following intravenous administration was 108 litres/hour.
Croatian: Vilanterol Klirens vilanterola iz plazme nakon intravenske primjene iznosio je 108 litara/sat.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Croatian: Kada ste spremni primijeniti vaš inhalator, odlijepite poklopac kako bi otvorili podložak.
English: What ANORO ELLIPTA is and what it is used for What ANORO ELLIPTA is
Croatian: Što je ANORO ELLIPTA i za što se koristi Što je ANORO ELLIPTA
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Croatian: S obzirom na opseg tih promjena, ne očekuje se klinički značajna interakcija pri istodobnoj primjeni umeklidinija/vilanterola s inhibitorima CYP2D6 niti pri primjeni umeklidinija/vilanterola u bolesnika s genetski nedostatnom aktivnošću CYP2D6 (slabi metabolizatori).
English: Following oral administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in faeces.
Croatian: Nakon peroralne primjene radioaktivno označene doze, masena bilanca pokazala je da se 70% radioaktivno označene doze izlučilo mokraćom, a 30% fecesom.
English: The active substances are umeclidinium bromide and vilanterol.
Croatian: Djelatne tvari su umeklidinijev bromid i vilanterol.
English: The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
Croatian: Upute u nastavku koje opisuju uporabu inhalatora s 30 doza (terapija za 30 dana) odnose se i na inhalator sa 7 doza (terapija za 7 dana).
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: Upon initiation of treatment with umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon uvođenja liječenja umeklidinijem/vilanterolom, razine glukoze u plazmi treba pobliže nadzirati u bolesnika sa šećernom bolešću.
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Croatian: Nakon intravenske primjene u zdravih dobrovoljaca, srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže iznosila je 165 litara.
English: Eye problems during treatment with ANORO ELLIPTA
Croatian: Očne tegobe tijekom liječenja lijekom ANORO ELLIPTA
English: There are no data from the use of umeclidinium/vilanterol in pregnant women.
Croatian: Nema podataka o primjeni umeklidinija/vilanterola u trudnica.
English: The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers.
Croatian: Učinak umeklidinija/vilanterola na QT-interval ocijenjen je u placebom i aktivnim lijekom (moksifloksacinom) kontroliranim ispitivanjima QT-intervala, u kojima se umeklidinij/vilanterol u dozi od 113/22 mikrograma ili 500/100 mikrograma (odmjerena doza, koja sadrži umeklidinij u osam puta većoj dozi od preporučene, a vilanterol u četiri puta većoj dozi od preporučene) primjenjivao jedanput na dan tijekom 10 dana u 103 zdrava dobrovoljca.
English: If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with ANORO ELLIPTA:
Croatian: Ako se tijekom liječenja lijekom ANORO ELLIPTA pojave bol ili nelagoda u oku, privremeno zamagljenje vida, aureole ili obojani krugovi oko izvora svjetlosti u kombinaciji s crvenilom očiju:
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Croatian: približno 58% primijenjene radioaktivno označene doze (ili 73% pronađene radioaktivnosti) izlučilo se fecesom unutar 192 sata nakon primjene doze.
English: The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Croatian: Upute za uporabu inhalatora prikazane u nastavku odnose se i na inhalator s 30 doza (terapija za 30 dana) i na inhalator sa 7 doza (terapija za 7 dana).
English: ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Croatian: Primjena lijeka ANORO ELLIPTA smanjila je uporabu salbutamola kao lijeka za hitno ublažavanje simptoma (engl. rescue medication) u razdoblju od 1-24 tjedna u usporedbi s placebom i umeklidinijem (vidjeti Tablicu 1) te pokazala proporcionalno povećanje u danima naspram početne vrijednosti kada uporaba lijeka za hitno ublažavanje simptoma nije bila potrebna (u prosjeku 11,1%) u usporedbi sa smanjenjem naspram početne vrijednosti kod placeba (u prosjeku 0,9%).
English: An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Croatian: Zbog djelovanja pojedinih sastojaka, predoziranje umeklidinijem/vilanterolom vjerojatno će izazvati znakove i simptome koji odgovaraju poznatim nuspojavama koje se javljaju kod primjene inhalacijskih muskarinskih antagonista (npr. suha usta, poremećaji vidne akomodacije i tahikardija) ili kod predoziranja drugim beta2-adrenergičkim agonistima (npr. aritmije, tremor, glavobolja, palpitacije, mučnina, hiperglikemija i hipokalijemija).
English: Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Croatian: Zbog antimuskarinskog djelovanja, umeklidinij/vilanterol treba primjenjivati uz oprez u bolesnika s urinarnom retencijom ili glaukomom uskog kuta.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost inhaliranog vilanterola iznosila je 27% doze, pri čemu je udio oralne apsorpcije bio zanemariv.
English: In COPD the muscles around the airways tighten.
Croatian: U bolesnika s KOPB-om mišići oko dišnih putova se stežu.
English: White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter.
Croatian: Bijeli prašak u svijetlosivom inhalatoru (ELLIPTA) s crvenim poklopcem nastavka za usta i brojačem doza.
English: Not for acute use Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.
Croatian: Umeklidinij/vilanterol nije indiciran za liječenje akutnih epizoda bronhospazma.
English: • painful and frequent urination (may be signs of a urinary tract infection)
Croatian: • bolno i učestalo mokrenje (to mogu biti znakovi infekcije mokraćnog sustava)
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine:
Croatian: Ako se javi stezanje u prsnom košu, kašalj, piskanje pri disanju ili nedostatak zraka neposredno nakon primjene ovog lijeka:
English: ANORO ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Croatian: ANORO ELLIPTA (N = 454) naspram tiotropija 18 µg (N = 451) (ispitivanje ZEP117115)
English: In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Croatian: U 6-mjesečnim ispitivanjima faze III, primjena umeklidinija/vilanterola dovela je do klinički značajnih poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u 1 sekundi [FEV1]) u odnosu na placebo tijekom 24 sata nakon primjene jedanput na dan, koja su bila primjetna 15 minuta nakon primjene prve doze (poboljšanje za 112 ml u odnosu na placebo (p<0,001∗)).
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Croatian: U ispitivanju u ljudi s primjenom radioaktivno označenog lijeka, metabolički profili u plazmi nakon peroralne primjene vilanterola bili su u skladu s opsežnim metabolizmom prvog prolaza.
English: Plasma clearance following intravenous administration was 151 litres/hour.
Croatian: Umeklidinij Klirens iz plazme nakon intravenske primjene iznosio je 151 litara/sat.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol (FF/VI 92/22 micrograms) administered once daily as a single inhaler.
Croatian: U randomiziranom, dvostruko slijepom, 52-tjednom ispitivanju (CTT116855, IMPACT), 10 355 odraslih bolesnika s simptomatskim KOPB-om koji su u proteklih 12 mjeseci imali 1 ili više umjerenih/teških egzacerbacija bili su randomizirani (1:2:2) za primanje umeklidinij/vilanterola (UMEC/VI 55/22 mikrograma), flutikazonfuroat/umeklidinij/vilanterola (FF/UMEC/VI 92/55/22 mikrograma) ili flutikazonfuroat/vilanterola (FF/VI 92/22 mikrograma) pomoću jednog inhalatora primijenjenim jedanput na dan.
English: ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: ANORO ELLIPTA se ne smije primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: ANORO ELLIPTA is an inhalation powder, pre-dispensed.
Croatian: ANORO ELLIPTA je prašak inhalata, dozirani.
English: ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: ANORO ELLIPTA je indiciran kao bronhodilatator u terapiji održavanja u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB) s ciljem ublažavanja simptoma.
English: Co-administration with ketoconazole (400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively.
Croatian: (400 mg) u zdravih dobrovoljaca povećala je srednju vrijednost AUC(0-t) vilanterola za 65%, a srednju vrijednost Cmax, za 22%.
English: How to store ANORO ELLIPTA Contents of the pack and other information Step-by-step instructions
Croatian: Kako čuvati ANORO ELLIPTA 6. Sadržaj pakiranja i druge informacije
English: Mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo was 224 ml (p<0.001∗) at Week 24.
Croatian: Nakon 24 tjedna, srednje poboljšanje vršne vrijednosti FEV1 unutar prvih 6 sati nakon primjene lijeka u odnosu na placebo iznosilo je 224 ml (p<0,001*).
English: The maximum dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Croatian: Maksimalna doza je jedna inhalacija lijeka ANORO ELLIPTA od 55/22 mikrograma jedanput na dan.
English: Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Croatian: Nakon inhalacijske primjene umeklidinija u zdravih dobrovoljaca, Cmax je dosegnut nakon 5 do 15 minuta.
English: Therefore, umeclidinium/vilanterol should be used with caution in patients with severe cardiovascular disease.
Croatian: Stoga umeklidinij/vilanterol treba primjenjivati uz oprez u bolesnika s teškom kardiovaskularnom bolešću.
English: The recommended dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.
Croatian: Preporučena doza je jedna inhalacija lijeka ANORO ELLIPTA od 55/22 mikrograma jedanput na dan.
English: Open the cover when ready to inhale a dose.
Croatian: Otvorite poklopac kada ste spremni inhalirati dozu.
English: Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Croatian: Drugi lijekovi za KOPB Iako nisu provedena formalna ispitivanja interakcija in vivo, pri istodobnoj primjeni inhalacijskog umeklidinija/vilanterola i drugih lijekova za KOPB, uključujući kratkodjelujuće simpatomimetičke bronhodilatatore i inhalacijske kortikosteroide, nije bilo kliničkih dokaza interakcija između spomenutih lijekova.
English: Each inhaler contains either 7 or 30 doses.
Croatian: Jedan inhalator sadrži 7 ili 30 doza.
English: ANORO ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Croatian: ANORO ELLIPTA je doveo do statistički značajnog smanjenja ukupnog SGRQ rezultata u usporedbi s tiotropijem u jednom od triju ispitivanja s aktivnim usporednim lijekom (vidjeti Tablicu 1).
English: ANORO ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Croatian: ANORO ELLIPTA 55/22 μg prašak inhalata umeklidinij/vilanterol
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when 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 umeklidinija/vilanterola s inhibitorima P-gp-a.
English: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA).
Croatian: Umeklidinij/vilanterol je kombinirani inhalacijski dugodjelujući antagonist muskarinskih receptora i dugodjelujući beta2-adrenergički agonist (engl. long-acting muscarinic receptor antagonist/longacting beta2-adrenergic agonist, LAMA/LABA).
English: ANORO ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Croatian: ANORO ELLIPTA je u nekoliko ispitivanja pokazao poboljšanja plućne funkcije (definirana promjenom najniže vrijednosti FEV1 u odnosu na početnu vrijednost).
English: There are no data on the effects of umeclidinium/vilanterol on human fertility.
Croatian: Nema podataka o učincima umeklidinija/vilanterola na plodnost u ljudi.
English: Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Croatian: Umeklidinij/vilanterol treba primjenjivati uz oprez u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika s neuobičajeno dobrim odgovorom na beta2-adrenergičke agoniste.
English: Frequency cannot be estimated from the available data: • dizziness.
Croatian: Učestalost se ne može procijeniti na temelju dostupnih podataka:
English: SGRQ Total Score
Croatian: Ukupan SGRQ rezultat
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Croatian: U klinički razvojni program uključeno je 2354 bolesnika koji su primali umeklidinij/vilanterol jedanput na dan u kliničkim ispitivanjima faze III u trajanju od 24 ili više tjedana; od kojih je 1296 bolesnika primalo preporučenu dozu od 55/22 mikrograma u 24-tjednim ispitivanjima, 832 bolesnika primala su veću dozu od 113/22 mikrograma u 24-tjednim ispitivanjima, a 226 bolesnika primalo je dozu od
English: ANORO ELLIPTA contains lactose
Croatian: ANORO ELLIPTA sadrži laktozu
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Croatian: Udio bolesnika koji su nakon 24 tjedna postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio je veći kod primjene lijeka ANORO ELLIPTA (49%) u usporedbi s placebom (34%) ili bilo kojom od sastavnica u monoterapiji (44% za umeklidinij i 48% za vilanterol).
English: Excipient with known effect Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Croatian: Jedna primijenjena doza sadrži približno 25 mg laktoze (u obliku hidrata).
English: In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Croatian: Ispitivanja in vitro pokazala su da se umeklidinij prvenstveno metabolizira posredstvom citokroma P450 2D6 (CYP2D6) i da je supstrat za prijenosnik P-glikoproteina (P-gp).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms/22 micrograms
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE) 55 mikrograma/22 mikrograma
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with FF/VI and UMEC/VI.
Croatian: Primarna mjera ishoda bila je smanjenje godišnje stope umjerenih i teških egzacerbacija u ispitanika liječenih s FF/UMEC/VI u usporedbi s FF/VI i
English: The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter.
Croatian: Ellipta inhalator sastoji se od svijetlosivog plastičnog tijela, crvenog poklopca nastavka za usta i brojača doza.
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Croatian: U druga dva ispitivanja, rizik od umjerenih/teških egzacerbacija KOPB-a bio je povećan za 20% odnosno 90% u usporedbi s tiotropijem (HR 1,2; 95% CI: 0,5, 2,6; p=0,709 odnosno HR 1,9; 95% CI: 1,0, 3,6; p=0,062).
English: This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Croatian: To odgovara odmjerenoj dozi od 74,2 mikrograma umeklidinijeva bromida, što odgovara količini od 62,5 mikrograma umeklidinija i 25 mikrograma vilanterola (u obliku trifenatata).
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Harmire Road
Croatian: Glaxo Operations UK Ltd. (posluje pod nazivom Glaxo Wellcome Operations) Harmire Road
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 citokroma P450 3A4 (CYP3A4) i da je supstrat za prijenosnik P-gp-a.
English: The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, FF/VI, and UMEC/VI respectively.
Croatian: Srednja vrijednost godišnje stope egzacerbacija bila je 0,91 za FF/UMEC/VI, 1,07 za FF/VI i 1,21 za UMEC/VI.
English: Uncommon Rare
Croatian: Rijetke nuspojave