FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure-adjusted all-cause mortality per 100 patients/year (%/yr) was: fluticasone furoate/vilanterol, 3.1 %/yr; placebo, 3.5 %/yr; fluticasone furoate, 3.2 %/yr; and vilanterol, 3.4 %/yr.
Croatian: Smrt zbog bilo kojeg uzroka na 100 bolesnik-godina (%/god.) prilagođena za izloženost iznosila je 3,1%/god. uz flutikazonfuroat/vilanterol, 3,5%/god. uz placebo, 3,2%/god. uz flutikazonfuroat te 3,4%/god. uz vilanterol.
English: In patients with a cardiovascular history/risk factors, fluticasone furoate/vilanterol 92/22 micrograms resulted in a significantly lower annual rate of moderate/severe COPD exacerbations compared with vilanterol (adjusted mean annual rates of 0.83 and 1.18 respectively, 30% reduction (95% CI 16, 42%, p<0.001)).
Croatian: U bolesnika s kardiovaskularnim bolestima u anamnezi/čimbenicima rizika za te bolesti, primjena flutikazonfuroata/vilanterola od 92/22 mikrograma rezultirala je značajno nižom godišnjom stopom umjerenih/teških egzacerbacija KOPB-a u odnosu na vilanterol (prilagođene srednje godišnje stope od 0,83 odnosno 1,18, smanjenje od 30% (95% CI 16, 42%, p<0,001)).
English: If you are breast-feeding, you must check with your doctor before you use Relvar Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego primijenite Relvar Ellipta.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Relvar Ellipta.
Croatian: Kardiovaskularni učinci Simpatomimetici, uključujući Relvar Ellipta, mogu izazvati kardiovaskularne učinke kao što su srčane aritmije, npr. supraventrikularna tahikardija i ekstrasistole.
English: In HZA106827/HZA106829 the co-primary efficacy endpoints were change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the treatment period in all subjects and weighted mean serial FEV1 over 0-24 hours post-dose calculated in a subset of subjects at the end of the treatment period.
Croatian: U ispitivanjima HZA106827/HZA106829 dvije primarne mjere ishoda djelotvornosti bile su promjena od početne najniže vrijednosti (prije primjene brohnodilatatora i prije uzimanja lijeka) FEV1 pri kliničkom posjetu na kraju terapijskog razdoblja u svih ispitanika te ponderirana srednja vrijednost
English: • fever or chills
Croatian: • vrućica ili zimica
English: No comparative studies versus salmeterol/FP or versus other established bronchodilators have been conducted to appropriately compare the effects on COPD exacerbations.
Croatian: Nisu provedena usporedna ispitivanja sa salmeterolom/flutikazonpropionatom niti drugim poznatim bronhodilatatorima kojima bi se primjereno usporedili učinci na egzacerbacije KOPB-a.
English: If you are breast-feeding, check with your doctor before you use Relvar Ellipta.
Croatian: Ako dojite, obratite se svom liječniku prije nego primijenite Relvar Ellipta.
English: Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 130 mL (fluticasone furoate/vilanterol) and 108 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Croatian: Prilagođena srednja terapijska povećanja ponderirane srednje vrijednosti 24-satnog FEV1 od 130 ml (flutikazonfuroat/vilanterol) odnosno 108 ml (salmeterol/flutikazonpropionat) u odnosu na početnu vrijednost pokazala su ukupno poboljšanje plućne funkcije tijekom 24 sata kod obje terapije.
English: The effects of age on the pharmacokinetics of fluticasone furoate and vilanterol were determined in phase III studies in COPD and asthma.
Croatian: Učinci životne dobi na farmakokinetiku flutikazonfuroata i vilanterola utvrđeni su u ispitivanjima faze
English: • patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
Croatian: • u bolesnika adekvatno kontroliranih inhalacijskim kortikosteroidima i dugodjelujućim inhalacijskim beta2-agonistima.
English: The recommended dose to treat asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
Croatian: Preporučena doza za liječenje astme je jedna inhalacija (92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola) jedanput na dan, u isto vrijeme svakoga dana.
English: Fluticasone furoate and vilanterol are substrates for P-glycoprotein (P-gp), however, concomitant administration of fluticasone furoate/vilanterol with P-gp inhibitors is considered unlikely to alter fluticasone furoate or vilanterol systemic exposure since they are both well absorbed molecules.
Croatian: Međutim, ne smatra se vjerojatnim da bi istodobna primjena flutikazonfuroata/vilanterola s inhibitorima P-gp-a mogla izmijeniti sistemsku izloženost flutikazonfuroatu ili vilanterolu jer se obje molekule dobro apsorbiraju.
English: What Relvar Ellipta contains - The active substances are fluticasone furoate and vilanterol.
Croatian: Sadržaj pakiranja i druge informacije Što Relvar Ellipta sadrži - Djelatne tvari su flutikazonfuroat i vilanterol.
English: • increased mucus production, change in mucus colour
Croatian: • pojačano lučenje sluzi, promjena boje sluzi
English: Your Relvar Ellipta inhaler carton contains
Croatian: Vaša kutija s Relvar Ellipta inhalatorom sadrži
English: Teл.
Croatian: Ellipta.
English: Vilanterol trifenatate is a selective long-acting, beta2-adrenergic agonist (LABA).
Croatian: Vilanteroltrifenatat je dugodjelujući selektivni agonist beta2-adrenergičkih receptora.
English: Multipack of 3 x 30 dose Inhalers.
Croatian: Višestruko pakiranje s 3 inhalatora x 30 doza.
English: If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists.
Croatian: • u bolesnika u kojih astma nije dovoljno dobro kontrolirana inhalacijskim kortikosteroidima te kratkodjelujućim inhalacijskim beta2-agonistima koji se primjenjuju 'prema potrebi'.
English: Moderate and severe exacerbations Adjusted mean annual rate
Croatian: Prilagođena srednja vrijednost godišnje stope
English: Hold the inhaler away from your mouth and breathe out as far as is comfortable.
Croatian: Držite inhalator dalje od usta i izdahnite koliko možete, do granice neugode.
English: fluticasone furoate/ vilanterol
Croatian: Flutikazon furoat/ vilanterol
English: Fluticasone furoate/vilanterol
Croatian: Flutikazon furoat / vilanterol
English: At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively.
Croatian: U ispitivanjima HZC112206 i HZC112207 na probiru je srednja vrijednost FEV1 prije primjene bronhodilatatora iznosila 42,6% odnosno 43,6% predviđene vrijednosti, a srednja vrijednost reverzibilnosti 15,9% odnosno 12,0%.
English: Forty four percent of patients in the fluticasone furoate/vilanterol 92/22 micrograms group were well controlled (ACQ7 ≤0.75) at end of treatment compared to 36% of subjects in the FF 92 micrograms group (p<0.001 95% CI 1.23, 1.82).
Croatian: U 44% bolesnika u skupini koja je primala flutikazonfuroat/vilanterol od 92/22 mikrograma bolest je na kraju liječenja bila dobro kontrolirana (ACQ7 ≤0,75), a isto je zabilježeno u 36% ispitanika u skupini koja je primala flutikazonfuroat od 92 mikrograma (p<0,001 95% CI 1,23; 1,82).
English: Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Croatian: Dostupne su dvije različite doze lijeka Relvar Ellipta: flutikazonfuroat od 92 mikrograma/vilanterol od 22 mikrograma i flutikazonfuroat od 184 mikrograma/vilanterol od 22 mikrograma.
English: In an integrated analysis of HZC102970 and HZC102871 at week 52, an improvement was seen when comparing the fluticasone furoate/vilanterol 92/22 micrograms versus vilanterol 22 micrograms in adjusted mean trough FEV1 (42 mL 95% CI: 19, 64mL, p<0.001).
Croatian: U objedinjenoj analizi ispitivanja HZC102970 i HZC102871 u 52. tjednu usporedba flutikazonfuroata/vilanterola od 92/22 mikrograma i vilanterola od 22 mikrograma pokazala je poboljšanje u prilagođenoj srednjoj najnižoj vrijednosti FEV1 (42 ml 95% CI: 19, 64 ml, p<0,001).
English: The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
Croatian: Preporučena doza za liječenje KOPB-a je jedna inhalacija (92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola) jedanput na dan, u isto vrijeme svakoga dana.
English: Overall, the greatest effects on the early asthmatic response were seen with fluticasone furoate/vilanterol 92/22 micrograms compared with FF 92 micrograms or vilanterol 22 micrograms alone.
Croatian: Ukupno je najbolji učinak na rani astmatički odgovor zabilježen kod primjene flutikazonfuroata/vilanterola od 92/22 mikrograma u usporedbi s flutikazonfuroatom od 92 mikrograma ili vilanterolom od 22 mikrograma primijenjene samostalno.
English: In a 24 week study (HZA113091) in adult and adolescent patients with uncontrolled persistent asthma both fluticasone furoate/vilanterol 92/22 micrograms given once daily in the evening and salmeterol/FP 50/250 micrograms given twice daily demonstrated improvements from baseline in lung function.
Croatian: U 24-tjednom ispitivanju (HZA113091) s odraslim osobama i adolescentima s nekontroliranom trajnom astmom, i flutikazonfuroat/vilanterol od 92/22 mikrograma jedanput na dan uvečer i salmeterol/ flutikazonpropionat od 50/250 mikrograma dvaput na dan doveli su do poboljšanja plućne funkcije u odnosu na početnu vrijednost.
English: Open the cover when ready to inhale a dose.
Croatian: Kako pripremiti dozu Otvorite poklopac kad ste spremni inhalirati dozu.
English: • high temperature (fever)
Croatian: • visoka tjelesna temperatura (vrućica) • bol u zglobovima
English: • skin rash (hives) or redness
Croatian: • kožni osip (koprivnjača) ili crvenilo
English: In a placebo-controlled study (SUMMIT) in subjects with moderate COPD (mean percent postbronchodilator screening FEV1 of 60%, SD 6%), and a history of, or an increased risk of cardiovascular disease, the incidence of pneumonia with FF/VI, FF, VI and placebo was: adverse events (6%, 5%, 4%, 5%); serious adverse events (3%, 4%, 3%, 3%); adjudicated on treatment deaths due to pneumonia (0.3%, 0.2%, 0.1%, 0.2%); the exposure adjusted rates (per 1000 treatment years) were: adverse events (39.5, 42.4, 27.7, 38.4); serious adverse events (22.4, 25.1, 16.4, 22.2); adjudicated on-treatment deaths due to pneumonia (1.8, 1.5, 0.9, 1.4) respectively.
Croatian: U placebom kontroliranom ispitivanju (SUMMIT) u ispitanika s umjerenim KOPB-om (srednji postotak FEV1 nakon primjene bronhodilatatora pri probiru iznosio je 60%, SD = 6%) i kardiovaskularnom bolešću u anamnezi ili povećanim rizikom od kardiovaskularne bolesti, incidencija pneumonije uz flutikazonfuroat/vilanterol, flutikazonfuroat, vilanterol odnosno placebo bila je sljedeća: nuspojave (6%, 5%, 4%, 5%); ozbiljne nuspojave (3%, 4%, 3%, 3%), smrtni slučajevi tijekom liječenja za koje je utvrđeno da su uzrokovani pneumonijom (0,3%, 0,2%, 0,1%, 0,2%).
English: At the 24-week time point FF and FP increased trough FEV1 by 146 mL (95% CI 36, 257 mL, p=0.009) and 145 mL (95% CI 33, 257 mL, p=0.011) respectively compared to placebo.
Croatian: Nakon 24 tjedna, primjena flutikazonfuroata povećala je najnižu vrijednost FEV1 za 146 ml (95% CI 36, 257 ml, p=0,009), a primjena flutikazonpropionata za 145 ml (95% CI 33, 257 ml, p=0,011) u odnosu na placebo.
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of pneumonia per 1000 patient years was 18.4 for FF/VI 184/22 versus 9.6 for FF/VI 92/22 and 8.0 in the placebo group.
Croatian: U objedinjenoj analizi 11 ispitivanja u bolesnika s astmom (7034 bolesnika), incidencija pneumonije na 1000 bolesnik-godina iznosila je 18,4 za flutikazonfuroat/vilanterol od 184/22 mikrograma u usporedbi s 9,6 za flutikazonfuroat/vilanterol od 92/22 mikrograma te 8,0 u placebo skupini.
English: Pack sizes of 14 or 30 dose Inhalers.
Croatian: Veličine pakiranja: inhalatori sa 14 ili 30 doza.
English: How to store Relvar Ellipta
Croatian: Kako čuvati Relvar Ellipta
English: Fluticasone furoate/vilanterol 92/22 micrograms increased trough FEV1 by 46 mL compared to vilanterol (95% CI: 8, 83mL, p= 0.017).
Croatian: Flutikazonfuroat/vilanterol od 92/22 mikrograma povećao je najnižu vrijednost FEV1 za 46 ml u odnosu na vilanterol (95% CI: 8, 83 ml, p= 0,017).
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: 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 s nedostatkom zraka ili piskanjem pri disanju.
English: Relvar Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Relvar Ellipta se ne smije primjenjivati za ublažavanje simptoma u slučaju naglog napadaja s nedostatkom zraka ili piskanjem pri disanju.
English: In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily.
Croatian: U ispitivanju HZA106837 ispitanici su randomizirani da primaju flutikazonfuroat/vilanterol od 92/22 mikrograma [n=1009] ili flutikazonfuroat od 92 mikrograma [n=1010], oba jedanput na dan.
English: Following oral administration, vilanterol was eliminated mainly by metabolism followed by excretion of metabolites in urine and faeces approximately 70% and 30% of the radioactive dose respectively in a human radiolabel study conducted by the oral route.
Croatian: U ispitivanju u ljudi, u kojem je peroralnim putem primijenjen radiooznačen lijek, vilanterol se nakon peroralne primjene eliminirao prvenstveno metabolizmom, a metaboliti su se izlučivali u mokraću i feces, pa je tako približno 70% radioaktivne doze pronađeno u mokraći, a 30% u fecesu.
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations), Harmire Road,
Croatian: Glaxo Operations UK Ltd (posluje kao GlaxoWellcome Operations), Harmire Road,
English: Relvar Ellipta is for inhalation use only.
Croatian: Relvar Ellipta namijenjen je isključivo za inhaliranje.
English: Change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period was a powered secondary.
Croatian: Promjena u postotku 24-satnih razdoblja bez terapije za olakšanje simptoma tijekom 24-tjednog terapijskog razdoblja bila je sekundarna mjera ishoda sa statističkom snagom.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Harmire Road,
Croatian: Glaxo Operations UK Limited (posluje kao GlaxoWellcome Operations), Harmire Road,
English: - Contact your doctor if you experience blurred vision or other visual disturbances.
Croatian: Tijekom liječenja lijekom Relvar Ellipta obratite se svom liječniku ako primijetite da Vam je vid zamućen ili ako primijetite druge poremećaje vida.
English: In adolescents (12 years or older), there are no recommended dose modifications.
Croatian: Nema preporuka za prilagođavanje doze u adolescenata (u dobi od 12 ili više godina).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street,
Croatian: Glaxo Operations UK Limited (posluje pod nazivom Glaxo Wellcome Operations), Priory Street,
English: Nasopharyngitis Paradoxical bronchospasm Oropharyngeal pain Sinusitis
Croatian: prsišta i sredoprsja nazofaringitis paradoksalni bronhospazam bol u usnoj šupljini i ždrijelu sinusitis faringitis rinitis kašalj disfonija vrlo često rijetko često
English: There was no increase in tumour incidence in rats or mice at exposures 2- or 30-fold, respectively, those at the maximum recommended human dose, based on AUC.
Croatian: Nije primijećeno povećanje incidencije tumora u štakora odnosno miševa pri razinama izloženosti koje su bile 2 odnosno 30 puta veće od izloženosti pri najvećoj preporučenoj dozi u ljudi, utvrđene na temelju AUC-a.
English: In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Croatian: U objedinjenoj analizi dvaju replikacijskih jednogodišnjih ispitivanja u bolesnika s umjerenim do teškim KOPB-om (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru bila je 45% predviđene vrijednosti, uz standardnu devijaciju (SD) od 13%) koji su u prethodnoj godini doživjeli egzacerbaciju bolesti (n = 3255), broj događaja pneumonije na 1000 bolesnik-godina iznosio je 97,9 u skupini koja je primala flutikazonfuroat/vilanterol od 184/22 mikrograma, 85,7 u skupini koja je primala flutikazonfuroat/vilanterol od 92/22 mikrograma i 42,3 u skupini koja je primala vilanterol od 22 mikrograma.
English: The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 micrograms was 0.755 (95% CI 0.603, 0.945).
Croatian: Omjer stope egzacerbacije za flutikazonfuroat/vilanterol od 92/22 mikrograma u odnosu na flutikazonfuroat od 92 mikrograma iznosio je 0,755 (95% CI 0,603; 0,945).
English: HZA106829 was 24 weeks in duration and evaluated the efficacy of fluticasone furoate/vilanterol 184/22 micrograms [n=197] and FF 184 micrograms [n=194]) both administered once daily compared with FP 500 micrograms twice daily [n=195].
Croatian: Ispitivanje HZA106829 trajalo je 24 tjedna, a njime se ocjenjivala djelotvornost flutikazonfuroata/vilanterola od 184/22 mikrograma [n=197] i flutikazonfuroata od 184 mikrograma [n=194], oba jedanput na dan, u usporedbi s flutikazonpropionatom od 500 mikrograma dvaput na dan [n=195].
English: For patients with moderate or severe hepatic impairment the maximum dose is 92/22 micrograms (see section 4.4).
Croatian: Najveća doza za bolesnike s umjerenim ili teškim oštećenjem jetrene funkcije je 92/22 mikrograma
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Croatian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
English: Change from Baseline in Percentage of Symptom-Free 24-hour Periods Treatment difference
Croatian: Promjena u postotku 24-satnih razdoblja bez simptoma od početne vrijednosti Terapijska razlika
English: 3-4 seconds).
Croatian: (vidjeti dio 4.4).
English: Mortality risk with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.88; 95% CI: 0.74 to 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 to 1.15; p=0.681) or vilanterol (HR 0.91; 95% CI: 0.77 to 1.09; p=0.299).
Croatian: 95% CI: 0,74 do 1,04; p=0,137), flutikazonfuroata (HR: 0,96; 95% CI: 0,81 do 1,15; p=0,681) ili vilanterola (HR: 0,91; 95% CI: 0,77 do 1,09; p=0,299).
English: HZC112206 evaluated the efficacy of fluticasone furoate/vilanterol 46 /22 micrograms [n=206] and fluticasone furoate/vilanterol 92/22 micrograms [n=206] compared with FF 92 micrograms [n=206], vilanterol 22 micrograms [n=205] and placebo [n = 207], all administered once daily.
Croatian: Ispitivanjem HZC112206 ocjenjivala se djelotvornost flutikazonfuroata/vilanterola od 46/22 mikrograma [n=206] i flutikazonfuroata/vilanterola od 92/22 mikrograma [n=206] u odnosu na flutikazonfuroat od 92 mikrograma [n=206], vilanterol od 22 mikrograma [n=205] i placebo [n = 207] (svi su se primjenjivali jedanput na dan).
English: COPD (Chronic Obstructive Pulmonary Disease)
Croatian: Kronična opstruktivna plućna bolest (KOPB)
English: • muscle spasms
Croatian: • upala sinusa
English: 95% CI p-value % reduction (95% CI)
Croatian: 95% CI p-vrijednost % smanjenja (95% CI) Apsolutna razlika u godišnjem broju naspram VI (95% CI)
English: • becoming very wheezy, coughing or having difficulty in breathing
Croatian: • piskanje pri disanju, kašalj ili otežano disanje
English: There was no evidence for age to affect the pharmacokinetics of fluticasone furoate in subjects with COPD while there was an increase (37%) in AUC (0-24) of vilanterol over the observed age range of 41 to 84 years.
Croatian: ali došlo je do povećanja (37%) AUC (0-24) vilanterola u promatranom dobnom rasponu od 41 do 84 godine.
English: At Day 168 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean weighted mean FEV1 over 0-4 hours by 193mL (95% CI: 156, 230 mL, p<0.001) and 145 mL (95% CI: 108, 181 mL, p<0.001) respectively compared to placebo.
Croatian: 168. dana flutikazonfuroat/vilanterol od 92/22 mikrograma povećao je prilagođenu srednju vrijednost ponderiranog srednjeg FEV1 mjerenog od 0-4 sata za 193 ml (95% CI: 156, 230 ml, p<0,001), a vilanterol za 145 ml (95% CI: 108, 181 ml, p<0,001) u odnosu na placebo.
English: How to use Relvar Ellipta
Croatian: Kako primjenjivati Relvar Ellipta
English: No comparative studies versus salmeterol/FP or versus other ICS/LABA combinations have been conducted to appropriately compare the effects on asthma exacerbations.
Croatian: Nisu provedena usporedna ispitivanja sa salmeterolom/flutikazonpropionatom niti drugim kombinacijama inhalacijskog kortikosteroida/dugodjelujućeg beta2-agonista kojima bi se primjereno usporedili učinci na egzacerbacije astme.
English: Fluticasone furoate/vilanterol 92/22 micrograms increased adjusted mean weighted mean FEV1 over 0-4 hours by 148 ml compared to FF alone (95% CI: 112, 184 mL, p< 0.001).
Croatian: Flutikazonfuroat/vilanterol od 92/22 mikrograma povećao je prilagođenu srednju vrijednost ponderiranog srednjeg FEV1 mjerenog od 0-4 sata za 148 ml u odnosu na flutikazonfuroat primijenjen samostalno (95% CI: 112, 184 ml, p< 0,001).
English: - For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: - Doza od 184/22 μg: jedna pojedinačna inhalacija daje primijenjenu dozu (doza koja izlazi iz nastavka za usta) od 184 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).
English: These may affect up to 1 in 1,000 people:
Croatian: Mogu se javiti u do 1 na 100 osoba:
English: Adjusted mean treatment increases from baseline in weighted mean 0-24 hours FEV1 of 341 mL (fluticasone furoate/vilanterol) and 377 mL (salmeterol/FP) demonstrated an overall improvement in lung function over 24 hours for both treatments.
Croatian: Prilagođena srednja terapijska povećanja ponderirane srednje vrijednosti 24-satnog FEV1 od 341 ml (flutikazonfuroat/vilanterol) i 377 ml (salmeterol/
English: This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate).
Croatian: To odgovara odmjerenoj dozi od 200 mikrograma flutikazonfuroata i 25 mikrograma vilanterola (u obliku trifenatata).
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females) and 1091 subjects with COPD (340 females).
Croatian: Na temelju farmakokinetičke analize podataka prikupljenih u 856 ispitanika s astmom (500 žena) i 1091 ispitanika s KOPB-om (340 žena), nema dokaza da spol, tjelesna težina ili ITM utječu na farmakokinetiku vilanterola.
English: Each delivered dose contains 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna primijenjena doza sadrži 184 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).