natgillin/translations-raw huggingface dataset:
In vitro enzyme induction studies did not indicate a clinically relevant induction by glycopyrronium bromide for any of the cytochrome P450 isoenzymes tested or for UGT1A1 and the transporters MDR1 and MRP2. 
In vitro ispitivanja indukcije enzima nisu ukazala na klinički relevantnu indukciju glikopironijevim bromidom za testirane citokrom P450 izoenzime ili za UGT1A1 i transportere MDR1 i MRP2.
Concomitant use not recommended 
Kada se ne preporučuje istodobna primjena
A population pharmacokinetic analysis of data in COPD patients after inhalation of Ultibro Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium. 
Analiza podataka o farmakokinetici u populaciji bolesnika s KOPB-om nakon inhalacije Ultibro Breezhalera uputila je na nepostojanje značajnog učinka dobi, spola i (čiste tjelesne) težine na sistemsku izloženost indakaterolu i glikopironiju.
Method of administration For inhalation use only. 
Način primjene Samo za primjenu inhalacijom.
Ultibro Breezhaler showed clinically meaningful improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) in a number of clinical studies. 
Ultibro Breezhaler pokazao je klinički značajno poboljšanje plućne funkcije (mjereno forsiranim ekspiratornim volumenom u prvoj sekundi, FEV1) u brojnim kliničkim ispitivanjima.
Step 1b: Open inhaler 
Korak 1b: Otvorite inhalator
In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias (see section 4.5). 
U bolesnika s teškim KOPB-om hipokalijemija može biti potencirana hipoksijom i istodobno primijenjenim lijekovima, što može povećati osjetljivost za srčane aritmije (vidjeti dio 4.5).
Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. 
Tijelo i poklopac inhalatora napravljeni su od akrilonitril butadien stirena, tipke su napravljene od metil metakrilat akrilonitril butadien stirena.
Metabolism and nutrition disorders Hyperglycaemia and diabetes mellitus 
Poremećaji metabolizma i prehrane Hiperglikemija i šećerna bolest
In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2). 
U bolesnika s teškim oštećenjem bubrega (procijenjena glomerularna filtracija manja od 30 ml/min/1,73 m2), uključujući i one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Ultibro Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
Indacaterol, one of the active substances in Ultibro Breezhaler, may prevent labour due to its effect on the uterus. 
Indakaterol, jedna od djelatnih tvari Ultibro Breezhalera, može spriječiti porod zbog njegovog utjecaja na maternicu.
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 
Ultibro Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
How to inhale Ultibro Breezhaler - Ultibro Breezhaler is for inhalation use. 
Kako inhalirati Ultibro Breezhaler - Ultibro Breezhaler je za primjenu inhalacijom.
In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp. 
Daljnja in vitro istraživanja su pokazala da je indakaterol supstrat niskog afiniteta za P-gp pumpu za izbacivanje.
Check capsule is empty Open the inhaler to see if any powder is left in the capsule. 
Otvorite inhalator kako biste provjerili je li ostalo praška u kapsuli.
Not for acute use Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm. 
Nije za akutnu primjenu Ultibro Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma.
The highest dose level of 464 micrograms/86 micrograms Ultibro Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo). 
Najviše razine doze od 464 mikrograma/86 mikrograma Ultibro Breezhalera također su pokazale viši udio apsolutnih vrijednosti QTcF-a >450 ms (12,2% u usporedbi s 5,7% za placebo).
Psychiatric disorders Insomnia 
Psihijatrijski poremećaji Nesanica
There is no information on clinically relevant overdosing with Ultibro Breezhaler. 
Nema informacija o klinički relevantnom predoziranju Ultibro Breezhalerom.
- you have severe liver problems. 
- ako imate teške tegobe s jetrom.
Only pierce the capsule once. 
Probušite kapsulu samo jedanput.
No data are available for subjects with severe hepatic impairment. 
Nema dostupnih podataka za ispitanike s teškim oštećenjem jetre.
• combination of sore throat and runny nose - these may be signs of nasopharyngitis. 
• kombinacija grlobolje i curenja nosa - to bi mogli biti znakovi nazofaringitisa.
Mean renal clearance of glycopyrronium following inhalation was in the range of 17.4 and 24.4 litres/h. 
Srednji bubrežni klirens glikopironija nakon inhalacije bio je u rasponu od 17,4 do 24,4 litre/h.
Concomitant administration of other sympathomimetics (alone or as part of combination therapy) may potentiate the adverse events of indacaterol (see section 4.4). 
Istodobna primjena drugih simpatomimetika (samih ili u kombiniranom liječenju) može potencirati nuspojave indakaterola (vidjeti dio 4.4).
Genotoxicity studies did not reveal any mutagenic or clastogenic potential for glycopyrronium bromide. 
Ispitivanja genotoksičnosti nisu otkrila nikakav mutageni ili klastogeni potencijal glikopironijevog bromida.
Pre-clinical studies included in vitro and in vivo safety pharmacology assessments, repeated-dose inhalation toxicity studies in rats and dogs and an inhalation embryo-foetal development study in rats. 
Neklinička ispitivanja uključivala su in vitro i in vivo ocjene sigurnosne farmakologije, ispitivanja toksičnosti inhalacije ponovljenih doza u štakora i pasa te ispitivanje embrio-fetalnog razvoja uz inhalaciju u štakora.
Never wash your inhaler with water. 
Nikad ne perite inhalator vodom.
• difficulty breathing or swallowing, swelling of tongue, lips or face, urticaria, skin rash - these may be signs of an allergic reaction. 
• otežano disanje ili gutanje, oticanje jezika, usana ili lica, urtikarija, kožni osip - to bi mogli biti znakovi alergijske reakcije.
Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs. 
U pasa, učinci na kardiovaskularni sustav vezani za beta2-agonistička svojstva indakaterola uključuju tahikardiju, aritmije i lezije miokarda.
Glycopyrronium plasma concentrations declined in a multi-phasic manner. 
Koncentracije glikopironija u plazmi smanjivale su se u nekoliko faza.
Ultibro Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003). 
Ultibro Breezhaler nadalje je pokazao superiornost u smanjivanju godišnje stope svih egzacerbacija za 11% naspram flutikazona/salmeterola (p=0,003).
In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2). 
U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu smije se koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dijelove 4.4 i 5.2).
Indacaterol administered to dogs alone or in Ultibro Breezhaler was associated with a similar incidence and severity of myocardial lesions. 
Indakaterol primijenjen u pasa sam ili u Ultibro Breezhaleru bio je povezan sa sličnom incidencijom i težinom lezija miokarda.
Studies in subjects with severe hepatic impairment were not performed. 
Ispitivanja u osoba s teškim oštećenjem jetre nisu provedena.
Gender, smoking status and baseline FEV1 had no apparent effect on systemic exposure. 
Spol, pušački status i početni FEV1 izgleda da nemaju učinak na sistemsku izloženost.
The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Ultibro Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components. 
Navjeća vremenski usklađena razlika u odnosu na placebo bila je 4,62 ms (90% CI 0,40, 8,85 ms), najveće vremenski usklađeno smanjenje bilo je -2,71 ms (90% CI -6,97, 1,54 ms), što upućuje na to da Ultibro Breezhaler nije imao relevantan utjecaj na QT interval, kao što se očekivalo na temelju svojstava njegovih komponenti.
Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites. 
Fenolni O-glukuronidi indakaterola i hidroksilirani indakaterol bili su drugi važni metaboliti.
There are no data available for the use of Ultibro Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2). 
Nema dostupnih podataka o primjeni Ultibro Breezhalera u bolesnika s teškim oštećenjem jetre, stoga je potreban oprez u tih bolesnika (vidjeti dio 5.2).
Ultibro Breezhaler showed similar adverse reactions to the individual components. 
Ultibro Breezhaler imao je slične nuspojave kao i pojedinačne komponente.
Step 1d: 
Korak 1d:
There are no data from the use of Ultibro Breezhaler in pregnant women available. 
Nema dostupnih podataka o primjeni Ultibro Breezhalera u trudnica.
A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified. 
Dijastereomer hidroksiliranog derivata, N-glukuronid indakaterola i C- i N-dealkilirani produkti bili su sljedeći identificirani metaboliti.
Serum potassium and blood glucose 
Kalij u serumu i glukoza u krvi
The effects of Ultibro Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ultibro Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour. 
Učinci Ultibro Breezhalera na QTc interval istraživani su u zdravih dobrovoljaca nakon inhalacije Ultibro Breezhalera u dozi koja je bila do 4 puta veća od preporučene terapijske doze i to u četiri koraka s razmakom od jedan sat između svakog.
Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. 
Gikopironij djeluje tako da blokira bronhokonstriktorno djelovanje acetilkolina na glatke mišićne stanice dišnih puteva, te time širi dišne puteve.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine prema učestalosti, nuspojave su navedene od najozbiljnijih prema manje ozbiljnima.
Multiple CYP isoenzymes contribute to the oxidative biotransformation of glycopyrronium. 
Više CYP izoenzima doprinose oksidativnoj biotransformaciji glikopironija.
Following inhalation of Ultibro Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively. 
Nakon inhalacije Ultibro Breezhalera medijan vremena do postizanja vršne koncentracije indakaterola odnosno glikopironija u plazmi bilo je otprilike 15 minuta odnosno 5 minuta.
In patients with severe renal impairment or end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk. 
U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Ultibro Breezhaler smije se koristiti samo ako očekivana korist premašuje potencijalne rizike.
Your Ultibro Breezhaler Inhaler pack contains: 
Vaše pakiranje Ultibro Breezhaler inhalatora sadrži:
• eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of glaucoma. 
• bol i nelagoda u oku, privremeno zamagljenje vida, aureole oko izvora svjetlosti ili jako obojane slike zajedno sa crvenim očima - to bi mogli biti znakovi glaukoma.
The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on day 14 or day 15 compared to day 1, was in the range of 2.9 to 3.8 for once-daily inhaled doses between 60 micrograms and 480 micrograms (delivered dose). 
AUC tijekom 24satnog razdoblja doziranja 14. dana ili 15. dana u usporedbi s 1. danom bio je u rasponu od 2.9 do 3.8 za doze između 60 mikrograma i 480 mikrograma (isporučena doza) inhalirane jedanput na dan.
Cimetidine or other inhibitors of organic cation transport In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%. 
U kliničkom ispitivanju u zdravih dobrovoljaca, cimetidin, inhibitor transporta organskih kationa za koji se vjeruje da doprinosi izlučivanju glikopironija putem bubrega, povećao je ukupnu izloženost (AUC) glikopironiju za 22% te smanjio bubrežni klirens za 23%.
Improvements versus indacaterol and glycopyrronium were 0.26 and 0.21, respectively. 
Poboljšanja naspram indakaterola i glikopironija iznosila su 0,26 odnosno
Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. 
Indakaterol može inhibirati porod zbog učinka relaksacije na glatke mišiće maternice.
What Ultibro Breezhaler looks like and contents of the pack 
Kako Ultibro Breezhaler izgleda i sadržaj pakiranja
Pierce and release 
Probušite i otpustite
Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler. 
Jednostruko pakiranje koje sadrži 6x1, 10x1, 12x1, 30x1 ili 90x1 tvrdih kapsula, zajedno s 1 inhalatorom.
Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients. 
Ultibro Breezhaler se nije ispitivao u bolesnika s loše kontroliranom šećernom bolešću pa se u takvih bolesnika savjetuje oprez i odgovarajuće praćenje.
Clinical studies have not been conducted in patients with hepatic impairment. 
Klinička ispitivanja nisu se provodila u bolesnika s oštećenjem jetre.
Glycopyrronium at the recommended dose can be safely used in all age and body weight groups. 
Glikopironij u preporučenoj dozi može se sigurno primjenjivati u svim dobnim skupinama i skupinama prema tjelesnoj težini.
It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. 
Nije poznato izlučuju li se indakaterol, glikopironij i njihovi metaboliti u majčino mlijeko u ljudi.
Keep the inhaler dry. 
Držite inhalator suhim.
Active tubular secretion contributes to the renal elimination of glycopyrronium. 
Aktivna tubularna sekrecija doprinosi bubrežnoj eliminaciji glikopironija.
Due to the very low contribution of the urinary pathway to total body elimination of indacaterol maleate, a study in renal impaired subjects was not performed. 
Zbog vrlo malog doprinosa mokraćnih puteva u ukupnoj eliminaciji iz tijela, ispitivanje u bolesnika s oštećenjem bubrega nije provedeno.
In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ultibro Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo). 
U zdravih dobrovoljaca nakon primjene doze Ultibro Breezhalera koja je bila 4 puta veća od preporučene terapijske doze, učinak na kalij u serumu bio je vrlo mali (najveća razlika -0,14 mmol/l u usporedbi s placebom).
Glycopyrronium bromide is a high affinity muscarinic receptor antagonist. 
Glikopironijev bromid je antagonist muskarinskih receptora visokog afiniteta.
• difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention. 
• poteškoće i bol kod mokrenja - to bi mogli biti znakovi začepljenja mokraćnog mjehura ili zadržavanja mokraće.
Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ultibro Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol. 
Učinci na srčanu frekvenciju u zdravih dobrovoljaca ispitivani su nakon jedne doze koja je bila 4 puta veća od preporučene terapijske doze Ultibro Breezhalera primijenjene u četiri koraka s razmakom od jedan sat između svakog te uspoređeni s učinkom placeba, indakaterola, glikopironija i salmeterola.
Compared to fluticasone/salmeterol, Ultibro Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231). 
U usporedbi s flutikazonom/salmeterolom, Ultibro Breezhaler smanjio je godišnju stopu umjerenih, kao i teških egzacerbacija za 17% (p<0,001), a teških egzacerbacija (koje zahtijevaju hospitalizaciju) za 13% (nije statistički značajno, p=0,231).
Systemic exposures (AUC) in rats and mice at the no-observed-adverse-effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with indacaterol once a day at the maximum recommended therapeutic dose. 
Sistemska izloženost (AUC) pri razinama na kojima nisu bile zapažene nuspojave u ovim je ispitivanjima u štakora i miševa bila najmanje 7 odnosno 49 puta veća od one u ljudi liječenih indakaterolom jedanput na dan pri najvećoj preporučenoj terapijskoj dozi.
Time to first pneumonia was prolonged with Ultibro Breezhaler compared to fluticasone/salmeterol (p=0.013). 
Vrijeme do prve upale pluća produljeno je s Ultibro Breezhalerom u usporedbi s flutikazonom/salmeterolom (p=0,013).
• One Ultibro Breezhaler inhaler 
• Jedan Ultibro Breezhaler inhalator
The capsules should remain in the blister until you need to use them. 
Kapsule trebaju ostati u blisteru dok ne dođe vrijeme za primjenu.
Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ultibro Breezhaler at the recommended therapeutic dose (see section 5.1). 
U kliničkim ispitivanjima Ultibro Breezhalera nisu bili uočeni klinički značajni učinci hipokalijemije pri preporučenoj terapijskoj dozi (vidjeti dio 5.1).
diuretics (water tablets) used for high blood pressure (such as hydrochlorothiazide), 
To uključuje: steroide (npr. prednizolon), diuretike (tablete za mokrenje) koji se koriste kod visokog krvnog tlaka (kao što je hidroklorotiazid), lijekove za probleme s disanjem (kao što je teofilin).
Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ultibro Breezhaler and indacaterol monotherapy product. 
Na temelju podataka o in vitro rezultatima, očekuje se da će doza indakaterola isporučena u pluća biti slična za Ultibro Breezhaler i za monoterapiju indakaterolom.
In a 64-week study comparing Ultibro Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ultibro Breezhaler reduced the annualised rate of moderate or severe COPD exacerbations by 12% compared to glycopyrronium (p=0.038) and by 10% compared to tiotropium (p=0.096). 
64-tjednom ispitivanju u kojem su se uspoređivali Ultibro Breezhaler (n=729), glikopironij (n=739) i tiotropij (n=737), Ultibro Breezhaler smanjio je godišnju stopu umjerenih ili teških egzacerbacija KOPB-a za 12% u usporedbi s glikopironijem (p=0,038) te za 10% u usporedbi s tiotropijem (p=0,096).
• blocked nose, sneezing, cough, headache with or without fever - these may be signs of an upper respiratory tract infection. 
• začepljen nos, kihanje, kašalj, glavobolja sa ili bez vrućice - to bi mogli biti znakovi infekcije gornjeg dijela dišnog sustava.
Ultibro Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol. 
Ultibro Breezhaler povećao je FEV1 AUC0-12 nakon doze (primarni ishod) za 140 ml u 26. tjednu (p<0,001) u usporedbi s flutikazonom/salmeterolom.
Uncommon Adverse reaction observed with Ultibro Breezhaler, but not with the individual components. 
Nuspojava uočena uz Ultibro Breezhaler, ali ne uz pojedinačne komponente.
• fast heart beat. 
• ubrzani otkucaji srca.
Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ultibro Breezhaler. 
Pušački status i početni FEV1 nisu imali nikakav prividni učinak na sistemsku izloženost indakaterolu i glikopironiju nakon inhalacije Ultibro Breezhalera.
Inhibition or induction of the metabolism of glycopyrronium is unlikely to result in a relevant change of systemic exposure to the active substance. 
Mala je vjerojatnost da će inhibicija ili indukcija metabolizma glikopironija rezultirati relevantnom promjenom u sistemskoj izloženosti djelatnoj tvari.
Close the inhaler and replace the cap. 
Zatvorite inhalator i vratite poklopac.
• Do not blow into the mouthpiece. 
• Ne pušite u nastavak.
Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. 
Unutar svakog organskog sustava, nuspojave su poredane prema učestalosti tako da su najučestalije navedene prve.
Step 2a: 
Korak 2a:
Indacaterol: 
Indakaterol:
Only use the capsules with the inhaler provided in this pack (Ultibro 
Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Ultibro Breezhaler inhalator).
Biliary clearance contributes to the non-renal clearance, but the majority of non-renal clearance is thought to be due to metabolism. 
Klirens preko žuči doprinosi nebubrežnom klirensu, ali smatra se da je većina nebubrežnog klirensa uzrokovana metabolizmom.
Renal impairment has an impact on the systemic exposure to glycopyrronium bromide. 
Oštećenje bubrega ima učinak na sistemsku izloženost glikopironijevom bromidu.
Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder. 
Ultibro Breezhaler 85 mikrograma/43 mikrograma prašak inhalata, tvrde kapsule su bezbojne i žute i sadrže bijeli do gotovo bijeli prašak.
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. 
Beta2-adrenergički agonisti mogu uzrokovati značajnu hipokalijemiju u nekih bolesnika što može uzrokovati kardiovaskularne nuspojave.
Steady state concentrations of indacaterol were achieved within 12 to 15 days following once-daily administration. 
Stanje dinamičke ravnoteže koncentracija indakaterola bilo je postignuto unutar 12 do 15 dana nakon primjene jedanput na dan.
The capsules must always be stored in the original blister to protect from moisture and only removed immediately before use. 
Kapsule se moraju uvijek čuvati u originalnom blisteru radi zaštite od vlage te izvaditi tek neposredno prije primjene.
At 26 weeks (primary endpoint), Ultibro Breezhaler increased trough FEV1 by 80 ml in patients (Ultibro Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ultibro Breezhaler n=392, placebo n=190) with a higher degree of reversibility at baseline (≥5%) compared to placebo (p<0.001). 
U 26 tjedana (primarni ishod), Ultibro Breezhaler povećao je najniži FEV1 za 80 ml u bolesnika (Ultibro Breezhaler n=82; placebo n=42) s najnižim stupnjem reverzibilnosti (<5%) (p=0,053) te za 220 ml u onih bolesnika (Ultibro Breezhaler n=392, placebo n=190) s višim stupnjem reverzibilnosti na početku (≥5%) u usporedbi s placebom (p<0,001).
Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler. 
Rane reakcije preosjetljivosti su bile prijavljene nakon primjene indakaterola ili glikopironija, koji su djelatne tvari Ultibro Breezhalera.