FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol were further prominent metabolites.
Croatian: Fenolni O-glukuronidi indakaterola i hidroksilirani indakaterol bili su drugi važni metaboliti.
English: 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).
Croatian: Nema dostupnih podataka o primjeni Ultibro Breezhalera u bolesnika s teškim oštećenjem jetre, stoga je potreban oprez u tih bolesnika (vidjeti dio 5.2).
English: Ultibro Breezhaler showed similar adverse reactions to the individual components.
Croatian: Ultibro Breezhaler imao je slične nuspojave kao i pojedinačne komponente.
English: Step 1d:
Croatian: Korak 1d:
English: There are no data from the use of Ultibro Breezhaler in pregnant women available.
Croatian: Nema dostupnih podataka o primjeni Ultibro Breezhalera u trudnica.
English: A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified.
Croatian: Dijastereomer hidroksiliranog derivata, N-glukuronid indakaterola i C- i N-dealkilirani produkti bili su sljedeći identificirani metaboliti.
English: Serum potassium and blood glucose
Croatian: Kalij u serumu i glukoza u krvi
English: 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.
Croatian: 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.
English: Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Croatian: Gikopironij djeluje tako da blokira bronhokonstriktorno djelovanje acetilkolina na glatke mišićne stanice dišnih puteva, te time širi dišne puteve.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine prema učestalosti, nuspojave su navedene od najozbiljnijih prema manje ozbiljnima.
English: Multiple CYP isoenzymes contribute to the oxidative biotransformation of glycopyrronium.
Croatian: Više CYP izoenzima doprinose oksidativnoj biotransformaciji glikopironija.
English: 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.
Croatian: Nakon inhalacije Ultibro Breezhalera medijan vremena do postizanja vršne koncentracije indakaterola odnosno glikopironija u plazmi bilo je otprilike 15 minuta odnosno 5 minuta.
English: 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.
Croatian: 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.
English: Your Ultibro Breezhaler Inhaler pack contains:
Croatian: Vaše pakiranje Ultibro Breezhaler inhalatora sadrži:
English: • eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of glaucoma.
Croatian: • 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.
English: 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).
Croatian: 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.
English: 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%.
Croatian: 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%.
English: Improvements versus indacaterol and glycopyrronium were 0.26 and 0.21, respectively.
Croatian: Poboljšanja naspram indakaterola i glikopironija iznosila su 0,26 odnosno
English: Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Croatian: Indakaterol može inhibirati porod zbog učinka relaksacije na glatke mišiće maternice.
English: What Ultibro Breezhaler looks like and contents of the pack
Croatian: Kako Ultibro Breezhaler izgleda i sadržaj pakiranja
English: Pierce and release
Croatian: Probušite i otpustite
English: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Croatian: Jednostruko pakiranje koje sadrži 6x1, 10x1, 12x1, 30x1 ili 90x1 tvrdih kapsula, zajedno s 1 inhalatorom.
English: 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.
Croatian: Ultibro Breezhaler se nije ispitivao u bolesnika s loše kontroliranom šećernom bolešću pa se u takvih bolesnika savjetuje oprez i odgovarajuće praćenje.
English: Clinical studies have not been conducted in patients with hepatic impairment.
Croatian: Klinička ispitivanja nisu se provodila u bolesnika s oštećenjem jetre.
English: Glycopyrronium at the recommended dose can be safely used in all age and body weight groups.
Croatian: Glikopironij u preporučenoj dozi može se sigurno primjenjivati u svim dobnim skupinama i skupinama prema tjelesnoj težini.
English: It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se indakaterol, glikopironij i njihovi metaboliti u majčino mlijeko u ljudi.
English: Keep the inhaler dry.
Croatian: Držite inhalator suhim.
English: Active tubular secretion contributes to the renal elimination of glycopyrronium.
Croatian: Aktivna tubularna sekrecija doprinosi bubrežnoj eliminaciji glikopironija.
English: 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.
Croatian: Zbog vrlo malog doprinosa mokraćnih puteva u ukupnoj eliminaciji iz tijela, ispitivanje u bolesnika s oštećenjem bubrega nije provedeno.
English: 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).
Croatian: 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).
English: Glycopyrronium bromide is a high affinity muscarinic receptor antagonist.
Croatian: Glikopironijev bromid je antagonist muskarinskih receptora visokog afiniteta.
English: • difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention.
Croatian: • poteškoće i bol kod mokrenja - to bi mogli biti znakovi začepljenja mokraćnog mjehura ili zadržavanja mokraće.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Time to first pneumonia was prolonged with Ultibro Breezhaler compared to fluticasone/salmeterol (p=0.013).
Croatian: Vrijeme do prve upale pluća produljeno je s Ultibro Breezhalerom u usporedbi s flutikazonom/salmeterolom (p=0,013).
English: • One Ultibro Breezhaler inhaler
Croatian: • Jedan Ultibro Breezhaler inhalator
English: The capsules should remain in the blister until you need to use them.
Croatian: Kapsule trebaju ostati u blisteru dok ne dođe vrijeme za primjenu.
English: Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ultibro Breezhaler at the recommended therapeutic dose (see section 5.1).
Croatian: U kliničkim ispitivanjima Ultibro Breezhalera nisu bili uočeni klinički značajni učinci hipokalijemije pri preporučenoj terapijskoj dozi (vidjeti dio 5.1).
English: diuretics (water tablets) used for high blood pressure (such as hydrochlorothiazide),
Croatian: 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).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: • blocked nose, sneezing, cough, headache with or without fever - these may be signs of an upper respiratory tract infection.
Croatian: • začepljen nos, kihanje, kašalj, glavobolja sa ili bez vrućice - to bi mogli biti znakovi infekcije gornjeg dijela dišnog sustava.
English: Ultibro Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Croatian: 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.
English: Uncommon Adverse reaction observed with Ultibro Breezhaler, but not with the individual components.
Croatian: Nuspojava uočena uz Ultibro Breezhaler, ali ne uz pojedinačne komponente.
English: • fast heart beat.
Croatian: • ubrzani otkucaji srca.
English: Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ultibro Breezhaler.
Croatian: Pušački status i početni FEV1 nisu imali nikakav prividni učinak na sistemsku izloženost indakaterolu i glikopironiju nakon inhalacije Ultibro Breezhalera.
English: Inhibition or induction of the metabolism of glycopyrronium is unlikely to result in a relevant change of systemic exposure to the active substance.
Croatian: Mala je vjerojatnost da će inhibicija ili indukcija metabolizma glikopironija rezultirati relevantnom promjenom u sistemskoj izloženosti djelatnoj tvari.
English: Close the inhaler and replace the cap.
Croatian: Zatvorite inhalator i vratite poklopac.
English: • Do not blow into the mouthpiece.
Croatian: • Ne pušite u nastavak.
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava, nuspojave su poredane prema učestalosti tako da su najučestalije navedene prve.
English: Step 2a:
Croatian: Korak 2a:
English: Indacaterol:
Croatian: Indakaterol:
English: Only use the capsules with the inhaler provided in this pack (Ultibro
Croatian: Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Ultibro Breezhaler inhalator).
English: Biliary clearance contributes to the non-renal clearance, but the majority of non-renal clearance is thought to be due to metabolism.
Croatian: Klirens preko žuči doprinosi nebubrežnom klirensu, ali smatra se da je većina nebubrežnog klirensa uzrokovana metabolizmom.
English: Renal impairment has an impact on the systemic exposure to glycopyrronium bromide.
Croatian: Oštećenje bubrega ima učinak na sistemsku izloženost glikopironijevom bromidu.
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Croatian: Ultibro Breezhaler 85 mikrograma/43 mikrograma prašak inhalata, tvrde kapsule su bezbojne i žute i sadrže bijeli do gotovo bijeli prašak.
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Croatian: Beta2-adrenergički agonisti mogu uzrokovati značajnu hipokalijemiju u nekih bolesnika što može uzrokovati kardiovaskularne nuspojave.
English: Steady state concentrations of indacaterol were achieved within 12 to 15 days following once-daily administration.
Croatian: Stanje dinamičke ravnoteže koncentracija indakaterola bilo je postignuto unutar 12 do 15 dana nakon primjene jedanput na dan.
English: The capsules must always be stored in the original blister to protect from moisture and only removed immediately before use.
Croatian: Kapsule se moraju uvijek čuvati u originalnom blisteru radi zaštite od vlage te izvaditi tek neposredno prije primjene.
English: 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).
Croatian: 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).
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ultibro Breezhaler.
Croatian: Rane reakcije preosjetljivosti su bile prijavljene nakon primjene indakaterola ili glikopironija, koji su djelatne tvari Ultibro Breezhalera.
English: The incidence of pneumonia was 3.2% in the Ultibro Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Croatian: Incidencija upale pluća bila je 3,2% u terapijskoj skupini s Ultibro Breezhalerom u usporedbi s 4,8% u terapijskoj skupini s flutikazonom/salmeterolom (p=0,017).
English: No data are available in patients with urinary retention, therefore Ultibro Breezhaler should be used with caution in these patients.
Croatian: Nema dostupnih podataka u bolesnika s urinarnom retencijom, stoga se Ultibro Breezhaler mora koristiti s oprezom u tih bolesnika.
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Mišićno-koštana bol
English: A statistically significantly higher percentage of patients receiving Ultibro Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (68.1% and 57.5% respectively, p=0.004).
Croatian: Statistički značajno viši postotak bolesnika koji su primali Ultibro Breezhaler odgovorio je s poboljšanjem od 1 boda ili više u TDI fokalnom rezultatu u 26. tjednu u usporedbi s placebom (68,1% naspram 57,5%, p=0,004).
English: In the 52-week activecontrolled study, patients were enrolled who had moderate to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Croatian: U 52tjedno, aktivno kontrolirano ispitivanje uključeni su bolesnici s umjerenim do vrlo teškim KOPB-om s ≥1 umjerenom ili teškom egzacerbacijom KOPB-a u anamnezi u protekloj godini.
English: In the 52-week study comparing Ultibro Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ultibro Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
Croatian: U 52-tjednom ispitivanju kojim se uspoređivao Ultibro Breezhaler (n=1675) s flutikazonom/salmeterolom (n=1679), Ultibro Breezhaler ispunio je primarni cilj ispitivanja, neinferiornost s obzirom na stopu svih egzacerbacija KOPB-a (blagih, umjerenih ili teških) u usporedbi s flutikazonom/salmeterolom.
English: Show the pack of Ultibro Breezhaler.
Croatian: Pokažite pakiranje Ultibro Breezhalera.
English: Ultibro Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Croatian: Ultibro Breezhaler produljio je vrijeme do prve umjerene ili teške egzacerbacije uz smanjenje rizika od egzacerbacije za 22% (p<0,001), te produljio vrijeme do prve teške egzacerbacije, uz smanjenja rizika od egzacerbacije za 19% (p=0,046).
English: Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD.
Croatian: Glikopironij je inhalacijski dugodjelujući antagonist muskarinskih receptora (antikolinergik) za održavanje bronhodilatacijskog liječenja KOPB-a jedanput na dan.
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp), raises the systemic exposure of indacaterol up to two-fold.
Croatian: Metaboličke interakcije i interakcije temeljene na transporteru Inhibicija ključnih čimbenika koji pridonose klirensu indakaterola, CYP3A4 i P-glikoprotein (P-gp), podiže sistemsku izloženost indakaterola do dva puta.
English: Heart rate in COPD patients at supratherapeutic dose levels was investigated.
Croatian: Ispitivana je srčana frekvencija u bolesnika s KOPB-om pri supraterapijskim razinama doze.
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Ultibro Breezhaler showed a higher proportion of patients with QTcF increases vs. baseline between 30 ms and 60 ms (ranging from 16.0% to 21.6% vs. 1.9% for placebo), but there were no QTcF increases >60 ms from baseline.
Croatian: U bolesnika s KOPB-om, supraterapijske doze između 116 mikrograma/86 mikrograma i 464 mikrograma/86 mikrograma Ultibro Breezhalera pokazale su viši udio bolesnika s povećanjima QTcF-a u odnosu na početnu vrijednost između 30 ms i 60 ms (u rasponu od 16,0% do 21,6%, u usporedbi s 1,9% za placebo), ali nije bilo povećanja QTcF-a >60 ms od početne vrijednosti.
English: In the 64-week study patients were enrolled who had severe to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
Croatian: U 64-tjedno ispitivanje bili su uključeni bolesnici koji su imali težak do vrlo težak KOPB s ≥1 umjerenom ili teškom egzacerbacijom KOPB-a u anamnezi u protekloj godini.
English: What Ultibro Breezhaler is and what it is used for
Croatian: Što je Ultibro Breezhaler i za što se koristi
English: For instructions on use of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o korištenju lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
English: Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon početka liječenja Ultibro Breezhalerom, u bolesnika sa šećernom bolešću treba pomno pratiti glukozu u plazmi.
English: • palpitations - signs of abnormal heart beat.
Croatian: • osjećaj lupanja srca - znakovi nepravilnih otkucaja srca.
English: Ultibro Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Croatian: Ultibro Breezhaler također je statistički značajno smanjio godišnju stopu svih egzacerbacija KOPB-a (blagih, umjerenih ili teških) za 15% u usporedbi s glikopironijem (p=0,001) i za 14% u usporedbi s tiotropijem (p=0,002).
English: Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.
Croatian: Kapsule čuvati u originalnom blisteru radi zaštite od vlage i izvaditi tek neposredno prije primjene.
English: At week 26, Ultibro Breezhaler produced statistically significant improvement in peak FEV1 compared to placebo in the first 4 hours post dose (LS mean treatment difference 330 ml) (p<0.001).
Croatian: U 26. tjednu Ultibro Breezhaler proizveo je statistički značajno poboljšanje vršnog FEV1 u usporedbi s placebom u prva 4 sata nakon doze (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 330 ml) (p<0,001).
English: Ultibro Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Croatian: Ultibro Breezhaler potrebno je koristiti s oprezom u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajen odgovor na beta2-adrenergičke agoniste.
English: • irregular heartbeat.
Croatian: • nepravilni otkucaji srca.