natgillin/translations-raw huggingface dataset:
The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Prikaz sigurnosnog profila temelji se na iskustvu s Ulunar Breezhalerom i pojedinačnim djelatnim tvarima.
During long-term clinical studies, more patients on Ulunar Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Tijekom dugoročnih kliničkih ispitivanja, više je bolesnika koji su koristili Ulunar Breezhaler imalo klinički značajne promjene glukoze u krvi (4,9%) u preporučenoj dozi nego onih koji su primali placebo (2,7%).
Please read the full Instructions for Use before using the Ulunar Breezhaler.
Pročitajte u cijelosti Upute za primjenu prije korištenja Ulunar Breezhalera.
The components of Ulunar Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Za komponente Ulunar Breezhalera nije poznato da imaju potencijal produljenja QT potencijala pri kliničkim razinama doze.
This will also help you to remember to use it. You can inhale Ulunar Breezhaler any time before or after food or drink.
Možete inhalirati Ulunar Breezhaler u bilo kojem trenutku prije ili nakon uzimanja hrane ili pića.
The European Medicines Agency has waived the obligation to submit the results of studies with Ulunar Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Ulunar Breezhalera u svim podskupinama pedijatrijske populacije s kroničnom opstruktivnom plućnom bolešću (KOPB) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
There were no relevant effects of Ulunar Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Nije bilo značajnih učinaka Ulunar Breezhalera na srednju srčanu frekvenciju tijekom 24 h te na srčanu frekvenciju određenu nakon 30 minuta, 4 h i 24 h.
Ulunar Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Ulunar Breezhaler treba primjenjivati s oprezom u bolesnika s kardiovaskularnim poremećajima (bolest koronarnih arteria, akutni infarkt miokarda, srčane aritmije, hipertenzija).
The safety experience with Ulunar Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Iskustvo sa sigurnošću Ulunar Breezhalera obuhvaća izloženost u trajanju do 15 mjeseci pri preporučenoj terapijskoj dozi.
No specific interaction studies were conducted with Ulunar Breezhaler.
Nisu provedena specifična ispitivanja interakcija s Ulunar Breezhalerom.
Ulunar Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ulunar Breezhaler belong (see section 4.5).
Ulunar Breezhaler ne smije se primjenjivati istodobno s lijekovima koji sadrže druge dugodjelujuće beta-adrenergičke agoniste ili dugodjelujuće muskarinske antagoniste, farmakoterapijske skupine kojima pripadaju komponente Ulunar Breezhalera (vidjeti dio 4.5).
The combination of indacaterol and glycopyrronium in Ulunar Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Kombinacija indakaterola i glikopironija u Ulunar Breezhaleru pokazala je brzi nastup djelovanja u roku od 5 minuta od uzimanja doze.
6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
6 ili 10 Ulunar Breezhaler kapsula za korištenje u inhalatoru
Ulunar Breezhaler is used as an ongoing treatment for your COPD.
Ulunar Breezhaler se koristi kao kontinuirana terapija za Vaš KOPB.
The co-administration of Ulunar Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Istodobna primjena Ulunar Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila ispitivana pa se stoga ne preporučuje (vidjeti dio 4.4).
A population pharmacokinetic analysis of data in COPD patients after inhalation of Ulunar 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 Ulunar Breezhalera uputila je na nepostojanje značajnog učinka dobi, spola i (čiste tjelesne) težine na sistemsku izloženost indakaterolu i glikopironiju.
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, Ulunar 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, Ulunar Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
There is no information on clinically relevant overdosing with Ulunar Breezhaler.
Nema informacija o klinički relevantnom predoziranju Ulunar Breezhalerom.
The effects on heart rate for Ulunar Breezhaler increased in magnitude and duration when compared with the changes observed for each component alone consistent with an additive response.
Učinci na srčanu frekvenciju za Ulunar Breezhaler povećali su se opsegom i trajanjem u usporedbi s promjenama uočenima za svaku komponentu zasebno koje su bile dosljedne aditivinom odgovoru.
Ulunar 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.
Ulunar Breezhaler pokazao je klinički značajno poboljšanje plućne funkcije (mjereno forsiranim ekspiratornim volumenom u prvoj sekundi, FEV1) u brojnim kliničkim ispitivanjima.
No effects on the embryo or foetus were seen at any dose level of Ulunar Breezhaler during an embryo-foetal development study in rats.
Nisu uočeni nikakvi učinci na embrio i fetus pri bilo kojoj razini Ulunar Breezhalera tijekom ispitivanja embrio-fetalnog razvoja u štakora.
What Ulunar Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Što Ulunar Breezhaler sadrži - Djelatne tvari su indakaterol (u obliku indakaterolmaleata) i glikopironijev bromid.
Not for acute use Ulunar Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Nije za akutnu primjenu Ulunar Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma.
Indacaterol, one of the active substances in Ulunar Breezhaler, may prevent labour due to its effect on the uterus.
Indakaterol, jedna od djelatnih tvari Ulunar Breezhalera, može spriječiti porod zbog njegovog utjecaja na maternicu.
There are no data available for the use of Ulunar Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
Nema dostupnih podataka o primjeni Ulunar Breezhalera u bolesnika s teškim oštećenjem jetre, stoga je potreban oprez u tih bolesnika (vidjeti dio 5.2).
How to inhale Ulunar Breezhaler - Ulunar Breezhaler is for inhalation use.
Kako inhalirati Ulunar Breezhaler - Ulunar Breezhaler je za primjenu inhalacijom.
Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Ulunar Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
Show the pack of Ulunar Breezhaler.
Pokažite pakiranje Ulunar Breezhalera.
Increased heart rates were apparent in dogs at all doses of Ulunar Breezhaler and each monotherapy component.
Povišene srčane frekvencije bile su uočljive u pasa pri svim dozama Ulunar Breezhalera i uz monoterapiju svakom od komponenti.
Indacaterol administered to dogs alone or in Ulunar Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Indakaterol primijenjen u pasa sam ili u Ulunar Breezhaleru bio je povezan sa sličnom incidencijom i težinom lezija miokarda.
The highest dose level of 464 micrograms/86 micrograms Ulunar 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 mikrogramaUlunar Breezhalera također su pokazale viši udio apsolutnih vrijednosti QTcF-a >450 ms (12,2% u usporedbi s 5,7% za placebo).
Ulunar Breezhaler showed similar adverse reactions to the individual components.
Ulunar Breezhaler imao je slične nuspojave kao i pojedinačne komponente.
Only use the capsules with the inhaler provided in this pack (Ulunar
Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Ulunar Breezhaler inhalator).
Ulunar Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Ulunar Breezhaler nadalje je pokazao superiornost u smanjivanju godišnje stope svih egzacerbacija za 11% naspram flutikazona/salmeterola (p=0,003).
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 Ulunar 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 Ulunar Breezhaler nije imao relevantan utjecaj na QT interval, kao što se očekivalo na temelju svojstava njegovih komponenti.
Administration of Ulunar Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Primjena Ulunar Breezhalera može dovesti doparadoksalnog bronhospazma koji može biti opasan po život.
There are no data from the use of Ulunar Breezhaler in pregnant women available.
Nema dostupnih podataka o primjeni Ulunar Breezhalera u trudnica.
What Ulunar Breezhaler is and what it is used for
Što je Ulunar Breezhaler i za što se koristi
The effects of Ulunar Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Ulunar Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Učinci Ulunar Breezhalera na QTc interval istraživani su u zdravih dobrovoljaca nakon inhalacije Ulunar 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.
Ulunar 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.
Ulunar Breezhaler se nije ispitivao u bolesnika s loše kontroliranom šećernom bolešću pa se u takvih bolesnika savjetuje oprez i odgovarajuće praćenje.
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 mikrogramai 480 mikrograma (isporučena doza) inhalirane jedanput na dan.
Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.
Jedno pakiranje koje sadrži 6x1, 10x1, 12x1, 30x1 ili 90x1 tvrdih kapsula, zajedno s 1 inhalatorom.
In patients with severe renal impairment or end-stage renal disease requiring dialysis, Ulunar 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, Ulunar Breezhaler smije se koristiti samo ako očekivana korist premašuje potencijalne rizike.
Uncommon Adverse reaction observed with Ulunar Breezhaler, but not with the individual components.
Nuspojava uočena uz Ulunar Breezhaler, ali ne uz pojedinačne komponente.
Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ulunar 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 Ulunar Breezhalera primijenjene u četiri koraka s razmakom od jedan sat između svakog te uspoređeni s učinkom placeba, indakaterola, glikopironija i salmeterola.
Time to first pneumonia was prolonged with Ulunar Breezhaler compared to fluticasone/salmeterol (p=0.013).
Vrijeme do prve upale pluća produljeno je s Ulunar Breezhalerom u usporedbi s flutikazonom/salmeterolom (p=0,013).
In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Ulunar 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 Ulunar 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).
Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Ulunar Breezhaler.
Pušački status i početni FEV1 nisu imali nikakav prividni učinak na sistemsku izloženost indakaterolu i glikopironiju nakon inhalacije Ulunar Breezhalera.
Following inhalation of Ulunar Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Nakon inhalacije Ulunar Breezhalera medijan vremena do postizanja vršne koncentracije indakaterola odnosno glikopironija u plazmi bilo je otprilike 15 minuta odnosno 5 minuta.
Compared to fluticasone/salmeterol, Ulunar 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, Ulunar 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).
In a 64-week study comparing Ulunar Breezhaler (n=729), glycopyrronium (n=739) and tiotropium (n=737), Ulunar 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 Ulunar Breezhaler (n=729), glikopironij (n=739) i tiotropij (n=737), Ulunar 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).
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.
U 52-tjedno, 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.
Clinically relevant effects of hypokalaemia have not been observed in clinical studies of Ulunar Breezhaler at the recommended therapeutic dose (see section 5.1).
U kliničkim ispitivanjima Ulunar Breezhalera nisu bili uočeni klinički značajni učinci hipokalijemije pri preporučenoj terapijskoj dozi (vidjeti dio 5.1).
Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ulunar Breezhaler and indacaterol monotherapy product.
Na temelju podataka o in vitro rezultatima, očekuje se da će doza indakaterola isporučena u pluća biti slična za Ulunar Breezhaler i za monoterapiju indakaterolom.
Ulunar Breezhaler increased post-dose FEV1 AUC0-12 (primary endpoint) by 140 ml at 26 weeks (p<0.001) compared to fluticasone/salmeterol.
Ulunar Breezhaler povećao je FEV1 AUC0-12 nakon doze (primarni ishod) za 140 ml u 26. tjednu (p<0,001) u usporedbi s flutikazonom/salmeterolom.
Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ulunar Breezhaler.
Rane reakcije preosjetljivosti su bile prijavljene nakon primjene indakaterola ili glikopironija, koji su djelatne tvari Ulunar Breezhalera.
At 26 weeks (primary endpoint), Ulunar Breezhaler increased trough FEV1 by 80 ml in patients (Ulunar Breezhaler n=82; placebo n=42) with the lowest degree of reversibility (<5%) (p=0.053) and by 220 ml in those patients (Ulunar 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), Ulunar Breezhaler povećao je najniži FEV1 za 80 ml u bolesnika (Ulunar Breezhaler n=82; placebo n=42) s najnižim stupnjem reverzibilnosti (<5%) (p=0,053) te za 220 ml u onih bolesnika (Ulunar Breezhaler n=392, placebo n=190) s višim stupnjem reverzibilnosti na početku (≥5%) u usporedbi s placebom (p<0,001).
In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Ulunar 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.
U bolesnika s KOPB-om, supraterapijske doze između 116 mikrograma/86 mikrograma i 464 mikrograma/86 mikrogramaUlunar 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.
No data are available in patients with urinary retention, therefore Ulunar Breezhaler should be used with caution in these patients.
Nema dostupnih podataka u bolesnika s urinarnom retencijom, stoga se Ulunar Breezhaler mora koristiti s oprezom u tih bolesnika.
A statistically significantly higher percentage of patients receiving Ulunar 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).
Statistički značajno viši postotak bolesnika koji su primali Ulunar 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).
In the 52-week study comparing Ulunar Breezhaler (n=1,675) and fluticasone/salmeterol (n=1,679), Ulunar Breezhaler met the primary study objective of non-inferiority in rate of all COPD exacerbations (mild, moderate or severe) compared to fluticasone/salmeterol.
U 52-tjednom ispitivanju kojim se uspoređivao Ulunar Breezhaler (n=1675) s flutikazonom/salmeterolom (n=1679), Ulunar Breezhaler ispunio je primarni cilj ispitivanja, neinferiornost s obzirom na stopu svih egzacerbacija KOPB-a (blagih, umjerenih ili teških) u usporedbi s flutikazonom/salmeterolom.
• Do not use the Ulunar Breezhaler inhaler to take any other capsule medicine.
• Nemojte koristiti Ulunar Breezhaler inhalator za uzimanje kapsula bilo kojeg drugog lijeka.
Ulunar 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).
Ulunar 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).
Ulunar 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).
Ulunar 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).
Do not use Ulunar Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Što morate znati prije nego počnete primjenjivati Ulunar Breezhaler Nemojte primjenjivati Ulunar Breezhaler - ako ste alergični na indakaterol ili glikopironij ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
The incidence of pneumonia was 3.2% in the Ulunar Breezhaler arm compared to 4.8% in the fluticasone/salmeterol arm (p=0.017).
Incidencija upale pluća bila je 3,2% u terapijskoj skupini s Ulunar Breezhalerom u usporedbi s 4,8% u terapijskoj skupini s flutikazonom/salmeterolom (p=0,017).
At week 26, Ulunar 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).
U 26. tjednu Ulunar 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).
Over 52 weeks, Ulunar Breezhaler reduced the use of rescue medication by 0.25 puffs per day compared to fluticasone/salmeterol (p<0.001).
Tijekom 52 tjedna, Ulunar Breezhaler smanjio je primjenu lijeka za hitno ublažavanja simptoma za 0,25 udisaja dnevno u usporedbi s flutikazonom/salmeterolom (p<0,001).
Ulunar Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Ulunar Breezhaler potrebno je koristiti s oprezom u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajen odgovor na beta2-adrenergičke agoniste.
Upon initiation of treatment with Ulunar Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Nakon početka liječenja Ulunar Breezhalerom, u bolesnika sa šećernom bolešću treba pomno pratiti glukozu u plazmi.
• One Ulunar Breezhaler inhaler
• Jedan Ulunar Breezhaler inhalator
If you forget to use Ulunar Breezhaler
Ako ste zaboravili uzeti Ulunar Breezhaler
No data are available in patients with narrow-angle glaucoma, therefore Ulunar Breezhaler should be used with caution in these patients.
Nema dostupnih podataka u bolesnika s glaukomom uskog kuta, stoga se Ulunar Breezhaler mora koristiti s oprezom u tih bolesnika.
In another study comparing Ulunar Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks , the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patients-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
U drugom ispitivanju u kojem se uspoređivao Ulunar Breezhaler (n=258) s flutikazonom/salmeterolom (n=264) tijekom 26 tjedana, broj umjerenih ili teških egzacerbacija KOPB-a/bolesnik-godine bio je 0,15 odnosno 0,18 (18 događaja naspram 22 događaja), (p=0,512), a broj svih egzacerbacija KOPB-a/bolesnik-godine (blagih, umjerenih ili teških) bio je 0,72 naspram 0,94 (86 događaja naspram 113 događaja), (p=0,098).