FrancophonIA/ELRC3.0 huggingface dataset:
English: Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Croatian: Pelgraz se daje kao pojedinačna doza od 6 mg koja se ubrizgava ispod kože najmanje 24 sata nakon kraja svakog ciklusa kemoterapije (terapije protiv raka).
English: What is Pelgraz and what is it used for?
Croatian: Što je Pelgraz i za što se koristi?
English: Pelgraz is a ‘biosimilar medicine'.
Croatian: Pelgraz je „biosličan lijek”.
English: Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz.
Croatian: Budući da je lijek Pelgraz biosličan lijek, ispitivanja djelotvornosti i sigurnosti pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Pelgraz.
English: Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Pelgraz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Pelgraz ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
English: Pelgraz can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Croatian: Pelgraz izdaje se samo na liječnički recept, a terapiju mora započeti i pratiti liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: An overview of Pelgraz and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Pelgraz i zašto je odobren u EU-u
English: Why is Pelgraz authorised in the EU?
Croatian: Zašto je lijek Pelgraz odobren u EU-u?
English: What are the risks associated with Pelgraz?
Croatian: Koji su rizici povezani s lijekom Pelgraz?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelgraz have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Pelgraz nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Pelgraz, kao i od lijeka Neulasta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: The reference medicine for Pelgraz is Neulasta.
Croatian: Referentni lijek za Pelgraz je Neulasta.
English: Other information about Pelgraz
Croatian: Ostale informacije o lijeku Pelgraz
English: Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Croatian: Pelgraz nije namijenjen za korištenje u bolesnika s rakom krvi, kroničnom mijeloičnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara veliki broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: In addition, a study involving 589 patients who had chemotherapy after surgery for breast cancer showed that Pelgraz was as effective as Neulasta in reducing the duration of neutropenia.
Croatian: Nadalje, ispitivanje koje je obuhvaćalo 589 bolesnika koji su prošli kemoterapiju nakon operativnog zahvata zbog raka dojke pokazalo je da je Pelgraz jednako učinkovit kao Neulasta u smanjivanju trajanja neutropenije.
English: As for all medicines, data on the use of Pelgraz are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Pelgraz kontinuirano se prate.
English: How does Pelgraz work?
Croatian: Kako djeluje Pelgraz?
English: For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Pelgraz pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Pelgraz, pegfilgrastim, sastoji se od filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta granulocita (G-CSF).
English: Pelgraz is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Pelgraz je lijek koji se primjenjuje u bolesnika s rakom radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: All these data were considered sufficient to conclude that Pelgraz will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Pelgraz za odobrene indikacije djelovati na isti način kao lijek Neulasta u pogledu djelotvornosti i sigurnosti.
English: In addition, a study in breast cancer patients undergoing chemotherapy has shown that the effectiveness of Pelgraz is equivalent to that of Neulasta in reducing the duration of neutropenia.
Croatian: Nadalje, u ispitivanju provedenom na bolesnicima s rakom dojke koji prolaze kemoterapiju pokazalo se da je djelotvornost lijeka Pelgraz jednaka djelotvornosti lijeka Neulasta u skraćivanju trajanja neutropenije.
English: How is Pelgraz used?
Croatian: Kako se Pelgraz koristi?
English: In Pelgraz, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Pelgraz filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: Laboratory studies comparing Pelgraz with Neulasta have shown that the active substance in Pelgraz is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Pelgraz i Neulasta pokazala su da je djelatna tvar u lijeku Pelgraz vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Croatian: stvaranje više bijelih krvnih stanica, što dovodi do povećanja broja bijelih krvnih stanica i liječenja neutropenije.
English: Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta.
Croatian: Ispitivanja su pokazala i da primjena lijeka Pelgraz dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Neulasta.
English: For the full list of side effects and restrictions with Pelgraz, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Pelgraz potražite u uputi o lijeku.
English: What benefits of Pelgraz have been shown in studies?
Croatian: Koje su koristi od lijeka Pelgraz utvrđene u ispitivanjima?
English: Pelgraz received a marketing authorisation valid throughout the EU on 21 September 2018.
Croatian: Pelgraz (pegfilgrastim) EMA/518618/2018
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2019.
English: COPD is a long-term disease and you should use Ulunar Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: KOPB je dugoročna bolest i trebate primijeniti Ulunar Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: Ulunar Breezhaler is recommended to be administered at the same time of the day each day.
Croatian: Preporučuje se da se Ulunar Breezhaler primjenjuje u isto vrijeme svakoga dana.
English: The safety and efficacy of Ulunar Breezhaler in children have not been established.
Croatian: Sigurnost i djelotvornost Ulunar Breezhalera u djece nisu ustanovljeni.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ulunar Breezhaler should any of these signs or symptoms develop.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Ulunar Breezhaler ako se pojavi bilo koji od tih znakova i simptoma.
English: - When you start a new pack, use the new Ulunar Breezhaler inhaler that is supplied in the pack.
Croatian: - Kada otvorite novo pakiranje, upotrijebite novi Ulunar Breezhaler inhalator koji je priložen u pakiranju.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ulunar Breezhaler inhaler.
Croatian: Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Ulunar Breezhaler inhalatora.
English: Talk to your doctor, pharmacist or nurse before using Ulunar Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Ulunar Breezhaler ako se bilo što od navedenoga odnosi na Vas: - ako imate astmu - ovaj lijek se ne smije koristiti za liječenje astme.
English: There is no relevant use of Ulunar Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Ulunar Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ulunar Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Croatian: Druge najčešće nuspojave povezane s lijekom (u najmanje 3% bolesnika za Ulunar Breezhaler i uz to češće nego za placebo) bile su kašalj, nazofaringitis i glavobolja.
English: Ulunar Breezhaler should be used with caution in these patient groups.
Croatian: Ulunar Breezhaler treba koristiti s oprezom u tih skupina bolesnika.
English: Therefore Ulunar Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Croatian: Zbog toga Ulunar Breezhaler ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje uvjerljivi razlozi.
English: The capsules must be administered only using the Ulunar Breezhaler inhaler (see section 6.6).
Croatian: Kapsule se moraju primjenjivati isključivo korištenjem inhalatora Ulunar Breezhaler (vidjeti dio 6.6).
English: Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Croatian: 08210 Barberà del Vallès, Barcelona Španjolska
English: You should not use Ulunar Breezhaler unless your doctor tells you to do so.
Croatian: Nemojte koristiti Ulunar Breezhaler osim ako Vam to nije rekao liječnik.
English: If you use more Ulunar Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Croatian: Ako ste inhalirali previše ovog lijeka ili ako netko zabunom uzme Vaše kapsule, morate odmah obavijestiti svog liječnika ili otići u najbližu hitnu pomoć.
English: The effect was significantly greater for Ulunar Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Croatian: Učinak je bio značajno veći za Ulunar Breezhaler kada se uspoređuje sa samim indakaterolom, glikopironijem ili tiotropijem (razlika 110 ml, za svaku usporedbu).
English: If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Croatian: Ako se pojave znakovi koji ukazuju na alergijsku reakciju osobito angioedem (poteškoće u disanju ili gutanju, oticanje jezika, usana i lica), urtikarija ili osip na koži, liječenje treba odmah prekinuti i započeti alternativnu terapiju.
English: Therefore, Ulunar Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Croatian: Stoga se Ulunar Breezhaler smije koristiti tijekom trudnoće samo ako očekivana korist za bolesnika opravdava potencijalni rizik za fetus.
English: Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Ulunar Breezhaler.
Croatian: Sveukupno, učinak na srčanu frekvenciju tijekom vremena nije pokazao dosljedan farmakodinamički učinak Ulunar Breezhalera.
English: • Ulunar Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Croatian: • Ulunar Breezhaler kapsule moraju se uvijek čuvati u blister kartici i izvaditi tek neposredno prije primjene.
English: There was no evidence for tachyphylaxis to the effect of Ulunar Breezhaler over time when compared to placebo or its monotherapy components.
Croatian: Nije bilo dokaza tahifilaksije na učinak Ulunar Breezhalera tijekom vremena u usporedbi s placebom ili monoterapijama njegovim komponentama.
English: Ulunar Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Croatian: Ulunar Breezhaler, primijenjen ujutro, smanjio je dinamičku hiperinflaciju i povećao vrijeme tijekom kojeg se može održavati napor od prve doze nadalje.
English: The use of Ulunar Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Croatian: Primjenu Ulunar Breezhalera u dojilja treba uzeti u obzir samo ako je očekivana korist za ženu veća od bilo kojeg mogućeg rizika za dojenče (vidjeti dio 5.3).
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
Croatian: - Drugi sastojci praška inhalata su laktoza hidrat i magnezijev stearat stearat (vidjeti dio 2 ispod „Ulunar Breezhaler sadrži laktozu“).
English: What Ulunar Breezhaler is and what it is used for What you need to know before you use Ulunar Breezhaler How to use Ulunar Breezhaler Possible side effects
Croatian: Što je Ulunar Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Ulunar Breezhaler Kako primjenjivati Ulunar Breezhaler Moguće nuspojave
English: Ulunar Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Croatian: Astma Ulunar Breezhaler ne smije se koristiti za liječenje astme zbog nedostatka podataka u ovoj indikaciji.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP),, koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMPa.
English: Following inhalation of Ulunar Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Croatian: Nakon inhalacije Ulunar Breezhalera apsolutna bioraspoloživost indakaterola procijenjena je na raspon od 61 do 85% isporučene doze, i za glikopironij oko 47% isporučene doze.
English: Ulunar Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Croatian: Ulunar Breezhaler se može koristiti u preporučenoj dozi u starijih bolesnika (u dobi od 75 i više godina).
English: When indacaterol and glycopyrronium are administered together in Ulunar Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Croatian: Kada se indakaterol i glikopironij primjenjuju zajedno u Ulunar Breezhaleru, pružaju dodatnu djelotvornost zbog svog različitog mehanizma djelovanja koji je usmjeren na različite receptore i puteve da bi se postiglo opuštanje glatkih mišića.
English: The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Croatian: Prikaz sigurnosnog profila temelji se na iskustvu s Ulunar Breezhalerom i pojedinačnim djelatnim tvarima.
English: 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%).
Croatian: 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%).
English: Please read the full Instructions for Use before using the Ulunar Breezhaler.
Croatian: Pročitajte u cijelosti Upute za primjenu prije korištenja Ulunar Breezhalera.
English: The components of Ulunar Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Croatian: Za komponente Ulunar Breezhalera nije poznato da imaju potencijal produljenja QT potencijala pri kliničkim razinama doze.
English: This will also help you to remember to use it. You can inhale Ulunar Breezhaler any time before or after food or drink.
Croatian: Možete inhalirati Ulunar Breezhaler u bilo kojem trenutku prije ili nakon uzimanja hrane ili pića.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Ulunar Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Croatian: Ulunar Breezhaler treba primjenjivati s oprezom u bolesnika s kardiovaskularnim poremećajima (bolest koronarnih arteria, akutni infarkt miokarda, srčane aritmije, hipertenzija).
English: The safety experience with Ulunar Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Croatian: Iskustvo sa sigurnošću Ulunar Breezhalera obuhvaća izloženost u trajanju do 15 mjeseci pri preporučenoj terapijskoj dozi.
English: No specific interaction studies were conducted with Ulunar Breezhaler.
Croatian: Nisu provedena specifična ispitivanja interakcija s Ulunar Breezhalerom.
English: 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).
Croatian: 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).
English: The combination of indacaterol and glycopyrronium in Ulunar Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Croatian: Kombinacija indakaterola i glikopironija u Ulunar Breezhaleru pokazala je brzi nastup djelovanja u roku od 5 minuta od uzimanja doze.
English: 6 or 10 Ultibro Breezhaler capsules to be used in the inhaler
Croatian: 6 ili 10 Ulunar Breezhaler kapsula za korištenje u inhalatoru
English: Ulunar Breezhaler is used as an ongoing treatment for your COPD.
Croatian: Ulunar Breezhaler se koristi kao kontinuirana terapija za Vaš KOPB.
English: 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).
Croatian: Istodobna primjena Ulunar Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila ispitivana pa se stoga ne preporučuje (vidjeti dio 4.4).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: There is no information on clinically relevant overdosing with Ulunar Breezhaler.
Croatian: Nema informacija o klinički relevantnom predoziranju Ulunar Breezhalerom.
English: 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.
Croatian: 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.
English: 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.
Croatian: Ulunar Breezhaler pokazao je klinički značajno poboljšanje plućne funkcije (mjereno forsiranim ekspiratornim volumenom u prvoj sekundi, FEV1) u brojnim kliničkim ispitivanjima.
English: No effects on the embryo or foetus were seen at any dose level of Ulunar Breezhaler during an embryo-foetal development study in rats.
Croatian: Nisu uočeni nikakvi učinci na embrio i fetus pri bilo kojoj razini Ulunar Breezhalera tijekom ispitivanja embrio-fetalnog razvoja u štakora.
English: What Ulunar Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Croatian: Što Ulunar Breezhaler sadrži - Djelatne tvari su indakaterol (u obliku indakaterolmaleata) i glikopironijev bromid.