FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary metabolic routes for umeclidinium bromide are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Croatian: Primarni metabolički putovi za umeklidinijev bromid su oksidativni (hidroksilacija, O-dealkilacija), a nakon njih slijedi konjugacija (glukuronidacija itd.), čime se stvara niz metabolita koji imaju ili smanjenu farmakološku aktivnost ili njihova farmakološka aktivnost još nije utvrđena.
English: Rolufta Ellipta should be administered once daily at the same time of the day each day to maintain bronchodilation.
Croatian: Lijek Rolufta Ellipta treba primjenjivati jedanput na dan, svakoga dana u isto vrijeme, kako bi se održao bronhodilatacijski učinak.
English: • Remove the inhaler from the mouth.
Croatian: • Izvadite inhalator iz usta.
English: Immediate breathing difficulties
Croatian: Trenutne tegobe s disanjem
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Croatian: Odmah prestanite primjenjivati lijek i zatražite liječničku pomoć jer možda imate ozbiljno stanje koje se zove paradoksalni bronhospazam.
English: For instructions for handling, see section 4.2.
Croatian: Za upute o rukovanju vidjeti dio 4.2.
English: • Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Croatian: • pogoršanje vida ili bol u očima zbog visokog tlaka (mogući znakovi glaukoma)
English: Paediatric population
Croatian: Pedijatrijska populacija
English: Slide the cover upwards as far as it will go, to cover the mouthpiece.
Croatian: Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
English: Driving and using machines
Croatian: Upravljanje vozilima i strojevima
English: No dosage adjustment is required in patients over 65 years (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina (vidjeti dio 5.2).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Acute symptoms should be treated with an inhaled short-acting bronchodilator.
Croatian: Akutne simptome treba liječiti kratkodjelujućim inhalacijskim bronhodilatatorom.
English: Step-by-step instructions for use What is the inhaler?
Croatian: Upute za primjenu korak po korak Što je inhalator?
English: These may affect up to 1 in 1,000 people: • eye pain
Croatian: Mogu se javiti u do 1 na 1000 osoba: • bol u oku
English: • Increase of the measured eye pressure
Croatian: • povišenje izmjerenog očnog tlaka
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Croatian: Preosjetljivost na djelatnu(e) tvar(i) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The first time you use Rolufta Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Croatian: Kada primjenjujete lijek Rolufta Ellipta po prvi puta ne morate provjeravati radi li inhalator ispravno; on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.
English: It is unlikely that this medicine will affect your ability to drive or use machines.
Croatian: Nije vjerojatno da bi ovaj lijek mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Umeclidinium bromide was not teratogenic in rats or rabbits.
Croatian: Umeklidinijev bromid nije bio teratogen u štakora ni kunića.
English: Other antimuscarinics
Croatian: Ostali antimuskarinici
English: Open the cover when ready to take a dose.
Croatian: Otvorite poklopac kada ste spremni uzeti dozu.
English: This medicinal product is subject to additional monitoring.
Croatian: Ovaj je lijek pod dodatnim praćenjem.
English: How to use the inhaler
Croatian: Kako koristiti inhalator
English: This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs.
Croatian: Ovaj lijek sprječava stezanje tih mišića te tako olakšava ulazak zraka u pluća i njegov izlazak iz pluća.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, antikolinergici; ATK oznaka: R03BB07
English: This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Ovaj se lijek koristi za liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Rolufta Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o tome hoće li se prekinuti dojenje ili liječenje lijekom Rolufta Ellipta, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za majku.
English: If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
Croatian: Ako želite očistiti nastavak za usta, upotrijebite suhu maramicu prije zatvaranja poklopca.
English: b) How to inhale the medicinal product
Croatian: b) Kako inhalirati lijek
English: *A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Croatian: (tzv. step-down), a ova je usporedba bila niža od usporedbe koja nije postigla statističku značajnost.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Deterioration of disease
Croatian: Pogoršanje bolesti
English: Umeclidinium bromide has no or negligible influence on the ability to drive and use machines.
Croatian: Umeklidinijev bromid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Croatian: Vrećicu sa sredstvom za sušenje treba baciti; ne smije se otvoriti, pojesti ili inhalirati.
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Croatian: Inhalator je višedijelna naprava koja se sastoji od polipropilena, polietilena visoke gustoće, polioksimetilena, polibutilen tereftalata, akrilonitril butadien stirena, polikarbonata i nehrđajućeg čelika.
English: Clinical efficacy
Croatian: Klinička djelotvornost
English: • Slide the cover down until you hear a “click”.
Croatian: • Povlačite poklopac prema dolje dok ne čujete „klik“.
English: It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm.
Croatian: Ne smije se koristiti za ublažavanje akutnih simptoma, tj. kao terapija za brzo ublažavanje simptoma (engl. rescue therapy) u liječenju akutnih epizoda bronhospazma.
English: 30 doses
Croatian: 30 doza
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium bromide are similar between COPD patients 65 years and older and those younger than 65 years of age.
Croatian: Populacijska farmakokinetička analiza pokazala je da je farmakokinetika umeklidinijeva bromida bila slična u bolesnika s KOPB-om u dobi od 65 ili više godina i onih mlađih od 65 godina.
English: • Take one long, steady, deep breath in.
Croatian: • Udahnite jednom dugo, ravnomjerno i duboko.
English: Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray.
Croatian: Kad se podložak otvori, inhalator se može koristiti najviše 6 tjedana, počevši od datuma otvaranja podloška.
English: Cardiovascular effects
Croatian: Kardiovaskularni učinci
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: If you think the above applies to you, don't use this medicine until you have checked with your doctor.
Croatian: Ako mislite da se gore navedeno odnosi na Vas, nemojte primijeniti lijek dok se ne posavjetujete sa svojim liječnikom.
English: 12-Week Study Treatment difference1 95% Confidence interval p-value
Croatian: 12-tjedno ispitivanje Terapijska razlika1 95% interval pouzdanosti p-vrijednost
English: Your medicine is now ready to be inhaled.
Croatian: Vaš je lijek sada spreman za inhaliranje.
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Croatian: Pokazuje polaganu reverzibilnost za podvrstu humanog M3 muskarinskog receptora in vitro te dugotrajno djelovanje in vivo kada se primijeni izravno u pluća u pretkliničkim modelima.
English: These may affect up to 1 in 100 people:
Croatian: Mogu se javiti u do 1 na 100 osoba:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rolufta Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Rolufta Ellipta u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your everyday life.
Croatian: Redovita primjena ovog lijeka može Vam pomoći kontrolirati dišne tegobe i ublažiti učinke KOPB-a na svakodnevni život.
English: Use this medicine for as long as your doctor recommends.
Croatian: Primjenjujte ovaj lijek onoliko dugo koliko Vam je liječnik preporučio.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Croatian: Nakon inhalacijske primjene umeklidinijeva bromida u zdravih dobrovoljaca, Cmax je dosegnut nakon 5 do 15 minuta.
English: There was no attenuation of the bronchodilator effect over time.
Croatian: Bronhodilatacijski učinak nije oslabio s vremenom.
English: • Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: If you use more Rolufta Ellipta than you should
Croatian: Ako primijenite više lijeka Rolufta Ellipta nego što ste trebali
English: Don't use Rolufta Ellipta as well as these other medicines.
Croatian: Nemojte primjenjivati lijek Rolufta Ellipta zajedno s tim drugim lijekovima.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije
English: The other ingredients are lactose monohydrate (see section 2 under ‘Rolufta Ellipta contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (vidjeti odlomak „Rolufta Ellipta sadrži laktozu“ u dijelu 2.) i magnezijev stearat.
English: The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who received doses of 55 micrograms or greater for up to one year.
Croatian: Sigurnosni profil umeklidinijeva bromida ocijenjen je u 1663 bolesnika s KOPB-om koji su primali doze od 55 mikrograma ili više tijekom najviše jedne godine.
English: Following repeat doses of umeclidinium 500 micrograms once daily for 10 days, no clinically relevant effect on prolongation of QT interval (corrected using the Fridericia method) or effects on heart rate were observed.
Croatian: Nakon primjene ponovljenih doza umeklidinija od 500 mikrograma jedanput na dan tijekom 10 dana, nije primijećen klinički značajan učinak na produljenje QT-intervala (korekcija metodom prema Fridericiji) niti učinci na srčani ritam.
English: If you do not have a quick-acting inhaler contact your doctor.
Croatian: Ako nemate brzodjelujući inhalacijski lijek, obratite se svom liječniku.
English: A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium bromide based on the effect of age, race, gender, inhaled corticosteroid use or weight.
Croatian: Populacijska farmakokinetička analiza pokazala je da nije potrebno prilagođavati dozu umeklidinijeva bromida na temelju učinaka dobi, rase, spola, primjene inhalacijskih kortikosteroida ili tjelesne težine.
English: If you are not sure what your medicine contains talk to your doctor or pharmacist.
Croatian: Ako niste sigurni što Vaš lijek sadrži, obratite se svom liječniku ili ljekarniku.
English: Adults
Croatian: Odrasli
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 RMP-a.
English: The date should be added as soon as the inhaler has been removed from the tray.
Croatian: Datum treba upisati čim je inhalator izvađen iz podloška.
English: Throw this desiccant sachet away - don't open, eat or inhale it.
Croatian: Bacite tu vrećicu sa sredstvom za sušenje - nemojte je otvarati, jesti niti udisati.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Croatian: • Ako se broj na brojaču doza ne smanji za 1 kada čujete „klik“, inhalator neće isporučiti lijek.
English: Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Croatian: Odmah prestanite primjenjivati ovaj lijek i zatražite liječničku pomoć jer bi to mogli biti znakovi akutnog napadaja glaukoma uskog kuta.
English: Store in the original package in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od vlage.
English: The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Croatian: Ellipta inhalator sadrži odmjerene doze i spreman je za uporabu.
English: In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
Croatian: U nekliničkim ispitivanjima s umeklidinijevim bromidom rezultati su bili jednaki onima koji se tipično povezuju s primarnom farmakologijom antagonista muskarinskih receptora i/ili lokalnom iritacijom.
English: • irregular heart beat
Croatian: • nepravilni otkucaji srca
English: If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
Croatian: U slučaju takvog napadaja morate primijeniti brzodjelujući inhalacijski lijek (kao što je salbutamol).
English: • feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
Croatian: • osjećaj pritiska ili boli u obrazima i čelu (to mogu biti znakovi upale sinusa koja se zove sinusitis)
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium bromide was assessed in healthy volunteers.
Croatian: Učinak umjerenoga inhibitora P-gp-a, verapamila (240 mg jedanput na dan), na farmakokinetiku umeklidinijeva bromida u stanju dinamičke ravnoteže ocijenjen je u zdravih dobrovoljaca.
English: What Rolufta Ellipta looks like and contents of the pack
Croatian: Kako Rolufta Ellipta izgleda i sadržaj pakiranja
English: • Difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention
Croatian: • poteškoće i bol prilikom mokrenja - ovo mogu biti znakovi opstrukcije mokraćnog mjehura ili zadržavanja mokraće
English: If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Croatian: Ako se poklopac inhalatora otvori i zatvori bez inhaliranja lijeka, doza će biti izgubljena.
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije.
English: if you have heart problems if you have an eye problem called narrow-angle glaucoma if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder if you have severe liver problems
Croatian: ako imate srčane tegobe ako imate bolest oka koja se zove glaukom uskog kuta ako imate povećanu prostatu, otežano mokrite ili imate otežan protok mokraće kroz mokraćni mjehur ako imate teške jetrene tegobe
English: Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this patient population.
Croatian: Umeklidinijev bromid se ne smije primjenjivati u bolesnika s astmom jer lijek nije ispitivan u toj populaciji bolesnika.
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Rolufta Ellipta on COPD exacerbation rate.
Croatian: Kratko trajanje ova dva ispitivanja i ograničeni broj pojava egzacerbacija, onemogućuje donošenje zaključka o dodatnom učinku lijeka Rolufta Ellipta na stopu egzacerbacija KOPB-a.
English: Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Croatian: Klinički značajne interakcije posredovane umeklidinijevim bromidom u kliničkim dozama ne smatraju se vjerojatnima zbog niskih koncentracija lijeka u plazmi nakon inhalacijske primjene.
English: 7 doses 30 doses
Croatian: 7 doza 30 doza
English: FAES FARMA, S.A. Tel.: +34 900 460 153 aweber@faes.es
Croatian: FAES FARMA, S.A. Tel.: +34 900 460 153 weber@faes.es
English: Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air.
Croatian: Dišne tegobe dodatno otežava stezanje mišića oko dišnih putova, koje sužava dišne putove i tako ograničava protok zraka.
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dohvata djece.
English: These studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the study if an exacerbation occurred.
Croatian: Ta ispitivanja nisu bila posebno oblikovana za ocjenjivanje učinka liječenja na egzacerbacije KOPB-a te su bolesnici bili isključeni iz ispitivanja u slučaju nastupa egzacerbacije.
English: Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
Croatian: Rolufta Ellipta sadrži djelatnu tvar umeklidinijev bromid, a pripada skupini lijekova koje nazivamo bronhodilatatorima.
English: To be used within 6 weeks of first opening of the tray.
Croatian: Upotrijebiti unutar 6 tjedana nakon prvog otvaranja podloška.
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Croatian: Glaxo Operations UK Ltd. (posluje pod nazivom Glaxo Wellcome Operations) Priory Street
English: In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to this medicine for breathing problems, e.g. tiotropium.
Croatian: Osobito je važno da obavijestite svog liječnika ili ljekarnika ako za dišne tegobe uzimate druge dugodjelujuće lijekove slične ovome lijeku, npr. tiotropij.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: 7 doses
Croatian: 7 doza
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Croatian: Glaxo Operations UK Limited (posluje pod nazivom Glaxo Wellcome Operations) Priory Street
English: • Put the mouthpiece between your lips, and close your lips firmly around it.
Croatian: • Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
English: Less than 1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral administration.
Croatian: Manje od 1% peroralno primijenjene doze (1% pronađene radioaktivnosti) izlučilo se u mokraću, što ukazuje na zanemarivu apsorpciju nakon peroralne primjene.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placeboand moxifloxacin-controlled QT trial of 103 healthy volunteers.
Croatian: Učinak umeklidinija u dozi od 500 mikrograma (doziranog) na QT-interval ocijenjen je u placebom i moksifloksacinom kontroliranom ispitivanju QT-intervala u 103 zdrava dobrovoljca.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Rolufta Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Croatian: Podnijeti završno izvješće o kliničkom ispitivanju za opservacijsko kohortno ispitivanje sigurnosti primjene nakon dobivanja odobrenja, koje ima za cilj kvantificirati incidenciju i usporediti sigurnost s obzirom na odabrane kardiovaskularne i cerebrovaskularne događaje u bolesnika s KOPB-om kod primjene lijeka Rolufta Ellipta u usporedbi s tiotropijem (ispitivanje: 201038), prema protokolu dogovorenom od strane Povjerenstva za ocjenu rizika na području farmakovigilancije.
English: Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
Croatian: BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
English: Not all pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles Tachycardia
Croatian: Srčani poremećaji fibrilacija atrija idioventrikularni ritam supraventrikularna tahikardija supraventrikularne ekstrasistole tahikardija manje često manje često manje često manje često često
English: Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle.
Croatian: Umeklidinijev bromid ostvaruje bronhodilatacijsku aktivnost kompetitivnim inhibiranjem vezanja acetilkolina za muskarinske kolinergičke receptore na glatkim mišićima dišnih putova.
English: In the event of deterioration of COPD during treatment with umeclidinium bromide, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Croatian: U slučaju pogoršanja KOPB-a tijekom liječenja umeklidinijevim bromidom, treba ponovno procijeniti stanje bolesnika i režim liječenja