FrancophonIA/ELRC3.0 huggingface dataset:
English: • Slide the cover down until you hear a “click”.
Croatian: • Povlačite poklopac prema dolje dok ne čujete 'klik'.
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 ni udisati.
English: Each time you open this, you prepare one dose of medicine.
Croatian: Poklopac Svaki put kad ga otvorite, pripremit ćete jednu dozu lijeka.
English: Umeclidinium and vilanterol belong to a group of medicines called bronchodilators.
Croatian: Umeklidinij i vilanterol pripadaju skupini lijekova koji se zovu bronhodilatatori.
English: This medicine widens these muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air to get in and out of the lungs.
Croatian: Ovaj lijek opušta te mišiće u plućima, čime smanjuje oticanje i nadraženost malih dišnih putova u plućima i tako olakšava ulazak zraka u pluća i izlazak iz njih.
English: Each delivered dose contains approximately 25 mg of lactose (as monohydrate).
Croatian: Jedna isporučena doza sadrži približno 25 mg laktoze (u obliku hidrata).
English: Before the inhaler has been used, it shows exactly 30 doses.
Croatian: Prije prvog korištenja inhalatora brojač pokazuje točno 30 doza.
English: Treatment difference (95% CI) Comparison with BUD/FOR
Croatian: (95% CI) Usporedba s kombinacijom BUD/FOR
English: Trelegy Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: Trelegy Ellipta mora se primjenjivati svaki dan, a ne samo onda kada imate dišne tegobe ili druge simptome KOPB-a.
English: Interaction with CYP3A4 inhibitor
Croatian: Interakcija s inhibitorima CYP3A4
English: Some medicines may affect how this medicine works, or make it more likely that you'll have side effects.
Croatian: Neki lijekovi mogu utjecati na način djelovanja ovog lijeka ili mogu povećati vjerojatnost pojave nuspojava.
English: Tell your doctor or pharmacist if you are taking any of these.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate neki od tih lijekova.
English: Because you are using this medicine for COPD, you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Croatian: Budući da primjenjujete ovaj lijek za KOPB, može postojati povećan rizik od nastanka plućne infekcije poznate kao upala pluća (pneumonija).
English: Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect.
Croatian: Ispiranje usta vodom odmah nakon primjene lijeka Trelegy Ellipta može pomoći spriječiti ovu nuspojavu.
English: Don't take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use of both non-selective and selective beta-blockers.
Croatian: Ako su beta-blokatori neophodni, treba razmotriti kardioselektivne beta-blokatore, no oprez je potreban pri istodobnoj primjeni i neselektivnih i selektivnih beta-blokatora.
English: When you take the inhaler out of the sealed tray, it will be in the ‘closed' position.
Croatian: Kad izvadite inhalator iz zatvorenog podloška, on je u 'zatvorenom' položaju.
English: Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions.
Croatian: Istodobnu primjenu treba izbjegavati, osim ako korist ne nadmašuje povećan rizik od sistemskih nuspojava kortikosteroida, u kom slučaju bolesnike treba nadzirati zbog mogućeg nastupa sistemskih nuspojava kortikosteroida.
English: Further management should be clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje mora biti u skladu s kliničkim indikacijama ili preporukama referentnog centra za trovanja, ako on postoji.
English: The precise mechanism through which fluticasone furoate affects COPD symptoms is not known.
Croatian: Točan mehanizam djelovanja putem kojega flutikazonfuroat utječe na simptome KOPB-a nije poznat.
English: These patients may have also been taking other COPD medications (e.g. mucolytics or leukotriene receptor antagonists).
Croatian: Ti su bolesnici mogli uzimati i neke druge lijekove za KOPB (npr. mukolitike ili antagoniste leukotrijenskih receptora).
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 poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Croatian: Vilanterol (u obliku alfa-fenilcinamata) i trifenilacetatna kiselina nisu bili genotoksični, što ukazuje na to da vilanterol (u obliku trifenatata) ne predstavlja genotoksičan rizik za ljude.
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Croatian: Faktori rizika za pneumoniju u bolesnika s KOPB-om uključuju aktivne pušače, stariju dob, nizak indeks tjelesne mase (ITM) i težak oblik KOPB-a.
English: The date should be added as soon as the inhaler has been removed from the tray.
Croatian: Taj datum treba napisati čim se inhalator izvadi iz podloška.
English: Don't use Trelegy Ellipta if you already use these medicines.
Croatian: Nemojte primijeniti Trelegy Ellipta ako već primjenjujete navedene lijekove.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trelegy Ellipta and to contact their doctor immediately should any of these signs or symptoms develop.
Croatian: Bolesnike treba upoznati sa znakovima i simptomima akutnog glaukoma uskog kuta te ih uputiti da prestanu primjenjivati Trelegy Ellipta i odmah se obrate svom liječniku ako se razvije bilo koji od tih znakova ili simptoma.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Trelegy 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 Trelegy Ellipta, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za ženu.
English: Trelegy Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Croatian: Trelegy Ellipta ne smije se primjenjivati u bolesnika s astmom jer nije ispitivan u toj populaciji bolesnika.
English: For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left, and then will show half red with the number 0 after the last dose is used.
Croatian: Brojač doza inhalatora s 14 doza također će biti napola crven kada u inhalatoru preostane manje od 10 doza, a kada se primijeni zadnja doza, bit će napola crven i prikazivati broj 0.
English: The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Croatian: Inhalator Ellipta sadrži odmjerene doze i spreman je za uporabu.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trelegy 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 Trelegy Ellipta u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Croatian: Smanjenje razine kalija u serumu obično je prolazno i ne zahtijeva nadomjesno liječenje.
English: Therefore, caution is advised in moderate to severe hepatic impairment, but no specific dose adjustment based on hepatic function is recommended.
Croatian: Stoga se u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije savjetuje oprez, ali se ne preporučuje nikakva specifična prilagodba doze na temelju jetrene funkcije.
English: One fatal case of pneumonia was reported in a patient who received Trelegy Ellipta.
Croatian: Prijavljen je jedan slučaj pneumonije sa smrtnim ishodom u bolesnika koji je primao Trelegy Ellipta.
English: When used regularly, it can help to 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: An overdose will likely produce signs, symptoms or adverse effects associated with the individual components' pharmacological actions (e.g. Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Croatian: Predoziranje će vjerojatno izazvati znakove, simptome ili nuspojave povezane s farmakološkim djelovanjem pojedinačnih sastavnica (npr. Cushingov sindrom, kušingoidni izgled, supresiju nadbubrežne žlijezde, smanjenje mineralne gustoće kosti, suha usta, poremećaje vidne akomodacije, tahikardiju, aritmije, tremor, glavobolju, palpitacije, mučninu, hiperglikemiju i hipokalijemiju).
English: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Croatian: Liječnici moraju pozorno pratiti mogući razvoj pneumonije u bolesnika s KOPB-om jer se kliničke manifestacije takvih infekcija podudaraju sa simptomima egzacerbacija KOPB-a.
English: No clinically relevant effects requiring dose adjustment were observed.
Croatian: Nisu opaženi klinički važni učinci koji bi zahtijevali prilagodbu doze.
English: When fewer than 10 doses are left, half of the dose counter shows red.
Croatian: Kada ostane manje od 10 doza, polovica brojača doza označena je crvenom bojom.
English: Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Croatian: Čuvajte inhlator u zatvorenom podlošku radi zaštite od vlage i izvadite ga tek neposredno prije prve uporabe.
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Croatian: Farmakološki učinci beta2-adrenergičkih agonista, uključujući vilanterol, barem se djelomično mogu pripisati stimulaciji unutarstanične adenilat ciklaze, enzima koji katalizira pretvorbu adenozin trifosfata (ATP) u ciklički-3',5'-adenozin monofosfat (ciklički AMP).
English: Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Croatian: Blokatori beta2-adrenergičkih receptora mogu oslabiti ili antagonizirati učinak beta2-adrenergičkih agonista, poput vilanterola.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Trelegy Ellipta contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (pogledajte odlomak 'Trelegy Ellipta sadrži laktozu' u dijelu 2.) i magnezijev stearat.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Trelegy Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Croatian: Pneumonija koja je zahtijevala hospitalizaciju nastupila je u 1% bolesnika liječenih lijekom Trelegy Ellipta i < 1% onih koji su primali budezonid/formoterol tijekom najviše 24 tjedna.
English: Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, which could lead to an increased potential for adverse reactions.
Croatian: Preporučuje se oprez pri istodobnoj primjeni sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, ritonavirom, lijekovima koji sadrže kobicistat) jer postoji mogućnost povećane sistemske izloženosti i flutikazonfuroatu i vilanterolu, što bi moglo povećati potencijal za razvoj nuspojava.
English: Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism
Croatian: Interakcija s inhibitorima CYP2D6/polimorfizmima CYP2D6
English: Fluticasone furoate was not teratogenic in rats or rabbits, but delayed development in rats and caused abortion in rabbits at maternally toxic doses.
Croatian: Flutikazonfuroat nije imao teratogenih učinaka na štakore ni kuniće, ali je usporio razvoj u štakora i izazvao abortus u kunića pri primjeni doza toksičnih za majku.
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Croatian: Ako bolesnik ima simptome kao što su zamagljen vid ili druge smetnje vida, treba razmotriti njegovo upućivanje oftalmologu radi ocjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti poput centralne serozne korioretinopatije (engl. central serous chorioretinopathy, CSCR), prijavljene nakon primjene sistemskih i topikalnih kortikosteroida.
English: If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
Croatian: Ako se broj na brojaču doza ne smanji za 1 kada čujete 'klik', inhalator neće isporučiti dozu i trebate ga vratiti ljekarniku i zatražiti savjet.
English: Fluticasone furoate, umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Croatian: Flutikazonfuroat, umeklidinij i vilanterol supstrati su prijenosnika P-glikoproteina (P-gp).
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 višedijelni uređaj načinjen od polipropilena, polietilena visoke gustoće, polioksimetilena, polibutilen tereftalata, akrilonitril butadien stirena, polikarbonata i nehrđajućeg čelika.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što primijenite ovaj lijek.
English: The primary metabolic routes for umeclidinium 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 umeklidinij su oksidacijski (hidroksilacija, O-dealkilacija), a nakon njih slijedi konjugacija (glukuronidacija itd.), čime nastaje niz metabolita koji imaju ili smanjenu farmakološku aktivnost ili njihova farmakološka aktivnost nije utvrđena.
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Croatian: Učinak umjerenog inhibitora P-gp-a, verapamila (240 mg jedanput na dan), na farmakokinetiku umeklidinija i vilanterola u stanju dinamičke ravnoteže ocijenjen je u zdravih dobrovoljaca.
English: Adverse reactions detected during these clinical trials are listed by MedDRA system organ class.
Croatian: Nuspojave utvrđene tijekom tih kliničkih ispitivanja navedene su prema MedDRA klasifikaciji organskih sustava.
English: Don't use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, podlošku i inhalatoru iza oznake ‘EXP'.
English: A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor).
Croatian: U zdravih je ispitanika provedeno ispitivanje s primjenom ponovljenih doza kombinacije flutikazonfuroat/vilanterol (184/22 mikrograma) i ketokonazola (400 miligrama, snažan inhibitor CYP3A4).
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Croatian: Ne smijete primjenjivati ovaj lijek ako ste trudni, osim ako Vam to ne kaže liječnik.
English: Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures.
Croatian: Primjenu kardioselektivnih beta-blokatora treba razmotriti samo kod teških učinaka predoziranja vilanterolom koji su klinički značajni i ne reagiraju na potporne mjere liječenja.
English: Patients should not stop therapy with Trelegy Ellipta without physician supervision since symptoms may recur after discontinuation.
Croatian: Bolesnici ne smiju prekinuti liječenje lijekom Trelegy Ellipta bez liječničkog nadzora jer se nakon prekida njegove primjene simptomi mogu vratiti.
English: Vision blurred (see section 4.4)
Croatian: Poremećaji oka zamagljen vid (vidjeti dio 4.4)
English: Covariate analysis showed higher FF apparent clearance (42%) when comparing FF/VI to FF/UMEC/VI; however, this is not considered clinically relevant.
Croatian: Analiza kovarijance pokazala je veći prividni klirens flutikazonfuroata (42%) kada se FF/VI uspoređivao s kombinacijom FF/UMEK/VI; međutim, to se ne smatra klinički značajnim.
English: The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day.
Croatian: Preporučena i maksimalna doza je jedna inhalacija lijeka Trelegy Ellipta od 92/55/22 mikrograma jedanput na dan, svaki dan u isto doba.
English: The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate or blood potassium.
Croatian: Povećanje izloženosti vilanterolu nije bilo povezano s povećanjem sistemskih učinaka beta2-agonista na srčani ritam ni razinu kalija u krvi.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Croatian: Ne postoje uvjerljivi klinički dokazi o razlikama u veličini rizika od pneumonije između pojedinih lijekova iz skupine inhalacijskih kortikosteroida.
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Trading Services Limited GSK Logo
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Trading Services Limited GSK Logo
English: The active substances are present as a white powder in separate blister strips inside the inhaler.
Croatian: Djelatne tvari dolaze u obliku bijeloga praška u zasebnim blister trakama unutar inhalatora.
English: Trelegy Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Trelegy Ellipta koristi se za liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose eliminated in the urine.
Croatian: Nakon peroralne primjene flutikazonfuroat se u ljudi uglavnom eliminirao metabolizmom, a metaboliti su se izlučivali gotovo isključivo u feces, dok se < 1% pronađene radioaktivne doze izlučilo u mokraću.
English: There are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Croatian: Nema kliničkih podataka koji bi poduprli primjenu lijeka Trelegy Ellipta za liječenje akutnih epizoda bronhospazma ili akutne egzacerbacije KOPB-a (npr. kao terapije za hitno ublažavanje simptoma).
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: In terms of other patient characteristics, a study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Croatian: Što se tiče ostalih značajki bolesnika, u ispitivanju provedenom u slabih metabolizatora CYP2D6 nisu pronađeni dokazi klinički značajnog učinka genskog polimorfizma CYP2D6 na sistemsku izloženost umeklidiniju.
English: Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5).
Croatian: Potreban je oprez kada se Trelegy Ellipta primjenjuje s drugim lijekovima koji također mogu uzrokovati hipokalijemiju (vidjeti dio 4.5).
English: In vitro protein binding studies between subjects with severe renal impairment and healthy volunteers were conducted, and no clinically significant evidence of altered protein binding was seen.
Croatian: Provedena su ispitivanja vezanja za proteine u plazmi in vitro u ispitanika s teškim oštećenjem bubrežne funkcije i zdravih dobrovoljaca, u kojima nisu pronađeni klinički značajni dokazi promijenjenog vezanja za proteine.
English: Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle.
Croatian: Umeklidinij ostvaruje bronhodilatacijsku aktivnost kompetitivnim inhibiranjem vezanja acetilkolina za muskarinske receptore na glatkim mišićima dišnih putova.
English: Umeclidinium is a long-acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Croatian: Umeklidinij je dugodjelujući antagonist muskarinskih receptora (naziva se još i antikolinergikom).
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No dosage adjustment is required in patients with mild, moderate or severe hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem jetrene funkcije.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
Croatian: Ako Vam se simptomi KOPB-a (nedostatak zraka, piskanje pri disanju, kašalj) ne poboljšaju ili se pogoršaju, ili primjenjujete brzodjelujući inhalacijski lijek češće nego inače: obratite se svom liječniku što je prije moguće.
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Croatian: Svi inhalacijski kortikosteroidi mogu imati sistemske učinke, osobito ako se dugotrajno primjenjuju u visokim dozama.
English: After you have used the last dose, half of the dose counter shows red and the number 0 is displayed.
Croatian: Nakon primjene posljednje doze polovica brojača doza označena je crvenom bojom i prikazuje se broj 0.