FrancophonIA/ELRC3.0 huggingface dataset:
English: After inhalation, patients should rinse their mouth with water without swallowing.
Croatian: Nakon inhalacije, bolesnici trebaju isprati usta vodom, ali vodu ne smiju progutati.
English: Adults and adolescents aged 12 years and over
Croatian: Odrasle osobe i adolescenti u dobi od 12 i više godina
English: P value (95% CI)
Croatian: P vrijednost (95% CI)
English: If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol).
Croatian: U slučaju takvog napadaja morate primijeniti brzodjelujući inhalacijski lijek (kao što je salbutamol).
English: Tell your doctor as soon as possible if you develop any of these symptoms.
Croatian: Obavijestite svog liječnika što je prije moguće ako se pojavi neki od navedenih simptoma.
English: Systemic corticosteroid effects
Croatian: Sistemski učinci kortikosteroida
English: Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.
Croatian: Kortikosteroidi također pomažu u sprječavanju napadaja astme i pogoršanja KOPB-a.
English: If your 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 (nedostatak zraka, piskanje pri disanju, kašalj) ne poboljšaju ili se pogoršaju, ili primjenjujete brzodjelujući inhalacijski lijek češće nego inače:
English: It relaxes the muscles of the small air passages in the lungs.
Croatian: Opušta mišiće malih dišnih putova u plućima.
English: Table 1 - Results of primary and key secondary endpoints in HZA106827 and HZA106829
Croatian: Tablica 1 - Rezultati primarnih i ključnih sekundarnih mjera ishoda u ispitivanjima HZA106827 i HZA106829
English: Close the inhaler and rinse your mouth
Croatian: Zatvorite inhalator i isperite usta
English: HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks).
Croatian: U ispitivanju HZA106837 trajanje liječenja je variralo (od najmanje 24 tjedna do najviše 76 tjedana, s time da je većina ispitanika liječena najmanje 52 tjedna).
English: 184/22 micrograms
Croatian: 184/22 mikrograma
English: If 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: Ako primjenjujete ovaj lijek za KOPB, može postojati povećan rizik od nastanka infekcije pluća poznate kao upala pluća.
English: The allergen was house dust mite, cat dander, or birch pollen; the selection was based on individual screening tests.
Croatian: Alergeni su bili kućne grinje, ljuskice mačje kože ili pelud breze, a odabir se temeljio na individualnim rezultatima testova probira.
English: Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD.
Croatian: Ovaj se lijek ne smije davati djeci mlađoj od 12 godina za liječenje astme ni djeci i adolescenatima bilo koje dobi za liječenje KOPB-a.
English: The date should be added as soon as the inhaler has been removed from the tray.
Croatian: Datum treba dodati čim je inhalator izvađen iz podloška.
English: Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice.
Croatian: Liječnici moraju redovito kontrolirati bolesnike kako bi jačina flutikazonfuroata/vilanterola koju primaju ostala optimalna i mijenjala se isključivo na savjet liječnika.
English: In the 12 months prior to the study, 61% of subjects reported no COPD exacerbations and 39% of subjects reported ≥1 moderate/severe COPD exacerbation.
Croatian: U razdoblju od 12 mjeseci prije početka ispitivanja, 61% ispitanika nije prijavilo egzacerbacije KOPB-a, dok je 39% ispitanika prijavilo ≥ 1 umjerene/teške egzacerbacije KOPB-a.
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost kod razina izloženosti koje nisu klinički značajne (vidjeti dio 5.3).
English: • infection of the nose sinuses or throat
Croatian: • infekcija nosnih sinusa ili grla
English: Description of selected adverse reactions *Pneumonia (see section 4.4)
Croatian: Opis odabranih nuspojava *Pneumonija (vidjeti dio 4.4)
English: Some medicines may affect how this medicine works, or make it more likely that you will have side effects.
Croatian: Neki lijekovi mogu utjecati na način djelovanja ovog lijeka ili mogu povećati vjerojatnost pojave nuspojava.
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: 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 upotrijebiti unutar 6 tjedana, počevši od datuma otvaranja podloška.
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Relvar Ellipta.
Croatian: Bolesnike treba uputiti da nastave liječenje, ali i da zatraže liječnički savjet ako se simptomi astme i dalje ne mogu kontrolirati ili se pogoršaju nakon početka terapije lijekom Relvar Ellipta.
English: 12 month studies
Croatian: 12-mjesečna ispitivanja
English: 14 doses
Croatian: 14 doza
English: When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone.
Croatian: Ako redovito uzimate ova dva lijeka zajedno, bolje ćete kontrolirati tegobe s disanjem nego da bilo koji od njih uzimate samostalno.
English: The adjusted mean treatment difference of -37 mL between the groups was not statistically significant (p=0.162).
Croatian: Prilagođena srednja vrijednost terapijskih razlika od 37 ml između skupina nije bila statistički značajna (p=0,162).
English: How to inhale the medicine
Croatian: Kako inhalirati lijek
English: There are no fertility data in humans.
Croatian: Nema podataka o učinku na plodnost u ljudi.
English: Further management should be as 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: In HZA106837 the primary endpoint was the time to first severe asthma exacerbation.
Croatian: U ispitivanju HZA106837 primarna mjera ishoda bilo je vrijeme do prve teške egzacerbacije astme.
English: A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Croatian: Teška egazcerbacija astme definirana je kao pogoršanje astme koje zahtijeva primjenu sistemskih kortikosteroida tijekom najmanje 3 dana ili hospitalizaciju ili posjet hitnoj službi zbog astme koja je zahtijevao primjenu sistemskih kortikosteroida.
English: If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and tell your doctor immediately.
Croatian: Ako imate bilo koji od sljedećih simptoma nakon primjene lijeka Relvar Ellipta prekinite primjenu ovog lijeka i odmah obavijestite svog liječnika.
English: Administration of fluticasone furoate combined with vilanterol did not result in any significant new toxicity.
Croatian: Primjena flutikazonfuroata u kombinaciji s vilanterolom nije rezultirala značajnom novom toksičnošću.
English: However, there was no evidence for the higher systemic exposure in this population to be associated with greater effect on 24 hour urinary cortisol excretion.
Croatian: Međutim, nije bilo dokaza da je veća sistemska izloženost u ovoj populaciji povezana s većim učinkom na izlučivanje kortizola u mokraću tijekom 24 sata.
English: The primary endpoint was the annual rate of moderate and severe exacerbations.
Croatian: Primarna mjera ishoda bila je godišnja stopa umjerenih i teških egzacerbacija.
English: In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma.
Croatian: U objedinjenoj analizi 11 ispitivanja u bolesnika s astmom (7034 bolesnika) incidencija fraktura bila je <1%, a u pravilu su bile povezane s traumom.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucosegalactose malabsorption should not use this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli primjenjivati ovaj lijek.
English: Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease.
Croatian: Bolesnicima s astmom treba propisati onu jačinu lijeka Relvar Ellipta koja sadrži odgovarajuću dozu flutikazonfuroata (FF) za njihovu težinu bolesti.
English: Following intravenous dosing, both fluticasone furoate and vilanterol are extensively distributed with average volumes of distribution at steady state of 661 L and 165 L, respectively.
Croatian: Nakon intravenske primjene i flutikazonfuroat i vilanterol se opsežno raspodjeljuju, uz prosječne volumene distribucije u stanju dinamičke ravnoteže od 661 l odnosno 165 l.
English: However, there was no evidence that this higher vilanterol Cmax resulted in clinically significant effects on heart rate.
Croatian: Međutim, nema dokaza da je povećani Cmax vilanterola rezultirao klinički značajnim učincima na srčani ritam.
English: When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way.
Croatian: Kada se inhalator koristi prvi puta, ne treba provjeravati radi li ispravno niti ga treba posebno pripremati za uporabu.
English: - The other ingredients are lactose monohydrate (See section 2) and magnesium stearate.
Croatian: - Drugi sastojci su laktoza hidrat (pogledajte dio 2.) i magnezijev stearat.
English: Slide the cover down until you hear a ‘click'.
Croatian: Povlačite poklopac prema dolje dok ne čujete ''klik''.
English: • swelling, sometimes of the face or mouth (angioedema)
Croatian: • oticanje, katkada lica ili usta (angioedem)
English: • Slide the cover down until you hear a “click”.
Croatian: • Povlačite poklopac prema dolje dok ne čujete ''klik''.
English: Do not use this medicine after the expiry date which is stated on the pack after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
English: Time to first exacerbation: Hazard ratio (95% CI) % risk reduction p-value p<0.001
Croatian: Vrijeme do prve egzacerbacije: Omjer rizika (95% CI) % smanjenja rizika p-vrijednost p<0,001
English: Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists.
Croatian: Blokatori beta2-adrenergičkih receptora mogu oslabiti ili antagonizirati učinak beta2-adrenergičkih agonista.
English: Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.
Croatian: Može se pojaviti paradoksalni bronhospazam uz pojačano piskanje pri disanju neposredno nakon primjene lijeka.
English: In genetic toxicity studies, vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Croatian: U ispitivanjima genske toksičnosti 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: Check with your doctor before you use this medicine if you think any of these applies to you.
Croatian: Obratite se svom liječniku prije primjene ovog lijeka ako mislite da se nešto od navedenoga odnosi na Vas.
English: This is because larger doses of Relvar Ellipta may reduce the amount of steroid hormones produced naturally by your body.
Croatian: Ellipta mogu smanjiti količinu steroidnih hormona koje Vaše tijelo prirodno stvara.
English: A decision must be made whether to discontinue breast-feeding or to discontinue fluticasone furoate/vilanterol therapy taking into account the benefit of breast-feeding 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 flutikazonfuroatom/vilanterolom, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za majku.
English: Step by step instructions
Croatian: Upute za primjenu korak po korak
English: The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT).
Croatian: Klinički razvojni program za bolesnike s KOPB-om obuhvaćao je jedno 12-tjedno (HZC113107), dva 6-mjesečna (HZC112206, HZC112207), dva jednogodišnja ispitivanja (HZC102970, HZC102871) i jedno ispitivanje koje je trajalo > 1 godine (SUMMIT).
English: They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems.
Croatian: Smanjuju oticanje i nadraženost malih dišnih putova u plućima i na taj način postupno ublažavaju tegobe s disanjem.
English: Moderate/ severe exacerbations were defined as worsening symptoms that required treatment with oral corticosteroids and/or antibiotics or in-patient hospitalisation.
Croatian: Umjerene/teške egzacerbacije definirane su kao pogoršanje simptoma koje je zahtijevalo liječenje peroralnim kortikosteroidima i/ili antibioticima ili hospitalizaciju.
English: The inhaler is packaged in a tray.
Croatian: Inhalator je zapakiran u podložak.
English: Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala na utjecaj flutikazonfuroata/vilanteroltrifenatata na plodnost (vidjeti dio 5.3).
English: Pneumonia (infection of the lung) (common side effect, may affect up to 1 in 10 people) Tell your doctor if you have any of the following while taking Relvar Ellipta - they could be symptoms of a lung infection:
Croatian: Upala pluća (infekcija pluća) (česta nuspojava, može se javiti u do 1 na 10 osoba) Obavijestite svog liječnika ako se pri primjeni lijeka Relvar Ellipta pojavi bilo koja od sljedećih nuspojava - može se raditi o simptomima infekcije pluća:
English: The incidence of cardiovascular history/risk factors was similar across the treatment groups with patients most commonly suffering from hypertension (46%), followed by hypercholesterolemia (29%) and diabetes mellitus (12%).
Croatian: Incidencija kardiovaskularnih bolesti/čimbenika rizika bila je slična u svim terapijskim skupinama, a bolesnici su najčešće patili od hipertenzije (46%), hiperkolesterolemije (29%) i šećerne bolesti (12%).
English: • inflammation of the lungs (bronchitis)
Croatian: • upala pluća (bronhitis)
English: Chronic obstructive pulmonary disease (COPD) is a serious, long term lung disease where the airways become inflamed and thickened.
Croatian: Kronična opstruktivna plućna bolest (KOPB) je ozbiljna i dugotrajna plućna bolest kod koje dišni putovi postaju upaljeni i zadebljani.
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Croatian: Kad izvadite inhalator iz podloška, bit će u 'zatvorenom 'položaju.
English: The precise mechanism through which fluticasone furoate affects asthma and COPD symptoms is not known.
Croatian: Točan mehanizam djelovanja putem kojega flutikazonfuroat utječe na simptome astme i KOPB-a nije poznat.
English: Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats.
Croatian: Ni flutikazonfuroat ni vilanteroltrifenatat nisu imali štetne učinke na plodnost niti na prenatalni i postnatalni razvoj u štakora.
English: If you accidentally take more Relvar Ellipta than your doctor has instructed, talk to your doctor or pharmacist.
Croatian: Ako slučajno primijenite više lijeka Relvar Ellipta nego što Vam je liječnik rekao, obratite se svom liječniku ili ljekarniku.
English: This should be treated immediately with a short-acting inhaled bronchodilator.
Croatian: Stanje treba odmah liječiti kratkodjelujućim inhalacijskim bronhodilatatorom.
English: Don't open the tray until you are ready to start using your new inhaler.
Croatian: Nemojte otvarati podložak dok ne budete spremni početi koristiti svoj novi inhalator.
English: if you experience blurred vision or other visual disturbances.
Croatian: u slučaju zamućenog vida ili drugih poremećaja vida.
English: If you have been told by your doctor that you have an intolerance to some sugars, or to milk protein, contact your doctor before using this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere ili mliječne proteine, obratite se liječniku prije nego što primijenite ovaj lijek.
English: • awareness of heart beat (palpitations)
Croatian: • osjećaj lupanja srca (palpitacije)
English: Immediate breathing difficulties after using Relvar Ellipta are rare.
Croatian: Tegobe s disanjem neposredno nakon primjene lijeka Relvar Ellipta su rijetke.
English: Pneumonia in patients with asthma
Croatian: Pneumonija u bolesnika s astmom
English: Overall, across the two studies combined 2009 (62%) patients had cardiovascular history/risk factors at screening.
Croatian: Promatrajući oba ispitivanja zajedno, ukupno je 2009 (62%) bolesnika prilikom probira imalo kardiovaskularne bolesti u anamnezi/čimbenika rizika za te bolesti.
English: Vilanterol trifenatate was not teratogenic in rats.
Croatian: Vilanteroltrifenatat nije imao teratogen učinak u štakora.
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 zamućen vid ili neke druge poremećaje vida, treba razmotriti potrebu da ga se uputi oftalmologu radi procjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti kao što je centralna serozna korioretinopatija (CSCR) koja je zabilježena nakon sustavne i topikalne uporabe kortikosteroida.
English: Vilanterol belongs to a group of medicines called long acting bronchodilators.
Croatian: Vilanterol pripada skupini lijekova koje nazivamo dugodjelujućim bronhodilatatorima.
English: If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms once daily).
Croatian: Ako imate umjerenu ili tešku jetrenu bolest, Vaš liječnik će ograničiti dozu lijeka Relvar Ellipta na manju jačinu (92/22 mikrograma jedanput na dan).
English: Relvar Ellipta contains lactose
Croatian: Relvar Ellipta sadrži laktozu
English: Other medicines and Relvar Ellipta
Croatian: Drugi lijekovi i Relvar Ellipta
English: The increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects on heart rate, blood potassium or QTcF interval.
Croatian: Povećanje izloženosti vilanterolu nije bilo povezano s povećanjem sistemskih učinaka beta2-agonista na srčani ritam, razinu kalija u krvi niti QTcF interval.
English: If you use more Relvar Ellipta than you should
Croatian: Ako primijenite više lijeka Relvar Ellipta nego što ste trebali
English: Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see section 5.2).
Croatian: Ispitivanja u ispitanika s blagim, umjerenim i teškim oštećenjem jetrene funkcije ukazala su na povećanje sistemske izloženosti flutikazonfuroatu (i Cmax i AUC) (vidjeti dio 5.2).
English: You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
Croatian: Lijek Relvar Ellipta ne morate posebno pripremati za primjenu, čak ni kada ga koristite prvi puta.
English: The inhaler contains two aluminium foil laminate strips of 14 or 30 doses.
Croatian: Inhalator sadrži dvije trake od višeslojne aluminijske folije s 14 ili 30 doza.
English: The incidence of pneumonia in patients with asthma was common at the higher dose.
Croatian: Incidencija pneumonije u bolesnika s astmom bila je česta pri primjeni veće doze.
English: • voice disorders
Croatian: • glasovni poremećaji
English: LIST OF EXCIPIENTS Also contains lactose and magnesium stearate.
Croatian: POPIS POMOĆNIH TVARI Također sadrži laktozu i magnezijev stearat.
English: Fluticasone furoate is primarily metabolised through hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Croatian: Flutikazonfuroat se prvenstveno metabolizira putem hidrolize skupine S-fluorometil karbotioata na metabolite sa značajno smanjenim kortikosteroidnim djelovanjem.
English: 14 doses 30 doses
Croatian: 14 doza 30 doza
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Ako dođe do predoziranja, treba pratiti bolesnika i primijeniti odgovarajuće potporne mjere liječenja.
English: If the inhaler cover is opened and closed without inhaling the medicine, the dose will be lost.
Croatian: Ako se poklopac inhalatora otvori i zatvori bez inhaliranja lijeka, doza će se izgubiti.
English: In a placebo-controlled study in subjects with moderate COPD and a history of, or an increased risk of cardiovascular disease, there was no increase in the risk of cardiovascular events in patients receiving fluticasone furoate/vilanterol compared with placebo (see section 5.1).
Croatian: U placebom kontroliranom ispitivanju u bolesnika s umjerenim KOPB-om i kardiovaskularnom bolešću u anamnezi ili povećanim rizikom od kardiovaskularne bolesti, nije zabilježeno povećanje rizika od kardiovaskularnih događaja u bolesnika koji su uzimali flutikazonfuroat/vilanterol u usporedbi s onima koji su primali placebo (vidjeti dio 5.1).
English: • increased cough or increased breathing difficulties
Croatian: • pojačan kašalj ili otežano disanje
English: Pharmacological and toxicological effects seen with fluticasone furoate or vilanterol in nonclinical studies were those typically associated with either glucocorticoids or beta2-agonists.
Croatian: Farmakološki i toksikološki učinci zabilježeni kod primjene flutikazonfuroata ili vilanterola u nekliničkim ispitivanjima bili su oni koji se tipično povezuju s glukokortikoidima ili beta2-agonistima.
English: INFORMATION IN BRAILLE relvar ellipta 184:22
Croatian: 16. PODACI NA BRAILLEOVOM PISMU relvar ellipta 184:22
English: Vilanterol is primarily metabolised by O-dealkylation to a range of metabolites with significantly reduced 1- and 2-agonist activity.
Croatian: Vilanterol se prvenstveno metabolizira putem O-dealkilacije na niz metabolita sa značajno smanjenim β1 i β2-agonističkim djelovanjem.
English: There have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus.
Croatian: U bolesnika sa šećernom bolešću prijavljene su povećane razine glukoze u krvi pa to treba uzeti u obzir prilikom propisivanja lijeka bolesnicima sa šećernom bolešću u anamnezi.
English: Oral corticosteroids and antibiotics were allowed for the acute treatment of COPD exacerbations with specific guidelines for use.
Croatian: Primjena peroralnih kortikosteroida i antibiotika bila je dopuštena za akutno liječenje egzacerbacija KOPB-a, uz posebne smjernice za primjenu.