FrancophonIA/ELRC3.0 huggingface dataset:
English: By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs.
Croatian: na interleukin-5 i blokirajući njegovu aktivnost, Cinqaero smanjuje broj eozinofila u krvi i plućima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinqaero 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 Cinqaero nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is available as a concentrate for making a solution for infusion (drip) into a vein.
Croatian: Lijek je dostupan kao koncentrat za otopinu za infuziju (drip) u venu.
English: For more information about treatment with Cinqaero, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Cinqaero pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Additionally there was evidence of an improvement in lung function and asthma symptoms, and a decrease in number of eosinophils in the blood in patients given Cinqaero.
Croatian: Osim toga, došlo je do napretka u funkciji pluća i simptoma astme te smanjenje broja eozinofila u krvi pacijenata koji su primali Cinqaero.
English: The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease.
Croatian: Koristi lijeka Cinqaero dokazane su u dvama ispitivanjima koja su uključivala 953 pacijenta s eozinofilnom astmom koja nije bila dobro nadzirana inhalacijskim kortikosteroidima i drugim lijekovima za astmu korištenima za prevenciju bolesti.
English: The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma.
Croatian: Smanjenje pogoršanja i poboljšanje funkcije pluća zabilježeni kod primjene lijeka Cinqaero smatraju se klinički relevantnima, posebice za bolesnike koje je nemoguće adekvatno nadzirati s visokim dozama inhalacijskih kortikosteroida i drugim lijekom korištenim za prevenciju astme.
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Croatian: Simptomi eozinofilne astme povezani su s prevelikim brojem bijelih krvnih stanica zvanih eozinofili u krvi te flegmom u plućima.
English: For practical information about using Cinqaero, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Cinqaero pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Cinqaero is an asthma medicine that is used to treat adults with a particular type of asthma called eosinophilic asthma.
Croatian: Cinqaero je lijek protiv astme koji se koristi za liječenje odraslih s posebnom vrstom astme zvanom eozinofilna astma.
English: How does Cinqaero work?
Croatian: Kako djeluje Cinqaero?
English: The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Croatian: Aktivna tvar u lijeku Cinqaero, reslizumab, monoklonsko je protutijelo osmišljeno da se veže na tvar zvanu interleukin-5 koja stimulira rast i aktivnost eozinofila.
English: What benefits of Cinqaero have been shown in studies?
Croatian: Koje su koristi lijeka Cinqaero utvrđene u ispitivanjima?
English: How is Cinqaero used?
Croatian: Kako se Cinqaero koristi?
English: It is used as an additional treatment in adults with severe asthma that is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Croatian: Koristi se kao dodatni lijek za odrasle s jakim simptomima astme koji se ne mogu dobro nadzirati kombinacijom visoke doze inhalacijskih kortikosteroida i dodatnog lijeka za prevenciju astme.
English: Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma.
Croatian: Cinqaero se izdaje samo na liječnički recept, a liječenje treba započeti liječnik iskusan u liječenju eozinofilne astme.
English: For the full list of all side effects and restrictions with Cinqaero, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Cinqaero potražite u uputi o lijeku.
English: pipettes
Croatian: Ciljne vrste životinja
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Croatian: Datum prvog odobrenja: 08. svibnja 2014 Datum posljednje obnove odobrenja: 11. siječanj 2019
English: If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine and tell your doctor immediately.
Croatian: Ako imate bilo koji od sljedećih simptoma nakon uzimanja lijeka LAVENTAIR ELLIPTA, prestanite primjenjivati ovaj lijek i odmah se javite svom liječniku.
English: Elderly patients No dose adjustment is required in patients over 65 years.
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
English: tiotropium, indacaterol.
Croatian: tiotropij, indakaterol.
English: The first time you use LAVENTAIR 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 LAVENTAIR ELLIPTA po prvi puta, ne morate provjeravati radi li inhalator ispravno; on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.
English: LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Croatian: LAVENTAIR ELLIPTA treba primjenjivati svakoga dana u isto vrijeme, kako bi se održao bronhodilatacijski učinak.
English: If you forget to use LAVENTAIR ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili primijeniti LAVENTAIR ELLIPTA Nemojte inhalirati još jednu dozu kako biste nadoknadili zaboravljanu dozu.
English: It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.
Croatian: Vrlo je važno da LAVENTAIR ELLIPTA primjenjujete svakoga dana prema uputama liječnika.
English: The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (vidjeti dio 2 pod „ANORO ELLIPTA sadrži laktozu“) i magnezijev stearat.
English: EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
Croatian: EU/1/14/899/001 1 inhalator sa 7 doza EU/1/14/899/002 1 inhalator s 30 doza
English: Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare.
Croatian: Trenutne tegobe s disanjem nakon uzimanja lijeka LAVENTAIR ELLIPTA su rijetke.
English: The European Medicines Agency has waived the obligation to submit the results of studies with LAVENTAIR 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 LAVENTAIR ELLIPTA u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka LAVENTAIR ELLIPTA u pedijatrijskoj populaciji (bolesnici mlađi od 18 godina) za indikaciju KOPB-a.
English: Don't use LAVENTAIR ELLIPTA if you already use these medicines.
Croatian: Nemojte koristiti LAVENTAIR ELLIPTA ako već primjenjujete navedene lijekove.
English: The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Croatian: Sigurnosni profil lijeka LAVENTAIR ELLIPTA temelji se na iskustvu povezanom sa sigurnošću primjene umeklidinija/vilanterola i njegovih pojedinačnih sastavnica u kliničkom razvojnom programu kojim je obuhvaćeno 6855 bolesnika s KOPB-om i iz spontanih prijava.
English: Throw this desiccant sachet away - don't open, eat or inhale it.
Croatian: Bacite tu vrećicu sa sredstvom za sušenje - nemojte je otvarati, progutati niti udisati.
English: Contents of the pack and other information What LAVENTAIR ELLIPTA contains
Croatian: Sadržaj pakiranja i druge informacije Što LAVENTAIR ELLIPTA sadrži
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 umjerenoga 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: 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 Laventair 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 Laventair Ellipta u usporedbi s tiotropijem (ispitivanje 201038), prema protokolu dogovorenom od strane Povjerenstva za ocjenu rizika na području farmakovigilancije.
English: There was no evidence for tachyphylaxis in the effect of LAVENTAIR ELLIPTA over time.
Croatian: Nije bilo znakova tahifilaksije na učinke lijeka LAVENTAIR ELLIPTA tijekom vremena.
English: If you use more LAVENTAIR ELLIPTA than you should
Croatian: Ako primijenite više lijeka LAVENTAIR ELLIPTA nego što ste trebali
English: If you are breast-feeding, you must check with your doctor before you use LAVENTAIR ELLIPTA.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego uzmete LAVENTAIR ELLIPTA.
English: It is unlikely that LAVENTAIR ELLIPTA will affect your ability to drive or use machines.
Croatian: Nije vjerojatno da bi LAVENTAIR ELLIPTA mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Croatian: U druga dva ispitivanja s aktivnim usporednim lijekom sličan je udio bolesnika postigao barem MCID i uz primjenu lijeka LAVENTAIR ELLIPTA i uz primjenu tiotropija; 49% i 54% uz LAVENTAIR ELLIPTA od 55/22 mikrograma te 52% i 55% uz tiotropij.
English: What LAVENTAIR ELLIPTA looks like and contents of the pack
Croatian: Kako LAVENTAIR ELLIPTA izgleda i sadržaj pakiranja
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 primjene ovoga lijeka.
English: It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk.
Croatian: Nije poznato mogu li se sastojci lijeka LAVENTAIR ELLIPTA izlučiti u majčino mlijeko.
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Croatian: Kada ste spremni uzeti vaš inhalator, povucite unatrag poklopac kako bi otvorili podložak.
English: those for the LAVENTAIR ELLIPTA dose and provided additional supportive evidence for the efficacy of LAVENTAIR ELLIPTA.
Croatian: Rezultati su bili slični onima za dozu lijeka LAVENTAIR ELLIPTA te su pružili dodatne dokaze koji govore u prilog djelotvornosti lijeka LAVENTAIR ELLIPTA.
English: In the second study, the treatment difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Croatian: U drugom je ispitivanju terapijska razlika EET vrijednosti između lijeka LAVENTAIR ELLIPTA od 55/22 mikrograma i placeba iznosila 21,9 sekundi (p=0,234) nakon 12 tjedana.
English: LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Croatian: LAVENTAIR ELLIPTA se koristi za liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with LAVENTAIR
Croatian: Ishodi povezani s plućnom funkcijom, simptomima i kvalitetom života vezanom uz zdravlje nakon 24 tjedna
English: LAVENTAIR ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Croatian: LAVENTAIR ELLIPTA je u sva tri ispitivanja pokazao značajnije proporcionalno povećanje u danima, naspram početne vrijednosti kada nije bila potrebna primjena lijeka za hitno ublažavanje simptoma (prosjek u rasponu od 17,6% do 21,5%) u usporedbi s tiotropijem (prosjek u rasponu od 11,7% do 13,4%).
English: Other medicines and LAVENTAIR ELLIPTA
Croatian: Drugi lijekovi i LAVENTAIR ELLIPTA
English: LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Croatian: LAVENTAIR ELLIPTA sadrži dvije djelatne tvari, umeklidinij bromid i vilanterol.
English: The use of LAVENTAIR ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution.
Croatian: Primjena lijeka LAVENTAIR ELLIPTA nije ispitivana u bolesnika s teškim oštećenjem jetrene funkcije pa se mora primjenjivati uz oprez.
English: Use LAVENTAIR ELLIPTA regularly
Croatian: Primjenjujte LAVENTAIR ELLIPTA redovito
English: What LAVENTAIR ELLIPTA is and what it is used for What LAVENTAIR ELLIPTA is
Croatian: Što je LAVENTAIR ELLIPTA i za što se koristi Što je LAVENTAIR ELLIPTA
English: To use LAVENTAIR ELLIPTA, you breathe it into your lungs through your mouth using the ELLIPTA inhaler.
Croatian: LAVENTAIR ELLIPTA se primjenjuje tako da ga udahnete kroz usta u pluća uz pomoć ELLIPTA inhalatora.
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
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: What you need to know before you use LAVENTAIR ELLIPTA 3.
Croatian: Što morate znati prije nego počnete primjenjivati LAVENTAIR ELLIPTA
English: • decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Croatian: • povišenje izmjerenog očnog tlaka • slabljenje vida ili bol u očima zbog povišenog tlaka (mogući znaci glaukoma)
English: LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Croatian: Primjena lijeka LAVENTAIR ELLIPTA smanjila je uporabu salbutamola kao lijeka za hitno ublažavanje simptoma (engl. rescue medication) u razdoblju od 1-24 tjedna u usporedbi s placebom i umeklidinijem (vidjeti Tablicu 1) te pokazala proporcionalno povećanje u danima naspram početne vrijednosti, kada uporaba lijeka za hitno ublažavanje simptoma nije bila potrebna (u prosjeku 11,1%) u usporedbi sa smanjenjem naspram početne vrijednosti, kod placeba (u prosjeku 0, 9%).
English: LAVENTAIR ELLIPTA contains lactose
Croatian: LAVENTAIR ELLIPTA sadrži laktozu
English: LAVENTAIR ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: LAVENTAIR ELLIPTA se ne smije primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.
Croatian: Inhalator sadrži dva blistera od višeslojne aluminijske folije sa 7 ili 30 doza Veličine pakiranja: inhalatori sa 7 ili 30 doza.
English: In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Croatian: 6-mjesečnim ispitivanjima faze III, primjena umeklidinija/vilanterola dovela je do klinički značajnih poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u 1 sekundi [FEV1]) u odnosu na placebo tijekom 24 sata nakon primjene jedanput na dan, koja su bila primjetna 15 minuta nakon primjene prve doze (poboljšanje za 112 ml u odnosu na placebo (p<0,001∗)).
English: If you stop using LAVENTAIR ELLIPTA
Croatian: Ako prestanete primjenjivati LAVENTAIR ELLIPTA
English: • tremor
Croatian: • osip • tremor
English: LAVENTAIR ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Croatian: LAVENTAIR ELLIPTA (N = 454) naspram tiotropija 18 µg (N = 451) (ispitivanje ZEP117115)
English: LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: LAVENTAIR ELLIPTA je indiciran kao bronhodilatator u terapiji održavanja u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB) s ciljem ublažavanja simptoma.
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with FF/VI and UMEC/VI.
Croatian: Primarna mjera ishoda bila je smanjenje godišnje stope umjerenih i teških egzacerbacija u ispitanika liječenih s FF/UMEC/VI u usporedbi s FF/VI i UMEC/VI.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol (FF/VI 92/22 micrograms) administered once daily as a single inhaler.
Croatian: U randomiziranom, dvostruko slijepom, 52-tjednom ispitivanju (CTT116855, IMPACT) provedenom u 10 355 odraslih bolesnika s KOPB-om koji su u proteklih 12 mjeseci imali 1 ili više umjerenih ili teških egzacerbacija bili su randomizirani (1:2:2) za primanje umeklidinij/vilanterola (UMEC/VI 55/22 micrograma), flutikazonfuroat/umeklidinij/vilanterola (FF/UMEC/VI 99/55/22 mikrograma) ili flutikazonfuroat/vilanterola (FF/VI 99/22 mikrograma) pomoću jednog inhalatora primijenjenim jedanput na dan.
English: LAVENTAIR ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Croatian: LAVENTAIR ELLIPTA je u nekoliko ispitivanja pokazao poboljšanja plućne funkcije (definirana promjenom najniže vrijednosti FEV1 u odnosu na početnu vrijednost).
English: Eye problems during treatment with LAVENTAIR ELLIPTA
Croatian: Očne tegobe tijekom liječenja lijekom LAVENTAIR ELLIPTA
English: LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed.
Croatian: LAVENTAIR ELLIPTA je prašak inhalata, dozirani.
English: The maximum dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Croatian: Maksimalna doza je jedna inhalacija lijeka LAVENTAIR ELLIPTA od 55/22 mikrograma jedanput na dan.
English: The recommended dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Croatian: Preporučena doza je jedna inhalacija lijeka LAVENTAIR ELLIPTA od 55/22 mikrograma jedanput na dan.
English: - ketoconazole or itraconazole, to treat fungal infections - clarithromycin or telithromycin, to treat bacterial infections - ritonavir, to treat HIV infection - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or some medicines used to treat asthma (such as methylxanthine or steroids) - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
Croatian: lijekove koji se zovu beta blokatori (poput propranolola), a koriste se za liječenje visokog krvnog tlaka ili drugih srčanih tegoba ketokonazol ili itrakonazol, koji se koriste za liječenje gljivičnih infekcija klaritromicin ili telitromicin, koji se koriste za liječenje bakterijskih infekcija ritonavir, koji se koristi za liječenje HIV infekcije lijekove koji smanjuju količinu kalija u krvi, poput nekih diuretika (tableta za izmokravanje viška tekućine iz tijela) ili neke lijekove koji se koriste za liječenje astme (kao što su metilksantin ili steroidi)
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for LAVENTAIR ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Croatian: Udio bolesnika koji su nakon 24 tjedna postigli barem MCID u SGRQ rezultatu (definiran kao smanjenje za 4 boda od početne vrijednosti) bio je veći kod primjene lijeka LAVENTAIR ELLIPTA (49%) u usporedbi s placebom (34%) ili bilo kojom od sastavnica u monoterapiji (44% za umeklidinij i 48% za vilanterol).
English: An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Croatian: Zbog djelovanja pojedinih sastojaka, predoziranje umeklidinijem/vilanterolom vjerojatno će izazvati znakove i simptome koji odgovaraju poznatim nuspojavama koje se javljaju kod primjene inhalacijskih muskarinskih antagonista (npr. suha usta, poremećaji vidne akomodacije i tahikardija) ili kod predoziranja drugim beta2-adrenergičkim agonistima (npr. aritmije, tremor, glavobolja, palpitacije,
English: The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, FF/VI, and UMEC/VI respectively.
Croatian: Srednja godišnja stopa egzacerbacija bila je 0.91 za FF/UMEC/VI, 1.07 za FF/VI i 1.21 za UMEC/VI.
English: LAVENTAIR ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Croatian: LAVENTAIR ELLIPTA 55/22 µg prašak inhalata umeklidinij/vilanterol
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for LAVENTAIR ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Croatian: Udio bolesnika koji su nakon 24 tjedna odgovorili barem najmanjom klinički važnom razlikom (engl. minimum clinically important difference, MCID) od 1 boda u ukupnom TDI rezultatu bio je veći kod primjene lijeka LAVENTAIR ELLIPTA (58%) u usporedbi s primjenom placeba (41%) ili bilo koje od sastavnica u monoterapiji (53% za umeklidinij i 51% za vilanterol).