FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC : ↑ 21 % Cmin: ↑ 17 % Cmax: ↑ 15% (CYP3A4 inhibition)
Croatian: Cmax: ↑ 15% (inhibicija CYP3A4)
English: Bupropion: AUC: ↓ 55% (↓ 48 to ↓ 62)
Croatian: maravirok: AUC12: ↓ 45% (↓ 38 do
English: AUC: ↓ 51% Cmax: ↓ 21% Dihydroartemisinin: AUC: ↓ 46% Cmax: ↓ 38% Lumefantrine:
Croatian: dihidroartemisinin: AUC: ↓ 46% Cmax: ↓ 38%
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Croatian: AUC: ↓ 75% (↓ 62 do ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
English: Indinavir/ritonavir/Efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Croatian: Preporuke za istodobnu primjenu s efavirenzom indinavir/ritonavir/efavirenz (800 mg dvaput na dan/100 mg dvaput na dan/600 mg jedanput na dan)
English: 3, or in PI or NNRTI-experienced patients.
Croatian: 3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
English: Simeprevir/Efavirenz (150 mg once daily /600 mg once daily)
Croatian: Preporuke za istodobnu primjenu s efavirenzom simeprevir/efavirenz (150 mg jedanput na dan /600 mg jedanput na dan)
English: Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
Croatian: AUC: ↓ 43% (↓ 7 do ↓ 65) Cmax: ↔
English: Buprenorphine:
Croatian: bupropion:
English: It is very important that you use Temybric Ellipta every day, as instructed by your doctor.
Croatian: Vrlo je važno da Temybric Ellipta primjenjujete svakoga dana prema uputama liječnika.
English: The first time you use Temybric 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 koristite Temybric Ellipta po prvi puta, ne morate provjeravati radi li inhalator ispravno; on sadrži prethodno odmjerene doze i odmah je spreman za uporabu.
English: Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Temybric Ellipta.
Croatian: Liječnik će Vas možda htjeti pažljivo nadzirati ako uzimate neki od tih lijekova jer oni mogu pojačati nuspojave lijeka Temybric Ellipta.
English: Administration of Temybric Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Croatian: Primjenu lijeka Temybric Ellipta u trudnica treba razmotriti samo ako očekivana korist za majku opravdava mogući rizik za plod.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Veći postotak bolesnika liječenih lijekom Temybric Ellipta odgovorio je klinički značajnim poboljšanjem SGRQ rezultata u 24. tjednu ispitivanja FULFIL u usporedbi s bolesnicima koji su primjenjivali BUD/FOR (50% odnosno 41%; omjeri izgleda [engl. odds ratio, OR] za odgovor u odnosu na izostanak odgovora [1,41; 95% CI: 1,16; 1,70]), kao i u 52. tjednu ispitivanja IMPACT u usporedbi s bolesnicima koji su primjenjivali FF/VI i UMEK/VI (42%, 34% odnosno 34%; OR u odnosu na FF/VI [1,41; 95% CI: 1,29; 1,55]; OR u odnosu na UMEK/VI [1,41; 95% CI: 1,26; 1,57]).
English: Temybric Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: Temybric Ellipta mora se primjenjivati svaki dan, a ne samo onda kada imate dišne tegobe ili druge simptome KOPB-a.
English: Don't use Temybric Ellipta if you already use these medicines.
Croatian: Nemojte primijeniti Temybric Ellipta ako već primjenjujete navedene lijekove.
English: Rinsing your mouth out with water immediately after using Temybric Ellipta may help prevent this side effect.
Croatian: Ispiranje usta vodom odmah nakon primjene lijeka Temybric Ellipta može pomoći spriječiti ovu nuspojavu.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Temybric 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 Temybric 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 Temybric Ellipta 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 lijekom Temybric Ellipta, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za ženu.
English: Temybric Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Croatian: Temybric Ellipta ne smije se primjenjivati u bolesnika s astmom jer nije ispitivan u toj populaciji bolesnika.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Temybric 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 Temybric Ellipta u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Temybric 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 Temybric Ellipta i < 1% onih koji su primali budezonid/formoterol tijekom najviše 24 tjedna.
English: One fatal case of pneumonia was reported in a patient who received Temybric Ellipta.
Croatian: Prijavljen je jedan slučaj pneumonije sa smrtnim ishodom u bolesnika koji je primao Temybric Ellipta.
English: Temybric Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Temybric Ellipta koristi se za liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: Patients should not stop therapy with Temybric Ellipta without physician supervision since symptoms may recur after discontinuation.
Croatian: Bolesnici ne smiju prekinuti liječenje lijekom Temybric Ellipta bez liječničkog nadzora jer se nakon prekida njegove primjene simptomi mogu vratiti.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (pogledajte odlomak 'Temybric Ellipta sadrži laktozu' u dijelu 2.) i magnezijev stearat.
English: The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day.
Croatian: Preporučena i maksimalna doza je jedna inhalacija lijeka Temybric Ellipta od 92/55/22 mikrograma jedanput na dan, svaki dan u isto doba.
English: There are no clinical data to support the use of Temybric 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 Temybric Ellipta za liječenje akutnih epizoda bronhospazma ili akutne egzacerbacije KOPB-a (npr. kao terapije za hitno ublažavanje simptoma).
English: Caution should be exercised when Temybric 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 Temybric Ellipta primjenjuje s drugim lijekovima koji također mogu uzrokovati hipokalijemiju (vidjeti dio 4.5).
English: If you use more Temybric Ellipta than you should
Croatian: Ako primijenite više lijeka Temybric Ellipta nego što ste trebali
English: The fluticasone furoate/vilanterol component of Temybric Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Croatian: Kombinacija flutikazonfuroat/vilanterol, sadržana u lijeku Temybric Ellipta, ocjenjivala se u bolesnika sa svim stupnjevima oštećenja jetrene funkcije (Child-Pugh stadij A, B ili C).
English: Tabulated summary of adverse reactions The safety profile of Temybric Ellipta is based on three phase III clinical studies.
Croatian: Sigurnosni profil lijeka Temybric Ellipta temelji se na trima kliničkim ispitivanjima faze III.
English: Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Croatian: Temybric Ellipta sadrži tri djelatne tvari koje se zovu flutikazonfuroat, umeklidinij i vilanterol.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA - SAMO VIŠESTRUKO PAKIRANJE)
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Temybric Ellipta - these could be symptoms of a lung infection:
Croatian: Upala pluća (infekcija pluća) u bolesnika s KOPB-om (česta nuspojava) Obavijestite svog liječnika ako se pri primjeni lijeka Temybric Ellipta pojavi bilo koja od sljedećih nuspojava - možda se radi o simptomima infekcije pluća:
English: In the event of deterioration of COPD during treatment with Temybric Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Croatian: U slučaju pogoršanja KOPB-a tijekom liječenja lijekom Temybric Ellipta potrebno je ponovno ocijeniti stanje bolesnika i režim liječenja KOPB-a.
English: There is no specific treatment for an overdose with Temybric Ellipta.
Croatian: Nema specifične terapije za predoziranje lijekom Temybric Ellipta.
English: Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Croatian: 4.1 Terapijske indikacije Temybric Ellipta indiciran je kao terapija održavanja u odraslih bolesnika s umjerenom do teškom kroničnom opstruktivnom plućnom bolešću (KOPB) koji nisu adekvatno liječeni kombinacijom inhalacijskog kortikosteroida i dugodjelujućeg β2-agonista ili kombinacijom dugodjelujućeg β2-agonista i dugodjelujućeg antagonista muskarinskih receptora (za učinke na kontrolu simptoma i prevenciju egzacerbacija vidjeti dio 5.1).
English: Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Temybric Ellipta treba primjenjivati uz oprez u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
English: If you are breast-feeding, you must check with your doctor before you use Temybric Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego što primijenite Temybric Ellipta.
English: The efficacy of Temybric Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Croatian: Djelotvornost lijeka Temybric Ellipta (92/55/22 mikrograma) primijenjenog jedanput na dan ocjenjivala se u bolesnika s kliničkom dijagnozom KOPB-a u dvama aktivnim lijekom kontroliranim ispitivanjima i jednom ispitivanju neinferiornosti.
English: Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility in rats.
Croatian: Flutikazonfuroat, umeklidinij i vilanterol nisu imali štetnih učinaka na plodnost mužjaka i ženki štakora.
English: Eye problems during treatment with Temybric Ellipta If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with Temybric Ellipta:
Croatian: Ako se tijekom liječenja lijekom Temybric Ellipta pojave bol ili nelagoda u oku, privremeno zamagljenje vida, odbljesak ili krugovi duginih boja pred očima, kao i crvenilo očiju:
English: Upon initiation of treatment with Temybric Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon uvođenja liječenja lijekom Temybric Ellipta potrebno je pobliže nadzirati razine glukoze u plazmi u bolesnika sa šećernom bolešću.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
Croatian: U prenatalnom i postnatalnom ispitivanju supkutana primjena umeklidinija u štakora smanjila je prirast majčine tjelesne težine i unos hrane te blago smanjila tjelesnu težinu mladunčadi prije prestanka sisanja u ženki koje su primale dozu od 180 mikrograma/kg na dan (izloženost približno 61 puta veća od kliničke izloženosti u ljudi nakon primjene dnevne doze umeklidinija od 55 mikrograma, što je utvrđeno na temelju AUC-a).
English: Temybric Ellipta contains lactose
Croatian: Temybric Ellipta sadrži laktozu
English: Use Temybric Ellipta regularly
Croatian: Primjenjujte Temybric Ellipta redovito
English: In FULFIL, bronchodilatory effects with Temybric Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Croatian: U ispitivanju FULFIL, bronhodilatacijski učinci lijeka Temybric Ellipta bili su primjetni već prvog dana liječenja, a održali su se tijekom čitavog 24-tjednog razdoblja liječenja (srednja vrijednost promjene FEV1 u odnosu na početnu vrijednost iznosila je 90 - 222 ml prvog dana te 160 - 339 ml u 24. tjednu).
English: Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Croatian: Sistemske razine (Cmax i AUC u stanju dinamičke ravnoteže) flutikazonfuroata, umeklidinija i vilanterola nakon primjene kombinacije FF/UMEK/VI u jednom inhalatoru (trojna kombinacija) bile su unutar raspona razina opaženih nakon primjene kombinacije FF/VI + UMEK dvama inhalatorima, nakon primjene dvojnih kombinacija (FF/VI i UMEK/VI), kao i nakon primjene pojedinačnih lijekova (flutikazonfuroat, umeklidinij i vilanterol).
English: The incidence of pneumonia with Temybric Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Croatian: Incidencija pneumonije kod primjene lijeka Temybric Ellipta usporediva je s onom primijećenom u skupini liječenoj flutikazonfuroatom/vilanterolom (FF/VI) u dozi od 100/25 mikrograma u kliničkim ispitivanjima primjene kombinacije FF/VI kod KOPB-a.
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Temybric Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Croatian: Pneumonija sa smrtnim ishodom zabilježena je u 12 od 4151 bolesnika (3,5 na 1000 bolesnik-godina) koji je primjenjivao Temybric Ellipta, 5 od 4134 bolesnika (1,7 na 1000 bolesnik-godina) koja su primjenjivala flutikazonfuroat/vilanterol te 5 od 2070 bolesnika (2,9 na 1000 bolesnik-godina) koji su primjenjivali umeklidinij/vilanterol.
English: Patients with moderate to severe hepatic impairment receiving Temybric Ellipta should be monitored for systemic corticosteroid-related adverse reactions (see section 5.2).
Croatian: Bolesnike s umjerenim do teškim oštećenjem jetrene funkcije koji se liječe lijekom Temybric Ellipta treba nadzirati zbog mogućih sistemskih nuspojava kortikosteroida (vidjeti dio 5.2).
English: Other medicines and Temybric Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: In Study 200812, Temybric Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Croatian: U ispitivanju 200812, Temybric Ellipta bio je neinferioran flutikazonfuroatu/vilanterolu (FF/VI) + umeklidiniju (UMEK), primijenjenima istodobno dvama inhalatorima, s obzirom na poboljšanje najniže vrijednosti FEV1 od početka ispitivanja do 24. tjedna.
English: What you need to know before you use Temybric Ellipta
Croatian: Što morate znati prije nego počnete primjenjivati Temybric Ellipta
English: Your Temybric Ellipta inhaler carton contains
Croatian: Vaša kutija s Temybric Ellipta inhalatorom sadrži
English: Therefore, Temybric Ellipta should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Croatian: Stoga Temybric Ellipta treba primjenjivati uz oprez u bolesnika s nestabilnom ili po život opasnom kardiovaskularnom bolešću.
English: What Temybric Ellipta is and what it is used for
Croatian: Što je Temybric Ellipta i za što se koristi
English: Temybric Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Croatian: Temybric Ellipta treba primjenjivati uz oprez u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika s neuobičajeno dobrim odgovorom na beta2-adrenergičke agoniste.
English: The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Croatian: Najčešće prijavljene nuspojave kod primjene lijeka Temybric Ellipta bile su nazofaringitis (7%),
English: In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Temybric Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Croatian: Među ukupno 1810 bolesnika s uznapredovalim KOPB-om (srednja vrijednost FEV1 nakon primjene bronhodilatatora pri probiru: 45% predviđene vrijednosti; standardno odstupanje: 13%), od kojih je njih 65% doživjelo umjerenu/tešku egzacerbaciju KOPB-a unutar godinu dana prije uključivanja u ispitivanje (ispitivanje CTT116853), prijavljena je viša incidencija događaja pneumonije tijekom najviše 24 tjedna u bolesnika koji su primali Temybric Ellipta (20 bolesnika, 2%) nego u onih koji su primali budezonid/formoterol (7 bolesnika, < 1%).
English: Treatment with Temybric Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Croatian: Liječenje lijekom Temybric Ellipta značajno je smanjilo godišnju stopu teških egzacerbacija za 34% u odnosu na UMEK/VI (95% CI: 22; 44; p < 0,001).
English: If you stop using Temybric Ellipta
Croatian: Ako prestanete primjenjivati Temybric Ellipta
English: Temybric Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Croatian: Temybric Ellipta treba primjenjivati uz oprez u bolesnika s tuberkulozom pluća te u bolesnika s kroničnim ili neliječenim infekcijama.
English: In FULFIL, Temybric Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004).
Croatian: U ispitivanju FULFIL, Temybric Ellipta značajno je smanjio rizik od umjerene/teške egzacerbacije u odnosu na BUD/FOR tijekom 24 tjedna (33%; 95% CI: 12; 48; p = 0,004).
English: In IMPACT, Temybric Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Croatian: U ispitivanju IMPACT, TemybricEllipta značajno je poboljšao (p < 0,001) plućnu funkciju u usporedbi s kombinacijama FF/VI i UMEK/VI tijekom 52-tjednog razdoblja (vidjeti Tablicu 2).
English: Temybric Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Croatian: Temybric Ellipta ne smije se primjenjivati za ublažavanje naglog napadaja nedostatka zraka ili piskanja pri disanju.
English: In IMPACT, treatment with Temybric Ellipta reduced the annual rate of severe exacerbations (i.e., requiring hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064).
Croatian: U ispitivanju IMPACT, liječenje lijekom Temybric Ellipta smanjilo je godišnju stopu teških egzacerbacija (tj. onih koje su zahtijevale hospitalizaciju ili imale smrtni ishod) za 13% u odnosu na FF/VI (95% CI: -1; 24; p = 0,064).
English: In FULFIL, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1).
Croatian: U ispitivanju FULFIL, Temybric Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma između 1. i 24. tjedna u odnosu na BUD/FOR (razlika između liječenja: -0,2 primjene na dan; 95% CI: -0,3; -0,1).
English: Temybric Ellipta is for inhalation use only.
Croatian: Način primjene Temybric Ellipta namijenjen je isključivo za inhaliranje.
English: Co-administration of Temybric Ellipta with other long-acting muscarinic antagonists or long-acting beta2adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions (see section 4.8 and section 4.9).
Croatian: Drugi dugodjelujući antimuskarinici i dugodjelujući beta2-adrenergički agonisti Istodobna primjena lijeka Temybric Ellipta s drugim dugodjelujućim muskarinskim antagonistima ili dugodjelujućim beta2-adrenergičkim agonistima nije se ispitivala te se ne preporučuje jer može potencirati nuspojave (vidjeti dijelove 4.8 i 4.9).
English: In IMPACT, Temybric Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per day) at each 4-week time period compared with FF/VI and UMEC/VI.
Croatian: U ispitivanju IMPACT, Temybric Ellipta značajno je smanjio (p < 0,001) uporabu lijekova za hitno ublažavanje simptoma (broj primjena na dan) u svakom 4-tjednom razdoblju u odnosu na FF/VI i UMEK/VI.
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Temybric Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Croatian: udio bolesnika s odgovorom također je bio značajno veći (p < 0,001) uz Temybric Ellipta (36%) nego uz FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) i UMEK/VI (30%; OR 1,33; 95% CI: 1,13; 1,57).
English: If you forget to use Temybric Ellipta
Croatian: Ako ste zaboravili primijeniti Temybric Ellipta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1378/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1378/001
English: INFORMATION IN BRAILLE temybric ellipta
Croatian: 16. PODACI NA BRAILLEOVOM PISMU temybric ellipta
English: GSK Services Sp. z o.o.
Croatian: Laboratori Guidotti S.p.A.
English: Contents of the pack and other information Step-by-step instructions
Croatian: Kako čuvati Temybric Ellipta Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
English: In FULFIL, based upon data up to 24 weeks, Temybric Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Croatian: Prema podacima prikupljenima do 24. tjedna u ispitivanju FULFIL, TemybricEllipta je značajno smanjio (p = 0,002) godišnju stopu umjerenih/teških egzacerbacija za 35% (95% CI: 14; 51) u odnosu na BUD/FOR.