FrancophonIA/ELRC3.0 huggingface dataset:
English:  Tell your doctor if you are taking these or any other medicines.
Croatian: Ako uzimate ove ili bilo koje druge lijekove, obavijestite svog liječnika.
English: • Feeling tired
Croatian: • osjećaj nadutosti
English: Changes in measures of bone mineral density In both studies tenofovir alafenamide was associated with smaller mean percentage decreases in bone mineral density (BMD; as measured by hip and lumbar spine dual energy X ray absorptiometry
Croatian: U oba je ispitivanja nakon 96 tjedana liječenja tenofoviralafenamid povezan s manjom srednjom vrijednosti postotka smanjenja mineralne gustoće kostiju (engl. bone mineral density, BMD; mjereno analizom podataka dobivenih apsorpciometrijom s pomoću X-zraka dviju različitih energija (engl. dual energy X ray absorptiometry, DXA) u području kuka i lumbalne kralježnice) u usporedbi s onim uočenim nakon 96 tjedana liječenja tenofovirdizoproksilfumaratom.
English: Tenofovir ↓ Cmax 0.70 (0.65, 0.74)
Croatian: ↓ Cmax 0,70 (0,65; 0,74) ↔ AUC 0,77 (0,74; 0,81)
English: ↑ Cmin 1.85 (1.78, 1.92)
Croatian: ↑ Cmax 1,80 (1,48; 2,18) ↑ AUC 1,75 (1,55; 1,98)
English: The pharmacokinetics of tenofovir alafenamide and tenofovir were evaluated in HIV-1 infected, treatment-naïve adolescents who received tenofovir alafenamide (10 mg) given with elvitegravir,
Croatian: Farmakokinetika tenofoviralafenamida i tenofovira procijenjivana je u adolescenata zaraženih HIV-1
English: rifabutin, rifampicin or rifapentine
Croatian: Vemlidy ili rilpivirina.
English: Norgestrel ↔ Cmax 1.10 (1.02, 1.18) ↔ AUC 1.09 (1.01, 1.18) ↔ Cmin 1.11 (1.03, 1.20)
Croatian: ↔ Cmax 1,10 (1,02; 1,18) ↔ AUC 1,09 (1,01; 1,18) ↔ Cmin 1,11 (1,03; 1,20)
English: No dose adjustment of Vemlidy or sertraline is required.
Croatian: Vemlidy ili sertralina.
English: Darunavir ↔ Cmax 0.99 (0.91, 1.08) ↔ AUC 1.01 (0.96, 1.06) ↔ Cmin 1.13 (0.95, 1.34)
Croatian: ↔ Cmax 0,99 (0,91; 1,08) ↔ AUC 1,01 (0,96; 1,06) ↔ Cmin 1,13 (0,95; 1,34)
English: Ethinylestradiol ↔ Cmax 1.22 (1.15, 1.29) ↔ AUC 1.11 (1.07, 1.16) ↔ Cmin 1.02 (0.93, 1.12)
Croatian: ↔ Cmax 1,22 (1,15; 1,29) ↔ AUC 1,11 (1,07; 1,16) ↔ Cmin 1,02 (0,93; 1,12)
English: • Diarrhoea
Croatian: • glavobolja
English: • tenofovir alafenamide
Croatian: Tenofoviralafenamidc
English: No dose adjustment of Vemlidy or dolutegravir is required.
Croatian: Nije potrebna prilagodba doze lijeka Vemlidy ili efavirenza.
English: d A sensitive CYP3A4 substrate.
Croatian: CYP2D6.
English: No dose adjustment of Vemlidy or ledipasvir/sofosbuvir is required.
Croatian: Nije potrebna prilagodba doze lijeka Vemlidy ili ledipasvira/sofosbuvira.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Croatian: Izlučivanje nepromijenjenog tenofoviralafenamida bubrezima manji je put eliminacije pri kojem se
English: Following oral administration of Vemlidy under fasted conditions in adult patients with chronic hepatitis B, peak plasma concentrations of tenofovir alafenamide were observed approximately 0.48 hours post-dose.
Croatian: vršne koncentracije tenofoviralafenamida u plazmi uočene su otprilike 0,48 sati nakon uzimanja doze.
English: System organ class Frequency
Croatian: Organski sustav
English: Ethinylestradiol (0.025 mg orally, q.d.)
Croatian: (0,025 mg peroralno, q.d.)
English: Rifapentine
Croatian: OBLIK
English: c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (> 30 U/L males and > 19 U/L females) at baseline.
Croatian: American Association of the Study of Liver Diseases, AASLD) (> 30 U/l za muškarce i > 19 U/l za žene) na početku liječenja.
English: ↑ Cmin 3.21 (2.90, 3.54) Darunavir ↔ Cmax 1.02 (0.96, 1.09)
Croatian: ↑ Cmax 2,42 (1,98; 2,95) ↑ AUC 2,05 (1,54; 2,72)
English: • Being sick (vomiting)
Croatian: • povraćanje • mučnina
English: Medicines used in treating hepatitis B infection
Croatian: Lijekovi koji se koriste pri liječenju infekcije hepatitisom B Nemojte uzimati Vemlidy s drugim lijekovima koji sadrže:
English: (may affect more than 1 in 10 people) • Headache
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 od 10 osoba)
English: ↑ Cmin 1.35 (1.21, 1.51)
Croatian: ↑ Cmax 1,77 (1,28; 2,44) ↑ AUC 1,91 (1,55; 2,35)
English: HIV ANTIRETROVIRAL AGENTS - INTEGRASE INHIBITORS Dolutegravir (50 mg orally, q.d.)
Croatian: LIJEKOVI ZA LIJEČENJE HIV-A - INHIBITORI INTEGRAZE Dolutegravir
English: HCV ANTIVIRAL AGENTS Sofosbuvir (400 mg orally, q.d.)
Croatian: Sofosbuvir (400 mg peroralno, q.d.)
English: Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži tenofoviralafenamidfumarat što odgovara 25 mg tenofoviralafenamida.
English: Changes in measures of renal function
Croatian: Promjene u izmjerenoj mineralnoj gustoći kostiju
English: Expected: ↑ Tenofovir alafenamide
Croatian: Tenofoviralafenamidh
English: Tenofovir ↓ Cmax 0.75 (0.67, 0.86)
Croatian: ↓ Cmax 0,75 (0,67; 0,86) ↔ AUC 0,80 (0,73; 0,87) ↔ Cmin 0,82 (0,75; 0,89)
English: Tenofovir ↔ Cmax 1.10 (0.96, 1.25)
Croatian: ↔ Cmax 1,10 (0,96; 1,25) ↑ AUC 1,25 (1,06; 1,47)
English: No dose adjustment of Vemlidy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
Croatian: (CrCl) ≥ 15 ml/min ni u bolesnika s CrCl < 15 ml/min koji su na hemodijalizi.
English: ↓ Tenofovir alafenamide
Croatian: Tenofoviralafenamide
English: Co-administration of strong inhibitors of P-gp with Vemlidy is not recommended.
Croatian: P-gp-a s lijekom Vemlidy.
English: • Itchiness
Croatian: • omaglica
English: • antibiotics used to treat bacterial infections including tuberculosis, containing:
Croatian: • antibiotike koji se koriste za liječenje bakterijskih infekcija, uključujući tuberkulozu, a sadrže: rifabutin, rifampicin ili rifapentin
English: Vemlidy should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil.
Croatian: Vemlidy se ne smije istodobno primjenjivati s lijekovima koji sadrže tenofovirdizoproksilfumarat,
English: ↔ Cmin 1.18 (1.06, 1.31) Cobicistat ↔ Cmax 0.96 (0.92, 1.00)
Croatian: ↔ Cmax 1,00 (0,86; 1,16) ↔ AUC 0,96 (0,89; 1,03)
English: Fatigue
Croatian: ALT
English: Contents of the pack and other information What Vemlidy contains
Croatian: Što Vemlidy sadrži
English: Tablet core
Croatian: Oštećenja funkcije bubrega
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Croatian: Gilead Sciences Poland Sp. z o.o. Tel: + 48 (0) 22 262 8702
English: ↔ Cmin 1.01 (0.95, 1.09) Voxilaprevir ↔ Cmax 0.96 (0.84, 1.11)
Croatian: ↔ Cmax 1,05 (0,96; 1,16) ↔ AUC 1,01 (0,94; 1,07) ↔ Cmin 1,01 (0,95; 1,09)
English: HBsAg loss / seroconversion
Croatian: Gubitak/serokonverzija HBsAg-a N/P = nije primjenjivo
English: ↔ Cmin 1.02 (0.98, 1.07) Sofosbuvir ↔ Cmax 0.96 (0.89, 1.04)
Croatian: ↔ Cmax 0,98 (0,89; 1,07) ↔ AUC 0,99 (0,96; 1,01) ↔ Cmin 1,00 (0,96; 1,04)
English: Tenofovir alafenamidec (10 mg orally, q.d.)
Croatian: Efavirenz (600 mg peroralno, q.d.)
English: ↔ Cmin 0.97 (0.82, 1.15) Cobicistat ↔ Cmax 1.06 (1.00, 1.12)
Croatian: ↔ Cmax 0,95 (0,86; 1,05) ↔ AUC 1,01 (0,97; 1,06)
English: HIV ANTIRETROVIRAL AGENTS - NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Efavirenz (600 mg orally, q.d.)
Croatian: LIJEKOVI ZA LIJEČENJE HIV-A -NENUKLEOZIDNI INHIBITORI REVERZNE TRANKSRIPTAZE
English: Table 5: HBV DNA and additional efficacy parameters at Week 96a
Croatian: Tablica 5: HBV DNK i dodatni parametri djelotvornosti u 96. tjednua Ispitivanje 108 (negativni na HBeAg) Ispitivanje 110 (pozitivni na HBeAg) Vemlidy (N = 285)
English: Film-coating
Croatian: ANTIKONVULZIVI
English: Children and adolescents Don't give this medicine to children or adolescents below the age of 18 years.
Croatian: Ovaj lijek se ne smije davati djeci ni adolescentima mlađima od 18 godina
English: UMEC/VI
Croatian: UMEK/VI
English: It is very important that you use Elebrato Ellipta every day, as instructed by your doctor.
Croatian: Vrlo je važno da Elebrato Ellipta primjenjujete svakoga dana prema uputama liječnika.
English: Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):
Croatian: Pojavile su se i druge nuspojave, ali njihova točna učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): • zamagljen vid
English: • infection of the nose, sinuses or throat
Croatian: • infekcija nosa, sinusa ili grla
English: The first time you use Elebrato 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 Elebrato 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 Elebrato Ellipta.
Croatian: Liječnik će Vas možda htjeti pažljivo nadzirati ako uzimate neki od tih lijekova jer oni mogu pojačati nuspojave lijeka Elebrato Ellipta.
English: Administration of Elebrato 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 Elebrato 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 Elebrato 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: Elebrato Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: Elebrato Ellipta mora se primjenjivati svaki dan, a ne samo onda kada imate dišne tegobe ili druge simptome KOPB-a.
English: Don't use Elebrato Ellipta if you already use these medicines.
Croatian: Nemojte primijeniti Elebrato Ellipta ako već primjenjujete navedene lijekove.
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 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: 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 Elebrato Ellipta may help prevent this side effect.
Croatian: Ispiranje usta vodom odmah nakon primjene lijeka Elebrato 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 Elebrato 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 Elebrato Ellipta i odmah se obrate svom liječniku ako se razvije bilo koji od tih znakova ili simptoma.
English: Elebrato Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Croatian: Elebrato Ellipta ne smije se primjenjivati u bolesnika s astmom jer nije ispitivan u toj populaciji bolesnika.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Elebrato 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 Elebrato Ellipta, uzimajući pritom u obzir korist dojenja za dijete te korist liječenja za ženu.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato 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 Elebrato Ellipta u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta.
Croatian: Prijavljen je jedan slučaj pneumonije sa smrtnim ishodom u bolesnika koji je primao Elebrato Ellipta.
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Elebrato 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 Elebrato Ellipta i < 1% onih koji su primali budezonid/formoterol tijekom najviše 24 tjedna.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose') and magnesium stearate.
Croatian: Drugi sastojci su laktoza hidrat (pogledajte odlomak 'Elebrato Ellipta sadrži laktozu' u dijelu 2.) i magnezijev stearat.
English: Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may recur after discontinuation.
Croatian: Bolesnici ne smiju prekinuti liječenje lijekom Elebrato Ellipta bez liječničkog nadzora jer se nakon prekida njegove primjene simptomi mogu vratiti.
English: Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Elebrato Ellipta koristi se za liječenje kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: There are no clinical data to support the use of Elebrato 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 Elebrato Ellipta za liječenje akutnih epizoda bronhospazma ili akutne egzacerbacije KOPB-a (npr. kao terapije za hitno ublažavanje simptoma).
English: Caution should be exercised when Elebrato 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 Elebrato Ellipta primjenjuje s drugim lijekovima koji također mogu uzrokovati hipokalijemiju (vidjeti dio 4.5).
English: The recommended and maximum dose is one inhalation of Elebrato Ellipta 92/55/22 micrograms once daily, at the same time each day.
Croatian: Preporučena maksimalna doza je jedna inhalacija lijeka Elebrato Ellipta od 92/55/22 mikrograma jedanput na dan, svaki dan u isto doba.
English: Tabulated summary of adverse reactions The safety profile of Elebrato Ellipta is based on three phase III clinical studies.
Croatian: Sigurnosni profil lijeka Elebrato Ellipta temelji se na trima kliničkim ispitivanjima faze III.
English: There is no specific treatment for an overdose with Elebrato Ellipta.
Croatian: Nema specifične terapije za predoziranje lijekom Elebrato Ellipta.
English: The steady-state pharmacokinetics of umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Croatian: Farmakokinetika umeklidinija u stanju dinamičke ravnoteže ocijenjena je u zdravih dobrovoljaca koji nemaju CYP2D6 (slabi metabolizatori).
English: The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Croatian: Kombinacija flutikazonfuroat/vilanterol, sadržana u lijeku Elebrato Ellipta, ocjenjivala se u bolesnika sa svim stupnjevima oštećenja jetrene funkcije (Child-Pugh stadij A, B ili C).
English: If you use more Elebrato Ellipta than you should
Croatian: Ako primijenite više lijeka Elebrato Ellipta nego što ste trebali
English: In the event of deterioration of COPD during treatment with Elebrato 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 Elebrato Ellipta potrebno je ponovno ocijeniti stanje bolesnika i režim liječenja KOPB-a.
English: Use Elebrato Ellipta regularly
Croatian: Primjenjujte Elebrato Ellipta redovito
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Elebrato 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 Elebrato Ellipta pojavi bilo koja od sljedećih nuspojava - možda se radi o simptomima infekcije pluća:
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: bolesnika treba liječiti suportivno te po potrebi uvesti odgovarajuće praćenje.
English: If you are breast-feeding, you must check with your doctor before you use Elebrato Ellipta.
Croatian: Ako dojite, morate se obratiti svom liječniku prije nego što primijenite Elebrato Ellipta.
English: Elebrato 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 Elebrato 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: Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Croatian: Elebrato Ellipta sadrži tri djelatne tvari koje se zovu flutikazonfuroat, umeklidinij i vilanterol.
English: Elebrato Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Elebrato Ellipta treba primjenjivati uz oprez u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
English: The efficacy of Elebrato 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 Elebrato 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: Don't use Elebrato Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Elebrato Ellipta: - ako ste alergični na flutikazonfuroat, umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka
English: Eye problems during treatment with Elebrato 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 Elebrato Ellipta:
Croatian: Ako se tijekom liječenja lijekom Elebrato 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 Elebrato Ellipta, plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon uvođenja liječenja lijekom Elebrato Ellipta potrebno je pobliže nadzirati razine glukoze u plazmi u bolesnika sa šećernom bolešću.
English: Co-administration of Elebrato 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: Istodobna primjena lijeka Elebrato 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: What you need to know before you use Elebrato Ellipta
Croatian: Što morate znati prije nego počnete primjenjivati Elebrato Ellipta
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta and budesonide/formoterol arms was equal at 2%.
Croatian: U podskupini od 430 bolesnika liječenih tijekom najviše 52 tjedna, prijavljena incidencija događaja pneumonije bila je jednaka u skupini liječenoj lijekom Elebrato Ellipta i u onoj koja je primala budezonid/formoterol (2%).
English: In FULFIL, bronchodilatory effects with Elebrato 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 Elebrato 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: Other medicines and Elebrato 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: Elebrato Ellipta is for inhalation use only.
Croatian: Način primjene Elebrato Ellipta namijenjen je isključivo za inhaliranje.
English: White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter.
Croatian: Bijeli prašak u svijetlosivom inhalatoru (Ellipta ) s bež poklopcem nastavka za usta i brojačem doza.
English: Your Elebrato Ellipta inhaler carton contains
Croatian: Vaša kutija s Elebrato Ellipta inhalatorom sadrži
English: The incidence of pneumonia with Elebrato 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 Elebrato 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: Patients with moderate to severe hepatic impairment receiving Elebrato 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 Elebrato Ellipta treba nadzirati zbog mogućih sistemskih nuspojava kortikosteroida (vidjeti dio 5.2).