FrancophonIA/ELRC3.0 huggingface dataset:
English: Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore electrolyte abnormalities should be monitored and corrected in all patients before starting treatment.
Croatian: Poremećaji elektrolita kao što su hipokalemija, hipokalcemija ili hipomagnezemija povećavaju rizik od produljenja QT intervala, pa stoga treba pratiti poremećaje elektrolita i ispraviti ih u svih bolesnika prije početka liječenja.
English: The minimal washout period in clinical trials was of 4 weeks.
Croatian: U kliničkim ispitivanjima minimalno razdoblje ispiranja lijeka iz organizma iznosilo je 4 tjedna.
English: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal antihypertensive therapy
Croatian: Sistolički KT ≥160 mmHg ili dijastolički KT ≥100 mmHg usprkos optimalnoj antihipertenzivnoj terapiji
English: Body weight below 60 kg
Croatian: Tjelesna težina manja od 60 kg
English: No data with the combination are available for most of the special populations.
Croatian: Za većinu posebnih populacija nema dostupnih podataka o kombiniranoj primjeni lijekova.
English: Proteinuria led to permanent treatment discontinuation in 4.8% of patients.
Croatian: Proteinurija je dovela do trajnog prestanka liječenja u 4,8% bolesnika.
English: Kisplyx may be restarted once adequate wound healing is established.
Croatian: Kisplyx se može nastaviti primati kada se utvrdi odgovarajuće cijeljenje rana.
English: The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Croatian: Kapsule treba ostaviti u tekućini najmanje 10 minuta, a zatim miješati barem 3 minute da se otope ovojnice kapsula.
English: • Caregivers should not open capsules to avoid exposure to the contents of the capsule.
Croatian: • Osobe koje skrbe o Vama ne smiju otvarati kapsule kako bi izbjegle izlaganje sadržaju kapsule.
English: Lenvatinib may adversely affect the wound healing process as do other agents of the same class.
Croatian: Lenvatinib može štetno utjecati na cijeljenje rana kao i drugi lijekovi iste skupine.
English: Lenvatinib shows minimal or no inhibitory activities toward P-gp mediated and BCRP mediated transport activities.
Croatian: Lenvatinib pokazuje minimalne ili nikakve inhibitorne aktivnosti prema transportnim aktivnostima posredovanim P-gp-om i BCRP-om.
English: Resolves to Grade 0-1.
Croatian: Povukla se na 0-1. stupanj
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (e.g., Grade 3).
Croatian: Liječenje treba potpuno prekinuti u slučaju životno ugrožavajućih nuspojava (npr. 4. stupnja), uz iznimku abnormalnosti laboratorijskih nalaza za koje se procijeni da nisu životno ugrožavajuće i koje u tom slučaju treba zbrinjavati kao teške nuspojave (npr. 3. stupnja).
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Croatian: Ostavite ih u tekućini najmanje 10 minuta, a zatim miješajte barem 3 minute da se otope ovojnice kapsula.
English: Blood calcium levels should be monitored at least monthly and calcium should be replaced as necessary during lenvatinib treatment.
Croatian: Koncentracije kalcija u krvi treba pratiti barem jednom mjesečno, a kalcij nadomještati prema potrebi tijekom liječenja lenvatinibom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with lenvatinib in all subsets of the paediatric population in Renal Cell Carcinoma (RCC).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka lenvatinib u svim podskupinama pedijatrijske populacije za liječenje karcinoma bubrežnih stanica (RCC).
English: The final dose level in the combination arm was 18 mg for 29% of patients, 14 mg for 31% of patients, 10 mg for 23% of patients, 8 mg for 16% of patients and 4 mg for 2% of patients.
Croatian: Konačna razina doze u skupini koja je primala kombinaciju lijekova bila je 18 mg za 29% bolesnika, 14 mg za 31% bolesnika, 10 mg za 23% bolesnika, 8 mg za 16% bolesnika i 4 mg za 2% bolesnika.
English: Based on the results of a post-hoc exploratory analysis in a limited number of patients per subgroup, the positive effect on PFS was seen regardless of which prior VEGF-targeted therapy was used: sunitinib (Hazard ratio [HR] = 0.356 [95% CI: 0.188, 0.674] or other therapies (HR = 0.350 [95% CI: 0.148, 0.828]).
Croatian: Na temelju rezultata post hoc eksploratorne analize provedene na ograničenom broju bolesnika po podskupini, pozitivni učinak na PFS opažen je bez obzira na to koja je VEGF-ciljana terapija bila prethodno primijenjena: sunitinib (omjer hazarda [engl. hazard ratio, HR] = 0,356 [95% CI: 0,188; 0,674] ili druge terapije (HR = 0,350 [95% CI: 0,148; 0,828]).
English: Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Croatian: Slučajevi intrakranijalnog krvarenja sa smrtnim ishodom zabilježeni su u nekih bolesnika s metastazama u mozgu ili bez njih.
English: No adjustment of starting dose is required on the basis of body weight.
Croatian: Nije potrebna prilagodba početne doze s obzirom na tjelesnu težinu.
English: Further dose adjustments may be necessary on the basis of individual tolerability.
Croatian: Mogu biti potrebne daljnje prilagodbe doze na temelju podnošljivosti u pojedinog bolesnika.
English: • changes in blood test results for liver enzymes, white blood cells (low), blood magnesium (low)
Croatian: • promjene u nalazima krvnih pretraga za jetrene enzime, bijele krvne stanice (snižene), magnezij u krvi (snižen)
English: Patients with body weight <60 kg
Croatian: Bolesnici tjelesne težine <60 kg
English: Resolves to Grade 0, 1 or 2.
Croatian: Povukla se na 0, 1. ili 2. stupanj
English: What Kisplyx contains
Croatian: Što Kisplyx sadrži
English: • severe pain in your belly (abdomen) - this may be due to a hole in the wall of your gut or a fistula (a hole in your gut which links through a tube-like passage to another part of your body or skin).
Croatian: • jaki bol u trbuhu (abdomenu) - to može biti zbog puknuća u stijenci crijeva ili fistule (puknuće u stijenci crijeva koje poput cjevastog prolaza spaja crijevo s nekim drugim dijelom Vašeg tijela ili kožom)
English: Preferred terms have been reassigned to the SOC most relevant to the target organ.
Croatian: Preporučeni izrazi dodijeljeni su klasi organskog sustava najrelevantnijoj za ciljni organ.
English: cData cut-off date = 31 Jul 2015
Croatian: cDatum zaključavanja baze podataka = 31. srpnja 2015.
English: Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Croatian: Druga mogućnost je da se kapsule lenvatiniba bez prethodnog drobljenja ili otvaranja kapsula, stave u malu čašu i doda žlica vode ili soka od jabuke kako bi se dobila suspenzija.
English: The Efron method was used for correction for tied events.
Croatian: Za korekciju vezanih događaja primijenjena je Efronova metoda.
English: All events of hypothyroidism in the lenvatinib plus everolimus-treated group were of Grade 1 or 2.
Croatian: Svi događaji hipotireoze u skupini liječenoj lenvatinibom i everolimusom bili su 1. ili 2. stupnja.
English: • are a woman able to become pregnant (see the section “Contraception, pregnancy and breast-feeding”
Croatian: • ste žena koja može zatrudnjeti (pogledajte niže dio Kontracepcija, trudnoća i dojenje)
English: Electrocardiograms should be monitored in all patients with a special attention for those with congenital long QT syndrome, congestive heart failure, bradyarrhythmics, and those taking medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics.
Croatian: Potrebno je elektrokardiografski pratiti sve bolesnike, a posebnu pozornost treba posvetiti onima s kongenitalnim sindromom dugog QT intervala, kongestivnim zatajenjem srca, bradiaritmijama i onima koji uzimaju lijekove za koje se zna da produljuju QT interval, uključujući antiaritmike skupine Ia i III.
English: Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Croatian: Na temelju vrijednosti AUC(0 - inf), na lenvatinib je otpalo 60% ukupne radioaktivnosti u plazmi i 64% ukupne radioaktivnosti u krvi.
English: To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them.
Croatian: Da biste ih otopili, stavite jednu žlicu vode ili soka od jabuke u malu čašu i dodajte kapsule u tekućinu bez prethodnog drobljenja ili otvaranja kapsula.
English: In vitro studies indicate that lenvatinib is a substrate for P-gp and BCRP.
Croatian: In vitro ispitivanja pokazuju da je lenvatinib supstrat P-gp-a i BCRP-a.
English: Do not resume
Croatian: Ne nastavljati
English: • feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding in your brain, or the effect on your brain of a severe increase in blood pressure.
Croatian: • osjećaj utrnulosti ili slabosti na jednoj strani tijela, jaka glavoblja, napadaj, smetenost, otežan govor, promjene vida ili osjećaj omaglice - to mogu biti znakovi moždanog udara, krvarenja u mozak ili učinka jako povišenog krvnog tlaka na mozak
English: The incidence of serious haemorrhage was 4.8% (cerebral haemorrhage, gastric haemorrhage and haemarthrosis).
Croatian: Incidencija ozbiljnog krvarenja iznosila je 4,8% (cerebralno krvarenje, krvarenje iz želuca i hemartroza).
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Croatian: Primjenu lenvatiniba treba privremeno prekinuti ili prilagoditi dozu prema potrebi, ovisno o težini poremećaja, prisutnosti promjena u EKG-u i ustrajnom postojanju hipokalcemije.
English: Blood pressure (BP) level
Croatian: Razina krvnog tlaka (KT)
English: For toxicities thought to be related to both lenvatinib and everolimus, lenvatinib should be reduced (see Table 2) prior to reducing everolimus.
Croatian: Za toksičnosti za koje se smatra da su povezane i s lenvatinibom i everolimusom, dozu lenvatiniba treba smanjiti (vidjeti tablicu 2) prije smanjenja doze everolimusa.
English: Patients were stratified by haemoglobin level (≤13 g/dL vs. >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs. <10 mg/dL).
Croatian: Stratificirani su prema razini hemoglobina (≤13 g/dl naspram >13 g/dl za muškarce i ≤11,5 g/dl naspram >11,5 g/dl za žene) i korigiranom kalciju u serumu (≥10 mg/dl naspram <10 mg/dl).
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of the combination, unless intolerable to the patient despite optimal management.
Croatian: Blage do umjerene nuspojave (npr. 1. ili 2. stupnja) u pravilu ne zahtijevaju privremeni prekid kombinirane terapije, osim ako su bolesniku nepodnošljive unatoč optimalnom zbrinjavanju.
English: Table 5 Efficacy results in renal cell carcinoma lenvatinib 18 mg + everolimus 5 mg (N=51)
Croatian: Tablica 5 Rezultati djelotvornosti kod karcinoma bubrežnih stanica lenvatinib 18 mg + everolimus 5 mg (N = 51)
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Croatian: Osobe koje skrbe o bolesniku ne smiju otvarati kapsulu kako bi izbjegle ponavljano izlaganje sadržaju kapsule.
English: Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti visokoučinkovitu kontracepciju tijekom uzimanja lenvatiniba i još mjesec dana nakon prestanka liječenja (vidjeti dio 4.6).
English: Lenvatinib should not be started in patients with fistulae to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Croatian: Primjena lenvatiniba ne smije se započeti u bolesnika s fistulom kako bi se izbjeglo pogoršanje, a lenvatinib treba trajno ukinuti u bolesnika s ezofagealnom fistulom ili fistulom traheobronhalnog stabla i bilo kojom fistulom 4. stupnja (vidjeti dio 4.2); dostupni su ograničeni podaci o privremenom prekidu ili sniženju doze kao načinu zbrinjavanja drugih događaja, ali u nekim je slučajevima opaženo pogoršanje pa je potreban oprez.
English: • severe pain in the upper left part of the belly (abdomen) which may be associated with fever, chills,
Croatian: • jaki bol u gornjem lijevom dijelu trbuha (abdomena), koji može biti praćen vrućicom, zimicom,
English: It is used in combination with everolimus to treat patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.
Croatian: Primjenjuje se u kombinaciji s everolimusom za liječenje bolesnika s uznapredovalim rakom bubrega (uznapredovali karcinom bubrežnih stanica) kad drugi načini liječenja (tzv. VEGF-ciljana terapija) nisu pomogli u zaustavljanju bolesti.
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, abdominal tenderness, epigastric discomfort, and gastrointestinal pain.
Croatian: Gastrointestinalni i abdominalni bol uključuje: abdominalnu nelagodu, abdominalni bol, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena, abdominalnu osjetljivost, nelagodu u epigastriju i gastrointestinalni bol.
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Croatian: Kada je sistolički tlak KT ≤150 mmHg, dijastolički KT ≤95 mmHg, a bolesnik je na stabilnoj dozi antihipertenzivne terapije najmanje 48 sati, nastavite s primjenom lenvatiniba u sniženoj dozi (vidjeti dio 4.2)
English: In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.1 - 10 μg/mL, mesylate).
Croatian: In vitro, omjer koncentracije lenvatiniba u krvi i plazmi bio je u rasponu od 0,589 do 0,608 (0,1 - 10 μg/ml, mesilat).
English: The Phase 2 portion enrolled a total of 153 patients with unresectable advanced or metastatic RCC following 1 prior VEGF-targeted treatment.
Croatian: Faza 2 uključila je ukupno 153 bolesnika s neoperabilnim uznapredovalim ili metastatskim karcinomom bubrežnih stanica nakon jednog prethodnog liječenja terapijom koja djeluje ciljano na VEGF.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method (see section 4.6).
Croatian: Trenutno nije poznato može li lenvatinib smanjiti učinkovitost hormonskih kontraceptiva pa stoga žene koje koriste oralnu hormonsku kontracepciju trebaju dodatno koristiti i mehaničku metodu (vidjeti dio 4.6).
English: Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
Croatian: Lenvatinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog nuspojava kao što su umor i omaglica.
English: Accidental medication errors resulting in single doses of 40 to 48 mg have also occurred in clinical trials.
Croatian: U kliničkim su se ispitivanjima dogodile i slučajne medikacijske pogreške kada su primijenjene pojedinačne doze od 40 do 48 mg.
English: • have a history of abnormal passageways (known as a fistula) between different organs in the body or from an organ to the skin
Croatian: • ste imali stvaranje abnormalnih kanala (poznatih pod nazivom fistula) između različitih organa u tijelu ili između nekog organa i kože
English: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Croatian: Hepatocelularno oštećenje i hepatitis uključuju: oštećenje jetre uzrokovano lijekom, steatozu jetre i kolestatsko oštećenje jetre.
English: Optimal medical management (i.e. treatment or therapy) for nausea, vomiting, and diarrhoea should be initiated prior to any lenvatinib therapy interruption or dose reduction; however, gastrointestinal toxicity should be actively treated in order to reduce the risk of development of renal impairment or renal failure (see section 4.4 Renal failure and impairment).
Croatian: Optimalno medicinsko zbrinjavanje (tj. liječenje ili terapija) mučnine, povraćanja i proljeva treba započeti prije bilo kakvog privremenog prekida terapije lenvatinibom ili smanjenja doze; međutim, gastrointestinalnu toksičnost treba aktivno liječiti kako bi se smanjio rizik od razvoja oštećenja funkcije bubrega ili zatajenja bubrega (vidjeti dio 4.4, Zatajenje bubrega i oštećenje bubrežne funkcije).
English: Resolves to <480 ms or baseline
Croatian: Povukla se na <480 ms ili na početno stanje
English: Tumour assessments were evaluated according to RECIST 1.1.
Croatian: Procjena tumora provodila se prema RECIST 1.1.
English: Discontinue lenvatinib and institute appropriate medical management.
Croatian: Prestanite s primjenom lenvatiniba i započnite s odgovarajućim medicinskim liječenjem.
English: The safety profile of lenvatinib in combination with everolimus is based on data from 62 subjects, allowing characterisation only of common adverse drug reactions in RCC patients.
Croatian: Sigurnosni profil lenvatiniba u kombinaciji s everolimusom temelji se na podacima dobivenim za 62 ispitanika, što omogućava karakterizaciju samo čestih nuspojava lijeka u bolesnika s karcinomom bubrežnih stanica.
English: Discontinue
Croatian: Prestati
English: • other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe).
Croatian: • druge vrste fistula (abnormalan spoj između različitih tjelesnih organa ili između nekog organa, poput grla i dušnika, i kože koja se nalazi iznad).
English: Prompt medical management of diarrhoea should be instituted in order to prevent dehydration.
Croatian: Potrebno je brzo uvesti medicinsko zbrinjavanje proljeva kako bi se spriječila dehidracija.
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method.
Croatian: Trenutno nije poznato može li lenvatinib smanjiti učinkovitost hormonskih kontraceptiva, pa stoga žene koje koriste oralnu hormonsku kontracepciju trebaju dodatno koristiti i mehaničku metodu.
English: Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-fourth of the radiolabel were eliminated in the faeces and urine, respectively.
Croatian: Nakon primjene radioaktivno označenog lenvatiniba u 6 bolesnika sa solidnim tumorima, približno je dvije trećine radioaktivno označene tvari bilo eliminirano stolicom, a jedna četvrtina mokraćom.
English: Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Croatian: Prije početka liječenja lenvatinibom, krvni tlak treba dobro kontrolirati, a bolesnici za koje se zna da imaju hipertenziju trebaju biti na stabilnoj dozi antihipertenzivne terapije najmanje tjedan dana prije početka liječenja lenvatinibom.
English: The median of average daily dose in the combination arm per subject was 13.5 mg of lenvatinib (75.0% of the intended dose of 18 mg) and 4.7 mg of everolimus (93.6% of the intended dose of 5 mg).
Croatian: Medijan prosječne dnevne doze po ispitaniku u skupini koja je primala kombinaciju lijekova bio je 13,5 mg lenvatiniba (75,0% od namjeravane doze od 18 mg) i 4,7 mg everolimusa (93,6% od namjeravane doze od 5 mg).
English: Lenvatinib should be discontinued following an arterial thrombotic event.
Croatian: Primjenu lenvatiniba treba prekinuti nakon pojave događaja arterijske tromboze.
English: The daily doses of lenvatinib and, if necessary, everolimus are to be modified as needed according to the dose/toxicity management plan.
Croatian: Dnevne doze lenvatiniba i, ako treba, everolimusa prilagođavaju se po potrebi, prema planu određivanja doze s obzirom na toksičnost.
English: Overall survival was longer in the lenvatinib plus everolimus arm (see Table 5 and Figure 2).
Croatian: Ukupno preživljenje bilo je duže u skupini koja je primala lenvatinib i everolimus (vidjeti tablicu 5 i sliku 2).
English: Benefit-risk in these patients has not been evaluated.
Croatian: U tih bolesnika nije procijenjen omjer koristi i rizika.
English: The Phase 1b portion included 11 patients who received the combination of 18 mg of lenvatinib plus 5 mg of everolimus.
Croatian: Faza 1b uključila je 11 bolesnika koji su primali kombinaciju od 18 mg lenvatiniba i 5 mg everolimusa.
English: For toxicities thought to be related to lenvatinib (see Table 1), upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in Table 2.
Croatian: Za toksičnosti za koje se smatra da su povezane s lenvatinibom (vidjeti tablicu 1), nakon povlačenja nuspojave / poboljšanja na 0 do 1. stupnja ili vraćanja na početno stanje, liječenje treba nastaviti smanjenom dozom lenvatiniba prema preporukama iz tablice 2.
English: Adverse reactions observed in clinical trials and reported from post-marketing use of lenvatinib are listed in Table 4..
Croatian: Nuspojave opažene u kliničkim ispitivanjima i prijavljene nakon stavljanja lijeka u promet navedene su u Tablici 4.
English: Results for ORR were consistent with that of the investigators' assessments, 35.3% in the lenvatinib plus everolimus arm, with one complete response and 17 partial responses; no subject had an objective response in the everolimus arm (P < 0.0001) in favour of the lenvatinib plus everolimus arm.
Croatian: Rezultati za ORR podudarali su se s rezultatima procjene ispitivača, 35,3% u skupini koja je primala lenvatinib i everolimus, s jednim potpunim odgovorom i 17 djelomičnih odgovora; nijedan ispitanik nije imao objektivan odgovor u skupini liječenoj everolimusom (P < 0,0001) što govori u prilog skupini liječenoj lenvatinibom i everolimusom.
English: Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Croatian: U bolesnika koji primaju lijekove s djelovanjem na renin-angiotenzin-aldosteronski sustav potrebno je postupati s oprezom zbog potencijalno većeg rizika za akutno zatajenje bubrega uz kombinirano liječenje.
English: Within each frequency category, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane prema ozbiljnosti, padajućim redoslijedom.