FrancophonIA/ELRC3.0 huggingface dataset:
English: • loss of appetite or weight loss
Croatian: • gubitak apetita ili gubitak na tjelesnoj težini
English: Data cut-off date = 13 Nov 2016.
Croatian: Zaključni datum prikupljanja podataka = 13.11.2016.
English: Concomitant administration of lenvatinib, carboplatin, and paclitaxel has no significant impact on the pharmacokinetics of any of these 3 substances.
Croatian: Istodobna primjena lenvatiniba, karboplatina i paklitaksela nema značajan utjecaj na farmakokinetiku nijedne od te 3 tvari.
English: Talk to your doctor before taking LENVIMA if you:
Croatian: Obratite se svom liječniku prije nego uzmete LENVIMU ako:
English: When administered with food to healthy subjects, peak plasma concentrations are delayed by 2 hours.
Croatian: Kad se u zdravih ispitanika primjenjuje s hranom, vršne koncentracije u plazmi postižu se 2 sata kasnije.
English: Lenvatinib use has been associated with cases of fistulae including reactions resulting in death.
Croatian: Primjena lenvatiniba bila je povezana sa slučajevima fistule uključujući reakcije koje su imale smrtni ishod.
English: • Very common (≥1/10)
Croatian: • vrlo često (≥1/10)
English: P-value d
Croatian: P-vrijednost d
English: • If it is 12 hours or more until your next dose: take the missed dose as soon as you remember.
Croatian: • Ako do sljedeće doze ima 12 ili više sati: uzmite propuštenu dozu čim se sjetite.
English: Urine protein should be monitored regularly.
Croatian: Potrebno je redovito pratiti proteine u mokraći.
English: Lenvatinib is mainly eliminated via the liver and exposure might be increased in these patient populations.
Croatian: Lenvatinib se uglavnom eliminira putem jetre i izloženost se može povećati u tim populacijama bolesnika.
English: Patients with body weight <60 kg
Croatian: Bolesnici s tjelesnom težinom <60 kg
English: In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy.
Croatian: U većini su slučajeva gastrointestinalna perforacija i fistule nastale u bolesnika s čimbenicima rizika kao što su prethodni kirurški zahvat ili radioterapija.
English: What LENVIMA is and what it is used for What you need to know before you take LENVIMA How to take LENVIMA
Croatian: Što je LENVIMA i za što se koristi Što morate znati prije nego počnete uzimati LENVIMU Kako uzimati LENVIMU
English: In both treatment arms in the REFLECT study, median OS was approximately 9 months longer in subjects who received post-treatment anticancer therapy than in those who did not.
Croatian: U obje terapijske skupine u ispitivanju REFLECT, medijan OS-a bio je približno 9 mjeseci duži u ispitanika koji su primili terapiju protiv raka nakon liječenja nego u onih koji nisu.
English: Prior surgery and radiotherapy may be contributing risk factors.
Croatian: Prethodni kirurški zahvat i radioterapija mogu biti dodatni čimbenici rizika.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE29
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE29
English: Similar adverse reactions were observed in clinical trials in DTC and HCC.
Croatian: Slične nuspojave zapažene su u kliničkim ispitivanjima DTC-a i HCC-a.
English: For haematologic toxicity, dosing can restart when resolved to Grade 2; proteinuria, resume when resolves to less than 2g/24 hours e.
Croatian: Kod hematološke toksičnosti, doziranje može ponovno započeti kada se povuče do stupnja 2; proteinurija, nastaviti liječenje kada se povuče na manje od 2 g/24 sata.
English: The results for surrogate endpoints (PFS and ORR) are presented in Table 7 below.
Croatian: Rezultati za surogatne mjere ishoda (PFS i ORR) prikazani su u Tablici 7 u nastavku.
English: The mean terminal exponential halflife of lenvatinib is approximately 28 hours.
Croatian: Srednja vrijednost terminalnog eksponencijalnog poluvijeka lenvatiniba je približno 28 sati.
English: • Absence of MPVI, extra-hepatic tumour spread (EHS) or both: 30%
Croatian: • Odsutnost MPVI-a, širenje tumora izvan jetre (EHS) ili i jedno i drugo: 30%
English: It is used on its own to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease.
Croatian: Primjenjuje se sama za liječenje progresivnog ili uznapredovalog raka štitnjače u odraslih kad liječenje radioaktivnim jodom nije pomoglo u zaustavljanju bolesti.
English: No specific studies with lenvatinib have been conducted in animals to evaluate the effect on fertility.
Croatian: Nisu provedena posebna ispitivanja lenvatiniba na životinjama da bi se procijenio njegov učinak na plodnost.
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 dodati kapsule lenvatiniba bez lomljenja ili drobljenja sa žlicom vode ili soka od jabuke u malu čašu kako bi se stvorila suspenzija.
English: • anal fistula (a small channel that forms between the anus and the surrounding skin)
Croatian: • analna fistula (mali kanal koji se stvori između čmara i okolnog tkiva)
English: Reduce dose in succession based on the previous dose level (12 mg, 8 mg, 4 mg or 4 mg every other day).
Croatian: Smanjite dozu u slijedu na temelju prethodne razine doze (12 mg, 8 mg, 4 mg ili 4 mg svaki drugi dan).
English: European Knowledge Centre, Mosquito Way, Hatfield, Herfordshire, AL10 9SN, United Kingdom Or
Croatian: European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo
English: Other medicines and LENVIMA
Croatian: Drugi lijekovi i LENVIMA
English: In vitro transporter studies
Croatian: Ispitivanja transportera in vitro
English: Noninferiority margin for hazard ratio (HR: lenvatinib vs sorafenib = 1.08).
Croatian: Granica neinferiornosti za omjer hazarda (HR: lenvatinib naspram sorafeniba = 1,08).
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Croatian: U 1,1% bolesnika, hipertenzija je dovela do trajnog prekida liječenja.
English: Lenvatinib has not been studied in patients who have had an arterial thromboembolism within the previous 6 months, and therefore should be used with caution in such patients.
Croatian: Lenvatinib nije ispitan u bolesnika koji su imali arterijsku tromboemboliju u prethodnih 6 mjeseci pa ga stoga treba primjenjivati s oprezom u takvih bolesnika.
English: Pancreatitis includes: pancreatitis and acute pancreatitis.
Croatian: Pankreatitis uključuje: pankreatitis i akutni pankreatitis.
English: Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with median latency of about 3 months.
Croatian: Reakcije su zabilježene u različitim vremenskim točkama tijekom liječenja, u rasponu od dva tjedna do dulje od 1 godine od početka primjene lenvatiniba, s medijanom latencije od otprilike 3 mjeseca.
English: Dose proportionality and accumulation
Croatian: Proporcionalnost dozi i akumulacija doze
English: Lenvatinib is a substrate for P-gp and BCRP.
Croatian: Lenvatinib je supstrat P-gp-a i BCRP-a.
English: Haematologic toxicity or proteinuria-no dose adjustment required for first occurrence.
Croatian: Hematološka toksičnost ili proteinurija-nije potrebno prilagođavanje doze kod prve pojave.
English: However, in vivo data indicated that non-P450-mediated pathways contributed to a significant portion of the overall metabolism of lenvatinib.
Croatian: Međutim, in vivo podaci pokazali su da putevi koji se ne odvijaju putem P450 pridonose značajnom dijelu ukupnog metabolizma lenvatiniba.
English: • The recommended dose of LENVIMA is usually 24 mg once a day
Croatian: • Preporučena doza LENVIME je obično 24 mg jedanput na dan
English: Before taking LENVIMA, your doctor may carry out some tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood.
Croatian: Prije nego što uzmete LENVIMU liječnik će Vam možda napraviti neke pretrage kako bi npr. provjerio krvni tlak i funkciju jetre ili bubrega i ustanovio imate li u krvi niske razine soli te visoku razinu hormona koji stimulira štitnjaču.
English: No adjustment of starting dose is required on the basis of age.
Croatian: Nije potrebna prilagodba početne doze na temelju dobi.
English: Your doctor will discuss the results of these tests with you and decide whether you can be given LENVIMA.
Croatian: Liječnik će Vam objasniti rezultate tih pretraga i odlučiti možete li uzimati lijek LENVIMA.
English: • increase in lipase and amylase (enzymes involved in digestion)
Croatian: • povišena lipaza i amilaza (enzimi koji sudjeluju u probavi)
English: Consequently, in vivo, inducers and inhibitors of CYP 3A4 had a minimal effect on lenvatinib exposure (see section 4.5).
Croatian: Posljedično tome, induktori i inhibitori CYP 3A4 imali su in vivo minimalni učinak na izloženost lenvatinibu (vidjeti dio 4.5).
English: Any grade
Croatian: Bilo kojeg stupnja
English: After drinking, the same amount of water or apple juice (one tablespoon) must be added to the glass and swirled a few times.
Croatian: Nakon toga, istu količinu vode ili soka od jabuke (jednu žlicu) mora se dodati u čašu i nekoliko puta zavrtiti.
English: Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg).
Croatian: U tom se rasponu medijan indeksa akumulacije (Rac) kretao od 0,96 (20 mg) do 1,54 (6,4 mg).
English: • If you could become pregnant, use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Croatian: • Ako možete zatrudnjeti, koristite visokoučinkovitu kontracepciju tijekom uzimanja ovog lijeka i još najmanje mjesec dana nakon što završite liječenje.
English: What you need to know before you take LENVIMA
Croatian: Što morate znati prije nego počnete uzimati LENVIMU
English: • Swallow the capsules whole with water or dissolved.
Croatian: • Progutajte kapsule cijele, s vodom ili otopljene.
English: If you take more LENVIMA than you should, talk to a doctor or pharmacist straight away.
Croatian: Ako uzmete više LENVIME nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
English: The percentage of the dose of lenvatinib excreted in urine was low in all cohorts (<2.16% across treatment cohorts).
Croatian: Postotak doze lenvatiniba izlučen mokraćom bio je nizak u svim kohortama (<2,16% u svakoj terapijskoj kohorti).
English: Lenvatinib should not be used in children younger than 2 years of age because of safety concerns identified in animal studies (see section 5.3).
Croatian: Lenvatinib se ne smije primjenjivati u djece mlađe od 2 godine zbog sigurnosnih razloga utvrđenih ispitivanjima na životinjama (vidjeti dio 5.3).
English: If you are not sure talk to your doctor before taking LENVIMA.
Croatian: Ako niste sigurni, obratite se liječniku prije nego što uzmete LENVIMU.
English: Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications.
Croatian: Izvješća o fistulama koje zahvaćaju druga područja osim želuca i crijeva zabilježena su za različite indikacije.
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Croatian: Ostavite ih tako najmanje 10 minuta i zatim miješajte najmanje 3 minute da bi se otopila ovojnica kapsule.
English: • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
Croatian: • srčane tegobe i krvni ugrušci u plućima (otežano disanje, bol u prsištu) ili drugim organima
English: There are no data on the use of lenvatinib immediately following sorafenib or other anticancer treatments and there may be a potential risk for additive toxicities unless there is an adequate washout period between treatments.
Croatian: Nema podataka o primjeni lenvatiniba neposredno nakon liječenja sorafenibom ili drugim lijekovima protiv raka i može postojati mogući rizik od aditivnih toksičnih učinaka, osim ako je između liječenja proteklo odgovarajuće razdoblje ispiranja (engl. washout).
English: Kaplan-Meier Curve of Overall Survival - HCC
Croatian: Slika 2 Kaplan-Meierova krivulja ukupnog preživljenja - HCC
English: People get LENVIMA when their liver cancer has spread or cannot be taken out by surgery.
Croatian: Osobe će dobiti lijek LENVIMA kada se rak jetre proširio ili se ne može odstraniti kirurškim zahvatom.
English: The Rac in HCC subjects with mild and moderate liver impairment was similar to that reported for other solid tumours.
Croatian: Rac u ispitanika sa HCC-om s blagim i umjerenim oštećenjem funkcije jetre bio je sličan onom koji je prijavljen za druge solidne tumore.
English: Recommended daily dose
Croatian: Preporučena dnevna doza
English: Appropriate measures should be taken to control blood pressure (see section 4.4, Hypertension).
Croatian: Potrebno je poduzeti odgovarajuće mjere za kontrolu krvnog tlaka (vidjeti dio 4.4, Hipertenzija).
English: Frequencies are defined as:
Croatian: Učestalosti se definiraju kao:
English: Plasma concentrations decline bi-exponentially following Cmax.
Croatian: Koncentracije u plazmi opadaju bieksponencijalno nakon Cmax.
English: The safety profile of lenvatinib is based on data from 452 DTC patients and 496 HCC patients; allowing characterisation only of common adverse drug reactions in DTC and HCC patients.
Croatian: Sigurnosni profil lenvatiniba temelji se na podacima dobivenim od 452 bolesnika sa DTC-om i 496 bolesnika sa HCC-om; dopuštajući karakterizaciju samo čestih nuspojava u bolesnika sa DTC-om i HCC-om.
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30,60 or 90 hard capsules.
Croatian: • Kapsule dolaze u blisterima od poliamida/aluminija/PVC-a zatvorenima protisnom aluminijskom folijom u kutijama s 30, 60 ili 90 tvrdih kapsula.
English: Hepatocellular Carcinoma
Croatian: Hepatocelularni karcinom
English: Before initiating lenvatinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka lenvatiniba potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: First dose reduction
Croatian: Prvo sniženje doze
English: Manufacturer Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Croatian: Proizvođač Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, Ujedinjeno Kraljevstvo.
English: These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent.
Croatian: Ovi nalazi pokazuju da lenvatinib ima teratogeni potencijal, što je vjerojatno povezano s farmakološkom aktivnošću lenvatiniba kao antiangiogene tvari.
English: Arterial thromboembolic events also occurred at an increased incidence in this age group.
Croatian: Arterijski tromboembolijski događaji javili su se također s povećanom incidencijom u toj dobnoj skupini.
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 rupe u stijenci crijeva ili fistule (rupa u stijenci crijeva koja poput cjevastog prolaza spaja crijevo s nekim drugim dijelom Vašeg tijela ili kožom)
English: The adverse reactions presented in this section are based on safety data of both DTC and HCC patients (see section 5.1).
Croatian: Nuspojave prikazane u ovom dijelu temelje se na podacima o sigurnosti primjene u bolesnika sa DTC-om i HCC-om (vidjeti dio 5.1).
English: Baseline demographics and disease characteristics were well balanced for both treatment groups.
Croatian: Početne demografske značajke i obilježja bolesti bili su ujednačeno raspoređeni u obje liječene skupine.
English: P-value is for the superiority test of lenvatinib versus sorafenib.
Croatian: d P-vrijednost za test superiornosti lenvatiniba naspram sorafeniba.
English: For the following transporters, OAT1, OAT3, OATP1B1, OCT1, OCT2, and BSEP, clinically relevant inhibition was excluded based on a cutoff of IC50> 50  Cmax,unbound.
Croatian: Za sljedeće je transportere, OAT1, OAT3, OATP1B1, OCT1, OCT2 i BSEP, klinički važna inhibicija bila isključena na temelju granične vrijednosti od IC50>50  Cmax,nevezan.
English: • are a woman able to become pregnant (see the section below on Contraception, pregnancy and breast-feeding)
Croatian: • ste žena koja može zatrudnjeti (pogledajte niže dio o kontracepciji, trudnoći i dojenju)
English: There are no data on the use of lenvatinib in pregnant women.
Croatian: Nema podataka o primjeni lenvatiniba u trudnica.
English: LENVIMA may cause side effects that can affect your ability to drive or use machines.
Croatian: LENVIMA može uzrokovati nuspojave koje mogu utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: For those patients already on antihypertensive medication, the dose of the current agent may be increased, if appropriate, or one or more agents of a different class of antihypertensive should be added.
Croatian: U onih bolesnika koji već uzimaju antihipertenzivnu terapiju, doza lijeka koji trenutno uzimaju može se povisiti, ako je to primjereno, ili treba dodati jedan ili više lijekova iz druge skupine antihipertenziva.
English: Patients may be at increased risk for the development of fistulae when treated with lenvatinib.
Croatian: Bolesnici mogu biti pod povećanim rizikom od razvoja fistule kad se liječe lenvatinibom.
English: Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure.
Croatian: Gastrointestinalnu toksičnost treba aktivno liječiti kako bi se smanjio rizik od razvoja oštećenja funkcije ili zatajenja bubrega.
English: Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment.
Croatian: Testove funkcije jetre treba pratiti prije početka liječenja, zatim svaka 2 tjedna tijekom prva 2 mjeseca, a nakon toga svakog mjeseca tijekom liječenja.
English: • Your doctor may reduce your dose if you have problems with side effects.
Croatian: • Vaš liječnik može smanjiti dozu ako imate problema s nuspojavama.
English: Hypothyroidism should be treated according to standard medical practice to maintain euthyroid state.
Croatian: Hipotireozu je potrebno liječiti prema standardnoj medicinskoj praksi kako bi se održalo eutiroidno stanje.
English: A risk to newborns or infants cannot be excluded and, therefore, lenvatinib is contraindicated during breast-feeding (see section 4.3).
Croatian: Ne može se isključiti rizik za novorođenče ili dojenče pa je, stoga, lenvatinib kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: In addition, lenvatinib had selective, direct antiproliferative activity in hepatocellular cell lines dependent on activated FGFR signalling, which is attributed to the inhibition of FGFR signalling by lenvatinib.
Croatian: Osim toga, lenvatinib je pokazao selektivnu, direktnu antiproliferativnu aktivnost u hepatocelularnim staničnim linijama ovisnu o signalizaciji aktiviranog FGFR-a, što se pripisuje inhibicijskom djelovanju lenvatiniba na signalizaciju putem FGFR-a.
English: The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2' (~11% of the dose) and M2 (~4.4 of the dose).
Croatian: Metabolit M3 bio je prevladavajući analit u stolici i mokraći (~17% doze), a nakon njega M2' (~11% doze) te M2 (~4,4% doze).
English: See section 4.8 Description of selected adverse reactions for further characterisation.
Croatian: ‡: Vidjeti dio 4.8, Opis odabranih nuspojava za dodatni opis.
English: In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib.
Croatian: In vitro, citokrom P450 3A4 pokazao se kao prevladavajući (>80%) izooblik uključen u metabolizam lenvatiniba koji se odvija putem P450.
English: The median time to onset was 26 days.
Croatian: Medijan vremena do pojave bio je 26 dana.
English: • drowsiness, confusion, poor concentration, loss of consciousness that may be signs of liver failure
Croatian: • omamljenost, smetenost, slaba koncentracija, gubitak svijesti koji mogu biti znakovi zatajenja jetre
English: It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Croatian: Trenutno nije poznato povećava li lenvatinib rizik od tromboembolijskih događaja kad se uzima u kombinaciji s oralnom kontracepcijom.
English: There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95% CI: 0.50, 1.07, p=0.1032).
Croatian: Nije bilo statistički značajne razlike u ukupnom preživljenju između liječenih skupina u vrijeme primarne analize djelotvornosti (HR=0,73; 95% CI: 0,50-1,07; p=0,1032).
English: • dry skin, thickening and itching of the skin
Croatian: • suha koža, zadebljanje i svrbež kože
English: Estimated using the Kaplan-Meier method; the 95% CI was constructed with a generalised Brookmeyer and Crowley method in patients with a best overall response of complete response or partial response.
Croatian: Procijenjeno pomoću Kaplan-Meierove metode; 95% CI bio je konstruiran generaliziranom Brookmeyerovom i Crowleyjevom metodom u bolesnika s najboljim ukupnim odgovorom potpunog odgovora ili djelomičnog odgovora.
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 moraju ostati u tekućini najmanje 10 minuta i mora se miješati najmanje 3 minute da bi se otopila ovojnica kapsule.
English: The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Croatian: Važno je rano otkrivanje i učinkovito liječenje hipertenzije kako bi se smanjila potreba za privremenim prekidom primjene i sniženjem doze lenvatiniba.
English: Not Known (the following side effects have been reported since the marketing of LENVIMA but the frequency for them to occur is not known)
Croatian: Nepoznato (ove nuspojave zabilježene su otkako je lijek LENVIMA stavljen u promet, ali njihova učestalost nije poznata)
English: Third occurrence (same reaction or new reaction)
Croatian: Treća pojava (ista nuspojava ili nova nuspojava)
English: One occurred in a patient with no liver metastases.
Croatian: Jedan se dogodio u bolesnika bez jetrenih metastaza.
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: • changes in blood test results for liver function
Croatian: • promjene u nalazu krvnih pretraga za funkciju jetre
English: • Underlying cirrhosis (by independent imaging review): 75%
Croatian: • Istovremeno prisutna ciroza (neovisnom procjenom snimke): 75%
English: LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Croatian: Liječenje lijekom LENVIMA treba započeti i nadzirati zdravstveni radnik s iskustvom u primjeni terapija protiv raka.
English: • The active substance is lenvatinib.
Croatian: • Djelatna tvar je lenvatinib.