FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should undergo a head and neck examination, consisting of at least a visual inspection of oral mucosa and lymph node palpation prior to initiation of treatment and every 3 months during treatment.
Croatian: Prije započinjanja te svaka 3 mjeseca tijekom liječenja kod bolesnika je potrebno napraviti pregled glave i vrata koji se minimalno mora sastojati od vizualnog pregleda sluznice usne šupljine i palpacije limfnih čvorova.
English: 2nd occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
Croatian: Drugi nastup produljenja QTc na > 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje < 60 ms
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib.
Croatian: Kod liječenja vemurafenibom zabilježene su ozbiljne reakcije preosjetljivosti, uključujući anafilaksiju.
English: NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg tablets vemurafenib
Croatian: Zelboraf 240 mg tablete vemurafenib
English: Sarcoidosis (1)(2)(j)
Croatian: (1)(2)(j)
English: 3rd occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
Croatian: Treći nastup produljenja QTc na > 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje < 60 ms
English: Concomitant use of vemurafenib with agents metabolized by CYP1A2 and CYP3A4 with narrow therapeutic windows is not recommended.
Croatian: Ne preporučuje se istodobna primjena vemurafeniba s lijekovima koji imaju usku terapijsku širinu, a metaboliziraju se putem CYP1A2 i CYP3A4.
English: 1st occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
Croatian: Prvi nastup produljenja QTc na > 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje < 60 ms
English: alkaline phosphatase increased (c), AST increased (c),bilirubin increased (c) GGT increased (c, weight decreased, electrocardiogram QT prolonged, blood creatinine increased(1)(2) (h)
Croatian: smanjenje tjelesne težine, produljen QTinterval na elektrokardiogramu, povišena vrijednost kreatinina u krvi
English: ● If you get any side effects, talk to your doctor.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma.
Croatian: U nekontroliranom otvorenom ispitivanju faze II u prethodno liječenih bolesnika s metastatskim melanomom opaženo je produljenje QT-intervala ovisno o izloženosti lijeku.
English: Kidney or liver problems
Croatian: Tegobe s bubrezima ili jetrom
English: The bioavailability at steady state ranged between 32 and 115% (mean 64%) relative to an intravenous microdose, in a phase I study with uncontrolled food conditions in 4 patients with BRAF V600 positive malignancies.
Croatian: U ispitivanju faze I u kojem se nije kontrolirala primjena lijeka s obzirom na unos hrane, u 4 bolesnika koji su imali zloćudnu bolest pozitivnu na mutaciju BRAF V600 bioraspoloživost vemurafeniba u stanju dinamičke ravnoteže kretala se u rasponu od 32% do 115% (srednja vrijednost 64%) u odnosu na intravensku mikrodozu.
English: Vemurafenib is a Class IV substance (low solubility and permeability), using the criteria described in the Biopharmaceutics Classification System.
Croatian: Prema kriterijima opisanima u Biofarmaceutskom sustavu klasifikacije vemurafenib je tvar klase IV (niska topljivost i permeabilnost).
English: ● Back pain
Croatian: • bol u leđima
English: Gastrointestinal disorders
Croatian: Tablični sažeti prikaz nuspojava
English: Non-Cutaneous Squamous Cell Carcinoma (non-cuSCC) Cases of non-cuSCC have been reported in clinical trials where patients received vemurafenib.
Croatian: U bolesnika koji su u kliničkim ispitivanjima primali vemurafenib zabilježeni su slučajevi planocelularnog karcinoma čije sijelo nije bilo na koži.
English: Following discontinuation of vemurafenib, monitoring for non-cuSCC should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Croatian: Nakon prestanka liječenja vemurafenibom, tijekom 6 mjeseci ili do započinjanja liječenja nekim drugim lijekom za liječenje novotvorina potrebno je provoditi nadzor radi otkrivanja eventualnog planocelularnog karcinoma čije sijelo nije na koži.
English: Vemurafenib is absorbed with a median Tmax of approximately 4 hours following a single 960 mg dose (four 240 mg tablets).
Croatian: Nakon jednokratne doze od 960 mg (4 tablete od 240 mg), vemurafenib se apsorbira uz medijan Tmax od približno 4 sata.
English: ● Inflammation of joints
Croatian: Toksičnost za bubrege
English: December 30, 2010 data cut-off date (y) Overall Response Rate (95% CI)
Croatian: Stopa ukupnog odgovora na liječenje (95% CI)
English: ● Rash
Croatian: • osip
English: Talc
Croatian: WT
English: This is especially important if you are taking:
Croatian: To je naročito je važno ako uzimate:
English: • how well you respond to a dose
Croatian: • kako dobro odgovarate na dozu
English: Active Control (a)
Croatian: Aktivna kontrola (a)
English: Latuda with food, drink and alcohol
Croatian: Latuda s hranom, pićem i alkoholom
English: It may take several days or even weeks before this medicine will have a full effect.
Croatian: Može proći nekoliko dana ili tjedana prije nego ovaj lijek postigne potpuno djelovanje.
English: This is because alcohol will have an additive negative effect.
Croatian: To je stoga što alkohol ima pospješujuće negativno djelovanje.
English: Date of first authorisation: 21 March 2014
Croatian: Datum prvog odobrenja: 21. ožujka 2014.
English: Current available data are described in section 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Croatian: Ovaj lijek se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina zbog nedostatka podataka o primjeni u ovih bolesnika.
English: You should be aware that these conditions may be caused by this medicine
Croatian: Morate biti svjesni da je ta stanja mogao prouzročiti ovaj lijek
English: What Latuda is and what it is used for
Croatian: Što je Latuda i za što se koristi
English: This difference neared, but did not reach, statistical significance.
Croatian: Ta razlika se približila statistički značajnoj, ali ju nije dosegla.
English: Estimate (SE; 95% CI)
Croatian: Procjena (SE; 95% IP)
English: • if you are taking some other medicines (see section 2, Other medicines and Latuda)
Croatian: • uzimate li druge lijekove (pogledajte dio 2, Drugi lijekovi i Latuda)
English: Patients should be closely monitored during this period.
Croatian: Bolesnici trebaju biti pažljivo praćeni tijekom ovog razdoblja.
English: Date of latest renewal: 14 November 2018
Croatian: Datum posljednje obnove odobrenja: 14. studenog 2018
English: • medicines that lower blood pressure, as this medicine can also lower blood pressure
Croatian: • lijekove koji snižavaju krvni tlak, jer ovaj lijek također može snižavati krvni tlak
English: If your doctor decides that the potential benefit of treatment during pregnancy justifies the potential risk to your unborn baby, your doctor will monitor your baby closely after birth.
Croatian: Ako Vaš liječnik odluči da potencijalna korist od liječenja tijekom trudnoće opravdava potencijalni rizik za Vaše nerođeno dijete, Vaš će liječnik pozorno pratiti Vaše dijete nakon rođenja.
English: • sudden death associated with heart disease.
Croatian: • iznenadna smrt povezana s bolesti srca.
English: No initial dose titration is required.
Croatian: Nije potrebna početna titracija doze.
English: Your dose will be decided by your doctor and may depend on:
Croatian: Vašu će dozu odrediti Vaš liječnik, a ona ovisi o tome:
English: However, the primary and key secondary efficacy endpoints were not met in younger patients (below 15 years of age).
Croatian: Međutim, primarne i ključne sekundarne mjere ishoda djelotvornosti nisu zadovoljene kod mlađih bolesnika (ispod 15 godina starosti).
English: Limited data have been collected in healthy subjects ≥ 65 years.
Croatian: Ograničeni podaci prikupljeni su u zdravih osoba ≥ 65 godina.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Croatian: Povećani rizik ne može se isključiti ni kod drugih antipsihotika ili drugih populacija bolesnika.
English: This medicine is used to improve your symptoms of schizophrenia.
Croatian: Ovaj se lijek koristi za poboljšanje Vaših simptoma shizofrenije.
English: If you miss one dose, take your next dose on the day after the missed dose.
Croatian: Ako propustite jednu dozu, uzmite sljedeću na dan nakon propuštene doze.
English: Other medicines and Latuda
Croatian: Drugi lijekovi i Latuda
English: Dose adjustment due to interactions
Croatian: Prilagodba doze zbog interakcija
English: The safety and efficacy of lurasidone in children aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lurasidona u djece mlađe od 18 godina nije ustanovljena.
English: There was no clear correlation between obtained plasma exposure and age or body weight.
Croatian: Nije bilo jasne korelacije između postignute plazmatske izloženosti i dobi ili tjelesne težine.
English: Alcohol should be avoided when taking this medicine.
Croatian: Za vrijeme uzimanja ovog lijeka alkohol se mora izbjegavati.
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Croatian: Ne vozite niti upotrebljavajte strojeve dok ne potvrdite da lijek ne utječe na Vas na negativni način.
English: Consequently, newborns should be monitored carefully.
Croatian: Zbog toga, novorođenačad treba pažljivo pratiti.
English: You should not take this medicine during pregnancy unless this has been agreed with your doctor.
Croatian: Ovaj lijek ne biste smjeli uzimati tijekom trudnoće osim ako se s tim slaže Vaš liječnik.
English: -5.7 (1.39; -8.4 to -3.0)
Croatian: -5,7 (1,39; -8,4 do -3,0)
English: Hypotension and circulatory collapse should be treated with appropriate measures.
Croatian: Hipotenziju i cirkulatorni kolaps treba liječiti odgovarajućim mjerama.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take a few days to some weeks.
Croatian: Tijekom liječenja antipsihoticima, do poboljšanja bolesnikovog kliničkog stanja može proći od par dana do nekoliko tjedana.
English: • problems with erections
Croatian: • problemi s erekcijom
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses and in some cases has been reported early after initiation or switch of antipsychotic therapy.
Croatian: Pojava suicidalnog ponašanja svojstvena je psihičkim bolestima i u nekim slučajevima zabilježena je rano nakon započinjanja ili promjene antipsihotika u terapiji.
English: These could be symptoms of a condition known as neuroleptic malignant syndrome.
Croatian: To mogu biti simptomi stanja koje je poznato kao neuroleptički maligni sindrom.
English: • any medicines that also work in the brain, as their effects could be additive in a negative way with the effects of Latuda on your brain
Croatian: • bilo kakve lijekove koji djeluju na mozak, jer njihov učinak može biti pospješujući u negativnom smislu s djelovanjem Latude na Vaš mozak
English: Following administration of lurasidone, the elimination half-life was 20-40 hours.
Croatian: Nakon primjene lurasidona, poluvrijeme eliminacije bilo je 20-40 sati.
English: • Suicidal thoughts or behaviour
Croatian: • ako imate suicidalne misli ili ponašanje
English: While these symptoms can occur at low doses, they occur more frequently and with greater severity, higher potency and at higher doses of first generation antipsychotic medicinal products.
Croatian: Premda se ovi simptomi mogu javiti pri malim dozama, oni se događaju puno češće i s većom težinom, većom potencijom i u većim dozama prve generacije antipsihotika.
English: Pharmacotherapeutic group: Psycholeptics, antipsychotics.
Croatian: Farmakoterapijska skupina: Psiholeptici, antipsihotici.
English: Lurasidone should not be used during pregnancy unless clearly necessary.
Croatian: Lurasidon se ne smije koristiti tijekom trudnoće, osim ako je to izričito neophodno.
English: You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Croatian: Ovaj lijek ne smijete prestati uzimati osim ako Vam Vaš liječnik kaže da to učinite, jer se simptomi mogu vratiti.
English: People with this disorder may also feel depressed, anxious, guilty, or tense.
Croatian: Osobe s tim poremećajem također mogu osjećati depresivnost, uznemirenost, krivnju ili napetost.
English: If you miss two or more doses, contact your doctor.
Croatian: Ako ste propustili dvije doze ili više, obratite se svom liječniku.
English: Talk to your doctor or pharmacist before taking this medicine, or during treatment, especially if you have:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek, ili tijekom liječenja, naročito:
English: Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that lurasidone does not affect them adversely (see section 4.8).
Croatian: Bolesnike treba upozoriti da ne koriste opasne strojeve, uključujući motorna vozila, dok se ne uvjere da lurasidon ne utječe negativno na njih (vidjeti dio 4.8).
English: If you stop taking this medicine you will lose the effects of the medicine.
Croatian: Ako prestanete uzimati ovaj lijek, djelovanje lijeka će se izgubiti.
English: The following side effects may also happen:
Croatian: Mogu se također javiti sljedeće nuspojave:
English: Dose increase should be based on physician judgement and observed clinical response.
Croatian: Povećanje doze treba se zasnivati na liječničkoj procjeni i vidljivom kliničkom odgovoru.
English: If taken without food, it is anticipated that lurasidone exposure will be significantly lower as compared to when taken with food (see section 5.2).
Croatian: Ako se uzimaju bez hrane, očekuje se da će izloženost lurasidonu biti značajno niža u usporedbi s onom kada se uzima s hranom (vidjeti dio 5.2).
English: The recommended starting dose is 18.5 mg.
Croatian: Preporučena početna doza je 18,5 mg.
English: Grapefruit can affect the way this medicine works.
Croatian: Grejpfrut može utjecati na djelovanje ovog lijeka.
English: Cerebrovascular accident
Croatian: Cerebrovaskularni incidenti
English: Анджелини Фарма България ЕООД бул.
Croatian: Bulgaria/ България Анджелини Фарма България ЕООД бул.
English: • are allergic to lurasidone or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na lurasidon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: • sudden feelings of anxiety
Croatian: • iznenadni osjećaji tjeskobe
English: Bipolar Depression
Croatian: Bipolarna depresija
English: These prolactin-related effects are not considered to be relevant to human reproduction.
Croatian: Ovo djelovanje povezano s prolaktinom ne smatra se relevantnim u humanoj reprodukciji.
English: ****ADRs noted in Phase 2 and 3 controlled and uncontrolled studies; however, the incidence of occurrence for these are too low to estimate frequencies.
Croatian: ****Nuspojave zabilježene u Fazi 2 i 3 kontroliranih i nekontroliranih ispitivanja; incidencija pojavljivanja ovih nuspojava je preniska za procjenu učestalosti.
English: Of the data collected, similar exposure was obtained compared with subjects < 65 years.
Croatian: U prikupljenim podacima, slično je bilo i u usporedbi s osobama < 65 godina.
English: For all other doses patients can be restarted on their previous dose without need for up-titration.
Croatian: Za sve ostale doze liječenje se može nastaviti prethodnom dozom bez potrebe titracije na više doze.
English: • The active substance is lurasidone.
Croatian: • Djelatna tvar je lurasidon.
English: However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see “Renal impairment” below).
Croatian: Međutim, budući da stariji bolesnici mogu imati smanjenu bubrežnu funkciju, može biti potrebno prilagođavanje doze ovisno o funkcionalnom stanju njihovih bubrega (vidjeti pod „Oštećenje bubrega“ u nastavku).
English: Clinical monitoring of weight is recommended.
Croatian: Preporučuje se kliničko praćenje tjelesne težine.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom smanjivanja ozbiljnosti.
English: Efficacy was also confirmed in a secondary analysis of treatment response (defined as ≥ 30% decrease from Baseline in PANSS
Croatian: Djelotvornost je također potvrđena i u drugom ispitivanju odgovora na liječenje (definirano kao ≥ 30% smanjenje od početne vrijednosti ukupnih PANSS bodova).
English: In the short-term studies there was no consistent dose-response correlation observed.
Croatian: U kratkotrajnim ispitivanima nije bilo sustavne korelacije odgovora s obzirom na dozu.
English: There is no specific antidote to lurasidone, therefore, appropriate supportive measures should be instituted and close medical supervision and monitoring should continue until the patient recovers.
Croatian: Nema specifičnog antidota za lurasidon, stoga treba započeti s odgovarajućim potpornim mjerama, a pažljivi nadzor i praćenje treba nastaviti sve dok se bolesnik ne oporavi.
English: Patient should be advised to seek medical attention if they experience any signs and symptoms.
Croatian: Bolesnike treba uputiti da zatraže liječničku pomoć u slučaju pojave bilo kakvih znakova i simptoma.
English: Stamullen, Co. Meath, K32 YD60,
Croatian: Meath, K32 YD60,
English: What Latuda is and what it is used for What you need to know before you take Latuda How to take Latuda
Croatian: Što je Latuda i za što se koristi Što morate znati prije nego počnete uzimati lijek Latuda Kako uzimati lijek Latuda
English: What Latuda looks like and contents of the pack
Croatian: Kako Latuda izgleda i sadržaj pakiranja
English: • armodafinil, modafinil (to treat sleepiness)
Croatian: • armodafinil, modafinil (za liječenje nesanice)
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (<1 /10,000) and not known (cannot be estimated from the available data).
Croatian: Koriste se sljedeći pojmovi i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Latuda film-coated tablets are for oral use, to be taken once daily together with a meal.
Croatian: Latuda filmom obložene tablete primjenjuju se peroralno, uzimanjem jednom dnevno uz obrok.
English: In elderly people with dementia, a small increase in the number of deaths has been reported for patients Reporting of side effects taking medicines for schizophrenia compared with those not receiving these medicines.
Croatian: U starijih osoba s demencijom, zabilježen je mali porast u broju smrti kod bolesnika koji su uzimali lijekove za shizofreniju u usporedbi s onima koji nisu primali te lijekove.
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Croatian: Kardiovaskularno praćenje treba započeti odmah, uključujući kontinuirano EKG praćenje zbog mogućih aritmija.
English: Urine comprised mostly of a number of metabolites with minimal renal excretion of parent compound.
Croatian: Urin je sadržavao uglavnom brojne metabolite s minimalnim renalnim izlučivanjem početne tvari.
English: Studies in animals have shown a number of effects on fertility, mainly related to prolactin increase, which are not considered to be relevant to human reproduction (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su brojne učinke na plodnost, većinom povezane s povišenjem prolaktina, što se ne smatra bitnim za reprodukciju kod ljudi (vidjeti dio 5.3).
English: Patients on doses higher than 111 mg once daily who discontinue their treatment for longer than 3 days should be restarted on 111 mg once daily and up-titrated to their optimal dose.
Croatian: U bolesnika koji uzimaju dozu veću od 111 mg jednom dnevno i prekinu liječenje na dulje od 3 dana, liječenje treba ponovno započeti dozom od 111 mg jednom dnevno i titrirati na više do optimalne doze.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Croatian: Distonija: Simptomi distonije, produženih abnormalnih kontrakcija mišićnih skupina, mogu se pojaviti u osjetljivih pojedinaca tijekom prvih par dana liječenja.
English: • medicines for Parkinson's disease and restless legs syndrome (e.g. levodopa) as this medicine can reduce their effects
Croatian: • lijekove za Parkinsonovu bolest i za sindrom nemirnih nogu (npr. levodopa) jer ovaj lijek može oslabiti njihovo djelovanje
English: The major biotransformation pathways are oxidative N-dealkylation, hydroxylation of norbornane ring, and S-oxidation.
Croatian: Glavni biotransformacijski putovi su oksidativna N-dealkilacija, hidroksilacija norbornanskog prstena i S-oksidacija.
English: • abnormal nerve impulses in the heart
Croatian: • nenormalno provođenje električnih impulsa u srcu
English: • dry mouth or excess saliva
Croatian: • suha usta ili prekomjerna slina
English: By blocking their receptors, lurasidone helps to normalise the activity of the brain, reducing the symptoms of schizophrenia.
Croatian: Blokirajući receptore, lurasidon pomaže u normalizaciji aktivnosti mozga i smanjuje simptome shizofrenije.
English: • swelling beneath the skin surface (angioedema)
Croatian: • oticanje ispod površine kože (angioedem)
English: • amprenavir, efavirenz, etravirine (to treat HIV infection)
Croatian: • amprenavir, efavirenz, etravirin (za liječenje HIV infekcije)
English: • reduced levels of white blood cells (which fight infection) and red blood cells (which carry oxygen around the body)
Croatian: • snižena razina bijelih krvnih stanica (koje suzbijaju infekciju) i crvenih krvnih stanica (koje nose kisik po organizmu)
English: Dopamine and serotonin are neurotransmitters (substances that allow nerve cells to communicate with each other) that are involved in the symptoms of schizophrenia.
Croatian: Dopamin i serotinin su neurotransmiteri (tvari koji omogućuju međusobnu komunikaciju živčanih stanica) koji su uključeni u simptome shizofrenije.
English: Frequency not known
Croatian: Frekvencija je nepoznata.
English: Pharmacokinetics in special patient groups:
Croatian: Farmakokinetika u posebnih skupina bolesnika
English: If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying parkinsonism symptoms.
Croatian: Ako se propisuju bolesnicima s Parkinsonovom bolešću, antipsihotici mogu pogoršati osnovne simptome postojećeg parkinsonizma.