FrancophonIA/ELRC3.0 huggingface dataset:
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with lurasidone and preventive measures undertaken.
Croatian: Budući da se bolesnici liječeni antipsihoticima često prikazuju sa stečenim rizičnim faktorima za VTE, svi mogući rizični faktori za VTE moraju biti identificirani prije i tijekom liječenja lurasidonom, kao i poduzete odgovarajuće preventivne mjere.
English: Latuda contains the active substance lurasidone and belongs to a group of medicines called antipsychotics.
Croatian: Latuda sadrži djelatnu tvar lurasidon i pripada skupini lijekova poznatih kao antipsihotici.
English: • painful or absence of menstrual periods
Croatian: • bolni ili izostali menstruacijski ciklusi
English: If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose, monitor you more closely or stop treatment with Latuda.
Croatian: Ako imate bilo koje od ovih stanja, obratite se svom liječniku, jer će on/ona možda htjeti prilagoditi dozu, pozornije Vas pratiti ili prekinuti liječenje Latudom.
English: Following oral administration of a radiolabelled dose, approximately 67% dose was recovered in faeces and 19% in urine.
Croatian: Nakon peroralne primjene radiooznačene doze, približno 67% doze pojavilo se u fecesu, a 19% u urinu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with lurasidone in one or more subsets of the paediatric population in schizophrenia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka lurasidona u jednoj ili više podskupina pedijatrijske populacije u shizofreniji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: ATC code: N05AE05
Croatian: ATK oznaka: N05AE05
English: Latuda tablets should be swallowed whole, in order to mask the bitter taste.
Croatian: Latuda tablete trebaju se progutati cijele, kako bi se prikrio gorki okus.
English: Adrenaline and dopamine should not be used, or other sympathomimetics with beta agonist activity, since beta stimulation may worsen hypotension in the setting of lurasidone-induced alpha blockade.
Croatian: Ne smiju se koristiti adrenalin i dopamin, kao ni drugi simpatomimetici s beta agonističkim djelovanjem, budući da beta stimulacija može pogoršati hipotenziju u slučaju alfa blokade inducirane lurasidonom.
English: • A serious blistering rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
Croatian: • Ozbiljan osip s mjehurima na koži, ustima, očima i genitalijama (Stevens-Johnsonov sindrom)
English: • a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots
Croatian: • ako imate anamnezu krvnih ugrušaka, ili ako netko drugi u Vašoj obitelji ima anamnezu krvnih ugrušaka, budući da se lijekovi za shizofreniju povezuju s nastankom krvnih ugrušaka
English: Statistically significant differences favouring lurasidone over placebo were shown for these endpoints for the total population studied, beginning at Week 2 and were maintained at each study visit through to the end of the study.
Croatian: Statistički značajne razlike u korist lurasidona naspram placeba dokazane su za te mjere ishoda u ukupnoj ispitivanoj populaciji, s početkom u 2. tjednu i održavane su u svakom posjetu u ispitivanju do završetka ispitivanja.
English: • Parkinson's disease or dementia
Croatian: • ako imate Parkinsonovu bolest ili demenciju
English: It is used to treat symptoms of schizophrenia in adults aged 18 years or over.
Croatian: Koristi se za liječenje simptoma shizofrenije u odraslih u dobi od 18 ili više godina.
English: Lurasidone reaches peak serum concentrations in approximately 1-3 hours.
Croatian: Lurasidon dostiže vršnu serumsku koncentraciju za otprilike 1-3 sata.
English: Lurasidone showed significant separation from placebo from as early as Day 4.
Croatian: Lurasidon je pokazao značajnu razliku u odnosu na placebo već od Dana 4.
English: Overall, lurasidone had a negligible effect on weight and other metabolic parameters including total cholesterol, triglycerides, and glucose levels.
Croatian: Sve u svemu, lurasidon je imao beznačajan utjecaj na tjelesnu težinu i druge metaboličke parametre uključujući totalni kolesterol, trigliceride i razinu glukoze.
English: Lurasidone has minor influence on the ability to drive and use machines.
Croatian: Lurasidon ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: • feeling of restlessness and inability to sit still • sleepiness.
Croatian: • osjećaj nemira i nemogućnost mirnog sjedenja
English: Subjects with ESRD (CrCl<15 ml/min) have not been investigated.
Croatian: Ispitanici s završnim stadijem bolesti bubrega (CrCl < 15 ml/min) nisu bili ispitivani.
English: The pharmacokinetics of lurasidone in paediatric patients was investigated in 49 children aged 6-12 years and 56 adolescents aged 13-17 years.
Croatian: Farmakokinetika lurasidona u pedijatrijskih bolesnika ispitana je u 49 djece u dobi od 6 do 12 godina i 56 adolescenata u dobi od 13 do 17 godina.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „EXP“.
English: Convulsion****
Croatian: konvulzije****
English: If your baby develops any of these symptoms you should contact your doctor.
Croatian: Ako se kod Vašeg djeteta javi bilo koji od ovih simptoma, morate obavijestiti svog liječnika.
English: In the primary analysis of time to relapse in which patients that withdrew without relapse were censored at the time of withdrawal, patients on lurasidone showed a significantly longer time to relapse compared with patients on placebo (p=0.039).
Croatian: U primarnoj analizi vremena do relapsa u kojoj su bolesnici koji su prekinuli ispitivanje bez relapsa cenzurirani u vrijeme prekida, bolesnici na lurasidonu imali su značajno dulje vrijeme do relapsa u usporedbi s bolesnicima na placebu (p=0,039).
English: Dosing recommendations for elderly patients with normal renal function (CrCl ≥ 80 ml/min) are the same as for adults with normal renal function.
Croatian: Preporučeno doziranje za starije bolesnike s normalnom bubrežnom funkcijom (CrCl) ≥ 80 ml/min) isto je kao i za odrasle s normalnom bubrežnom funkcijom.
English: Latuda tablets should be taken at the same time every day to aid compliance.
Croatian: Latuda tablete trebaju se uzimati svaki dan u isto vrijeme radi bolje suradljivosti.
English: Patients were randomized to flexibly dosed lurasidone 18-74 mg once daily or placebo.
Croatian: Bolesnici su bili randomizirani u fleksibilno doziran lurasidon 18-74 mg jednom dnevno ili placebo.
English: If you notice any of these symptoms seek medical advice immediately.
Croatian: Ako primijetite bilo koji od tih simptoma, odmah potražite medicinsku pomoć.
English: In a long-term trial designed to assess the maintenance of effect, lurasidone was more effective than placebo in maintaining symptom control and delaying relapse of schizophrenia.
Croatian: U dugotrajnom ispitivanju dizajniranom za ocjenu trajanja odgovora, lurasidon je bio učinkovitiji od placeba u održavanju kontrole simptoma i odlaganju relapsa shizofrenije.
English: Lurasidone does not impact concentrations of lithium.
Croatian: Lurasidon ne utječe na koncentraciju litija.
English: Based on in vitro studies utilising human liver enzymes, lurasidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of lurasidone.
Croatian: Zasnovano na in vitro ispitivanjima korištenjem ljudskih jetrenih enzima, lurasidon nije supstrat za CYP1A2; stoga pušenje ne bi trebalo utjecati na farmakokinetiku lurasidona.
English: This is because the following symptoms may occur in newborn babies of mothers that have used lurasidone in the last trimester (last three months) of their pregnancy:
Croatian: To je stoga što se u novorođenčadi majki koje su lurasidon uzimale u zadnjem tromjesečju (zadnja tri mjeseca) trudnoće mogu javiti slijedeći simptomi:
English: The pharmacokinetics of lurasidone in paediatric patients aged 6-17 years was generally comparable to those observed in adults.
Croatian: Farmakokinetika lurasidona u pedijatrijskih bolesnika u dobi od 6 do 17 godina općenito je bila usporediva s onom opaženom u odraslih.
English: Latuda is indicated for the treatment of schizophrenia in adults aged 18 years and over.
Croatian: Latuda je indicirana za liječenje shizofrenije u odraslih u dobi od 18 godina i starijih.
English: Hungary/ Magyarország Angelini Pharma Magyarország Kft Dayka Gábor u. 3., 214-215. számú iroda
Croatian: Hungary/ Magyarország Angelini Pharma Magyarország Kft Dayka Gábor u. 3., 214-215. számú iroda H-1118 Budapest
English: Lurasidone demonstrated superior efficacy compared with placebo across Phase 3 studies (see Table 2).
Croatian: Lurasidon je pokazao superiornost djelotvornosti u usporedbi s placebom tijekom Faze 3 ispitivanja (vidjeti tablicu 2).
English: If you notice any of the following symptoms seek medical attention immediately:
Croatian: Ako primijetite neku od sljedećih nuspojava, odmah potražite medicinsku pomoć:
English: You should take your dose regularly every day at the same time of the day, so that it is easier to remember it. You must take this medicine with food or just after eating, as this helps the body to take up the medicine and allows it to work better.
Croatian: Ovaj lijek morate uzeti s hranom ili neposredno nakon jela, jer to pomaže organizmu da prihvati lijek i omogući mu bolje djelovanje.
English: Prins Bernhardplein 200 1097 JB Amsterdam, Netherlands med.infoeu@sunovion.com
Croatian: 1097 JB Amsterdam, Netherlands med.infoeu@sunovion.com
English: Lurasidone is not subject to active uptake transport by OATP1B1 or OATP1B3.
Croatian: Lurasidon nije podložan aktivnom transportu unosa preko OATP1B1 ili OATP1B3.
English: However, an increase in exposure in elderly subjects may be expected for patients if they have impaired renal or hepatic function.
Croatian: U svakom slučaju, povećanje u izloženosti kod starijih osoba može se očekivati za bolesnike ukoliko imaju smanjenu bubrežnu ili jetrenu funkciju.
English: Lurasidone is a selective blocking agent of dopamine and monoamine effects.
Croatian: Lurasidon je selektivni blokator učinaka dopamina i monoamina.
English: Orthostatic hypotension/syncope
Croatian: Ortostatska hipotenzija/sinkopa
English: Angelini Pharma Polska Sp. z o.o.
Croatian: Angelini Pharma Polska Sp. z o.o. ul.
English: Therefore, lurasidone can be coadministered with oral contraceptives.
Croatian: Stoga se lurasidon može primjenjivati istovremeno s oralnim kontraceptivima.
English: The safety profile of lurasidone in children included in this short-term study is in general consistent with that observed when treated within the approved indication in adults, however, differences in frequency of the most commonly occurred adverse reactions have been observed in paediatric patients for nausea (very common), diarrhea (common) and decreased appetite (common), compared with adults (common, unknown, and uncommon, respectively).
Croatian: Sigurnosni profil lurasidona u djece uključene u ovo kratkoročno ispitivanje uglavnom je bio u skladu s onim opaženim kad su bili liječeni unutar odobrene indikacije u odraslih, međutim, razlike u učestalosti nuspojava koje su se najčešće pojavljivale opažene su u pedijatrijskih bolesnika za mučninu (vrlo često), proljev (često) i smanjen apetit (često), u usporedbi s odraslima (često, nepoznato odnosno manje često).
English: In that study the rate of relapse over a 12-month period was 20% for lurasidone and 16% for risperidone.
Croatian: U tom ispitivanju stopa relapsa u razdoblju od 12 mjeseci bila je 20% za lurasidon i 16% za risperidon.
English: In patients with moderate (Creatinine Clearance (CrCl) ≥ 30 and < 50 ml/min), severe renal impairment (CrCL >15 and < 30 ml/min) and End Stage Renal Disease (ESRD) patients (CrCl < 15 ml/min), the recommended starting dose is 18.5 mg and the maximum dose should not exceed 74 mg once daily.
Croatian: U bolesnika s umjerenim (klirens kreatinina (CrCl) ≥ 30 i < 50 ml/min), teškim bubrežnim oštećenjem (CrCl > 15 i < 30 ml/min) i završnim stadijem bubrežne bolesti kod kojih je CrCl < 15 ml/min), preporučena početna doza je 18,5 mg, dok najviša doza ne smije prelaziti 74 mg jednom dnevno.
English: Grapefruit juice should be avoided during treatment with lurasidone.
Croatian: Sok od grejpa treba izbjegavati tijekom liječenja lurasidonom.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lurasidone in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lurasidona u trudnica ograničeni (manje od 300 ishoda trudnoća).
English: An elevated risk of acute dystonia is observed in males and younger age groups.
Croatian: Povećani rizik akutne distonije uočen je u muškaraca i u mlađim dobnim skupinama.
English: The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis.
Croatian: Mogućnost stanja smanjene svijesti, epileptičkih napadaja ili distoničke reakcije glave i vrata nakon predoziranja mogu izazvati rizik od aspiracije kod induciranog povraćanja.
English: Given the primary central nervous system effects of lurasidone, lurasidone should be used with caution in combination with other centrally acting medicinal products and alcohol.
Croatian: Kao lijek koji djeluje prvenstveno na središnji živčani sustav, lurasidon treba koristiti s oprezom u kombinaciji s drugim lijekovima koji djeluju centralno i s alkoholom.
English: Potential for other medicinal products to affect lurasidone
Croatian: Potencijal drugih lijekova za utjecaj na lurasidon
English: These findings are common in rodents treated with antipsychotic medicinal products with dopamine D2 blocking activity and are considered to be rodent-specific.
Croatian: Ovi nalazi uobičajeni su za glodavce tretirane antipsihoticima s dopaminskim D2 blokirajućim djelovanjem i smatraju se specifičnim za glodavce.
English: Potential for lurasidone to affect other medicinal products
Croatian: Potencijal lurasidona za djelovanje na druge lijekove
English: Dose adjustment is recommended in moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) patients.
Croatian: Prilagodba doze preporučuje se u bolesnika s umjerenim (Child Pugh stadij B) i teškim (Child Pugh stadij C) oštećenjem jetre.
English: These reactions are seen rarely (may affect up to 1 in 1,000 people).
Croatian: Te se reakcije rijetko javljaju (mogu zahvatiti do 1 na 1000 osoba).
English: Lurasidone is metabolised into two active metabolites (ID-14283 and ID-14326) and two non-active metabolites (ID-20219 and ID-20220).
Croatian: Lurasidon se metabolizira u dva aktivna metabolita (ID-14283 i ID-14326) i dva neaktivna metabolita (ID-20219 i ID-20220).
English: Lurasidone may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism.
Croatian: Lurasidon može uzrokovati ortostatsku hipotenziju, moguće zbog njegovog antagonističkog djelovanja na α1-adrenergičke receptore.
English: • blood pressure dropping upon standing up which may cause fainting
Croatian: • pad krvnog tlaka pri ustajanju što može dovesti do nesvjestice
English: You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Croatian: Možete osjetiti pospanost, umor, neuobičajene pokrete tijela, poteškoće sa stajanjem i hodanjem, omaglicu zbog niskog krvnog tlaka, te nenormalne otkucaje srca.
English: • lack of energy (lethargy)
Croatian: • manjak energije (letargija)
English: Swallow your tablet(s) whole with water, in order to mask the bitter taste.
Croatian: Tabletu(tablete) progutajte cijele s vodom, kako bi se prikrio gorki okus.
English: The use of an immediate release formulation of diltiazem could result in a larger increase in lurasidone exposure.
Croatian: Primjena diltiazema u formulaciji s trenutnim oslobađanjem može rezultirati većim povećanjem izloženosti lurasidonu.
English: • difficulty sleeping, tiredness, agitation and anxiety
Croatian: • poteškoće sa spavanjem, umor, nemir, tjeskoba
English: The following medicines may decrease the level of lurasidone in your blood:
Croatian: Sljedeći lijekovi mogu sniziti razinu lurasidona u krvi:
English: Dose adjustment of lurasidone may be necessary in combination with mild and moderate CYP3A4 inducers (see section 4.5).
Croatian: Prilagodba doze lurasidona može biti neophodna u kombinaciji s blagim ili umjerenim CYP3A4 induktorima (vidjeti dio 4.5).
English: Lurasidone was not genotoxic in a battery of tests.
Croatian: Lurasidon nije bio genotoksičan u nizu testova.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna za konačan zaključak o trudnoći, embrionalnom/fetalnom razvoju, porođaj i postnatalnom razvoju (vidjeti dio 5.3).
English: Do not drink grapefruit juice while you are taking this medicine.
Croatian: Dok uzimate ovaj lijek nemojte konzumirati sok od grejpfruta.
English: The dose may be increased or decreased by your doctor within the dose range of 18.5 mg to 148 mg once a day.
Croatian: Vaš liječnik može dozu povećati ili smanjiti u rasponu od 18,5 mg do 148 mg jednom dnevno.
English: Hypromellose 2910 (E 464) Magnesium stearate (E 470b)
Croatian: hipromeloza 2910 (E 464) magnezijev stearat (E 470b)
English: • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Croatian: • krvni ugrušci u venama, posebno u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati krvnim žilama do pluća uzrokujući bol u prsnom košu i poteškoće s disanjem.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including lurasidone, should be considered.
Croatian: Ukoliko se pojave simptomi tardivne diskinezije, treba razmotriti prestanak davanja svih antipsihotika, uključujući i lurasidon.
English: Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, difficulty swallowing, difficulty breathing, and/or protrusion of the tongue.
Croatian: Simptomi distonije uključuju: spazam vratnih mišića, koji ponekad napreduje do stezanja grla, otežanog gutanja, otežanog disanja i/ili protruzije jezika.
English: The recommended starting dose is 37 mg once a day.
Croatian: Preporučena početna doza je 37 mg, jednom dnevno.
English: It is effective in a dose range of 37 to 148 mg once daily.
Croatian: Lijek je učinkovit u rasponu doza od 37 do 148 mg jednom dnevno.
English: The following medicines may increase the level of lurasidone in your blood:
Croatian: Sljedeći lijekovi mogu povisiti razinu lurasidona u krvi:
English: Concomitant administration of BCRP substrates may result in increases in the plasma concentrations of these substrates.
Croatian: Istovremena primjena BCRP supstrata može rezultirati povećanjem koncentracije tih supstrata u plazmi.
English: Lurasidone was excreted in milk of rats during lactation (see section 5.3).
Croatian: Lurasidon se izlučuje u mlijeku štakorica tijekom laktacije (vidjeti dio 5.3).
English: • heart disease or heart disease treatment that makes you prone to low blood pressure or have a family history of irregular heart beat (including QT prolongation)
Croatian: • ako imate bolest srca ili liječenje bolesti srca koje uzrokuje sklonost niskom krvnom tlaku ili obiteljsku anamnezu nepravilnih srčanih otkucaja (uključujući produljenje QT)
English: AndersonBrecon (UK) Ltd. Units 2-7
Croatian: AndersonBrecon (UK) Ltd.
English: CYP3A4 is the major enzyme responsible for metabolism of the active metabolite ID-14283.
Croatian: CYP3A4 je glavni enzim odgovoran za metabolizam aktivnog metabolita ID-14283.
English: Hypertension Hypotension Orthostatic hypotension Hot flush Blood pressure increased
Croatian: Krvožilni poremećaji hipertenzija hipotenzija ortostatska hipotenzija navale vrućine povećanje krvnog tlaka
English: Lurasidone is metabolised mainly via CYP3A4.
Croatian: Lurasidon se metabolizira uglavnom preko CYP3A4.
English: Lurasidone should be used with caution in elderly patients with dementia who have risk factors for stroke.
Croatian: Lurasidon treba koristiti s oprezom u starijih bolesnika s demencijom koji imaju rizične faktore za moždani udar.
English: Placebo Lurasidone dose 18.5-74 mg (a) (b)
Croatian: Statistika ispitivanja Placebo Lurasidone doza 18,574 mg (a) (b)
English: Angina**** AV block first degree**** Bradycardia****
Croatian: Srčani poremećaji tahikardija angina**** AV blok prvog stupnja**** bradikardija****
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: ATC code: N05AE05 Mechanism of action
Croatian: ATK oznaka: N05AE05 Mehanizam djelovanja
English: After having been treated for an acute episode and stabilized for a minimum of 12 weeks with lurasidone, patients were then randomised in a double-blind manner to either continue on lurasidone or on placebo until they experienced a relapse in schizophrenia symptoms.
Croatian: Nakon liječenja akutne epizode i stabilizacije od barem 12 tjedana sa lurasidonom, bolesnici su randomizirani na dvostruko-slijepi način u skupine koje su nastavile ili s lurasidonom ili s placebom sve do ponovne pojave simptoma shizofrenije.
English: An approximately 3-fold increased risk of cerebrovascular adverse reactions has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole and olanzapine.
Croatian: Približno 3 puta veći rizik cerebrovaskularnih nuspojava viđen je u randomiziranim placebo-kontroliranim kliničkim istraživanjima u populaciji s demencijom s nekim od atipičnih antipsihotika, uključujući risperidon, aripiprazol i olanzapin.
English: The maximum daily dose should not exceed 148 mg.
Croatian: Ne smije se prekoračiti maksimalna dnevna doza od 148 mg.
English: Lurasidone was excreted in milk of rats during lactation.
Croatian: Lurasidon se izlučuje u mlijeku štakorica tijekom laktacije.
English: • speech problems, unusual muscle movements; a collection of symptoms known as extrapyramidal symptoms (EPS) which typically will involve unusual purposeless involuntary muscle movements.
Croatian: • poteškoće u govoru, neuobičajeni pokreti mišića; skupina simptoma pozna kao ekstrapiramidni simptomi (EPS) koji obično uključuju neuobičajene, bezrazložne, nevoljne pokrete mišića
English: It is not known whether lurasidone or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se lurasidon ili njegovi metaboliti u majčino mlijeko u ljudi.
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
Croatian: • nevoljni pokreti usta, jezika i udova (tardivna diskinezija)
English: • increase in eosinophils (a type of white blood cell).
Croatian: • porast eozinofila (vrsta bijelih krvnih stanica).