FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of ADRs reported in clinical trials is tabulated by frequency category.
Croatian: Incidencija nuspojava na lijek prijavljenih u kliničkim ispitivanjima tabelirana je prema kategoriji učestalosti.
English: Concomitant administration of the P-gp substrate dabigatran etexilate may result in increased dabigatran plasma concentrations.
Croatian: P-gp supstrata dabigatran eteksilata može rezultirati povećanim koncentracijama dabigatrana u plazmi.
English: Interaction with grapefruit juice Grapefruit juice should be avoided during treatment with lurasidone (see section 4.5).
Croatian: Interakcije sa sokom od grejpa Tijekom liječenja lurasidonom treba izbjegavati sok od grejpa (vidjeti dio 4.5).
English: Talk to your doctor if you are breast-feeding, or if you plan to breast-feed.
Croatian: Obratite se svom liječniku ako dojite ili ako namjeravate dojiti.
English: A fertility study in female rats resulted in prolonged oestrous cycle and delayed copulation at ≥1.5 mg/kg/day lurasidone hydrochloride, whilst the copulation and fertility indices, and the numbers of corpora lutea, implantations and live foetuses were decreased at 150 mg/kg/day lurasidone hydrochloride.
Croatian: Ispitivanja plodnosti u ženki štakora pokazala su produljeno razdoblje estrusa i usporenu kopulaciju pri ≥ 1,5 mg/kg/dan lurasidonklorida, dok su se pri 150 mg/kg/dan lurasidonklorida indikatori kopulacije i plodnosti, te broj corpus luteuma, implantacija i živih fetusa smanjili.
English: Study Statistic
Croatian: Statistika ispitivanja
English: Baseline Mean (SD) LS Mean Change (SE) Treatment Difference vs. placebo
Croatian: Srednja početna vrijednost (SD) LS srednja vrijednost promjene (SE) Razlika Liječeni naspram placebo
English: Placebo-adjusted LS mean change (95% CI) from Baseline to Week 6 LOCF in CDRS-R total score for the lurasidone group was -1.8 (-5.6, 2.0) for subjects in the 10- to 14year-old age patients and was -8.6 (-12.4, -4.8) for subjects in the 15- to 17-year-old age patients.
Croatian: Srednja vrijednost promjene dobivene metodom najmanjih kvadrata (LS) prilagođena placebom (95% IP) od početne vrijednosti do zadnjeg opažanja prenesenog nadalje (engl. last observation carried forward, LOCF) u 6. tjednu u ukupnom rezultatu CDRS-R-a za lurasidon skupinu bila je -1,8 (-5,6; 2,0) za ispitanike u dobi od 10 do 14 godina starosti i -8,6 (-12,4; -4,8) za ispitanike u dobi od 15 do 17 godina starosti.
English: Similarly the alpha-blocking properties of bretylium might be additive to those of lurasidone, resulting in problematic hypotension.
Croatian: Slično, alfa-blokirajuće djelovanje bretilijuma može biti aditivno onom lurasidona, rezultirajući problemima s hipotenzijom.
English: Mammary gland and/or pituitary gland tumours were observed in the mouse and rat carcinogenicity studies and are most likely due to the increased blood prolactin levels.
Croatian: U ispitivanjima kancerogenosti u miševa i štakora zabilježeni su tumori dojki i/ili hipofize, najvjerojatnije uslijed povećanja razine prolaktina u krvi.
English: Estimate (SE)
Croatian: Procjena (SE) p-vrijednost
English: In a dose range finding study in pregnant rats, 150 mg/kg/day lurasidone hydrochloride caused fetal growth retardation without signs of teratogenicity.
Croatian: U ispitivanju određivanja doza u skotnih štakorica, 150 mg/kg/dan lurasidonklorida uzrokovalo je zastoj u fetalnom rastu bez znakova teratogeneze.
English: A starting dose of 18.5 mg is recommended and the maximum dose of lurasidone should not exceed 74 mg once daily in combination with moderate CYP3A4 inhibitors.
Croatian: Preporučuje se početna doza od 18,5 mg, a najviša doza lurasidona ne smije preći 74 mg jednom dnevno u kombinaciji s umjerenim CYP3A4 inhibitorima.
English: Elderly patients with dementia Lurasidone has not been studied in elderly patients with dementia.
Croatian: Stariji bolesnici s demencijom Lurasidon nije ispitivan na starijim bolesnicima s demencijom.
English: • decreased liver function
Croatian: • ako Vam je oslabljena funkcija jetre
English: Coadministration of lurasidone with midazolam, a sensitive CYP3A4 substrate, resulted in a < 1.5-fold increase in midazolam exposure.
Croatian: Istovremena primjena lurasidona s midazolamom, osjetljivim supstratom za CYP3A4, rezultirala je < 1,5 puta povećanjem u izloženosti midazolamu.
English: Renal impairment The serum concentrations of lurasidone are increased in healthy subjects with mild, moderate and severe renal impairment with an increased exposure of 1.5, 1.9 and 2.0-fold respectively.
Croatian: Serumska koncentracija lurasidona bila je povećana u zdravih ispitanika s blagim,umjerenim i teškim oštećenjem bubrega s povećanjem izloženosti od 1,5; 1,9; odnosno 2 puta.
English: Lurasidone and its active metabolite ID-14283 are primarily metabolised by CYP3A4.
Croatian: Lurasidon i njegov aktivni metabolit ID-14283 se primarno metaboliziraju preko CYP3A4.
English: In placebo controlled clinical studies in adult patients with schizophrenia there was an increased occurrence of EPS following treatment with lurasidone compared to placebo.
Croatian: U placebo kontroliranim kliničkim ispitivanjima u odraslih bolesnika sa shizofrenijom, nastanak ekstrapiramidnih simptoma bio je povećan kod bolesnika liječenih lurasidonom u usporedbi s placebom.
English: • aprepitant (to treat nausea and vomiting)
Croatian: • aprepitant (za liječenje mučnine i povraćanja)
English: Healthcare professionals are asked to report any suspected adverse reactions via the following website: www.mhra.gov.uk/yellowcard.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu droge putem sljedeće internetske stranice: www.halmed.hr.
English: Coadministration of lurasidone with medicinal products that moderately inhibit CYP3A4 (e.g. diltiazem, erythromycin, fluconazole verapamil) may increase exposure to lurasidone.
Croatian: Istovremena primjena lurasidona s lijekovima koji umjereno inhibiraju CYP3A4 (npr. diltiazem, eritromicin, flukonazol, verapamil) može povećati izloženost lurasidonu.
English: Lurasidone doses ranging from 9 to 74 mg administered to healthy subjects produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, in the caudate, putamen and ventral striatum detected by positron emission tomography.
Croatian: Pozitronskom emisijskom tomografijom detektirano je da je lurasidon, primijenjen u dozama u rasponu od 9 do 74 mg u zdravih ispitanika, izazvao o dozi ovisno smanjenje vezanja 11C-rakloprida, liganda D2/D3 receptora, u kaudatumu, putamenu i ventralnom strijatumu.
English: Tell your doctor if you take any of these medicines since your doctor may have to change the dose of that medicine during treatment with Latuda.
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od ovih lijekova, jer će on možda htjeti prilagoditi dozu tog lijeka za vrijeme dok se liječite lijekom Latuda.
English: Caution is advised when prescribing lurasidone with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g. quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Croatian: Oprez se preporučuje kada se lurasidon propisuje s lijekovima za koje se zna da produžuju QT interval, npr. skupina IA antiaritmika (npr. kinidin, dizopiramid) i skupina III antiaritmika (npr. amiodaron, sotalol), neki antihistaminici, neki drugi antipsihotici i neki antimalarici (npr. meflokin).
English: Lurasidone and its active metabolite ID-14283 both contribute to the pharmacodynamic effect at the dopaminergic and serotonergic receptors.
Croatian: Lurasidon i njegov aktivni metabolit ID-14283 zajedno pridonose farmakodinamskom djelovanju na dopaminergičke i serotoninergičke receptore.
English: 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets
Croatian: 14 x 1 filmom obloženih tableta 28 x 1 filmom obloženih tableta 30 x 1 filmom obloženih tableta 56 x 1 filmom obloženih tableta 60 x 1 filmom obloženih tableta 90 x 1 filmom obloženih tableta 98 x 1 filmom obloženih tableta
English: In this event, lurasidone, should be discontinued.
Croatian: U ovom slučaju, liječenje lurasidonom, mora biti prekinuto.
English: • increase in creatinine (a marker of kidney function) seen in blood tests.
Croatian: • porast kreatinina (biljeg funkcije bubrega) vidljiv iz krvnih pretraga.
English: • fast heart beat
Croatian: • brzi otkucaji srca
English: Lurasidone binds strongly to dopaminergic D2- and to serotonergic 5-HT2A and 5-HT7- receptors with high binding affinity of 0.994, 0.47 and 0.495 nM, respectively.
Croatian: Lurasidon se veže snažno na dopaminske D2- i serotoninske 5-HT2A i 5-HT7-receptore s visokim afinitetom vezanja od 0,994; 0,47; odnosno 0,495 nM. On također blokira α2c-adrenergičke receptore i α2a-adrenergičke receptore s afinitetom vezanja od 10,8; odnosno 40,7 nM.
English: Lurasidone also exhibits partial agonism at the 5HT-1A receptor with a binding affinity of 6.38 nM. Lurasidone does not bind to histaminergic or muscarinic receptors.
Croatian: Lurasidon također pokazuje djelomični agonizam na 5HT-1A receptore s afinitetom vezanja od 6,38 nM.
English: It was noted that Asian subjects had 1.5-fold increased exposure to lurasidone compared to Caucasian subjects.
Croatian: Zabilježeno je da je azijska rasa bolesnika imala 1,5 puta povećanu izloženost lurasidonu u usporedbi s bijelom rasom bolesnika.
English: Alanine aminotransferase increased
Croatian: Poremećaji jetre i žuči povećanje alanin aminotransferaze
English: D1050233.
Croatian: Ispitivanje D1050233
English: Lurasidone was administered as lurasidone hydrochloride at daily doses of either 20, 40, 80, 120 mg (6-17 years) or 160 mg (10-17 years only) for
Croatian: Lurasidon je bio primijenjen u obliku lurasidon klorida u dnevnim dozama od 20, 40, 80 ili 120 mg (6-17 godina) ili 160 mg (samo 10-17 godina) tijekom 7 dana.
English: Table 2.1 Bipolar Depression Paediatric Study: Children's Depression Rating Scale, Revised (CDRS-R) Total Score and Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score (Depression) - Change From Baseline to Week 6 - MMRM for Study D1050326: Intent-to-Treat Analysis Set
Croatian: Tablica 2.1 Pedijatrijsko ispitivanje bipolarne depresije: Ukupni broj bodova na ljestvici depresije u djece (CDRS-R) i CGI-BP-S bodovanje za vrijednost težine bolesti rezultat depresije (depresija) - promjena od početne vrijednosti do 6. tjedna - MMRM za Ispitivanje D1050326: set za analizu podataka bolesnika predviđenih za liječenje (engl.
English: Patients should be counseled on signs and symptoms of elevated prolactin, such as gynecomastia, galactorrhea, amenorrhea and erectile dysfunction.
Croatian: Bolesnike treba upoznati sa znakovima i simptomima povišenog prolaktina poput ginekomastije, galaktoreje i erektilne disfunkcije.
English: Coadministration of lurasidone with lithium indicated that lithium had clinically negligible effects on the pharmacokinetics of lurasidone, therefore no dose adjustment of lurasidone is required when coadministered with lithium.
Croatian: Istovremena primjena lurasidona s litijem upućuje na klinički zanemariv utjecaj litija na farmakokinetiku lurasidona, stoga nije potrebna prilagodba doze lurasidona kada se daje istovremeno s litijem.
English: Pale green, film-coated oval tablets of 12 mm x 7 mm debossed with ‘LD'
Croatian: Blijedo zelene, filmom obložene ovalne tablete veličine 12 mm x 7 mm s utisnutim „LD“
English: Hyperprolactinaemia Lurasidone elevates prolactin levels due to antagonism of dopamine D2 receptors.
Croatian: Lurasidon povećava razinu prolaktina zbog antagonističkog djelovanja na dopaminske D2 receptore.
English: Limited data are available in elderly people treated with higher doses of lurasidone.
Croatian: Podaci o liječenju starijih osoba višim dozama lurasidona su ograničeni.
English: Study D1050233 N=120 -
Croatian: Ispitivanje D1050233 N=120
English: Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks.
Croatian: Lurasidonse ne smije koristiti u bolesnika sa završnim stadijem bubrežne bolesti, osim ako potencijana korist ne nadjačava potencijalni rizik.
English: Lurasidone is not expected to have a clinically relevant inhibitory potential on transporters OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, MATE2K or BSEP based on in vitro data.
Croatian: Na temelju in vitro podataka, ne očekuje se da lurasidon ima klinički značajan inhibicijski potencijal za transportere OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, MATE2K ili BSEP.
English: Monitoring is recommended when lurasidone and CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) are coadministered.
Croatian: Preporučuje se praćenje kada se lurasidon i supstrati za CYP3A4 poznati po uskom terapijskom indeksu (npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ili ergot alkaloidi [ergotamin, dihidroergotamin]) primjenjuju zajedno.
English: • Latuda 74 mg film-coated tablets are pale green, film-coated oval tablets debossed with “LD”.
Croatian: • Latuda 74 mg filmom obložene tablete su blijedo zelene, filmom obložene ovalne tablete s utisnutim „LD“.
English: Adverse drug reactions (ADRs) based upon pooled data are shown by system, organ class and by preferred term are listed below.
Croatian: Nuspojave na lijek temeljene na udruženim podacima prikazane prema klasifikaciji organskih sustava i preporučenim izrazima su niže navedene.
English: Caution should be exercised when treating patients ≥65 years of age with higher doses of lurasidone.
Croatian: ≥ 65 godina liječe višim dozama lurasidona.
English: Medicinal products with dopamine receptor antagonistic properties have been associated with extrapyramidal adverse reactions including rigidity, tremors, mask-like face, dystonias, drooling of saliva, drooped posture and abnormal gait.
Croatian: Lijekovi s osobinama antagonista dopaminskih receptora povezani su s ekstrapiramidnim nuspojavama uključujući rigidnost, tremor, lice poput maske, distoniju, curenje sline, pognuto držanje tijela i promijenjeni hod.
English: • low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (hyponatremia).
Croatian: • niska razina natrija u krvi što može uzrokovati umor i smetenost, trzanje mišića, napadaje i komu (hiponatremija).
English: • are taking medicines which may affect the level of lurasidone in your blood such as: medicines for fungal infections such as itraconazole, ketoconazole (except as a shampoo), posaconazole or voriconazole medicines for an infection such as the antibiotic clarithromycin or telithromycin medicines for HIV infections such as cobicistat, indinavir, nelfinavir, ritonavir, and saquinavir boceprevir, and telaprevir (medicines for chronic hepatitis) nefazodone (a medicine for depression) rifampicin (a medicine for tuberculosis) carbamazepine, phenobarbital and phenytoin (medicines for seizures) St John's wort (Hypericum perforatum) (herbal medicine for depression).
Croatian: • ako uzimate lijekove koji mogu utjecati na razinu lurasidona u krvi, kao što su: - lijekovi za gljivične infekcije kao itrakonazol, ketokonazol (osim kao šampon), pozakonazol ili vorikonazol - lijekovi za infekcije poput antibiotika klaritromicina ili telitromicina - lijekovi za HIV infekcije kao što su kobicistat, indinavir, nelfinavir, ritonavir i sakvinavir - boceprevir i telaprevir (lijekove za liječenje kroničnog hepatitisa) - nefazodon (lijek za liječenje depresije) - rifampicin (lijek za liječenje tuberkuloze) - karbamazepin, fenobarbital i fenitoin (lijekove za epileptičke napadaje) - gospina trava (Hypericum perforatum) (biljni lijek koji se koristi za liječenje depresije).
English: Mannitol (E 421) Starch, pregelatinised Croscarmellose sodium (E468)
Croatian: Jezgra manitol (E 421) škrob, prethodno geliran karmelozanatrij, umrežena (E 468)
English: Treatment Difference vs. placebo
Croatian: Razlika Liječeninaspram placebo
English: The short-term efficacy of lurasidone was studied in a 6-week multicentre, randomized, double-blind, placebo-controlled, study of children and adolescent patients (10-17 years of age) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a major depressive episode associated with bipolar I disorder, with or without rapid cycling, and without psychotic features (N=350).
Croatian: Kratkoročna djelotvornost lurasidona ispitivana je u 6-tjednom multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju bolesne djece i adolescenata (u dobi od 10-17 godina) koji su zadovoljili kriterije Dijagnostičkog i statističkog priručnika mentalnih poremećaja, peto izdanje (DSM-V) za veliku depresivnu epizodu povezanu s bipolarnim
English: In a long-term dog repeat-dose study, high serum prolactin levels were associated with effects on male and female reproductive tissues.
Croatian: U ispitivanju dugotrajnih uzastopnih doza u pasa, visoki serumski prolaktin bio je povezan s učincima na muška i ženska reproduktivna tkiva.
English: Co-administration of lurasidone and posaconazole (strong CYP3A4 inhibitor) resulted in an approximate 4-5 fold increase in lurasidone exposure.
Croatian: Istodobna primjena lurasidona i posakonazola (jaki inhibitor CYP3A4) rezultirala je otprilike 4 - 5 puta većom izloženošću lurasidonu.
English: Infections and infestations
Croatian: Infekcije i infestacije nazofaringitis
English: Study Statistic Placebo Lurasidone dose (b)
Croatian: Doza lurasidona (b)
English: There were no clinically relevant differences in the pharmacokinetics of lurasidone in a population pharmacokinetic analysis in patients with schizophrenia.
Croatian: Nije bilo klinički relevantnih razlika u farmakokinetici lurasidona u populaciji bolesnika sa shizofrenijom kod kojih je ispitivana farmakokinetika.
English: The primary efficacy endpoint was defined as the mean change from baseline to Week 6 in Children's Depression Rating Scale, Revised (CDRS-R) Total Score.
Croatian: Primarna mjera ishoda djelotvornosti definirana je kao srednja vrijednost promjene ukupnoga broja bodova od početne vrijednosti do 6. tjedna na ljestvici depresije u djece (engl.
English: • nausea (feeling sick), vomiting (being sick)
Croatian: • mučnina (osjećaj mučnine), povraćanje
English: If used in ESRD, clinical monitoring is advised.
Croatian: Ako se koristi kod završnog stadija bubrežne bolesti, savjetuje se kliničko praćenje ovih bolesnika.
English: There were no clinically relevant differences between genders in the pharmacokinetics of lurasidone in a population pharmacokinetic analysis in patients with schizophrenia.
Croatian: Nije bilo klinički relevantnih razlika među spolovima u farmakokinetici lurasidona u populaciji bolesnika sa shizofrenijom kod kojih je ispitivana farmakokinetika.
English: Cartons contain 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 or 98 x 1 tablets in aluminium/aluminium perforated unit dose blisters.
Croatian: Kutija sadrži 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 ili 98 x 1 tabletu u aluminij/aluminij perforiranim blisterima s jediničnim dozama.
English: • a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath,
Croatian: • jaka alergijska reakcija koja se ispoljava kao vrućica, otečena usta, lice, usnica ili jezik, nedostatak zraka, svrbež, kožni osip i ponekad pad krvnog tlaka.
English: • Latuda 18.5 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LA”
Croatian: • Latuda 18,5 mg filmom obložene tablete su bijele do gotovo bijele, filmom obložene okrugle tablete s utisnutim „LA“
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (može zahvatiti do 1 na 1000 osoba):
English: Lurasidone is an in vitro substrate of the efflux transporters P-gp and BCRP.
Croatian: Lurasidon je in vitro supstrat P-gp transportnog glikoproteina i BCRP.
English: Lurasidone is a substrate of P-gp and BCRP in vitro and the in vivo relevance of this is unclear.
Croatian: Lurasidon je in vitro supstrat za P-gp i BCRP, a nejasno je kakvo je značenje toga in vivo.
English: • nafcillin (to treat infections)
Croatian: • nafcilin (za liječenje infekcija)
English: Coadministration of lurasidone with mild (e.g. armodafinil, amprenavir, aprepitant, prednisone, rufinamide) or moderate (e.g. bosentan, efavirenz, etravirine, modafinil, nafcillin) inducers of CYP3A4 would be expected to give a <2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.
Croatian: Može se očekivati da će istovremena primjena lurasidona s blagim CYP3A4 induktorima (npr. armodafinil, amprenavir, aprepitant, prednison, rufinamid) ili umjerenim CYP3A4 induktorima (npr. bosentan, efavirenz, etravirin, modafinil, nafcilin) izazvati < 2 puta smanjenu izloženost lurasidonu tijekom istovremene primjene, kao i do 2 tjedna nakon što se iz liječenja isključe blagi ili umjereni induktori CYP3A4.
English: Based on this data, lurasidone is not expected to affect the pharmacokinetics of medicinal products that are substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Croatian: Temeljem tih podataka, ne očekuje se utjecaj lurasidona na farmakokinetiku lijekova koji su supstrati za CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP2E1.
English: • erythromycin (to treat infections)
Croatian: • eritromicin (za liječenje infekcija)
English: Coadministration of lurasidone with diltiazem (slow-release formulation), a moderate CYP3A4 inhibitor, resulted in a 2.2 and 2.4-fold increase in exposure of lurasidone and ID-14283 respectively (see section 4.2).
Croatian: Istovremena primjena lurasidona s diltiazemom (formulacija sa sporim oslobađanjem), umjerenim inhibitorom CYP3A4, rezultira 2,2 puta većom izloženošću lurasidonu i 2,4 puta ID-14283 (vidjeti dio 4.2).
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (može zahvatiti više od 1 na 10 osoba):
English: • a history of seizures (fits) or epilepsy
Croatian: • ako imate anamnezu epileptičkih napadaja ili epilepsije
English: • fluconazole (to treat fungal infections)
Croatian: • flukonazol (za liječenje gljivičnih infekcija)
English: Weight increased
Croatian: Povećanje tjelesne težine
English: Coadministration of lurasidone with the strong CYP3A4 inhibitor ketoconazole resulted in a 9- and 6-fold increase in exposure of lurasidone and its active metabolite ID-14283 respectively.
Croatian: Istovremena primjena lurasidona s jakim CYP3A4 inhibitorom ketokonazolom rezultira 9 puta većom izloženosti lurasidonu i 6 puta njegovom aktivnom metabolitu ID-14283.
English: Latuda 18.5 mg tablets lurasidone
Croatian: Latuda 18,5 mg tablete lurasidon
English: Slovak republic/ Slovenská republika Angelini Pharma Slovenská republika s.r.o.
Croatian: Slovak republic/ Slovenská republika Angelini Pharma Slovenská republika s.r.o. Júnová 33
English: Lurasidone is contraindicated with strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum)) (see section 4.3).
Croatian: Lurasidon je kontraindiciran s jakim CYP3A4 induktorima (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, gospina trava (Hypericum perforatum)) (vidjeti dio 4.3).
English: Key Secondary Endpoint: CGI-BP-S Depression Score
Croatian: CGI-BP-S rezultat depresije
English: Based on in vitro studies lurasidone is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes.
Croatian: Zasnovano na ispitivanjima in vitro, lurasidon nije supstrat CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP2E1 enzima.
English: • Latuda 37 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LB”
Croatian: • Latuda 37 mg filmom obložene tablete su bijele do gotovo bijele, filmom obložene okrugle tablete s utisnutim „LB“