FrancophonIA/ELRC3.0 huggingface dataset:
English: • ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as neuroleptic malignant syndrome) or if you have ever experienced rigidity, tremors or problems moving (extrapyramidal symptoms) or abnormal movements of the tongue or face (tardive dyskinesia).
Slovenian: • če vam je bilo kdaj ugotovljeno stanje s simptomi, ki so vključevali visoko telesno temperaturo in mišično okorelost (znano tudi kot maligni nevroleptični sindrom), ste kdaj imeli težave z okorelostjo, tresenjem ali gibanjem (ekstrapiramidni simptomi) ali težave z nenormalnim gibi jezika ali obraza (tardivna diskinezija).
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Slovenian: V meta-analizi 17 nadzorovanih kliničnih preskušanj so pri starostnikih z demenco, ki so se zdravili z drugimi atipičnimi antipsihotiki, vključno z risperidonom, aripiprazolom, olanzapinom in kvetiapinom, ugotovili večje tveganje za umrljivost v primerjavi s placebom.
English: • Fever, sweating, muscle stiffness, and reduced consciousness.
Slovenian: • Zvišana telesna temperatura, znojenje, mišična togost in zmanjšana zavest.
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
Slovenian: Zdravila z antagonističnim delovanjem na dopaminske receptorje so bila povezana s pojavom tardivne diskinezije z značilnimi nehotnimi ritmičnimi zgibki, predvsem jezika in/ali obraza.
English: • bosentan (to treat high blood pressure or ulcers of the fingers)
Slovenian: • bosentan (za zdravljenje visokega krvnega tlaka ali razjed na prstih)
English: Lurasidone and its active metabolite ID-14283 both contribute to the pharmacodynamic effect at the dopaminergic and serotonergic receptors.
Slovenian: Tako lurasidon kot njegov aktivni presnovek ID-14283 prispevata k farmakodinamičnemu učinku na dopaminergične in serotoninergične receptorje.
English: Lurasidone demonstrated superior efficacy compared with placebo across Phase 3 studies (see Table 2).
Slovenian: V študijah 3. faze je bil lurasidon učinkovitejši od placeba (glejte tabelo 2).
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal products should be administered.
Slovenian: V primeru hudih ekstrapiramidnih simptomov je treba bolniku dati antiholinergike.
English: Lurasidone is an inhibitor of P-gp, BCRP and OCT1 in vitro (see section 4.5).
Slovenian: Lurasidon je in vitro zaviralec P-gp, BCRP in OCT1 (glejte poglavje 4.5).
English: Switching between antipsychotic medicinal products Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Slovenian: Zaradi različnega farmakodinamičnega in farmakokinetičnega profila antipsihotikov je pri zamenjavi zdravljenja z drugim antipsihotikom potreben nadzor zdravnika.
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.
Slovenian: Primarni cilj študije učinkovitosti je bil določen kot povprečna sprememba od izhodiščne vrednosti do 6. tedna glede na skupno vrednost na revidirani ocenjevalni lestvici za merjenje depresije pri otrocih (CDRS-R).
English: • abnormal breast enlargement, breast pain, milk secretion from breasts
Slovenian: • nenormalno povečanje dojk, bolečina v dojkah, spontano odtekanje mleka iz dojke
English: Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks.
Slovenian: Pri bolnikih s končno ledvično odpovedjo se lurasidona ne sme uporabljati, razen če možne koristi zdravljenja prevladajo nad možnimi tveganji.
English: If your baby develops any of these symptoms you should contact your doctor.
Slovenian: Če se pri otroku pojavi kateri koli od teh simptomov, se morate posvetovati z zdravnikom.
English: Neonates exposed to antipsychotics (including lurasidone) during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Slovenian: Pri novorojenčkih, ki so bili med tretjim trimesečjem nosečnosti izpostavljeni antipsihotikom (vključno z lurasidonom), obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
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
Slovenian: 14 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta
English: • medicines containing ergot alkaloid derivatives (used for treating migraines), and other medicines including terfenadine and astemizole (used for treating hay fever and other allergic conditions), cisapride (used for treating digestive problems), pimozide (used to treating psychiatric illnesses), quinidine (used for treating heart conditions), bepridil (used for treating chest pain).
Slovenian: • zdravila, ki vsebujejo derivate ergot alkaloidov (uporabljamo jih za zdravljenje migrene) in druga zdravila, ki vsebujejo terfenadin in astemizol (uporabljamo ju za zdravljenje senenega nahoda in drugih alergijskih bolezni), cisaprid (uporabljamo ga za zdravljenje prebavnih težav), pimozid (uporabljamo ga za zdravljenje duševnih bolezni), kinidin (uporabljamo ga za zdravljenje bolezni srca), bepridil (uporabljamo ga za zdravljenje bolečine v prsnem košu).
English: • speech problems, unusual muscle movements; a collection of symptoms known as extrapyramidal symptoms (EPS) which typically will involve unusual purposeless involuntary muscle movements.
Slovenian: • težave z govorom, nenavadni gibi mišic, skupek simptomov, znanih kot ekstrapiramidni simptomi, ki tipično vključujejo neobičajne, nesmiselne in nehotne gibe mišic
English: Venous thromboembolism: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs -Frequency unknown.
Slovenian: Venska trombembolija: Pri uporabi antipsihotikov so poročali o primerih venske trombembolije, vključno s primeri pljučne embolije in globoke venske tromboze, njihova pogostnost pa ni znana.
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
Slovenian: Bolniki so lurasidon v obliki lurasidonijevega klorida prejemali 7 dni v dnevnih odmerkih 20, 40, 80, 120 mg (bolniki, stari od 6 do 17 let) ali 160 mg (le bolniki, stari od 10 do 17 let).
English: 37 mg 74 mg 111 mg 148 mg
Slovenian: 111 mg 148 mg
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.
Slovenian: V študijah kancerogenosti so pri miših in podganah ugotovili tumorje mlečne žleze in/ali hipofize, ki so bili najverjetneje posledica zvišane vrednosti prolaktina v krvi.
English: Neuroleptic malignant syndrome (NMS)
Slovenian: Maligni nevroleptični sindrom
English: Study Statistic Placebo Lurasidone dose (b)
Slovenian: Odmerek lurasidona (b)
English: In the main clinical efficacy studies, lurasidone was administered at doses of 37-148 mg lurasidone.
Slovenian: V glavnih študijah klinične učinkovitosti so lurasidon uporabljali v odmerkih od 37 do 148 mg lurasidona.
English: Cerebrovascular accident
Slovenian: Cerebrovaskularni inzult
English: Events of interest to the class Extrapyramidal symptoms (EPS): In the short-term placebo controlled studies, the incidence of reported events related to EPS, excluding akathisia and restlessness, was 13.5% for lurasidone-treated subjects versus 5.8% for placebo-treated subjects.
Slovenian: Ekstrapiramidni simptomi: V kratkotrajnih, s placebom nadzorovanih študijah, je pojavnost sporočenih dogodkov, povezanih z ekstrapiramidnimi simptomi, razen akatizije in nemira, pri osebah, ki so se zdravile z lurasidonom znašala 13,5 %, pri osebah, ki so prejemale placebo pa 5,8 %.
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.
Slovenian: Lurasidon se močno in z visoko vezavno afiniteto veže na dopaminergične D2 (vezavna afiniteta: 0,994 nM) in serotoninergične 5-HT2A (vezavna afiniteta: 0,47 nM) ter 5-HT7 (vezavna afiniteta: 0,495 nM) receptorje.
English: Latuda tablets should be swallowed whole, in order to mask the bitter taste.
Slovenian: Bolnik mora Latuda tablete pogoltniti cele, da se prikrije njihov grenek okus.
English: Similarly the alpha-blocking properties of bretylium might be additive to those of lurasidone, resulting in problematic hypotension.
Slovenian: Podobno bi bretilij z zaviranjem alfa receptorjev lahko imel aditiven učinek k tovrstnemu učinki lurasidona, kar bi lahko povzročilo težavno hipotenzijo.
English: Akathisia Somnolence*
Slovenian: Bolezni živčevja akatizija somnolenca*
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.
Slovenian: Od 2. tedna dalje so bile za te opazovane dogodke pri celotni populaciji ugotovljene statistično značilne razlike v korist zdravila lurasidon v primerjavi s placebom, ki so bile prisotne med vsakim študijskim pregledom do zaključka študije.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take a few days to some weeks.
Slovenian: Klinično stanje bolnika se lahko izboljša šele po nekaj dneh do tednih zdravljenja z antipsihotikom.
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.
Slovenian: Škatla s 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 ali 98 x 1 tableto v aluminij/aluminij perforiranih enoodmernih pretisnih omotih.
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.
Slovenian: To zdravilo morate jemati skupaj s hrano ali neposredno po jedi, kar izboljša absorpcijo zdravila in omogoča njegovo boljše delovanje.
English: Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech and behaviour and emotional flatness.
Slovenian: Shizofrenija je bolezen s simptomi, kot so prisluhi, prividi ali drugi občutki brez stvarne podlage, zmotna prepričanja, pretirana sumničavost, zaprtost vase, nepovezano govorjenje in vedenje ter čustvena praznina.
English: Lurasidone and its active metabolite ID-14283 are primarily metabolised by CYP3A4.
Slovenian: Lurasidon in njegov aktivni presnovek ID-14283 se presnavljata predvsem s CYP3A4.
English: In a long-term dog repeat-dose study, high serum prolactin levels were associated with effects on male and female reproductive tissues.
Slovenian: V dolgoročni študiji ponavljajočih se odmerkov pri psih, so bile visoke vrednosti prolaktina v serumu povezane z učinki na reproduktivno tkivo samcev in samic.
English: What Latuda is and what it is used for What you need to know before you take Latuda How to take Latuda
Slovenian: Kaj je zdravilo Latuda in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Latuda Kako jemati zdravilo Latuda Možni neželeni učinki
English: No data are available in elderly people treated with 148 mg of lurasidone.
Slovenian: Pri starostnikih ni podatkov o zdravljenju z lurasidonom v odmerku 148 mg.
English: Angelini Pharmaceuticals România SRL Str. Carol Davila, Nr. 9, Sector 5
Slovenian: Romania/ România Angelini Pharmaceuticals România SRL Str. Carol Davila, Nr. 9, Sector 5 RO-București 050451
English: Lurasidone is an in vitro substrate of the efflux transporters P-gp and BCRP.
Slovenian: Lurasidon je in vitro substrat za efluksna prenašalca P-gp in BCRP.
English: Kaplan-Meier estimates of the probability of relapse at Week 28 were 42.2% for lurasidone and 51.2% for placebo.
Slovenian: Kaplan-Meierjeve ocene verjetnosti ponovitve v 28. tednu so za lurasidon znašale 42,2 %, za placebo pa 51,2 %.
English: If you forget to take Latuda
Slovenian: Če ste pozabili vzeti zdravilo Latuda
English: Breast feeding in women receiving lurasidone should be considered only if the potential benefit of treatment justifies the potential risk to the child.
Slovenian: Doječe matere se z lurasidonom lahko zdravijo le, če možna korist zdravljenja odtehta možno tveganje za dojenega otroka.
English: Grapefruit juice inhibits CYP3A4 and may increase the serum concentration of lurasidone.
Slovenian: Sok grenivke zavira CYP3A4 in lahko zviša koncentracijo lurasidona v serumu.
English: Convulsion****
Slovenian: parkinsonizem**
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
Slovenian: • nenadzorovani gibi ust, jezika in okončin (zapoznela ali tardivna diskinezija)
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.
Slovenian: V študiji plodnosti so pri samicah podgan pri odmerku lurasidonijevega klorida ≥ 1,5 mg/kg/dan ugotovili podaljšanje estrusnega cikla in zadržanje parjenja, medtem ko so se parjenje in indeksi plodnosti ter število rumenih telesc, implantacij in živih plodov zmanjšali pri odmerku lurasidonijevega klorida 150 mg/kg/dan.
English: D1050233.
Slovenian: Študija D1050233
English: Caution should be exercised when treating patients ≥65 years of age with higher doses of lurasidone.
Slovenian: Pri bolnikih, starih ≥ 65 let, je treba večje odmerke lurasidona uporabljati previdno.
English: Urine comprised mostly of a number of metabolites with minimal renal excretion of parent compound.
Slovenian: Z urinom se izločajo predvsem številni presnovki, izločanje izvorne spojine preko ledvic pa je minimalno.
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).
Slovenian: Varnostni profil lurasidona pri otrocih, ki so sodelovali v tej kratkotrajni študiji, se v glavnem sklada s profilom, opaženim v okviru zdravljenja odobrene indikacije pri odraslih, vendar se razlikujejo po pogostnosti najpogostejših neželenih učinkov, opaženih pri pediatričnih bolnikih, in sicer pri navzea (zelo pogosti), driska (pogosti), zmanjšan apetit (pogosti), v primerjavi z odraslimi (navzea (pogosti), driska (neznana pogostnost), zmanjšan apetit (občasni)).
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:
Slovenian: Pri novorojenčkih mater, ki so se v zadnjem trimesečju nosečnosti zdravile z lurasidonom, se namreč lahko pojavijo naslednji simptomi:
English: The incidence of ADRs reported in clinical trials is tabulated by frequency category.
Slovenian: Pojavnost neželenih učinkov, o katerih so poročali v kliničnih preskušanjih, je prikazana po kategorijah.
English: It is not known if lurasidone passes into breast milk.
Slovenian: Ni znano, če se lurasidon izloča z materinim mlekom.
English: Coadministration of lurasidone with P-gp and BCRP inhibitors may increase exposure to lurasidone.
Slovenian: Pri sočasni uporabi lurasidona in zaviralcev P-gp ali BCRP se izpostavljenost lurasidonu lahko poveča.
English: • slow heart rate
Slovenian: • počasen srčni utrip
English: (a) p-values for lurasidone vs. placebo were adjusted for multiple comparisons.
Slovenian: (a) p-vrednosti za lurasidon v primerjavi s placebom so bile prilagojene za večkratne primerjave.
English: Concomitant administration of the P-gp substrate dabigatran etexilate may result in increased dabigatran plasma concentrations.
Slovenian: Pri sočasni uporabi dabigatran eteksilata, ki je substrat za P-gp, se koncentracije dabigatrana v plazmi lahko povečajo.
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.
Slovenian: V s placebom nadzorovanih kliničnih študijah je bila pojavnost ekstrapiramidnih simptomov pri odraslih bolnikih s shizofrenijo večja pri zdravljenju z lurasidonom v primerjavi s placebom.
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).
Slovenian: • če jemljete zdravila, ki lahko vplivajo na nivo lurasidona v krvi, kot so: zdravila za zdravljenje glivičnih okužb, kot so itrakonazol, ketokonazol (razen v obliki šampona), posakonazol ali vorikonazol zdravila za zdravljenje okužb, kot sta antibiotika klaritromicin ali telitromicin zdravila za zdravljenje okužbe z virusom HIV, kot so kobicistat, indinavir, nelfinavir, ritonavir in sakvinavir boceprevir in telaprevir (zdravili za zdravljenje kroničnega hepatitisa) nefazodon (zdravilo za zdravljenje depresije) rifampicin (zdravilo za zdravljenje tuberkuloze) karbamazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije) šentjanževka (Hypericum perforatum) (zeliščno zdravilo za zdravljenje depresije).
English: In a food effect study, lurasidone mean Cmax and AUC increased approximately by 2-3-times and 1.5-2-times, respectively, when administered with food compared to the levels observed under fasting conditions.
Slovenian: V študiji vpliva hrane je bila srednja vrednost Cmax lurasidona pri jemanju skupaj s hrano približno 2- do 3-krat večja, srednja vrednost AUC lurasidona pa približno 1,5- do 2-krat večja kot pri jemanju na tešče.
English: Coadministration of lurasidone with medicinal products that moderately inhibit CYP3A4 (e.g. diltiazem, erythromycin, fluconazole verapamil) may increase exposure to lurasidone.
Slovenian: Pri sočasni uporabi lurasidona in zdravil, ki zmerno zavirajo CYP3A4 (npr. diltiazem, eritromicin, flukonazol, verapamil), se izpostavljenost lurasidonu lahko poveča.
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.
Slovenian: Zdravila z antagonističnim delovanjem na dopaminske receptorje so bila povezana s pojavom ekstrapiramidnih neželenih učinkov, vključno z okorelostjo, tremorjem, neizraznostjo obraza, distonijami, slinjenjem, povešeno držo in nenormalno hojo.
English: Moderate CYP3A4 inhibitors are estimated to result in a 2-5-fold increase in exposure of CYP3A4 substrates.
Slovenian: Ocenjujejo, da zmerni zaviralci CYP3A4 izpostavljenost substratom za CYP3A4 povečajo za 2- do 5-krat.
English: • nafcillin (to treat infections)
Slovenian: • nafcilin (za zdravljenje okužb)
English: Post marketing reports of clinically serious cases of skin and other hypersensitivity reactions have been reported in association with lurasidone treatment, including some reports of Stevens-Johnson syndrome.
Slovenian: V povezavi z zdravljenjem z lurasidonom so bila po začetku trženja objavljena poročila o klinično resnih primerih kožnih in drugih preobčutljivostnih reakcij, vključno z nekaterimi poročili o Stevens-Johnsonovem sindromu.
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
Slovenian: Tabela 2.1 Pediatrična študija o bipolarni motnji: Skupna vrednost na revidirani ocenjevalni lestvici za merjenje depresije pri otrocih (CDRS-R) in vrednost depresije na lestvici kliničnega vtisa glede na stopnjo bipolarne motnje in resnost bolezni (CGI-BP-S) - sprememba od izhodiščne vrednosti do 6. tedna - MMRM za raziskavo D1050326: Analiza bolnikov, ki so jih nameravali zdraviti
English: The incidence of akathisia for lurasidone-treated subjects was 12.9% versus 3.0% for placebo-treated subjects.
Slovenian: Pojavnost akatizije je bila pri osebah, ki so se zdravile z lurasidonom 12,9 %, pri osebah, ki so prejemale placebo pa 3,0 %.
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.
Slovenian: Pri sočasni uporabi lurasidona in blagih (npr. armodafinil, amprenavir, aprepitant, prednizon, rufinamid) ali zmernih (npr. bosentan, efavirenz, etravirin, modafinil, nafcilin) induktorjev CYP3A4 pričakujemo, da bo izpostavljenost lurasidonu med sočasno uporabo in še do 2 tedna po prekinitvi zdravljenja z blagim ali zmernim induktorjem CYP3A4 manjša za manj kot 2-krat.
English: The pharmacokinetics of lurasidone in paediatric patients aged 6-17 years was generally comparable to those observed in adults.
Slovenian: Pri pediatričnih bolnikih, starih od 6 do 17 let, je bila farmakokinetika v glavnem primerljiva s farmakokinetiko pri odraslih.
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6- MMRM for Studies D1050229, D1050231, and D1050233: Intent-to-Treat Analysis Set
Slovenian: Študije shizofrenije: Skupna ocena na lestvici pozitivnih in negativnih sindromov za shizofrenijo (PANSS) - sprememba od izhodišča do 6. tedna - mešani model ponovljene meritve (MMRM) za študije D1050229, D1050231 in D1050233: analiza seta vseh vključenih bolnikov (Intent-to-Treat Analysis Set)
English: Bipolar Depression
Slovenian: Bipolarna motnja
English: (b) p-values for lurasidone vs. placebo were adjusted for multiple comparisons.
Slovenian: (b) p-vrednosti za lurasidon v primerjavi s placebom so bile prilagojene za multiple primerjave.
English: Dose adjustment is recommended in moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) patients.
Slovenian: Pri bolnikih z zmerno (razred B po Child-Pughovi klasifikaciji) in s hudo (razred C po Child-Pughovi klasifikaciji) okvaro jeter je odmerek priporočljivo prilagoditi.