FrancophonIA/ELRC3.0 huggingface dataset:
English: Major findings in repeat-dose toxicity studies of lurasidone were centrally-mediated endocrine changes resulting from serum prolactin elevations in rats, dogs and monkeys.
Slovenian: Glavne ugotovitve v študijah toksičnosti ponavljajočih se odmerkov lurasidona pri podganah, psih in opicah so bile centralno povzročene endokrine spremembe zaradi zvišanja vrednosti prolaktina v serumu.
English: In a dose range finding study in pregnant rats, 150 mg/kg/day lurasidone hydrochloride caused fetal growth retardation without signs of teratogenicity.
Slovenian: V študiji za določitev razpona odmerkov pri brejih podganah so pri odmerku lurasidonijevega klorida 150 mg/kg/dan ugotovili zastoj rasti plodov brez znakov teratogenih učinkov.
English: Lurasidone was not teratogenic in rats or rabbits at an exposure similar to or below the maximum recommended human dose (148 mg lurasidone ).
Slovenian: Lurasidon pri podganah in kuncih pri izpostavljenosti, ki je bila podobna ali nižja od izpostavljenosti človeka pri največjem priporočenem odmerku (148 mg lurasidona), ni deloval teratogeno.
English: A clinical drug interaction study investigating the effect of coadministration of lurasidone on patients taking oral combination contraceptives including norgestimate and ethinyl estradiol, indicated that lurasidone had no clinically or statistically meaningful effects on the pharmacokinetics of the contraceptive or sex hormone binding globulin (SHBG) levels.
Slovenian: Pri bolnicah, ki so jemale peroralne kombinirane kontraceptive z norgestimatom in etinilestradiolom, lurasidon v klinični študiji interakcij med zdravili ni imel klinično ali statistično pomembnih učinkov na farmakokinetiko kontraceptivov ali na nivo spolne hormone vezočega globulina.
English: Grapefruit juice should be avoided during treatment with lurasidone.
Slovenian: Med zdravljenjem z lurasidonom se je treba izogibati uživanju soka grenivke.
English: Co-administration of lurasidone and posaconazole (strong CYP3A4 inhibitor) resulted in an approximate 4-5 fold increase in lurasidone exposure.
Slovenian: Sočasna uporaba lurasidona in posakonazola (močan zaviralec CYP3A4) je povzročila približno 4 do 5 kratno povečanje izpostavljenosti lurasidonu.
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.
Slovenian: Na osnovi in vitro podatkov ne pričakujemo, da bi lurasidon imel klinično pomemben zaviralni potencial za prenašalce OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, MATE2K ali BSEP.
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.
Slovenian: Litij pri sočasni uporabi z lurasidonom ni imel klinično pomembnih učinkov na farmakokinetiko lurasidona, zato pri sočasni uporabi z litijem odmerka lurasidona ni treba prilagoditi.
English: Long-term maintenance efficacy of lurasidone (37 to 148 mg lurasidone once daily ) was demonstrated in a 12 month non-inferiority trial with quetiapine extended release (200 to 800 mg once daily).
Slovenian: Dolgoročna učinkovitost lurasidona (37 do 148 mg lurasidona enkrat na dan) pri vzdrževalnem zdravljenju je bila dokazana v 12-mesečnem preskušanju ne-inferiornosti v primerjavi s kvetiapinom s podaljšanim sproščanjem (200 do 800 mg enkrat na dan).
English: Latuda tablets should be taken at the same time every day to aid compliance.
Slovenian: Bolnik mora Latuda tablete jemati vsak dan ob istem času, da se tako zmanjša možnost, da bi jih pozabil vzeti.
English: • shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Slovenian: • tresenje, okorelost in/ali oslabelost mišic, zaspanost, tesnoba s posledičnim motoričnim nemirom, težave z dihanjem in motnje hranjenja.
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).
Slovenian: Pri predpisovanju lurasidona skupaj z zdravili, ki podaljšajo interval Q-T, npr. antiaritmiki razreda IA (npr. kinidin, dizopiramid) in antiaritmiki razreda III (npr. amiodaron, sotalol), nekaterimi antihistaminiki, nekaterimi drugimi antipsihotiki in nekaterimi zdravili proti malariji (npr. meflokin), je potrebna previdnost.
English: • enlarged breasts in male (gynecomastia), milky nipple discharge (galactorrhea), absence of menstruation (amenorrhea) or erectile dysfunction
Slovenian: • če imate povečane prsi in ste moškega spola (ginekomastija), mlečni izcedek iz dojk (galaktoreja), izostanek menstruacije (amenoreja) ali erektilno disfunkcijo
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.
Slovenian: Priporočeni začetni odmerek v kombinaciji z zmernimi zaviralci CYP3A4 je 18,5 mg, največji odmerek lurasidona pa v takšni kombinaciji ne sme preseči 74 mg enkrat na dan. Odmerek lurasidona bo morda treba prilagoditi tudi v kombinaciji z blagimi ali zmernimi induktorji CYP3A4 (glejte poglavje 4.5).
English: • Parkinsonism: This is a medical term that describes many symptoms which include increase in saliva secretion or watery mouth, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression in the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex)
Slovenian: To je medicinski izraz, ki opisuje številne simptome, ki vključujejo čezmerno nastajanje sline ali vlažna usta, slinjenje, trzaje pri upogibanju okončin, počasne, omejene ali motene telesne gibe, brezizraznost obraza, zategnjenost mišic, okorelost vratu, okorelost mišic,
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: • erythromycin (to treat infections)
Slovenian: • eritromicin (za zdravljenje okužb)
English: Tel: +44 (0) 207 821 2899
Slovenian: Sunovion Pharmaceuticals Europe Ltd. Tel: +44 (0) 207 821 2899
English: Alanine aminotransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje ravni alanin-aminotransferaze
English: High serum prolactin levels in long-term repeat-dose studies in female rats were associated with effects on bones, adrenal glands, and reproductive tissues.
Slovenian: V dolgoročnih študijah ponavljajočih se odmerkov so bile visoke vrednosti prolaktina v serumu pri samicah podgan povezane z učinki na kosti, nadledvične žleze in reproduktivno tkivo.
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.
Slovenian: Na podlagi tega podatka ne pričakujemo, da bi lurasidon vplival na farmakokinetiko zdravil, ki so substrati za encime CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP2E1.
English: Close supervision of high-risk patients should accompany antipsychotic therapy.
Slovenian: Med antipsihotičnim zdravljenjem je treba bolnike z visokim tveganjem skrbno nadzirati.
English: How to take Latuda
Slovenian: Kako jemati zdravilo Latuda
English: Limited data have been collected in healthy subjects ≥ 65 years.
Slovenian: Pri zdravih osebah, starih 65 let in starejših, so bili pridobljeni omejeni podatki, ki kažejo, da je izpostavljenost enaka kot pri osebah, mlajših od 65 let.
English: Angina**** AV block first degree**** Bradycardia****
Slovenian: Srčne bolezni tahikardija angina pektoris**** atrioventrikularni blok I. stopnje**** bradikardija****
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Slovenian: Pri bolnikih s sladkorno boleznijo in pri bolnikih z dejavniki tveganja za razvoj sladkorne bolezni je priporočljiv ustrezen klinični nadzor.
English: The key secondary endpoint was Clinical Global Impression - Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score.
Slovenian: Glavni sekundarni cilj raziskave je bil določiti vrednost depresije na lestvici kliničnega vtisa glede na stopnjo bipolarne motnje in resnost bolezni (CGI-BP-S).
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
Slovenian: • katero koli zdravilo, ki prav tako deluje v možganih.
English: Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.
Slovenian: Pri bolnikih, ki so dovzetni za hipotenzijo, je treba razmisliti o spremljanju ortostatskih vitalnih znakov.
English: • if you have kidney or liver problems.
Slovenian: • morebitnih težav z ledvicami ali jetri.
English: • blood pressure dropping upon standing up which may cause fainting
Slovenian: • nenadno znižanje krvnega tlaka pri vstajanju iz sedečega ali ležečega položaja, kar lahko povzroči omedlevico
English: • aprepitant (to treat nausea and vomiting)
Slovenian: • aprepitant (za preprečevanje siljenja na bruhanje in bruhanja)
English: Caution should be exercised when lurasidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, hypokalaemia, and in concomitant use with other medicinal products thought to prolong the QT interval.
Slovenian: Pri predpisovanju lurasidona bolnikom z znano srčnožilno boleznijo, družinsko anamnezo podaljšanega intervala Q-T ali s hipokaliemijo je potrebna previdnost.
English: It was noted that Asian subjects had 1.5-fold increased exposure to lurasidone compared to Caucasian subjects.
Slovenian: Pri osebah azijskega porekla je bila izpostavljenost lurasidonu 1,5-krat večja kot pri belcih.
English: Lurasidone is a substrate of P-gp and BCRP in vitro and the in vivo relevance of this is unclear.
Slovenian: Lurasidon je in vitro substrat za P-gp in BCRP, pomen tega in vivo pa ni znan.
English: Limited data are available in elderly people treated with higher doses of lurasidone.
Slovenian: Podatki o zdravljenju starostnikov z večjimi odmerki lurasidona so omejeni.
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).
Slovenian: Pri sočasni uporabi lurasidona in diltiazema (oblika s počasnim sproščanjem), zmernega zaviralca CYP3A4, se je izpostavljenost lurasidonu povečala za 2,2-krat, izpostavljenost njegovemu aktivnemu presnovku ID-14283 pa za 2,4-krat (glejte poglavje 4.2).
English: Key Secondary Endpoint: CGI-BP-S Depression Score
Slovenian: Glavni sekundarni cilj: Vrednost depresije po
English: P-values for olanzapine and quetiapine XR vs. placebo were unadjusted.
Slovenian: P-vrednosti za olanzapin in kvetiapin XR v primerjavi s placebom niso bile prilagojene.
English: Based on in vitro studies lurasidone is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes.
Slovenian: Na podlagi študij in vitro lurasidon ni substrat za encime CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP2E1.
English: Latuda 18.5 mg tablets lurasidone
Slovenian: Latuda 18,5 mg tablete lurasidon
English: Lurasidone is an in vitro inhibitor of the efflux transporter BCRP and the clinical relevance of intestinal BCRP inhibition cannot be excluded.
Slovenian: Lurasidon je in vitro zaviralec efluksnega prenašalca BCRP zato kliničnega pomena zaviranja BCRP v črevesu ni mogoče izključiti.
English: If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of QT-prolonging effects when administered in patients with an acute overdose of lurasidone.
Slovenian: Če je potrebno zdravljenje z antiaritmiki, dizopiramid, prokainamid in kinidin pri bolnikih z akutnim prevelikim odmerjanjem lurasidona predstavljajo teoretično tveganje za podaljšanje intervala Q-T.
English: • swelling beneath the skin surface (angioedema)
Slovenian: • otekanje podkožnega tkiva (angioedem)
English: • nausea (feeling sick), vomiting (being sick)
Slovenian: • navzea (siljenje na bruhanje), bruhanje
English: Nightmare Catatonia
Slovenian: • nočne more
English: • a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath,
Slovenian: • huda alergijska reakcija z znaki, kot so zvišana telesna temperatura, otekanje ust, obraza, ustnic ali jezika, težko dihanje, srbenje, kožni izpuščaj in včasih tudi znižanje krvnega tlaka.
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.
Slovenian: Med zdravljenjem z zdravilom Latuda bo zdravnik morda moral spremeniti odmerek tega zdravila.
English: Lurasidone is contraindicated with strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum)) (see section 4.3).
Slovenian: Uporaba lurasidona je kontraindicirana skupaj z močnimi induktorji CYP3A4 (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, šentjanževka (Hypericum perforatum)) (glejte poglavje 4.3).
English: What you need to know before you take Latuda Do NOT take Latuda if you:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Latuda
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.
Slovenian: Pri sočasni uporabi lurasidona in ketokonazola, močnega zaviralca CYP3A4, se je izpostavljenost lurasidonu povečala za 9-krat, izpostavljenost njegovemu aktivnemu presnovku ID-14283 pa za 6-krat.
English: Lurasidone is contraindicated with strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (see section 4.3).
Slovenian: Uporaba lurasidona je kontraindicirana skupaj z močnimi zaviralci CYP3A4 (npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol) (glejte poglavje 4.3).
English: Via Vecchia del Pinocchio, 22 60100
Slovenian: Aziende Chimiche Riunite Angelini Francesco ACRAF SPA Via Vecchia del Pinocchio, 22 60100
English: Coadministration of lurasidone with midazolam, a sensitive CYP3A4 substrate, resulted in a < 1.5-fold increase in midazolam exposure.
Slovenian: Pri sočasni uporabi lurasidona in midazolama, občutljivega substrata za CYP3A4, se je izpostavljenost midazolamu povečala za manj kot 1,5-krat.
English: - Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) and strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum) (see section 4.5).
Slovenian: - Sočasna uporaba močnih zaviralcev CYP3A4 (npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol) in močnih induktorjev CYP3A4 (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, šentjanževka (Hypericum perforatum) (glejte poglavje 4.5).
English: In the short-term trials, the primary efficacy endpoint was defined as the mean change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total scores, a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Slovenian: Lestvica PANSS je validirani vprašalnik z več postavkami v petih sklopih, ki vrednotijo pozitivne simptome, negativne simptome, neorganizirane misli, nenadzorovano sovražnost/razburjenje in tesnobo/depresijo.
English: Vomiting Dyspepsia Salivary hypersecretion Dry mouth Upper abdominal pain Stomach discomfort
Slovenian: Bolezni prebavil navzea bruhanje dispepsija hipersalivacija suha usta bolečina v zgornjem predelu trebuha neugodje v želodcu flatulenca driska**** disfagija**** gastritis****
English: Tel: + 421 2 59 207 320
Slovenian: Tel: + 421 2 59 207 320 office@angelini.sk
English: • how well you respond to a dose
Slovenian: • vašega odziva na odmerek.
English: Package leaflet: Information for the patient Latuda 18.5 mg film-coated tablets Latuda 37 mg film-coated tablets Latuda 74 mg film-coated tablets lurasidone
Slovenian: Latuda 18,5 mg filmsko obložene tablete Latuda 37 mg filmsko obložene tablete Latuda 74 mg filmsko obložene tablete lurasidon
English: Tabulated summary of adverse reactions
Slovenian: Tabelarični seznam neželenih učinkov
English: Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg lurasidone.
Slovenian: Ena 18,5 mg tableta vsebuje lurasidonijev klorid v količini, ki ustreza 18,6 mg lurasidona.
English: • newborn babies may show the following: agitation, increase or decreases in muscle tone, tremor,
Slovenian: • pri novorojenčkih se lahko pojavi naslednje: agitacija (nemir), povečana ali zmanjšana mišična napetost, tresenje, zaspanost, težave z dihanjem ali motnje hranjenja
English: Eosinophilia Leukopenia**** Neutropenia****
Slovenian: Bolezni krvi in limfatičnega sistema eozinofilija levkopenija**** nevtropenija**** anemija****
English: The most common adverse drug reactions (ADRs) (≥ 10%) were akathisia and somnolence, which were dose-related up to
Slovenian: Najpogostejša neželena učinka (≥ 10 %) sta bila akatizija in somnolenca, ki sta bila povezana z odmerki do 111 mg na dan.
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.
Slovenian: Pri sočasni uporabi lurasidona in substratov za CYP3A4 z ozkim terapevtskim indeksom (npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ali ergot alkaloidi [ergotamin, dihidroergotamin]) priporočamo nadziranje.
English: These findings are common in rodents treated with antipsychotic medicinal products with dopamine D2 blocking activity and are considered to be rodent-specific.
Slovenian: Po dajanju antipsihotikov z zaviralnim delovanjem na dopaminske D2 receptorje so te ugotovitve pri glodavcih pogoste in veljajo kot specifične za glodavce.
English: Lurasidone is an in vitro inhibitor of the efflux transporter P-gp and the clinical relevance of intestinal P-gp inhibition cannot be excluded.
Slovenian: Ker je lurasidon in vitro zaviralec efluksnega prenašalca P-gp, kliničnega pomena zaviranja P-gp v črevesu ni mogoče izključiti.
English: Decreased appetite Blood glucose increased Hyponatraemia
Slovenian: Presnovne in prehranske motnje povečanje telesne mase zmanjšanje apetita zvišanje ravni glukoze v krvi hiponatriemija
English: EU/1/14/913/016 28 x 1 film-coated tablets EU/1/14/913/017 30 x 1 film-coated tablets EU/1/14/913/018 56 x 1 film-coated tablets EU/1/14/913/019 60 x 1 film-coated tablets EU/1/14/913/020 90 x 1 film-coated tablets EU/1/14/913/021 98 x 1 film-coated tablets
Slovenian: EU/1/14/913/015 14 x 1 filmsko obložena tableta EU/1/14/913/016 28 x 1 filmsko obložena tableta EU/1/14/913/017 30 x 1 filmsko obložena tableta EU/1/14/913/018 56 x 1 filmsko obložena tableta EU/1/14/913/019 60 x 1 filmsko obložena tableta EU/1/14/913/020 90 x 1 filmsko obložena tableta EU/1/14/913/021 98 x 1 filmsko obložena tableta
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.
Slovenian: V randomiziranih, s placebom nadzorovanih kliničnih preskušanjih so pri populaciji bolnikov z demenco, ki so se zdravili z nekaterimi atipičnimi antipsihotiki, vključno z risperidonom, aripiprazolom in olanzapinom, ugotovili približno 3-krat večje tveganje za cerebrovaskularne neželene učinke.
English: Elderly patients with dementia
Slovenian: Starostniki z demenco
English: • Latuda 37 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LB”
Slovenian: • Latuda 37 mg filmsko obložene tablete so bele ali skoraj bele, okrogle (premer 8 mm), filmsko obložene tablete z oznako “LB”.
English: EU/1/14/913/002 28 x 1 film-coated tablets EU/1/14/913/003 30 x 1 film-coated tablets EU/1/14/913/004 56 x 1 film-coated tablets EU/1/14/913/005 60 x 1 film-coated tablets EU/1/14/913/006 90 x 1 film-coated tablets EU/1/14/913/007 98 x 1 film-coated tablets
Slovenian: EU/1/14/913/001 14 x 1 filmsko obložena tableta EU/1/14/913/002 28 x 1 filmsko obložena tableta EU/1/14/913/003 30 x 1 filmsko obložena tableta EU/1/14/913/004 56 x 1 filmsko obložena tableta EU/1/14/913/005 60 x 1 filmsko obložena tableta EU/1/14/913/006 90 x 1 filmsko obložena tableta EU/1/14/913/007 98 x 1 filmsko obložena tableta
English: Alcohol should be avoided when taking this medicine.
Slovenian: Zdravilo Latuda skupaj s hrano, pijačo in z alkoholom Med jemanjem tega zdravila se morate izogibati uživanju alkohola.
English: • Latuda 18.5 mg film-coated tablets are white to off-white, film-coated round tablets debossed with “LA”
Slovenian: • Latuda 18,5 mg filmsko obložene tablete so bele ali skoraj bele, okrogle (premer 6 mm),
English: • Latuda 74 mg film-coated tablets are pale green, film-coated oval tablets debossed with “LD”.
Slovenian: • Latuda 74 mg filmsko obložene tablete so svetlozelene, ovalne (12 mm x 7 mm), filmsko obložene tablete z oznako “LD”.
English: 1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300
Slovenian: Angelini Farmacêutica, Lda Rua João Chagas, 53, Piso 3 1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300 apoio.utente@angelini.pt
English: A single dose of 10 mg/kg lurasidone hydrochloride to pregnant rats resulted in fetal exposure.
Slovenian: Po enkratnem odmerku lurasidonijevega klorida 10 mg/kg so pri brejih podganah ugotovili izpostavljenost plodov.
English: Tel: + 36 1 336 1614
Slovenian: Tel: + 36 1 336 1614 office@angelini.hu
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur lurasidone.
Slovenian: Pri zdravljenju z lurasidonom so poročali o malignem nevroleptičnem sindromu, značilnem po hipertermiji, mišični okorelosti, avtonomni nestabilnosti, spremenjenem stanju zavesti in zvišani vrednosti kreatin-kinaze v serumu.
English: Tel: + 420 546 123 111
Slovenian: Tel: + 420 546 123 111 info@angelini.cz
English: magnesium stearate (E470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172)
Slovenian: Obloga tablete hipromeloza 2910 (E464) titanov dioksid (E171) makrogol 8000 karnauba vosek (E903)
English: Latuda film-coated tablets are for oral use, to be taken once daily together with a meal.
Slovenian: Latuda filmsko obložene tablete so namenjene za peroralno uporabo.
English: Suicidal behaviour**** Panic attack**** Sleep disorder****
Slovenian: Psihiatrične motnje nespečnost agitacija tesnoba nemir nočne more katatonija samomorilno vedenje**** napadi panike**** motnje spanja****