FrancophonIA/ELRC3.0 huggingface dataset:
English: Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Danish: Dystoni:Symptomer på dystoni, forlængede anormale sammentrækninger af muskelgrupper, kan opstå hos tilbøjelige personer i løbet af de første par dage af behandlingen.
English: Nightmare Catatonia
Danish: Mareridt Katatoni
English: Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
Danish: Gastrisk lavage (efter intubation, hvis patienten er bevidstløs) og indgift af aktivt kul sammen med et laksativ bør overvejes.
English: • Parkinson's disease or dementia
Danish: • har Parkinsons sygdom eller demens.
English: Limited data have been collected in healthy subjects ≥ 65 years.
Danish: Der er indsamlet begrænsede data fra raske forsøgspersoner ≥ 65 år.
English: Following administration of lurasidone, the elimination half-life was 20-40 hours.
Danish: Efter administration var eliminationshalveringstiden for lurasidon 20-40 timer.
English: Dose adjustment due to interactions
Danish: Dosisjustering som følge af interaktioner
English: • amprenavir, efavirenz, etravirine (to treat HIV infection)
Danish: • amprenavir, efavirenz, etravirin (til behandling af HIV-infektion)
English: Latuda is indicated for the treatment of schizophrenia in adults aged 18 years and over.
Danish: Latuda er indiceret til behandling af skizofreni hos voksne på 18 år og derover.
English: Key Secondary Endpoint: CGI-BP-S Depression Score
Danish: Vigtigste sekundære endepunkt: CGI-BP-S Depression Score
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including lurasidone, should be considered.
Danish: Hvis der opstår tegn og symptomer på tardiv dyskinesi, skal det overvejes at seponere alle antipsykotika, herunder lurasidon.
English: If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying parkinsonism symptoms.
Danish: Hvis antipsykotiske lægemidler ordineres til patienter med Parkinson's sygdom, kan de underliggende parkinsonistiske-symptomer forværres.
English: Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks.
Danish: Lurasidon må ikke anvendes til patienter med ESRD, medmindre de potentielle fordele opvejer de potentielle risici.
English: A persistent effect of posaconazole on lurasidone exposure was observed up to 2-3 weeks after stop of posaconazole co-administration.
Danish: Der blev observeret en vedvarende virkning af posaconazol på lurasidoneksponering i op til 2-3 uger, efter at samtidig administration af posaconazol blev standset.
English: Orthostatic hypotension/syncope
Danish: Ortostatisk hypotension/synkope
English: • diabetes or are prone to diabetes
Danish: • har diabetes eller tilbøjelighed til diabetes.
English: Latuda tablets should be swallowed whole, in order to mask the bitter taste.
Danish: Latuda-tabletterne skal synkes hele for at dække over den bitre smag.
English: The maximum daily dose should not exceed 148 mg.
Danish: Den maksimale daglige dosis bør ikke overstige 148 mg.
English: Lurasidone does not impact concentrations of lithium.
Danish: Lurasidon påvirker ikke koncentrationerne af litium.
English: Studies in animals have shown a number of effects on fertility, mainly related to prolactin increase, which are not considered to be relevant to human reproduction (see section 5.3).
Danish: Dyreforsøg har vist tegn på påvirkning af fertiliteten, der især var forbundet med prolaktinstigningen, og som ikke anses for at være relevant for den menneskelige reproduktion (se pkt.
English: Hypertension Hypotension Orthostatic hypotension Hot flush Blood pressure increased
Danish: Hypertension Hypotension Ortostatisk hypotension Hedeture Forhøjet blodtryk
English: Concomitant administration of BCRP substrates may result in increases in the plasma concentrations of these substrates.
Danish: Samtidig administration af BCRP substrater kan resultere i øget plasmakoncentrationer af disse substrater.
English: Overall, lurasidone had a negligible effect on weight and other metabolic parameters including total cholesterol, triglycerides, and glucose levels.
Danish: Samlet set havde lurasidon ingen betydelig effekt på vægt og andre metaboliske parametre, herunder total kolesterol, triglycerider og glukoseniveauer.
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
Danish: • tidligere har haft blodpropper, eller nogen i din familie har haft blodpropper, da medicin mod skizofreni er blevet forbundet med dannelse af blodpropper.
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.
Danish: Som følge af lurasidons primære effekt på centralnervesystemet bør der udvises forsigtighed, når lurasidon anvendes i kombination med andre centralt virkende lægemidler og alkohol.
English: Dosing recommendations for elderly patients with normal renal function (CrCl ≥ 80 ml/min) are the same as for adults with normal renal function.
Danish: Den anbefalede dosis til ældre med normal nyrefunktion (CrCl ≥ 80 ml/ min.) er den samme som for voksne med normal nyrefunktion.
English: Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.
Danish: Monitorering af ortostatiske, vitale tegn bør overvejes hos patienter med tilbøjelighed til hypotension.
English: It is used to treat symptoms of schizophrenia in adults aged 18 years or over.
Danish: Det anvendes til behandling af symptomer på skizofreni hos voksne på 18 år eller derover.
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
Danish: • ufrivillige bevægelser af mund, tunge og lemmer (tardiv dyskinesi)
English: Dose adjustment is recommended in moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) patients.
Danish: Dosisjustering anbefales til patienter med moderat (Child-Pugh, klasse B) og patienter med alvorligt nedsat leverfunktion (Child-Pugh, klasse C).
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.
Danish: Hos patienter med moderat (kreatinin-clearance (CrCl) på ≥ 30 og < 50 ml/min), alvorligt nedsat nyrefunktion (CrCL >15 og < 30 ml/min) og patienter med End Stage Renal Disease (ESRD) (CrCl < 15 ml/min) er den anbefalede startdosis 18,5 mg, og den maksimale dosis må ikke overstige 74 mg givet én gang dagligt.
English: Following administration of 37 mg of lurasidone, the mean approximate apparent volume of distribution was 6000 L. Lurasidone is highly bound (~99%) to serum proteins.
Danish: Efter administration af 37 mg lurasidon var den gennemsnitlige tilnærmelsesvise synlige volumenfordeling 6000 L. Lurasidon bindes i høj grad (~99 %) til serumproteiner.
English: Angina**** AV block first degree**** Bradycardia****
Danish: Angina**** 1. grads atrioventrikulær blok**** Bradykardi****
English: Patients were randomized to flexibly dosed lurasidone 18-74 mg once daily or placebo.
Danish: Patienter blev randomiseret til fleksibelt doseret lurasidon 18-74 mg en gang dagligt eller placebo.
English: Baseline Mean (SD)
Danish: Baseline, middel (SD)
English: No initial dose titration is required.
Danish: Initial dosistitrering er ikke nødvendig.
English: If taken without food, it is anticipated that lurasidone exposure will be significantly lower as compared to when taken with food (see section 5.2).
Danish: Hvis de indtages uden et måltid, forventes det, at lurasidon-eksponeringen vil være betydeligt lavere sammenlignet med, når de indtages sammen med et måltid (se pkt.
English: The pharmacokinetics of lurasidone in paediatric patients was investigated in 49 children aged 6-12 years and 56 adolescents aged 13-17 years.
Danish: Farmakokinetikken for lurasidon hos pædiatriske patienter blev undersøgt hos 49 børn i alderen 6-12 år og hos 56 unge i alderen 13-17 år.
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.
Danish: Risikoen for omtåget adfærd, krampeanfald eller en dystonisk reaktion i hoved og nakke efter en overdosis kan medføre en risiko for aspiration ved fremkaldt emese.
English: It is effective in a dose range of 37 to 148 mg once daily.
Danish: Det er virkningsfuldt i en dosis på 37 til 148 mg taget én gang dagligt.
English: Urine comprised mostly of a number of metabolites with minimal renal excretion of parent compound.
Danish: Urin bestod fortrinsvis af et antal metabolitter med minimal udskillelse af modersubstansen via nyrerne.
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.
Danish: Efter at være blevet behandlet for en akut episode og stabiliseret i mindst 12 uger med lurasidon, blev patienterne randomiseret i et dobbelt-blindet studie til enten at fortsætte med lurasidon eller med placebo, indtil de oplevede tilbagefald af skizofrenisymptomer.
English: The use of an immediate release formulation of diltiazem could result in a larger increase in lurasidone exposure.
Danish: Anvendelse af diltiazem-formuleringer, der frigives hurtigt, kan medføre en større øgning i lurasidon-eksponeringen.
English: Lurasidone demonstrated superior efficacy compared with placebo across Phase 3 studies (see Table 2).
Danish: Lurasidon udviste bedre effekt sammenlignet med placebo på tværs af fase 3-undersøgelser (se tabel 2).
English: Lurasidone may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism.
Danish: Lurasidon kan medføre ortostatisk hypotension, som muligvis forårsages af dens α1-adrenerge receptorantagonisme.
English: • an increase in your weight
Danish: • oplever en øgning af din kropsvægt
English: The safety of lurasidone has been evaluated at doses of 18.5 -148 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks and in the post-marketing setting.
Danish: Sikkerheden af lurasidon er blevet evalueret ved doser på 18,5-148 mg i kliniske studier med patienter med skizofreni, som blev be handlet i op til 52 uger og efter markedsføring.
English: The following medicines may decrease the level of lurasidone in your blood:
Danish: Følgende lægemidler kan sænke niveauet af lurasidon i dit blod:
English: In elderly people with dementia, a small increase in the number of deaths has been reported for patients Reporting of side effects taking medicines for schizophrenia compared with those not receiving these medicines.
Danish: Der er blevet rapporteret om en lille forøgelse i antallet af dødsfald blandt ældre mennesker med demens, som tager lægemidler mod skizofreni, sammenlignet med mennesker, der ikke tager disse lægemidler.
English: Cardiovascular disorders/QT prolongation
Danish: Kardiovaskulære lidelser/QT-forlængelse
English: Lurasidone was not genotoxic in a battery of tests.
Danish: Lurasidon var ikke genotoksisk i en række af tests.
English: The incidence of ADRs reported in clinical trials is tabulated by frequency category.
Danish: Forekomsten af bivirkninger rapporteret i kliniske forsøg er opstillet i tabellen efter frekvenskategori.
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.
Danish: I kortvarige forsøg blev det primære effektendepunkt defineret som den gennemsnitlige ændring fra baseline til uge 6 af den samlede PANSS-score (Positive and Negative Syndrome Scale), en valideret samling af flere elementer, som består af fem faktorer til at evaluere positive symptomer, negative symptomer, uorganiserede tanker, ukontrolleret fjendtlighed/ophidselse og angst/depression.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: The major biotransformation pathways are oxidative N-dealkylation, hydroxylation of norbornane ring, and S-oxidation.
Danish: Hovedbiotransformationsvejene er oxidativ N-dealkylering, hydroxylering af norbonan-kæden og S-oxidering.
English: Carnauba wax (E 903)
Danish: Carnaubavoks (E 903)
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).
Danish: Den primære analyse af tiden for tilbagefald, hvor patienter, der stoppede uden tilbagefald, blev frasorteret, viste, at patienter behandlet med lurasidon var signifikant længere tid om at få tilbagefald sammenlignet med patienter på placebo (p=0,039).
English: • armodafinil, modafinil (to treat sleepiness)
Danish: • armodafinil, modafinil (til behandling af søvnighed)
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
Danish: Lurasidon blev administreret som lurasidonhydrochlorid i daglige doser på enten 20, 40, 80, 120 mg (6-17 år) eller 160 mg (10-17 år udelukkende) i 7 dage.
English: • speech problems, unusual muscle movements; a collection of symptoms known as extrapyramidal symptoms (EPS) which typically will involve unusual purposeless involuntary muscle movements.
Danish: • Taleproblemer, usædvanlige muskelbevægelser, en samling af symptomer kendt som ekstrapyramidale symptomer (EPS), der typisk vil indebære usædvanlige, formålsløse,
English: The following medicines may increase the level of lurasidone in your blood:
Danish: Følgende lægemidler kan øge niveauet af lurasidon i dit blod:
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.
Danish: Du skal tage denne medicin sammen med et måltid eller lige efter at have spist, da dette hjælper kroppen til at optage medicinen og tilllader den at virke bedre.
English: However, an increase in exposure in elderly subjects may be expected for patients if they have impaired renal or hepatic function.
Danish: Imidlertid kan der forventes en øget eksponering i ældre forsøgspersoner, hvis de har nedsat nyre- eller leverfunktion.
English: The key secondary endpoint was Clinical Global Impression - Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score.
Danish: Det vigtigste sekundære endepunkt var Clinical Global Impression - Bipolar Version, Severity of Illness (CGI-BPS) Depression Score.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Danish: Der er blevet rapporteret om tilfælde af venøs tromboemboli (VTE) i forbindelse med antipsykotiske lægemidler.
English: Therefore, lurasidone can be coadministered with oral contraceptives.
Danish: Derfor kan lurasidon administreres samtidig med orale præventionsmidler.
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)
Danish: • lider af en hjertesygdom eller er i behandling for en hjertesygdom, som giver dig tendens til lavt blodtryk, eller der har været fortilfælde af uregelmæssig hjerterytme i din familie (herunder QT-forlængelse).
English: Lurasidone is not subject to active uptake transport by OATP1B1 or OATP1B3.
Danish: Lurasidon er ikke underlagt aktiv optagelsestransport fra OATP1B1 og OATP1B3.
English: These findings are common in rodents treated with antipsychotic medicinal products with dopamine D2 blocking activity and are considered to be rodent-specific.
Danish: Disse fund er almindelige hos gnavere, som er blevet behandlet med antipsykotiske midler med dopamin D2-blokerende aktivitet og anses for specifikt at gælde for gnavere.
English: Adverse drug reactions (ADRs) based upon pooled data are shown by system, organ class and by preferred term are listed below.
Danish: Bivirkninger, der er baseret på poolede data, er opstillet i listen nedenfor efter system, organklasse og efter foretrukken term.
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.
Danish: Det primære effektendepunkt blev defineret som den gennemsnitlige ændring i uge 6 sammenlignet med baseline i Children's Depression Rating Scale, Revised (CDRS-R) Total Score.
English: Potential for lurasidone to affect other medicinal products
Danish: Potentiel risiko for, at lurasidon kan påvirke andre lægemidler
English: • increase in eosinophils (a type of white blood cell).
Danish: • Forhøjet niveau af eosinofiler (en type hvide blodlegemer).
English: Serum creatinine increased
Danish: Forhøjet serum-kreatinin
English: The probability of all-cause discontinuation at Week 28 were 58.2% for lurasidone and 69.9% for placebo (p=0.072).
Danish: Sandsynligheden for ophør, alle årsager, ved uge 28 var 58,2 % for lurasidon og 69,9 % for placebo (p=0,072).
English: • abnormal breast enlargement, breast pain, milk secretion from breasts
Danish: • unormal brystforstørrelse, smerter i brystet, sekretion af mælk fra brysterne
English: The pharmacokinetics of lurasidone in paediatric patients aged 6-17 years was generally comparable to those observed in adults.
Danish: Farmakokinetikken for lurasidon hos pædiatriske patienter i aldersgruppen 6-17 år var generelt sammenlignelig med observationer hos voksne.
English: Physicians should therefore weigh the risks versus the benefits when prescribing Lurasidone to patients with Parkinson's disease.
Danish: Lægerne skal derfor opveje risici i forhold til fordelene, når de ordinerer lurasidon til patienter med Parkinson's sygdom.
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.
Danish: Venøs tromboemboli:Tilfælde af venøs tromboemboli, herunder tilfælde af pulmonær emboli og tilfælde af dyb venetrombose, er blevet rapporteret i forbindelse med antipsykotiske lægemidlerhyppighed ukendt.
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.
Danish: I et studie af effekten af mad var den gennemsnitlige Cmax og AUC forøget med hhv. 2-3 gange og 1,5-2 gange, når det blev administreret sammen med mad sammenlignet med de niveauer, som blev observeret under faste.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Danish: Relevant klinisk monitorering tilrådes under behandlingen af patienter med diabetes mellitus og patienter med risikofaktorer for udvikling af diabetes mellitus.
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.
Danish: Lægemidler med dopaminreceptor-antagonistiske egenskaber er blevet forbundet med fremkaldelse af tardiv dyskinesi, der er karakteriseret ved ufrivillige rytmiske bevægelser, overvejende i tungen og/eller ansigtet.
English: Lurasidone is metabolised into two active metabolites (ID-14283 and ID-14326) and two non-active metabolites (ID-20219 and ID-20220).
Danish: Lurasidon metaboliseres til to aktive metabolitter (ID-14283 og ID-14326) og to ikke-aktive metabolitter (ID-20219 og ID-20220).
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.
Danish: • Blodpropper i årerne, især i benene (symptomer omfatter hævelse, smerte, rødmen i benet), som kan bevæge sig gennem blodkarrene til lungerne, hvor den medfører brystsmerter og åndedrætsbesvær.
English: The maximum dose should not exceed 148 mg once a day.
Danish: Den maksimale dosis bør ikke overstige 148 mg en gang om dagen.
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.
Danish: Hvis du har nogle af disse tilstande, bør du tale med lægen, som muligvis vil justere din dosis, kontrollere dig hyppigere i en periode eller stoppe behandlingen med Latuda.
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.
Danish: Startende i uge 2 viste lurasidon statistisk signifikante forskelle sammenlignet med placebo for disse endepunkter for hele studiepopulationen, og disse blev opretholdt ved hvert forsøgsbesøg til studiet sluttede.
English: It was noted that Asian subjects had 1.5-fold increased exposure to lurasidone compared to Caucasian subjects.
Danish: Det blev bemærket, at asiatiske forsøgspersoner havde en 1,5-foldig forøgelse af eksponeringen for lurasidon sammenlignet med kaukasiske forsøgspersoner.
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.
Danish: I placebokontrollerede kliniske forsøg med voksne patienter med skizofreni var der en øget forekomst af EPS efter behandling med lurasidon sammenlignet med placebo.
English: Table 1
Danish: Tabel 1:
English: • lack of energy (lethargy)
Danish: • mangel på eneri (letargi)
English: Lurasidone works by blocking receptors in the brain to which the substances dopamine and serotonin attach.
Danish: Lurasidon virker ved at blokere receptorer i hjernen, som stofferne dopamin og serotonin binder sig til.
English: Lurasidone reaches peak serum concentrations in approximately 1-3 hours.
Danish: Lurasidon når højeste koncentration i serum efter ca. 1-3 timer.
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.
Danish: Skizofreni er en lidelse, hvis symptomer bl.a. er, at man hører, ser eller mærker ting, som ikke er der, opfatter ting forkert, er usædvanligt mistroisk, bliver indadvendt, taler usammenhængende og får en afstumpet opførsel og følelsesmæssig opfattelse.
English: Limited data are available in elderly people treated with higher doses of lurasidone.
Danish: Der er begrænset data tilgængelig for behandling af ældre mennesker med højere doser af lurasidon.
English: Overall mortality
Danish: Samlet dødelighed
English: ****ADRs noted in Phase 2 and 3 controlled and uncontrolled studies; however, the incidence of occurrence for these are too low to estimate frequencies.
Danish: ****Bivirkninger blev observeret i fase 2 og 3 af kontrollerede og ukontrollerede studier.