FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking this medicine you will lose the effects of the medicine.
Danish: Hvis du holder op med at tage dette lægemiddel, forsvinder virkningerne af lægemidlet.
English: Other side effects (it is not known how many people are affected):
Danish: Andre bivirkninger (det vides ikke, hvor mange patienter der oplever dette)
English: Caution should be exercised when prescribing with other medicinal products.
Danish: Der skal udvises forsigtighed ved ordination med andre lægemidler.
English: • pain in arms or legs or both,
Danish: • smerter i arme og/eller ben
English: Gastric lavage and treatment with an emetic may be useful immediately after overdose.
Danish: Maveskylning og behandling med et emetikum kan være nyttigt umiddelbart efter en overdosis.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code N05AX16
Danish: Farmakoterapeutisk klassifikation: Psycholeptica, andre antipsychotica, ATC-kode N05AX16
English: If your baby has any of these symptoms you should contact your doctor.
Danish: Hvis dit barn får nogen af disse symptomer, skal du kontakte lægen.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: It is unknown whether brexpiprazole/metabolites are excreted in human milk.
Danish: Det er ukendt, om brexpiprazol/metabolitter udskilles i human mælk.
English: RXULTI may increase the effect of medicines used to lower the blood pressure.
Danish: RXULTI kan forstærke virkningen af medicin, der sænker blodtrykket.
English: It is important that you get your blood checked regularly as this may be fatal.
Danish: Det er vigtigt, at du regelmæssigt får tjekket dit blod, da disse sygdomme kan være dødelige.
English: Consequently, new-borns should be monitored carefully.
Danish: Derfor bør nyfødte overvåges omhyggeligt.
English: RXULTI is indicated for the treatment of schizophrenia in adult patients.
Danish: RXULTI er indiceret til behandling af skizofreni hos voksne patienter.
English: • diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family has diabetes).
Danish: • har diabetes eller risikofaktorer for diabetes (f.eks. overvægt eller hvis nogen i din familie har diabetes).
English: Thereafter, if according to clinical response, further dose adjustments are required, the dose may be increased up to a maximum of three times the recommended daily dose.
Danish: Hvis det derefter som følge af det kliniske respons er nødvendigt at justere dosis yderligere, kan dosen øges op til højst 3 gange den anbefalede daglige dosis.
English: Administer half of the recommended dose
Danish: Administrér halvdelen af den anbefalede dosis
English: A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotics.
Danish: Et syndrom af potentielt irreversible, ufrivillige dyskinetiske bevægelser kan udvikles hos patienter behandlet med antipsykotika.
English: Brexpiprazole is an atypical antipsychotic agent.
Danish: Brexpiprazol er et atypisk antipsykotisk lægemiddel.
English: • from day 8 onwards take one film-coated tablet of the strength prescribed by your doctor each day.
Danish: • fra dag 8 og derefter skal du tage én filmovertrukket tablet pr. dag af den styrke, som lægen har ordineret.
English: RXULTI contains the active substance brexpiprazole, which belongs to a group of medicines called antipsychotics.
Danish: RXULTI indeholder det aktive stof brexpiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: Brexpiprazole steady-state concentrations are attained within 10 days to 12 days of dosing.
Danish: Brexpiprazols steady state-koncentration opnås inden for 10 dage til 12 dage efter administration.
English: Even if you feel better, do not alter or stop your daily dose of RXULTI unless told to do so by your doctor as your symptoms may return.
Danish: Selv hvis du får det bedre, må du ikke holde op med at tage din daglige dosis RXULTI eller ændre dosen, medmindre du får besked på det af lægen, da dine symptomer ellers kan vende tilbage.
English: The maximum recommended daily dose is 4 mg.
Danish: Den maksimale anbefalede daglige dosis er 4 mg.
English: Unstructured variance-covariance matrix structure was used.
Danish: Der er anvendt en ustruktureret varians/kovarians-matrix.
English: Population PK evaluation identified gender as statistically significant covariate.
Danish: En farmakokinetisk populationsanalyse identificerede køn som en statistisk signifikant kovariat.
English: Brexpiprazole has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Danish: Brexpiprazol er ikke undersøgt hos ældre patienter med demens og anbefales ikke til behandling af ældre patienter med demens på grund af en øget risiko for samlet mortalitet.
English: Alcohol should be avoided as it can influence how this medicine works.
Danish: Du bør undgå at indtage alkohol, da det kan påvirke effekten af dette lægemiddel.
English: Brexpiprazole can elevate prolactin levels.
Danish: Brexpiprazol kan medføre forhøjet prolaktinniveau.
English: Genotoxicity, carcinogenicity
Danish: Genotoksicitet, karcinotoksicitet
English: The key secondary endpoint in trials 1, 2 and 4 was the Clinical Global Impression of Severity (CGI-S) of schizophrenia, a 7-point clinician's assessment of the severity of disease.
Danish: Det vigtigste sekundære endepunkt i forsøg 1, 2 og 4 var CGI-S (Clinical Global Impression of Severity) for skizofreni, der er en 7-punkts lægevurdering af sygdommens sværhedsgrad.
English: Oesophageal dysmotility and aspiration have been associated with antipsychotic use.
Danish: Øsofageal dysmotilitet og aspiration har været forbundet med brugen af antipsykotika.
English: Tell your doctor if this happens.
Danish: Fortæl det til lægen, hvis du oplever dette
English: There is a chance that the medicine could affect your ability to drive and use machines.
Danish: Der er risiko for, at lægemidlet kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Your doctor will also inform you how to act if you switch from RXULTI to other medicine.
Danish: Lægen vil også oplyse dig om, hvordan du skal gøre, hvis du skifter fra RXULTI til et andet lægemiddel.
English: Fasting plasma glucose should be assessed before or soon after the initiation of the antipsychotic treatment.
Danish: Fastende plasmaglukose bør vurderes før eller straks efter påbegyndelse af antipsykotisk behandling.
English: Dose adjustments due to interactions
Danish: Dosisjustering på grund af interaktioner
English: Brexpiprazole maintained symptom control and functioning compared to placebo.
Danish: Brexpiprazol fastholdt kontrollen med symptomer og funktionsevnen sammenholdt med placebo.
English: Body temperature regulation
Danish: Regulering af kropstemperatur
English: Standard error
Danish: Standardfejl
English: However, your doctor may prescribe a lower or higher dose to a maximum of 4 mg once a day.
Danish: Lægen kan imidlertid ordinere en lavere eller højere dosis op til i alt 4 mg én gang dagligt.
English: All ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics.
Danish: Forstyrrelse af kroppens evne til at reducere kroppens kernetemperatur er blevet forbundet med antipsykotika.
English: Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.
Danish: Selvom forekomsten af syndromet synes at være højest blandt ældre, især ældre kvinder, er det ved påbegyndelse af antipsykotisk behandling ikke muligt at forlade sig på prævalensestimater for at forudsige, hvilke patienter der sandsynligvis vil udvikle syndromet.
English: Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Danish: Risikofaktorer, der kan disponere patienterne for svære komplikationer, omfatter overvægt og diabetes i familieanamnesen.
English: Generally, these risks are greatest at the beginning of treatment with antipsychotics and during dose escalation.
Danish: Generelt er risikoen for disse bivirkninger størst ved påbegyndelse af behandling med antipsykotika og under dosiseskalering.
English: Please check that you are not feeling dizzy or sleepy before you start driving or handling machines.
Danish: Du skal sikre dig, at du ikke føler dig svimmel eller søvnig, før du fører motorkøretøj eller betjener maskiner.
English: • muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Danish: • muskelsvækkelse, ømhed eller smerter, især hvis du samtidig føler dig utilpas, har høj feber eller har mørk urin.
English: At steady-state, DM-3411 represents 23.1 % to 47.7 % of brexpiprazole exposure (AUC) in plasma.
Danish: Ved steady state udgør DM-3411 23,1 % til 47,7 % af brexpiprazol-eksponeringen (AUC) i plasma.
English: DK 2500 Valby Denmark
Danish: DK 2500 Valby Danmark
English: Please inform your doctor if you take any other medicines that are known to prolong the QT interval.
Danish: Fortæl det til din læge, hvis du tager andre lægemidler, der kan forlænge QT-intervallet
English: Leukopenia, neutropenia and agranulocytosis
Danish: Leukopeni, neutropeni og agranulocytose
English: • an electrolyte imbalance (problems with the amount of salts in your blood).
Danish: • har elektrolytforstyrrelser (problemer med mængden af salt i blodet)
English: The effect of brexpiprazole on blood pressure reduction is attributed to the expected blockade of α1-adrenoceptors in peripheral blood vessels.
Danish: Brexpiprazols indvirkning på blodtrykket (blodtryksfald) tilskrives den forventede blokering af α1-adrenoceptorer i de perifere blodkar.
English: • thoughts or feelings about hurting yourself or to commit suicide or a suicide attempt (uncommon side effect - may affect up to 1 in 100 people).
Danish: • tanker eller ønsker om at skade dig selv eller at begå selvmord eller selvmordsforsøg (ikke almindelig bivirkning - kan forekomme hos op til 1 ud af 100 patienter).
English: Your doctor will need to check your blood sugar regularly since it may be increased by this medicine.
Danish: Lægen vil tjekke dit blodsukker regelmæssigt, da dette lægemiddel kan få det til at stige.
English: While taking RXULTI you should avoid getting over-heated or dehydrated.
Danish: Under behandlingen med RXULTI skal du undgå at blive overophedet eller dehydreret.
English: Patients with a prior history of impulse-control disorders may be at increased risk and should be monitored carefully.
Danish: Patienter med manglende impulskontrol i anamnesen kan have en øget risiko og bør overvåges nøje.
English: In long-term, open-label trials, TEAEs related to suicidality were reported for 23 subjects (1.6 %).
Danish: I åbne langtidsstudier blev TEAE'er relateret til suicidalitet indberettet hos 23 forsøgspersoner (1,6 %).
English: In such patients, a lower starting dose and slower titration should be considered, and orthostatic vital signs should be monitored (see section 4.2).
Danish: Det bør overvejes at give disse patienter en lavere startdosis og langsommere titrering, og de ortostatiske vitale tegn bør overvåges (se pkt.
English: RXULTI with food and alcohol
Danish: Brug af RXULTI sammen med mad og alkohol
English: Hypromellose Talc
Danish: Hypromellose Talcum
English: • have any difficulty in swallowing.
Danish: • har svært ved at synke
English: Factors
Danish: Faktorer
English: Talk to your doctor or pharmacist before taking RXULTI, or during treatment if you have
Danish: Kontakt lægen eller apotekspersonalet, før du tager RXULTI eller i løbet af behandlingen, hvis du:
English: Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
Danish: Patienter med neutropeni bør omhyggeligt overvåges for feber eller andre symptomer eller tegn på infektion og bør i givet fald behandles øjeblikkeligt.
English: • or had heart problems or a history of stroke, especially if you know that you have other risks factors for stroke.
Danish: • får eller tidligere har haft hjerteproblemer eller slagtilfælde, især hvis du ved, at du har andre risikofaktorer for slagtilfælde
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: An electrocardiogram should be obtained in case of overdose and if QT interval prolongation is present, cardiac monitoring should be instituted.
Danish: Et elektrokardiogram bør tages i tilfælde af en overdosis, og hvis der ses forlængelse af QT-intervallet, bør monitorering af hjertefunktionen iværksættes.
English: • are having any thoughts or feelings about hurting yourself or to commit suicide.
Danish: • tænker eller fornemmer, at du vil skade dig selv eller begå selvmord.
English: Less than 1 % of unchanged brexpiprazole was excreted in the urine and approximately 14 % of the oral dose was recovered unchanged in the faeces.
Danish: Mindre end 1 % uomdannet brexpiprazol blev udskilt i urinen, og ca. 14 % af den orale dosis blev genfundet uomdannet i fæces.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Orthostatic hypotension
Danish: Venøs tromboemboli (inklusive lungeemboli og dyb venetrombose) Ortostatisk hypotension
English: Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Danish: Håndteringen af overdosering bør i øvrigt fokusere på understøttende behandling, opretholdelse af frie luftveje, sikring af tilstrækkelig iltning og ventilering samt behandling af symptomerne.
English: Overall in the brexpiprazole clinical development program for schizophrenia, one death due to suicide, considered not drug related by the investigator, occurred.
Danish: Samlet set er der i løbet af det kliniske brexpiprazol-udviklingsprogram for skizofreni observeret ét dødsfald som følge af selvmord, som investigator vurderede ikke var lægemiddelrelateret.
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 hvis nogen i din familie tidligere har haft blodpropper, da lægemidler mod skizofreni er blevet forbundet med dannelse af blodpropper
English: At week 52 brexpiprazole (13.5 %) reduced the risk of impending relapse by 71 % compared with placebo (38.5 %).
Danish: I uge 52 havde brexpiprazol (13,5 %) reduceret risikoen for imminent recidiv med 71 % sammenholdt med placebo (38,5 %).
English: The exposure (AUC) of brexpiprazole in women was estimated to be 25 % higher than in men (see section 4.8).
Danish: Eksponeringen (AUC) for brexpiprazol hos kvinder skønnedes at være 25 % højere end hos mænd (se pkt.
English: Due to the testing hierarchy the greater improvement shown for both 2 mg/day and 4 mg/day on the CGI-S can only be considered supportive for trials 2, 3 and 4 (see table 3).
Danish: På grund af testhierarkiet kan den større forbedring for både 2 mg/dag og 4 mg/dag på CGI-S kun anses for at understøtte forsøg 2, 3 og 4 (se tabel 3).
English: The volume of distribution of brexpiprazole following intravenous administration is high (1.56 L/kg ± 0.418 L/kg), indicating extravascular distribution.
Danish: Fordelingsvolumenet for brexpiprazol efter intravenøs administration er højt (1,56 l/kg ± 0,418 l/kg), hvilket indikerer ekstravaskulær fordeling.
English: Short-term trials
Danish: Kortvarige forsøg
English: If you have taken more RXULTI than your prescribed dose, contact your doctor or your local hospital immediately.
Danish: Hvis du har taget flere RXULTI-tabletter end den ordinerede dosis, skal du øjeblikkeligt kontakte lægen eller det lokale hospital.
English: These can be the signs of the so-called neuroleptic malignant syndrome (it is not known how many people are affected).
Danish: Dette kan være tegn på såkaldt malignt neuroleptikasyndrom (det vides ikke, hvor mange patienter der oplever dette).
English: • symptoms related to 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 (uncommon side effect - may affect up to 1 in 100 people).
Danish: • symptomer relateret til blodpropper i venerne, især i benene (symptomerne omfatter hævelse, smerte og rødme i benet), som kan bevæge sig gennem blodkarrene til lungerne og medføre brystsmerter og åndedrætsbesvær (ikke-almindelig bivirkning - kan forekomme hos op til 1 ud af 100 patienter).
English: Brexpiprazole is very persistent and very bioaccumulative but not toxic, to the environment: possible enrichment of brexpiprazole in terrestrial food chains might pose a concern (see section 6.6).
Danish: Brexpiprazol er meget persisterende og meget bioakkumulerende i, men ikke toksisk for, miljøet; mulig opformering af brexpiprazol i fødekæden på land kan udgøre et problem (se pkt.
English: Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Danish: Tegn på højt blodsukker er kraftig tørst, øget vandladning, øget appetit og en følelse af svaghed
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Danish: Ekstrapyramidale symptomer (herunder akut dystoni) er kendte klasseeffekter for antipsykotika.
English: Following a single oral dose of [14C]-labelled brexpiprazole, approximately 24.6 % and 46 % of the administered radioactivity was recovered in the urine and faeces, respectively.
Danish: Efter en enkelt oral dosis af [14C]-mærket brexpiprazol blev ca. 24,6 % og 46 % af den administrerede radioaktivitet genfundet i hhv. urinen og fæces.
English: The categorisation of blood prolactin increased is based on Potentially Clinically Relevant (PCR) criteria of > 1 × upper limit of normal (ULN).
Danish: Kategoriseringen af forhøjet blodprolaktin er baseret på kriterier for potentiel klinisk relevans > 1 × øvre normalgrænse.
English: Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.
Danish: Brexpiprazol påvirker ikke absorptionen af lægemidler, der er substrater for brystkræftresistent protein (BCRP) og P-glykoprotein (P-gp)-transportører.
English: Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.
Danish: Baseret på resultater af in vitro-forsøg påvirkes brexpiprazols proteinbinding ikke af warfarin, diazepam og digitoxin.
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking brexpiprazole.
Danish: Patienter kan opleve en øget trang til især hasardspil og en manglende evne til at styre denne trang, når de tager brexpiprazol.
English: It is especially important to mention the following medicines to your doctor:
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du får følgende lægemidler:
English: • antibiotics to treat bacterial infections (such as clarithromycin),
Danish: • antibiotika til behandling af bakterielle infektioner (f.eks. clarithromycin)
English: Other urges, reported, include: compulsive sexual behaviours, compulsive shopping, binge eating, and other impulsive and compulsive behaviours.
Danish: Andre former for trang, der er blevet rapporteret, omfatter: kompulsiv seksuel adfærd, kompulsiv købeadfærd, overspisning samt anden impulsiv og kompulsiv adfærd.
English: • antifungal medicines (such as ketoconazole, itraconazole),
Danish: • svampemidler (f.eks. ketoconazol eller itraconazol)
English: Following oral administration in pregnant rats, foetus and milk transfer of brexpiprazole was demonstrated at concentrations that were generally comparable to levels seen in maternal blood.
Danish: Efter oral administration hos drægtige rotter blev der påvist overførsel af brexpiprazol til fostre og i mælken ved koncentrationer, der generelt var sammenlignelige med niveauer, der er set i maternelt blod.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with brexpiprazole and preventive measures undertaken.
Danish: Da patienter, der er i behandling med antipsykotika, ofte har sygdomsbetingede risikofaktorer for VTE, skal alle mulige risikofaktorer for VTE identificeres før og under behandling med brexpiprazol, og der skal iværksættes forebyggende foranstaltninger.
English: • or had problems with your movements called extrapyramidal symptoms (EPS) in the past.
Danish: • tidligere har haft problemer med dine bevægelser (såkaldte ekstrapyramidale symptomer).
English: Talk to your doctor about the best way to feed your baby if you are taking RXULTI.
Danish: Tal med lægen om, hvordan du bedst kan ernære dit barn, mens du tager RXULTI.
English: During the stabilisation, brexpiprazole improved clinical symptomology (as assessed by PANSS, CGI-S and CGI-I, [Analysis of Covariance - ANCOVA Last Observation Carried Forward - LOCF]) and functioning (as assessed by Global Assessment of Functioning (GAF) [ANCOVA LOCF]).
Danish: Under stabiliseringen forbedrede brexpiprazol den kliniske symptomologi (som vurderet ved PANSS, CGI-S og CGI-I [kovariansanalyse (ANCOVA) - Last Observation Carried Forward (LOCF)]) og funktionsevne (som vurderet ved Global Assessment of Functioning (GAF) [ANCOVA LOCF]).
English: Babies of mothers who take this medicine during the last three months of their pregnancy may show the following symptoms: shaking, muscle stiffness and/or muscle weakness, sleepiness, restlessness, breathing problems and difficulty in feeding.
Danish: Babyer af mødre, der tager dette lægemiddel gennem de sidste tre måneder af graviditeten, kan have følgende symptomer: rystelser, muskelstivhed og/eller muskelsvækkelse, søvnighed, rastløshed, vejrtrækningsproblemer og spisebesvær.
English: These improvements were maintained during the 52-week double-blind maintenance phase in patients on brexpiprazole whereas patients randomised to placebo showed deterioration in PANSS, CGI-S and CGI-I, and GAF scores [ANCOVA LOCF]).
Danish: Disse forbedringer blev fastholdt gennem den 52-uger lange dobbeltblindede vedligeholdelsesfase hos patienter på brexpiprazol, mens patienter, der var randomiseret til placebo, oplevede en forværring af PANSS-, CGI-S- og CGI-I- samt GAF-scorerne [ANCOVA LOCF]).