FrancophonIA/ELRC3.0 huggingface dataset:
English: A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves.
Danish: Et lille antal mennesker, der behandles med antiepileptiske lægemidler som lacosamid, har haft tanker om at gøre skade på eller dræbe sig selv.
English: The dose is determined based on body weight.
Danish: Dosis bestemmes ud fra kropsvægt.
English: They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths.
Danish: Børn starter normalt behandling med siruppen og skifter kun til tabletter, hvis de kan synke tabletter og få den korrekte dosis med de forskellige tabletstyrker.
English: If you are allergic to peanut or soya, do not use this medicinal product.
Danish: Hvis De er allergisk over for peanuts eller soja, må De ikke anvende dette lægemiddel.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • Take Lacosamide Accord twice each day- once in the morning and once in the evening.
Danish: • Tag Lacosamide Accord to gange om dagen - en gang om morgenen og en gang om aftenen.
English: Table: Start of the treatment (the first 4 weeks)
Danish: Tabel: Behandlingsstart (de første 4 uger)
English: Irritability, trouble sleeping, depression;
Danish: • Irritabilitet, søvnbesvær, depression
English: • Swallow the Lacosamide Accord tablet with a glass of water.
Danish: • Synk Lacosamide Accord-tabletten med et glas vand.
English: It is not recommended to take Lacosamide Accord if you are pregnant or breast-feeding, as the effects of lacosamide on pregnancy and the unborn baby or the new-born child are not known.
Danish: Det frarådes at tage Lacosamide Accord, hvis De er gravid eller ammer, da Lacosamide Accords virkning på graviditeten og det ufødte barn eller det nyfødte barn, ikke er kendt.
English: Therefore, this medicinal product should be used with caution in patients allergic to peanut or soya.
Danish: Derfor bør dette lægemiddel anvendes med forsigtighed til patienter, der er allergiske over for jordnødder eller soja.
English: This pack (treatment initiation pack) is used when you start your treatment with Lacosamide Accord.
Danish: Denne pakke (behandlingsstartpakken) skal bruges, når De starter på behandling med Lacosamide Accord.
English: Week Package to be used
Danish: Uge Æske, der skal bruges
English: If you are not sure whether you are allergic, please discuss with your doctor
Danish: Hvis De ikke er sikker på, om De er allergisk, så drøft det med lægen
English: This medicinal product contains lecithin (soya).
Danish: Dette lægemiddel indeholder lecithin (soja).
English: • It is used to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation.
Danish: • Det bruges til at behandle en bestemt type epilepsi karakteriseret ved forekomsten af partielle anfald med eller uden sekundær generalisering.
English: Troubles with your memory, thinking or finding words, confusion;
Danish: • Hukommelsesbesvær, problemer med at tænke eller finde ord, forvirring
English: Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Danish: • Alvorlig allergisk reaktion, som medfører hævelse af ansigt, hals, hænder, fødder, ankler eller underben
English: if you have a certain type of heart beat problem called second- or third-degree AV block.
Danish: • hvis De har en bestemt form for hjertesygdom kaldet AV-blok af anden eller tredje grad.
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Danish: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien eller
English: • you have severe heart disease such as heart failure or have had a heart attack.
Danish: • De har en alvorlig hjertesygdom, så som hjertesvigt eller har haft et hjerteanfald.
English: Lacosamide Accord with alcohol As a safety precaution do not take Lacosamide Accord with alcohol.
Danish: Brug af Lacosamide Accord sammen med alkohol Som sikkerhedsforanstaltning bør Lacosamide Accord ikke tages sammen med alkohol.
English: Each package contains a different dosage strength of Lacosamide Accord, so you will increase your dose gradually.
Danish: Hver æske indeholder en forskellig Lacosamide Accord-dosisstyrke, så Deres dosis vil stige gradvist.
English: • if you are allergic to peanut or soya.
Danish: • hvis De er allergisk over for peanuts eller soja
English: For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Danish: Det gælder for alle antiepileptiske lægemidler, at forekomsten af misdannelser hos børn af kvinder, der er behandlet for epilepsi, er 2-3 gange højere end for den generelle befolkning, hvor forekomsten er ca. 3 %.
English: • medicines used to treat certain types of irregular heart beat or heart failure.
Danish: • Medicin, der anvendes til behandling af visse typer af uregelmæssig puls eller hjertesvigt.
English: In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400mg/day and after lacosamide is titrated to steady-state.
Danish: Hos disse patienter bør det overvejes at tage et EKG, før dosis af lacosamid øges til over 400 mg/dag, og efter lacosamid er titreret til steady state.
English: Talk to your doctor before taking Lacosamide Accord if:
Danish: Kontakt lægen før De tager Lacosamide Accord hvis:
English: Listed below are the normal recommended doses of Lacosamide Accord for different age groups and weights.
Danish: Nedenfor er de normale anbefalede doser af Lacosamide Accord til forskellige aldersgrupper og vægte angivet.
English: In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 50 % increased compared to young men, respectively.
Danish: I et studie, som omfattede 4 ældre mænd og kvinder >75 år, var AUC henholdsvis ca. 30 og 50 % forøget sammenlignet med AUC hos raske unge mænd.
English: Talk to your doctor or pharmacist if you get any of the following:
Danish: Tal med lægen eller apotekspersonalet, hvis De oplever nogen af følgende:
English: • medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
Danish: • Medicin, der kan øge "PR-intervallet" ved hjerteskanning (EKG eller elektrokardiogram) såsom lægemidler mod epilepsi eller smerte kaldet carbamazepin, lamotrigin eller pregabalin;
English: Initiation of lacosamide treatment with a loading dose
Danish: Initiering af lacosamidbehandling med en støddosis
English: Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Danish: Dosering hos unge og børn på 50 kg eller derover er den samme som hos voksne (se ovenfor).
English: Double vision (diplopia).
Danish: • Dobbeltsyn (diplopi)
English: Packs of 14, 56, 60 or 168 tablets
Danish: Pakninger med 14, 56, 60 eller 168 tabletter
English: Lacosamide Accord treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient´s response and tolerability.
Danish: Lacosamide Accord-behandlingsstartpakken indeholder 4 forskellige pakninger (én til hver tabletstyrke) med 14 tabletter i hver til de første 2-4 ugers behandling afhængigt af virkningen og bivirkningsprofilen hos den enkelte patient.
English: They will help you decide if you should take Lacosamide Accord or not.
Danish: Lægen vil hjælpe Dem med at beslutte, om De skal tage Lacosamide Accord eller ej.
English: • a medicine for HIV called ritonavir;
Danish: • Et lægemiddel mod HIV kaldet ritonavir;
English: Lacosamide Accord is not recommended for children aged under 4 years.
Danish: Lacosamide Accord bør ikke anvendes til børn under 4 år.
English: The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both lacosamide and placebo groups had a similar and stable health-related quality of life during the entire treatment period.
Danish: Den livskvalitet, der blev bedømt af Pediatric Quality of Life Inventory , indikerede, at forsøgspersoner i både lacosamid- og placebo-gruppen havde en lignende og stabil helbredsrelateret livskvalitet i løbet af hele behandlingsperioden.
English: When you take Lacosamide Accord with other antiepileptic medicines Start of the treatment (the first 4 weeks)
Danish: Hvis De tager Lacosamide Accord sammen med anden medicin mod epilepsi: Behandlingsstart (de første 4 uger)
English: • Lacosamide Accord is used in adults, adolescents and children aged 4 years and older.
Danish: • Lacosamide Accord bruges til voksne, unge og børn i alderen 4 år og ældre.
English: A safety pharmacology study with intravenous administration of lacosamide in anesthetized dogs showed transient increases in PR interval and QRS complex duration and decreases in blood pressure most likely due to a cardiodepressant action.
Danish: Et farmakologisk sikkerhedsstudie med intravenøs indgift af lacosamid i bedøvede hunde viste kortvarige stigninger i PR-interval og QRS-kompleks og fald i blodtrykket, hvilket højst sandsynligt skyldes kardiodepression.
English: Balance disorder Memory impairment Cognitive disorder Somnolence Tremor
Danish: Balanceforstyrrelse Svækket hukommelse Kognitiv forstyrrelse Døsighed
English: Subjects must have achieved the minimum target dose for their body weight category for the final 3 days of the titration period to be eligible for entry into the 10-week maintenance period.
Danish: Forsøgspersonerne skal have opnået minimums-måldosen for deres kropsvægtskategori for de sidste 3 dage i titreringsperioden for at være egnede til at gå videre til den 10 ugers vedligeholdelsesperiode.
English: • If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
Danish: • Hvis De har glemt at tage en dosis inden for de første 6 timer efter den planlagte dosis, skal De tage den, så snart De husker det.
English: • medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
Danish: • Medicin mod svampeinfektioner kaldet fluconazol, itraconazol eller ketoconazol;
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomized trial.
Danish: Lacosamids effekt og sikkerhed ved konvertering til monoterapi er blevet undersøgt i et historisk kontrolleret, dobbeltblindt, randomiseret multicenterstudie.
English: Also tell your doctor or pharmacist if you are taking any of the following medicines - this is because they may increase or decrease the effect of Lacosamide Accord on your body:
Danish: Fortæl det også til lægen eller apotekspersonalet, hvis De tager nogen af følgende lægemidler, da de kan forøge eller formindske effekten af Lacosamide Accord på Deres krop:
English: Feeling sleepy or lacking in energy (lethargy).
Danish: • Træthedsfølelse eller manglende energi (letargi).
English: Indigo carmine aluminum lake (E132)
Danish: Indigokarmin aluminium lake (E132)
English: After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long term treatment.
Danish: Vedligeholdelsesbehandling (efter de første 4 uger) Efter de første 4 behandlingsuger kan lægen justere dosis til den, som de skal fortsætte Deres langtidsbehandling med.
English: If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time.
Danish: Hvis patienten bemærker den glemte dosis inden for 6 timer før den næste , skal han/hun instrueres til at vente med at tage den næste dosis af lacosamid til det normale tidspunkt.
English: Your doctor may increase your twice daily dose every week by 50 mg.
Danish: Lægen kan øge hver af Deres to daglige doseringer med 50 mg hver uge.
English: This is because Lacosamide Accord may make you feel dizzy or cause blurred vision.
Danish: Dette skyldes, at Lacosamide Accord kan gøre Dem svimmel eller forårsage sløret syn.
English: Lacosamide Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.
Danish: Lacosamide Accord filmovertrukne tabletter er pakket i PVC-PVDC/blister med aluminiumsfolie.
English: Children and adolescents below 50 kg The treatment initiation pack is not suitable for children and adolescents weighing less than 50 kg.
Danish: Børn og unge, der vejer mindre end 50 kg Behandlingsstartpakken er ikke egnet til børn og unge, der vejer mindre end 50 kg.
English: In treated patients who completed titration and started withdrawing antiepileptic medicinal products ( 284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Danish: Hos behandlede patienter, som fuldførte titrering og påbegyndte seponering af antiepileptiske lægemidler (henholdsvis 284 og 99), blev monoterapi opretholdt i 57105 dage (median 71 dage) hos henholdsvis 71,5 % og 70,7 % af patienterne i løbet af den forudbestemte 70-dages observationsperiode.
English: • You may take Lacosamide Accord with or without food.
Danish: • De må tage Lacosamide Accord sammen med eller uden mad.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona SPAIN
Danish: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona SPANIEN
English: Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Danish: • Langsom puls, hjertebanken, uregelmæssig puls eller andre ændringer i hjertets elektriske aktivitet (ledningsforstyrrelse)
English: Film-coat: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), lecithin (soya) and colorants* * The colorants are
Danish: Filmovertræk: Polyvinylalkohol, polyethylenglycol, talkum, titandioxid (E171), lecithin (soja) og farvestoffer* *Farvestofferne er
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
English: Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.
Danish: Lacosamide Accord fås i pakninger med 14, 56, 60 eller 168 filmovertrukne tabletter.
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain or
Danish: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spanien eller
English: These trials, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or without secondary generalisation.
Danish: Disse studier, der omfattede 1308 patienter, som i gennemsnit havde haft fokale anfald i 23 år, blev designet til at vurdere lacosamids sikkerhed og virkning, når det blev givet samtidig med 1-3 antiepileptiske lægemidler til patienter med ukontrollerede fokale anfald med eller uden sekundær generalisering.
English: 14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 168 film-coated tablets 14 x 1 film-coated tablet 56 x 1 film-coated tablet
Danish: 14 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 168 filmovertrukne tabletter 14 x 1 filmovertrukket tablet 56 x 1 filmovertrukket tablet
English: The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Danish: Effekten af lacosamid som tillægsbehandling ved de anbefalede doser (200 mg daglig, 400 mg daglig) blev dokumenteret i 3 randomiserede, placebo-kontrollerede, multicenter-kliniske studier med en vedligeholdelsesperiode på 12 uger.
English: • If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore.
Danish: • Hvis De har glemt at tage en dosis mere end de første 6 timer efter den planlagte dosis, må De ikke længere tage den glemte tablet.
English: However, cases with second and third-degree AV Block associated with lacosamide treatment have been reported in postmarketing experience.
Danish: Tilfælde af AV-blok af anden eller tredje grad i forbindelse med lacosamidbehandling er imidlertid blevet rapporteret efter markedsføring.
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Lacosamide Accord 50 mg film-coated tablets
Danish: Behandlingsstartpakning (kun til unge og børn, der vejer 50 kg eller derover og til voksne) Lacosamide Accord 50 mg filmovertrukne tabletter
English: Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen.
Danish: Behandling med lacosamid kan også indledes med en enkelt støddosis på 200 mg, efterfulgt af vedligeholdelsesbehandling med 100 mg to gange daglig (200 mg/dag) ca. 12 timer senere.
English: In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for patients randomized to lacosamide and 1.6 % for patients randomized to placebo.
Danish: I alle disse kontrollerede studier var seponeringsraten på grund af bivirkninger 12,2 % for patienter randomiseret til lacosamid, og 1,6 % for patienter randomiseret til placebo.
English: Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
Danish: Symptomer Symptomer observeret efter en tilsigtet eller utilsigtet overdosis med lacosamid er hovedsageligt forbundet med centralnervesystemet eller mave-tarm-kanalen.
English: • you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
Danish: • De har et hjerteproblem, der påvirker hjerterytmen, og De ofte har en særlig langsom, hurtig eller uregelmæssig puls (som f.eks. AV-blok, atrieflimren og atrieflagen).
English: • medicines used to treat bacterial infections called clarithromycin or rifampicin;
Danish: • Medicin, der anvendes til behandling af bakterieinfektioner kaldet clarithromycin eller rifampicin;
English: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Hungary
Danish: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Ungarn
English: The most frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population was first-degree AV block.
Danish: Den hyppigst forekommende hjerterelaterede bivirkning, som blev rapporteret hos den ældre population sammenlignet med den yngre voksenpopulation, var første grads AV-blok.
English: 50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) For the full list of excipients, see section 6.1.
Danish: 50 mg: Hver filmovertrukket tablet indeholder 0,105 mg lecithin (soja) 100 mg: Hver filmovertrukket tablet indeholder 0,210 mg lecithin (soja) 150 mg: Hver filmovertrukket tablet indeholder 0,315 mg lecithin (soja) 200 mg: Hver filmovertrukket tablet indeholder 0,420 mg lecithin (soja)
English: Blood tests may show abnormal liver function , liver injury;
Danish: • Blodprøver kan vise unormal leverfunktion, leverskade
English: Outer carton
Danish: Yderkarton
English: Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) and in patients treated with antiarrhythmics.
Danish: Lacosamid bør anvendes med forsigtighed hos patienter i behandling med lægemidler, som man ved, er forbundet med PR-forlængelse (herunder natriumkanalblokerende antiepileptika) samt hos patienter i behandling med antiarytmetika.
English: Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive therapy trials, although the efficacy was similar to 400 mg/day and patients were less likely to tolerate this dose because of CNS- and gastrointestinal-related adverse reactions.
Danish: Lacosamid 600 mg viste sig også at være effektiv i kontrollerede studier med tillægsbehandling, selvom effekten var den samme som ved 400 mg/dag og patienterne ofte tålte denne dosis dårligere på grund af bivirkninger relateret til centralnervesystemet og mavetarm-kanalen.
English: Depending on response and tolerability, Lacosamide Accord 150 mg tablets may be taken twice a day during the third week and Lacosamide Accord 200 mg tablets twice a day during the fourth week.
Danish: Afhængigt af respons og tolerabilitet kan Lacosamide Accord 150 mg-tabletter tages to gange daglig i tredje uge og Lacosamide Accord 200 mg-tabletter to gange daglig i fjerde uge.
English: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Hungary or
Danish: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Ungarn eller
English: You will start your treatment with a low dose of Lacosamide Accord, usually 50 mg twice a day, and increase it week by week.
Danish: De starter behandlingen med en lav dosis Lacosamide Accord, almindeligvis 50 mg 2 gange dagligt, og dosis øges uge efter uge.
English: The most frequently reported adverse reactions (≥10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Danish: De mest almindeligt rapporterede bivirkninger (≥10 %) ved lacosamidbehandling var svimmelhed, hovedpine, kvalme og diplopi (dobbeltsyn).
English: • Sore throat (pharyngitis);
Danish: • Ondt i halsen (pharyngitis);
English: Adolescents and children weighing 50 kg or more and adults only When you take Lacosamide Accord on its own The usual starting dose of Lacosamide Accord is 50 mg twice a day.
Danish: Unge og børn der vejer 50 kg eller derover og voksne Hvis De kun tager Lacosamide Accord mod epilepsi Den sædvanlige startdosis af Lacosamide Accord er 50 mg to gange dagligt.
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision; A spinning sensation (vertigo), feeling drunk;
Danish: • Hurtige og ukontrollerbare øjenbevægelser (nystagmus), sløret syn
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Danish: Johnsons syndrom(1) Toksisk epidermal nekrolyse(1)
English: The patients were randomized to carbamazepine CR or lacosamide, provided as tablets, in a 1:1 ratio.
Danish: Patienterne blev randomiseret i forholdet 1:1 til enten carbamazepin CR eller lacosamid, givet som tabletter.
English: Microcrystalline cellulose Hydroxy propyl cellulose-L Hydroxy propyl cellulose (low substituted) Silica, colloidal, anhydrous Crospovidone
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose-L Hydroxypropylcellulose (lavsubstitueret) Silica, kolloid, vandfri Crospovidon
English: Overall the proportion of subjects with a 50% reduction in seizure frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day.
Danish: Samlet var omfanget af personer med en 50 % reduktion i hyppigheden af anfald 23 %, 34 % og 40 % for placebo, lacosamid 200 mg/dag og lacosamid 400 mg/dag.