FrancophonIA/ELRC3.0 huggingface dataset:
English: Trouble with your memory, thinking or finding words, confusion;
Danish: • Hukommelsesbesvær, problemer med at tænke eller finde ord, forvirring;
English: Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
Danish: Lacosamid elimineres først og fremmest fra det systemiske kredsløb ved udskillelse gennem nyrerne og ved biotransformation.
English: Only clear solution free from particles and discoloration should be used.
Danish: Kun en klar opløsning uden partikler eller misfarvning må bruges.
English: The oral bioavailability of lacosamide tablets is approximately 100 %.
Danish: Lacosamid-tabletters orale biotilgængelighed er ca. 100 %.
English: Each package contains a different dosage strength of Lacosamide UCB, so you will increase your dose gradually.
Danish: Hver æske indeholder en forskellig Lacosamide UCB-dosisstyrke, så Deres dosis vil stige gradvist.
English: A safety pharmacology study with intravenous administration of lacosamide in anesthetised 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: For precautionary measures, breast-feeding should be discontinued during treatment with lacosamide.
Danish: Af forsigtighedshensyn bør amning ophøre under behandling med lacosamid.
English: An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.
Danish: Et in vitro-studie har vist, at lacosamid ikke transporteres af P-glycoprotein i tarmen.
English: If you take more than 12.5 ml of syrup each day and are on a controlled sodium diet, take this into consideration.
Danish: Hvis De tager mere end 12,5 ml syrup hver dag og er på en kontrolleret natriumdiæt, skal De tage højde for dette.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid denne medicin præcis som lægen eller apotekspersonalet har anvist.
English: Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach CBCL and BRIEF that were applied at baseline and throughout the studies and where mainly stable during the course of the trials.
Danish: Adfærdsmæssig, kognitiv og emotionel funktion blev målt med spørgeskemaet Achenbach CBCL og BRIEF, som blev anvendt ved baseline og gennem hele studierne og var generelt stabile under studiernes forløb.
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 0 % (0/356) of placebo patients.
Danish: ALATstigning til ≥ 3 x øvre normalgrænse forekom hos 0,7 % (7/935) af Lacosamide UCB-patienterne og hos 0 % (0/356) af placebopatienterne.
English: Treatment of lacosamide overdose should include general supportive measures and may include haemodialysis if necessary (see section 5.2).
Danish: Behandlingen af en overdosis lacosamid bør omfatte generelle understøttende tiltag og kan om nødvendigt omfatte hæmodialyse (se pkt.
English: Use the measuring cup provided in this pack.
Danish: • Brug målebægeret i denne pakning
English: Product with particulate matter or discolouration should not be used.
Danish: Produkt med partikler eller misfarvning må ikke anvendes.
English: • A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Danish: • Udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnsons syndrom), og en mere alvorlig form, der forårsager hudafskalning på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse);
English: Population pharmacokinetic analyses in different age groups estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.
Danish: Farmakokinetiske analyser i forskellige aldersgrupper vurderede, at samtidig behandling med andre enzym-inducerende antiepileptiske lægemidler (carbamazepin, phenytoin, phenobarbital i forskellige doser) nedsatte lacosamids samlede systemiske eksponering med 25 % hos voksne og 17 % hos pædiatriske patienter.
English: The dose was based on dose-response and ranged from 400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide.
Danish: Dosis var baseret på dosis-respons og varierede fra 400 til 1.200 mg/dag for carbamazepin CR og fra 200 til 600 mg/dag for lacosamid.
English: Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was observed between the lacosamide and the placebo group.
Danish: Der blev observeret statistisk signifikant (p=0,0003) og klinisk relevant reduktion i frekvensen af partielle anfald pr. 28 dage fra baseline til vedligeholdelsesperioden mellem lacosamid- og placebogruppen.
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptiske lægemidler har vist en let forøget risiko for selvmordstanker og -adfærd.
English: Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.
Danish: Der kan indtræffe bivirkninger, der er forbundet med forlængelse af PR-intervallet (f.eks. atrioventrikulær blok, synkope, bradykardi).
English: Lacosamide film-coated tablets are for oral use.
Danish: Lacosamid filmovertrukne tabletter er til oral anvendelse.
English: The plasma concentration of O-desmethyl-lacosamide is approximately 15 % of the concentration of lacosamide in plasma.
Danish: Plasmakoncentrationen af O-desmethyl-lacosamid svarer til ca. 15 % af lacosamidkoncentrationen i plasma.
English: The maximum recommended dose is 400 mg/day.
Danish: Den anbefalede maksimale dosis er 400 mg/dag.
English: The percent reduction over placebo based on analysis of covariance was 31.72 % (95 % CI: 16.342, 44.277).
Danish: Den procentvise reduktion over placebo var, på basis af analyse af kovarians, 31,72 % (95 % CI: 16,342, 44,277).
English: Instructions for use: oral syringe
Danish: Brugsanvisning: Oral sprøjte
English: A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg twice daily oral administration.
Danish: En enkelt støddosis på 200 mg nærmer sig steady-state-koncentrationer, der kan sammenlignes med oral administration af 100 mg to gange dagligt.
English: Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day every week.
Danish: Afhængigt af respons og tolerabilitet kan vedligeholdelsesdosis forøges yderligere med 2 mg/kg/dag hver uge.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Danish: Selvmordstanker og -adfærd er rapporteret hos patienter i behandling med antiepileptiske lægemidler.
English: Follow these steps the first time you take Lacosamide UCB:
Danish: Følg disse trin første gang De tager Lacosamide UCB:
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 antiarytmika.
English: Lacosamide protected against seizures in a broad range of animal models of partial and primary generalised seizures and delayed kindling development.
Danish: Lacosamid beskyttede mod anfald i en lang række dyremodeller med fokale og primært generaliserede anfald og forsinkede udviklingen af 'kindling'.
English: Lacosamide has minor to moderate influence on the ability to drive and use machines.
Danish: Lacosamid påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
Danish: Blodprøver kan vise øgede niveauer af leverenzymer og en type hvide blodlegemer (eosinofili);
English: Common: may affect up to 1 in 10 people Injection site pain or discomfort or irritation.
Danish: Almindelige: kan påvirke op til 1 ud af 10 personer • Smerte, ubehag eller irritation på injektionsstedet.
English: Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm).
Danish: Patienter med moderat nedsat leverfunktion (Child-Pugh B) viste højere koncentrationer af lacosamid i plasma (ca. 50 % højere AUCnorm).
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: Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a pharmacodynamic effect cannot be excluded.
Danish: Selvom der ikke er tilgængelige farmakokinetiske data om interaktion mellem lacosamid og alkohol, kan en farmakodynamisk effekt ikke udelukkes.
English: Clear, colourless solution.
Danish: Klar og farveløs opløsning.
English: Accordingly, patients should be advised not to drive or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities.
Danish: Patienterne bør derfor rådes til først at føre motorkøretøj eller betjene andre potentielt farlige maskiner, når de er fortrolige med, hvilken effekt lacosamid har på deres evne til at udføre sådanne aktiviteter.
English: Animal studies have shown excretion of lacosamide in breast milk.
Danish: Dyrestudier har påvist udskillelse af lacosamid i modermælk.
English: In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma concentrations observed in clinical trials.
Danish: In vitro-studier viser, at enzymerne CYP1A2, CYP2B6 og CYP2C9 ikke induceres, og at CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 og CYP2E1 ikke hæmmes af lacosamid ved plasmakoncentrationer observeret i kliniske studier.
English: The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of age with partial-onset seizures.
Danish: Farmakokinetikken og sikkerheden ved en enkelt støddosis af lacosamid intravenøst blev bestemt i et åbent multicenterstudie, der havde til formål at vurdere sikkerhed og tolerabilitet ved hurtig initiering af lacosamidbehandling under anvendelse af en enkelt intravenøs støddosis (indeholdende 200 mg), efterfulgt af to daglige orale doser (svarende til den intravenøse dosis) som tillægsbehandling hos voksne forsøgspersoner i alderen 16 til 60 år med anfald af partiel type.
English: In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).
Danish: Hvis det er påkrævet at seponere lacosamidbehandlingen, anbefales det i henhold til gældende klinisk praksis, at det sker gradvist (daglig dosis nedtrappes med f.eks. 200 mg/uge).
English: This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial.
Danish: Denne medicin indeholder 2,6 mmol (eller 59,8 mg) natrium pr. hætteglas.
English: The overall duration of treatment with intravenous lacosamide is at the physician's discretion; there is experience from clinical trials with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy.
Danish: Den samlede behandlingsvarighed med intravenøs lacosamid fastsættes efter lægens skøn; der er erfaringer fra kliniske studier med lacosamid-infusioner to gange daglig i op til 5 dage ved tillægsbehandling.
English: There is experience with twice daily infusions of Lacosamide UCB for up to 5 days.
Danish: Der er erfaring med infusioner af Lacosamide UCB to gange dagligt i op til 5 dage.
English: PVC/PVDC blister sealed with an aluminium foil.
Danish: PVC/PVDC blister med aluminiumsfolie.
English: Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).
Danish: Åbn flasken ved at trykke på hætten, mens den drejes mod uret (figur 1).
English: In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to the expected clinical exposure.
Danish: Hos ungrotter blev der observeret en reduceret kropsvægt ved systemiske eksponeringsniveauer svarende til den forventede kliniske eksponering.
English: Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 33.3 % in the placebo group.
Danish: Samlet var andelen af forsøgspersoner med mindst 50 % reduktion i hyppigheden af partielle anfald pr. 28 dage fra baseline til vedligeholdelsesperioden på 52,9 % i lacosamid-gruppen, sammenlignet med 33,3 % i placebo-gruppen.
English: Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies.
Danish: Der er observeret dosisrelaterede forlængelser af PR-intervallet med lacosamid i kliniske studier.
English: For longer term treatment Lacosamide UCB tablets and syrup are available.
Danish: Ved længerevarende behandling er Lacosamide UCB-tabletter og syrup til rådighed.
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomised trial.
Danish: Lacosamids effekt og sikkerhed ved konvertering til monoterapi er blevet undersøgt i et historisk kontrolleret, dobbeltblindt, randomiseret multicenterstudie.
English: The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, randomised, placebo-controlled study.
Danish: Effekten, der var understøttet af ovennævnte ekstrapoleringsprincip, blev bekræftet af et dobbeltblindet, randomiseret, placebo-kontrolleret studie.
English: Depression Confusional state Insomnia(1)
Danish: Depression Konfusionstilstand Insomni(1)
English: If you take more than 3 graduation marks of syrup each day and are on a controlled sodium diet, take this into consideration.
Danish: Hvis De tager mere end 3 målestreger syrup hver dag og er på en kontrolleret natriumdiæt, skal De tage højde for dette.
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: Lacosamide treatment has been associated with dizziness or blurred vision.
Danish: Behandling med lacosamid er blevet forbundet med svimmelhed eller sløret syn.
English: Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead to increased systemic exposure of lacosamide.
Danish: Forsigtighed anbefales ved samtidig behandling med potente hæmmere af CYP2C9 (f.eks. fluconazol) eller CYP3A4 (f.eks. itraconazol, ketoconazol, ritonavir, clarithromycin), da det kan forårsage øget systemisk eksponering af lacosamid.
English: Subjects were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and entered in the blinded taper period.
Danish: Forsøgspersonerne skulle forblive på en stabil lacosamid-dosis under hele vedligeholdelsesperioden, ellers blev de trukket ud og indsat i den blindede nedtrapningsperiode.
English: The use of lacosamide is associated with dose-related increase in the PR interval.
Danish: Brug af lacosamid er forbundet med en dosisrelateret forlængelse af PR-intervallet.
English: Lacosamide is less than 15 % bound to plasma proteins.
Danish: Lacosamid er bundet mindre end 15 % til plasmaproteiner.
English: You may take Lacosamide UCB with or without food.
Danish: • De må tage Lacosamide UCB sammen med eller uden mad.
English: There was no clinically relevant interaction between lacosamide and metformin.
Danish: Der var ingen klinisk relevant interaktion mellem lacosamid og metformin.
English: Depending on response and tolerability, Lacosamide UCB 150 mg tablets may be taken twice a day during the third week and Lacosamide UCB 200 mg tablets twice a day during the fourth week.
Danish: Afhængigt af respons og tolerabilitet kan Lacosamide UCB 150 mg-tabletter tages to gange daglig i tredje uge og Lacosamide UCB 200 mg-tabletter to gange daglig i fjerde uge.
English: Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Danish: Effekten af lacosamid som monoterapi blev klarlagt i et dobbeltblindt, non-inferioritetssammenligningsstudie med parallelle grupper med carbamazepin CR hos 886 patienter på 16 år og derover med nydiagnosticeret eller nyligt diagnosticeret epilepsi.
English: In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at about 3 times the clinical exposure.
Danish: I toksicitetsstudier med gentagne doser blev der observeret lette reversible leverforandringer i rotter, disse leverforandringer begyndte ved ca. 3 gange den kliniske eksponering.
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.
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 Behandlingstartpakken er ikke egnet til børn og unge, der vejer mindre end 50 kg.
English: • Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalised tonic-clonic seizures, status epilepticus).
Danish: • Bivirkninger, som patienterne oplevede efter indtagelse af mere end 800 mg, er svimmelhed, kvalme, opkastning, kramper (generaliserede toksisk-kloniske anfald, status epilepticus).
English: The bottle containing Lacosamide UCB syrup should be shaken well before use.
Danish: Flasken med Lacosamide UCB syrup skal omrystes grundigt inden brug.
English: Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Danish: • At være syg (opkastning), tør mund, forstoppelse, fordøjelsesbesvær, overdreven gas i mave eller tarm, diarré;
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18
Danish: Farmakoterapeutisk klassifikation: antiepileptiske lægemidler, øvrige antiepileptiske lægemidler, ATC-kode: N03AX18
English: Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer.
Danish: Farveløs type I-hætteglas af glas lukket med en chlorbutyl-gummiprop overtrukket med en fluorpolymer.
English: Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls.
Danish: Behandling med lacosamid er blevet forbundet med svimmelhed, der kan øge forekomsten af tilskadekomst eller fald.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) carbamazepine CR patients.
Danish: I et klinisk studie, som sammenlignede monoterapibehandling med lacosamid og carbamazepin CR, blev der rapporteret synkope hos 7/444 (1,6 %) af lacosamid-patienterne og hos 1/442 (0,2 %) af carbamazepin CR-patienterne.
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: This was reported with lacosamide in 4.8 % (3/62) in elderly patients versus 1.6 % (6/382) in younger adult patients.
Danish: For lacosamid blev dette rapporteret hos 4,8 % (3/62) af de ældre patienter versus 1,6 % (6/382) af de yngre voksne patienter.
English: When you take Lacosamide UCB with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Danish: Hvis De tager Lacosamide UCB sammen med anden medicin mod epilepsi - Behandlingsstart (de første 4 uger)
English: Erythema(4)
Danish: Erythem(4)
English: For most patients the maintenance dose is between 200 mg and 400 mg per day.
Danish: For de fleste patienter ligger vedligeholdelsesdosis mellem 200 mg og 400 mg dagligt.
English: Children (from 4 years of age) and adolescents weighing below 50 kg This presentation is not suitable for this category of patients.
Danish: Børn (fra 4 år) og unge, der vejer mindre end 50 kg Denne præsentation er ikke egnet til denne patientktegori.
English: Take the oral syringe out of the adaptor (figure 10).
Danish: • Tag den orale sprøjte ud af adapteren (figur 10).
English: In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.
Danish: Til patienter, der har nået en dosis over 400 mg/dag, og som har brug for et supplerende antiepileptikum, skal den nedenfor anførte anbefalede dosering for tillægsbehandling følges.
English: In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in patients less than 65 years of age.
Danish: I det kliniske studie med monoterapi, som sammenlignede lacosamid med carbamazepin CR, synes typen af bivirkninger relateret til lacosamid hos ældre patienter (≥ 65 år) at være tilsvarende den, som blev observeret hos patienter under 65 år.
English: Intermediate Carton
Danish: Indre karton
English: Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; Feeling angry or agitated;
Danish: • Tanker om at gøre skade på eller dræbe Dem selv eller selvmordsforsøg: Fortæl det straks til
English: Initiation of lacosamide treatment with a loading dose 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: Initiering af lacosamidbehandling med en støddosis 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.