FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
Danish: Behandling af patienter med nyresygdom i slutstadiet skal udføres med forsigtighed, da der er begrænset klinisk erfaring og akkumulation af en metabolit (med ukendt farmakologisk aktivitet).
English: Lacosamide is rapidly and completely absorbed after oral administration.
Danish: Lacosamid absorberes hurtigt og fuldstændigt efter oral indgift.
English: Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
Danish: Administration af støddosis er ikke blevet undersøgt under akutte tilstande, såsom status epilepticus.
English: In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported.
Danish: Hos patienter med proarytmiske tilstande er ventrikulær takyarytmi blevet rapporteret.
English: Cardiac conduction disorders, shock and coma have also been observed.
Danish: Der er også observeret tilfælde af kardielle overledningsforstyrrelser, shock og koma.
English: (only for the outer carton) Oral use
Danish: (kun for den ydre pakning) Oral anvendelse
English: Lacosamide UCB is used as a long term treatment.
Danish: Lacosamide UCB bruges som langtidsbehandling.
English: There are no adequate data from the use of lacosamide in pregnant women.
Danish: Der findes ingen adækvate data vedrørende anvendelse af lacosamid til gravide kvinder.
English: Additional side effects in children
Danish: Øvrige bivirkninger hos børn
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
Danish: • Hurtige og ukontrollerbare øjenbevægelser (nystagmus), sløret syn;
English: Antiepileptic medicinal products
Danish: Antiepileptiske lægemidler
English: The dose should be gradually adjusted until the optimum response is obtained.
Danish: Dosis skal gradvist justeres, indtil det optimale respons opnås.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er nævnt i pkt.
English: Once you have opened the syrup bottle, do not use beyond 2 months.
Danish: Når De har åbnet flasken med syrup, må De ikke bruge indholdet længere end 2 måneder.
English: This pack (treatment initiation pack) is used when you start your treatment with Lacosamide UCB.
Danish: Denne pakke (behandlingsstartpakken) skal bruges, når De starter på behandling med Lacosamide UCB.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Ikke relevant
English: Wash the oral syringe with water only (figure 13).
Danish: • Vask den orale sprøjte kun med vand (figur 13).
English: These changes included an increased organ weight, hypertrophy of hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and triglycerides.
Danish: Forandringerne omfattede øget organvægt, hypertrofi af hepatocytter, stigninger i leverenzymer i serum og stigninger i total kolesterol og triglycerider.
English: It is unknown whether the increased metabolite exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological activity of the metabolite has been identified.
Danish: Det vides ikke, om forøget eksponering for metabolitten hos personer med nyresygdom i slutstadiet kan forårsage stigning af bivirkningerne, men der er ikke identificeret nogen farmakologisk aktivitet af metabolitten.
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: This substance may be harmful for people with phenylketonuria (a rare metabolic disease).
Danish: Dette stof kan være skadeligt for mennesker med phenylketonuri (en sjælden stofskiftesygdom).
English: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products.
Danish: Multiorgan-overfølsomhedsreaktioner (også kaldet lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer, DRESS) er rapporteret hos patienter behandlet med visse antiepileptiske lægemidler.
English: The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.
Danish: Sikkerheden og effekten af lacosamid hos pædiatriske patienter med epilepsisyndrom, hvor fokale og generaliserede anfald kan eksistere sammen, er ikke blevet bestemt.
English: Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults.
Danish: Anfald af partiel type har et lignende klinisk udtryk hos børn fra 4 år som hos voksne.
English: Aspartame (E951): a source of phenylalanine.
Danish: • Aspartam (E 951): En kilde til phenylalanin.
English: Push the piston up to get rid of any bubbles (figure 7).
Danish: • Skub stemplet op for at slippe af med eventuelle bobler (figur 7).
English: The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week.
Danish: Pakken indeholder 4 forskellige æsker til de første 4 ugers behandling, én æske for hver uge.
English: This means that you should take care until you are used to the effects of this medicine.
Danish: Dette betyder, at De skal være forsigtig, indtil De har vænnet Dem til, hvilken virkning denne medicin har.
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: A dosing chart is provided below.
Danish: Et dosisskema er angivet nedenfor.
English: Potential for electro-clinical worsening in specific paediatric epilepsy syndromes
Danish: Potentiale for elektroklinisk forværring af specifikke pædiatriske epilepsisyndromer
English: Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier.
Danish: Studier med rotter viste, at lacosamid og/eller dets metabolitter nemt krydsede placentabarrieren.
English: Table: Start of the treatment (the first 4 weeks) Week Package to be used
Danish: Tabel: Behandlingsstart (de første 4 uger) Uge Æske, der skal bruges
English: Suicidal ideation and behaviour
Danish: Selvmordstanker og adfærd
English: Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
Danish: Blodprøver kan vise et alvorligt fald i en specifik klasse af hvide blodlegemer (agranulocytose);
English: The higher exposure was partly due to a reduced renal function in the studied subjects.
Danish: Den højere eksponering skyldtes til dels nedsat nyrefunktion hos de undersøgte patienter.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden og -forholdene inden anvendelse brugerens ansvar og bør ikke være længere end 24 timer ved 2 til 8 °C, medmindre fortyndingen er foregået under kontrollerede og validerede aseptiske forhold.
English: A general dose reduction is not considered to be necessary unless indicated due to reduced renal function (see section 4.2).
Danish: En generel dosisreduktion anses ikke for at være påkrævet, medmindre en sådan er indiceret på grund af nedsat nyrefunktion (se pkt.
English: Do not take Lacosamide UCB if any of the above applies to you.
Danish: Tag ikke Lacosamide UCB, hvis noget af ovenstående gælder for Dem.
English: In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400 mg/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: You would then start your ongoing maintenance dose 12 hours later.
Danish: De vil herefter starte langtidsbehandling med en vedligeholdelsesdosis 12 timer senere.
English: Following a 4-hour haemodialysis treatment, AUC of lacosamide is reduced by approximately 50 %.
Danish: Efter 4 timers hæmodialysebehandling nedsættes lacosamids AUC med ca. 50 %.
English: The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) and its O-desmethyl metabolite less than 30 %.
Danish: De vigtigste forbindelser, der udskilles i urinen, er uomdannet lacosamid (ca. 40 % af dosis) og dets O-desmethyl-metabolit mindre end 30 %.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2)
Danish: Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)(1,2)
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: Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.
Danish: Der er rapporteret om dødsfald hos patienter efter en akut overdosering med en enkeltdosis på flere gram lacosamid.
English: Atrioventricular block(1,2)
Danish: Atrioventrikulært blok(1,2)
English: The safety and efficacy of lacosamide in children aged below 4 years have not yet been established.
Danish: Lacosamids sikkerhed og virkning hos børn under 4 år er endnu ikke klarlagt.
English: The solution for infusion is infused over a period of 15 to 60 minutes twice a day.
Danish: Infusionsvæsken infunderes over 15 til 60 minutter to gange daglig.
English: In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
Danish: In vitro-elektrofysiologiske studier har vist, at lacosamid selektivt øger den langsomme inaktivering af de spændingsstyrede natriumkanaler, der medfører en stabilisering af de hyperexcitable neuronale membraner.
English: A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was detected only in small amounts (0-2 %) in human plasma of some subjects.
Danish: En polær fraktion, der formodes at være serin-derivater, tegnede sig for ca. 20 % i urinen, men kunne kun påvises i små mængder (0-2 %) i plasma hos visse patienter.
English: This is because Lacosamide UCB may make you feel dizzy or cause blurred vision.
Danish: Dette skyldes, at Lacosamide UCB kan gøre Dem svimmel eller forårsage sløret syn.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
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 skade eller dræbe sig selv.
English: * The colourants are:
Danish: * Farvestofferne er:
English: Swallow the Lacosamide UCB tablet with a glass of water.
Danish: • Slug Lacosamide UCB-tabletten med et glas vand.
English: Lacosamide UCB can be started by: - taking the medicine by mouth or - by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse.
Danish: • Lacosamide UCB kan opstartes ved: - At tage medicinen igennem munden eller - Ved at få den som en intravenøs infusion (også kaldet en "IV-infusion"), hvor lægemidlet indgives i Deres blodåre af en læge eller sygeplejerske.
English: Chemin du Foriest B-1420 Braine-L'Alleud BELGIUM
Danish: Chemin du Foriest B-1420 Braine-l'Alleud BELGIEN
English: These reactions are variable in expression, but typically present with fever and rash and can be associated with involvement of different organ systems.
Danish: Disse reaktioner er af varierende form, men typisk ses feber og udslæt, og forskellige organsystemer kan inddrages.
English: • Runny nose (nasopharyngitis);
Danish: • Løbende næse (nasopharyngitis);
English: After oral and intravenous administration of radiolabeled lacosamide, approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the faeces.
Danish: Efter oral og intravenøs indgift af radioaktivt mærket lacosamid blev ca. 95 % af den indgivne radioaktivitet genfundet i urinen og under 0,5 % i fæces.
English: The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Danish: Lægen skal ordinere den passende formulering og styrke i henhold til vægt og dosis.
English: The patients had to present with unprovoked partial-onset seizures with or without secondary generalisation.
Danish: Patienterne skulle have uprovokerede partielle anfald med eller uden sekundær generalisering.
English: Single loading dose (if applicable)
Danish: Enkelt støddosis (hvis relevant)
English: Solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Danish: Infusionsvæske er et alternativ til patienter, når oral indgift midlertidigt ikke er mulig.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Danish: Indehaver af markedsføringstilladelsen UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgien.
English: Do not stop treatment without talking to your doctor first as this could increase your fits (seizures).
Danish: Stop ikke behandlingen uden først at tale med Deres læge, da dette kan øge antallet af anfald (krampeanfald).
English: Any unused solution should be discarded.
Danish: Al ubrugt opløsning skal kasseres.
English: The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
Danish: Det aktive stof, lacosamid (R-2-acetamid-N-benzyl-3-methoxypropionamid), er en funktionaliseret aminosyre.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine (see section 4.8).
Danish: Patienterne bør derfor rådes til at udvise forsigtighed, indtil de er fortrolige med medicinens mulige virkninger (se pkt.
English: Lacosamide has a low protein binding of less than 15 %.
Danish: Lacosamid har en lav proteinbinding på under 15 %.
English: In absence of haemodialysis in patients with end-stage renal disease, the levels were increased and continuously rising during the 24-hour sampling.
Danish: Ved fravær af hæmodialyse hos patienter med nyresygdom i slutstadiet var niveauerne forhøjet og steg uafbrudt under 24-timers prøvetagningen.
English: In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only marginally higher than those observed in patients, which leaves low or non-existing margins to human exposure.
Danish: I toksicitetsstudierne var de opnåede lacosamid plasmakoncentrationer lig med eller kun en anelse højere end dem, man observerede hos patienter, hvorfor marginen for human eksponering er lille eller ikke-eksisterende.
English: (2) Dosage in adolescents 50 kg or more is the same as in adults.
Danish: (2) Dosering hos unge på 50 kg eller mere er den samme som hos voksne.
English: When you reach the dose that works for you, this is called the “maintenance dose”, you then take the same amount each day.
Danish: Når De når den dosis, der virker for Dem, kaldes dette "vedligeholdelsesdosis".
English: SPECIAL STORAGE CONDITIONS Do not refrigerate.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares i køleskab.
English: Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal impairment' and section 5.2).
Danish: Aldersrelateret nedsat renal clearance med en stigning i AUC-niveauerne bør overvejes hos ældre patienter (se afsnittet ”Nedsat nyrefunktion” nedenfor og pkt.
English: Following oral administration, the plasma concentration of unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose.
Danish: Efter oral indgift stiger plasmakoncentrationen af intakt lacosamid hurtigt og når Cmax ca. 0,5 til 4 timer efter dosisindtagelsen.
English: Blood tests may show abnormal liver function, liver injury;
Danish: • Blodprøver kan vise unormal leverfunktion, leverskade;
English: An infusion duration of at least 30 minutes for administration > 200 mg per infusion (i.e. > 400 mg/day) is preferred.
Danish: Der anbefales, at infusionsvarigheden er mindst 30 minutter ved administration af > 200 mg pr. infusion (dvs. > 400 mg/dag).
English: Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.
Danish: Behandling med lacosamid kan også indledes med 100 mg to gange daglig, baseret på lægens vurdering af den nødvendige anfaldsreduktion versus potentielle bivirkninger.
English: Your doctor will work out the right dose for you:
Danish: Lægen vil udarbejde den rigtige dosis til Dem:
English: A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted.
Danish: En støddosis kan anvendes til patienter, hvor lægen vurderer, at hurtig opnåelse af steady state plasmakoncentrationer af lacosamid og terapeutisk effekt er påkrævet.
English: Listed below are the normal recommended doses of Lacosamide UCB for different age groups and weights.
Danish: Nedenfor er de normale anbefalede doser af Lacosamide UCB til forskellige aldersgrupper og vægte angivet.
English: Not known: frequency cannot be estimated from available data Changes in behaviour, not acting like themselves.
Danish: Ikke kendt: frekvensen kan ikke vurderes ud fra tilgængelige data • Ændringer i adfærd, virker ikke som sig selv.
English: Put the adaptor into the top of the bottle (figure 3).
Danish: • Sæt adapteren i toppen af flasken (figur 3).
English: Lacosamide UCB 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 UCB-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: Uncommon: may affect up to 1 in 100 children Feeling sleepy or lacking in energy (lethargy).
Danish: Ikke almindelige: kan påvirke op til 1 ud af 100 børn • Træthedsfølelse eller manglende energi (letargi).
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: In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Danish: Hos patienter, som udvikler alvorlig hjertearytmi, skal der foretages en klinisk benefit/risk-vurdering, og om nødvendigt skal lacosamid seponeres.
English: Pull the piston down to fill the oral syringe with a small amount of solution (figure 6).
Danish: • Træk stemplet ned for at fylde den orale sprøjte med en lille mængde opløsning (figur 6).
English: o there are 3.5 mg sodium in each 2.5 ml dose from the oral syringe.
Danish: o Der er 3,5 mg natrium i hver 2,5 ml dosis fra den orale sprøjte.
English: The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Danish: Eksponeringen af O-desmethyl-metabolitten var forhøjet adskillige gange hos patienter med moderat og alvorlig nedsat nyrefunktion.
English: No adverse reactions on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).
Danish: Der er ikke observeret skadelige virkninger på fertilitet eller reproduktion hos han- og hunrotter ved doser, der øger plasmaeksponering (AUC) op til ca. 2 gange plasma-AUC hos mennesker ved den maksimalt anbefalede humane dosis (MRHD).
English: Following twice daily dosing, steady state plasma concentrations are achieved after a 3 day period.
Danish: Med dosering to gange daglig nås steady-state plasmakoncentrationerne efter 3 dage.
English: Irritability Feeling drunk Injection site pain or discomfort (4) Irritation(4)
Danish: Smerte eller ubehag i injektionsstedet(4) Irritation(4)
English: Lacosamide UCB may be used on its own or with other antiepileptic medicines.
Danish: • Lacosamide UCB kan bruges alene eller med andre antiepileptiske lægemidler.
English: The volume of distribution is approximately 0.6 L/kg.
Danish: Fordelingsvolumet er ca. 0,6 l/kg.
English: The metabolism of lacosamide has not been completely characterised.
Danish: Lacosamids metabolisme er ikke komplet beskrevet.
English: Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks.
Danish: Lacosamid bør kun anvendes til voksne og pædiatriske patienter med svært nedsat leverfunktion, når de terapeutiske fordele forventes at opveje de mulige risici.
English: In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects.
Danish: I ikke-kliniske studier viste lacosamid i kombination med levetiracetam, carbamazepin, phenytoin, valproat, lamotrigin, topiramat eller gabapentin synergistiske eller additive antikonvulsive effekter.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant
English: The table below shows the frequencies of adverse reactions which have been reported in clinical trials and post-marketing experience.
Danish: Nedenstående tabel viser hyppigheden af bivirkninger, der er rapporteret i kliniske studier og postmarketing erfaring.
English: Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
Danish: Fyld målebægeret til milliliter (ml) dosismærket ordineret af Deres læge.
English: Risk related to epilepsy and antiepileptic medicinal products in general 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: Risiko relateret til epilepsi og antiepileptiske lægemidler generelt 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: In the elderly population, the maintenance lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the dose was escalated to over 400 mg/day in 1 patient (1.6 %).
Danish: Hos den ældre population var vedligeholdelsesdosis af lacosamid 200 mg/dag hos 55 patienter (88,7 %), 400 mg/dag hos 6 patienter (9,7 %), og dosis blev titreret op til over 400 mg/dag hos 1 patient (1,6 %).