FrancophonIA/ELRC3.0 huggingface dataset:
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Danish: Lægen bør ordinere den mest hensigtsmæssige lægemiddelform, formulering og styrke afhængigt af alder, vægt og dosis.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Danish: Patienter (og plejepersonale) bør rådes til straks at kontakte læge, hvis der opstår tegn på depression og/eller selvmordstanker eller -adfærd.
English: For adults and children aged 4 years and older
Danish: Til voksne og børn fra 4 år og ældre
English: Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Danish: Forekomsten er betydeligt højere hos patienter af japansk afstamning i forhold til patienter af ikke-japansk afstamning.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Danish: Medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), hypersensitivitet (inklusive angioødem og anafylaksi)
English: Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Danish: Maksimale plasmakoncentrationer (Cmax) opnås 1,3 time efter indtagelse.
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Danish: Farmakokinetiske resultater indikerer, at halveringstiden var kortere (5,3 timer) end for voksne (7,2 timer), og clearance er tilsyneladende hurtigere (1,5 ml/min/kg) end hos voksne (0,96 ml/min/kg).
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Danish: Dog oplevede individer behandlet med levetiracetam i langtids-openlabelopfølgningsundersøgelsen i gennemsnit ikke forværring af deres adfærds- og følelsesmæssige funktion; særligt blev graden af aggressiv adfærd ikke forværret i forhold til baseline.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig eller planlægger at tage anden medicin.
English: There is no modification of the clearance after repeated administration.
Danish: Der ses ikke ændringer i clearance efter gentagen dosering.
English: In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
Danish: Hos personer med let og moderat leverfunktionsnedsættelse fandtes der ikke nogen relevant ændring af levetiracetamclearance.
English: Empty the contents of the syringe in a glass of water by pushing down the plunger.
Danish: Tøm indholdet af sprøjten i et glas med vand ved at skubbe stemplet ned.
English: More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Danish: Mere end halvdelen af patienterne forblev anfaldsfrie i 12 måneder (hhv. 56,6 % på levetiracetam og 58,5 % på carbamazepin CR).
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Danish: Der findes kun begrænset evidens på neuroudvikling hos børn udsat for levetiracetam monoterapi in utero.
English: No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Danish: Der blev ikke identificeret nye sikkerhedsmæssige betænkeligheder ved levertiracetam hos spædbørn under 12 måneder med epilepsi.
English: The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 24% of the dose, respectively during the first 48 hours.
Danish: Den akkumulerede urinudskillelse af levetiracetam og dets primære metabolit var indenfor de første 48 timer henholdsvis 66 % og 24 % af dosis.
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Danish: Patienterne skulle have uprovokerede partielle anfald eller have generaliserede tonisk-kloniske anfald.
English: The apparent body clearance was 1.1 ml/min/kg.
Danish: Den tilsyneladende clearance fra kroppen var 1,1 ml/min/kg.
English: • decreased number of all blood cell types;
Danish: • nedsat antal af alle typer blodlegemer;
English: The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Danish: Plamahalveringstiden for levetiracetam hos voksne var 7±1 timer og påvirkedes hverken af dosis, administrationsvej eller gentagen dosering.
English: In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
Danish: I begge disse aldersgrupper er data suppleret med erfaringer fra anvendelse af levetiracetam efter markedsføring.
English: Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Danish: Sikkerhedsresultaterne for pædiatriske patienter, som deltog i de placebokontrollerede kliniske studier, var i overensstemmelse med levetiracetams sikkerhedsprofil hos voksne bortset fra adfærdsmæssige og psykiatriske bivirkninger, som var hyppigere hos børn end hos voksne.
English: Therefore there is no need for plasma level monitoring of levetiracetam.
Danish: Der er derfor ikke behov for monitorering af plasmakoncentrationen af levetiracetam.
English: This leaflet was last revised in {month/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ }
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Danish: Undersøgelsen konkluderede, at levetiracetam ikke adskilte sig fra placebo (noninferiort) i forhold til ændring fra baseline med hensyn til Leiter-R Opmærksomhed og Hukommelse, Hukommelsesscreening samlede score per-protokol population.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Danish: Epilepsi er en tilstand, hvor patienter har gentagne anfald.
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Danish: Bivirkninger som ikke var observeret i kliniske studier, men set hos rotte og i mindre udstrækning hos mus ved eksponeringsniveauer der svarede til eksponeringsniveauet hos menneske og med mulig relevans for klinisk anvendelse, var leverændringer, som tyder på et adaptivt respons så som vægtstigning, centrilobulær hypertrofi, fedtinfiltration og forhøjede leverenzymer i plasma.
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Danish: Det primære mål for effektivitet var responsraten (procent af patienter med ≥ 50 % reduktion i frekvensen af daglige partielle anfald i forhold til baseline) vurderet af en centralt blindet læser ved brug af 48 timers video EEG.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. ml, dvs. den er i det væsentlige natrium-fri.
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Danish: Retrospektiv vurdering af farmakokinetiske interaktioner hos børn og unge (4 til 17 år) med epilepsi bekræftede, at samtidig behandling med oralt administreret levetiracetam ikke havde indflydelse på steady-state serumkoncentrationer af samtidigt administreret carbamazepin og valproat.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam, er et pyrrolidon derivat (S-enantiomer af α-ethyl-2-oxo-1-pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.
English: Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Danish: Kontakt omgående lægen eller skadestuen, hvis De oplever:
English: Levetiracetam is rapidly absorbed after oral administration.
Danish: Levetiracetam absorberes hurtigt efter oral indgift.
English: End-stage renal disease patients undergoing dialysis (1)
Danish: Patienter i slutstadiet af nyresygdom, som får dialyse (1)
English: In the population pharmacokinetic analysis conducted in patients from 1 month to 16 years of age, body weight was significantly correlated to apparent clearance (clearance increased with an increase in body weight) and apparent volume of distribution.
Danish: I den populationsbaserede farmakokinetiske analyse udført med patienter i alderen fra 1 måned til 16 år var kropsvægten korreleret til den tilsyneladende clearance (clearance steg med øget kropsvægt) og tilsyneladende fordelingsvolumen i signifikant grad.
English: Infants and children (1 month to 4 years)
Danish: Spædbørn og børn (1 måned til 4 år)
English: However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Danish: Hvis behandling med levetiracetam imidlertid er nødvendig under amning, skal fordele/risici ved behandlingen afvejes i forhold til fordele ved amning.
English: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
Danish: Der er rapporteret fald i methotraxat-clearance ved samtidig administration af levetiracetam og methotrexat, hvilket resulterede i forhøjet/forlænget methotrexat-koncentration i blodet til potentielt toksiske niveauer.
English: In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
Danish: Hos patienter med svært nedsat leverfunktion, kan kreatininclearance underestimere nyreinsufficiensen.
English: Push the plunger in slowly to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 7).
Danish: Træk langsomt stemplet til mærket der svarer til den mængde i milliliter (ml), som din læge har foreskrevet (figur 7).
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Danish: Levetiracetam er et antiepileptisk lægemiddel (et lægemiddel, som anvendes til behandling af epileptiske anfald)
English: ks= 0.45 in term infants to 1 year old; ks= 0.55 in children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Danish: Serumkreatinin (mg/dl)ks= 0,45 hos spædbørn op til 1 år; ks= 0,55 hos børn under 13 år og hos unge kvinder; ks= 0,7 hos unge drenge.
English: These could be symptoms of an encephalopathy.
Danish: Disse symptomer kan være tegn på hjernepåvirkning (encefalopati).
English: The dose level of 1,800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies.
Danish: Dosisniveauet på 1.800 mg/kg/dag inducerede markant maternel toksicitet samt et fald i fostervægt associeret med en øget forekomst af fostre med kardiovaskulære/skeletale anomalier.
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Danish: Præ-marketing data fra kliniske undersøgelser med voksne tyder på, at levetiracetam ikke påvirker serumkoncentrationerne af eksisterende antiepileptika (phenytoin, carbamazepin, valproat, phenobarbital, lamotrigin, gabapentin og primidon), og at disse antiepileptika ikke påvirker levetiracetams farmakokinetik.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
Danish: • et udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsorganerne (Stevens-Johnson syndrom)
English: This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
Danish: Dette bindingssted er det synaptiske vesikel protein 2A, som formodes at være involveret i vesikelfusion og exocytose af neurotransmittere.
English: Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Danish: Peak-plasmakoncentration blev observeret 0,5 til 1,0 timer efter dosering.
English: A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Danish: Signifikant korrelation mellem spyt- og plasmakoncentrationer er blevet påvist hos voksne og børn (ratio af spyt/plasmakoncentrationer strakte sig fra 1 til 1,7 for henholdsvis orale tabletformuleringer og orale opløsningsformuleringer 4 timer efter dosering).
English: Ear and labyrinth disorders
Danish: Øre og labyrinth
English: The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
Danish: In vitro data og in vivo interaktionsdata med orale antikonceptionsmidler, digoxin og warfarin viste, at der ikke kan forventes signifikant enzyminduktion in vivo.
English: In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Danish: I en samlet analyse var den procentdel af patienterne, som opnåede 50 % eller større reduktion fra baseline i frekvensen af partielle anfald pr. uge ved stabil dosis (12/14 uger) på 27,7 %, 31,6 % og 41,3 % for patienter, som fik hhv. 1.000, 2.000 eller 3.000 mg levetiracetam og på 12,6 % hos patienter, som fik placebo.
English: The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
Danish: Risikoen for anoreksi er større, når levetiracetam administreres samtidigt med topiramat.
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Danish: Desuden påvirker levetiracetam ikke in vitro glukuronidering af valproatsyre.
English: Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Danish: Levetiracetam giver beskyttelse i en lang række dyrestudiemodeller med partielle og primært generaliserede anfald uden at udvise en pro-konvulsiv virkning.
English: • If you notice any slow down in the growth or unexpected puberty development of your child,
Danish: • Hvis du bemærker en stagnation i væksten eller uventet pubertetsudvikling hos dit barn, så kontakt din læge.
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Danish: Disse data er suppleret med data fra brug af levetiracetam i tilsvarende åbne forlængede studier og erfaringer efter markedsføring.
English: To measure the dosing quantity, use one hand to hold the dosing body and the other hand to pull up the plunger until you reach the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 1).
Danish: Til måling af doseringsmængden bruges den ene hånd til at holde fast på doseringsdelen mens den anden hånd bruges til at trække op i stemplet indtil du når mærket, der svarer til den mængde i milliliter (ml) som lægen har foreskrevet (figur 1).
English: A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har vist en let øget risiko for selvmordstanker og -adfærd.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplika tioner
English: The administration of levetiracetam to patients with renal impairment may require dose adjustment.
Danish: Anvendelse af levetiracetam til patienter med nedsat nyrefunktion kan kræve dosisjustering.
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Danish: Nedenfor nævnte bivirkningsprofil er baseret på analyse af sammenfattede placebokontrollerede kliniske studier med alle indikationer med i alt 3.416 patienter, der blev behandlet med levetiracetam.
English: • weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
Danish: • svaghed, føler Dem ør i hovedet eller svimmel, eller har vejrtrækningsbesvær, da disse symptomer kan være tegn på en alvorlig allergisk (anafylaktisk) reaktion
English: Do not use after 7 months of first opening the bottle.
Danish: Skal anvendes indenfor 7 måneder efter første åbning af flaske.
English: 43.6% of the levetiracetam treated patients and 19.6% of the patients on placebo were considered as responders.
Danish: 43,6 % af de patienter, som blev behandlet med levetiracetam, og 19,6 % af de patienter, som fik placebo, blev betragtet som responderende.
English: For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Danish: Til børn med nedsat nyrefunktion skal levetiracetam dosis justeres i forhold til nyrefunktionen, da levetiracetamclearance er afhængigt af nyrefunktionen.
English: Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
Danish: Der er blevet beskrevet sjældne tilfælde med fald i blodcelletallet (neutropeni, agranulocytose, leukopeni, trombocytopeni og pancytopeni) i forbindelse med administration af levetiracetam, især i begyndelsen af behandlingen.
English: • weight decrease, weight increase;
Danish: • vægttab, vægtstigning;
English: The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Danish: Renal udskillelse af levetiracetam og ucb L057 er henholdsvis 0,6 og 4,2 ml/min/kg, hvilket tyder på at levetiracetam udskilles ved hjælp af glomerulær filtration og efterfølgende tubulær reabsorption og at den primære metabolit også udskilles ved hjælp af aktiv tubulær sekretion som tillæg til glomerulær filtration.
English: There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam.
Danish: Der foreligger enkeltstående indberetninger om nedsat effekt af levetiractam i tilfælde, hvor osmotisk afførende macrogol blev administreret samtidig med oral levetiracetam.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres frekvens er defineret på følgende måde: 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) og meget sjælden (<1/10.000).
English: The extent of absorption is dose-independent and is not altered by food.
Danish: Absorptionen er ikke dosisafhængig og ændres ikke ved fødeindtagelse.
English: • symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
Danish: • symptomer, såsom nedsat urinmængde, træthed, kvalme, opkastning, forvirring og hævelse af benene, anklerne eller fødderne, da disse kan være tegn på pludseligt nedsat nyrefunktion
English: Results related to behavioral and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Danish: Resultater relateret til adfærds- og følelsesmæssig funktion indikerede en forværring i aggressiv adfærd, vurderet ved brug af et systematisk og valideret instrument (CBLC - Achenbach Child Behaviour Checklist), hos patienter behandlet med levetiracetam.
English: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Danish: Levetiracetam påvirker i mindre grad eller i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/ kg twice daily every two weeks).
Danish: Hvis behandlingen med levetiracetam skal afbrydes, anbefales det at seponere gradvist (f.eks. for voksne og unge, som vejer mere end 50 kg: reduktion med 500 mg to gange dagligt hver anden til fjerde uge; for spædbørn over 6 måneder, børn og unge, som vejer under 50 kg: dosis bør ikke reduceres med mere end 10 mg/kg to gange dagligt hver anden uge; for spædbørn (under 6 måneder): dosis bør ikke reduceres med mere end 7 mg/kg to gange dagligt hver anden uge).
English: The patients were randomized to carbamazepine CR 400 - 1,200 mg/day or levetiracetam 1,000 - 3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Danish: Patienterne blev randomiseret til carbamazepin CR 400-1.200 mg/dag eller levetiracetam 1.000-3.000 mg/dag, varigheden af behandlingen var op til 121 uger afhængigt af respons.
English: 300 ml oral solution
Danish: 300 ml oral opløsning
English: Excretion via faeces accounted for only 0.3% of the dose.
Danish: Udskillelse via fæces omfattede kun 0,3 % af dosis.