FrancophonIA/ELRC3.0 huggingface dataset:
English: Should your doctor decide to stop your Levetiracetam Actavis Group treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Actavis Group.
Danish: Hvis lægen beslutter at stoppe din behandling med Levetiracetam Actavis Group, vil han/hun instruere dig i, hvordan du gradvist skal ophøre med at tage Levetiracetam Actavis Group.
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP:.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og flasken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The majority of patients presented with juvenile myoclonic epilepsy.
Danish: De fleste af patienterne havde juvenil myoklon epilepsi.
English: The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Danish: Den farmakokinetiske profil er sammenlignelig hos raske forsøgspersoner og hos patienter med epilepsi.
English: In both population pharmacokinetic analyses, there was about a 20% increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
Danish: I begge populationsbaserede farmakokinetiske analyser var der omkring 20 % stigning i den tilsyneladende clearance for levetiracetam, når levetiracetam blev administreret samtidig med et enzyminducerende antiepileptikum.
English: The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response.
Danish: Dosis kan øges med yderligere 250 mg to gange daglig hver anden uge, afhængig af den kliniske effekt.
English: Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Danish: Det anbefales, at foretage en komplet blodtælling hos patienter, som oplever betydelig svækkelse, pyreksi, tilbagevendende infektioner eller koagulationsforstyrrelser (se pkt.
English: Thrombocytopenia, leukopenia
Danish: Trombocytopeni, leukopeni
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Danish: Justering af dosis anbefales hos ældre patienter med nedsat nyrefunktion (se “Nedsat nyrefunktion” nedenfor).
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Danish: • et mere alvorligt udslæt, der forårsager afskalning af huden på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse)
English: The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the creatinine clearance.
Danish: Den tilsyneladende clearance af levetiracetam og dens primære metabolit fra kroppen er korreleret til kreatininclearance.
English: Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Danish: Levetiracetam 1.000 mg daglig påvirker ikke farmakokinetikken af orale kontraceptiva (ethinylestradiol og levonorgestrel); endokrine parametre (luteiniserende hormon og progesteron) blev ikke ændret.
English: Levetiracetam is a highly soluble and permeable compound.
Danish: Levetiracetam er en højt opløselig og permeabel substans.
English: Contact your doctor if you took more Levetiracetam Actavis Group than you should.
Danish: Kontakt lægen, hvis du har mere Levetiracetam Actavis Group, end du burde.
English: Push the plunger down slowly to introduce air inside the bottle (Figure 3).
Danish: Skub stemplet langsomt ned for at indføre luft ind i flasken (figur 3).
English: Turn the bottle the right way up and remove the syringe (Figure 8).
Danish: Vend flasken den rigtige vej op og fjern sprøjten (figur 8).
English: Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
Danish: Levetiracetam må kun anvendes under graviditeten, hvis Deres læge efter omhyggelig vurdering mener, at det er nødvendigt.
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Danish: Sikkerhedsprofilen for levetiracetam er generelt den samme på tværs af aldersgrupper (voksne og pædiatriske patienter) og for alle godkendte epilepsi-indikationer.
English: Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Danish: Der er observeret fald i plasmakoncentration af levetiracetam under graviditet.
English: Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Danish: Lineær og dosisproportional stigning blev observeret for peak-plasmakoncentrationer og AUC.
English: No enantiomeric interconversion was evidenced in vivo for either levetiracetam or its primary metabolite.
Danish: In vivo blev der ikke påvist enantiomerisk omdannelse for levetiracetam og dets primære metabolit.
English: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Danish: Lægen vil ordinere den mest hensigtsmæssige lægemiddelform af Levetiracetam Actavis Group afhængigt af alder, vægt og dosis.
English: In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours during interdialytic and intradialytic periods, respectively.
Danish: Hos voksne patienter i anurisk slutstadium af nyresygdom var halveringstiden henholdsvis ca. 25 og 3,1 timer mellem og i dialyseperioderne.
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Danish: Hos spædbørn og børn i alderen 1 måned til under 4 år blev der hyppigere rapporteret om irritabilitet (meget almindelig, 11,7 %) og koordinationsforstyrrelser (almindelig, 3,3 %) end i andre aldersgrupper eller i den samlede sikkerhedsprofil.
English: Levetiracetam is not extensively metabolised in humans.
Danish: Levetiracetam metaboliseres ikke i udtalt grad hos mennesker.
English: • Levetiracetam Actavis Group is used as a chronic treatment.
Danish: • Levetiracetam Actavis Group anvendes til kronisk behandling.
English: Dose in adults and adolescents (12 to 17 years):
Danish: Dosis til voksne og unge (12 til 17 år):
English: • sudden decrease in kidney function;
Danish: • pludseligt nedsat nyrefunktion;
English: The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Danish: Den farmakokinetiske profil er lineær med lille variation hos det enkelte individ og mellem individer.
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Danish: Levetiracetam og beslægtede analoger udviser en rangordnet affinitet for binding til det synaptiske vesikelprotein 2A, som korrelerer med styrken af deres anti-anfalds beskyttelse i den audiogene epilepsimodel hos mus.
English: • decreased number of blood platelets, decreased number of white blood cells;
Danish: • nedsat antal blodplader og hvide blodlegemer;
English: This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
Danish: Dette fund tyder på, at interaktionen mellem levetiracetam og det synaptiske vesikelprotein 2A ser ud til at bidrage til lægemidlets antiepileptiske virkningsmekanisme.
English: Pull the plunger down and fill the syringe with a quantity of solution slightly beyond the prescribed dose (Figure 5).
Danish: Træk stemplet ned og fyld sprøjten med en mængde opløsning lidt ud over den anviste dosis (figur 5).
English: In most subjects with severe hepatic impairment, the clearance of levetiracetam was reduced by more than 50% due to a concomitant renal impairment (see section 4.2).
Danish: Hos de fleste personer med svært nedsat leverfunktion var levetiracetamclearance nedsat med mere end 50 % på grund af samtidig nyrefunktionsnedsættelse (se pkt.
English: No tissue distribution data are available in humans.
Danish: Der foreligger ingen data vedrørende vævsfordeling hos mennesker.
English: • swelling of the face, lips, tongue and throat (Quincke's oedema);
Danish: • hævelse af ansigt, læber, tunge eller svælg (Quinckes ødem)
English: In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Danish: Hos patienter med svært nedsat leverfunktion anbefales bestemmelse af nyrefunktion før valg af dosis (se pkt.
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
Danish: In vitro undersøgelser viste, at levetiracetam og dets primære metabolit ikke hæmmer de vigtigste human lever cytochrom P450 isoformer (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 og 1A2), glucuronyltransferase (UGT1A1 og UGT1A6) og epoxid hydroxylase aktiviteter.
English: lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
Danish: (mangel på energi og entusiasme), tremor (ufrivillig rysten);
English: Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam.
Danish: Det er påvist, at probenecid (500 mg fire gange daglig), en substans som blokerer den tubulære sekretion i nyrerne, hæmmer renal udskillelse af den primære metabolit, men ikke af levetiracetam.
English: Dose in children 50 kg or greater is the same as in adults.
Danish: Dosis til børn, som vejer 50 kg eller mere, er den samme som til voksne.
English: The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Danish: Brug af levetiracetam er i meget sjældne tilfælde blevet forbundet med akut nyreskade, som indtræffer fra få dage til flere måneder efter behandlingsstart.
English: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Danish: • rabdomyolyse (nedbrydning af muskelvæv) og forbundet med forhøjet indhold af kreatinkinase i blodet.
English: Peak concentrations (Cmax) are typically 31 and 43 µg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Danish: Maksimale koncentrationer er (Cmax) er normalt 31 og 43 ug/ml efter henholdsvis en enkelt dosis på 1.000 mg og gentagen dosering 1.000 mg 2 gange daglig.
English: Propylene glycol (E1520)
Danish: Propylenglycol (E1520)
English: Each ml contains 100 mg of levetiracetam.
Danish: Hver ml indeholder 100 mg levetiracetam.
English: • a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme);
Danish: • et hududslæt, der kan danne blærer, og som ligner små skydeskiver (mørk plet i midten omgivet af et blegere område, med en mørk ring om kanten) (erythema multiforme)
English: Weight decreased , weight increase
Danish: Vægttab, vægtstigning
English: Pancytopenia, neutropenia, agranulocytosis
Danish: Pancytopeni, neutropeni, agranulocytose
English: Creatinine clearance (ml/min/1.73m2)
Danish: Kreatininclearance (ml/min/1.73m2)
English: 35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
Danish: 35 spædbørn under 1 år med partiel epilepsi har været eksponeret i et placebokontrolleret klinisk studie, heraf var kun 13 yngre end 6 måneder.
English: Dose and frequency (1) Infants 1 to less than 6 months
Danish: Dosis og hyppighed (1) Spædbørn fra 1 måned til under 6 måneder
English: The mean total body clearance was 0.96 ml/min/kg.
Danish: Den gennemsnitlige helkrops clearance var 0,96 ml/min/kg.
English: This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
Danish: Denne pakningsstørrelse bør ordineres til børn over 4 år, unge og voksne.
English: At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Danish: Kun i ét af de to embryo-føtale udviklingsstudier med 3.600 mg/kg/dag var der et lille fald i fostervægt forbundet med en marginal forøgelse af skeletale ændringer/mindre anomalier.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Levetiracetam Actavis Group på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: The content of the syringe can also be emptied in a glass of water or baby´s bottle.
Danish: Indholdet af sprøjten kan også udtømmes i et glas vand eller i en sutteflaske.
English: Monotherapy for adults and adolescents from 16 years of age
Danish: Monoterapi til voksne og unge over 16 år
English: Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520).
Danish: Indeholder E216, E218, flydende maltitol (E965) og propylenglycol (E1520).
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Danish: Efter en akut overdosis bør maven tømmes ved hjælp af maveskylning og induktion af opkastning.
English: Infants 6 to 23 months, children and adolescents weighing less than 50 kg
Danish: Spædbørn mellem 6 og 23 måneder, børn og unge som vejer under 50 kg
English: Asthenia/fatigue
Danish: Asteni/træthed
English: Alopecia, eczema, pruritus,
Danish: Alopeci, eksem, pruritus
English: • flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
Danish: • influenzalignende symptomer og udslæt i ansigtet, som efterfølges af udbredt udslæt med feber, forhøjede leverenzymniveauer i blodprøver og et forhøjet antal af en bestemt type hvide blodlegemer (eosinofili) og forstørrede lymfekirtler (lægemiddelreaktion med eusinofili og systemiske reaktioner [DRESS])
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Danish: Effekten af levetiracetam blev påvist i et 24 ugers dobbeltblindt placebokontrolleret forsøg, som omfattede voksne og unge samt et begrænset antal børn med idiopatisk generaliseret epilepsi med primært generaliserede tonisk-kloniske anfald (PGTC) i forskellige syndromer (juvenil myoklon epilepsi, juvenil absence epilepsi, børne absence epilepsi eller epilepsi med Grand Mal anfald ved opvågning).
English: In this study, the patients received levetiracetam as a fixed dose of 60 mg/kg/day (with twice a day dosing).
Danish: I dette forsøg fik patienterne levetiracetam som en fast dosis på 60 mg/kg/dag (fordelt på to doser daglig).
English: In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
Danish: Levetiracetam fremkaldte ikke enzyminduktion i dyrkede humane hepatocytter, og levetiracetam havde ingen eller lille effekt på CYP1A2, SULT1E1 eller UGT1A1.
English: Specialist advice should be given to women who are of childbearing potential.
Danish: Der bør gives medicinsk specialistrådgivning til kvinder i den fertile alder.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
Danish: • myoklone anfald (korte, chok-lignende ryk i en muskel eller i en gruppe af muskler) hos voksne og unge over 12 år med juvenil myoklon epilepsi
English: 58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Danish: 58,3 % af de patienter, som fik levetiracetam, og 23,3 % af de patienter, som fik placebo, havde mindst 50 % reduktion i antal dage med myoklone anfald pr. uge.
English: Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Danish: Efter gentagen oral dosering (20 til 60 mg/kg/dag) til epileptiske børn (4-12 år) blev levetiracetam hurtigt absorberet.
English: 233 of these patients were treated with levetiracetam in placebo-controlled studies.
Danish: 233 af disse patienter blev behandlet med levetiracetam i placebokontrollerede studier.
English: Levetiracetam Actavis Group treatment for as long as your doctor has told you.
Danish: Du skal fortsætte behandling med Levetiracetam Actavis Group i så lang tid, som din læge har fortalt dig.
English: Instruction for use for 1 ml and 3 ml syringes with an adaptor
Danish: Brugsanvisning til 1 ml og 3 ml sprøjter med adapter
English: Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue.
Danish: Endvidere er det ved in vitro forsøg påvist, at levetiracetam binder sig til et specifikt sted i hjernevæv hos gnavere.
English: • suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
Danish: • selvmord, personlighedsforstyrrelser (adfærdsproblemer), unormal tankevirksomhed (langsom tankegang, koncentrationsbesvær);
English: Each ml contains 100 mg levetiracetam.
Danish: Hver ml indeholder 100 mg levetiracetam
English: • partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age
Danish: • partielle anfald med eller uden generalisering hos voksne, unge, børn og spædbørn, der er over 1 måned gamle
English: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Danish: Den anbefalede initialdosis er 250 mg to gange daglig, som efter to uger øges til en initial terapeutisk dosis på 500 mg to gange daglig.
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
Danish: Døsighed, agitation aggression, nedsat bevidsthed, respirationshæmning og koma blev set ved overdosering med levetiracetam.
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Danish: Effekten af levetiracetam hos voksne er blevet demonstreret i 3 dobbeltblinde placebokontrollerede forsøg med hhv. 1.000 mg, 2.000 mg eller 3.000 mg/dag, fordelt på to doser, med en behandlingsvarighed på op til 18 uger.
English: The daily dose must be individualised according to renal function.
Danish: Døgndosis skal afpasses individuelt i forhold til nyrefunktion.
English: Muscular weakness, myalgia
Danish: Muskelsvækkelse, myalgi
English: Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Danish: Samtidig indtagelse af digoxin, orale kontraceptiva og warfarin påvirkede ikke levetiracetams farmakokinetik.
English: Take the syringe and pull back the plunger a little way (Figure 2).
Danish: Tag sprøjten og træk stemplet lidt tilbage (figur 2).
English: The active substance is called levetiracetam.
Danish: Det aktive stof er levetiracetam.
English: The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Danish: Bivirkningsprofilen for levetiracetam er generelt den samme på tværs af aldersgruppe og for alle godkendte epilepsi-indikationer.
English: Hepatic failure, hepatitis
Danish: Leverinsufficiens, hepatitis
English: If stopping treatment, Levetiracetam Actavis Group should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Levetiracetam Actavis Group ligesom andre lægemidler mod epilepsi nedtrappes gradvist for at undgå en forøgelse af anfald.
English: No clinical data are available, potential risk for human is unknown.
Danish: Den potentielle risiko for mennesker er ukendt.
English: Dose recommendations for infants from 6 months of age, children and adolescents:
Danish: Dosisanbefalinger til spædbørn fra 6 måneder, børn og unge:
English: • depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
Danish: • depression, fjendtlighed eller aggression, angst, søvnløshed, nervøsitet eller irritabilitet;
English: You should not stop your treatment without discussing this with your doctor.A risk of birth defects for your unborn child cannot be completely excluded.
Danish: Risiko for medfødte misdannelser hos dit ufødte barn kan ikke udelukkes helt.
English: Maltitol liquid
Danish: Flydende maltitol
English: Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Danish: Efter administration af en enkelt dosis (20 mg/kg) 100 mg/ml oral opløsning til epileptiske børn (1 måned til 4 år) blev levetiracetam hurtigt absorberet og peak-plasmakoncentrationer blev observeret ca. 1 time efter administration.
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Danish: NOAEL var < 200 mg/kg/dag for hunnerne og 200 mg/kg/dag for fostrene (svarende til MRHD på basis af mg/m2).
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Danish: Der blev udført et peri- og postnatalt udviklingsstudier med levetiracetam-doser på 70, 350 og 1.800 mg/kg/dag i rotter.
English: Completed suicide, personality disorder, thinking abnormal, delirium
Danish: Selvmord, personlighedsforstyrrelse, abnorm tankegang, delirium
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Danish: I dette forsøg var dosis af levetiracetam 3.000 mg/dag for voksne og unge eller 60 mg/kg/dag for børn, fordelt på 2 doser.
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Danish: Tillægsbehandling til voksne (≥ 18 år) og unge (12 til 17 år) som vejer 50 kg eller mere
English: Levetiracetam Actavis Group 100 mg/ml oral solution contains 3,26 mg propylene glycol (E1520) in each ml.
Danish: Levetiracetam Actavis Group 100 mg/ml oral opløsning indeholder 3,26 mg propylenglycol (E1520) I hver ml.
English: (2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Danish: (2) Efter dialyse anbefales 250 mg til 500 mg som supplerende dosis.
English: From 50 kg (2)
Danish: Fra 50 kg (2)
English: Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Danish: Tillægsbehandling til spædbørn i alderen 6 til 23 måneder, børn (2 til 11 år) og unge (12 til 17 år), som vejer mindre end 50 kg
English: (1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
Danish: (1) En 750 mg støddosis anbefales på første behandlingsdag med levetiracetam.