FrancophonIA/ELRC3.0 huggingface dataset:
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 inden for de første 48 timer henholdsvis 66 % og 24 % af dosis.
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: Directions for the proper use of Levetiracetam Hospira is provided in section 3.
Danish: Retningslinjer for korrekt anvendelse af Levetiracetam Hospira findes i punkt 3.
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Danish: • alvorlige allergiske reaktioner (DRESS, anafylaktisk reaktion (alvorlig og vigtig allergisk reaktion), Quinckes ødem (hævelse af ansigt, læber, tunge og svælg));
English: Should your doctor decide to stop your Levetiracetam Hospira treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Hospira.
Danish: Hvis lægen beslutter at stoppe din behandling med Levetiracetam Hospira, vil han/hun instruere dig i, hvordan du gradvist skal ophøre med at tage Levetiracetam Hospira.
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of
Danish: I et studie, som afspejlede klinisk praksis, kunne samtidig antiepileptisk medicin seponeres hos et afgrænset antal patienter, som responderede på levetiracetam som tillægsbehandling (36 voksne patienter ud af 69).
English: No enantiomeric interconversion was evidenced in vivo for either levetiracetam or its primary metabolite.
Danish: In vivo blev der ikke påvist enantiomerisk omlejring hverken af levetiracetam eller dets primære metabolit.
English: Ca currents and by reducing the release of Ca from intraneuronal stores.
Danish: N-type Ca strømme og ved reduktion af frigivelsen af Ca fra intraneuronale lagre.
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1,500 mg intravenous infusion for 4 days with twice daily dosing.
Danish: Den tidsuafhængige farmakokinetiske profil af levetiracetam blev også bekræftet efter 1.500 mg intravenøs infusion i 4 dage med dosering to gange dagligt.
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: 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: Nedennævnte bivirkningsprofil er baseret på analyse af sammenfattede placebokontrollerede kliniske forsøg med alle indikationer med i alt 3.416 patienter, der blev behandlet med levetiracetam.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam er et pyrrolidon derivat (S-enantiomer af D-ethyl-2-oxo-1-pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.
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 dyreforsøgsmodeller med partielle og primært generaliserede anfald uden at udvise en pro-konvulsiv virkning.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Danish: Dosisniveauet på 1.800 mg/kg/dag inducerede markant maternel toksicitet og et fald i fostervægt associeret med en øget forekomst af fostre med kardiovaskulære/skeletale anomalier.
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: 5 ml glass vial (type I) with bromobutyl coated rubber stoppers and an aluminium flip-off seal.
Danish: 5 ml hætteglas (type I) med brombutyl overtrukne gummipropper og en aluminium flip-off forsegling.
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 sammenfattende 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), 27,7 %, 31,6 % og 41,3 % for patienter, som fik hhv. 1.000, 2.000 eller 3.000 mg levetiracetam, og 12,6 % for patienter, som fik placebo.
English: If you get any side effects talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
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: 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 dagligt hver anden uge afhængigt af den kliniske effekt.
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 tillægsbehandling med oralt administreret levetiracetam ikke havde indflydelse på steady state -serumkoncentrationer af samtidigt administreret carbamazepin og valproat.
English: The mean total body clearance was 0.96 ml/min/kg.
Danish: Den gennemsnitlige totale clearance var 0,96 ml/min/kg.
English: In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Danish: In vitro- og in vivo-studier tyder på, at levetiracetam ikke ændrer cellens basale egenskaber og normale neurotransmission.
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: Data fra kliniske studier før markedsføring 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: • weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
Danish: • svaghed, føler dig ør i hovedet eller svimmel, eller har vejrtrækningsbesvær, da disse symptomer kan være tegn på en alvorlig allergisk (anafylaktisk) reaktion
English: Each carton contains 10 or 25 vials.
Danish: Hver pakning indeholder 10 eller 25 hætteglas.
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-studier 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: 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 placebokontrollerede kliniske studier, heraf var kun 13 yngre end 6 måneder.
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: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
Danish: Døsighed, agitation, aggression, nedsat bevidsthedsniveau, respirationshæmning og koma blev set ved overdosering med levetiracetam.
English: • swelling of the face, lips, tongue and throat (Quincke's oedema)
Danish: • hævelse af ansigt, læber, tunge og svælg (Quinckes ødem)
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Danish: [140-alder (år)] x vægt (kg) CLcr (ml/min) = ------------------------------------- (x 0,85 for kvinder) 72 x serum-kreatinin (mg/dl)
English: Dose and frequency Children from 4 years and adolescents weighing less than 50 kg
Danish: Dosis og hyppighed Børn over 4 år og unge som vejer under 50 kg
English: However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Danish: Baseret på levetiracetams farmakokinetiske egenskaber tyder det imidlertid på, at farmakokinetikken hos voksne efter intravenøs administration og farmakokinetikken hos børn efter oral administration, at eksponeringen for levetiracetam (AUC) er den samme hos pædiatriske patienter fra 4 til 12 år efter intravenøs og oral administration.
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 din læge efter omhyggelig vurdering mener, at det er nødvendigt.
English: The active substance is levetiracetam.
Danish: - Aktivt stof: Levetiracetam.
English: Thrombocytopenia, leukopenia
Danish: Trombocytopeni , leukopeni
English: Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily.
Danish: Afhængigt af det kliniske respons og tolerabilitet kan dosis øges til 30 mg/kg to gange daglig.
English: A meta-analysis of randomized placebo-controlled trials of antiepileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptika har vist en let øget risiko for selvmordstanker og -adfærd.
English: A small number of people being treated with antiepileptics such as Levetiracetam Hospira have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Levetiracetam Hospira, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: If stopping treatment, as with other antiepileptic medicines, Levetiracetam Hospira should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Levetiracetam Hospira ligesom andre lægemidler mod epilepsi nedtrappes gradvist for at undgå en forøgelse af anfald.
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: General dose: between 1,000 mg and 3,000 mg each day.
Danish: Den sædvanlige dosis er: mellem 1.000 mg og 3.000 mg dagligt.
English: • Sodium chloride 9 mg/ml (0.9%) solution for injection
Danish: • Natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Danish: Levetiracetam 2.000 mg dagligt påvirkede ikke farmakokinetikken af digoxin og warfarin; protrombin-tider blev ikke ændret.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes straks, medmindre fortyndingsmetoden udelukker risiko for mikrobiel kontaminering.
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 under dialyseperioderne.
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 dets primære metabolit fra kroppen er korreleret til kreatininclearance.
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures (fits) in epilepsy).
Danish: Levetiracetam er et lægemiddel mod epilepsi (et lægemiddel som anvendes til behandling af epileptiske anfald).
English: Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Danish: Efter dialyse anbefales 250 til 500 mg som supplerende dosis.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: For opbevaringsbetingelser for det fortyndede lægemiddel, se pkt.
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: Alopecia, eczema, pruritus
Danish: Alopeci, eksem, pruritus
English: Do not use Levetiracetam Hospira
Danish: Brug ikke Levetiracetam Hospira
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Danish: Dosisjustering anbefales hos ældre patienter med nedsat nyrefunktion (se “Nedsat nyrefunktion” nedenfor).
English: There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Danish: Der er ingen erfaring med intravenøs indgivelse af levetiracetam i mere end 4 dage.
English: Bone marrow suppression was identified in some of the cases of pancytopenia.
Danish: Knoglemarvssupression identificeres i nogle af pancytopenitilfældene.
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 dagligt påvirker ikke farmakokinetikken af orale kontraceptiva (ethinylestradiol og levonorgestrel); endokrine parametre (luteiniserende hormon og progesteron) blev ikke ændret.
English: The intravenous administration of doses up to 4,000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2,500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Danish: Intravenøs administration af doser på op til 4.000 mg fortyndet i 100 ml 0,9 % natriumchlorid infunderet over 15 minutter og doser op til 2.500 mg fortyndet i 100 ml 0,9 % natriumchlorid infunderet over 5 minutter blev evalueret.
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 children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 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 børn og unge, som vejer under 50 kg: dosis bør ikke reduceres med mere end 10 mg/kg to gange dagligt hver anden uge).
English: If you stop using Levetiracetam Hospira:
Danish: Hvis du holder op med at bruge Levetiracetam Hospira:
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 dagligt), en substans som blokerer den tubulære sekretion i nyrerne, hæmmer renal udskillelse af den primære metabolit, men ikke af levetiracetam.
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose).
Danish: (1,6 % af dosis) og den anden ved åbning af pyrrolidonringen (0,9 % af dosis).
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Danish: 10-20 mg/kg (0,10 til 0,20 ml/kg) én gang dagligt En 15 mg/kg (0,15 ml/kg) støddosis anbefales på den første behandlingsdag med levetiracetam.
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: Hos børn med nedsat nyrefunktion skal levetiracetam -dosis justeres i forhold til nyrefunktionen, da levetiracetamclearance afhænger af nyrefunktionen.
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: Levetiracetam Hospira concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Danish: Levetiracetam Hospira koncentrat er kun til intravenøs anvendelse, og den anbefalede dosis skal fortyndes i mindst 100 ml kompatibel opløsningsvæske og administreres intravenøst som en 15minutters intravenøs infusion (se pkt.6.6).
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Danish: CLcr i ml/min/1,73 m kan hos unge teenagere og børn beregnes ud fra serum-kreatinin (mg/dl) ved at anvende følgende formel (Schwartz formel):
English: Therefore, breast-feeding is not recommended.
Danish: Amning anbefales derfor ikke.
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type
Danish: In vitro-studier viser, at levetiracetam påvirker de intraneuronale Ca niveauer ved delvis hæmning af
English: This medicinal product is for single use only, any unused solution should be discarded.
Danish: Dette lægemiddel er kun til enkeltdosisbrug, ubrugt opløsning skal destrueres.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin, har gjort det for nylig, eller planlægger at tage anden medicin.
English: Levetiracetam is excreted in human breast milk.
Danish: Levetiracetam udskilles i human mælk.
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Danish: Den anbefalede dosis skal fortyndes med mindst 100 ml forenelig fortyndingsvæske og infunderes i løbet af 15 minutter.
English: • uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
Danish: • ukontrollerede muskelspasmer med indvirkning på hovedet, kroppen samt arme og ben, vanskelighed med at kontrollere kroppens bevægelser, hyperkinesi (ufrivillige bevægelser);
English: Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution.
Danish: Levetiracetam Hospira koncentrat til infusionsvæske, opløsning (sterilt koncentrat) er en klar, farveløs, steril væske.
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 høj feber, forhøjede leverenzymniveauer i blodprøver og et forhøjet antal af en bestemt type hvide blodlegemer (eosinofili) og forstørrede lymfekirtler (lægemiddelreaktion med eosinofili og systemiske reaktioner [DRESS])
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), 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: • 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), et udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsorganerne (StevensJohnsons syndrom) eller en mere alvorlig form, der forårsager afskalning af huden på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse).
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 udviklingsforsøg med 3.600 mg/kg/dag var der et lille fald i fostervægt forbundet med en marginal forøgelse af skeletale ændringer/mindre anomalier.
English: Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1,500 mg infused over 15 minutes was 51 ± 19 micrograms/ml (arithmetic average ± standard deviation).
Danish: Maksimal plasmakoncentration (Cmax) observeret hos 17 forsøgspersoner efter en intravenøs enkeltdosis på 1.500 mg infunderet i løbet af 15 minutter og var 51 ± 19 mikrogram/ml (aritmetisk gennemsnit ± standardafvigelse).
English: Levetiracetam Hospira is for intravenous use.
Danish: Levetiracetam Hospira er beregnet til intravenøs anvendelse.
English: The maximum dose is 1,500 mg twice daily.
Danish: Den maksimale dosis er 1.500 mg to gange dagligt.