FrancophonIA/ELRC3.0 huggingface dataset:
English: No special precautions for storage prior to reconstitution.
Danish: Ingen særlige opbevaringsbetingelser før rekonstitution.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ (E) Læs indlægssedlen inden brug.
English: This medicine contains 57.21 mg sodium (main component of cooking/table salt) in each maximum single dose.
Danish: Dette lægemiddel indeholder 57.21 mg natrium (hoved komponent af madlavnings-/bordsalt) pr. maksimal enkeltdosis.
English: This medicinal product contains 57.21 mg sodium per maximum single dose, equivalent to 2.86 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 57.21 mg natrium pr. maksimale enkeltdosis, svarende til 2.86 % af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Danish: In vitro-studier viser, at levetiracetam påvirker de intraneuronale Ca2+ -niveauer ved delvis hæmning af N-type Ca2+ -strømme og ved reduktion af frigivelsen af Ca2+ fra intraneuronale lagre.
English: This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Danish: Dette fald er mere udtalt i 3. trimester (op til 60 % af baselinekoncentrationen før graviditet).
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: Warnings and precautions Talk to your doctor before taking Matever
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før De får Matever
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: In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Danish: Desuden ophæver det delvist reduktionen i GABA- og glycin -medierede strømme, induceret af zink og βcarboliner.
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 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: However, data suggested a 20 % higher levetiracetam clearance in children taking enzymeinducing antiepileptic medicinal products.
Danish: Data tydede imidlertid på en 20 % højere levetiracetamclearance hos børn, som fik enzyminducerende antiepileptika.
English: •Sodium chloride (0.9 %) injection
Danish: • Natriumchlorid (0,9 %) injektionsvæske
English: Do not take macrogol (a medicine used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.
Danish: Tag ikke macrogol (et lægemiddel, som anvendes som afføringsmiddel) en time før og en time efter levetiracetam, da dette kan medføre tab af levetiracetams virkning.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in fetal 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: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Danish: CLcr (ml/min) = -----------------------------------------(x 0,85 for kvinder) 72 x serum-kreatinin (mg/dl)
English: Swallow Matever tablets with a sufficient quantity of liquid (e.g. a glass of water).
Danish: Matever tabletter synkes med rigelig væske (f.eks. et glas vand).
English: Matever contains sodium
Danish: Matever indeholder natrium
English: If stopping treatment Matever should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Matever gradvist for at undgå en forøgelse af anfald.
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Danish: - Bivirkninger rapporteret fra kliniske studier (voksne, unge, børn og spædbørn >1 måned) og efter markedsføring er angivet i nedenstående tabel i henhold til systemorganklasse og hyppighed.
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: 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: Det blev konkluderet, at levetiracetam ikke adskilte sig (non-inferiort) fra placebo hvad angår ændring i forhold til baseline i score opnået i ”Leiter-R Attention and Memory, Memory Screen Composite"-testen i per protokol-populationen.
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95 % CI: -7.8 8.2).
Danish: 6 måneders anfaldsfrihed blev opnået hos 73,0 % af de patienter, som blev behandlet med levetiracetam og hos 72,8 % af de patienter, som blev behandlet med carbamazepin CR; den tilpassede absolutte forskel mellem behandlingerne var 0,2 % (95 % CI: -7,8 8,2).
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 1000, 2000 or 3000 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 stopping treatment, as with other antiepileptic medicines, Matever should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Matever ligesom andre lægemidler mod epilepsi nedtrappes gradvist for at undgå en forøgelse af anfald.
English: An oral solution is the preferred formulation for use in this population.
Danish: En oral opløsning bør foretrækkes til denne population.
English: Levetiracetam 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dose.
Danish: Levetiracetam 100 mg/ml oral opløsning er den bedst egnede lægemiddelformulering til spædbørn og børn under 6 år og til børn og unge (fra 6 til 17 år), som vejer mindre end 50 kg, og hvor tabletter ikke muliggøre nøjagtig dosis.
English: • if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Danish: • Hvis De er allergisk over for levetiracetam, pyrrolidonderivater eller et af de øvrige indholdsstoffer i Matever (angivet i punkt 6).
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: 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: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Matever overdoses.
Danish: Døsighed, agitation, aggression, nedsat bevidsthedsniveau, respirationshæmning og koma blev set ved overdosering med Matever.
English: Matever may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Danish: Matever kan påvirke Deres evne til at køre bil, motorcykel, cykle eller betjene værktøj og maskiner, da det kan give døsighed.
English: quinoline yellow aluminium lake (E104)
Danish: Quinolingul Aluminium Lake (E104)
English: Multipack: 200 (2 packs of 100) film-coated tablets
Danish: Multipakning: 200 (2 pakninger af 100) filmovertrukne tabletter
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 De tageranden medicin, har gjort det for nylig eller planlægger at tage anden medicin.
English: Matever is used:
Danish: Matever indeholder:
English: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily
Danish: 500 til 1.500 mg to gange dagligt 500 til 1.000 mg to gange dagligt 250 til 750 mg to gange dagligt 250 til 500 mg to gange dagligt 500 til 1.000 mg en gang dagligt
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Danish: Hverken levetiracetam eller den primære metabolit bindes i signifikant grad til plasmaproteiner (10
English: The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9 % sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9 % sodium chloride infused over 5 minutes was evaluated.
Danish: Intravenøs administration af doser op til 4.000 mg fortyndet i 100 ml 0,9 % natriumchlorid infunderet i løbet af 15 minutter og doser op til 2.500 mg fortyndet i 100 ml 0,9 % natriumchlorid infunderet i løbet af 5 minutter blev evalueret.
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 dagligt.
English: Orion Pharma A/S Tlf: +45 49 12 66 00
Danish: Orion Pharma A/S Tel: +45 49 12 66 00
English: Do not use Matever
Danish: Brug ikke Matever
English: Weight decreased, 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: 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: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme
Danish: Toksisk epidermal nekrolyse, StevensJohnsons syndrom, erythema multiforme
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: See Table 1 for the recommended preparation and administration of Matever concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Danish: Se Tabel 1 for den anbefalede fremstilling og administration af Matever-koncentrat for at opnå en samlet daglig dosis på 500 mg, 1.000 mg, 2.000 mg eller 3.000 mg fordelt på to doser.
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: 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: At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in fetal 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: Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Derfor bør patienterne overvåges for, om de får tegn på depression og/eller selvmordstanker og adfærd, og passende behandling bør overvejes.
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Danish: Eksempel: Hvis Deres daglige dosis er 1.000 mg, kan De tage 2 tabletter på 250 mg om morgenen og 2 tabletter på 250 mg om aftenen.
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<1/100); rare (≥1/10,000 to<1/1,000) and very rare (<1/10,000)
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed 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: Do not take Matever
Danish: Tag ikke Matever
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 <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed 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: Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1500 mg infused over 15 minutes was 51 ± 19 µg/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 var 51 ± 19 µg/ml (aritmetiskt middelværdi ± standardafvigelse).
English: The patients were randomized to carbamazepine CR 400 -1200 mg/day or levetiracetam 1000 -3000 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: Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Danish: Eksempel: Hvis Deres daglige dosis er 1.000 mg, er Deres lavere start-dosis 2 tabletter på 250 mg om morgenen og 2 tabletter på 250 mg om aftenen.
English: The other strengths of Matever tablets do not contain this ingredient.
Danish: De øvrige styrker af Matever indeholder ikke dette farvestof.
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: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold for det fortyndede lægemiddel, se pkt.
English: The daily dose must be individualised according to renal function.
Danish: Den daglige dosis skal justeres individuelt i forhold til nyrefunktion.
English: Matever concentrate is an alternative for patients when administration of the antiepileptic oral Matever medicine is temporarily not feasible.
Danish: Matever-koncentrat er et alternativ til patienter, når det midlertidigt ikke er muligt at indtage antiepileptisk Matever lægemiddel gennem munden.
English: Matever concentrate 5 ml vial is packed in a cardboard box of 10 vials.
Danish: Matever-koncentrat 5 ml hætteglas er pakket i en papæske med 10 hætteglas.
English: 1500 mg twice daily Children 25 kg or less should preferably start the treatment with levetiracetam 100 mg/ml oral solution.
Danish: 1500 mg to gange dagligt Børn på 25 kg og derunder bør starte behandlingen med Matever oral opløsning 100 mg/ml.
English: If you stop using Matever
Danish: Hvis De holder op med at bruge Matever
English: Matever 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: Matever-koncentrat er kun til intravenøs anvendelse, og den anbefalede dosis skal fortyndes i mindst 100 ml kompatibel opløsningsvæske og administreres intravenøst som en 15-minutters intravenøs infusion (se pkt.
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: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på de fremstilleren (fremstillerne), der er ansvarlig(e) for batchfrigivelse
English: Matever is indicated as adjunctive therapy
Danish: Indikationen for Matever er tillægsbehandling
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/711/014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/711/030
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Danish: CLcr (ml/min/1,73 m 2) = ----------------------------- x 1,73 Personens BSA (m
English: General dose: between 1000 mg and 3,000 mg each day.
Danish: Den sædvanlige dosis er mellem 1.000 mg og 3.000 mg dagligt.
English: Add-on therapy for infants and children less than 4 years
Danish: Tillægsbehandling til spædbørn og børn under 4 år
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: timer) end for voksne (7,2 timer), og tilsyneladende clearance var hurtigere (1,5 ml/min/kg) end hos voksne (0,96 ml/min/kg).
English: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone type A Hydroxypropylcellulose (L)
Danish: Calciumhydrogenphosphatdihydrat Cellulose, mikrokrystallinsk Crospovidon (type A) Hydroxypropylcellulose (L)
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: Deltagere, som fik levetiracetam i det langvarige, åbne opfølgningsstudie, oplevede imidlertid generelt ikke nogen forværring af deres adfærds- og følelsesmæssige funktion; navnlig var graden af aggressiv adfærd ikke forværret i forhold til baseline.
English: The intravenous formulation is an alternative to your oral administration.
Danish: Den intravenøse formulering er et alternativ til indtagelse gennem munden.
English: Pallini 15351, Attiki, Greece Tel.: +30 210 66 04 300
Danish: Pallini 15351, Attiki, Grækenland Tel.: +30 210 66 04 300
English: The safety and efficacy of Matever concentrate for solution for infusion in infants and children less than 4 years have not been established.
Danish: Sikkerhed og virkning af Matever-koncentrat til infusionsvæske, opløsning hos spædbørn og børn under 4 år er ikke fastslået.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behavior as measured in a standardized and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Danish: Resultater relateret til adfærds- og følelsesmæssig funktion indikerede en forværring af aggressiv adfærd hos patienter behandlet med levetiracetam, vurderet på en standardiseret og systematisk måde ved brug af et valideret værktøj (CBLCAchenbach Child Behavior Checklist).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge eller apotekspersonalet.
English: • Dextrose 5 % injection
Danish: • Glucose, 5 % injektionsvæske
English: Levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Danish: Levetiracetam oral opløsning bør anvendes ved doser under 250 mg, for doser, som ikke er delelig med 250 mg, når anbefalet dosis ikke kan opnås ved at tage flere tabletter og til patienter, som ikke er i stand til at synke tabletter.
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1,800, among which in more than 1,500 exposure occurred during the 1
Danish: En stor mængde data indsamlet efter markedsføring fra gravide kvinder, der har fået levetiracetam monoterapi (flere end 1.800, hvoraf eksponeringen hos flere end 1.500 forekom i løbet af 1. trimester) tyder ikke på en stigning i risikoen for alvorlige medfødte misdannelser.
English: Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25 °C.
Danish: Matever-koncentrat er fundet fysisk kompatibelt og kemisk stabilt i mindst 24 timer, når det blandes med følgende fortyndere og opbevares i PVC beholdere ved kontrolleret stuetemperatur på 15-25 °C.