natgillin/translations-raw huggingface dataset:
Hos mennesket har virkning ved tilstande med både partiel og generaliseret epilepsi (epileptiforme afladninger/ fotoparoxysmalt respons) bekræftet den bredspektrede farmakologiske profil af levetiracetam.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Tillægsbehandling af voksne og børn over 4 år med partiel epilepsi med eller uden sekundær generalisering:
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy:
1000 mg, 2000 mg eller 3000 mg/ dag, fordelt på to doser, med en behandlingsvarighed på op til 18 uger.
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/ day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
1000, 2000 eller 3000 mg levetiracetam og på 12, 6% hos patienter, som fik placebo.
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.
Effekten af levetiracetam hos pædiatriske patienter (4- 16 år) blev påvist i et dobbeltblindt placebokontrolleret forsøg med 198 patienter ogen behandlingsvarighed på 14 uger.
In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
I dette forsøg fik patienterne levetiracetam som en fast dosis på 60 mg/ kg/ dag (fordelt på to doser daglig).
In this study, the patients received levetiracetam as a fixed dose of 60 mg/ kg/ day (with twice a day dosing).
44, 6% af de patienter, som fik levetiracetam og 19, 6% af de patienter, som fik placebo, havde 50% eller større reduktion i frekvensen af partielle anfald pr. uge, i forhold til udgangsniveau.
8 44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Ved fortsat langtidsbehandling var 11, 4% af patienterne anfaldsfrie i mindst 6 måneder, og 7, 2% var anfaldsfrie i mindst 1 år.
With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Effekten af levetiracetam som monoterapi behandling blev påvist i et dobbeltblindt, ækvivalensstudie med parallelle grupper med carbamazepin depottabletter( CR) hos 576 patienter over 16 år med ny eller nyligt diagnosticeret epilepsi.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non- inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Patienterne skulle have uprovokerede partielle anfald eller have generaliserede toniske- kloniske anfald.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Patienterne blev randomiseret til carbamazepin CR 400- 1200 mg/ dag eller levetiracetam 1000- 3000 mg/ dag, varigheden af behandlingen var op til 121 uger afhængigt af respons.
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.
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).
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).
56, 6% på levetiracetam og 58, 5% på carbamazepin CR).
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).
8 I et forsøg, 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).
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 69).
I dette forsøg var dosis af levetiracetam 3000 mg/ dag fordelt på 2 doser.
In this study, levetiracetam, dose was 3000 mg/ day given in 2 divided doses.
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.
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.
Ved fortsat langtidsbehandling var 28, 6% af patienterne fri for myoklone anfald i mindst 6 måneder, og 21, 0% var fri for myoklone anfald i mindst 1 år.
With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
Tillægsbehandling af voksne og unge fra 12 år med idiopatisk generaliseret epilepsi med primære generaliserede toniske- kloniske anfald:
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
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 primære generaliserede toniske- kloniske anfald (PGTC) i forskellige syndromer (juvenil myoklon epilepsi, juvenil absence epilepsi, børne absence epilepsi eller epilepsi med Grand Mal anfald ved opvågning).
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).
I dette forsøg var dosis af levetiracetam 3000 mg/ dag for voksne og unge eller 60 mg/ kg/ dag for børn, fordelt på 2 doser.
In this study, levetiracetam dose was 3000 mg/ day for adults and adolescents or 60 mg/ kg/ day for children, given in 2 divided doses.
72, 2% af de patienter, som blev behandlet med levetiracetam, og 45, 2% af de patienter, som fik placebo, havde 50% eller større reduktion i frekvensen af PGTC anfald pr. uge.
72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater decrease in the frequency of PGTC seizures per week.
Ved fortsat langtidsbehandling var 47, 4% af patienterne fri for toniske- kloniske anfald i mindst 6 måneder og 31, 5% var fri for toniske- kloniske anfald i mindst 1 år.
With continued long-term treatment, 47.4% of the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic seizures for at least 1 year.
Den farmakokinetiske profil er lineær med lille variation hos det enkelte indvidid og mellem individer.
There is no modification of the clearance after repeated
Der ses ikke ændringer i clearance efter gentagen dosering.
9 administration.
På grund af fuldstændig og lineær absorption kan plasma niveauerne forudsiges udfra peroral dosis af levetiracetam udtrykt som mg/ kg legemsvægt.
Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/ kg bodyweight.
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.
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).
Levetiracetam absorberes hurtigt efter peroral indgift.
Levetiracetam is rapidly absorbed after oral administration.
Den absolutte perorale biotilgængelighed er næsten 100%.
Oral absolute bioavailability is close to 100%.
Maksimale plasmakoncentrationer (Cmax) opnås 1, 3 time efter indtagelse.
Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Maksimale koncentrationer er (Cmax) er normalt 31 og 43 ug/ ml efter henholdsvis en enkelt dosis på 1000 mg og gentagen dosering 1000 mg 2 gange daglig.
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.
9 Der foreligger ingen data vedrørende vævsfordeling hos mennesker.
No tissue distribution data are available in humans.
Hverken levetiracetam eller den primære metabolit bindes signifikant til plasmaproteiner (< 10%).
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10%).
0, 5 til 0. 7 l/ kg, en værdi der ligger tæt på total volumen af kropsvæske.
The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/ kg, a value close to the total body water volume.
Den vigtigste metaboliseringsvej (24% af dosis) er enzymatisk hydrolyse af acetamid gruppen.
The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
En blev opnået ved hydroxylering af pyrrolidonringen (1, 6% af dosis) og den anden ved åbning af pyrrolidonringen (0, 9% af dosis).
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).
Andre uidentificerede komponenter udgjorde kun 0, 6% af dosis.
Other unidentified components accounted only for 0.6% of the dose.
In vitro data og in vivo interaktionsdata med perorale antikonceptionsmidler, digoxin og warfarin viste, at der ikke kan forventes signifikant enzyminduktion in vivo.
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.
Derfor er interaktion af Keppra med andre lægemidler eller vice versa ikke sandsynlig.
Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.
Halveringstiden for levetiracetam hos voksne var 7±1 timer og påvirkedes hverken af dosis, administrationsvej eller gentagen dosering.
Elimination 10 The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Den gennemsnitlige helkrops clearance var 0, 96ml/ min/ kg.
The mean total body clearance was 0.96 ml/ min/ kg.
93% af dosis var udskilt indenfor 48 timer).
The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Udskillelse via fæces omfattede kun 0, 3% af dosis.
Excretion via faeces accounted for only 0.3% of the dose.
Den akkumulerede urinudskillelse af levetiracetam og dets primære metabolit var indenfor de første 48 timer henholdsvis 66% og 24% af dosis.
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 24% of the dose, respectively during the first 48 hours.
Renal udskillelse af levetiracetam og ucb L057 er henholdsvis 0, 6 og 4, 2ml/ 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.
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.
Elimination af levetiracetam er korreleret til kreatinin clearance.
Levetiracetam elimination is correlated to creatinine clearance.
40% (10 til 11 timer).
In the elderly, the half-life is increased by about 40% (10 to 11 hours).
Dette er relateret til nedsat nyrefunktion hos denne population (se afsnit 4. 2).
This is related to the decrease in renal function in this population (see section 4.2).
Efter indgivelse af en enkelt oral dosis (20 mg/ kg) til børn (6- 12 år) med epilepsi, var halveringstiden for levetiracetam 6, 0 timer.
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
30% højere end hos voksne med epilepsi.
The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Efter gentagen oral dosering (20 til 60 mg/ kg/ dag) til epileptiske børn (4- 12 år) blev levetiracetam hurtigt absorberet.
Following repeated oral dose administration (20 to 60 mg/ kg/ day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Linear
Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
10 og dosis proportionale øgninger blev observeret for peak plasma koncentrationer og AUC.
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Eliminerings halveringstiden var tilnærmelsesvis 5 timer.
The elimination half-life was approximately 5 hours.
Den tilsyneladende clearance fra kroppen var 1, 1 ml/ min/ kg.
The apparent body clearance was 1.1 ml/ min/ kg.
1 time efter administration.
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.
Farmakokinetiske reultater indikerer, at halveringstiden var kortere (5, 3 timer) end for voksne (7, 2 timer), og tilsyneladende clearance er hurtigere (1, 5 ml/ min/ kg) end hos voksne (0, 96 ml/ min/ kg).
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).
Den tilsyneladende kropsclearance af levetiracetam og dens primære metabolit er korreleret til kreatinin clearance.
The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the creatinine clearance.
Det anbefales derfor at justere daglig vedligeholdelses dosis af Keppra hos patienter med moderat og udtalt nyrefunktionsnedsættelse baseret på kreatinin clearance (se afsnit 4. 2).
It is therefore recommended to adjust the maintenance daily dose of Keppra, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
25 og 3, 1 timer mellem og indenfor dialyse perioderne.
In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours during interdialytic and intradialytic periods, respectively.
Den fraktionelle eliminering af levetiracetam var 51% under et karakteristiskt 4 timers dialyse forløb.
The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Hos personer med mild og moderat leverfunktionsnedsættelse fandtes der ikke nogen relevant ændring af clearance for levetiracetam.
In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
Hos de fleste personer med svært nedsat leverfunktion var clearance af levetiracetam reduceret med mere end 50% på grund af samtidig nyrefunktionsnedsættelse (se afsnit 4. 2).
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).
De ikke- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity.
Bivirkninger som ikke var observeret i kliniske undersøgelser, 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 vægtøgninger, centrilobulær hypertrofi, fedtinfiltration og forhøjede leverenzymer i plasma.
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.
I studier over reproduktiv toksicitet hos rotte inducerede levetiracetam udviklingstoksicitet (forøgelse af skeletale ændringer, mindre anomalier, forsinket vækst, forøget mortalitet af unger) ved eksponeringsniveauer der svarede til eller var større end eksponering hos menneske.
In reproductive toxicity studies in the rat, levetiracetam induced developmental toxicity (increase in skeletal variations/ minor anomalies, retarded growth, increased pup mortality) at exposure levels similar to or greater than the human exposure.
Ved kanin sås føtale effekter (embryonisk død, forøgede skelet anomalier og forøgelse af misdannelser) ved forekomst af maternal toksicitet.
In the rabbit foetal effects (embryonic death, increased skeletal anomalies, and increased malformations) were observed in the presence of maternal toxicity.
4 til 5 gange eksponering hos menneske.
The systemic exposure at the observed no effect level in the rabbit was about 4 to 5 times the human exposure.
Neonatale og juvenile dyrestudier med rotter og hunde demonstrerede, at der med doser op til 1800 mg/ kg/ dag svarende til 30 gange den maksimale anbefalede humane dosis, ikke var uønskede effekter på standardudviklings - og modningsmålepunkter.
Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/ kg/ day corresponding to 30 times the maximum recommended human dose.
11 Macrogol 6000 Silica, kolloid vandfri Magnesiumstearat
Sodium croscarmellose Macrogol 6000 Colloidal anhydrous silica Magnesium stearate
Filmovertræk Opadry 85F20694:
Film-coating Opadry 85F20694:
Polyvinylalkohol delvis hydrolyseret Titandioxid (E 171) Macrogol 3350 Talcum Indigotin I (E 132)
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Indigo carmine aluminium lake (E132)
Ingen.
No special precautions for storage.
Keppra 250 mg filmovertrukne tabletter er pakket i aluminium/ PVC blister, indlagt i papæsker indeholdende 20, 30, 50, 60, 100 og 200 film- overtrukne tabletter.
Keppra 250 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 and 200 film-coated tablets.
6. 6 Særlige forholdsregler ved bortskaffelse og anden håndtering af produktet
12 6.6 Special precautions for disposal and other handling
UCB Pharma SA Allée de la Recherche 60 B- 1070 Bruxelles Belgien
Allée de la Recherche 60 B-1070 Bruxelles Belgium
29. september 2000 Dato for sidste fornyelse:
29 September 2000 Date of last renewal:
8. juli 2005
08 July 2005
Keppra 500 mg filmovertrukne tabletter.
Keppra 500 mg film-coated tablets.
Gul, aflang, med delekærv og graveret med koden “ ucb ” og ” 500 ” på den ene side.
Yellow, oblong, scored and debossed with the code “ ucb” and “ 500” on one side.
Indikationen for Keppra er tillægsbehandling • af voksne og børn over 4 år med partiel epilepsi type med eller uden sekundær generalisering. • af voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald. • af voksne og unge over 12 år med Idiopatisk Generaliseret Epilepsi med primære generaliserede toniske- kloniske anfald.
Keppra is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Man kan starte med denne dosering fra den første behandlingsdag Afhængig af klinisk effekt og tolerabilitet kan den daglige dosis øges til 1500 mg to gange daglig.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily.
Justering af dosis anbefales hos ældre patienter med nedsat nyrefunktion (se “ Patienter med nedsat nyrefunktion ” nedenfor).
14 Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
14 Børn fra 4 til 11 år og unge (12 til 17 år) som vejer mindre end 50 kg
Children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
Den initiale, terapeutiske dosis er 10 mg/ kg to gange daglig.
The initial therapeutic dose is 10 mg/ kg twice daily.
Dosis til børn, der vejer 50 kg eller mere er den samme som hos voksne.
Dosage in children 50 kg or greater is the same as in adults.
Maximum dosis:
Maximum dose:
15 kg1 20 kg1 25 kg Fra 50 kg2 (1)
15 kg (1) 20 kg (1) 25 kg From 50 kg (2) (1)
150 mg to gange daglig 200 mg to gange daglig 250 mg to gange daglig 500 mg to gange daglig
150 mg twice daily 200 mg twice daily 250 mg twice daily 500 mg twice daily
450 mg to gange daglig 600 mg to gange daglig 750 mg to gange daglig 1500 mg to gange daglig
450 mg twice daily 600 mg twice daily 750 mg twice daily 1500 mg twice daily
Børn på 20 kg og under bør helst (2)
Children 20 kg or less should preferably start the treatment with Keppra 100 mg/ ml oral solution.
starte behandling med Keppra 100
(2) Dosage in children and adolescents 50 kg or more is the same as in adults.
Dosis til børn og unge over 50 kg er den samme som til voksne.
Infants and children less than 4 years
Dosisjustering for voksne patienter med nedsat nyrefunktion
15 Dosing adjustment for adult patients with impaired renal function
(3) En 750 mg støddosis anbefales ved første behandlingsdag med levetiracetam.
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
(4) Efter dialyse anbefales 250 mg til 500 mg som supplerende dosis.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
15 Til børn med nedsat nyrefunktion skal levetiracetam dosis justeres i forhold til nyrefunktionen da levetiracetam clearance er afhængig af nyrefunktionen.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Derfor bør patienterne overvåges for, om de får tegn på selvmordstanker og – adfærd, og passende behandling bør overvejes.
16 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
16 imidlertid på en 22% højere levetiracetam clearance hos børn, som tog enzyminducerende antiepileptiske lægemidler.
However, data suggested a 22% higher levetiracetam clearance in children taking enzyme- inducing antiepileptic medicinal products.