natgillin/translations-raw huggingface dataset:
CLcr i ml/ min kan beregnes ud fra serum kreatinin (mg/ dl) ved at anvende følgende formel:
The CLcr in ml/ min may be estimated from serum creatinine (mg/ dl) determination using the following formula:
[140- alder (år)] x vægt (kg) CLcr (ml/ min) = ----------------------------------------- (x 0, 85 for kvinder) 72 x serum kreatinin (mg/ dl)
[140-age (years)] x weight (kg) CLcr (ml/ min) = ----------------------------------------- 72 x serum creatinine (mg/ dl)
Derefter justeres CLcr for legemets overfladeareal (BSA) på følgende måde:
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (ml/ min) CLcr (ml/ min/ 1, 73 m2) = ----------------------------- x 1, 73 Personens BSA (m2)
CLcr (ml/ min) CLcr (ml/ min/ 1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
Dosisjustering for voksne patienter med nedsat nyrefunktion
3 Dosing adjustment for adult patients with impaired renal function
Kreatinin clearance (ml/ min/ 1, 73 m2)
Creatinine clearance (ml/ min/ 1.73m2)
Normal Mild Moderat Udtalt Patienter i slutstadiet af nyresygdom som modtager dialyse (1)
Normal Mild Moderate Severe End-stage renal disease patients Undergoing dialysis (1)
500 til 1500 mg to gange daglig 500 til 1000 mg to gange daglig 250 til 750 mg to gange daglig 250 til 500 mg to gange daglig 500 til 1000 mg en gang daglig (2)
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 (2)
(1) 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.
3 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.
Dosisjustering er ikke nødvendig hos patienter med mild til moderat nedsat leverfunktion.
No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Hos patienter med svært nedsat leverfunktion, kan kreatinin clearance underestimere nyreinsufficiensen.
In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
Derfor anbefales en 50% reduktion af daglig vedligeholdelsesdosis, når kreatinin clearance er < 70 ml/ min.
Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 70 ml/ min.
Overfølsomhed over for levetiracetam eller andre pyrrolidon derivater eller et eller flere af hjælpestofferne.
Hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients.
I overensstemmelse med nuværende klinisk praksis anbefales det, at Keppra, hvis behandlingen skal afbrydes, seponeres gradvist (f. eks. for voksne: reduktion med 500 mg to gange daglig hver anden til fjerde uge; for børn: dosis bør ikke reduceres med mere end 10 mg/ kg to gange daglig hver anden uge).
500 mg decreases twice daily every two to four weeks; in children: dose decrease should not exceed 10 mg/ kg twice daily every two weeks).
Tilgængelige data for børn tyder ikke på indflydelse på vækst og pubertet.
Available data in children did not suggest impact on growth and puberty.
Men langvarig indvirken på indlæring, intelligens, vækst, endokrin funktion, pubertet og indvirken på evnen til at få børn er ukendt.
However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
En forøgelse af anfaldsfrekvensen på mere end 25% blev rapporteret hos 14% af levetiracetam behandlede voksne og pædiatriske patienter med anfald af partiel type, hvorimod det blev rapporteret hos henholdsvis 26% og 21% af placebo behandlede voksne og pædiatriske patienter.
An increase in seizure frequency of more than 25% was reported in 14% of levetiracetam treated adult and paediatric patients with partial onset seizures, whereas it was reported in 26% and 21% of placebo treated adult and paediatric patients, respectively.
Når Keppra blev anvendt af voksne og unge til behandling af idiopatisk generaliseret epilepsi med primære generaliserede toniske- kloniske anfald, var der ingen virkning på frekvensen af absencer.
When Keppra was used to treat primary generalised tonic-clonic seizures in adults and adolescents with idiopathic generalised epilepsy, there was no effect on the frequency of absences.
Anvendelse af Keppra til patienter med nedsat nyrefunktion kan kræve dosisjustering.
The administration of Keppra to patients with renal impairment may require dose adjustment.
Hos patienter med svært nedsat leverfunktion anbefales bestemmelse af nyrefunktion før valg af dosis (se afsnit 4. 2).
In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Selvmordstanker og – adfærd er rapporteret hos patienter i behandling med antiepileptika.
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har vist en let forøget risiko for selvmordstanker og – adfærd.
A meta-analysis of randomized placebo-controlled trials of anti-epileptic drugs has shown a small increased risk of suicidal thoughts and behaviour.
Derfor bør patienterne overvåges for, om de får tegn på selvmordstanker og – adfærd, og passende behandling bør overvejes.
Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Patienter (og plejepersonale) bør tilrådes straks at søge læge, hvis der opstår tegn på selvmordstanker og – adfærd.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/ or suicidal ideation or behaviour emerge.
Præ- marketing data fra kliniske undersøgelser med voksne tyder på, at Keppra ikke påvirker serum koncentrationerne af eksisterende antiepileptika (phenytoin, carbamazepin, valproat, phenobarbital, lamotrigin, gabapentin og primidon), og at disse antiepileptika ikke påvirker Keppra’ s farmakokinetik.
Pre-marketing data from clinical studies conducted in adults indicate that Keppra 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 Keppra.
Som for voksne er der ikke nogen evidens for klinisk signifikante lægemiddelinteraktioner i pædiatriske patienter doseret med op til 60 mg/ kg levetiracetam pr. dag.
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/ kg/ day levetiracetam.
Data tydede
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.
4 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.
Dosisjustering er ikke nødvendig.
Dosage adjustment is not required.
Det antages at andre lægemidler, der udskilles ved aktiv tubulær sekretion også kan reducere renal udskillelse af metabolitten.
It is expected that other medicinal products excreted by active tubular secretion could also reduce the renal clearance of the metabolite.
Levetiracetams påvirkning på probenecid var ikke undersøgt og virkningen af levetiracetam på andre lægemidler som udskilles ved aktiv sekretion, f. eks.
The effect of levetiracetam on probenecid was not studied and the effect of levetiracetam on other actively secreted medicinal products, e. g.
NSAIDs, sulfonamider og metotrexat, er ukendt.
NSAIDs, sulfonamides and methotrexate, is unknown.
Levetiracetam 1000 mg daglig påvirker ikke farmakokinetikken af perorale anticonceptiva (etinyløstradiol og levonorgestrel); endokrine parametre (luteiniserende hormon og progesteron) blev ikke ændret.
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl- estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Levetiracetam 2000 mg daglig påvirkede ikke farmakokinetik af digoxin og warfarin; protrombin- tider blev ikke ændret.
Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Samtidig indtagelse af digoxin, perorale antikonceptiva og warfarin påvirkede ikke levetiracetam’ s farmakokinetik.
Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Der forefindes ikke data på anticidas påvirkning af levetiracetams absorption.
No data on the influence of antacids on the absorption of levetiracetam are available.
Der foreligger ikke data over interaktion af levetiracetam og alkohol.
No data on the interaction of levetiracetam with alcohol are available.
Der foreligger ikke tilstrækkelige data ved brug af Keppra hos gravide kvinder.
There are no adequate data from the use of Keppra in pregnant women.
Den potentielle risiko for mennesker kendes ikke.
The potential risk for human is unknown.
Keppra bør ikke anvendes under graviditet, med mindre det er absolut nødvendigt.
Keppra should not be used during pregnancy unless clearly necessary.
Som med andre antiepileptika kan fysiologiske forandringer under graviditeten påvirke koncentrationen af levetiracetam. Der er observeret fald i plasmakoncentration af levetiracetam under graviditet.
Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Dette fald er mere udtalt under tredje trimester (op til 60% af baseline- koncentrationen før graviditet).
This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Levetiracetam udskilles i human modermælk.
Levetiracetam is excreted in human breast milk.
Derfor anbefales amning ikke.
Therefore, breast-feeding is not recommended.
Hvis behandling med levetiracetam imidlertid er nødvendig under amning, skal fordele/ risici ved behandlingen afvejes i forhold til vigtigheden af amning.
However, if levetiracetam treatment is needed during breastfeeding, the benefit/ risk of the treatment should be weighed considering the importance of breastfeeding.
Da den individuelle følsomhed er forskellig, kan nogle patienter opleve træthed eller andre central nervesystems relaterede symptomer især i begyndelsen af behandlingen eller ved øgning af dosis.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose 5 increase.
Derfor tilrådes forsigtighed hos disse patienter ved udførelse af krævende opgaver, f. eks. kørsel eller betjening af maskiner.
Therefore, caution is recommended in those patients when performing skilled tasks, e. g. driving vehicles or operating machinery.
Patienter rådes til ikke at føre motorkøretøj eller betjene maskiner, før det er bevist, at deres evne til at udføre sådanne aktiviteter ikke er påvirket.
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Kumulerede sikkerhedsdata fra kliniske afprøvninger med orale Keppra formuleringer udført med voksne patienter med anfald af partiel type viste at 46, 4% af patienterne i Keppragruppen og 42, 2% af patienterne i placebogruppen fik bivirkninger.
Pooled safety data from clinical studies conducted with Keppra oral formulations in adult patients with partial onset seizures showed that 46.4% of the patients in the Keppra group and 42.2% of the patients in the placebo group experienced undesirable effects.
2, 4% af patienterne i Keppragruppen og 2, 0% af patienterne i placebogruppen fik alvorlige bivirkninger.
Serious undesirable effects were experienced in 2.4% of the patients in the Keppra and 2.0% of the patients in the placebo groups.
De hyppigst rapporterede bivirkninger var somnolens, asteni og svimmelhed.
The most commonly reported undesirable effects were somnolence, asthenia and dizziness.
I de samlede sikkerhedsanalyser fandtes ingen klar dosis- respons sammenhæng, men hyppighed og sværhedsgrad af centralnervesystem relaterede bivirkninger aftog over tiden.
In the pooled safety analysis, there was no clear dose-response relationship but incidence and severity of the central nervous system related undesirable effects decreased over time.
5 49, 8% af patienterne i monoterapibehandling fik mindst én bivirkning relateret til lægemidlet.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
De hyppigst rapporterede bivirkninger var træthed og somnolens.
The most frequently reported undesirable effects were fatigue and somnolence.
En undersøgelse udført med pædiatriske patienter (4- 16 år) med anfald af partiel type viste at 55, 4% af patienterne i Keppragruppen og 40, 2% af patienterne i placebogruppen oplevede bivirkninger.
A study conducted in paediatric patients (4 to 16 years) with partial onset seizures showed that 55.4% of the patients in the Keppra group and 40.2% of the patients in the placebo group experienced undesirable effects.
0, 0% af patienterne i Keppragruppen og 1, 0% af patienterne i placebo gruppen oplevede alvorlige bivirkninger.
Serious undesirable effects were experienced in 0.0% of the patients in the Keppra group and 1.0% of the patients in the placebo group.
De mest almindelige rapporterede bivirkninger i den pædiatriske population var somnolens, fjendtlighed, nervøsitet, emotionel labilitet, agitation, anorexi, asteni og hovedpine.
The most commonly reported undesirable effects were somnolence, hostility, nervousness, emotional lability, agitation, anorexia, asthenia and headache in the paediatric population.
Resultaterne med hensyn til sikkerhed for pædiatriske patienter var de samme, som sikkerhedsprofilen af levetiracetam viste for voksne med undtagelse af opførselsrelaterede og psykiatriske bivirkninger, som var hyppigere hos børn end hos voksne (38, 6% vs.
Safety results in paediatric patients were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse events which were more common in children than in adults (38.6% versus 18.6%).
Men den relative risiko var sammenlignelig for børn og voksne.
However, the relative risk was similar in children as compared to adults.
En undersøgelse udført med voksne og unge patienter med myoklone anfald (12- 65 år) viste, at 33, 3% af patienterne i Keppragruppen og 30, 0% af patienterne i placebogruppen oplevede bivirkninger bedømt som relateret til behandlingen.
A study conducted in adults and adolescents with myoclonic seizures (12 to 65 years) showed that 33.3% of the patients in the Keppra group and 30.0% of the patients in the placebo group experienced undesirable effects that were judged to be related to treatment.
De mest almindelige rapporterede bivirkninger var hovedpine og somnolens.
The most commonly reported undesirable effects were headache and somnolence.
Forekomsten af bivirkninger hos patienter med myoklone anfald var lavere end hos voksne patienter med anfald af partiel type (33, 3% mod 46, 4%).
The incidence of undesirable effects in patients with myoclonic seizures was lower than that in adult patients with partial onset seizures (33.3% versus 46.4%).
En undersøgelse udført med voksne og børn (4- 65 år) med idiopatisk generaliseret epilepsi med primært generaliserede toniske- kloniske anfald, viste at 39, 2% af patienterne i Keppragruppen og 29, 8% af patienterne i placebogruppen oplevede bivirkninger vurderet som relateret til behandlingen.
A study conducted in adults and children (4 to 65 years) with idiopathic generalised epilepsy with primary generalised tonic-clonic seizures showed that 39.2% of the patients in the Keppra group and 29.8% of the patients in the placebo group experienced undesirable effects that were judged to be related to treatment.
Den mest almindelige rapporterede bivirkning var træthed.
The most commonly reported undesirable effect was fatigue.
Bivirkninger rapporteret i kliniske afprøvninger (børn og voksne) eller fra erfaring efter markedsføring vises i nedenstående tabel med organklasse og frekvens.
Undesirable effects reported in clinical studies (adults and children) or from post-marketing experience are listed in the following table per System Organ Class and per frequency.
(≥1/ 10000, < 1/ 1000); meget sjælden (< 1/ 10000), inklusive enkeltstående indberetninger:
For clinical trials, the frequency is defined as follows: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Data efter markedsføring er utilstrækkelige til at underbygge et estimat over incidensen i den population som skal behandles.
Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
- Almene lidelser og reaktioner på indgivelsesstedet
- General disorders and administration site conditions
Meget almindelig: asteni/ træthed
Very common: asthenia/ fatigue
- Sygdomme i nervesystemet
- Nervous system disorders
Meget almindelig: somnolens Almindelig: amnesi, ataksi, krampe, svimmelhed, hovedpine, hyperkinesi, tremor, balanceforstyrrelser, koncentrationssvækkelse, hukommelsessvækkelse.
Very common: somnolence Common: amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment.
Erfaring efter markedsføring: paraesthesi
Post-marketing experience: paraesthesia
- Psykiske lidelser
- Psychiatric disorders
Almindelig: agitation, depression, emotionel labilitet/ humørsvingninger, fjendtlighed/ aggression, søvnløshed, nervøsitet/ irritabilitet, personlighedsforstyrrelse, abnorm tænkning Erfaring efter markedsføring: unormal adfærd, vrede, angst, forvirring, hallucinationer, psykotisk lidelse, selvmord, selvmordsforsøg og selvmordstanker
Common: agitation, depression, emotional lability/ mood swings, hostility/ aggression, insomnia, nervousness/ irritability, personality disorders, thinking abnormal Post-marketing experience: abnormal behaviour, anger, anxiety, confusion, hallucination, psychotic disorder, suicide, suicide attempt and suicidal ideation
- Gastrointestinale sygdomme
- Gastrointestinal disorders
Almindelig: mavesmerter, diarré, dyspepsi, kvalme, opkastning Erfaring efter markedsføring: pancreatitis
Common: abdominal pain, diarrhoea, dyspepsia, nausea, vomiting Post-marketing experience: pancreatitis
- Lever - og galdevejslidelser
- Hepatobiliary disorders:
Erfaring efter markedsføring: leversvigt, hepatitis, unormal leverfunktionstest
Post-marketing experience: hepatic failure, hepatitis, liver function test abnormal
- Stofskiftesygdomme og ernæringsbetingede sygdomme
- Metabolism and nutrition disorders
Almindelig: anoreksi, vægtøgning.
Common: anorexia, weight increase.
Risikoen for anoreksi er større, når topiramat gives samtidig med levetiracetam
The risk of anorexia is higher when topiramate is coadministered with levetiracetam.
6 Erfaring efter markedsføring: vægttab
Post-marketing experience: weight loss
- Sygdomme i det ydre og det indre øre
- Ear and labyrinth disorders
- Øjensygdomme
- Eye disorders
Almindelig: diplopi, sløret syn
Common: diplopia, vision blurred
- Muskuloskeletale -, bindevævs - og knoglelidelser
- Musculoskeletal and connective tissue disorders
Almindelig: myalgi
Common: myalgia
- Skader, forgiftninger og komplikationer ved medicinske procedurer
- Injury, poisoning and procedural complications
Almindelig: skader ved uheld
Common: accidental injury
- Infektiøse og parasitære sygdomme
- Infections and infestations
Almindelig: infektion, nasopharyngitis
Common: infection, nasopharyngitis
- Respiratoriske lidelser, lidelser i thorax og mediastinum
- Respiratory, thoracic and mediastinal disorders
Almindelig: forværret hoste
Common: cough increased
- Sygdomme i hud og subkutane væv
- Skin and subcutaneous tissue disorders
Almindelig: hududslæt, eksem, pruritus Erfaring efter markedsføring: alopeci: i flere tilfælde blev der set bedring af tilstanden når Keppra blev seponeret
Common: rash, eczema, pruritus Post-marketing experience: alopecia: in several cases, recovery was observed when Keppra was discontinued.
- Sygdomme i blod - og lymfesystem
- Blood and lymphatic system disorders
Almindelig: trombocytopeni Erfaring efter markedsføring: leukopeni, neutropeni, pancytopeni (hvor der i nogle af tilfældene blev identificeret knoglemarvsdepression)
Common: thrombocytopenia Post-marketing experience: leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases)
Somnolens, agitation aggression, nedsat bevidsthed, repirationshæmning og coma blev set ved overdosering med Keppra.
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Efter en akut overdosis bør maven tømmes ved hjælp af maveskylning og induktion af opkastning.
7 After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Der kendes ingen specifik antidot for levetiracetam.
There is no specific antidote for levetiracetam.
Effektiviteten ved dialyse ekstraktion er 60% for levetiracetam og 74% for den primære metabolit.
The dialyser extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
ATC kode:
Pharmacotherapeutic group: antiepileptics, ATC code:
Den virksomme substans, levetiracetam er et pyrrolidon derivat (S- enantiomer af α- ethyl- 2- oxo- 1 - pyrrolidin acetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive substanser.
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.
7 Virkningsmekanismen for levetiracetam mangler stadig at blive fuldstændigt belyst, men den ser ud til at være forskellig fra mekanismerne hos andre antiepileptiske lægemidler.
The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products.
In vitro forsøg viser, at levetiracetam påvirker de intraneuronale Ca2+ niveauer ved delvis hæmning af Ca2+ strømme af N- type og ved at reducere frigivelsen af Ca2+ fra intraneuronale lagre.
In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N- type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Desuden ophæver det delvist reduktionen i GABA- og glycin medierede strømme induceret af zink og β - carboliner.
In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β - carbolines.
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.
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.
Levetiracetam giver beskyttelse i en lang række dyreforsøgsmodeller med partielle og primært generaliserede anfald uden at udvise en pro- konvulsiv virkning.
Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.