FrancophonIA/ELRC3.0 huggingface dataset:
English: Available data in children did not suggest impact on growth and puberty.
Danish: Tilgængelige data for børn tyder ikke på nogen indvirkning på vækst og pubertet.
English: 220 Hafnarfjörður Iceland
Danish: 220 Hafnarfjördur Island
English: There was no effect on embryomortality and no increased incidence of malformations.
Danish: Der var ingen effekt på embryo mortaliteten og ingen øget forekomst af malformationer.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du eller dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Danish: Hvis din baby er yngre end 4 uger, skal du tale med din læge eller apotek, før du giver barnet dette lægemiddel, især hvis barnet får andre lægemidler, der indeholder propylenglycol eller alkohol.
English: Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Danish: Derfor bør macrogol ikke indtages oralt i en time før og en time efter indtagelse af levetiracetam.
English: Levetiracetam Actavis Group must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam Actavis Group skal tages to gange dagligt, om morgenen og om aftenen, på omtrent samme tidspunkt hver dag.
English: In such case, the lowest effective dose is recommended.
Danish: I så fald anbefales den laveste effektive dosis.
English: Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Danish: Hydrolyse af acetamidgruppen var målelig i en lang række væv inklusive blodceller.
English: The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Danish: Den vigtigste metaboliseringsvej (24 % af dosis) er enzymatisk hydrolyse af acetamid gruppen.
English: Excipients with known effect:
Danish: Hjælpestoffer med kendt virkning:
English: Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant.
Danish: Behandling med levetiracetam bør revurderes, når en kvinde planlægger at blive gravid.
English: BG-5600 Troyan Bulgaria
Danish: BG-5600 Troyan
English: No impact on fertility was detected in animal studies (see section 5.3).
Danish: Der er ikke fundet nogen indvirkning på fertilitet i dyrestudier (se pkt.
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Danish: Herudover har 101 spædbørn under 12 måneder været eksponeret i et post-marketing sikkerhedsstudie.
English: Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Danish: Tilfælde af encefalopati forekom generelt i begyndelsen af behandlingen (fra få dage til flere måneder) og var reversible efter seponering af behandlingen.
English: Repeat until there are no bubbles in the syringe (Figure 6).
Danish: Gentag indtil der ikke er flere bobler i sprøjten (figur 6).
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.
Danish: Niveauet af methotrexat og levetiracetam i blodet bør omhyggeligt monitoreres hos patienter, som behandles samtidigt med de to lægemidler.
English: 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 increase.
Danish: Da den individuelle følsomhed er forskellig, kan nogle patienter opleve døsighed eller andre central nervesystems relaterede symptomer især i begyndelsen af behandlingen eller ved øgning af dosis.
English: The mechanism of action of levetiracetam still remains to be fully elucidated.
Danish: Virkningsmekanismen for levetiracetam mangler stadig at blive fuldstændigt belyst.
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 tegn på depression og/eller selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: Oral contraceptives and other pharmacokinetics interactions
Danish: Orale kontraceptiva og andre farmakokinetiske interaktioner
English: Dose adjustment is not required.
Danish: Dosisjustering er ikke nødvendig.
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: En blev opnået ved hydroxylering af pyrrolidonringen (1,6 % af dosis) og den anden ved åbning af pyrrolidonringen (0,9 % af dosis).
English: Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Danish: Derfor anbefales en 50 % reduktion af daglig vedligeholdelsesdosis, når kreatininclearance er < 60 ml/min/1,73 m2.
English: Take the oral solution following your doctor's instructions.
Danish: Tag den orale opløsning efter lægens anvisninger.
English: These effects should however decrease over time.
Danish: Disse bivirkninger vil imidlertid normalt mindskes efterhånden.
English: Physiological changes during pregnancy may affect levetiracetam concentration.
Danish: Fysiologiske forandringer under graviditeten påvirke koncentrationen af levetiracetam.
English: However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Danish: Langtidsvirkninger på indlæring, intelligens, vækst, endokrin funktion, pubertet og fertilitetspotentiale hos børn kendes imidlertid ikke.
English: Duration of treatment:
Danish: Behandlingsvarighed:
English: Be sure to drink the whole contents of the glass (Figure 9).
Danish: Vær sikker på at hele glassets indhold drikkes (figur 9).
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Danish: Effektanalyserne omfattede 109 patienter, som havde mindst 24 timers video EEG i både baseline samt i evalueringsperioderne.
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Danish: Du må ikke køre eller anvende maskiner, før du er helt sikker på, at din evne til at udføre sådanne aktiviteter ikke er påvirket.
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Danish: Effektiviteten ved dialyse ekstraktion er 60 % for levetiracetam og 74 % for den primære metabolit.
English: Therefore, the interaction of levetiracetam with other substances, or vice versa, is unlikely.
Danish: Derfor er interaktion mellem levetiracetam og andre lægemidler eller vice versa ikke sandsynlig.
English: When you will first start taking Levetiracetam Actavis Group, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Danish: Når du begynder at tage Levetiracetam Actavis Group, vil din læge ordinere en lavere dosis i 2 uger, før du får den laveste vedligeholdelsesdosis.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10%).
Danish: Hverken levetiracetam eller den primære metabolit bindes signifikant til plasmaproteiner (<10 %).
English: Push the plunger in slowly and allow the child to swallow the content of the syringe.
Danish: Skub langsomt stemplet ind og lad barnet sluge indholdet af sprøjten.
English: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced.
Danish: Absorptionen af levetiracetam blev ikke ændret ved fødeindtagelse, men absorptionshastigheden blev lettere reduceret.
English: • elevated/abnormal values in a liver function test;
Danish: • forhøjede/unormale værdier i leverfunktionsprøver;
English: There is no specific antidote for levetiracetam.
Danish: Der er ingen specifik antidot for levetiracetam.
English: Children (4 to 12 years)
Danish: Børn (4 til 12 år)
English: If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Danish: Hvis du har symptomer på depression og/eller selvmordstanker, så kontakt din læge.
English: The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Danish: Fordelingsvolumen for levetiracetam er ca. 0,5 til 0,7 l/kg, en værdi der ligger tæt på total volumen af kropsvæske.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women)
Danish: CLcr (ml/min) = ----------------------------------------- (x 0,85 for kvinder)
English: This is related to the decrease in renal function in this population (see section 4.2).
Danish: Dette er relateret til nedsat nyrefunktion hos denne population (se pkt.
English: Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Danish: Der skal sikres en passende klinisk kontrol af gravide kvinder, som behandles med levetiracetam..
English: To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Danish: For at anvende denne doseringstabel er det nødvendigt at beregne patientens kreatininclearance (CLcr) i ml/min.
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Danish: I flere tilfælde af alopeci blev der observeret en bedring af tilstanden, når levetiracetam blev seponeret.
English: Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Danish: Derfor tilrådes forsigtighed hos disse patienter ved udførelse af krævende opgaver, f.eks. kørsel og betjening af maskiner.
English: Push the tip of the syringe into the adaptor opening.
Danish: Pres spidsen af sprøjten ind i adapterens åbning.
English: 72 x serum creatinine (mg/dl)
Danish: 72 x serumkreatinin (mg/dl)
English: For young children gently put the tip of the syringe into the child´s mouth to the inside of the cheek.
Danish: Hos små børn placeres spidsen af sprøjten forsigtigt i barnets mund op mod indersiden af kinden.
English: EXP Do not use after 7 months of first opening the bottle.
Danish: EXP Skal anvendes indenfor 7 måneder efter første åbning af flasken.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for levetiracetam, pyrrolidonderivater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
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: BSA subject (m2)
Danish: Personens BSA (m2)
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 i kliniske undersøgelser (voksne, unge, børn og spædbørn >1 måned) og fra erfaring efter markedsføring vises i nedenstående tabel med organklasse og frekvens.
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.
Danish: Tag ikke macrogol (et lægemiddel, som anvendes som afføringsmiddel), en time før og en time efer levetiracetam, da dette kan medføre en nedsat virkning af levetiracetam.
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Danish: * Prævalensen er signifikant højere hos patienter af japansk afstamning i forhold til patienter af ikkejapansk afstamning.
English: • infection;
Danish: • infektion;
English: Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
Danish: Levetiracetam forårsagede let induktion af CYP2B6 og CYP3A4.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: Præ-kliniske data viser ingen særlig risiko for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Danish: Levetiracetam anvendes til den type epilepsi, hvor anfaldene til at begynde med kun påvirker en side af hjernen, men kan efterfølgende udvide sig til større områder i begge sider af hjernen (partiel epilepsi med eller uden sekundær generalisering).
English: The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Danish: Den orale opløsning kan fortyndes i et glas vand eller i en sutteflaske, og kan tages med eller uden mad.
English: Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Danish: Samtidig administration med substrater til alkoholdehydrogenase, såsom ethanol, kan fremkalde alvorlige bivirkninger hos nyfødte.
English: For adult patients, refer to the following table and adjust the dose as indicated.
Danish: Til voksne patienter, se nedenstående tabel og juster dosis som angivet.
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Danish: Denne effekt var udtalt for de yngste spædbørn og aftog med stigende alder for til sidst at forsvinde omkring 4 års alderen.
English: Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight.
Danish: På grund af fuldstændig og lineær absorption kan plasmaniveauerne forudsiges ud fra oral dosis af levetiracetam udtrykt som mg/kg legemsvægt.
English: There is no evidence for any relevant gender, race or circadian variability.
Danish: Der er ikke holdepunkter for nogen relevant køn, race eller døgnvariation.
English: The total daily dose was administered twice daily.
Danish: Den daglige dosis blev administreret 2 gange daglig.
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Danish: Dannelse af den primære metabolit, ucb L057 er ikke afhængigt af lever cytochrom P450 isoformer.
English: • anorexia (loss of appetite);
Danish: • anoreksi (appetitløshed);
English: as an add-on to other antiepileptic medicines to treat:
Danish: • som tillægsbehandling til andre antiepileptika til behandling af:
English: The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Danish: Den tilsyneladende vægtjusterede krops clearance var ca. 30 % højere end hos voksne med epilepsi.
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Danish: • tegn på alvorlige mentale forandringer, eller hvis nogen omkring Dem bemærker tegn på forvirring, somnolens (døsighed), amnesi (hukommelsestab), hukommelsessvækkelse (glemsomhed), unormal adfærd, eller andre neurologiske tegn, herunder ufrivillige eller ukontrollerede bevægelser.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Danish: 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.
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Danish: Reykjavíkurvegur 76-78 220 Hafnarfjördur Island
English: Bone marrow suppression was identified in some of the cases of pancytopenia.
Danish: Knoglemarvssupression identificeres i nogle af tilfældene af pancytopeni.
English: This recommendation is based on a study in adult renally impaired patients.
Danish: Denne anbefaling er baseret på et studie med voksne patienter med nedsat nyrefunktion.
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 β carboliner.
English: Treatment of an overdose will be symptomatic and may include haemodialysis.
Danish: Behandling af overdosering er symptomatisk og kan omfatte hæmodialyse.
English: The metabolite ucb L057 is pharmacologically inactive.
Danish: Metabolitten ucb LO57 er farmakologisk inaktiv.
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 tog enzyminducerende antiepileptiske lægemidler.
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Danish: Patienter skal rådes til ikke at føre motorkøretøj og betjene maskiner, før det er bevist, at deres evne til at udføre sådanne aktiviteter ikke er påvirket.
English: Breast-feeding is not recommended during treatment.
Danish: Det anbefales ikke at amme under behandlingen.
English: A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
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: 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.
Danish: 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.
English: 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).
Danish: Hovedparten blev udskilt via urinen, gennemsnitligt 95 % af dosis (ca. 93 % af dosis var udskilt indenfor 48 timer).
English: The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Danish: Den fraktionelle eliminering af levetiracetam var 51 % under et typisk 4-timers dialyseforløb.
English: Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed.
Danish: Levetiracetam kan anvendes under graviditeten, hvis det efter omhyggelig vurdering anses for klinisk nødvendigt.
English: No data on the interaction of levetiracetam with alcohol are available.
Danish: Der foreligger ikke data over interaktion mellem levetiracetam og alkohol.
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 forsøg tyder på, at levetiracetam ikke ændrer cellens basale egenskaber og normale neurotransmission.
English: • A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Levetiracetam Actavis Group, har haft selvmordstanker eller tanker om at skade sig selv.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Danish: Selvmord, selvmordsforsøg, selvmordstanker og -adfærd er rapporteret hos patienter i behandling med antiepileptika (inklusive levetiracetam).
English: If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and pull it back again.
Danish: Hvis der kommer bobler i sprøjten holdes flasken fortsat på hovedet, stemplet presses lidt ind og derefter tilbage igen.
English: In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Danish: Hos mennesket har virkning ved tilstande med både partiel og generaliseret epilepsi (epileptiforme afladninger/fotoparoxysmalt respons) bekræftet den bredspektrede farmakologiske profil af levetiracetam.
English: Before starting the measuring procedure make sure that the transparent dosing body of the syringe as well as the white plunger are in the bottom most position.
Danish: Før afmålingen påbegyndes, tjekkes det at den transparente doseringsdel af sprøjten såvel som det hvide stempel er helt i bundposition.
English: • vertigo (sensation of rotation);
Danish: • vertigo (følelse af at snurre rundt);
English: After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral solution may be diluted in a glass of water or baby's bottle.
Danish: Efter afmåling af den korrekte dosis med en passende sprøjte kan Levetiracetam Actavis Group oral opløsning fortyndes i et glas vand eller en sutteflaske.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Danish: Toksisk epidermal nekrolyse, StevensJohnsons syndrom, erythema multiforme
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Danish: I begyndelsen af behandlingen eller i forbindelse med dosisøgning kan bivirkninger såsom søvnighed, træthed og svimmelhed være mere almindelige.
English: Levetiracetam Actavis Group may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Danish: Levetiracetam Actavis Group kan påvirke din evne til at køre eller betjene værktøj eller maskiner, da det kan give døsighed.
English: The contents of the syringe can also be given directly from the syringe into the mouth or emptied onto a spoon (Figure 3).
Danish: Indholdet af sprøjten kan også gives direkte fra sprøjten ind i munden eller ved udtømning på en ske (figur 3).
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14
Danish: Farmakoterapeutisk klassifikation: antiepileptica, ATC-kode: NO3AX14.
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 69).
Danish: 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).