FrancophonIA/ELRC3.0 huggingface dataset:
English: You may experience confusion, agitation and aggressive behaviour.
Danish: Du kan opleve forvirring, ophidselse og aggressiv opførsel.
English: - Oral contraceptives (also called “hormonal contraceptives”).
Danish: - Orale præventionsmidler (som også kaldes ”hormonal prævention”).
English: Do not stop treatment without first discussing it with your doctor.
Danish: Du må ikke stoppe behandlingen uden først at diskutere det med lægen.
English: and 12 mg (24 ml) depending on your response.
Danish: 12 mg (24 ml) afhængigt af dit respons.
English: Wash the oral syringe with clean water and dry thoroughly.
Danish: Vask den orale sprøjte med rent vand, og tør grundigt.
English: Shake for at least 5 seconds before use.
Danish: Omrystes i mindst 5 sekunder før brug.
English: Study 332 included 22 adolescents between the ages of 12 and 18.
Danish: Studie 332 inkluderede 22 unge fra 12 til 18 år.
English: It should not be chewed, crushed or split.
Danish: Den må ikke tygges, knuses eller deles.
English: The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Danish: Tmax var forsinket med ca. 1 time sammenlignet med fastende tilstande.
English: The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Danish: Den følgende konvention er blevet brugt til klassifikation af bivirkninger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Of the 140 subjects who completed the Study 332, 114 subjects (81.4%) had entered the Extension phase.
Danish: Ud af de 140 personer, som gennemførte studie 332, indgik 114 personer (81,4 %) i forlængelsesfasen.
English: There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Danish: Der er utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af perampanel til gravide kvinder.
English: You can take Fycompa with or without food.
Danish: Du kan tage Fycompa sammen med eller uden mad.
English: Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Danish: Fycompa skal titreres i henhold til det individuelle patientrespons for at optimere balancen mellem virkning og tolerabilitet.
English: The mean average daily dose was 10.05 mg.
Danish: Den gennemsnitlige daglige dosis var 10,05 mg.
English: No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).
Danish: Der blev ikke set nogen virkning på vægt, højde og kønsudvikling efter op til 104 ugers behandling (n = 114).
English: Subjects experiencing intolerable adverse events could remain on the same dose or have their dose decreased to the previously tolerated dose.
Danish: Personerne, der oplevede intolerable uønskede hændelser, kunne blive på den samme dosis, eller deres dosis kunne nedsættes til den tidligere tolererede dosis.
English: The population included 164 patients (perampanel N = 82, placebo N = 82).
Danish: Populationen omfattede 164 patienter (perampanel N=82, placebo N=82).
English: General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Generel støttebehandling af patienten er indiceret, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: - Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
Danish: - Fycompa kan gøre dig svimmel eller søvnig, især i begyndelsen af behandlingen.
English: In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required.
Danish: I kombination med den manglende aldersrelaterede forskel i perampanel-eksponering indikerer resultaterne, at der ikke er behov for dosisjustering hos ældre.
English: The cap should be replaced after each use.
Danish: Låget skal sættes på igen efter hver brug.
English: Cognitive function
Danish: Kognitiv funktion
English: Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment.
Danish: De fleste rapporterede hændelser var enten lette eller moderate, og patienterne kom i bedring enten spontant eller efter dosisjustering.
English: Do not drive or use machines until you know how Fycompa affects you.
Danish: Lad være med at føre motorkøretøj eller betjene maskiner, indtil du ved, hvordan Fycompa påvirker dig.
English: There is no available specific antidote to the effects of perampanel.
Danish: Der er ingen tilgængelig specifik antidot mod virkningerne af perampanel.
English: These effects may also be seen when Fycompa is used in combination with other central nervous system (CNS) depressants.
Danish: Disse virkninger kan også forekomme, når Fycompa anvendes i kombination med andre undertrykkere af centralnervesystemet (CNS).
English: The effect of these interactions on average steady state concentration is summarised in the following table.
Danish: Virkningen af disse interaktioner på de gennemsnitlige steady-state koncentrationer opsummeres i den følgende tabel.
English: If this happens to you, do not drive or use any tools or machines.
Danish: Hvis dette forekommer, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.
Danish: Den kognitive funktion blev vurderet ved Cognitive Drug Research (CDR) System Global Cognition t-Score, som er en sammensat score afledt fra 5 domæner, der tester Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, og Speed of Memory.
English: *The colourants are:
Danish: *Farvestofferne er:
English: Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Danish: Ud af disse vendte 14 patienter (27 %) tilbage til tillægsbehandling i de følgende måneder.
English: The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
Danish: Den præcise mekanisme, hvorved perampanel udøver sin antiepileptiske virkninger hos mennesker, mangler stadig at blive helt belyst.
English: - Don't take more Fycompa than your doctor has recommended.
Danish: - Du må ikke tage mere Fycompa, end din læge har anbefalet.
English: However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies).
Danish: Tanker om at udøve skade på andre, fysiske overgreb eller truende adfærd blev imidlertid observeret hos nogle patienter (< 1 % i kliniske studier med perampanel).
English: Dysarthria Balance disorder Irritability
Danish: Ataksi Dysartri Balanceforstyrrelser Irritabilitet
English: Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Danish: Forberedelse: Press-in-bottle-adapteren (PIBA), som leveres i præparatets æske, skal sættes godt fast i flaskehalsen før brug og skal blive på plads, mens flaskes bruges.
English: Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation.
Danish: Glutamat er den primære eksitatoriske neurotransmitter i centralnervesystemet, og det er impliceret i flere neurologiske sygdomme forårsaget af neuronal overeksitering.
English: Insert the oral syringe into the opening of the adaptor as far as possible.
Danish: Indsæt den orale sprøjte så langt ind i adapteren åbning som muligt.
English: - You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa.
Danish: - Du skal bruge en pålidelig præventionsmetode for at undgå at blive gravid, mens du behandles med Fycompa.
English: There was no statistically significant difference between the treatment groups (p = 0.145).
Danish: Der var ingen statistisk signifikant forskel mellem behandlingsgrupperne (p = 0,145).
English: For example, if you decide to take Fycompa with food, always take it that way.
Danish: Hvis du f.eks. vælger at tage Fycompa sammen med mad, skal du altid tage det på denne måde.
English: Subjects had partial-onset seizures with or without secondary generalisation and were not adequately controlled with one to three concomitant AEDs.
Danish: Personerne havde partielle anfald med eller uden sekundær generalisering, og var ikke tilstrækkeligt kontrollerede med en til tre samtidige AED'er.
English: There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Danish: Der var ingen ændringer, der direkte kunne tilskrives perampanel, i klinisk patologi eller histopatologi.
English: Instructions on how to use the oral syringe and adaptor are provided below:
Danish: Anvisninger i, hvordan den orale sprøjte og adapteren anvendes, gives herunder:
English: These data were consistent with those for percent change in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time from about week 26 through the end of year 2.
Danish: Disse data var i overensstemmelse med data for den procentvise ændring i anfaldshyppighed og viste, at for PGTG var 50 %-responsraten generelt stabil i tidsperioden fra ca. uge 26 til og med slutningen af år 2.
English: Activation of AMPA receptors by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain.
Danish: Det menes, at aktivering af AMPA-receptorerne med glutamat er ansvarlig for de fleste hurtige eksitatoriske synaptiske transmissioner i hjernen.
English: Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Danish: Data fra in vitro-studier indikerer, at perampanel er ca. 95 % bundet til plasmaproteiner.
English: Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Danish: Lignende resultater blev observeret, når alle anfald og absencer versus myokloniske anfald blev evalueret over tid.
English: A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
Danish: Et lille antal personer, der behandles med antiepileptika, har tænkt på at gøre skade på dem selv eller begå selvmord.
English: However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Danish: På grund af den lange halveringstid og den efterfølgende langsomme reduktion i plasmakoncentration kan perampanel dog seponeres pludseligt, hvis det er absolut nødvendigt.
English: Fycompa is for oral use.
Danish: Fycompa er til oral anvendelse.
English: Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Danish: Mellem 85,3 % og 89,1 % af patienterne tog to til tre samtidige AED'er med eller uden samtidig stimulation af vagusnerven.
English: Effect of perampanel on CYP3A substrates
Danish: Virkning af perampanel på CYP3A-substrater
English: After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.
Danish: Efter op til 52 ugers behandling med perampanel (n = 114) blev der ikke observeret nogen virkning på knoglevæksten.
English: <10% decrease
Danish: <10 % reduktion
English: The excretion into breast milk was measured in rats at 10 days post-partum.
Danish: Udskillelse i mælken hos dyr blev målt hos rotter 10 dage post-partum.
English: In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Danish: I disse tre studier havde personerne en gennemsnitlig epilepsivarighed på ca. 21,06 år.
English: It belongs to a group of medicines called anti-epileptics.
Danish: Det tilhører en gruppe af lægemidler, der kaldes antiepileptika.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Graviditet og amning Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Swallow the tablet whole with a glass of water.
Danish: Slug tabletten hel sammen med et glas vand.
English: Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
Danish: En enkelt glemt dosis: Da perampanel har en lang halveringstid, bør patienten vente og tage den næste dosis som planlagt.
English: A larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa doses cannot be excluded.
Danish: En større reduktion i eksponeringen over for midazolam (eller andre følsomme CYP3Asubstrater) ved højere doser af Fycompa kan ikke udelukkes.
English: If at any time you have these thoughts, contact your doctor straight away.
Danish: Hvis du på noget tidspunkt har sådanne tanker, skal du straks kontakte lægen.
English: There is limited clinical experience with perampanel overdose in humans.
Danish: Der er begrænset klinisk erfaring med en overdosering af perampanel hos mennesker.
English: If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
Danish: Hvis der opstår tegn eller symptomer, som tyder på sådanne reaktioner, bør perampanel omgående seponeres, og en alternativ behandling bør overvejes (efter behov).
English: Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%.
Danish: AUC for ethinyløstradiol blev ikke påvirket af Fycompa 12 mg, hvorimod Cmax blev reduceret med 18 %.
English: Behavioural and reproductive development of the offspring was not affected, but some parameters of physical development showed some delay, which is probably secondary to the pharmacology-based CNS effects of perampanel.
Danish: Den adfærdsmæssige udvikling og reproduktionsudviklingen hos afkommet var ikke påvirket, men nogle parametre for fysisk udvikling viste nogen forsinkelse, som sikkert er sekundær til de farmakologi-baserede CNS-virkninger af perampanel.
English: Clonazepam No influence
Danish: Clonazepam Ingen indflydelse
English: If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or pharmacist.
Danish: Hvis du får noget af det ovenstående, efter du tager Fycompa (eller du ikke er sikker), skal du tale med din læge eller apoteket.
English: In a report of an intentional overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered mental status, agitation and aggressive behaviour and recovered without sequelae.
Danish: I en rapport om en tilsigtet overdosering, der kunne have resulteret i en dosis på op til 264 mg, oplevede patienten hændelser med ændret psykisk status, ophidselse og aggressiv adfærd og kom sig uden sequelae.
English: Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects.
Danish: Carbamazepin, en kendt potent enzyminduktor, reducerede perampanel-niveauerne med to tredjedele i et studie, der blev udført med raske personer.
English: Patients' response should be monitored when they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme inducing medicinal products and vice versa.
Danish: Patienternes respons bør overvåges, når de skiftes fra samtidige ikke-inducerende antiepileptika til enzyminducerende lægemidler og omvendt.
English: The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Danish: Administrationen af maksimalt tolererede doser til rotter og aber resulterede i farmakologisk baserede kliniske CNS-tegn og nedsat terminal kropsvægt.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Danish: Farmakoterapeutisk klassifikation; Antiepileptika, andre antiepileptika, ATC-kode: N03AX22
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Danish: Du må ikke starte eller stoppe med at tage andre lægemidler uden at tale med lægen eller apotekspersonalet.
English: Push down and turn cap to open bottle.
Danish: Tryk låget ned, og drej det for at åbne flasken.
English: Perampanel is dosed to clinical effect regardless of other AEDs.
Danish: Perampanel doseres til klinisk virkning uanset andre AED'er.
English: It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures.
Danish: Det anbefales, at seponering foretages gradvist for at minimere risikoen for recidiverende epilepsianfald.
English: Abuse potential
Danish: Mulighed for misbrug
English: In all three trials, the Titration Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to remain on a stable dose of perampanel.
Danish: I alle tre studier blev titreringsfasen efterfulgt af en vedligeholdelsesfase, der varede 13 uger, hvor patienterne skulle blive på en stabil dosis af perampanel.
English: Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Danish: Det er blevet vist, at felbamat reducerer koncentrationen af nogle lægemidler og kan muligvis også reducere perampanelkoncentrationen.
English: Clinical studies of Fycompa in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Danish: Kliniske studier af epilepsi med Fycompa omfattede ikke et tilstrækkeligt antal personer, i alderen fra 65 år til at bestemme om de responderede anderledes end yngre personer.
English: The safety and efficacy of perampanel in children below 12 years of age have not been established yet.
Danish: Perampanels sikkerhed og virkning hos børn under 12 år er endnu ikke klarlagt.
English: The tablet should be swallowed whole with a glass of water.
Danish: Tabletten skal sluges hel sammen med et glas vand.
English: In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Danish: I urin og fæces bestod den genfundne radioaktivitet primært af en blanding af oxidative og konjugerede metabolitter.
English: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Danish: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Storbritannien
English: Be careful about consuming alcohol with epilepsy medicines including Fycompa.
Danish: Vær forsigtig, hvis du indtager alkohol sammen med epilepsimedicin, herunder Fycompa.
English: It has been given to you by your doctor to reduce the number of fits that you have.
Danish: Du har fået det af din læge for at reducere antallet af dine anfald.
English: If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Danish: Hvis en patient har afbrudt perampanel i en sammenhængende periode på over 5 halveringstider, anbefales det, at de indledende doseringsanbefalinger, der beskrives ovenfor, følges.
English: Analysis of safety information in 905 perampanel-treated elderly subjects (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile.
Danish: Analyse af sikkerhedsinformation hos 905 perampanelbehandlede ældre personer (i dobbeltblinde studier af ikkeepileptiske indikationer) afslørede ingen aldersrelaterede forskelle i sikkerhedsprofil.
English: Women of childbearing potential and contraception in males and females
Danish: Kvinder i den fertile alder og kontraception hos mænd og kvinder
English: Open date:
Danish: Dato for åbning:
English: This effect should be taken into account and managed when adding or withdrawing these anti-epileptic drugs from a patient's treatment regimen.
Danish: Denne virkning skal tages med i overvejelserne og behandles, når disse antiepileptika tilføjes eller seponeres fra patientens behandlingsprogram.
English: Do not use this medicine after the expiry date which is stated on the carton and blister.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisteren.
English: The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Danish: Antallet af personer, der fik perampanel og tog enzyminducerende antiepileptika, var lille (n=9).
English: Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see sections 4.4 and 4.5).
Danish: Det frarådes, at patienterne fører motorkøretøj, betjener komplicerede maskiner eller foretager andre potentielt farlige aktiviteter, indtil det vides, om perampanel påvirker deres evne til at udføre disse opgaver (se pkt.
English: Fycompa contains lactose (a type of sugar).
Danish: Fycompa indeholder lactose (en form for sukker).
English: 19% decrease
Danish: 19 % reduktion
English: The usual starting dose is 2 mg once a day before you go to bed.
Danish: Den sædvanlige startdosis er 2 mg én gang dagligt, før du går i seng.
English: The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Danish: De tre pivotale dobbeltblinde placebokontrollerede fase 3-studier inkluderede 143 unge fra 12 til 18 år.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Derfor skal patienterne overvåges for tegn på selvmordstanker og -adfærd, og der skal overvejes hensigtsmæssig behandling.
English: - If you have mild or moderate liver problems, your dose should not be more than 8 mg each day and your dose increases should be at least 2 weeks apart.
Danish: - Hvis du har lette eller moderate leverproblemer, bør din dosis ikke overstige 8 mg dagligt, og der skal være mindst 2 uger mellem dine dosisforhøjelser.
English: A dose adjustment in the elderly is not considered to be necessary (see section 4.2).
Danish: Dosisjustering anses ikke for at være nødvendig hos ældre (se pkt.
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Danish: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Storbritannien
English: During a 6-week baseline period, subjects were required to have more than five seizures with no seizure-free period exceeding 25 days.
Danish: I løbet af en 6-ugers baselineperiode skulle personerne have over fem epilepsianfald og ingen anfaldsfri periode længere end 25 dage.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket og kartonen.
English: Contains sorbitol: see leaflet for further information.
Danish: Indeholder sorbitol: Læs indlægssedlen for yderligere information.