FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when combining Fycompa oral suspension with other antiepileptic medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect absorption of some drugs.
Danish: Der bør udvises forsigtighed, hvis Fycompa oral suspension kombineres med andre antiepileptika indeholdende sorbitol, da en kombineret indtagelse på over 1 gram sorbitol kan påvirke absorptionen af nogle lægemidler.
English: The majority of these patients had a history of partial onset seizures.
Danish: Hovedparten af disse patienter havde partielle anfald i anamnesen.
English: Patients were titrated over four weeks to a target dose of 8 mg per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level achieved at the end of the titration period.
Danish: Patienterne blev titreret til en måldosis på 8 mg dagligt eller den højeste tolererede dosis i løbet af fire uger og behandlet i yderligere 13 uger med det sidste dosisniveau, der blev opnået ved slutningen af titreringsperioden.
English: In view of its long half-life, the effects caused by perampanel could be prolonged.
Danish: Når den lange halveringstid tages med i overvejelserne, kan de virkninger, der forårsages af perampanel, være langvarige.
English: Fycompa is not recommended for children aged under 12.
Danish: Fycompa bør ikke anvendes til børn under 12 år.
English: Following administration of a radiolabeled perampanel dose to either 8 healthy adults or elderly subjects, approximately 30% of recovered radioactivity was found in the urine and 70% in the faeces.
Danish: Efter administration af en radioaktivt mærket perampanel-dosis til enten 8 raske voksne eller ældre personer blev ca. 30 % af den genfundne radioaktivitet fundet i urinen og 70 % i fæces.
English: PVC/aluminium blisters
Danish: PVC/aluminiumblisters
English: Fycompa should be taken as single oral dose at bedtime.
Danish: Fycompa skal tages som en enkelt oral dosis ved sengetid.
English: It may be taken with or without food (see section 5.2).
Danish: Den kan tages sammen med eller uden mad (se pkt.
English: Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Danish: Vend på hovedet, og træk den ordinerede mængde Fycompa ud af flasken.
English: Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary.
Danish: Fycompa bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre det er klart nødvendigt.
English: The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe.
Danish: Perampaneldosis bør reduceres, hvis sådanne symptomer opstår, og perampanel bør straks seponeres, hvis symptomerne er svære.
English: Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.
Danish: På grund af den lave renale clearance er det usandsynligt, at særlige indgreb, såsom forceret dialyse eller hæmoperfusion, er nyttige.
English: - It is used to treat fits that affect one part of your brain (called a “partial seizure”).
Danish: - Det anvendes til at behandle anfald, der påvirker den ene side af hjernen (det kaldes ”partielle anfald”).
English: The pharmacokinetics of perampanel have not been formally evaluated in patients with renal impairment.
Danish: Perampanels farmakokinetik er ikke blevet formelt evalueret hos patienter med nedsat nyrefunktion.
English: Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential.
Danish: Prækliniske data viser, at perampanel ikke var genotoksisk og ikke udviste karcinogenicitet.
English: There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Danish: Der er tilsyneladende en forøget faldtendens, især hos ældre.
English: Contains lactose: see leaflet for further information.
Danish: Indeholder lactose: Læs indlægssedlen for yderligere information.
English: Benefit at the dose of 12 mg was observed in some patients who tolerate the dose of 8 mg and when the clinical response to that dose was insufficient.
Danish: Fordele ved en dosis på 12 mg blev observeret hos nogle patienter, der tolererer en dosis på 8 mg, og hvor det kliniske respons ved den dosis ikke var tilstrækkeligt.
English: A decrease in PGTC seizure frequency of at least 50% was seen in 65.9% of subjects after 1 year of treatment during the Extension Phase (relative to their pre-perampanel baseline seizure frequency).
Danish: En reduktion i hyppigheden af PGTC-krampeanfald på mindst 50 % blev set hos 65,9 % af personerne efter 1 års behandling i løbet af forlængelsesfasen (i forhold til deres baselineanfaldshyppighed før perampanel).
English: Perampanel did not prolong the QTc interval when administered in daily doses up to 12 mg/day, and did not have a dose-related or clinically important effect on QRS duration.
Danish: Perampanel forlængede ikke QTc-intervallet ved administration af daglige doser på op til 12 mg/dag og havde ikke en dosisrelateret eller klinisk vigtig virkning på QRS-varigheden.
English: A clinically meaningful reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing when patients reached a daily dose of 4 mg.
Danish: En klinisk meningsfuld reduktion i hyppigheden af epilepsianfald i forhold til placebo blev opnået allerede ved den anden uges dosering, når patienter nåede op på en daglig dosis på 4 mg.
English: The tablets cannot be split accurately as there is no break line.
Danish: Tabletterne kan ikke deles akkurat, da de ikke har en delekærv.
English: Adverse reactions leading to discontinuation:
Danish: Bivirkninger, der fører til seponering:
English: Psychomotor performance testing returned to baseline within 2 weeks of cessation of perampanel dosing.
Danish: Den psykomotoriske præstationstestning vendte tilbage til niveauet ved baseline i løbet af 2 uger efter seponering af perampanel-dosering.
English: It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Danish: Det er vigtigt at bemærke, at der kan forekomme tidlige manifestationer af overfølsomhed, såsom feber eller lymfadenopati, selv om der ikke er synligt udslæt.
English: Blister Pack (PVC/Aluminium blister)
Danish: Blisterpakning (PVC/aluminiumsblister)
English: In in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that perampanel is a noncompetitive AMPA receptor antagonist.
Danish: I in vitro-studier konkurrerede perampanel ikke med AMPA for binding til AMPA-receptoren, men perampanel-bindingen blev fortrængt af nonkompetitive AMPAreceptorantagonister, hvilket indikerer, at perampanel er en nonkompetitiv AMPA-receptorantagonist.
English: - If you are allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for perampanel eller et af de øvrige indholdsstoffer i Fycompa (angivet i punkt 6).
English: Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted.
Danish: Patienter og plejere skal informeres om straks at kontakte en sundhedsperson, hvis der bemærkes signifikante ændringer i humør eller adfærdsmønster.
English: You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Danish: Du skal tale med lægen om, hvordan din epilepsi påvirker din evne til at føre motorkøretøj eller betjene maskiner.
English: Clobazam No influence
Danish: Clobazam Ingen indflydelse
English: You should also do this for one month after stopping treatment.
Danish: Det bør du også gøre i en måned, efter du stopper behandlingen.
English: You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa.
Danish: Du bør anvende andre former for sikker og effektiv prævention (såsom et kondom eller en spiral), når du tager Fycompa.
English: No influence
Danish: Ingen indflydelse
English: Insert adaptor into the neck of the bottle until a tight seal is made.
Danish: Indsæt adapteren i flaskehalsen, indtil der opstår en tæt forsegling.
English: Tablet core (2 mg and 4 mg tablets):
Danish: Tabletkerne (2 mg og 4 mg tabletter):
English: Carbamazepine 2.75 fold decrease
Danish: Carbamazepin 2,75 gange reduktion
English: Open label extension phase
Danish: Åben forlængelsesfase
English: Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective.
Danish: Fycompa kan gøre visse andre hormonelle præventionsmidler, såsom levonorgestrel, mindre effektive.
English: - Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg depending on your response.
Danish: - Din læge kan forøge dette i trin på 2 mg til en vedligeholdelsesdosis mellem 4 mg og 12 mg afhængigt af dit respons.
English: The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.
Danish: Perampanels virkning på komplicerede opgaver, såsom evnen til at føre motorkøretøj, var additiv eller supra-additiv til den hæmmende virkning af alkohol.
English: These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
Danish: Disse lægemidler anvendes til at behandle epilepsi - hvis der opstår gentagne anfald (epileptiske anfald).
English: Therefore, the possibility of decreased efficacy of progestative-containing oral contraceptives should be considered for women needing Fycompa 12 mg/day and an additional reliable method (intra-uterine device (IUD), condom) is to be used (see section 4.4).
Danish: Derfor skal muligheden for en nedsat effektivitet af progesteron-indeholdende oral kontraception overvejes for kvinder, der har behov for Fycompa 12 mg/dag, og der skal bruges en anden sikker metode (intrauterin anordning (IUD), kondom) (se pkt.
English: Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
Danish: Perampanel bliver metaboliseret i udstrakt grad via primær oxidation og sekventiel glukuronidering.
English: DO NOT TAKE Fycompa: - If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking perampanel.
Danish: TAG IKKE Fycompa: - hvis du nogensinde har haft alvorligt hududslæt eller hudafskalning, blærer og/eller mundsår, efter at du har taget perampanel.
English: Suicidal ideation Suicide attempt
Danish: Selvmordstanker Selvmordsforsøg
English: You should continue doing this for one month after stopping treatment.
Danish: Det bør du også fortsætte med at gøre i en måned, efter du stopper behandlingen.
English: Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy in people aged 12 years and older.
Danish: Fycompa anvendes sammen med andre antiepileptika til at behandle visse former for epilepsi hos personer fra 12-års alderen.
English: Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.
Danish: Dosisøgninger hos patienter med let til moderat nedsat leverfunktion skal baseres på klinisk respons og tolerabilitet.
English: Larger effects cannot be excluded when perampanel is combined with a CYP3A inhibitor with longer half-life than ketoconazole or when the inhibitor is given for a longer treatment duration.
Danish: Større virkninger kan ikke udelukkes, hvis perampanel kombineres med en CYP3A4-hæmmer med en længere halveringstid end ketoconazol, eller hvis hæmmeren gives til mere langvarig behandling.
English: No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in the overall population.
Danish: Der blev ikke observeret en behandlingsfordel ved en dosis på 12 mg sammenlignet med en dosis på 8 mg i den samlede population.
English: Fycompa has moderate influence on the ability to drive and use machines.
Danish: Fycompa påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding.
Danish: Lægen vil opveje fordele og risici for dit barn, hvis du tager Fycompa, mens du ammer.
English: AED coadministered
Danish: Samtidig administreret AED
English: Primary Generalised Tonic-Clonic Seizures
Danish: Primært generaliserede tonisk-kloniske anfald
English: The effect of perampanel on monohydroxycarbazepine concentrations is not known.
Danish: Virkningen af perampanel på monohydroxycarbazepinkoncentrationer er ukendt.
English: Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
Danish: Lactosemonohydrat Lavsubstitueret hydroxypropylcellulose Povidon K-29/32
English: These studies show that once-daily administration of perampanel at doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this population.
Danish: Disse studier viser, at administration af perampanel ved doser på 4 mg til 12 mg én gang dagligt var signifikant mere virkningsfuld end placebo som tillægsbehandling hos denne population.
English: Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Danish: Hvis der skiftes mellem tabletter og suspension, skal det gøres med forsigtighed (se pkt.
English: You can take Fycompa with or without food and should always take it the same way.
Danish: Du kan tage Fycompa sammen med eller uden mad, og du bør altid tage det på samme måde.
English: Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Danish: Oxcarbazepin metaboliseres hurtigt af cytosolisk reduktaseenzym til den aktive metabolit, monohydroxycarbazepin.
English: - Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
Danish: - Midazolam (et lægemiddel til at stoppe langvarige, akutte (pludselige) anfald, til bedøvelse og søvnproblemer) kan blive påvirket af Fycompa.
English: Uncommon (may affect more than 1 user in 1000) are: - thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
Danish: Ikke almindelig (kan forekomme hos flere end 1 ud af 1000 brugere) er: - tanker om at skade dig selv eller tage livet af dig selv (selvmordstanker), forsøg på at tage livet af dig selv (selvmordsforsøg).
English: It is not known whether perampanel is excreted in human milk.
Danish: Det er ukendt, om perampanel udskilles i human mælk.
English: - Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines.
Danish: - Hvis du drikker alkohol, mens du tager Fycompa, kan det gøre dig mindre opmærksom og påvirke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
Danish: I den farmakokinetiske analyse af epilepsipopulationen fandtes det, at perampanel reducerede clearance af oxcarbazepin med 26 %.
English: Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Danish: Perampanel oral suspension er bioækvivalent mg pr. mg til perampanel tabletter i fastende tilstand.
English: Ten (10) patients were followed up for at least 18 months and, of these, 3 patients (30%) remained on perampanel monotherapy for at least 18 months.
Danish: Ti (10) patienter blev fulgt i mindst 18 måneder, og ud af disse blev 3 patienter (30 %) på monoterapi med perampanel i mindst 18 måneder.
English: The metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy subjects administered radiolabeled perampanel and supported by in vitro studies using recombinant human CYPs and human liver microsomes.
Danish: Metabolismen af perampanel er primært medieret via CYP3A baseret på resultater fra kliniske studier hos raske personer, der fik administreret radioaktivt mærket perampanel, og støttet af in vitro-studier med rekombinante humane CYP'er og humane levermikrosomer.
English: Psychomotor performance
Danish: Psykomotorisk præstation
English: Film coating Hypromellose 2910 Talc
Danish: Filmovertræk Hypromellose 2910 Talcum
English: In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
Danish: In vitro hæmmede perampanel en AMPA-induceret (men ikke NMDA-induceret) forøgelse i intracellulært calcium.
English: In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
Danish: I et retrospektivt studie af klinisk praksis konverterede 51 patienter med epilepsi, der fik perampanel som tillægsbehandling, til monoterapi med perampanel.
English: Perampanel suspension should be taken orally once daily at bedtime.
Danish: Perampanel-suspensionen skal tages oralt én gang dagligt ved sengetid.
English: - Drinking alcohol while taking Fycompa may make these effects worse.
Danish: - Hvis du drikker alkohol, mens du tager Fycompa, kan disse virkninger forstærkes.
English: The effects of perampanel on tasks involving alertness and vigilance such as driving ability were additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction study in healthy subjects.
Danish: Virkningen af perampanel på opgaver, der kræver opmærksomhed og årvågenhed, såsom evnen til at føre motorkøretøj, var additive eller supra-additive til alkohols egen virkning, som fundet i et farmakodynamisk interaktionsstudie med raske personer.
English: Data from placebo-controlled studies demonstrate that improvement in seizure control is observed with a once-daily perampanel dose of 4 mg and this benefit is enhanced as the dose is increased to 8 mg/day.
Danish: Data fra placebokontrollerede studier viser, at forbedring i kontrol af epilepsianfald ses med en perampanel-dosis én gang dagligt på 4 mg, og denne fordel øges, når dosis forøges til 8 mg/dag.
English: The effect of perampanel on human fertility has not been established.
Danish: Perampanels virkning på human fertilitet er ikke klarlagt.
English: Ninety-seven percent of the patients who completed the randomised trials in patients with partial-onset seizures were enrolled in the open label extension study (n = 1186).
Danish: 97 % af de patienter, der gennemførte de randomiserede studier med partielle anfald, blev inkluderet i det åbne forlængelsesstudie (n=1.186).
English: In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
Danish: I en populationsfarmakokinetisk analyse af puljede data fra 19 fase 1-studier var den gennemsnitlige t1/2 af perampanel 105 timer.
English: When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Danish: Ved dosering i kombination med den potente CYP3A-induktor carbamazepin var den gennemsnitlige t1/2 25 timer.
English: The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Danish: Den sædvanlige startdosis er 2 mg (4 ml) én gang dagligt, før du går i seng.
English: Fycompa with alcohol
Danish: Brug af Fycompa sammen med alkohol
English: CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline.
Danish: CDR System Global Cognition t-Scores for placebo og perampanel var hhv. 41,2 (10,7) og 40,8 (13,0) ved baseline.
English: The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal products and was 69.4% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Danish: 50 %-responsraten var 22,2 % i kombination med enzyminducerende antiepileptika og 69,4 %, når perampanel blev givet i kombination med ikke-enzyminducerende antiepileptika.
English: In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Danish: I begge analyser er perampanel-eksponering korreleret med en nedsat anfaldshyppighed.
English: Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Danish: Enkelt eller gentagen dosering af 8 mg og 12 mg fremkaldte en dosisrelateret hæmning af den psykomotoriske præstation hos raske frivillige.
English: In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 subjects have received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.
Danish: I alle kontrollerede og ikke-kontrollerede studier af patienter med partielle anfald fik 1.639 personer perampanel, hvoraf 1.147 er blevet behandlet i 6 måneder, og 703 patienter er blevet behandlet i over 12 måneder.
English: The mean apparent clearance of unbound perampanel in mildly impaired subjects was 188 ml/min vs. 338 ml/min in matched controls, and in moderately impaired subjects was 120 ml/min vs. 392 ml/min in matched controls.
Danish: Den gennemsnitlige tilsyneladende clearance af ubundet perampanel hos personer med let nedsat leverfunktion var 188 ml/min vs. 338 ml/min hos matchede kontroller, og hos personer med moderat nedsat leverfunktion var den 120 ml/min vs. 392 ml/min hos matchede kontroller.
English: In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel.
Danish: I et placebokontrolleret studie udført hos unge patienter blev der ikke observeret nogen signifikante ændringer i kognitiv funktion for perampanel i forhold til placebo målt ved Cognitive Drug Research (CDR) System Global Cognition Score.
English: Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at bruge perampanel og kontakte din læge eller søge lægehjælp omgående.
English: Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.
Danish: Før du tager dette lægemiddel skal du altid fortælle lægen, hvis du tidligere har haft et alkohol- eller stofmisbrug.
English: Post-marketing use
Danish: Anvendelse efter markedsføringen
English: Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
Danish: Omvendt kan seponering af en samtidig CYP450 3A-enzyminduktor forventes at øge plasmakoncentrationerne af perampanel, og det kan være nødvendigt med en dosisreduktion.
English: Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations and the potential for higher plasma concentrations of reactive metabolites in their presence has not been excluded.
Danish: Potente CYP-induktorer, såsom rifampicin og perikon, forventes at reducere perampanelkoncentrationen, og muligheden for højere plasmakoncentrationer af reaktive metabolitter under deres tilstedeværelse kan ikke udelukkes.
English: Co-administration of perampanel tablets with a high fat meal had no impact on the peak plasma exposure (Cmax) or total exposure (AUC0-inf) of perampanel.
Danish: Administration af perampanel-tabletter sammen med et måltid med et højt fedtindhold påvirkede ikke den maksimale plasmaeksponering (Cmax) eller den totale eksponering (AUC0-inf) af perampanel.
English: In the Extension Phase, 73.7% of subjects have a modal daily perampanel dose of greater than 4 to 8 mg/day and 16.7% had a modal daily dose of greater than 8 to 12 mg/day.
Danish: I forlængelsesfasen fik 73,7 % af personerne en modal daglig perampaneldosis på over 4 til 8 mg/dag, og 16,7 % fik en modal daglig dosis på over 8 til 12 mg/dag.