FrancophonIA/ELRC3.0 huggingface dataset:
English: - Felbamate (a medicine used to treat epilepsy) may also affect Fycompa.
Danish: - Felbamat (et lægemiddel mod epilepsi) kan også påvirke Fycompa.
English: You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.
Danish: Du bør ikke tage Fycompa, hvis du har svære leverproblemer eller moderate eller svære nyreproblemer.
English: Tell your doctor if you are taking hormonal contraceptives.
Danish: Fortæl altid lægen, hvis du tager hormonal prævention.
English: Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
Danish: Der er blevet rapporteret aggressiv og fjendtlig adfærd hos patienter, der fik perampanel.
English: Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months.
Danish: Fireogtredive (34) patienter blev fulgt i mindst 6 måneder, og ud af disse blev 24 patienter (71 %) på monoterapi med perampanel i mindst 6 måneder.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og deres plejere) skal rådes til at søge lægehjælp, hvis der opstår tegn på selvmordstanker eller -adfærd.
English: It is not known whether the ingredients of Fycompa can pass into breast milk.
Danish: Det er ukendt, om Fycompas indholdsstoffer kan udskilles i mælk hos mennesker.
English: Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo.
Danish: To studier (studie 304 og 305) sammenlignede doser af perampanel på 8 og 12 mg/dag med placebo, og det tredje studie (studie 306) sammenlignede doser af perampanel på 2, 4 og 8 mg/dag med placebo.
English: Push plunger of oral syringe completely down.
Danish: Skub stemplet på den orale sprøjte helt ned.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Fycompa seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Taking Fycompa with certain other medicines may cause side effects or affect how they work.
Danish: Hvis du tager Fycompa sammen med visse andre lægemidler, kan det forårsage bivirkninger, eller det kan påvirke deres virkning.
English: The efficacy of perampanel in the treatment of absence seizures has not been demonstrated.
Danish: Perampanels virkning til behandling af absenceanfald er ikke blevet demonstreret.
English: Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 brugere) er: - følelse af svimmelhed - følelse af at være søvnig (søvnighed eller døsighed).
English: Following administration of radiolabeled perampanel, only trace amounts of perampanel metabolites were observed in plasma.
Danish: Efter administration af radioaktivt mærket perampanel blev der kun observeret sporstoffer fra perampanel-metabolitter i plasma.
English: Sorbitol (E420) liquid (crystallising)
Danish: Sorbitol (E420) flydende (krystalliserende)
English: The total clearance of Fycompa was increased when administered with carbamazepine (2.75-fold), phenytoin (1.7-fold) and oxcarbazepine (1.9-fold), which are known inducers of enzymes of metabolism (see section 5.2).
Danish: Den totale clearance af Fycompa blev forøget, når det blev administreret med carbamazepin (2,75 gange), phenytoin (1,7 gange) og oxcarbazepin (1,9 gange), som er kendte induktorer af enzymer for metabolismen (se pkt.
English: Open label extension study
Danish: Åbent forlængelsesstudie
English: Interactions between Fycompa and other anti-epileptic medicinal products
Danish: Interaktioner mellem Fycompa og andre antiepileptika:
English: If you stop taking Fycompa
Danish: Hvis du holder op med at tage Fycompa
English: In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency.
Danish: I nedenstående tabel er de bivirkninger, der blev identificeret baseret på en gennemgang af hele databasen over kliniske studier med Fycompa opstillet pr. systemorganklasse og hyppighed.
English: The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Danish: Den orale sprøjte skal indsættes i PIBA og dosis trækkes fra flasken, mens den en vendt på hovedet.
English: Compared with positive controls (including phenobarbital, rifampicin), perampanel was found to weakly induce CYP2B6 (30 µmol/l) and CYP3A4/5 (≥ 3 µmol/l) among major hepatic CYPs and UGTs in cultured human hepatocytes.
Danish: Sammenlignet med positive kontroller (herunder phenobarbital, rifampicin) blev det fundet, at perampanel havde en svag inducerede virkning på CYP2B6 (30 µmol/l) og CYP3A4/5 (≥3 µmol/l) blandt større hepatiske CYP'er og UGT'er i humane hepatocytter i kultur.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
Danish: Der blev rapporteret selvmordstanker og -adfærd hos patienter behandlet med antiepileptika for flere indikationer.
English: During the Titration Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 2 mg/day to the target dose.
Danish: I alle tre studiers titreringsfase blev behandlingen påbegyndt med 2 mg/dag og øget gradvist hver uge med 2 mg/dag til måldosis.
English: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse.
Danish: Der bør udvises forsigtighed hos patienter med tidligere stofmisbrug, og patienterne bør overvåges for symptomer på misbrug af perampanel.
English: In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
Danish: I humane levermikrosomer havde perampanel (30 µmol/l) en svag hæmmende virkning på CYP2C8 og UGT1A9 blandt større hepatiske CYP'er og UGT'er.
English: The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, demographically matched subjects.
Danish: Perampanels farmakokinetik efter en enkelt 1 mg dosis blev evalueret hos 12 personer med let til moderat nedsat leverfunktion (hhv. Child-Pugh A og B), sammenlignet med 12 raske, demografisk matchede personer.
English: In a pre- and postnatal development toxicity study in rats, abnormal delivery and nursing conditions were observed at maternally toxic doses, and the number of stillbirths was increased in offspring.
Danish: I et toksicitetsstudie af præ- og postnatal udvikling hos rotter blev der observeret unormale fødsler og diegivningsforhold ved maternelt toksiske doser, og antallet af dødfødsler var forhøjet hos afkommet.
English: Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Danish: Hver æske indeholder en flaske, to 20 ml graduerede orale doseringssprøjter og en LDPE press-in bottle-adapter (PIBA).
English: Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Fycompa, hvis du har leverproblemer eller moderate eller svære nyreproblemer.
English: It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Danish: Den leveres i en flaske med 340 ml med 2 graduerede orale sprøjter og en LDPE press-in bottle-adapter (PIBA).
English: Levodopa In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa.
Danish: Hos raske personer havde Fycompa (4 mg én gang dagligt i 19 dage) ingen virkning på Cmax eller AUC af levodopa.
English: - Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa.
Danish: - Andre antiepileptika, såsom carbamazepin, oxcarbazepin og phenytoin, der anvendes til at behandle anfald, kan påvirke Fycompa.
English: Levetiracetam No influence
Danish: Levetiracetam Ingen indflydelse
English: The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Danish: 0,09 % eller mindre af den administrerede dosis blev detekteret i fosteret.
English: Perampanel should be taken orally once daily at bedtime.
Danish: Perampanel skal tages oralt én gang dagligt ved sengetid.
English: Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Fycompa indeholder sorbitol (E420) og derfor bør det ikke anvendes til patienter med hereditær fructoseintolerans.
English: 2 oral syringes
Danish: 2 orale sprøjter
English: However, population pharmacokinetic analysis demonstrated that under simulated steady state exposure conditions, Cmax and AUC, of perampanel oral suspension were bioequivalent to the tablet formulation under both fasted and fed conditions.
Danish: En populationsfarmakokinetisk analyse viste imidlertid under simulerede forhold med steady-state-eksponering, at Cmax og AUC, for perampanel oral suspension var bioækvivalente til tabletformuleringen i både fastende tilstand og efter et måltid.
English: In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast Cancer Resistance Protein (BCRP).
Danish: In vitro-studier viser, at perampanel ikke er et substrat eller en signifikant hæmmer af organiske aniontransporterende polypeptider (OATP) 1B1 og 1B3, organiske aniontransportere (OAT) 1, 2, 3 og 4, organiske kationtransportere (OCT) 1, 2 og 3, og efflux-transportere P-glykoprotein og Breast Cancer Resistance Protein (BCRP).
English: In the controlled and uncontrolled trial in patients with primary generalised tonic-clonic seizures, 114 subjects have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months.
Danish: I de kontrollerede og ikke-kontrollerede studier hos patienter med primært generaliserede toniskkloniske anfald har 114 personer fået perampanel, hvoraf 68 blev behandlet i 6 måneder, og 36 patienter blev behandlet i mere end 12 måneder.
English: If you forget to take Fycompa - If you forget to take a tablet, wait until your next dose and then carry on as usual.
Danish: Hvis du har glemt at tage Fycompa - Hvis du har glemt at tage en tablet, skal du vente til din næste dosis og fortsætte som sædvanligt.
English: Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing anti-epileptic medicinal products.
Danish: Responsrater efter tilføjelse af perampanel ved faste doser var mindre, hvis patienterne fik samtidige CYP3A-enzyminducerende antiepileptika (carbamazepin, phenytoin, oxcarbazepin) sammenlignet med responsrater hos patienter, der fik samtidige ikke-enzyminducerende antiepileptika.
English: Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with perampanel from 4 to 12 mg/day.
Danish: Opmærksomhedsniveauet (arousal) blev reduceret på en dosisrelateret facon hos raske personer, der fik en dosis perampanel fra 4 til 12 mg/dag.
English: Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details see section 5.3).
Danish: Studier med diegivende rotter viser, at perampanel og/eller dets metabolitter udskilles i mælk (se pkt.
English: In a healthy volunteer study to assess the effects of perampanel on alertness, and memory using a standard battery of assessments, no effects of perampanel were found following single and multiple doses of perampanel up to 12 mg/day.
Danish: I et studie med raske frivillige til vurdering af virkningerne af perampanel på opmærksomhed og hukommelse ved hjælp af standardvurderinger blev der ikke fundet nogen virkning af perampanel efter enkelt og gentagen dosering af perampanel op til 12 mg/dag.
English: Some anti-epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel.
Danish: Nogle antiepileptika, som kaldes CYP450 3A-enzyminduktorer (carbamazepin, phenytoin, oxcarbazepin), har vist sig at øge perampanels clearance og derved sænke plasmakoncentrationen af perampanel.
English: Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4).
Danish: Perampanel bør anvendes med forsigtighed til ældre, og muligheden for lægemiddelinteraktioner hos patienter i behandling med flere lægemidler skal tages i betragtning (se pkt.
English: In the open label extension, no significant changes were observed in global CDR system score after 52 weeks of perampanel treatment (see section 5.1 Paediatric population).
Danish: I det åbne forlængelsesstudie blev der ikke observeret nogen signifikante ændringer i global score med CDR-systemet efter 52 uger med perampanelbehandling (se pkt.
English: In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population.
Danish: I en populationsfarmakokinetisk analyse af de unge patienter i fase 3 kliniske studier var der ingen bemærkelsesværdig forskel mellem denne population og den samlede population.
English: Use in patients with moderate or severe renal impairment or patients undergoing haemodialysis is not recommended.
Danish: Anvendelse til patienter med moderat eller svært nedsat nyrefunktion eller til patienter, der gennemgår hæmodialyse, anbefales ikke.
English: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Danish: Fycompa er indiceret som tillægsbehandling af partielle anfald med eller uden sekundær generalisering hos voksne og unge patienter fra 12 år med epilepsi.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Danish: Følgende bivirkninger er ikke observeret i kliniske studier, men er set i dyrestudier efter eksponering for plasmakoncentrationer, der svarer til human terapeutiske doser, og kan muligvis være klinisk relevante:
English: A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures.
Danish: En farmakokinetisk-farmakodynamisk analyse (af virkning) blev udført på de puljede data fra 3 studier af virkning ved partielle anfald.
English: Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia.
Danish: Symptomerne på DRESS omfatter typisk, men ikke udelukkende, feber, udslæt i forbindelse med anden organsystempåvirkning, lymfadenopati, unormale leverfunktionsprøver og eosinofili.
English: Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver ml oral suspension indeholder 175 mg sorbitol (E420).
English: Discuss with your doctor what may be appropriate contraception for you.
Danish: Rådfør dig med din læge om, hvad er den bedste præventionsmetode til dig.
English: The active substance is perampanel.
Danish: Aktivt stof: Perampanel.
English: Fycompa is available in packs of:
Danish: Fycompa fås i pakninger med:
English: If you forget to take Fycompa - If you forget to take Fycompa, wait until your next dose and then carry on as usual.
Danish: Hvis du har glemt at tage Fycompa - Hvis du har glemt at tage Fycompa, skal du vente til din næste dosis og fortsætte som sædvanligt.
English: Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with sorbitol.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager andre lægemidler mod epilepsi, der indeholder sorbitol.
English: Not known (the frequency of this side effect cannot be estimated from the available data) are: - widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Danish: Ikke kendt (denne bivirknings hyppighed kan ikke estimeres ud fra forhåndenværende data) er: - udbredt udslæt, høj kropstemperatur, forhøjede leverenzymer, uregelmæssigheder i blodet (eosinofili), forstørrede lymfeknuder og påvirkning af andre organer i kroppen (lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer, også kendt som DRESS eller lægemiddeloverfølsomhedssyndrom).
English: In vitro assessment of drug interactions
Danish: Vurdering af lægemiddelinteraktioner in vitro
English: Potential interactions between Fycompa (up to 12 mg once daily) and other anti-epileptic drugs (AEDs) were assessed in clinical studies and evaluated in the population PK analysis of four pooled Phase 3 studies including patients with partial-onset seizures and primary generalised tonic-clonic seizures.
Danish: De mulige interaktioner mellem Fycompa (op til 12 mg én gang dagligt) og andre antiepileptika (AED'er) blev vurderet i kliniske studier og evalueret i den populationsfarmakokinetiske analyse af fire puljede fase 3-studier, herunder patienter med partielle anfald og primært generaliserede tonisk-kloniske anfald.
English: Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets
Danish: Fycompa 2 mg filmovertrukne tabletter Fycompa 4 mg filmovertrukne tabletter Fycompa 6 mg filmovertrukne tabletter Fycompa 8 mg filmovertrukne tabletter Fycompa 10 mg filmovertrukne tabletter Fycompa 12 mg filmovertrukne tabletter
English: Eligible patients on a stable dose of 1 to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline period were randomised to either perampanel or placebo.
Danish: Egnede patienter på en stabil dosis af 1 til 3 AED'er, der oplevede mindst 3 primært generaliserede tonisk-kloniske anfald i løbet af den 8-ugers baselineperiode, blev randomiseret til enten perampanel eller placebo.
English: Influence of Fycompa on AED concentration
Danish: Fycompas indflydelse på AEDkoncentrationen
English: The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), adults and adolescents with partial-onset seizures and primary generalised tonic-clonic seizures, adults with Parkinson's disease, adults with diabetic neuropathy, adults with multiple sclerosis, and subjects with hepatic impairment.
Danish: Perampanels farmakokinetik er blevet undersøgt hos raske voksne personer (aldersinterval fra 18 til 79 år), voksne og unge med partielle anfald og primært generaliserede tonisk-kloniske anfald, voksne med Parkinsons sygdom, voksne med diabetisk neuropati, voksne med multipel sklerose og personer med nedsat leverfunktion.
English: - Your doctor may increase this in 2 mg (4 ml) steps to a maintenance dose between 4 mg (8 ml)
Danish: - Din læge kan forøge dette i trin på 2 mg (4 ml) til en vedligeholdelsesdosis mellem 4 mg (8 ml) og
English: For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91).
Danish: For patienter, der fik perampanel i det åbne forlængelsesstudie (n = 112), var den gennemsnitlige ændring (SD) fra baseline til slutningen af den åbne behandling (52 uger) i CDR System Global Cognition t-Score (minus) -1,0 (9,91).
English: What Fycompa looks like and contents of the pack All strengths of Fycompa are round, biconvex film-coated tablets 2 mg: orange, marked with E275 on one side and 2 on other side 4 mg: red, marked with E277 on one side and 4 on other side 6 mg: pink, marked with E294 on one side and 6 on other side 8 mg: purple, marked with E295 on one side and 8 on other side 10 mg: green, marked with E296 on one side and 10 on other side 12 mg: blue, marked with E297 on one side and 12 on other side
Danish: Alle styrker af Fycompa er runde, hvælvede (bikonvekse), filmovertrukne tabletter 2 mg: orange, mærket med E275 på den ene side og med 2 på den anden side 4 mg: rød, mærket med E277 på den ene side og med 4 på den anden side 6 mg: lyserød, mærket med E294 på den ene side og med 6 på den anden side 8 mg: lilla, mærket med E295 på den ene side og med 8 på den anden side 10 mg: grøn, mærket med E296 på den ene side og med 10 på den anden side 12 mg: blå, mærket med E297 på den ene side og med 12 på den anden side
English: Drug interaction studies
Danish: Studier af lægemiddelinteraktion
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Fycompa in one or more subsets of the paediatric population in treatment-resistant epilepsies (localisation-related and age-related epilepsy syndromes) (see section 4.2 for information on adolescent use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Fycompa i en eller flere undergrupper af den pædiatriske population med behandlingsresistent epilepsi (fokale og aldersrelaterede epilepsisyndromer) (se pkt.
English: The adverse reactions most commonly (≥ 1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence.
Danish: De bivirkninger, der hyppigst (≥1 % i den samlede perampanel-gruppe og højere end placebo) førte til seponering var svimmelhed og døsighed.
English: Common (may affect more than 1 user in 100) are: - increased or decreased appetite, weight gain - feeling aggressive, angry, irritable, anxious or confused - difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) - slow speech (dysarthria) - blurred vision or double vision (diplopia) - spinning sensation (vertigo) - feeling sick (nausea) - back pain - feeling very tired (fatigue) - falling down
Danish: Almindelig (kan forekomme hos flere end 1 ud af 100 brugere) er: - øget eller nedsat appetit, vægtøgning - aggressivitet, vredesudbrud, irritabilitet, angst eller forvirring - problemer med at gå eller andre problemer med balancen (ataksi, gangbesvær, balanceforstyrrelse) - langsom tale (dysartri) - sløret syn eller dobbeltsyn (diplopi) - snurrende fornemmelse (vertigo) - sygdomsfølelse (kvalme) - rygsmerter - meget kraftig træthedsfølelse - faldtendens.
English: Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
Danish: Perampanel har, ved doser på 4 mg/dag til 12 mg/dag, vist sig at være en virkningsfuld behandling til partielle anfald.