natgillin/translations-raw huggingface dataset:
Disse lægemidler anvendes til at behandle epilepsi - hvis der opstår gentagne anfald (epileptiske anfald). 
These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
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. 
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).
Perampanel bliver metaboliseret i udstrakt grad via primær oxidation og sekventiel glukuronidering. 
Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
TAG IKKE Fycompa: - hvis du nogensinde har haft alvorligt hududslæt eller hudafskalning, blærer og/eller mundsår, efter at du har taget perampanel. 
DO NOT TAKE Fycompa: - If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking perampanel.
Selvmordstanker Selvmordsforsøg 
Suicidal ideation Suicide attempt
Det bør du også fortsætte med at gøre i en måned, efter du stopper behandlingen. 
You should continue doing this for one month after stopping treatment.
Fycompa anvendes sammen med andre antiepileptika til at behandle visse former for epilepsi hos personer fra 12-års alderen. 
Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy in people aged 12 years and older.
Dosisøgninger hos patienter med let til moderat nedsat leverfunktion skal baseres på klinisk respons og tolerabilitet. 
Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.
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. 
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.
Der blev ikke observeret en behandlingsfordel ved en dosis på 12 mg sammenlignet med en dosis på 8 mg i den samlede population. 
No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in the overall population.
Fycompa påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
Fycompa has moderate influence on the ability to drive and use machines.
Lægen vil opveje fordele og risici for dit barn, hvis du tager Fycompa, mens du ammer. 
The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding.
Samtidig administreret AED 
AED coadministered
Primært generaliserede tonisk-kloniske anfald 
Primary Generalised Tonic-Clonic Seizures
Virkningen af perampanel på monohydroxycarbazepinkoncentrationer er ukendt. 
The effect of perampanel on monohydroxycarbazepine concentrations is not known.
Lactosemonohydrat Lavsubstitueret hydroxypropylcellulose Povidon K-29/32 
Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
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. 
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.
Hvis der skiftes mellem tabletter og suspension, skal det gøres med forsigtighed (se pkt. 
Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Du kan tage Fycompa sammen med eller uden mad, og du bør altid tage det på samme måde. 
You can take Fycompa with or without food and should always take it the same way.
Oxcarbazepin metaboliseres hurtigt af cytosolisk reduktaseenzym til den aktive metabolit, monohydroxycarbazepin. 
Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
- Midazolam (et lægemiddel til at stoppe langvarige, akutte (pludselige) anfald, til bedøvelse og søvnproblemer) kan blive påvirket af Fycompa. 
- Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
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). 
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)
Det er ukendt, om perampanel udskilles i human mælk. 
It is not known whether perampanel is excreted in human milk.
- 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. 
- Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines.
I den farmakokinetiske analyse af epilepsipopulationen fandtes det, at perampanel reducerede clearance af oxcarbazepin med 26 %. 
In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
Perampanel oral suspension er bioækvivalent mg pr. mg til perampanel tabletter i fastende tilstand. 
Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
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. 
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.
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. 
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.
Psykomotorisk præstation 
Psychomotor performance
Filmovertræk Hypromellose 2910 Talcum 
Film coating Hypromellose 2910 Talc
In vitro hæmmede perampanel en AMPA-induceret (men ikke NMDA-induceret) forøgelse i intracellulært calcium. 
In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
I et retrospektivt studie af klinisk praksis konverterede 51 patienter med epilepsi, der fik perampanel som tillægsbehandling, til monoterapi med perampanel. 
In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
Perampanel-suspensionen skal tages oralt én gang dagligt ved sengetid. 
Perampanel suspension should be taken orally once daily at bedtime.
- Hvis du drikker alkohol, mens du tager Fycompa, kan disse virkninger forstærkes. 
- Drinking alcohol while taking Fycompa may make these effects worse.
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. 
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.
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. 
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.
Perampanels virkning på human fertilitet er ikke klarlagt. 
The effect of perampanel on human fertility has not been established.
97 % af de patienter, der gennemførte de randomiserede studier med partielle anfald, blev inkluderet i det åbne forlængelsesstudie (n=1.186). 
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).
I en populationsfarmakokinetisk analyse af puljede data fra 19 fase 1-studier var den gennemsnitlige t1/2 af perampanel 105 timer. 
In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
Ved dosering i kombination med den potente CYP3A-induktor carbamazepin var den gennemsnitlige t1/2 25 timer. 
When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Den sædvanlige startdosis er 2 mg (4 ml) én gang dagligt, før du går i seng. 
The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Brug af Fycompa sammen med alkohol 
Fycompa with alcohol
CDR System Global Cognition t-Scores for placebo og perampanel var hhv. 41,2 (10,7) og 40,8 (13,0) ved baseline. 
CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline.
50 %-responsraten var 22,2 % i kombination med enzyminducerende antiepileptika og 69,4 %, når perampanel blev givet i kombination med ikke-enzyminducerende antiepileptika. 
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.
I begge analyser er perampanel-eksponering korreleret med en nedsat anfaldshyppighed. 
In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Enkelt eller gentagen dosering af 8 mg og 12 mg fremkaldte en dosisrelateret hæmning af den psykomotoriske præstation hos raske frivillige. 
Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
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. 
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.
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. 
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.
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. 
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.
Hvis du udvikler disse symptomer, skal du stoppe med at bruge perampanel og kontakte din læge eller søge lægehjælp omgående. 
Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Før du tager dette lægemiddel skal du altid fortælle lægen, hvis du tidligere har haft et alkohol- eller stofmisbrug. 
Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.
Anvendelse efter markedsføringen 
Post-marketing use
Omvendt kan seponering af en samtidig CYP450 3A-enzyminduktor forventes at øge plasmakoncentrationerne af perampanel, og det kan være nødvendigt med en dosisreduktion. 
Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
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. 
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.
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. 
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.
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. 
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.
- Felbamat (et lægemiddel mod epilepsi) kan også påvirke Fycompa. 
- Felbamate (a medicine used to treat epilepsy) may also affect Fycompa.
Du bør ikke tage Fycompa, hvis du har svære leverproblemer eller moderate eller svære nyreproblemer. 
You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.
Fortæl altid lægen, hvis du tager hormonal prævention. 
Tell your doctor if you are taking hormonal contraceptives.
Der er blevet rapporteret aggressiv og fjendtlig adfærd hos patienter, der fik perampanel. 
Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
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. 
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.
Patienter (og deres plejere) skal rådes til at søge lægehjælp, hvis der opstår tegn på selvmordstanker eller -adfærd. 
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Det er ukendt, om Fycompas indholdsstoffer kan udskilles i mælk hos mennesker. 
It is not known whether the ingredients of Fycompa can pass into breast milk.
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. 
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.
Skub stemplet på den orale sprøjte helt ned. 
Push plunger of oral syringe completely down.
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. 
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.
Hvis du tager Fycompa sammen med visse andre lægemidler, kan det forårsage bivirkninger, eller det kan påvirke deres virkning. 
Taking Fycompa with certain other medicines may cause side effects or affect how they work.
Perampanels virkning til behandling af absenceanfald er ikke blevet demonstreret. 
The efficacy of perampanel in the treatment of absence seizures has not been demonstrated.
Meget almindelig (kan forekomme hos flere end 1 ud af 10 brugere) er: - følelse af svimmelhed - følelse af at være søvnig (søvnighed eller døsighed). 
Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence)
Efter administration af radioaktivt mærket perampanel blev der kun observeret sporstoffer fra perampanel-metabolitter i plasma. 
Following administration of radiolabeled perampanel, only trace amounts of perampanel metabolites were observed in plasma.
Sorbitol (E420) flydende (krystalliserende) 
Sorbitol (E420) liquid (crystallising)
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. 
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).
Åbent forlængelsesstudie 
Open label extension study
Interaktioner mellem Fycompa og andre antiepileptika: 
Interactions between Fycompa and other anti-epileptic medicinal products
Hvis du holder op med at tage Fycompa 
If you stop taking Fycompa
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. 
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.
Den orale sprøjte skal indsættes i PIBA og dosis trækkes fra flasken, mens den en vendt på hovedet. 
The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
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. 
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.
Der blev rapporteret selvmordstanker og -adfærd hos patienter behandlet med antiepileptika for flere indikationer. 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
I alle tre studiers titreringsfase blev behandlingen påbegyndt med 2 mg/dag og øget gradvist hver uge med 2 mg/dag til måldosis. 
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.
Der bør udvises forsigtighed hos patienter med tidligere stofmisbrug, og patienterne bør overvåges for symptomer på misbrug af perampanel. 
Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse.
I humane levermikrosomer havde perampanel (30 µmol/l) en svag hæmmende virkning på CYP2C8 og UGT1A9 blandt større hepatiske CYP'er og UGT'er. 
In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
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. 
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.
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. 
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.
Hver æske indeholder en flaske, to 20 ml graduerede orale doseringssprøjter og en LDPE press-in bottle-adapter (PIBA). 
Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Kontakt lægen eller apotekspersonalet, før du tager Fycompa, hvis du har leverproblemer eller moderate eller svære nyreproblemer. 
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.
Den leveres i en flaske med 340 ml med 2 graduerede orale sprøjter og en LDPE press-in bottle-adapter (PIBA). 
It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Hos raske personer havde Fycompa (4 mg én gang dagligt i 19 dage) ingen virkning på Cmax eller AUC af levodopa. 
Levodopa In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa.
- Andre antiepileptika, såsom carbamazepin, oxcarbazepin og phenytoin, der anvendes til at behandle anfald, kan påvirke Fycompa. 
- Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa.
Levetiracetam Ingen indflydelse 
Levetiracetam No influence
0,09 % eller mindre af den administrerede dosis blev detekteret i fosteret. 
The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Perampanel skal tages oralt én gang dagligt ved sengetid. 
Perampanel should be taken orally once daily at bedtime.
Fycompa indeholder sorbitol (E420) og derfor bør det ikke anvendes til patienter med hereditær fructoseintolerans. 
Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
2 orale sprøjter 
2 oral syringes
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. 
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.
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). 
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).
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. 
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.