natgillin/translations-raw huggingface dataset:
Dyreforsøg indikerede ingen teratogen virkning hos rotter og kaniner, men der blev observeret embryotoksicitet hos rotter ved doser, der medførte toksicitet hos moderen (se pkt.
Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats at maternally toxic doses (see section 5.3).
50 %-responsraten for primært generaliserede tonisk-kloniske anfald i løbet af vedligeholdelsesperioden var signifikant højere i perampanelgruppen (58,0 %) end i placebogruppen (35,8 %), p=0,0059.
The 50% primary generalised tonic-clonic seizures responder rate during the Maintenance Period was significantly higher in the perampanel group (58.0%) than in the placebo group (35.8%), P = 0.0059.
Perampanels virkning ved partielle anfald blev fastlagt i tre 19-ugers, randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier med tillægsbehandling hos voksne og unge patienter.
The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent patients.
Hos raske personer reducerede Fycompa (6 mg én gang dagligt i 20 dage) AUC for midazolam med 13 %.
In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%.
Patienterne bør overvåges nøje for tolerabilitet og klinisk respons, når CYP-induktorer eller -hæmmere tilføjes eller fjernes, da plasmaniveauerne af perampanel kan falde eller stige.
Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly.
T1/2 var længere hos personer med let nedsat leverfunktion (306 t vs. 125 t) og hos personer med moderat nedsat leverfunktion (295 t vs. 139 t), sammenlignet med matchede raske personer.
The t½ was longer in mildly impaired (306 h vs. 125 h) and moderately impaired (295 h vs. 139 h) subjects compared to matched healthy subjects.
Ved administration sammen med et måltid med et højt fedtindhold var Cmax og AUC0-inf for en enkelt dosis på 12 mg perampanel oral suspension hhv. ca. 22 % og 13 % lavere sammenlignet med fastende tilstande.
When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions.
Den gennemsnitlige ændring (SD) fra baseline til slutningen af den dobbeltblindede behandling (19 uger) i CDR System Global Cognition t-Score var 1,1 (7,14) i placebogruppen og (minus) -1,0 (8,86) i perampanelgruppen med en forskel mellem behandlingsgrupperne i mindste kvadraters-gennemsnit på (95 % CI) = (minus) -2,2 (-5,2; 0,8).
The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) -1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) -2.2 (-5.2, 0.8).
Der er ikke behov for dosisjustering hos patienter med let nedsat nyrefunktion.
Dose adjustment is not required in patients with mild renal impairment.
Fycompa indeholder lactose, og derfor bør det ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose-/galactosemalabsorption.
Fycompa contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Fycompa indeholder et stof, der kaldes perampanel.
Fycompa contains a medicine called perampanel.
Fycompa bør ikke anvendes under graviditeten.
Fycompa is not recommended during pregnancy.
De orale doseringssprøjter er gradueret i 0,5 ml inddelinger.
The oral dosing syringes are graduated in 0.5 ml increments.
- Dette partielle anfald kan måske eller måske ikke efterfølges af et anfald, der påvirker hele din hjerne (det kaldes ”sekundær generalisering”).
- These partial seizures may or may not then be followed by a fit affecting all of your brain
Den aktive metabolit monohydroxycarbazepin blev ikke vurderet.
1) Active metabolite monohydroxycarbazepine was not assessed.
Hvis mere end 1 dosis glemmes i en sammenhængende periode på mindre end 5 halveringstider (3 uger for patienter, der ikke tager perampanel metabolisme-inducerende antiepileptika (AED), 1 uge for patienter, der tager perampanel metabolisme-inducerende AED'er (se pkt.
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking perampanel metabolism-inducing AEDs (see section 4.5)), consideration should be given to re-start treatment from the last dose level.
In vivo forlængede perampanel signifikant latens af epilepsianfald i en model af AMPA-induceret epilepsi.
In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
- DRESS viser sig typisk, men ikke udelukkende, som influenzalignende symptomer og udslæt ledsaget af høj kropstemperatur, forhøjede leverenzymer konstateret ved blodprøver, forhøjede niveauer af en type hvide blodlegemer (eosinofili) og forstørrede lymfeknuder.
- DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
AED'ers indflydelse på Fycompa-koncentrationen
Influence of AED on Fycompa concentration
Partielle anfald
Partial-Onset Seizures
- Hvis du har sprunget over mere end 7 dages behandling med Fycompa, skal du straks kontakte lægen.
- If you have missed more than 7 days of treatment with Fycompa, talk to your doctor immediately.
- Hvis du drikker alkohol, mens du tager Fycompa, kan det også forstærke vredesudbrud, forvirring og nedtrykthed.
- Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.
- Fycompa kan forårsage en øget faldtendens, især hvis du er en ældre person.
- Fycompa may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
I kliniske studier blev aggression, vrede og irritabilitet rapporteret hyppigere hos perampanelbehandlede patienter ved højere doser.
In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses.
Perampanel er en first-in-class selektiv, nonkompetitiv antagonist for den inotrope α-amino-3hydroxy-5-methyl-4-isoxazol-propionsyre (AMPA)-glutamatreceptor på postsynaptiske neuroner.
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons.
Perampanel kan forårsage svimmelhed og døsighed, og derfor kan det påvirke evnen til at føre motorkøretøj eller betjene maskiner.
Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or use machines.
I en populationsfarmakokinetisk analyse af de unge patienter med puljede resultater fra fase 2 og 3 kliniske studier var der ingen bemærkelsesværdig forskel mellem denne population og den samlede population.
In a population pharmacokinetic analysis of the adolescent patients pooled from the Phase 2 and 3 clinical studies, there were no notable differences between this population and the overall population.
Aggression Vrede
Aggression Anger
Patienterne bør optitreres med 2 mg (4 ml) doser, ikke hurtigere end hver 2. uge baseret på tolerabilitet og virkning.
Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
For patienter med let eller moderat nedsat leverfunktion kan doseringen påbegyndes med 2 mg.
For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg.
Den mediane procentvise ændring i hyppigheden af primære generaliserede tonisk-klonisk krampeanfald pr. 28 dage i løbet af titrerings- og vedligeholdelsesperioderne (kombineret), relativt til præ-randomisering, var større med perampanel (-76,5 %) end med placebo (-38,4 %), p<0,0001.
The median percent change in primary generalised tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), P < 0.0001.
Carmellosenatrium (E466)
Carmellose sodium (E466)
Hvis du tager Fycompa sammen med andre lægemidler mod epilepsi, der indeholder sorbitol, kan det påvirke deres virkning.
Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much they work.
I løbet af den 3 måneder lange vedligeholdelsesperiode holdt 30,9 % (25/81) af patienterne, der fik perampanel i de kliniske studier, op med at få PGTC-krampeanfald, sammenlignet med 12,3 % (10/81) i placebogruppen.
During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo.
Virkning af CYP-hæmmere på farmakokinetikken af perampanel Hos raske personer forøgede CYP3A4-hæmmeren ketoconazol (400 mg én gang dagligt i 10 dage) perampanel AUC med 20 %, og det forlængede halveringstiden af perampanel med 15 % (67,8 t vs. 58,4 t).
In healthy subjects, the CYP3A4 inhibitor ketoconazole (400 mg once daily for 10 days) increased perampanel AUC by 20% and prolonged perampanel half--life by 15% (67.8 h vs 58.4 h).
Der var ingen virkning på hannernes fertilitet.
There were no effects on male fertility.
Perampanel kan forårsage svimmelhed og døsighed, og derfor kan det påvirke evnen til at føre motorkøretøj eller betjene maskiner (se pkt.
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see section 4.7).
For patienter med let eller moderat nedsat leverfunktion kan doseringen påbegyndes med 2 mg (4 ml).
For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg (4 ml).
Filmovertræk (2 mg, 4 mg, 6 mg, 8 mg, 10 mg og 12 mg tabletter) Hypromellose 2910, talcum, macrogol 8000, titandioxid (E171), farvestoffer*
Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Samtidige CYP3A-inducerende antiepileptika
Concomitant CYP 3A inducing anti-epileptic medicinal products
Lad adapteren blive på, plads og sæt igen låget på flasken.
8 Leave the adaptor in place and replace cap on bottle.
Den bivirkning, der hyppigst (≥2 % i perampanelgruppen og større end placebo) førte til seponering, var svimmelhed.
The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
Fycompa er indiceret som tillægsbehandling af primært generaliserede tonisk-kloniske anfald hos voksne og unge patienter fra 12 år med idiopatisk generaliseret epilepsi (se pkt.
Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy (see section 5.1).
Lactosemonohydrat, lavsubstitueret hydroxypropylcellulose, povidon, magnesiumstearat (E470b)
Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, magnesium stearate (E470b)
Flere doser af perampanel 12 mg/dag forøgede niveauerne af vredesudbrud, forvirring og depression, som vurderet ved 5-punkts-skalaen Profile of Mood State (se pkt.
Multiple dosing of perampanel 12 mg/day increased levels of anger, confusion, and depression as assessed using the Profile of Mood State 5-point rating scale (see section 5.1).
I de kontrollerede fase 3 kliniske studier af partielle anfald var seponeringshyppigheden på grund af en bivirkning 1,7 %, 4,2 % og 13,7 % hos patienter, der blev randomiseret til at få perampanel med de anbefalede doser på hhv. 4 mg, 8 mg og 12 mg/dag, og 1,4 % hos patienter, der blev randomiseret til placebo.
In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7%, 4.2% and 13.7% in patients randomised to receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% in patients randomised to receive placebo.
7 filmovertrukne tabletter 28 filmovertrukne tabletter 98 filmovertrukne tabletter
7 film-coated tablets 28 film-coated tablets 98 film-coated tablets
Fycompa indeholder: - Aktivt stof: Perampanel.
What Fycompa contains - The active substance is perampanel.
Brug af anden medicin sammen med Fycompa
Other medicines and Fycompa
I det kontrollerede kliniske fase 3-studie af primært generaliserede tonisk-kloniske anfald var seponeringshyppigheden som et resultat af en bivirkning 4,9 % hos patienter, der blev randomiseret til at få perampanel 8 mg, og 1,2 % hos patienter, der blev randomiseret til placebo.
In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% in patients randomised to receive perampanel 8 mg, and 1.2% in patients randomised to receive placebo.
Der var ingen virkning på hannernes fertilitet (se pkt.
There were no effects on male fertility (see section 5.3).
Fycompa 0,5 mg/ml oral suspension er en hvid til off-white suspension.
What Fycompa looks like and contents of the pack Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension.
- Hvis du har sprunget over færre end 7 dages behandling med Fycompa, skal du fortsætte med at tage din daglige tablet, som du oprindeligt blev anvist af lægen.
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily tablet as originally instructed by your doctor.
- Det anvendes også til at behandle visse anfald, der påvirker hele din hjerne fra starten (det kaldes
- It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.
Gangforstyrrelser Træthed
Gait disturbance Fatigue
Alle anfald holdt op hos 23,5 % (19/81) af patienterne i perampanel-gruppen sammenlignet med 4,9 % (4/81) i placebogruppen.
Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo.
- Øvrige indholdsstoffer: Sorbitol (E420) flydende (krystalliserende), mikrokrystallinsk cellulose (E460), carmellosenatrium (E466), poloxamer 188, simeticon- emulsion 30 % (indeholdende renset vand, siliconeolie, polysorbat 65, methylcellulose, silica-gel, macrogolstearat, sorbinsyre, benzoesyre og svovlsyre), citronsyre, vandfri (E330), natriumbenzoat (E211) og renset vand.
- The other ingredients are sorbitol (E420) liquid (crystallising), microcrystalline cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid), citric acid, anhydrous (E330), sodium benzoate (E211) and purified water.
8 mg tablet: Jernoxid, rød (E172), jernoxid, sort (E172) 10 mg tablet: Jernoxid, gul (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)
8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)
Simeticon-emulsion 30 %, indeholdende renset vand, siliconeolie, polysorbat 65, methylcellulose, silica-gel, macrogolstearat, sorbinsyre, benzoesyre og svovlsyre Citronsyre, vandfri (E330)
Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid Citric acid, anhydrous (E330)
Hver flaske (340 ml) indeholder 170 mg perampanel.
1 bottle (340 ml) contains 170 mg perampanel.
- Hvis du har sprunget over færre end 7 dages behandling med Fycompa, skal du fortsætte med at tage din daglige dosis, som du oprindeligt blev anvist af lægen.
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose as originally instructed by your doctor.
Fycompa 2 mg filmovertrukne tabletter Pakning med 7, kun til den første uges dosering, 28 og 98.
Fycompa 2 mg film-coated tablets Pack of 7 only for first week of dosing, 28 and 98
- Fycompa bør ikke anvendes under graviditeten.
- Fycompa is not recommended in pregnancy.
Andre undertyper af idiopatisk generaliseret epilepsi Perampanels virkning og sikkerhed hos patienter med myokloniske anfald er ikke klarlagt.
The efficacy and safety of perampanel in patients with myoclonic seizures have not been established.
Fycompa anses ikke for at være en potent induktor eller hæmmer af CYP- eller UGT-enzymer (se pkt.
Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2).
1,7-5,8 % af patienterne, der fik perampanel i de kliniske studier, havde ikke epilepsianfald i løbet af den 3-måneders vedligeholdelsesperiode, sammenlignet med 0-1,0 % i placebogruppen.
1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%-1.0% on placebo.
I studie 332 stoppede anfaldene hos patienter med PGTC-anfald, der også havde samtidige myokloniske anfald, hos 16,7 % (4/24) af patienterne i perampanel-gruppen sammenlignet med 13,0 % (3/23) i placebogruppen.
In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on placebo.
Perampanel som tillægsbehandling hos patienter i alderen 12 år og derover med idiopatisk generaliseret epilepsi, der oplever primært generaliserede tonisk-kloniske anfald, blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (studie 332).
Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332).
7 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Hver filmovertrukket tablet indeholder 2 mg, 4 mg, 6 mg, 8 mg, 10 mg eller 12 mg perampanel.
Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Hos patienter med samtidige absenceanfald stoppede anfaldene hos 22,2 % (6/27) af patienterne i perampanel-gruppen sammenlignet med 12,1 % (4/33) i placebogruppen.
In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% (6/27) on perampanel compared to 12.1% (4/33) on placebo.
Tabletkerne (6 mg, 8 mg, 10 mg og 12 mg tabletter) Lactosemonohydrat, lavsubstitueret hydroxypropylcellulose, povidon, mikrokrystallinsk cellulose, magnesiumstearat (E470b)
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
2 mg tablet - pakning med 7, 28 og 98
2 mg tablet - pack of 7, 28 and 98
Kartoner med 7, 28, 84 og 98 tabletter
Cartons of 7, 28, 84 and 98 tablets
Behandling med Fycompa bør påbegyndes med en dosis på 2 mg/dag.
Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Det skal du vide, før du begynder at tage Fycompa
What you need to know before you take Fycompa
Karton med 7, 28 og 98 tabletter
Carton of 7, 28 and 98 tablets
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tabletter - pakninger med 7, 28, 84 og 98
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Hver flaske med 340 ml indeholder 170 mg perampanel.
Each bottle of 340 ml contains 170 mg perampanel
Svimmelhed Døsighed
Dizziness Somnolence
Svære kutane bivirkninger (SCARs), herunder lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Brug den medfølgende orale sprøjte og adapter til dosering.
For dosing please use the oral syringe and adaptor provided.
Fortæl altid lægen, hvis du tager disse former for medicin eller har gjort det for nylig, da det kan være nødvendigt at justere din dosis.
Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Behandling med Fycompa bør påbegyndes med en dosis på 2 mg/dag (4 ml/dag).
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Da en enkeltdosis på 12 mg af begge formuleringer blev administreret sammen med et måltid med et højt fedtindhold, opnåede perampanel oral suspension en ækvivalent AUC0-inf og en ca. 23 % lavere Cmax og en 2-timers forsinkelse i tiden til den maksimale eksponering (tmax) sammenlignet med tabletformuleringen.
perampanel oral suspension achieves equivalent AUC0-inf and approximately 23 % lower Cmax and 2 hours delay in time to peak exposure (tmax) compared to the tablet formulation.
Perampanel elimineres næsten udelukkende ved metabolisme efterfulgt af en hurtig udskillelse af metabolitterne.
Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion of metabolites; only trace amounts of perampanel metabolites are observed in plasma.
Afhængig af individuelt klinisk respons og tolerabilitet, kan dosis øges eller nedsættes i trin på 2 mg (se pkt.
Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2).
I en populationsfarmakokinetisk analyse af patienter med partielle anfald, der havde kreatinin-clearance i intervallet fra 39 til 160 ml/min og fik perampanel op til 12 mg/dag i placebokontrollerede kliniske studier, var perampanel-clearance ikke påvirket af kreatinin-clearance.
In a population pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical trials, perampanel clearance was not influenced by creatinine clearance.
Tag Fycompa, så længe som lægen anbefaler det. Du må ikke holde op, medmindre lægen anviser det. Din læge kan gradvist reducere din dosis, så du undgår, at dine anfald (epileptiske anfald) vender tilbage eller forværres.
Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.
6 mg tablet: Jernoxid, rød (E172)
6 mg tablet: Ferric Oxide, Red (E172)
I alle tre studier blev personerne randomiseret og titreret til den randomiserede dosis efter en 6-ugers baselinefase, der havde til formål at etablere hyppigheden af epilepsianfald ved baseline før randomisering.
In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose.
I en populationsfarmakokinetisk analyse af patienter med primært generaliserede tonisk-kloniske anfald, der fik perampanel op til 8 mg/dag i et placebokontrolleret klinisk studie, var perampanel-clearance ikke påvirket af kreatinin-clearance ved baseline.
In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.