natgillin/translations-raw huggingface dataset:
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).
Ispitivanja na životinjama nisu pokazala nikakve teratogene učinke u štakora ili kunića, ali opažena je embriotoksičnost u štakora pri dozama toksičnima za majku (vidjeti dio 5.3).
Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with sorbitol.
Obavijestite liječnika ili ljekarnika ako uzimate neki(e) drugi(e) lijek(ove) protiv epilepsije koji sadrži(e) sorbitol.
Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Jednokratne i višekratne doze od 8 mg i 12 mg narušile su psihomotornu sposobnost zdravih dobrovoljaca ovisno o dozi.
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.
Potreban je oprez kada se Fycompa oralna suspenzija kombinira s drugim antiepileptičkim lijekovima koji sadrže sorbitol, jer kombinirani unos više od 1 grama sorbitola može utjecati na apsorpciju nekih lijekova.
DO NOT TAKE Fycompa: - If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking perampanel.
NEMOJTE UZIMATI Fycompu: - ako ste ikad razvili teški kožni osip, iskusili ljuštenje kože ili stvaranje mjehurića i/ili rana u ustima nakon uzimanja perampanela.
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.
Deset (10) bolesnika praćeno je najmanje 18 mjeseci, a od toga su 3 bolesnika (30%) ostala na monoterapiji perampanelom najmanje 18 mjeseci.
Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.
Global Cognition t-Score) dobivenom u Cognitive Drug Research (CDR) sustavu testova za procjenu kognitivnih sposobnosti u kliničkim ispitivanjima, a taj rezultat je kompozitna vrijednost dobivena iz 5 domena kojima je procijenjena sposobnost usmjeravanja pozornosti, održavanja pozornosti, kvaliteta epizodnog sekundarnog pamćenja, kvaliteta radnog pamćenja i brzina zapamćivanja.
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Ako bolesnik ne uzima perampanel u neprekinutom razdoblju duljem od 5 poluvijekova, preporučuje se slijediti gore navedene preporuke za početak primjene.
Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.
Zbog niskog bubrežnog klirensa, posebne intervencije poput forsirane diureze, dijalize ili hemoperfuzije najvjerojatnije neće biti korisne.
The usual starting dose is 2 mg once a day before you go to bed.
Uobičajena početna doza je 2 mg jedanput na dan prije odlaska na spavanje.
Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Preokrenite bocu i izvucite propisanu količinu Fycompe.
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.
Doza od 12 mg bila je korisna u nekih bolesnika koji su podnosili dozu od 8 mg i kada su imali nedostatan klinički odgovor na tu dozu.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Bolesnicima (i njihovim skrbnicima) treba savjetovati da potraže savjet liječnika ako se pojave znakovi suicidalne ideacije i suicidalnog ponašanja.
Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy in people aged 12 years and older.
Fycompa se primjenjuje zajedno s drugim antiepileptičkim lijekovima za liječenje određenih oblika epilepsije u osoba u dobi od 12 ili više godina.
- Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
- Midazolam (lijek koji se uzima kako bi se zaustavili produljeni, akutni (iznenadni) konvulzivni napadaji te za smirenje i teškoće sa spavanjem) može biti pod utjecajem Fycompe.
These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
Ovi se lijekovi primjenjuju za liječenje epilepsije - kada se kod osobe napadaji ponavljaju.
At doses of 12 mg/day Fycompa may decrease the effectiveness of progestative-containing hormonal contraceptives; in this circumstance additional non-hormonal forms of contraception are recommended when using Fycompa (see section 4.5).
Pri dozama od 12 mg na dan, Fycompa može smanjiti učinkovitost hormonske kontracepcije progestagenima; u takvim okolnostima preporučuju se dodatni nehormonski oblici kontracepcije za vrijeme uzimanja Fycompe (vidjeti dio 4.5).
There were no effects on male fertility.
Nije bilo učinaka na plodnost u mužjaka.
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.
U ispitivanjima in vitro perampanel se nije natjecao s AMPA za vezanje na AMPA receptor, ali su vezanje perampanela istisnuli nekompetitivni antagonisti AMPA receptora, što pokazuje da je perampanel nekompetitivni antagonist AMPA receptora.
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).
U zdravih je ispitanika inhibitor CYP3A4 ketokonazol (400 mg jedanput na dan tijekom 10 dana) povećao AUC perampanela za 20% i produljio poluvijek perampanela za 15% (67,8 sati naspram 58,4 sati).
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.
Nakon primjene radiološki označene doze perampanela u 8 zdravih odraslih ili starijih ispitanika, približno 30% radioaktivnosti otkriveno je u mokraći, a 70% u stolici.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures.
Preporučuje se postupni prekid liječenja kako bi se minimalizirala mogućnost pojave napadaja uslijed ustezanja lijeka (engl. rebound seizures).
In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
U farmakokinetičkoj analizi populacije s epilepsijom pronašlo se da perampanel smanjuje klirens okskarbazepina za 26%.
Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Ujedinjeno Kraljevstvo
The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Primjena maksimalno podnošljivih doza štakorima i majmunima rezultirala je kliničkim znakovima središnjeg živčanog sustava temeljenim na farmakologiji i smanjila je krajnju tjelesnu težinu.
In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Radioaktivnost otkrivena u mokraći i stolici bila je primarno sastavljena od mješavine oksidativnih i konjugiranih metabolita.
In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
U obje analize, izloženost perampanelu korelira sa smanjenjem učestalosti napadaja.
Patients' response should be monitored when they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme inducing medicinal products and vice versa.
Potrebno je pratiti odgovor bolesnika kad se prebacuju s jednog antiepileptičkog lijeka koji ne inducira enzime na drugi koji ih inducira i obrnuto.
Decreased appetite Increased appetite
Poremećaji metabolizma i prehrane oslabljen apetit pojačan apetit
Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion of metabolites; only trace amounts of perampanel metabolites are observed in plasma.
Perampanel se eliminira gotovo isključivo metabolizmom nakon čega slijedi brzo izlučivanje metabolita; u plazmi su opaženi metaboliti perampanela samo u tragovima.
Open label extension phase
Faza otvorenog produžetka ispitivanja
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).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Fycompa u jednoj ili više podskupina pedijatrijske populacije u epilepsijama rezistentnim na liječenje (epileptički sindromi ovisno o lokalizaciji i dobi) (vidjeti dio 4.2 za informacije o primjeni u adolescenata).
The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Mali je broj ispitanika liječenih perampanelom uzimao antiepileptičke lijekove koji induciraju enzime (n=9).
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 sadrži laktozu pa stoga bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
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
Kako Fycompa izgleda i sadržaj pakiranja Sve jačine Fycompe su okrugle, bikonveksne, filmom obložene tablete 2 mg: narančasta, s oznakom E275 na jednoj strani i 2 na drugoj 4 mg: crvena s oznakom E277 na jednoj strani i 4 na drugoj 6 mg: ružičasta, s oznakom E294 na jednoj strani i 6 na drugoj 8 mg: ljubičasta, s oznakom E295 na jednoj strani i 8 na drugoj 10 mg: zelena, s oznakom E296 na jednoj strani i 10 na drugoj 12 mg: plava, s oznakom E297 na jednoj strani i 12 na drugoj
A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
Mali broj osoba koje se liječe antiepilepticima pomišljao je na to da se ozlijedi ili počini samoubojstvo.
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.
Ako bolesnik propusti uzeti više od 1 doze u neprekinutom razdoblju kraćem od 5 poluvijekova (3 tjedna za bolesnike koji ne uzimaju antiepileptike koji induciraju metabolizam perampanela i 1 tjedan za bolesnike koji uzimaju antiepileptike koji induciraju metabolizam perampanela (vidjeti dio 4.5)), potrebno je razmotriti ponovni početak liječenja počevši od zadnje razine doze.
In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
U populacijskoj farmakokinetičkoj analizi objedinjenih podataka iz 19 ispitivanja faze I, prosječni t1/2 perampanela bio je 105 sati.
Aggression
Agresija
The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Uobičajena početna doza je 2 mg (4 ml) jedanput na dan prije odlaska na spavanje.
Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each bottle contains 340 ml of suspension in an outer cardboard carton.
Boca izrađena od polietilen tereftalata (PET) s polipropilenskim (PP) zatvaračem sigurnim za djecu; svaka boca u kartonskoj kutiji sadrži 340 ml suspenzije.
Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Unutar svake kategorije po učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Prosječno trajanje epilepsije u ispitanika u ta tri ispitivanja iznosilo je približno 21,06 godina.
- If you have mild or moderate liver problems, your dose should not be more than 8 mg each day and your dose increases should be at least 2 weeks apart.
- Ako imate blage ili umjerene tegobe s jetrom, Vaša doza ne smije biti viša od 8 mg svakog dana, a povećanja doze trebaju biti u razmaku od najmanje 2 tjedna.
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial-onset seizures and primary generalised tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Na temelju baze podataka o 196 adolescenata izloženih perampanelu u dvostruko slijepim kliničkim ispitivanjima zbog parcijalnih napadaja i primarno generaliziranih toničko-kloničkih napadaja, ukupni profil sigurnosti primjene u adolescenata bio je sličan onome u odraslih, osim za agresiju, koja je bila opažena češće u adolescenata nego u odraslih.
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.
Perampanel nije produljio QTc interval kad se primjenjivao svakodnevno u dozama do 12 mg na dan i nije imao učinke povezane s dozom niti klinički važne učinke na trajanje QRS kompleksa.
Contains lactose: see leaflet for further information.
Sadrži laktozu: vidjeti uputu o lijeku za dodatne informacije.
- Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.
- Konzumiranje alkohola za vrijeme uzimanja Fycompe također može pojačati osjećaje ljutnje, smetenosti ili tuge.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima, te ih pozorno pratiti zbog moguće pojave kožnih reakcija.
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.
U sljedećoj tablici, nuspojave koje su bile prepoznate na temelju pregleda cijele baze sigurnosnih podataka iz kliničkih ispitivanja Fycompe navedene su prema klasifikaciji organskih sustava i učestalosti.
When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Kad se dozirao u kombinaciji s jakim induktorom CYP3A karbamazepinom, prosječni t1/2 bio je 25 sati.
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.
Očekuje se da će jaki induktori citokroma P450, kao što su rifampicin i gospina trava, smanjiti koncentracije perampanela, te se u njihovoj prisutnosti ne isključuje mogućnost povišenih koncentracija reaktivnih metabolita u plazmi.
The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Vrijednost tmax bila je dosegnuta s odgodom od približno 1 sata u usporedbi s vrijednošću postignutom mjerenjem natašte.
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.
Podaci iz placebom kontroliranih ispitivanja pokazuju da se poboljšanje kontrole napadaja opaža kod doze perampanela od 4 mg jedanput na dan i da se ta korist povećava s povišenjem doze na 8 mg na dan.
Conversion to monotherapy
Prelazak na monoterapiju
Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details see section 5.3).
Ispitivanja u ženki štakora tijekom laktacije pokazala su da se perampanel i/ili njegovi metaboliti izlučuju u mlijeko životinja (za detalje vidjeti dio 5.3).
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.
U usporedbi s pozitivnim kontrolama (uključujući fenobarbital, rifampicin), ustanovljeno je da perampanel slabo inducira CYP2B6 (30 µmol/l) i CYP3A4/5 (≥3 µmol/l) među glavnim jetrenim enzimima obitelji CYP i UGT u kulturi ljudskih hepatocita.
Fycompa has moderate influence on the ability to drive and use machines.
Fycompa umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
- Drinking alcohol while taking Fycompa may make these effects worse.
- Konzumiranje alkohola za vrijeme uzimanja Fycompe može pogoršati te učinke.
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.
U fazi produžetka ispitivanja, 73,7% ispitanika imalo je modalnu dnevnu dozu perampanela veću od 4 do 8 mg na dan, a 16,7% imalo je modalnu dnevnu dozu veću od 8 do 12 mg na dan.
If you stop taking Fycompa
Ako prestanete uzimati Fycompu
Fycompa contains sorbitol
Fycompa sadrži sorbitol
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).
Ukupni klirens Fycompe bio je povećan kad se primjenjivao s karbamazepinom (2,75 puta), fenitoinom (1,7 puta) i okskarbazepinom (1,9 puta), sve poznatim induktorima metaboličkih enzima (vidjeti dio 5.2).
In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined oral contraceptive, Fycompa was shown to decrease the levonorgestrel exposure (mean Cmax and AUC values were each decreased by 40%).
U zdravih žena koje su tijekom 21 dana primale 12 mg (ali ne 4 mg ili 8 mg na dan) istovremeno s kombiniranim oralnim kontraceptivom, pokazalo se da Fycompa smanjuje izloženost levonorgestrelu (srednje vrijednosti Cmax i AUC bile su smanjene za 40%).
Levodopa In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa.
U zdravih ispitanika, Fycompa (4 mg jedanput na dan tijekom 19 dana) nije imala učinka na Cmax ili AUC levodope.
The cap should be replaced after each use.
Bocu treba zatvoriti zatvaračem nakon svake upotrebe.
Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Priprema: Prije primjene, nastavak za utiskivanje u bocu (engl. press-in-bottle adapter, PIBA), priložen u kutiji s lijekom, treba se čvrsto umetnuti u vrat boce i tako ostati sve dok je boca u primjeni.
The effect of perampanel on monohydroxycarbazepine concentrations is not known.
Učinak perampanela na koncentracije monohidroksikarbazepina nije poznat.
Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%.
Fycompa od 12 mg nije utjecala na AUC etinilestradiola, dok je Cmax etinilestradiola bio smanjen za 18%.
Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Ako razvijete bilo koji od ovih simptoma prestanite koristiti perampanel i obratite se svom liječniku ili odmah zatražite liječničku pomoć.
In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
In vivo je perampanel značajno produljio latenciju napadaja u modelu napadaja induciranih AMPA-om.
Instructions on how to use the oral syringe and adaptor are provided below:
Upute kako upotrijebiti štrcaljku za usta i nastavak nalaze se u daljnjem tekstu:
These data were consistent with those for percent change in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time from about week 26 through the end of year 2.
Ovi su podaci bili sukladni onima za postotak promjene učestalosti napadaja i pokazali su da je stopa od 50% odgovora primarno generaliziranih toničko-kloničkih napadaja bila općenito stabilna tijekom vremena od otprilike 26. tjedna pa sve do kraja 2. godine.
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.
Ispitivanjem učinaka perampanela na budnost i pamćenje pomoću standardne baterije testova u zdravih dobrovoljaca nisu pronađeni nikakvi učinci perampanela nakon jednokratnih i višekratnih doza do 12 mg na dan.
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.
U svim kontroliranim i nekontroliranim ispitivanjima u bolesnika s parcijalnim napadajima, perampanel je primalo 1639 ispitanika od kojih je 1147 bilo liječeno 6 mjeseci, a 703 dulje od 12 mjeseci.
What you need to know before you take Fycompa
Što morate znati prije nego počnete uzimati Fycompu
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.
U populacijskoj farmakokinetičkoj analizi adolescentnih bolesnika u kliničkim ispitivanjima faze 3 nije bilo zamjetnih razlika između ove populacije i ukupne populacije.
There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Podaci o primjeni perampanela u trudnica su ograničeni (manje od 300 ishoda trudnoća).
Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce i kutiji.
In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
U mikrosomima ljudske jetre, perampanel (30 µmol/l) je imao slab inhibicijski učinak na CYP2C8 i UGT1A9 među glavnim jetrenim enzimima obitelji CYP i UGT.
Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Enzim reduktaza u citosolu brzo metabolizira okskarbazepin do aktivnog metabolita, monohidroksikarbazepina.
A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures.
Provedena je farmakokinetičko-farmakodinamička analiza (djelotvornosti) objedinjenih podataka iz 3 ispitivanja djelotvornosti kod parcijalnih napadaja.
During a 6-week baseline period, subjects were required to have more than five seizures with no seizure-free period exceeding 25 days.
Tijekom 6-tjednog početnog razdoblja, ispitanici su trebali imati više od pet napadaja, a razdoblje bez napadaja nije smjelo biti dulje od 25 dana.
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.
Istodobna primjena tableta perampanela s obrocima s visokim udjelom masti nije imao utjecaj na vršnu izloženost u plazmi (Cmax) ili ukupnu izloženost (AUC0-inf) perampanelu.