natgillin/translations-raw huggingface dataset:
Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects. 
Karbamazepin, znani močan induktor encimov, je v študiji, opravljeni pri zdravih prostovoljcih, zmanjšal ravni perampanela za dve tretjini.
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. 
V fazi podaljšanja je 73,7 % oseb imelo modalni dnevni odmerek perampanela med 4 in 8 mg/dan, 16,7 % oseb pa je imelo modalni dnevni odmerek med 8 in 12 mg/dan.
The effect of perampanel on monohydroxycarbazepine concentrations is not known. 
Učinek perampanela na koncentracije monohidroksikarbazepina ni znan.
Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - občutek omotičnosti - občutek zaspanosti (dremavost ali zaspanost)
What Fycompa is and what it is used for 
Kaj je zdravilo Fycompa in za kaj ga uporabljamo
Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary. 
Zdravila Fycompa ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen če je nujno potrebno.
Nervous system disorders 
Bolezni živčnega sistema
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. 
Če bolnik izpusti več kot 1 odmerek v neprekinjenem obdobju, krajšem kot 5 razpolovnih časov (3 tedne za bolnike, ki ne jemljejo antiepileptičnih zdravil (AEZ), ki inducirajo presnovo perampanela, 1 teden za bolnike, ki jemljejo AEZ, ki inducirajo presnovo perampanela (glejte poglavje 4.5)), je treba razmisliti o ponovnem začetku zdravljenja z ravnijo zadnjega odmerka.
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see section 4.7). 
Perampanel lahko povzroči omotico in zaspanost, zato lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.7).
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. 
V dveh študijah (študiji 304 in 305) so primerjali odmerke perampanela 8 in 12 mg/dan s placebom in v tretji študiji (študija 306) so primerjali odmerke perampanela 2, 4 in 8 mg/dan s placebom.
There is no available specific antidote to the effects of perampanel. 
Za učinke perampanela ni specifičnega antidota.
In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required. 
Rezultati v kombinaciji z razliko izpostavljenosti perampanelu, nepovezani s starostjo, kažejo, da odmerka pri starejših bolnikih ni treba prilagajati.
Do not stop unless your doctor advises you to. 
Ne prenehajte jemati zdravila, če vam tako ne svetuje vaš zdravnik.
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 podlagi podatkovne zbirke kliničnih preskušanj s 196 mladostniki, ki so bili izpostavljeni perampanelu v dvojno slepih študijah zaradi napadov s parcialnim izvorom in primarnih generaliziranih tonično-kloničnih napadov, je bil celotni varnostni profil pri mladostnikih podoben kot pri odraslih, razen agresivnosti, ki so jo pogosteje ugotavljali pri mladostnikih kot pri odraslih.
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. 
V fazi titriranja se je zdravljenje v vseh treh preskušanjih začelo z odmerkom 2 mg/dan, nato pa se je odmerek vsak teden povečal za 2 mg/dan do ciljnega odmerka.
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. 
Bolnike je treba pri dodajanju ali odstranjevanju spodbujevalcev ali zaviralcev citokroma P450 skrbno spremljati za prenašanje in klinični odziv, saj se lahko ravni perampanela v plazmi zmanjšajo ali povečajo; odmerek perampanela bo morda treba ustrezno prilagoditi.
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). 
Študije in vitro kažejo, da perampanel ni substrat ali pomemben zaviralec organskih anionskih transportnih polipeptidov (OATP) 1B1 in 1B3, organskih anionskih transporterjev (OAT) 1, 2, 3 in 4, organskih kationskih transporterjev (OCT) 1, 2 in 3 in efluksnih transporterjev P-glikoproteina in proteina dovzetnosti za raka dojke (BCRP - Breast Cancer Resistance Protein).
No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114). 
Po 104 tednih zdravljenja niso opazili nikakršnih učinkov telesno maso, telesno višino in spolni razvoj (n = 114).
Fycompa has moderate influence on the ability to drive and use machines. 
Zdravilo Fycompa ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves. 
Majhno število oseb, ki se zdravilo z antiepileptiki, je imelo misli o samopoškodovanju ali samomoru.
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. 
Vendar pa je populacijska farmakokinetična analiza pokazala, da sta bili v razmerah simuliranega stanja ravnovesja Cmax in AUC peroralne suspenzije perampanela biološko enakovredni zdravilu v obliki tablet tako na tešče kot po zaužitju hrane.
Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4). 
Perampanel je treba pri starejših uporabljati previdno in upoštevati možne interakcije zdravila pri bolnikih, ki prejemajo več zdravil (glejte poglavje 4.4).
- 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. 
- Če imate blage do zmerne težave z jetri, ne uporabite več kot 8 mg na dan, med povečanji odmerkov pa morata preteči vsaj 2 tedna.
The usual starting dose is 2 mg (4 ml) once a day before you go to bed. 
Običajni začetni odmerek je 2 mg (4 ml) enkrat na dan pred spanjem.
You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa. 
Pri jemanju zdravila Fycompa uporabljajte druge oblike varne in učinkovite kontracepcije (npr. kondom ali maternični vložek).
A decrease in PGTC seizure frequency of at least 50% was seen in 65.9% of subjects after 1 year of treatment during the Extension Phase (relative to their pre-perampanel baseline seizure frequency). 
Zmanjšanje pogostnosti primarnih generaliziranih napadov s tonično-kloničnimi krči za vsaj 50 % so opazili pri 65,9 % oseb po 1 letu zdravljenja v fazi podaljšanja (v primerjavi z njihovo izhodiščno pogostnostjo napadov pred zdravljenjem s perampanelom).
- Drinking alcohol while taking Fycompa may make these effects worse. 
- Uživanje alkohola med zdravljenjem z zdravilom Fycompa lahko te učinke še poslabša.
- Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa. 
- Druga antiepileptična zdravila, kot so karbamazepin, okskarbazepin in fenitoin, ki se uporabljajo za zdravljenje krčev, lahko vplivajo na zdravilo Fycompa.
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). 
Skupni očistek zdravila Fycompa se je povečal pri sočasnem dajanju s karbamazepinom (2,75-krat), fenitoinom (1,7-krat) in okskarbazepinom (1,9-krat), ki so znani induktorji presnove encimov (glejte poglavje 5.2).
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. 
V kontroliranem in nekontroliranem preskušanju pri bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči je perampanel prejemalo 114 oseb, od katerih je bilo 68 oseb zdravljenih 6 mesecev, 36 oseb pa več kot 12 mesecev.
If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or pharmacist. 
Če se po uporabi zdravila Fycompa pojavi kar koli od zgoraj navedenega (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom.
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. 
Pri dajanju dnevnih odmerkov do 12 mg/dan perampanel ni podaljšal intervala QTc in ni imel od odmerka odvisnega ali klinično pomembnega učinka na trajanje QRS.
The adverse reactions most commonly (≥ 1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence. 
Neželena učinka, ki sta najpogosteje (≥ 1 % v celotni skupini, ki je prejemala perampanel, in več kot pri placebu) povzročila prekinitev, sta bila omotica in zaspanost.
A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures. 
Farmakokinetično-farmakodinamično (učinkovitostno) analizo so izvedli na podlagi združenih podatkov 3 preskušanj učinkovitosti pri napadih s parcialnim izvorom.
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. 
V populacijski farmakokinetični analizi pri mladostnikih, združenih iz kliničnih študij 2. in 3. faze, ni bilo opaznih razlik med to populacijo in splošno populacijo.
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). 
Večkratno odmerjanje perampanela 12 mg/dan je povečalo ravni jeze, zmedenosti in depresije, kot je bilo ocenjeno s 5-točkovno lestvico po vprašalniku Profil stanja razpoloženja (POMS - Profile of Mood) (glejte poglavje 5.1).
- 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. 
- DRESS se običajno, čeprav ne izključno, pojavlja z gripi podobnimi simptomi in izpuščajem z visoko telesno temperaturo, zvišanimi ravnmi jetrnih encimov, ki jih opazimo pri krvnih preiskavah, ter povečanjem števila vrste belih krvnih celic (eozinofilija) in povečanimi bezgavkami.
Fycompa contains lactose (a type of sugar). 
Zdravilo Fycompa vsebuje laktozo (vrsto sladkorja).
If you forget to take Fycompa - If you forget to take a tablet, wait until your next dose and then carry on as usual. 
Če ste pozabili vzeti zdravilo Fycompa - Če ste pozabili vzeti tableto, počakajte do naslednjega odmerka, nato pa nadaljujte kot običajno.
Be careful about consuming alcohol with epilepsy medicines including Fycompa. 
Pri uživanju alkohola skupaj z zdravili proti epilepsiji, vključno z zdravilom Fycompa, bodite previdni.
A 19-week, randomised, double-blind, placebo-controlled study with an open-label extension phase (Study 235) was performed to assess the short-term effects on cognition of Fycompa (target dose range of 8 to 12 mg once daily) as adjunctive therapy in 133 (Fycompa n = 85, placebo n = 48) adolescent patients, ages 12 to less than 18 years old, with inadequately controlled partial-onset seizures. 
Izvedli so 19-tedensko randomizirano, dvojno slepo, s placebom kontrolirano študijo s fazo odprtega podaljšanja (študija 235), da bi ocenili kratkoročne učinke na kognitivne funkcije zdravila Fycompa (ciljni razpon odmerkov 8 do 12 mg enkrat na dan) kot adjuvantnega zdravljenja na 133 (zdravilo Fycompa n=85, placebo n=48) adolescentnih bolnikov, starih od 12 do manj kot 18 let, z nezadostno kontroliranimi napadi parcialnega izvora.
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. 
Nekatera antiepileptična zdravila, znana kot induktorji encima CYP450 3A (karbamazepin, fenitoin, okskarbazepin) povečajo očistek perampanela in posledično zmanjšajo koncentracijo perampanela v plazmi.
Conversion to monotherapy 
Prehod na monoterapijo
Levodopa In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa. 
Pri zdravih prostovoljcih zdravilo Fycompa (4 mg enkrat na dan za 19 dni) ni imelo učinka na Cmax ali AUC levodope.
No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in the overall population. 
Pri odmerku 12 mg v primerjavi z odmerkom 8 mg pri splošni populaciji niso opazili dodatnih koristi glede učinkovitosti.
Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or use machines. 
Perampanel lahko povzroči omotico in zaspanost, zato lahko vpliva na sposobnost vožnje in upravljanja strojev.
Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2). 
Zdravilo Fycompa ni močan induktor ali zaviralec citokroma P450 ali encimov UGT (glejte poglavje
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. 
Stopnje odzivnosti po dodajanju perampanela pri fiksnih odmerkih so bile nižje, če so bolniki sočasno prejeli antiepileptična zdravila, ki spodbujajo encim CYP3A (karbamazepin, fenitoin, okskarbazepin) v primerjavi s stopnjo odziva pri bolnikih, ki so sočasno prejeli antiepileptična zdravila, ki ne spodbujajo encimov.
Multiple dosing of perampanel 12 mg/day also enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion and depression as assessed using the Profile of Mood State 5-point rating scale. 
Večkratno odmerjanje perampanela 12 mg/dan je okrepilo tudi učinke alkohola na zbranost in budnost ter povečalo ravni jeze, zmedenosti in depresije po oceni s 5-točkovno lestvico po vprašalniku POMS.
Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%. 
12 mg ni vplivalo na AUC etinilestradiola, medtem ko se je Cmax zmanjšal za 18 %.
There were no effects on male fertility (see section 5.3). 
Učinkov na sposobnost razmnoževanja pri samcih ni bilo (glejte poglavje 5.3).
If at any time you have these thoughts, contact your doctor straight away. 
Če se pri vas kadar koli pojavijo take misli, da takoj posvetuje z zdravnikom.
Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with sorbitol. 
Povejte zdravniku ali farmacevtu, če jemljete eno ali več drugih zdravil proti epilepsiji s sorbitolom.
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. 
Farmakokinetiko perampanela so preučili pri zdravih odraslih prostovoljcih (razpon starosti 18 do 79 let), odraslih in mladostnikih z napadi parcialnega izvora in primarnimi generaliziranimi napadi s tonično-kloničnimi krči, odraslih s Parkinsonovo boleznijo, odraslih z diabetično nevropatijo, odraslih z multiplo sklerozo in osebah z jetrno okvaro.
and 12 mg (24 ml) depending on your response. 
4 mg in 12 mg, odvisno od vašega odziva.
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. 
Ugotovili so, da je v primerjavi s pozitivnimi kontrolami (vključno s fenobarbitalom, rifampicinom) perampanel šibek induktor CYP2B6 (30 µmol/l) in CYP3A4/5 (≥3 µmol/l) med pomembnejšimi jetrnimi encimi CYP in UGT v gojenih človeških hepatocitih.
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 izloča skoraj izključno s presnovo, ki jih sledi hitra izločitev presnovkov; v plazmi so opazili le presnovke perampanela v sledovih.
The active substance is perampanel. 
Učinkovina je perampanel.
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. 
Možne interakcije med zdravilom Fycompa (do 12 mg enkrat na dan) in drugimi antiepileptičnimi zdravili (AEZ) so ocenili v kliničnih študijah in ovrednotili v farmakokinetični analizi populacije štirih združenih študij 3. faze, ki so zajemale tudi bolnike z napadi parcialnega izvora in primarnimi generaliziranimi napadi s tonično-kloničnimi krči.
Fycompa with alcohol 
Zdravilo Fycompa skupaj z alkoholom
Push down and turn cap to open bottle. 
Zaporko potisnite navzdol in zasukajte, da plastenko odprete.
CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline. 
Rezultata vrednosti t globalnih kognitivnih funkcij sistema CDR za placebo in perampanel sta bila v izhodišču 41,2 (10,7) oziroma 40,8 (13,0).
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. 
Učinkovitost perampanela pri napadih s parcialnim izvorom so ugotavljali v treh 19-tedenskih, randomiziranih, dvojno slepih, s placebom kontroliranih multicentričnih preskušanjih z adjuvantnim zdravljenjem pri odraslih bolnikih in mladostnikih.
Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required. 
Obratno lahko pričakujemo, da bo ukinitev sočasnega induktorja encima CYP450 3A zvišala plazemske koncentracije perampanela in bo mogoče potrebno zmanjšanje odmerka.
Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation. 
Perampanel se obširno presnavlja s primarno oksidacijo, ki ji sledi glukuronidacija.
Tell your doctor if you are taking midazolam as your dose may need to be adjusted. 
Povejte zdravniku, če jemljete midazolam, ker vam bo moral mogoče prilagoditi odmerek.
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. 
V študiji pri zdravih prostovoljcih za ocenitev vpliva perampanela na budnost in spomin s standardnim nizom ocenitev po enkratnem in večkratnem odmerjanju perampanela do 12 mg/dan niso opazili vpliva perampanela.
There is limited clinical experience with perampanel overdose in humans. 
Kliničnih izkušenj s prevelikim odmerjanjem perampanela pri ljudeh je malo.
Psychomotor performance testing returned to baseline within 2 weeks of cessation of perampanel dosing. 
Psihomotorične sposobnosti so se obnovile v roku 2 tednov po prenehanju odmerjanja perampanela.
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. 
Srednji navidezni očistek nevezanega perampanela pri osebah z blago okvaro je bil 188 ml/min v primerjavi s kontrolno skupino, kjer je bil 338 ml/min, medtem ko je bil pri osebah z zmerno okvaro 120 ml/min v primerjavi s kontrolno skupino, kjer je bil 392 ml/min.
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures. 
Perampanel v odmerkih 4 mg/dan do 12 mg/dan se je izkazal kot učinkovito zdravljenje napadov parcialnega izvora.
- Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines. 
- Uživanje alkohola med jemanjem zdravila Fycompa lahko zmanjša vašo zbranost in vpliva na sposobnost vožnje, uporabe orodja in upravljanja strojev.
The pharmacokinetics of perampanel have not been formally evaluated in patients with renal impairment. 
Farmakokinetike perampanela pri bolnikih z okvaro ledvic niso formalno ocenili.
- Some other medicines such as rifampicin (a medicine used to treat bacterial infections), 
- Nekatera zdravila, kot so rifampicin (zdravilo za zdravljenje bakterijske okužbe), šentjanževka
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 
Pogosti (pojavijo se lahko pri več kot 1 od 100 bolnikov): - povečan ali zmanjšan apetit, pridobivanje telesne mase - agresivno, jezno, razdražljivo, tesnobno ali zmedeno razpoloženje - težave pri hoji ali druge težave z ravnotežjem (ataksija, motnje hoje, motnje ravnotežja) - upočasnjen govor (disartrija) - zamegljen ali dvojni vid (diplopija) - občutek vrtoglavice (vertigo) - občutek slabosti (navzea) - bolečina v hrbtu - občutek izčrpanosti (utrujenost) - padec
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). 
Zdravilo Fycompa je indicirano za adjuvantno zdravljenje primarnih generaliziranih napadov s tonično-kloničnimi krči pri odraslih bolnikih in mladostnikih od starosti 12 let naprej z idiopatsko generalizirano epilepsijo (glejte poglavje 5.1).
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. 
V populacijski farmakokinetični analizi mladostnikov v kliničnih študijah 3. faze ni bilo opaznih razlik med njimi in ostalo populacijo.
Other medicines and Fycompa 
Druga zdravila in zdravilo Fycompa
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. 
t1/2 je bil daljši pri osebah z blago okvaro (306 ur v primerjavi s 125 ur) in zmerno okvaro (295 ur v primerjavi s 139 ur) v primerjavi s kontrolo skupino zdravih prostovoljcev.