FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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.
Croatian: - 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Contains lactose: see leaflet for further information.
Croatian: Sadrži laktozu: vidjeti uputu o lijeku za dodatne informacije.
English: - Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.
Croatian: - Konzumiranje alkohola za vrijeme uzimanja Fycompe također može pojačati osjećaje ljutnje, smetenosti ili tuge.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima, te ih pozorno pratiti zbog moguće pojave kožnih reakcija.
English: In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency.
Croatian: 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.
English: When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Croatian: Kad se dozirao u kombinaciji s jakim induktorom CYP3A karbamazepinom, prosječni t1/2 bio je 25 sati.
English: 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.
Croatian: 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.
English: The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Croatian: Vrijednost tmax bila je dosegnuta s odgodom od približno 1 sata u usporedbi s vrijednošću postignutom mjerenjem natašte.
English: 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.
Croatian: 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.
English: Conversion to monotherapy
Croatian: Prelazak na monoterapiju
English: Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details see section 5.3).
Croatian: 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).
English: Compared with positive controls (including phenobarbital, rifampicin), perampanel was found to weakly induce CYP2B6 (30 µmol/l) and CYP3A4/5 (≥ 3 µmol/l) among major hepatic CYPs and UGTs in cultured human hepatocytes.
Croatian: 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.
English: Fycompa has moderate influence on the ability to drive and use machines.
Croatian: Fycompa umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - Drinking alcohol while taking Fycompa may make these effects worse.
Croatian: - Konzumiranje alkohola za vrijeme uzimanja Fycompe može pogoršati te učinke.
English: 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.
Croatian: 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.
English: If you stop taking Fycompa
Croatian: Ako prestanete uzimati Fycompu
English: Fycompa contains sorbitol
Croatian: Fycompa sadrži sorbitol
English: The total clearance of Fycompa was increased when administered with carbamazepine (2.75-fold), phenytoin (1.7-fold) and oxcarbazepine (1.9-fold), which are known inducers of enzymes of metabolism (see section 5.2).
Croatian: 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).
English: 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%).
Croatian: 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%).
English: Levodopa In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa.
Croatian: U zdravih ispitanika, Fycompa (4 mg jedanput na dan tijekom 19 dana) nije imala učinka na Cmax ili AUC levodope.
English: The cap should be replaced after each use.
Croatian: Bocu treba zatvoriti zatvaračem nakon svake upotrebe.
English: 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.
Croatian: 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.
English: The effect of perampanel on monohydroxycarbazepine concentrations is not known.
Croatian: Učinak perampanela na koncentracije monohidroksikarbazepina nije poznat.
English: Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%.
Croatian: Fycompa od 12 mg nije utjecala na AUC etinilestradiola, dok je Cmax etinilestradiola bio smanjen za 18%.
English: Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Ako razvijete bilo koji od ovih simptoma prestanite koristiti perampanel i obratite se svom liječniku ili odmah zatražite liječničku pomoć.
English: In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
Croatian: In vivo je perampanel značajno produljio latenciju napadaja u modelu napadaja induciranih AMPA-om.
English: Instructions on how to use the oral syringe and adaptor are provided below:
Croatian: Upute kako upotrijebiti štrcaljku za usta i nastavak nalaze se u daljnjem tekstu:
English: 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.
Croatian: 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.
English: In a healthy volunteer study to assess the effects of perampanel on alertness, and memory using a standard battery of assessments, no effects of perampanel were found following single and multiple doses of perampanel up to 12 mg/day.
Croatian: 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.
English: 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.
Croatian: 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.
English: What you need to know before you take Fycompa
Croatian: Što morate znati prije nego počnete uzimati Fycompu
English: In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population.
Croatian: U populacijskoj farmakokinetičkoj analizi adolescentnih bolesnika u kliničkim ispitivanjima faze 3 nije bilo zamjetnih razlika između ove populacije i ukupne populacije.
English: There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Croatian: Podaci o primjeni perampanela u trudnica su ograničeni (manje od 300 ishoda trudnoća).
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce i kutiji.
English: In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
Croatian: 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.
English: Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Croatian: Enzim reduktaza u citosolu brzo metabolizira okskarbazepin do aktivnog metabolita, monohidroksikarbazepina.
English: A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures.
Croatian: Provedena je farmakokinetičko-farmakodinamička analiza (djelotvornosti) objedinjenih podataka iz 3 ispitivanja djelotvornosti kod parcijalnih napadaja.
English: During a 6-week baseline period, subjects were required to have more than five seizures with no seizure-free period exceeding 25 days.
Croatian: Tijekom 6-tjednog početnog razdoblja, ispitanici su trebali imati više od pet napadaja, a razdoblje bez napadaja nije smjelo biti dulje od 25 dana.
English: 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.
Croatian: 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.
English: However, population pharmacokinetic analysis demonstrated that under simulated steady state exposure conditions, Cmax and AUC, of perampanel oral suspension were bioequivalent to the tablet formulation under both fasted and fed conditions.
Croatian: Međutim, analiza populacijske farmakokinetike pokazala je da su u simuliranim uvjetima izloženosti u stanju dinamičke ravnoteže vrijednosti Cmax i AUC oralne suspenzije perampanela bile bioekvivalentne formulaciji u tabletama i natašte i u sitom stanju.
English: Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4).
Croatian: Perampanel treba primjenjivati s oprezom u starijih osoba, jer treba uzeti u obzir mogućnost interakcije lijekova u bolesnika koji uzimaju više različitih lijekova (vidjeti dio 4.4).
English: If you have taken more Fycompa than you should contact your doctor straight away.
Croatian: Ako ste uzeli više Fycompe nego što ste trebali, odmah se obratite liječniku.
English: 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).
Croatian: Fycompa je indicirana za dodatno liječenje primarno generaliziranih toničko-kloničkih napadaja u odraslih bolesnika i adolescenata u dobi iznad 12 godina s idiopatskom generaliziranom epilepsijom (vidjeti dio 5.1).
English: In a pre- and postnatal development toxicity study in rats, abnormal delivery and nursing conditions were observed at maternally toxic doses, and the number of stillbirths was increased in offspring.
Croatian: U ispitivanjima prenatalne i postnatalne razvojne toksičnosti na štakorima bile su opažene nenormalnosti kod koćenja i dojenja pri dozama toksičnima za majku, a u potomstva je broj mrtvorođenih mladunaca bio povećan.
English: The pharmacokinetics of perampanel have not been formally evaluated in patients with renal impairment.
Croatian: Farmakokinetika perampanela nije službeno procijenjena u bolesnika s oštećenjem funkcije bubrega.
English: Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Croatian: Pomoćna tvar s poznatim učinkom: Jedan ml oralne suspenzije sadrži 175 mg sorbitola (E420).
English: The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), adults and adolescents with partial-onset seizures and primary generalised tonic-clonic seizures, adults with Parkinson's disease, adults with diabetic neuropathy, adults with multiple sclerosis, and subjects with hepatic impairment.
Croatian: Farmakokinetika perampanela ispitana je u zdravih odraslih ispitanika (raspon dobi od 18 do 79 godina), u odraslih i adolescenata s parcijalnim napadajima i primarno generaliziranim toničko-kloničkim napadajima, u odraslih s Parkinsonovom bolešću, odraslih s dijabetičkom neuropatijom, odraslih s multiplom sklerozom i ispitanika s oštećenjem funkcije jetre.
English: In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures.
Croatian: Uz to, provedena je farmakokinetičko-farmakodinamička analiza (djelotvornosti) u jednom ispitivanju djelotvornosti kod primarno generaliziranih toničko-kloničkih napadaja.
English: 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.
Croatian: Višekratna primjena perampanela u dozi od 12 mg na dan također je pojačala učinke alkohola na pozornost i budnost i povisila razinu ljutnje, smetenosti i depresije, kako je procijenjeno pomoću ocjenske ljestvice za procjenu stanja raspoloženja s 5 stupnjeva.
English: The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 subjects with mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, demographically matched subjects.
Croatian: Farmakokinetika perampanela nakon jednokratne doze od 1 mg bila je procijenjena u 12 ispitanika s blagim (Child-Pugh A) i umjerenim oštećenjem jetre (Child-Pugh B) u usporedbi s 12 zdravih, demografski sličnih ispitanika.
English: Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo.
Croatian: Dva ispitivanja (ispitivanja 304 i 305) uspoređivala su doze perampanela od 8 i 12 mg na dan s placebom, dok je treće ispitivanje (ispitivanje 306) uspoređivalo doze perampanela od 2, 4 i 8 mg na dan s placebom.
English: - Felbamate (a medicine used to treat epilepsy) may also affect Fycompa.
Croatian: - Felbamat (lijek koji se uzima za liječenje epilepsije) također može utjecati na Fycompu.
English: In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast Cancer Resistance Protein (BCRP).
Croatian: In vitro ispitivanja pokazuju da perampanel nije supstrat ili značajni inhibitor polipeptida za prijenos organskih aniona 1B1 i 1B3, prijenosnika organskih aniona (OAT) 1, 2, 3 i 4, prijenosnika organskih kationa (OCT) 1, 2, i 3, te efluksnih prijenosnika P-glikoproteina i proteina rezistencije na rak dojke (BCRP).
English: 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.
Croatian: Stopa ispitanika s 50% odgovora iznosila je 22,2% u kombinaciji s antiepileptičkim lijekovima koji induciraju enzime, a 69,4% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji ne induciraju enzime.
English: 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.
Croatian: Metabolizam perampanela posredovan je primarno enzimom CYP3A na temelju rezultata kliničkih ispitivanja u zdravih ispitanika kojima je bio primijenjen radioaktivno označen perampanel te potkrijepljenih in vitro ispitivanjima upotrebom rekombinantnih ljudskih enzima CYP i mikrosoma ljudske jetre.
English: The adverse reactions most commonly (≥ 1% in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and somnolence.
Croatian: Nuspojave koje su najčešće (≥1% u cijeloj skupini koja je uzimala perampanel i više nego placebo) dovele do prekida liječenja bile su omaglica i pospanost.
English: 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).
Croatian: Višekratne doze perampanela od 12 mg na dan povisile su razine ljutnje, smetenosti i depresije, kako se procijenilo pomoću ocjenske ljestvice profila stanja raspoloženja s 5 stupnjeva (vidjeti dio 5.1).
English: There is limited clinical experience with perampanel overdose in humans.
Croatian: Kliničko iskustvo s predoziranjam perampanela u ljudi je ograničeno.
English: 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.
Croatian: Prosječni prividni klirens nevezanog perampanela u ispitanika s blagim oštećenjem iznosio je 188 ml/min naspram 338 ml/min u sličnih kontrolnih ispitanika, a u ispitanika s umjerenim oštećenjem iznosio je 120 ml/min nasuprot 392 ml/min u sličnih kontrolnih ispitanika.
English: Following administration of radiolabeled perampanel, only trace amounts of perampanel metabolites were observed in plasma.
Croatian: Nakon primjene radiološki označenog perampanela, u plazmi su bili pronađeni metaboliti perampanela samo u tragovima.
English: During the Titration Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 2 mg/day to the target dose.
Croatian: Tijekom faze titracije u sva tri ispitivanja, liječenje je bilo započeto dozom od 2 mg na dan koja se povisivala za 2 mg na dan do ciljne doze.
English: The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding.
Croatian: Liječnik će odvagnuti koristi u odnosu na rizike uzimanja Fycompe za Vaše dijete u razdoblju dojenja.
English: It should not be chewed, crushed or split.
Croatian: Tabletu se ne smije žvakati, drobiti niti lomiti.
English: 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.
Croatian: Provedeno je 19-tjedno randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s fazom otvorenog produžetka (ispitivanje 235) kako bi se procijenili kratkotrajni učinci Fycompe na kognitivne sposobnosti (ciljni raspon doza od 8 do 12 mg jedanput na dan) kao dodatna terapija u 133 (Fycompa n=85, placebo n=48) adolescentna bolesnika u dobi od 12 do manje od 18 godina, s nezadovoljavajuće kontroliranim parcijalnim napadajima.
English: 1 bottle (340 ml) contains 170 mg perampanel.
Croatian: Jedna boca (340 ml) sadrži 170 mg perampanela.
English: Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing anti-epileptic medicinal products.
Croatian: Stope odgovora nakon dodavanja fiksnih doza perampanela bile su manje u bolesnika koji su istovremeno primali antiepileptičke lijekove koji induciraju enzim CYP3A (karbamazepin, fenitoin, okskarbazepin) u usporedbi sa stopama odgovora u bolesnika koji su istovremeno primali antiepileptičke lijekove koji ne induciraju enzime.
English: The effect of perampanel on human fertility has not been established.
Croatian: Učinak perampanela na plodnost u ljudi nije ustanovljen.
English: Perampanel is dosed to clinical effect regardless of other AEDs.
Croatian: Perampanel se dozira do postizanja kliničkog učinka bez obzira na druge antiepileptike.
English: Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Fycompu ako imate tegobe s jetrom ili umjerene do teške tegobe s bubrezima.
English: The active substance is perampanel.
Croatian: Djelatna tvar je perampanel.
English: In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%.
Croatian: U zdravih je ispitanika Fycompa (6 mg jedanput na dan tijekom 20 dana) smanjio AUC midazolama za 13%.