FrancophonIA/ELRC3.0 huggingface dataset:
English: In all three trials, the Titration Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to remain on a stable dose of perampanel.
Croatian: U sva tri ispitivanja, faza titracije bila je praćena fazom održavanja koja je trajala 13 tjedana, tijekom koje su bolesnici trebali ostati na stabilnoj dozi perampanela.
English: It is not known whether the ingredients of Fycompa can pass into breast milk.
Croatian: Nije poznato mogu li sastojci Fycompe prijeći u majčino mlijeko.
English: Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Croatian: Između 85,3% i 89,1% bolesnika uzimalo je istovremeno dva do tri antiepileptika sa ili bez istovremene stimulacije vagusnog živca.
English: - You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa.
Croatian: - Morate upotrebljavati pouzdanu metodu kontracepcije da izbjegnete trudnoću dok se liječite
English: Be careful about consuming alcohol with epilepsy medicines including Fycompa.
Croatian: Budite oprezni kad konzumirate alkohol s lijekovima protiv epilepsije uključujući Fycompu.
English: PVC/aluminium blisters
Croatian: PVC/aluminijski blisteri
English: Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted.
Croatian: Bolesnicima i njihovim skrbnicima treba savjetovati da odmah upozore zdravstvenog djelatnika ako opaze značajne promjene u raspoloženju ili obrascima ponašanja.
English: Analysis of safety information in 905 perampanel-treated elderly subjects (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile.
Croatian: Analiza podataka o sigurnosti primjene u 905 starijih ispitanika liječenih perampanelom (u dvostruko slijepim ispitivanjima provedenim u indikacijama koje nisu bile epilepsija) pokazala je da nema razlika u sigurnosnom profilu koje su povezane s dobi.
English: EXP After first opening: use within 90 days.
Croatian: Nakon prvog otvaranja: upotrijebiti u roku od 90 dana.
English: A clinically meaningful reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing when patients reached a daily dose of 4 mg.
Croatian: Klinički značajno smanjenje učestalosti napadaja u odnosu na placebo postiglo se već u drugom tjednu, kad su bolesnici dosegnuli dnevnu dozu od 4 mg.
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Croatian: Nemojte početi uzimati ili prestati uzimati druge lijekove a da o tome niste razgovarali s liječnikom ili ljekarnikom.
English: Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2).
Croatian: Fycompa se ne smatra jakim induktorom ili inhibitorom citokroma P450 ili enzima UGT (vidjeti dio 5.2).
English: Behavioural and reproductive development of the offspring was not affected, but some parameters of physical development showed some delay, which is probably secondary to the pharmacology-based CNS effects of perampanel.
Croatian: Bihevioralni i reproduktivni razvoj potomstva nije bio narušen, ali neki parametri fizičkog razvoja pojavili su se nešto kasnije, što je vjerojatno sekundarno farmakološkim učincima perampanela na središnji živčani sustav.
English: In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses.
Croatian: U bolesnika liječenih perampanelom u kliničkim ispitivanjima, agresija, ljutnja i razdražljivost zabilježeni su češće uz više doze.
English: - Don't take more Fycompa than your doctor has recommended.
Croatian: - Nemojte uzeti više Fycompe nego što Vam je liječnik preporučio.
English: Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects.
Croatian: Karbamazepin, poznati jaki induktor enzima, snizio je razine perampanela za dvije trećine u ispitivanju provedenom u zdravih ispitanika.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja pri razinama izloženosti sličnima razinama izloženosti u ljudi i s mogućom važnošću za kliničku primjenu, bile su sljedeće:
English: What Fycompa is and what it is used for
Croatian: Što je Fycompa i za što se koristi
English: - Fycompa is not recommended in pregnancy.
Croatian: - Fycompa se ne preporučuje u trudnoći.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga je bolesnike potrebno pratiti zbog znakova suicidalne ideacije i suicidalnog ponašanja te razmotriti odgovarajuće liječenje.
English: Do not stop treatment without first discussing it with your doctor.
Croatian: Nemojte prestati s liječenjem ako prethodno o tome niste razgovarali sa svojim liječnikom.
English: Fycompa contains a medicine called perampanel.
Croatian: Fycompa sadrži lijek koji se zove perampanel.
English: Taking Fycompa with certain other medicines may cause side effects or affect how they work.
Croatian: Uzimanje Fycompe s određenim drugim lijekovima može prouzročiti nuspojave ili utjecati na to kako djeluju.
English: No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).
Croatian: Do 104. tjedna liječenja nisu opaženi učinci na težinu, visinu i spolni razvoj (n=114).
English: Larger effects cannot be excluded when perampanel is combined with a CYP3A inhibitor with longer half-life than ketoconazole or when the inhibitor is given for a longer treatment duration.
Croatian: Veći se učinci ne mogu isključiti kad se perampanel kombinira s inhibitorom CYP3A čiji je poluvijek dulji od poluvijeka ketokonazola ili kad se inhibitor daje tijekom duljeg trajanja liječenja.
English: In the open label extension, no significant changes were observed in global CDR system score after 52 weeks of perampanel treatment (see section 5.1 Paediatric population).
Croatian: U otvorenom produžetku ispitivanja nisu opažene značajne promjene u rezultatu dobivenom sustavom CDR testova nakon 52 tjedna liječenja perampanelom (vidjeti dio 5.1 Pedijatrijska populacija).
English: Subjects had partial-onset seizures with or without secondary generalisation and were not adequately controlled with one to three concomitant AEDs.
Croatian: Ispitanici su imali parcijalne napadaje sa ili bez sekundarne generalizacije koji se nisu mogli odgovarajuće kontrolirati jednim do tri istovremeno primijenjena antiepileptika.
English: Discuss with your doctor what may be appropriate contraception for you.
Croatian: Porazgovarajte s liječnikom o tome koja bi Vam kontracepcija najviše odgovarala.
English: Ninety-seven percent of the patients who completed the randomised trials in patients with partial-onset seizures were enrolled in the open label extension study (n = 1186).
Croatian: Devedeset i sedam posto bolesnika koji su završili randomizirana ispitivanja u bolesnika s parcijalnim napadajima bilo je uključeno u otvoreni produžetak ispitivanja (n=1186).
English: - Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
Croatian: - Od Fycompe možete osjećati omaglicu ili pospanost, osobito na početku liječenja.
English: Fycompa contains lactose (a type of sugar).
Croatian: Fycompa sadrži laktozu (vrsta šećera).
English: The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.
Croatian: Učinci perampanela na složene zadatke, kao što je sposobnost upravljanja vozilima, bili su aditivni ili supraaditivni štetnim učincima alkohola.
English: Adverse reactions leading to discontinuation:
Croatian: Nuspojave koje su dovele do prekida liječenja:
English: Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.
Croatian: Povećanja doze u bolesnika s blagim i umjerenim oštećenjem funkcije jetre treba temeljiti na kliničkom odgovoru i podnošljivosti.
English: In a report of an intentional overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered mental status, agitation and aggressive behaviour and recovered without sequelae.
Croatian: U prijavljenom slučaju namjernog predoziranja, u kojem se mogla uzeti doza do 264 mg, kod bolesnika su se pojavili učinci kao što su promijenjeni mentalni status, agitacija i agresivno ponašanje, a bolesnik se oporavio bez posljedica.
English: Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Croatian: Pokazalo se da felbamat smanjuje koncentracije nekih lijekova i da može smanjiti i koncentracije perampanela.
English: Patients were titrated over four weeks to a target dose of 8 mg per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level achieved at the end of the titration period.
Croatian: Bolesnicima se titrirala doza tijekom četiri tjedna do ciljne doze od 8 mg na dan ili do najviše podnošljive doze, a potom su bili liječeni još dodatnih 13 tjedana zadnjom razinom doze postignutom na kraju razdoblja titracije.
English: The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Croatian: Tri glavna, dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 uključila su 143 adolescenta u dobi između 12 i 18 godina.
English: Contains sorbitol: see leaflet for further information.
Croatian: Sadrži sorbitol: vidjeti uputu o lijeku za dodatne informacije.
English: In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
Croatian: U retrospektivnom ispitivanju kliničke prakse, 51 bolesnik s epilepsijom koji je primao perampanel kao dodatno liječenje prebačen je na monoterapiju perampanelom.
English: 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).
Croatian: 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).
English: Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with sorbitol.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate neki(e) drugi(e) lijek(ove) protiv epilepsije koji sadrži(e) sorbitol.
English: Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Croatian: Jednokratne i višekratne doze od 8 mg i 12 mg narušile su psihomotornu sposobnost zdravih dobrovoljaca ovisno o dozi.
English: 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.
Croatian: 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.
English: DO NOT TAKE Fycompa: - If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking perampanel.
Croatian: NEMOJTE UZIMATI Fycompu: - ako ste ikad razvili teški kožni osip, iskusili ljuštenje kože ili stvaranje mjehurića i/ili rana u ustima nakon uzimanja perampanela.
English: 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.
Croatian: Deset (10) bolesnika praćeno je najmanje 18 mjeseci, a od toga su 3 bolesnika (30%) ostala na monoterapiji perampanelom najmanje 18 mjeseci.
English: 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.
Croatian: 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.
English: 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.
Croatian: Ako bolesnik ne uzima perampanel u neprekinutom razdoblju duljem od 5 poluvijekova, preporučuje se slijediti gore navedene preporuke za početak primjene.
English: Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.
Croatian: Zbog niskog bubrežnog klirensa, posebne intervencije poput forsirane diureze, dijalize ili hemoperfuzije najvjerojatnije neće biti korisne.
English: The usual starting dose is 2 mg once a day before you go to bed.
Croatian: Uobičajena početna doza je 2 mg jedanput na dan prije odlaska na spavanje.
English: Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Croatian: Preokrenite bocu i izvucite propisanu količinu Fycompe.
English: 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.
Croatian: 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.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnicima (i njihovim skrbnicima) treba savjetovati da potraže savjet liječnika ako se pojave znakovi suicidalne ideacije i suicidalnog ponašanja.
English: Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy in people aged 12 years and older.
Croatian: Fycompa se primjenjuje zajedno s drugim antiepileptičkim lijekovima za liječenje određenih oblika epilepsije u osoba u dobi od 12 ili više godina.
English: - Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
Croatian: - 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.
English: These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
Croatian: Ovi se lijekovi primjenjuju za liječenje epilepsije - kada se kod osobe napadaji ponavljaju.
English: 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).
Croatian: 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).
English: There were no effects on male fertility.
Croatian: Nije bilo učinaka na plodnost u mužjaka.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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.
Croatian: Nakon primjene radiološki označene doze perampanela u 8 zdravih odraslih ili starijih ispitanika, približno 30% radioaktivnosti otkriveno je u mokraći, a 70% u stolici.
English: It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures.
Croatian: Preporučuje se postupni prekid liječenja kako bi se minimalizirala mogućnost pojave napadaja uslijed ustezanja lijeka (engl. rebound seizures).
English: In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
Croatian: U farmakokinetičkoj analizi populacije s epilepsijom pronašlo se da perampanel smanjuje klirens okskarbazepina za 26%.
English: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Croatian: European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Ujedinjeno Kraljevstvo
English: The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Croatian: Primjena maksimalno podnošljivih doza štakorima i majmunima rezultirala je kliničkim znakovima središnjeg živčanog sustava temeljenim na farmakologiji i smanjila je krajnju tjelesnu težinu.
English: In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Croatian: Radioaktivnost otkrivena u mokraći i stolici bila je primarno sastavljena od mješavine oksidativnih i konjugiranih metabolita.
English: In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Croatian: U obje analize, izloženost perampanelu korelira sa smanjenjem učestalosti napadaja.
English: 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.
Croatian: Potrebno je pratiti odgovor bolesnika kad se prebacuju s jednog antiepileptičkog lijeka koji ne inducira enzime na drugi koji ih inducira i obrnuto.
English: Decreased appetite Increased appetite
Croatian: Poremećaji metabolizma i prehrane oslabljen apetit pojačan apetit
English: Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion of metabolites; only trace amounts of perampanel metabolites are observed in plasma.
Croatian: Perampanel se eliminira gotovo isključivo metabolizmom nakon čega slijedi brzo izlučivanje metabolita; u plazmi su opaženi metaboliti perampanela samo u tragovima.
English: Open label extension phase
Croatian: Faza otvorenog produžetka ispitivanja
English: 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).
Croatian: 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).
English: The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Croatian: Mali je broj ispitanika liječenih perampanelom uzimao antiepileptičke lijekove koji induciraju enzime (n=9).
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
Croatian: Mali broj osoba koje se liječe antiepilepticima pomišljao je na to da se ozlijedi ili počini samoubojstvo.
English: 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.
Croatian: 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.
English: In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
Croatian: U populacijskoj farmakokinetičkoj analizi objedinjenih podataka iz 19 ispitivanja faze I, prosječni t1/2 perampanela bio je 105 sati.
English: Aggression
Croatian: Agresija
English: The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Croatian: Uobičajena početna doza je 2 mg (4 ml) jedanput na dan prije odlaska na spavanje.
English: Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each bottle contains 340 ml of suspension in an outer cardboard carton.
Croatian: Boca izrađena od polietilen tereftalata (PET) s polipropilenskim (PP) zatvaračem sigurnim za djecu; svaka boca u kartonskoj kutiji sadrži 340 ml suspenzije.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije po učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Croatian: Prosječno trajanje epilepsije u ispitanika u ta tri ispitivanja iznosilo je približno 21,06 godina.