FrancophonIA/ELRC3.0 huggingface dataset:
English: Activation of AMPA receptors by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain.
Slovenian: Prevladuje mnenje, da je aktiviranje receptorjev AMPA z glutamatom odgovorno za večino hitrih ekscitatornih sinaptičnih prenosov v možganih.
English: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Slovenian: Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Velika Britanija
English: However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies).
Slovenian: Vendar pa so pri nekaterih bolnikih opazili razmišljanja o poškodovanju drugih, fizičnemu napadu ali grozečemu vedenju (< 1 % v kliničnih študijah s perampanelom).
English: Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Slovenian: Pokazalo se je, da felbamat znižuje koncentracije nekaterih zdravil in da lahko zmanjša tudi koncentracije perampanela.
English: The safety and efficacy of perampanel in children below 12 years of age have not been established yet.
Slovenian: Varnost in učinkovitost perampanela pri otrocih, starih do 12 let, še nista bili dokazani.
English: Contains sorbitol: see leaflet for further information.
Slovenian: Vsebuje sorbitol: glejte navodilo za uporabo za več informacij.
English: Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted.
Slovenian: Bolnikom in negovalcem je treba svetovati, da takoj obvestijo zdravstvenega delavca, če se pojavijo velike spremembe v razpoloženju ali vedenjskih vzorcih.
English: It belongs to a group of medicines called anti-epileptics.
Slovenian: Spada v skupino zdravil, ki jih imenujemo antiepileptiki.
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.
Slovenian: Vpliva na vedenjski in reprodukcijski razvoj mladičev ni bilo, vendar so nekateri parametri fizičnega razvoja pokazali rahlo upočasnitev, kar je verjetno posledica farmakoloških učinkov perampanela na OŽS.
English: A larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa doses cannot be excluded.
Slovenian: Večje zmanjšanje izpostavljenosti midazolamu (ali drugih občutljivih substratih CYP3A) pri višjih odmerkih zdravila Fycompa ni mogoče izključiti.
English: After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.
Slovenian: Po do 52 tednih zdravljenja s perampanelom (n = 114) niso ugotovili nikakršnega vpliva na rast kosti.
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Slovenian: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Velika Britanija
English: The cap should be replaced after each use.
Slovenian: Zaporko po vsaki uporabi spet namestite.
English: Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.
Slovenian: Vaš zdravnik lahko vaš odmerek postopoma zmanjšuje, da prepreči ponovni pojav ali poslabšanje napadov (epileptičnih napadov).
English: It is not known whether the ingredients of Fycompa can pass into breast milk.
Slovenian: Ni znano, ali sestavine zdravila Fycompa prehajajo v materino mleko.
English: Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Slovenian: Med 85,3 % in 89,1 % bolnikov je sočasno jemalo dve do tri AEZ s sočasno stimulacijo vagalnega živca ali brez nje.
English: Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see sections 4.4 and 4.5).
Slovenian: Bolnikom je treba odsvetovati vožnjo avtomobila, upravljanje z zahtevnimi stroji in opravljanje drugih dejavnosti, ki so lahko nevarne, dokler ni znano, ali perampanel vpliva na njihovo sposobnost opravljanja teh nalog (glejte poglavji 4.4 in 4.5).
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike opazovati za znake samomorilnih misli in vedenja in razmisliti o ustreznem zdravljenju.
English: Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
Slovenian: En izpuščen odmerek: ker ima perampanel dolg razpolovni čas, naj bolnik počaka in vzame naslednji odmerek kot načrtovano.
English: Wash the oral syringe with clean water and dry thoroughly.
Slovenian: Brizgo izperite s čisto vodo in jo dobro osušite.
English: The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Slovenian: Število oseb, ki so jemale perampanel in antiepileptična zdravila, ki spodbujajo encime, je bilo majhno (n = 9).
English: Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment.
Slovenian: Večina poročanih primerov je bila blaga ali zmerna in so izzveneli spontano ali s prilagoditvijo odmerka.
English: Gait disturbance Fatigue
Slovenian: Splošne težave motnje hoje utrujenost
English: Discuss with your doctor what may be appropriate contraception for you.
Slovenian: Posvetujte se z zdravnikom, katera kontracepcija je za vas najprimernejša.
English: - It is used to treat fits that affect one part of your brain (called a “partial seizure”).
Slovenian: - Uporablja se za zdravljenje napadov, ki prizadenejo del vaših možganov (imenovanih „parcialni napadi“).
English: Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Ne uporabljajte perampanela, če se pri vas pojavijo simptomi, in se posvetujte z zdravnikom ali nemudoma poiščite zdravniško pomoč.
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.
Slovenian: V vseh treh preskušanjih je fazi titriranja sledila faza vzdrževanja, ki je trajala 13 tednov, v kateri so bolniki prejemali stabilni odmerek perampanela.
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.
Slovenian: Analiza podatkov o varnosti pri 905 starejših bolnikih, zdravljenih s perampanelom (v dvojno slepih študijah, opravljenih za indikacijo, ki ni epilepsija), ni razkrila nobenih od starosti odvisnih razlik pri varnostnem profilu.
English: Swallow the tablet whole with a glass of water.
Slovenian: Tableto vzemite celo s kozarcem vode.
English: You can take Fycompa with or without food.
Slovenian: Zdravilo Fycompa lahko vzamete s hrano ali brez nje.
English: Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.
Slovenian: Preden boste vzeli to zdravilo, morate zdravniku povedati, če imate v anamnezi alkoholizem ali odvisnost od drugih snovi.
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.
Slovenian: Odziv bolnikov je treba spremljati, ko preidejo iz sočasne uporabe antiepileptičnih zdravil, ki ne spodbujajo encima, na zdravila, ki spodbujajo encim, in obratno.
English: Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Slovenian: Podatki iz študij in vitro nakazujejo, da se perampanel veže na beljakovine plazme v približno 95 %.
English: Clinical studies of Fycompa in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Slovenian: V klinične študije z zdravilom Fycompa za epilepsijo ni bilo vključenih dovolj oseb, starih 65 let in več, da bi lahko ugotovili, ali se odzivajo drugače kot mlajši bolniki.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Fycompa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Carbamazepine 2.75 fold decrease
Slovenian: karbamazepin 2,75-kratno zmanjšanje
English: The effects of perampanel on complex tasks such as driving ability were additive or supra-additive to the impairment effects of alcohol.
Slovenian: Učinki perampanela na zahtevne naloge, denimo sposobnost vožnje, so bili aditivni ali supra-aditivni na učinke alkohola.
English: There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Slovenian: Podatki o uporabi perampanela pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti).
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.
Slovenian: Pri namernem prevelikem odmerjanju, ki bi ustrezal odmerku do 264 mg, je bolnik doživel dogodke kot so spremenjeno duševno stanje, vznemirjenost in agresivno vedenje, nato pa je brez posledic okreval.
English: The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Slovenian: Tri osrednje dvojno slepe, s placebom kontrolirane študije 3. faze so vključevale 143 mladostnikov, starih med 12 in 18 let.
English: Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Slovenian: Pri prehodu med tabletami in suspenzijo je potrebna previdnost (glejte poglavje 5.2).
English: However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Slovenian: Vendar pa je mogoče zaradi dolgega razpolovnega časa, ki mu sledi počasen upad koncentracij v plazmi, z uporabo perampanela po potrebi prenehati naglo.
English: Contains lactose: see leaflet for further information.
Slovenian: Vsebuje laktozo: glejte navodilo za uporabo za več informacij.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih padec
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.
Slovenian: Bolniki so bili v obdobju štirih tednov titrirani do ciljnega odmerka 8 mg/dan oziroma do najvišjega tolerančnega odmerka in nato še dodatnih 13 tednov zdravljeni z zadnjo ravnijo odmerka, doseženo ob zaključku obdobja titracije.
English: A dose adjustment in the elderly is not considered to be necessary (see section 4.2).
Slovenian: Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 4.2).
English: Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Slovenian: Enkratni in večkratni odmerki 8 mg in 12 mg so okvarili psihomotorično sposobnost pri zdravih prostovoljcih na način, odvisen od odmerka.
English: - Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.
Slovenian: - Zaradi uživanja alkohola med jemanjem zdravila Fycompa se lahko občutki jeze, zmedenosti ali žalosti poslabšajo.
English: When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Slovenian: Pri dajanju v kombinaciji z močnim induktorjem CYP3A, karbamazepinom, je bil povprečni t1/2 25 ur.
English: Subjects experiencing intolerable adverse events could remain on the same dose or have their dose decreased to the previously tolerated dose.
Slovenian: Osebe, ki so doživele neželene učinke, ki jih niso mogle prenašati, so lahko ohranile enak odmerek ali se je odmerek znižal na odmerek, ki so ga prenašale.
English: Fycompa is not recommended for children aged under 12.
Slovenian: Uporaba zdravila Fycompa se ne priporoča pri otrocih, starih manj kot 12 let.
English: Adverse reactions leading to discontinuation:
Slovenian: Neželeni učinki, ki so povzročili prekinitev jemanja:
English: It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Slovenian: Pomembno je opozoriti, da so lahko prisotni zgodnji znaki preobčutljivosti, kot je zvišana telesna temperatura ali limfadenopatija, čeprav izpuščaj ni očiten.
English: Take Fycompa for as long as your doctor recommends.
Slovenian: Zdravilo Fycompa jemljite tako dolgo, kot vam priporoča vaš zdravnik.
English: The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%.
Slovenian: Združene 50-odstotne stopnje odziva so bile za placebo 19 %, za 4 mg 29 %, za 8 mg 35 % in za 12 mg 35 %.
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.
Slovenian: Koristi pri odmerku 12 mg so opazili pri nekaterih bolnikih, ki so odmerek 8 mg prenašali, klinični odziv na ta odmerek pa ni zadoščal.
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.
Slovenian: Po dajanju odmerka radioaktivno označenega perampanela 8 zdravim bodisi odraslim ali starejšim prostovoljcem je bilo približno 30 % rekuperirane radioaktivnosti najti v urinu in 70 % v blatu.
English: Aggression
Slovenian: Agresija
English: Alertness and mood
Slovenian: Zbranost in razpoloženje
English: In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses.
Slovenian: V kliničnih preskušanjih so za bolnike, zdravljene s perampanelom, pogosteje poročali o agresiji, jezi in razdražljivosti pri večjih odmerkih.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Za vsako pogostnost so neželeni učinki navedeni po padajoči resnosti.
English: These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
Slovenian: Ta zdravila se uporabljajo za zdravljenje epilepsije, stanja, pri katerem se ponavljajo napadi (epileptični napadi).
English: Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.
Slovenian: Zaradi nizkega ledvičnega očistka ni verjetno, da bi posebni ukrepi, denimo prisilna diureza, dializa ali hemoperfuzija pomagali.
English: The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Slovenian: Dajanje največjih tolerančnih odmerkov podganam in opicam je povzročilo farmakološke klinične znake na OŽS in zmanjšano končno telesno maso.
English: Instructions on how to use the oral syringe and adaptor are provided below:
Slovenian: Navodila o načinu uporabe brizge za peroralno dajanje in nastavka so spodaj:
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).
Slovenian: Študije na živalih niso pokazale teratogenih učinkov pri podganah ali kuncih, vendar so embriotoksičnost opazili pri podganah pri odmerkih, toksičnih za mater (glejte poglavje 5.3).
English: In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
Slovenian: V populacijski farmakokinetični analizi podatkov, združenih iz 19 študij 1. faze, je bil povprečni t1/2 za perampanel 105 ur.
English: - Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
Slovenian: - Zaradi zdravila Fycompa ste lahko omotični ali zaspani, zlasti na začetku zdravljenja.
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.
Slovenian: Deset (10) bolnikov so spremljali vsaj 18 mesecev in od njih so 3 bolniki (30 %) ostali na monoterapiji s perampanelom vsaj 18 mesecev.
English: Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details see section 5.3).
Slovenian: Študije pri podganah v laktaciji so pokazale izločanje perampanela in/ali njegovih presnovkov v materino mleko (za podrobnosti glejte poglavje 5.3).
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnike (in negovalce bolnikov) je treba opozoriti, da poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnih misli ali vedenja.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na etiketi plastenke in škatli.
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.
Slovenian: Priprava: vtisljiv nastavek za plastenko (PIBA), ki je priložen kartonski škatli z zdravilom, pred uporabo čvrsto vstavite v vrat plastenke, kjer naj ostane, dokler boste plastenko uporabljali.
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).
Slovenian: Pri odmerkih 12 mg/dan lahko zdravilo Fycompa zmanjša učinkovitost hormonskih kontraceptivov, ki vsebujejo progestagen; v tem primeru se pri uporabi zdravila Fycompa priporočajo dodatne oblike nehormonske kontracepcije (glejte poglavje 4.5).
English: Open label extension study
Slovenian: Odprta podaljšana študija
English: Use in patients with moderate or severe renal impairment or patients undergoing haemodialysis is not recommended.
Slovenian: Uporaba pri bolnikih z zmerno ali hudo okvaro ledvic ali pri bolnikih na hemodializi se ne priporoča.
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.
Slovenian: Pričakuje se, da bodo močni induktorji citokroma P450, kot sta rifampicin in šentjanževka, zmanjšala koncentracije perampanela in možnost višjih plazemskih koncentracij reaktivnih presnovkov v njihovi prisotnosti ni bila izključena.
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.
Slovenian: V študijah in vitro perampanel ni tekmoval z AMPA za vezavo na receptorje AMPA, je pa vezavo perampanela izpodrinil nekompetitivni antagonist receptorja AMPA, kar nakazuje na to, da je perampanel nekompetitiven antagonist receptorja AMPA.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Slovenian: V času predpisovanja je treba bolnike opozoriti na znake in simptome kožnih reakcij ter jih skrbno spremljati glede njihovega pojava.
English: Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Slovenian: Plastenko obrnite navzdol in izvlecite predpisano količino zdravila Fycompa iz plastenke.
English: It is not known whether perampanel is excreted in human milk.
Slovenian: Ni znano, ali se perampanel izloča v materino mleko.
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.
Slovenian: V vseh kontroliranih in nekontroliranih preskušanjih pri bolnikih z napadi parcialnega izvora je 1.639 oseb prejelo perampanel; 1.147 med njimi je bilo zdravljenih 6 mesecev in 703 dlje kot 12 mesecev.
English: The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Slovenian: Prehajanje skozi placento je bilo relativno nizko; v plodu so odkrili 0,09 % danega odmerka ali manj.
English: Taking Fycompa with certain other medicines may cause side effects or affect how they work.
Slovenian: Jemanje zdravila Fycompa z nekaterimi drugimi zdravili lahko povzroči neželene učinke ali vpliva na način njihovega delovanja.
English: In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
Slovenian: V retrospektivni študiji klinične prakse je 51 bolnikov z epilepsijo, ki so prejemali perampanel kot adjuvantno zdravilo, prešlo na monoterapijo s perampanelom.
English: Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.
Slovenian: Povečevanje odmerkov pri bolnikih z blago in zmerno okvaro jeter mora temeljiti na kliničnem odzivu in prenašanju.
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.
Slovenian: Ti podatki so bili konsistentni s tistimi o odstotni spremembi pogostnosti napadov in so pokazali, da je bila 50 % stopnja odziva pri primarnih generaliziranih napadih s tonično-kloničnimi krči na splošno stabilna ves čas od približno 26. tedna do konca 2. leta.
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.
Slovenian: Zdravilo Fycompa vsebuje laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
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).
Slovenian: Sedemindevetdeset odstotkov bolnikov, ki so končali randomizirano preskušanje pri bolnikih z napadi parcialnega izvora, je bilo vključenih v podaljšek odprte študije (n = 1.186).
English: Open label extension phase
Slovenian: Odprta podaljšana faza
English: Interactions between Fycompa and other anti-epileptic medicinal products
Slovenian: Medsebojno delovanje zdravila Fycompa in drugih antiepileptičnih zdravil:
English: In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Slovenian: Pri obeh analizah je izpostavljenost perampanelu sovpadala z zmanjšanjem pogostnosti epileptičnih napadov.
English: The usual starting dose is 2 mg once a day before you go to bed.
Slovenian: Običajni začetni odmerek je 2 mg enkrat na dan pred spanjem.