FrancophonIA/ELRC3.0 huggingface dataset:
English: CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
Slovenian: Obratno lahko pričakujemo, da bo ukinitev sočasnega induktorja encima CYP450 3A zvišala plazemske koncentracije perampanela in bo mogoče potrebno zmanjšanje odmerka.
English: Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
Slovenian: Perampanel se obširno presnavlja s primarno oksidacijo, ki ji sledi glukuronidacija.
English: Tell your doctor if you are taking midazolam as your dose may need to be adjusted.
Slovenian: Povejte zdravniku, če jemljete midazolam, ker vam bo moral mogoče prilagoditi odmerek.
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.
Slovenian: 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.
English: There is limited clinical experience with perampanel overdose in humans.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem perampanela pri ljudeh je malo.
English: Psychomotor performance testing returned to baseline within 2 weeks of cessation of perampanel dosing.
Slovenian: Psihomotorične sposobnosti so se obnovile v roku 2 tednov po prenehanju odmerjanja perampanela.
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.
Slovenian: 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.
English: Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
Slovenian: Perampanel v odmerkih 4 mg/dan do 12 mg/dan se je izkazal kot učinkovito zdravljenje napadov parcialnega izvora.
English: - Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines.
Slovenian: - Uživanje alkohola med jemanjem zdravila Fycompa lahko zmanjša vašo zbranost in vpliva na sposobnost vožnje, uporabe orodja in upravljanja strojev.
English: The pharmacokinetics of perampanel have not been formally evaluated in patients with renal impairment.
Slovenian: Farmakokinetike perampanela pri bolnikih z okvaro ledvic niso formalno ocenili.
English: - Some other medicines such as rifampicin (a medicine used to treat bacterial infections),
Slovenian: - Nekatera zdravila, kot so rifampicin (zdravilo za zdravljenje bakterijske okužbe), šentjanževka
English: 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
Slovenian: 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
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).
Slovenian: 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).
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.
Slovenian: V populacijski farmakokinetični analizi mladostnikov v kliničnih študijah 3. faze ni bilo opaznih razlik med njimi in ostalo populacijo.
English: Other medicines and Fycompa
Slovenian: Druga zdravila in zdravilo Fycompa
English: 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.
Slovenian: 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.
English: Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective.
Slovenian: Zdravilo Fycompa lahko povzroči manjšo učinkovitost nekaterih hormonskih kontraceptivov, kot je levonorgestrel.
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.
Slovenian: Podatki iz s placebom kontroliranih študij so pri uporabi perampanela enkrat na dan v odmerku 4 mg pokazali izboljšanje nadzora napadov, ta korist pa se s povečanjem odmerka na 8 mg/dan še izboljša.
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.
Slovenian: Sočasno jemanje tablet perampanela z zelo mastnim obrokom ni vplivalo na največjo plazemsko izpostavljenost (Cmax) ali celotno izpostavljenost (AUC0-inf) perampanela.
English: If you stop taking Fycompa
Slovenian: Če ste prenehali jemati zdravilo Fycompa
English: Following administration of radiolabeled perampanel, only trace amounts of perampanel metabolites were observed in plasma.
Slovenian: Po dajanju radioaktivno označenega perampanela so v plazmi opazili le presnovke perampanela v sledovih.
English: In healthy subjects, plasma concentrations of perampanel increased in direct proportion to administered doses over the range of 2 to 12 mg.
Slovenian: Pri zdravih prostovoljcih so se koncentracije perampanela v plazmi povečale premosorazmerno z uporabljenim odmerkom v razponu 2 do 12 mg.
English: Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets
Slovenian: Fycompa 2 mg filmsko obložene tablete Fycompa 4 mg filmsko obložene tablete Fycompa 6 mg filmsko obložene tablete Fycompa 8 mg filmsko obložene tablete Fycompa 10 mg filmsko obložene tablete Fycompa 12 mg filmsko obložene tablete
English: These studies show that once-daily administration of perampanel at doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this population.
Slovenian: Te študije so pokazale, da je uporaba perampanela enkrat na dan pri odmerkih 4 mg do 12 mg v tej populaciji značilno bolj učinkovita kot placebo.
English: In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures.
Slovenian: Poleg tega je bila v enem preskušanju učinkovitosti pri primarnih generaliziranih napadih s tonično-kloničnimi krči izvedena farmakokinetično-farmakodinamična (učinkovitostna) analiza.
English: - Felbamate (a medicine used to treat epilepsy) may also affect Fycompa.
Slovenian: - Tudi felbamat (zdravilo za zdravljenje epilepsije) lahko vpliva na zdravilo Fycompa.
English: What you need to know before you take Fycompa
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Fycompa
English: The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Slovenian: 50-odstotna stopnja odziva pri skupini 4 mg je bila 23,0 %, pri 8 mg je bila 31,5 % in pri 12 mg je bila 30,0 % v kombinaciji z antiepileptičnimi zdravili, ki spodbujajo encime, in 33,3 %, 46,5 % ali 50,0 %, ko je bil perampanel uporabljen v kombinaciji z antiepileptičnimi zdravili, ki ne spodbujajo encimov.
English: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse.
Slovenian: Previdnost je potrebna pri bolnikih, ki imajo v anamnezi odvisnost od drog; te bolnike je treba spremljati glede simptomov zlorabe perampanela.
English: The efficacy of perampanel in the treatment of absence seizures has not been demonstrated.
Slovenian: Učinkovitosti perampanela pri zdravljenju napadov z absencami niso dokazali.
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.
Slovenian: V študiji predporodne in poporodne toksičnosti za razvoj pri podganah so opazili nenormalne pogoje kotitve in laktacije pri odmerkih, toksičnih za mater, in večje število mrtvorojenih mladičev.
English: Patients from the randomised trial were converted to perampanel over 16 weeks followed by a long term maintenance period (≥ 1 year).
Slovenian: Bolniki iz randomiziranih preskušanj so prešli na perampanel v 16-tedenskem obdobju, ki mu je sledilo dolgo vzdrževalno obdobje (≥ 1 leto).
English: Not known (the frequency of this side effect cannot be estimated from the available data) are: - widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Slovenian: Neznana pogostnost (pogostnosti tega neželenega učinka iz razpoložljivih podatkov ni mogoče oceniti): - razširjen izpuščaj, visoka telesna temperatura, zvišanje vrednosti jetrnih encimov, nepravilnosti v krvi (eozinofilija), povečane bezgavke in vpletenost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, ki je znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo).
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving Fycompa up to 12 mg/day in placebo-controlled clinical trials, Fycompa did not affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the highest perampanel dose evaluated (12 mg/day).
Slovenian: V farmakokinetični analizi populacije bolnikov z napadi parcialnega izvora, ki so prejemali zdravilo Fycompa do 12 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, zdravilo Fycompa ni vplivalo na očistek klonazepama, levetiracetama, fenobarbitala, fenitoina, topiramata, zonisamida, karbamazepina, klobazama, lamotrigina in valprojske kisline na klinično pomemben način pri najvišjem ocenjenem odmerku perampanela (12 mg/dan).
English: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Slovenian: Zdravilo Fycompa je indicirano za adjuvantno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih bolnikih in mladostnikih z epilepsijo od starosti 12 let naprej.
English: Do not chew, crush or split the tablet.
Slovenian: Tablete ne žvečite, drobite ali delite.
English: It may take a few weeks to find the right dose of Fycompa for you.
Slovenian: Preden se določi za vas primeren odmerek zdravila Fycompa, lahko traja nekaj tednov.
English: Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Slovenian: Encim citostol reduktaza hitro presnovi okskarbazepin v aktivni presnovek, monohidroksikarbazepin.
English: For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg (4 ml).
Slovenian: Za bolnike z blago ali zmerno okvaro jeter se lahko odmerjanje začne pri 2 mg (4 ml).
English: For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91).
Slovenian: Pri bolnikih s perampanelom v odprtem podaljšanju (n = 112) je bila povprečna sprememba (SD) od izhodišča do konca odprtega zdravljenja (52 tednov) vrednosti t v globalnih kognitivnih funkcijah sistema CDR (minus) -1,0 (9,91).
English: The median percent change in primary generalised tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), P < 0.0001.
Slovenian: Mediana odstotna sprememba pogostnosti primarnih generaliziranih napadov s tonično-kloničnimi krči na 28 dni v obdobjih titriranja in vzdrževanja (kombinirano) v primerjavi z obdobjem pred randomizacijo je bila večja pri perampanelu (-76,5 %) kot pri placebu (-38,4 %), P < 0,0001.
English: If you forget to take Fycompa - If you forget to take Fycompa, wait until your next dose and then carry on as usual.
Slovenian: Če ste pozabili vzeti zdravilo Fycompa - Če ste pozabili vzeti zdravilo Fycompa, počakajte do naslednjega odmerka, nato pa nadaljujte kot običajno.
English: In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
Slovenian: In vitro je perampanel zavrl povečanje intracelularnega kalcija, ki ga sproži AMPA (vendar ga ne sproži NMDA).
English: Patients from the randomised trial were converted to perampanel over 6 weeks followed by a long term maintenance period (≥ 1 year).
Slovenian: Bolniki iz randomiziranega preskušanja so prešli na perampanel v obdobju 6 tednov, čemur je sledilo dolgo vzdrževalno obdobje (≥ 1 leto).
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.
Slovenian: Farmakokinetiko perampanela po enkratnem 1-mg odmerku so ocenili pri 12 osebah z blago in zmerno okvaro jeter (Child-Pugh A oz. B) in jo primerjali z 12 zdravimi prostovoljci z demografsko podobnostjo.
English: - If you have missed more than 7 days of treatment with Fycompa, talk to your doctor immediately.
Slovenian: - Če ste izpustili več kot 7 dni zdravljenja z zdravilom Fycompa, se takoj posvetujte z zdravnikom.
English: In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%.
Slovenian: Pri zdravih prostovoljcih je zdravilo Fycompa (6 mg enkrat na dan za 20 dni) zmanjšalo AUC midazolama za 13 %.
English: Excipient with known effect: Each ml of oral suspension contains 175 mg sorbitol (E420).
Slovenian: Pomožna snov z znanim učinkom: En mililiter peroralne suspenzije vsebuje 175 mg sorbitola (E420).
English: Uncommon (may affect more than 1 user in 1000) are: - thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
Slovenian: Občasni (pojavijo se lahko pri več kot 1 od 1000 bolnikov): - misli o samopoškodovanju ali samomoru (samomorilne misli), poskus samomora
English: 7 film-coated tablets 28 film-coated tablets 98 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 28 filmsko obloženih tablet 98 filmsko obloženih tablet
English: The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) -1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) -2.2 (-5.2, 0.8).
Slovenian: Povprečna sprememba (SD) od izhodišča do konca dvojno slepega zdravljenja (19 tednov) vrednosti t v globalnih kognitivnih funkcijah sistema CDR je bila 1,1 (7,14) v skupini s placebom in (minus) -1,0 (8,86) v skupini s perampanelom, z razliko med tretiranima skupinama v povprečju najmanjših kvadratov (95 % IZ) = (minus) -2,2 (-5,2, 0,8).
English: Influence of Fycompa on AED concentration
Slovenian: Vpliv zdravila Fycompa na koncentracijo AEZ
English: You can take Fycompa with or without food and should always take it the same way.
Slovenian: Zdravilo Fycompa lahko vzamete s hrano ali brez nje, vendar vedno na enak način.
English: PVC/aluminium blisters
Slovenian: PVC/aluminijevi pretisni omoti
English: Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Slovenian: Podobne rezultate so opazili tudi pri ovrednotenju vseh napadov in njihove odsotnosti v primerjavi z miokloničnimi napadi.
English: - Don't take more Fycompa than your doctor has recommended.
Slovenian: - Ne vzemite večjega odmerka zdravila Fycompa, kot vam je priporočil zdravnik.
English: There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Slovenian: Ni bilo sprememb v klinični patologiji ali histopatologiji, ki bi jih bilo mogoče neposredno pripisati učinkom perampanela.
English: The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
Slovenian: Neželeni učinek, ki je najpogosteje povzročil prekinitev jemanja (≥ 2 % v skupini, ki je prejemala perampanel, in pogostejši kot v skupini s placebom), je bila omotica.
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
Slovenian: 2 mg tableta: oranžna, z vtisom E275 na eni strani in "2" na drugi strani 4 mg tableta: rdeča, z vtisom E277 na eni strani in "4" na drugi strani 6 mg tableta: rožnata, z vtisom E294 na eni strani in "6" na drugi strani 8 mg tableta: vijolična, z vtisom E295 na eni strani in "8" na drugi strani 10 mg tableta: zelena, z vtisom E296 na eni strani in "10" na drugi strani 12 mg tableta: modra, z vtisom E297 na eni strani in "12" na drugi strani
English: Perampanel is dosed to clinical effect regardless of other AEDs.
Slovenian: Odmerjanje perampanela je neodvisno od drugih AEZ.
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:
Slovenian: V kliničnih študijah niso opazili neželenih učinkov, opazili pa so jih v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti.
English: Topiramate
Slovenian: Topiramat
English: Oral suspension 340 ml.
Slovenian: peroralna suspenzija 340 ml 1 plastenka
English: When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions.
Slovenian: Kadar so perampanel dali z zelo mastnim obrokom, sta bili Cmax in AUC0-inf enkratnega 12-miligramskega odmerka perampanela v obliki peroralne suspenzije približno 22 % oziroma 13 % manjši kot na tešče.
English: In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
Slovenian: In vivo je perampanel značilno podaljšal latentnost za epileptične napade v modelu napada, ki ga sproži AMPA.
English: Blister Pack (PVC/Aluminium blister)
Slovenian: Pretisni omot (pretisni omot iz PVC/aluminija)
English: For dosing please use the oral syringe and adaptor provided.
Slovenian: Za odmerjanje uporabljajte priloženo brizgo za peroralno dajanje in nastavek.
English: 1) Active metabolite monohydroxycarbazepine was not assessed.
Slovenian: Aktivnega presnovka monohidroksikarbazepina niso ocenili.
English: If any of these happens, talk to your doctor or pharmacist.
Slovenian: Če se kar koli od tega zgodi, obvestite svojega zdravnika ali farmacevta.
English: Psychomotor performance
Slovenian: Psihomotorična sposobnost
English: You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.
Slovenian: Zdravila Fycompa ne smete jemati, če imate resne težave z jetri ali zmerne do resne težave z ledvicami.
English: Fycompa contains sorbitol
Slovenian: Zdravilo Fycompa vsebuje sorbitol
English: Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo.
Slovenian: Vsi napadi so bili odpravljeni pri 23,5 % (19/81) bolnikov, ki so prejemali perampanel, v primerjavi s 4,9 % (4/81) bolnikov, ki so prejemali placebo.
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%).
Slovenian: Pri zdravih prostovoljkah se je pri 21-dnevnem jemanju zdravila Fycompa 12 mg (ne pa tudi pri 4 ali 8 mg/dan) sočasno s kombiniranim peroralnim kontraceptivom pokazalo zmanjšanje izpostavljenosti levonorgestrelu (povprečni vrednosti Cmax in AUC sta se zmanjšali za 40 %).
English: During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo.
Slovenian: Med 3-mesečnim obdobjem vzdrževanja je bilo 30,9 % (25/81) bolnikov na perampanelu v kliničnih študijah brez primarnih generaliziranih napadov s toničnokloničnimi krči, v primerjavi z 12,3 % (10/81) tistih, ki so prejemali placebo.
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet
English: 1 bottle (340 ml) contains 170 mg perampanel.
Slovenian: Ena plastenka (340 ml) vsebuje 170 mg perampanela.
English: Therefore, the possibility of decreased efficacy of progestative-containing oral contraceptives should be considered for women needing Fycompa 12 mg/day and an additional reliable method (intra-uterine device (IUD), condom) is to be used (see section 4.4).
Slovenian: Zato je treba pri ženskah, ki potrebujejo zdravilo Fycompa 12 mg/dan, pomisliti na možnost zmanjšane učinkovitosti peroralnih kontraceptivov, ki vsebujejo progestagen, in uporabiti dodatne zanesljive metode preprečevanja nosečnosti (maternični vložek (IUD), kondom) (glejte poglavje 4.4).