FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: NE JEMLJITE zdravila Fycompa: - če se je po uporabi perampanela pri vas kadar koli pojavil hud kožni izpuščaj ali lupljenje kože,
English: Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism.
Slovenian: Perampanel se hitro absorbira po peroralnem dajanju brez znakov znatne presnove prvega prehoda.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fycompa.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila Fycompa posvetujte s svojim zdravnikom.
English: - The other ingredients are sorbitol (E420) liquid (crystallising), microcrystalline cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid), citric acid, anhydrous (E330), sodium benzoate (E211) and purified water.
Slovenian: - Druge sestavine zdravila so sorbitol (E420) tekoči (kristalizirajoči), mikrokristalna celuloza (E460), natrijev karmelozat (E466), poloksamer 188, 30-odstotna simetikonska emulzija (vsebuje prečiščeno vodo, silikonsko olje, polisorbat 65, metilcelulozo, koloidni silicijev dioksid, makrogol stearat, sorbinsko kislino, benzojsko kislino in žveplovo kislino), brezvodna citronska kislina (E330), natrijev benzoat (E211) in prečiščena voda
English: What Fycompa contains - The active substance is perampanel.
Slovenian: Kaj vsebuje zdravilo Fycompa - Učinkovina je perampanel.
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose (30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic development.
Slovenian: V študiji plodnosti pri podganah so pri visokih odmerkih (30 mg/kg) pri samicah opazili podaljšane in neredne estrusne cikle, vendar te spremembe niso vplivale na sposobnost razmnoževanja in zgodnji razvoj zarodkov.
English: Concomitant CYP 3A inducing anti-epileptic medicinal products
Slovenian: Sočasna uporaba antiepileptičnih zdravil, ki spodbujajo encim CYP3A
English: Fycompa is for oral use.
Slovenian: Zdravilo Fycompa je namenjeno za peroralno uporabo.
English: Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Slovenian: Filmska obloga (2 mg, 4 mg, 6 mg, 8 mg, 10 mg in 12 mg tablete): hipromeloza 2910, smukec, makrogol 8000, titanov dioksid (E171), barvila*
English: Influence of AED on Fycompa concentration
Slovenian: Vpliv AEZ na koncentracijo zdravila Fycompa
English: A statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment Phase) as compared to the placebo group was observed with perampanel treatment at doses of 4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305).
Slovenian: Pri zdravljenju s perampanelom so opazili značilno bolj učinkovit učinek na zmanjšanje pogostnosti napadov (izhodišče do faze zdravljenja) v 28 dneh pri odmerkih 4 mg/dan (študija 306), 8 mg/dan (študije 304, 305 in 306) in 12 mg/dan (študiji 304 in 305) v primerjavi z zdravljenjem s placebom.
English: Eligible patients on a stable dose of 1 to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline period were randomised to either perampanel or placebo.
Slovenian: Primerni bolniki, ki so prejemali stabilen odmerek 1 do 3 zdravil AEZ in so imeli vsaj 3 primarne generalizirane napade s tonično-kloničnimi krči v 8-tedenskem izhodiščnem obdobju, so bili randomizirani v skupino s perampanelom ali placebom.
English: - If you have missed less than 7 days of treatment with Fycompa, continue taking your daily tablet as originally instructed by your doctor.
Slovenian: - Če ste izpustili manj kot 7 dni zdravljenja z zdravilom Fycompa, nadaljujte z jemanjem tablete vsak dan, kot vam je prvotno naročil vaš zdravnik.
English: Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Slovenian: Ena kartonska škatla vsebuje eno plastenko, dve 20-mililitrski merilni brizgi za peroralno dajanje in vtisljiv nastavek za plastenko (press-in bottle adapter - PIBA) iz LDPE.
English: Fycompa is not recommended during pregnancy.
Slovenian: - Uporaba zdravila Fycompa med nosečnostjo ni priporočljiva.
English: - If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose as originally instructed by your doctor.
Slovenian: - Če ste izpustili manj kot 7 dni zdravljenja z zdravilom Fycompa, nadaljujte z jemanjem odmerka vsak dan, kot vam je prvotno naročil vaš zdravnik.
English: Fycompa contains a medicine called perampanel.
Slovenian: Zdravilo Fycompa vsebuje zdravilno učinkovino, imenovano perampanel.
English: Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332).
Slovenian: Primarni generalizirani napadi s tonično-kloničnimi krči Perampanel kot adjuvantno zdravljenje pri bolnikih starosti 12 let in več z idiopatsko generalizirano epilepsijo, ki so imeli primarne generalizirane napade s tonično-kloničnimi krči, so proučili v multicentrični, randomizirani, dvojno slepi, s placebom kontrolirani študiji (študija 332).
English: Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised tonic-clonic seizures.
Slovenian: Primarni generalizirani napadi s tonično-kloničnimi krči Perampanel v odmerku do 8 mg/dan se je izkazal za učinkovitega pri primarnih generaliziranih napadih s tonično-kloničnimi krči.
English: Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much they work.
Slovenian: Jemanje zdravila Fycompa skupaj s kakim drugim zdravilom proti epilepsiji, ki vsebuje sorbitol, lahko vpliva na učinkovitost obeh zdravil.
English: 1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%-1.0% on placebo.
Slovenian: 1,7 % do 5,8 % bolnikov, ki so v kliničnih študijah prejemali perampanel, je bilo v 3-mesečnem vzdrževalnem obdobju brez napadov, v primerjavi z 0 % do 1,0 % odstotka bolnikov, ki so prejemali placebo.
English: Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals.
Slovenian: Bolnike, ki sočasno uporabljajo druga zdravila, ki ne skrajšajo razpolovnega časa perampanela (glejte poglavje 4.5), titriramo v intervalih, ki niso krajši kot 2 tedna.
English: Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Slovenian: Učinek induktorjev citokroma P450 na farmakokinetiko perampanela
English: In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7%, 4.2% and 13.7% in patients randomised to receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% in patients randomised to receive placebo.
Slovenian: V kontroliranih kliničnih preskušanjih 3. faze pri bolnikih z napadi parcialnega izvora je bila stopnja prekinitve kot posledica neželenega učinka 1,7 %, 4,2 % oz. 13,7 % pri bolnikih, randomiziranih v skupino s perampanelom s priporočenimi odmerki 4 mg, 8 mg oz. 12 mg/dan in 1,4 % pri bolnikih, randomiziranih v skupino s placebom.
English: Dysarthria Balance disorder Irritability
Slovenian: Bolezni živčevja omotica zaspanost ataksija disartrija motnje ravnotežja razdražljivost
English: Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2).
Slovenian: Odvisno od kliničnega odziva in prenašanja posameznika je mogoče odmerek povečevati ali zmanjševati za 2 mg (glejte poglavje 4.2).
English: Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia.
Slovenian: Simptomi DRESS med drugim običajno obsegajo zvišano telesno temperaturo, izpuščaj, povezan z vpletenostjo drugih organskih sistemov, limfadenopatijo, nenormalne rezultate preiskav jetrnih funkcij in eozinofilijo.
English: In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% (6/27) on perampanel compared to 12.1% (4/33) on placebo.
Slovenian: Pri bolnikih s sočasnimi napadi z absencami (odsotnostni napadi) so bili napadi odpravljeni pri 22,2 % (6/27) bolnikov, ki so prejemali perampanel, v primerjavi z 12,1 % (4/33) bolnikov, ki so prejemali placebo.
English: Fycompa 2 mg film-coated tablets Pack of 7 only for first week of dosing, 28 and 98
Slovenian: Fycompa 2 mg filmsko obložene tablete Pakiranje po 7 samo za odmerjanje v prvem tednu, 28 in 98
English: Insert the oral syringe into the opening of the adaptor as far as possible.
Slovenian: V odprtino nastavka vstavite brizgo za peroralno dajanje tako daleč, kot gre.
English: In vitro assessment of drug interactions
Slovenian: Ocena medsebojnega delovanja zdravila in vitro
English: Perampanel suspension should be taken orally once daily at bedtime.
Slovenian: Suspenzija perampanela se jemlje peroralno enkrat na dan ob uri, ko gre bolnik spat.
English: Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals.
Slovenian: Bolnike, ki sočasno uporabljajo zdravila, ki skrajšajo razpolovni čas perampanela (glejte poglavje 4.5), titriramo v intervalih, ki niso krajši kot 1 teden.
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.
Slovenian: Na podlagi rezultatov kliničnih študij pri zdravih preiskovancih, ki so prejeli radioaktivno označeni perampanel, ki jih podpirajo študije in vitro z uporabo rekombinantnih humanih encimov CYP in humanih jetrnih mikrosomov.
English: Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid Citric acid, anhydrous (E330)
Slovenian: 30-odstotna simetikonska emulzija, ki vsebuje prečiščeno vodo, silikonsko olje, polisorbat 65, metilcelulozo, koloidni silicijev dioksid, makrogol stearat, sorbinsko kislino, benzojsko kislino in žveplovo kislino brezvodna citronska kislina (E330) natrijev benzoat (E211) prečiščena voda
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.
Slovenian: Če se perampanel kombinira z zaviralcem CYP3A z daljšim razpolovnim časom kot ketokonazol, ali če se zaviralec daje daljše obdobje zdravljenja, ni mogoče izključiti večjega vpliva na farmakokinetiko.
English: - If you are allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).
Slovenian: mehurji na koži in/ali rane v ustih, - če ste alergični na perampanel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Carton of 7, 28 and 98 tablets
Slovenian: Škatla s 7, 28 in 98 tabletami
English: Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Slovenian: Jedro tablete (6 mg, 8 mg, 10 mg in 12 mg tablete): laktoza monohidrat, nizko substituirana hidroksipropilceluloza, povidon, mikrokristalna celuloza, magnezijev stearat (E470b)
English: It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Slovenian: Na voljo je v 340-mililitrski plastenki z 2 merilnima brizgama za peroralno dajanje in vtisljivim nastavkom za plastenko (press-in bottle adapter - PIBA) iz LDPE.
English: In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% in patients randomised to receive perampanel 8 mg, and 1.2% in patients randomised to receive placebo.
Slovenian: V kontroliranem kliničnem preizkušanju 3. faze pri bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči je bila stopnja prekinitve jemanja zaradi neželenega učinka 4,9 % pri bolnikih, randomiziranih v skupino za prejemanje 8 mg perampanela, ter 1,2 % pri bolnikih, randomiziranih v skupino s placebom.
English: Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons.
Slovenian: Perampanel je prvi predstavnik novega razreda zdravil in je selektiven, nekompetitiven antagonist ionotropnih receptorjev glutamat α-amino-3-hidroksi-5-metil-4-izoksazolepropionske kisline (AMPA) na postsinaptičnih nevronih.
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early embryonic development.
Slovenian: V študiji plodnosti pri podganah so pri visokih odmerkih (30 mg/kg) pri samicah opazili podaljšane in neredne estrus cikle pri največjem tolerančnem odmerku, vendar te spremembe niso vplivale na sposobnost razmnoževanja in zgodnji razvoj zarodkov.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v hrbtu
English: Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or severe kidney problems.
Slovenian: Pred začetkom jemanja zdravila Fycompa se posvetujte z zdravnikom ali s farmacevtom, če imate težave z jetri ali zmerne do hude težave z ledvicami.
English: Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg, 4 mg, 6 mg, 8 mg, 10 mg ali 12 mg perampanela.
English: Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Slovenian: Peroralna suspenzija perampanela je bioekvivalentna enakemu odmerku perampanela v miligramih v obliki tablet na tešče.
English: - Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg depending on your response.
Slovenian: - Vaš zdravnik lahko odmerek povečuje v korakih po 2 mg (4 ml), da dosežete vzdrževalni odmerek med 4 mg (8 ml) in 12 mg (24 ml), odvisno od vašega odziva.
English: In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on placebo.
Slovenian: V študiji 332 pri bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so imeli sočasno tudi mioklonične napade, so bili napadi odpravljeni pri 16,7 % (4/24) bolnikov, ki so prejemali perampanel, v primerjavi s 13,0 % (3/23) bolnikov, ki so prejemali placebo.
English: In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel.
Slovenian: V študiji, kontrolirani s placebom, ki so jo opravili na adolescentnih bolnikih, pri perampanelu niso ugotovili signifikantnih sprememb kognitivnih funkcij v primerjavi s placebom, izmerjenih z rezultati globalnih kognitivnih funkcij sistema kognitivnih raziskav zdravil (CDR) (Cognitive Drug Research (CDR) System Global Cognition Score) po 52 tednih zdravljenja s perampanelom (glejte poglavje 5.1 Pediatrična populacija).
English: What Fycompa looks like and contents of the pack Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension.
Slovenian: Fycompa 0,5 mg/ml peroralna suspenzija je bela do belkasta suspenzija.
English: Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics
Slovenian: Učinek zaviralcev citokroma P450 na farmakokinetiko perampanela
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
Slovenian: Pri bolnikih, zdravljenih z antiepileptiki, so pri številnih indikacijah poročali o samomorilnih mislih.
English: Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Slovenian: Povejte svojemu zdravniku, če jemljete ali ste pred kratkim jemali ta zdravila, ker bo morda treba odmerek prilagoditi.
English: Cartons of 7, 28, 84 and 98 tablets
Slovenian: Škatle s 7, 28, 84 in 98 tabletami
English: Suicidal ideation Suicide attempt
Slovenian: Psihiatrične motnje agresija jeza tesnoba stanje zmedenosti samomorilne misli poskus samomora
English: Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Slovenian: Povejte svojemu zdravniku, če jemljete ali ste pred kratkim jemali to zdravilo, ker bo morda treba odmerek prilagoditi.
English: The oral dosing syringes are graduated in 0.5 ml increments.
Slovenian: Oznake na brizgi za peroralno dajanje naraščajo po 0,5 mililitra.
English: Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with perampanel from 4 to 12 mg/day.
Slovenian: Raven zbranosti (prebujenosti) se je pri zdravih prostovoljcih, ki so dobivali odmerke perampanela od 4 do 12 mg/dan, zniževala v odvisnosti od odmerka.
English: Speak to your doctor before drinking alcohol.
Slovenian: Preden uživate alkohol, se posvetujte z zdravnikom.
English: Perampanel should be taken orally once daily at bedtime.
Slovenian: Perampanel se jemlje peroralno enkrat na dan ob uri, ko gre bolnik spat.
English: Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products
Slovenian: Druga sočasna zdravila, ki spodbujajo ali zavirajo citokrom P450 (ne antiepileptična)
English: Fycompa should be taken as single oral dose at bedtime.
Slovenian: Zdravilo Fycompa se jemlje kot enojni peroralni odmerek pred spanjem.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on perampanel clearance was found.
Slovenian: V populacijski farmakokinetični analizi bolnikov z napadi parcialnega izvora (razpon starosti od 12 do 74 let) in primarnimi generaliziranimi napadi s tonično-kloničnimi krči (razpon starosti od 12 do 58 let), ki so prejemali perampanel do 8 mg/dan ali 12 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, niso opazili značilnega učinka starosti na očistek perampanela.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical trials, perampanel clearance was not influenced by creatinine clearance.
Slovenian: V populacijski farmakokinetični analizi bolnikov z napadi parcialnega izvora z očistki kreatinina od 39 do 160 ml/min, ki so prejemali perampanel do 12 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, očistek kreatinina ni vplival na očistek perampanela.
English: Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Slovenian: Zaradi optimiranja ravnovesja med učinkovitostjo in prenašanjem je treba zdravilo Fycompa titrirati glede na odziv posameznega bolnika.
English: The efficacy and safety of perampanel in patients with myoclonic seizures have not been established.
Slovenian: Druge podvrste idiopatskih generaliziranih napadov Učinkovitosti in varnosti perampanela pri bolnikih z miokloničnimi napadi niso dokazali.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, perampanel clearance in females (0.54 l/h) was 18% lower than in males (0.66 l/h).
Slovenian: V populacijski farmakokinetični analizi bolnikov z napadi parcialnega izvora, ki so prejemali perampanel do 12 mg/dan, in bolnikov s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, je bil očistek kreatinina pri ženskah (0,54 l/h) 18 % nižji kot pri moških (0,66 l/h).
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Slovenian: Hude kožne neželene reakcije (severe cutaneous adverse reactions, SCAR), vključno z reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (drug reaction with eosinophilia and systemic symptoms, DRESS)
English: How to use Fycompa
Slovenian: Kako uporabljati zdravilo Fycompa
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported (frequency unknown; see section 4.8) in association with perampanel treatment.
Slovenian: V povezavi z zdravljenjem z perampanelom so poročali o hudih kožnih neželenih reakcijah (SCAR), vključno z reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko nevarne ali s smrtnim izidom (pogostnost neznana, glejte poglavje 4.8).
English: Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Slovenian: Fycompa 6 mg, 8 mg, 10 mg, 12 mg filmsko obložene tablete
English: The effect of perampanel on human fertility has not been established.
Slovenian: Učinkov perampanela na sposobnost razmnoževanja pri ljudeh niso ugotavljali.
English: Push plunger of oral syringe completely down.
Slovenian: Bat brizge za peroralno dajanje potisnite do konca dol.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day.
Slovenian: Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan se lahko odmerek zvečuje postopoma po 2 mg/dan do 12 mg/dan.
English: - Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
Slovenian: - Zdravilo Fycompa lahko vpliva na midazolam (zdravilo, ki se uporablja za zaustavljanje dolgotrajnih, akutnih (nenadnih) epileptičnih napadov s krči, za pomirjanje in nespečnost).
English: - You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa.
Slovenian: - Med zdravljenjem z zdravilom Fycompa morate uporabljati zanesljiv način kontracepcije, da ne zanosite.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased up to 12 mg/day, which may be effective in some patients (see section 4.4).
Slovenian: Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan se lahko odmerek zvečuje do 12 mg/dan, ki je pri nekaterih bolnikih lahko učinkovit (glejte poglavje 4.4).
English: hypericum (St. John's Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa.
Slovenian: (Hypericum perforatum) (zdravilo za zdravljenje blage anksioznosti) in ketokonazol (zdravilo za zdravljenje glivičnih okužb) lahko vplivajo na delovanje zdravila Fycompa.