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.
Croatian: Na početku ispitivanja t-rezultati za opće kognitivno funkcioniranje dobiveni sustavom CDR testova iznosili su 41,2 (10,7) za placebo i i 40,8 (13,0) za perampanel.
English: Concomitant CYP 3A inducing anti-epileptic medicinal products
Croatian: Istovremena primjena antiepileptičkih lijekova koji induciraju CYP3A
English: 1 press-in-bottle adapter (PIBA)
Croatian: 1 nastavak za utiskivanje u bocu (PIBA)
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Croatian: 7 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obložene tablete 98 filmom obloženih tableta
English: Psychomotor performance testing returned to baseline within 2 weeks of cessation of perampanel dosing.
Croatian: Psihomotorna se sposobnost, prema testovima, vratila na početnu razinu unutar 2 tjedna od prestanka doziranja perampanela.
English: The efficacy of perampanel in the treatment of absence seizures has not been demonstrated.
Croatian: Djelotvornost perampanela u liječenju apsans napadaja nije dokazana.
English: - If you have missed more than 7 days of treatment with Fycompa, talk to your doctor immediately.
Croatian: - Ako ste propustili uzimati Fycompu više od 7 dana, odmah se obratite liječniku.
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.
Croatian: Tijekom 3 mjeseca terapije održavanja, 30,9% (25/81) bolesnika liječenih perampanelom u kliničkim ispitivanjima prestalo je imati primarno generalizirane toničko-kloničke napadaje u usporedbi s 12,3% (10/81) bolesnika koji su uzimali placebo.
English: Drug metabolising enzyme inhibition
Croatian: Inhibicija enzima koji metaboliziraju lijekove
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).
Croatian: Stoga se u žena kojima je potrebna Fycompa u dozi od 12 mg na dan mora uzeti u obzir mogućnost smanjene djelotvornosti oralnih kontraceptiva koji sadrže progestagene i primjena dodatne pouzdane metode kontracepcije (intrauterini uložak, kondom) (vidjeti dio 4.4).
English: For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg.
Croatian: U bolesnika s blagim ili umjerenim oštećenjem funkcije jetre, doziranje može započeti s 2 mg.
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).
Croatian: Srednja vrijednost promjene (SD) od početka ispitivanja pa do kraja dvostruko slijepog liječenja (19 tjedana) prema t-rezultatu dobivenom sustavom CDR testova za procjenu općeg kognitivnog funkcioniranja iznosila je 1,1 (7,14) u skupini koja je primala placebo i (minus) -1,0 (8,86) u skupini koja je primala perampanel, s razlikom između terapijskih skupina u srednjim vrijednostima procijenjenim metodom najmanjih kvadrata (95% CI) od (minus) -2,2 (-5,2; 0,8).
English: Dose adjustment is not required in patients with mild renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem funkcije bubrega.
English: Each bottle of 340 ml contains 170 mg perampanel
Croatian: Jedna boca od 340 ml sadrži 170 mg perampanela.
English: - Your doctor may increase this in 2 mg (4 ml) steps to a maintenance dose between 4 mg (8 ml)
Croatian: - Liječnik je može povećavati po 2 mg (4 ml) do doze održavanja između 4 mg (8 ml) i 12 mg
English: - DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Croatian: - DRESS se uobičajeno, ali ne isključivo, pojavljuje u obliku simptoma nalik gripi i osipa s visokom tjelesnom temperaturom, povišenom razinom jetrenih enzima vidljivom u krvnim pretragama, porastom jedne vrste bijelih krvnih stanica (eozinofilija) te povećanih limfnih čvorova.
English: Psychomotor performance
Croatian: Psihomotorna sposobnost
English: For patients with mild or moderate hepatic impairment, dosing can be initiated at 2 mg (4 ml).
Croatian: U bolesnika s blagim ili umjerenim oštećenjem funkcije jetre, doziranje može započeti s 2 mg (4 ml).
English: For dosing please use the oral syringe and adaptor provided.
Croatian: Za doziranje upotrijebite priloženu štrcaljku za usta i nastavak.
English: The 50% primary generalised tonic-clonic seizures responder rate during the Maintenance Period was significantly higher in the perampanel group (58.0%) than in the placebo group (35.8%), P = 0.0059.
Croatian: Stopa ispitanika s primarno generaliziranim toničko-kloničkim napadajima koji su imali 50% odgovora tijekom razdoblja terapije održavanja bila je značajno viša u skupini koja je primala perampanel (58,0%) nego u skupini koja je primala placebo (35,8%), P=0,0059.
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.
Croatian: U kontroliranim kliničkim ispitivanjima faze 3 u bolesnika s parcijalnim napadajima, stopa prekida liječenja zbog nuspojave iznosila je 1,7%, 4,2% i 13,7% u bolesnika randomiziranih u skupinu koja je primala perampanel u preporučenim dozama od 4 mg, 8 mg odnosno 12 mg na dan te 1,4% u bolesnika randomiziranih u skupinu koja je primala placebo.
English: In view of its long half-life, the effects caused by perampanel could be prolonged.
Croatian: S obzirom na to da perampanel ima dugi poluvijek, njegovi učinci mogu dugo trajati.
English: Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Croatian: Učinak induktora citokroma P450 na farmakokinetiku perampanela
English: Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Croatian: Jedna filmom obložena tableta sadrži 2 mg, 4 mg, 6 mg, 8 mg, 10 mg ili 12 mg perampanela.
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)
Croatian: Jezgra tablete (tablete od 6 mg, 8 mg, 10 mg i 12 mg) laktoza hidrat, nisko supstituirana hidroksipropilceluloza, povidon, mikrokristalična celuloza, magnezijev stearat (E470b)
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.
Croatian: U bolesnika s istovremeno prisutnim apsans napadajima, potpuni prestanak napadaja postignut je u 22,2% (6/27) bolesnika koji su uzimali perampanel u usporedbi s 12,1% (4/33) bolesnika koji su uzimali placebo.
English: Carton of 7, 28 and 98 tablets
Croatian: Kutija od 7, 28 i 98 tableta
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.
Croatian: U ispitivanju 332, u bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su istovremeno imali miokloničke napadaje, potpuni prestanak napadaja postignut je u 16,7% (4/24) bolesnika koji su uzimali perampanel u usporedbi s 13,0% (3/23) bolesnika koji su uzimali placebo.
English: Perampanel suspension should be taken orally once daily at bedtime.
Croatian: Suspenzija perampanela uzima se peroralno jedanput na dan, u vrijeme odlaska na spavanje.
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.
Croatian: U kliničkim je ispitivanjima 1,7% do 5,8% bolesnika na perampanelu prestalo imati napadaje tijekom 3 mjeseca terapije održavanja u usporedbi s 0%-1,0% bolesnika na placebu.
English: - These partial seizures may or may not then be followed by a fit affecting all of your brain
Croatian: - Nakon ovih parcijalnih napadaja može ili ne mora slijediti napadaj koji zahvaća Vaš cijeli mozak (zove se “sekundarna generalizacija”).
English: If you forget to take Fycompa - If you forget to take a tablet, wait until your next dose and then carry on as usual.
Croatian: - Ako ste zaboravili uzeti tabletu, pričekajte do sljedeće doze i potom nastavite prema uobičajenom rasporedu.
English: Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2).
Croatian: Ovisno o kliničkom odgovoru i podnošljivosti u pojedinog bolesnika, doza se može povećavati ili snižavati za 2 mg (vidjeti dio 4.2).
English: The efficacy and safety of perampanel in patients with myoclonic seizures have not been established.
Croatian: Druge podvrste idiopatskih generaliziranih napadaja Djelotvornost i sigurnost perampanela u bolesnika s miokloničkim napadajima nisu ustanovljene.
English: In vitro assessment of drug interactions
Croatian: Procjena interakcija lijekova in vitro
English: 8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)
Croatian: *Bojila su: tableta od 2 mg: željezov oksid, žuti (E172), željezov oksid, crveni (E172) tableta od 4 mg: željezov oksid, crveni (E172) tableta od 6 mg: željezov oksid, crveni (E172) tableta od 8 mg: željezov oksid, crveni (E172), željezov oksid, crni (E172) tableta od 10 mg: željezov oksid, žuti (E172), FD&C Blue #2 indigo carmine aluminium lake (E132) tableta od 12 mg: FD&C Blue #2 indigo carmine aluminium lake (E132)
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.
Croatian: U usporedbi sa sličnim zdravim ispitanicima, t1/2 bio je dulji u ispitanika s blagim oštećenjem (306 h naspram 125 h) i onih s umjerenim oštećenjem (295 h naspram 139 h).
English: It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Croatian: Dostupna je u bocama od 340 ml s 2 graduirane (s oznakama mililitra) štrcaljke za usta i nastavkom za utiskivanje u bocu izrađenim od polietilena male gustoće (LDPE).
English: What Fycompa looks like and contents of the pack Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension.
Croatian: Fycompa 0,5 mg/ml oralna suspenzija bijela je do gotovo bijela suspenzija.
English: Dysarthria Balance disorder Irritability
Croatian: Poremećaji živčanog sustava omaglica somnolencija ataksija dizartrija poremećaj ravnoteže razdražljivost
English: 8 Leave the adaptor in place and replace cap on bottle.
Croatian: Nastavak ostavite na svom mjestu, a bocu zatvorite zatvaračem.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: Teške kožne nuspojave (SCAR), uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (DRESS)
English: Cartons of 7, 28, 84 and 98 tablets
Croatian: Kutija od 7, 28, 84 i 98 tableta
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.
Croatian: Bolesnicima koji istovremeno uzimaju lijekove koji ne skraćuju poluvijek perampanela (vidjeti dio 4.5) doza se ne smije titrirati u intervalima kraćim od 2 tjedna.
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.
Croatian: 6.1 Popis pomoćnih tvari sorbitol (E420) tekući (kristalizirajući) mikrokristalična celuloza (E460) karmelozanatrij (E466) poloksamer 188 simetikon emulzija 30%, sadrži pročišćenu vodu, silikonsko ulje, polisorbat 65, metilcelulozu, gel silicijevog dioksida, makrogolstearat, sorbatnu kiselinu, benzoatnu kiselinu i sulfatnu kiselinu citratna kiselina, bezvodna (E330) natrijev benzoat (E211) pročišćena voda
English: Suicidal ideation Suicide attempt
Croatian: Psihijatrijski poremećaji agresija ljutnja anksioznost stanje konfuzije suicidalna ideacija pokušaj samoubojstva
English: Fycompa should be taken as single oral dose at bedtime.
Croatian: Fycompa se uzima kao jednokratna peroralna doza prije odlaska na spavanje.
English: There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Croatian: Nije bilo kliničkopatoloških i patohistoloških promjena koje su se mogle izravno pripisati perampanelu.
English: Valproic Acid No influence
Croatian: 19% sniženje nema utjecaja valproatna kiselina nema utjecaja
English: Use in patients with moderate or severe renal impairment or patients undergoing haemodialysis is not recommended.
Croatian: Ne preporučuje se primjena u bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega ili u bolesnika na hemodijalizi.
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.
Croatian: Bolesnici koji su zadovoljavali kriterije na stabilnoj dozi od 1 do 3 antiepileptička lijeka koji su imali najmanje 3 primarno generalizirana toničko-klonička napadaja tijekom osmotjednog početnog razdoblja bili su randomizirani u skupinu koja je primala perampanel ili u skupinu koja je primala placebo.
English: If you forget to take Fycompa - If you forget to take Fycompa, wait until your next dose and then carry on as usual.
Croatian: - Ako ste zaboravili uzeti Fycompu, pričekajte do sljedeće doze i potom nastavite prema uobičajenom rasporedu.
English: Perampanel should be taken orally once daily at bedtime.
Croatian: Perampanel se uzima peroralno jedanput na dan, u vrijeme odlaska na spavanje.
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.
Croatian: U kontroliranom kliničkom ispitivanju faze 3 u bolesnika s primarno generaliziranim toničko-kloničkim napadajima, stopa prekida liječenja zbog nuspojave iznosila je 4,9% u bolesnika randomiziranih u skupinu koja je primala perampanel u dozi od 8 mg i 1,2% u bolesnika randomiziranih u skupinu koja je primala placebo.
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.
Croatian: Bolesnicima koji istovremeno uzimaju lijekove koji skraćuju poluvijek perampanela (vidjeti dio 4.5) doza se ne smije titrirati u intervalima kraćim od 1 tjedna.
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.
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima (u rasponu dobi od 12 do 74 godine) i primarno generaliziranim toničko-kloničkim napadajima (u rasponu dobi od 12 do 58 godina) koji su primali perampanel u dozi do 8 ili 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, nije pronađen značajni učinak dobi na klirens perampanela.
English: Weight increased
Croatian: Pretrage povećanje tjelesne težine
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.
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su imali klirens kreatinina u rasponu od 39 do 160 ml/min i primali perampanel u dozama do 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, klirens kreatinina nije utjecao na klirens perampanela.
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Croatian: Liječenje Fycompom treba započeti dozom od 2 mg na dan.
English: Systemic Symptoms (DRESS)*
Croatian: Reakcija na lijek s eozinofilijo m i sustavnim simptomima (DRESS)*
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).
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima, klirens perampanela u žena (0,54 l/h) bio je 18% niži nego u muškaraca (0,66 l/h).
English: Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Croatian: Fycompa 6 mg, 8 mg, 10 mg, 12 mg filmom obložene tablete
English: Open label extension study
Croatian: Otvoreni produžetak ispitivanja
English: Sorbitol (E420) liquid (crystallising)
Croatian: - Drugi sastojci su sorbitol (E420) tekući (kristalizirajući), mikrokristalična celuloza (E460),
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Croatian: Liječenje Fycompom treba započeti dozom od 2 mg na dan (4 ml na dan).
English: Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Croatian: Uzet natašte, 1 mg oralne suspenzije perampanela bioekvivalent je 1 mg perampanela u tabletama.
English: A similar result was seen 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.
Croatian: Sličan se rezultat dobio populacijskom farmakokinetičkom analizom bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima.
English: Fycompa is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti lijek Fycompa tijekom trudnoće.
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.
Croatian: Prijavljene su teške kožne nuspojave (engl. severe cutaneous adverse reactions, SCAR) povezane s liječenjem perampanelom, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne (nepoznata učestalost, vidjeti dio 4.8).
English: Insert adaptor into the neck of the bottle until a tight seal is made.
Croatian: U vrat boce umetnite nastavak tako da bude dobro učvršćen.
English: Fycompa 0.5 mg/ml oral suspension perampanel
Croatian: Fycompa 0,5 mg/ml oralna suspenzija perampanel
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.
Croatian: Global Cognition Score) mjereno pomoću Cognitive Drug Research (CDR) sustava testova za ispitivanje kognitivne sposobnosti u kliničkim ispitivanjima, nisu opažene značajne promjene u kognitivnim sposobnostima uz perampanel u odnosu na placebo.
English: - If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose as originally instructed by your doctor.
Croatian: - Ako ste propustili uzimati Fycompu manje od 7 dana, nastavite svakodnevno uzimati dozu kako
English: Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with perampanel from 4 to 12 mg/day.
Croatian: Razina budnosti (pobuđenosti) u zdravih ispitanika koji su primali doze perampanela od 4 do 12 mg na dan snižavala se ovisno o dozi.
English: Abuse potential
Croatian: Moguća zloporaba
English: Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. Use in patients with severe hepatic impairment is not recommended.
Croatian: Doza perampanela u bolesnika s blagim i umjerenim oštećenjem ne smije biti veća od 8 mg.
English: 2 oral syringes
Croatian: 2 štrcaljke za usta
English: The effects of perampanel on tasks involving alertness and vigilance such as driving ability were additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction study in healthy subjects.
Croatian: Kako se pronašlo u ispitivanju farmakodinamičkih interakcija u zdravih ispitanika, učinci perampanela na aktivnosti koje zahtijevaju budnost i brzinu, kao što je sposobnost upravljanja vozilima, bili su aditivni ili supraaditivni učincima samog alkohola.
English: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Croatian: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg i 12 mg filmom obložene tablete perampanel
English: Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Croatian: Ozbiljne kožne nuspojave, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (DRESS) prijavljene su pri primjeni perampanela.
English: Diplopia Vision blurred
Croatian: Poremećaji oka diplopija zamagljen vid
English: Fycompa 0.5 mg/ml oral suspension
Croatian: Fycompa 0,5 mg/ml oralna suspenzija
English: Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ovaj lijek jer će Vam možda trebati prilagoditi dozu.
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).
Croatian: Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan, doza se može povisiti do 12 mg na dan, što može biti učinkovito u nekih bolesnika (vidjeti dio 4.4).
English: perampanel oral suspension achieves equivalent AUC0-inf and approximately 23 % lower Cmax and 2 hours delay in time to peak exposure (tmax) compared to the tablet formulation.
Croatian: Kada se jedna doza od 12 mg obiju formulacija primijeni uz obrok s visokim udjelom masti, u usporedbi s formulacijom u tabletama oralna suspenzija perampanela dosegne ekvivalentnu vrijednost za AUC0-inf, približno 23% niži Cmax te vršnu izloženost (tmax) s odgodom od 2 sata.
English: Carbamazepine 2.75 fold decrease
Croatian: Utjecaj Fycompe na koncentraciju antiepileptika karbamazepin sniženje za 2,75 puta