natgillin/translations-raw huggingface dataset:
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.
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.
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.
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).
What Fycompa looks like and contents of the pack Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension.
Fycompa 0,5 mg/ml peroralna suspenzija je bela do belkasta suspenzija.
Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics
Učinek zaviralcev citokroma P450 na farmakokinetiko perampanela
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
Pri bolnikih, zdravljenih z antiepileptiki, so pri številnih indikacijah poročali o samomorilnih mislih.
Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Povejte svojemu zdravniku, če jemljete ali ste pred kratkim jemali ta zdravila, ker bo morda treba odmerek prilagoditi.
Cartons of 7, 28, 84 and 98 tablets
Škatle s 7, 28, 84 in 98 tabletami
Suicidal ideation Suicide attempt
Psihiatrične motnje agresija jeza tesnoba stanje zmedenosti samomorilne misli poskus samomora
Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Povejte svojemu zdravniku, če jemljete ali ste pred kratkim jemali to zdravilo, ker bo morda treba odmerek prilagoditi.
The oral dosing syringes are graduated in 0.5 ml increments.
Oznake na brizgi za peroralno dajanje naraščajo po 0,5 mililitra.
Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with perampanel from 4 to 12 mg/day.
Raven zbranosti (prebujenosti) se je pri zdravih prostovoljcih, ki so dobivali odmerke perampanela od 4 do 12 mg/dan, zniževala v odvisnosti od odmerka.
Speak to your doctor before drinking alcohol.
Preden uživate alkohol, se posvetujte z zdravnikom.
Perampanel should be taken orally once daily at bedtime.
Perampanel se jemlje peroralno enkrat na dan ob uri, ko gre bolnik spat.
Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products
Druga sočasna zdravila, ki spodbujajo ali zavirajo citokrom P450 (ne antiepileptična)
Fycompa should be taken as single oral dose at bedtime.
Zdravilo Fycompa se jemlje kot enojni peroralni odmerek pred spanjem.
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.
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.
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.
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.
Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Zaradi optimiranja ravnovesja med učinkovitostjo in prenašanjem je treba zdravilo Fycompa titrirati glede na odziv posameznega bolnika.
The efficacy and safety of perampanel in patients with myoclonic seizures have not been established.
Druge podvrste idiopatskih generaliziranih napadov Učinkovitosti in varnosti perampanela pri bolnikih z miokloničnimi napadi niso dokazali.
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).
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).
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
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)
How to use Fycompa
Kako uporabljati zdravilo Fycompa
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.
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).
Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Fycompa 6 mg, 8 mg, 10 mg, 12 mg filmsko obložene tablete
The effect of perampanel on human fertility has not been established.
Učinkov perampanela na sposobnost razmnoževanja pri ljudeh niso ugotavljali.
Push plunger of oral syringe completely down.
Bat brizge za peroralno dajanje potisnite do konca dol.
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.
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.
- Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
- Zdravilo Fycompa lahko vpliva na midazolam (zdravilo, ki se uporablja za zaustavljanje dolgotrajnih, akutnih (nenadnih) epileptičnih napadov s krči, za pomirjanje in nespečnost).
- You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa.
- Med zdravljenjem z zdravilom Fycompa morate uporabljati zanesljiv način kontracepcije, da ne zanosite.
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).
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).
hypericum (St. John's Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa.
(Hypericum perforatum) (zdravilo za zdravljenje blage anksioznosti) in ketokonazol (zdravilo za zdravljenje glivičnih okužb) lahko vplivajo na delovanje zdravila Fycompa.
Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
Pri bolnikih, ki so prejemali zdravljenje s perampanelom, so poročali o agresiji in sovražnem vedenju.
Clonazepam No influence
Lamotrigin ni vpliva
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.
Podoben je bil rezultat populacijske farmakokinetične analize pri bolnikih z napadi parcialnega izvora, ki so prejemali perampanel do 12 mg/dan, in bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v kliničnih preskušanjih, kontroliranih s placebom.
Do not stop treatment without first discussing it with your doctor.
Preden prenehate z zdravljenjem, se posvetujte z zdravnikom.
In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
V populacijski farmakokinetični analizi bolnikov s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v klinični študiji, kontrolirani s placebom, izhodiščni očistek kreatinina ni vplival na očistek perampanela.
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.
Ko so dali enkraten 12-miligramski odmerek obeh oblik zdravila z zelo mastnim obrokom, je peroralna suspenzija perampanela dosegla enakovredno AUC0-inf in približno 23 % nižjo Cmax in dveurno podaljšanje časa do največje izpostavljenosti (tmax) v primerjavi z zdravilom v obliki tablet.
Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg in 12 mg filmsko obložene tablete perampanel
There were no effects on male fertility.
Na sposobnost razmnoževanja pri samcih ni bilo vpliva.
In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose.
V vseh treh preskušanjih so bile osebe randomizirane in titrirane do randomiziranega odmerka po 6-tedenski izhodiščni fazi, v kateri se je ugotavljala pogostnost napadov pred randomizacijo.
A clinically meaningful reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing when patients reached a daily dose of 4 mg.
Že v drugem tednu uporabe, ko so bolniki dosegli dnevni odmerek 4 mg, je bilo doseženo klinično pomembno zmanjšanje pogostnosti napadov v primerjavi s placebom.
Dose adjustment is not required in patients with mild renal impairment.
Pri bolnikih z blago okvaro ledvic ni treba prilagajati odmerka.
Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
Jedro laktoza monohidrat nizko substituirana hidroksipropilceluloza povidon K-29/32 magnezijev stearat (E470b)
Fycompa 0.5 mg/ml oral suspension Perampanel
Fycompa 0,5 mg/ml peroralna suspenzija perampanel
Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
Odmerek za bolnika je treba vsaka 2 tedna povečati za 2 mg (4 ml) glede na prenašanje in učinkovitost.
Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be effective in some patients (see section 4.4).
Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan (16 ml/dan) se lahko odmerek zvečuje do 12 mg/dan (24 ml/dan), ki je pri nekaterih bolnikih lahko učinkovit (glejte poglavje 4.4).
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, a linear relationship was found between dose and perampanel plasma concentrations.
V farmakokinetični analizi populacije pri bolnikih z napadi parcialnega izvora, ki so prejemali perampanel do 12 mg/dan, in bolnikih s primarnimi generaliziranimi napadi s tonično-kloničnimi krči, ki so prejemali perampanel do 8 mg/dan v kliničnih preskušanjih, kontroliranih s placebom, so ugotovili linearno razmerje med odmerkom in koncentracijami perampanela v plazmi.
Do not start or stop other medicines without talking to your doctor or pharmacist.
Pred začetkom ali prenehanjem uporabe drugih zdravil se posvetujte z zdravnikom ali farmacevtom.
Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 12 mg/day (24 ml/day).
Glede na individualni klinični odziv in prenašanje pri odmerku 8 mg/dan (16 ml/dan) se lahko odmerek zvečuje postopoma po 2 mg/dan (4 ml/dan) do 12 mg/dan (24 ml/dan).
- It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.
- Uporablja se tudi za zdravljenje nekaterih napadov, ki že od začetka prizadenejo cele možgane
Clobazam No influence
Klobazam ni vpliva
Each ml contains 0.5 mg perampanel.
En ml vsebuje 0,5 mg perampanela.
In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency.
Ugotovljeni so bili po pregledu celotne zbirke podatkov o varnosti kliničnih študij z zdravilom Fycompa.
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
2 mg tableta - pakiranje s 7, 28 in 98 tabletami 4 mg, 6 mg, 8 mg, 10 mg in 12 mg tableta - pakiranje s 7, 28, 84 in 98 tabletami
- Fycompa is not recommended in pregnancy.
Zdravila Fycompa ne uporabljajte pri nosečnicah.
If you have taken more Fycompa than you should contact your doctor straight away.
Če ste vzeli večji odmerek zdravila Fycompa, kot bi smeli Če ste vzeli večji odmerek zdravila Fycompa, kot bi smeli, se takoj posvetujte z zdravnikom.
Fycompa 2 mg, 4 mg film-coated tablets
Fycompa 2 mg, 4 mg filmsko obložene tablete
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.
V študiji farmakodinamičnih interakcij pri zdravih prostovoljcih so ugotovili, da so učinki perampanela na aktivnosti, za katere sta potrebni zbranost in budnost, denimo sposobnost vožnje bili aditivni ali supra-aditivni učinkom samega alkohola.
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)
2 mg tableta: železov oksid, rumeni (E172), železov oksid, rdeči (E172) 4 mg tableta: železov oksid, rdeči (E172) 6 mg tableta: železov oksid, rdeči (E172) 8 mg tableta: železov oksid, rdeči (E172), železov oksid, črni (E172) 10 mg tableta: železov oksid, rumeni (E172), indigotin (E132) 12 mg tableta: indigotin (E132)
Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. Use in patients with severe hepatic impairment is not recommended.
Odmerek perampanela naj pri bolnikih z blago do zmerno okvaro ne preseže 8 mg.
Valproic Acid No influence
19-odstotno zmanjšanje ni vpliva valprojska kislina ni vpliva
1.7 fold decrease
1,7-kratno zmanjšanje ni vpliva topiramat
Fycompa 0.5 mg/ml oral suspension
Fycompa 0,5 mg/ml peroralna suspenzija
7 Turn upright and remove the oral syringe.
Plastenko spet zasukajte navzgor in izvlecite brizgo za peroralno dajanje.
Each tablet contains 8 mg perampanel.
Ena tableta vsebuje 8 mg perampanela.
Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 2 mg tableta vsebuje 78,5 mg laktoze (v obliki monohidrata).
How to take Fycompa
Kako jemati zdravilo Fycompa
Insert adaptor into the neck of the bottle until a tight seal is made.
V vrat plastenke vstavite nastavek, ki plastenko neprepustno zatesni.
Each film-coated tablet contains 8 mg perampanel.
Ena filmsko obložena tableta vsebuje 8 mg perampanela.
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Pri uporabi perampanela so poročali o hudih kožnih reakcijah, vključno z reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - drug reaction with eosinophilia and systemic symptoms).
Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 8 mg tableta vsebuje 149,0 mg laktoze (v obliki monohidrata).
Each millilitre contains 0.5 mg of perampanel.
En mililiter vsebuje 0,5 mg perampanela.
Partial-Onset Seizures
Napadi parcialnega izvora
Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Fycompa 4 mg filmsko obložene tablete rdeča, okrogla, bikonveksna tableta z vtisom E277 na eni strani površini in "4" na drugi strani
Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Fycompa 2 mg filmsko obložene tablete oranžna, okrogla, bikonveksna tableta z vtisom E275 na eni strani in "2" na drugi strani
Each ml of oral suspension contains 0.5 mg perampanel
En mililiter peroralne suspenzije vsebuje 0,5 mg perampanela.
Treatment with Fycompa should be initiated at a dose of 2 mg/day (4 ml/day).
Zdravljenje z zdravilom Fycompa je treba začeti pri odmerku 2 mg/dan (4 ml/dan).
Systemic Symptoms (DRESS)*
Bolezni kože in podkožja reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)*
Levetiracetam No influence
Zonisamid ni vpliva ni vpliva
Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Fycompa 12 mg filmsko obložene tablete modra, okrogla, bikonveksna tableta z vtisom E297 na eni strani in "12" na drugi strani
Treatment with Fycompa should be initiated at a dose of 2 mg/day.
Zdravljenje z zdravilom Fycompa je treba začeti pri odmerku 2 mg/dan.
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Zdravljenje z zdravilom Fycompa je treba začeti z odmerkom 2 mg/dan (4 ml/dan).
Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Fycompa 10 mg filmsko obložene tablete zelena, okrogla, bikonveksna tableta z vtisom E296 na eni strani in "10" na drugi strani
The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Brizgo za peroralno dajanje vstavite v PIBA, zasukajte plastenko na glavo in izvlecite odmerek v brizgo.
1 press-in-bottle adapter (PIBA)
2 brizgi za peroralno dajanje 1 vtisljiv nastavek (PIBA)
Each tablet contains 12 mg perampanel.
Ena tableta vsebuje 12 mg perampanela.
Fycompa 8 mg film-coated tablets
Fycompa 8 mg filmsko obložene tablete
Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Fycompa 6 mg filmsko obložene tablete rožnata, okrogla, bikonveksna tableta z vtisom E294 na eni strani in "6" na drugi strani
Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 6 mg tableta vsebuje 151,0 mg laktoze (v obliki monohidrata).
Each tablet contains 10 mg perampanel.
Ena tableta vsebuje 10 mg perampanela.
Each tablet contains 4 mg perampanel.
Ena tableta vsebuje 4 mg perampanela.
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).
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) (glejte poglavje 4.4).
Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Zdravljenje z zdravilom Fycompa je treba začeti z odmerkom 2 mg/dan.
Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Fycompa 8 mg filmsko obložene tablete 8 mg - pakiranje po 7, 28, 84 in 98
- These partial seizures may or may not then be followed by a fit affecting all of your brain
- Tem delnim napadom lahko sledi napad, ki prizadene cele možgane (imenovan „sekundarna generalizacija“).
Each tablet contains 6 mg perampanel.
Ena tableta vsebuje 6 mg perampanela.
Each tablet contains 2 mg perampanel.
Ena tableta vsebuje 2 mg perampanela.
Each film-coated tablet contains 10 mg perampanel.
Ena filmsko obložena tableta vsebuje 10 mg perampanela.
Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 10 mg tableta vsebuje 147,0 mg laktoze (v obliki monohidrata).
Each film-coated tablet contains 12 mg perampanel.
Ena filmsko obložena tableta vsebuje 12 mg perampanela.
Each film-coated tablet contains 4 mg perampanel.
Ena filmsko obložena tableta vsebuje 4 mg perampanela.
What Fycompa contains
Kaj vsebuje zdravilo Fycompa
Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Fycompa 8 mg filmsko obložene tablete vijolična, okrogla, bikonveksna tableta z vtisom E295 na eni strani in "8" na drugi strani
The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Odmerek se lahko zvečuje na podlagi kliničnega odziva in prenašanja postopoma po 2 mg (4 ml) (bodisi vsak teden bodisi vsaka 2 tedna ob upoštevanju razpolovnega časa, kot je opisano spodaj) do vzdrževalnega odmerka 4 mg/dan (8 ml/dan) do 8 mg/dan (16 ml/dan).
Fycompa 8 mg film-coated tablets Perampanel
Fycompa 8 mg filmsko obložene tablete perampanel
Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 12 mg tableta vsebuje 145,0 mg laktoze (v obliki monohidrata).
Sorbitol (E420) liquid (crystallising)
6.1 Seznam pomožnih snovi sorbitol (E420) tekoči (kristalizirajoči) mikrokristalna celuloza (E460) natrijev karmelozat (E466) poloksamer 188
8 Leave the adaptor in place and replace cap on bottle.
Nastavek pustite v plastenki in jo zaprite z zaporko.
Each film-coated tablet contains 2 mg perampanel.
Ena filmsko obložena tableta vsebuje 2 mg perampanela.
Each film-coated tablet contains 6 mg perampanel.
Ena filmsko obložena tableta vsebuje 6 mg perampanela.
Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Pomožna snov z znanim učinkom: ena 4 mg tableta vsebuje 157,0 mg laktoze (v obliki monohidrata).
AED coadministered
Sočasna uporaba AEZ
Fycompa 10 mg film-coated tablets
Fycompa 10 mg filmsko obložene tablete
Fycompa 4 mg film-coated tablets 4 mg - packs of 7, 28, 84 and 98
Fycompa 4 mg filmsko obložene tablete 4 mg - pakiranje po 7, 28, 84 in 98
Fycompa 12 mg film-coated tablets 12 mg - packs of 7, 28, 84 and 98
Fycompa 12 mg filmsko obložene tablete 12 mg - pakiranje po 7, 28, 84 in 98
Fycompa 10 mg film-coated tablets 10 mg - packs of 7, 28, 84 and 98
Fycompa 10 mg filmsko obložene tablete 10 mg - pakiranje po 7, 28, 84 in 98
Fycompa 12 mg film-coated tablets
Fycompa 12 mg filmsko obložene tablete
Fycompa 10 mg film-coated tablets Perampanel
Fycompa 10 mg filmsko obložene tablete perampanel