natgillin/translations-raw huggingface dataset:
However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Vendar pa je mogoče zaradi dolgega razpolovnega časa, ki mu sledi počasen upad koncentracij v plazmi, z uporabo perampanela po potrebi prenehati naglo.
Contains lactose: see leaflet for further information.
Vsebuje laktozo: glejte navodilo za uporabo za več informacij.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih padec
Patients were titrated over four weeks to a target dose of 8 mg per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level achieved at the end of the titration period.
Bolniki so bili v obdobju štirih tednov titrirani do ciljnega odmerka 8 mg/dan oziroma do najvišjega tolerančnega odmerka in nato še dodatnih 13 tednov zdravljeni z zadnjo ravnijo odmerka, doseženo ob zaključku obdobja titracije.
A dose adjustment in the elderly is not considered to be necessary (see section 4.2).
Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 4.2).
Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Enkratni in večkratni odmerki 8 mg in 12 mg so okvarili psihomotorično sposobnost pri zdravih prostovoljcih na način, odvisen od odmerka.
- Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or sadness worse.
- Zaradi uživanja alkohola med jemanjem zdravila Fycompa se lahko občutki jeze, zmedenosti ali žalosti poslabšajo.
When dosed in combination with the strong CYP3A inducer carbamazepine, the average t½was 25 hours.
Pri dajanju v kombinaciji z močnim induktorjem CYP3A, karbamazepinom, je bil povprečni t1/2 25 ur.
Subjects experiencing intolerable adverse events could remain on the same dose or have their dose decreased to the previously tolerated dose.
Osebe, ki so doživele neželene učinke, ki jih niso mogle prenašati, so lahko ohranile enak odmerek ali se je odmerek znižal na odmerek, ki so ga prenašale.
Fycompa is not recommended for children aged under 12.
Uporaba zdravila Fycompa se ne priporoča pri otrocih, starih manj kot 12 let.
Adverse reactions leading to discontinuation:
Neželeni učinki, ki so povzročili prekinitev jemanja:
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Pomembno je opozoriti, da so lahko prisotni zgodnji znaki preobčutljivosti, kot je zvišana telesna temperatura ali limfadenopatija, čeprav izpuščaj ni očiten.
Take Fycompa for as long as your doctor recommends.
Zdravilo Fycompa jemljite tako dolgo, kot vam priporoča vaš zdravnik.
The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%.
Združene 50-odstotne stopnje odziva so bile za placebo 19 %, za 4 mg 29 %, za 8 mg 35 % in za 12 mg 35 %.
Benefit at the dose of 12 mg was observed in some patients who tolerate the dose of 8 mg and when the clinical response to that dose was insufficient.
Koristi pri odmerku 12 mg so opazili pri nekaterih bolnikih, ki so odmerek 8 mg prenašali, klinični odziv na ta odmerek pa ni zadoščal.
Following administration of a radiolabeled perampanel dose to either 8 healthy adults or elderly subjects, approximately 30% of recovered radioactivity was found in the urine and 70% in the faeces.
Po dajanju odmerka radioaktivno označenega perampanela 8 zdravim bodisi odraslim ali starejšim prostovoljcem je bilo približno 30 % rekuperirane radioaktivnosti najti v urinu in 70 % v blatu.
Alertness and mood
Zbranost in razpoloženje
In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses.
V kliničnih preskušanjih so za bolnike, zdravljene s perampanelom, pogosteje poročali o agresiji, jezi in razdražljivosti pri večjih odmerkih.
Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Za vsako pogostnost so neželeni učinki navedeni po padajoči resnosti.
These medicines are used to treat epilepsy - where someone has repeated fits (seizures).
Ta zdravila se uporabljajo za zdravljenje epilepsije, stanja, pri katerem se ponavljajo napadi (epileptični napadi).
Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.
Zaradi nizkega ledvičnega očistka ni verjetno, da bi posebni ukrepi, denimo prisilna diureza, dializa ali hemoperfuzija pomagali.
The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Dajanje največjih tolerančnih odmerkov podganam in opicam je povzročilo farmakološke klinične znake na OŽS in zmanjšano končno telesno maso.
Instructions on how to use the oral syringe and adaptor are provided below:
Navodila o načinu uporabe brizge za peroralno dajanje in nastavka so spodaj:
Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats at maternally toxic doses (see section 5.3).
Študije na živalih niso pokazale teratogenih učinkov pri podganah ali kuncih, vendar so embriotoksičnost opazili pri podganah pri odmerkih, toksičnih za mater (glejte poglavje 5.3).
In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
V populacijski farmakokinetični analizi podatkov, združenih iz 19 študij 1. faze, je bil povprečni t1/2 za perampanel 105 ur.
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
- Zaradi zdravila Fycompa ste lahko omotični ali zaspani, zlasti na začetku zdravljenja.
Ten (10) patients were followed up for at least 18 months and, of these, 3 patients (30%) remained on perampanel monotherapy for at least 18 months.
Deset (10) bolnikov so spremljali vsaj 18 mesecev in od njih so 3 bolniki (30 %) ostali na monoterapiji s perampanelom vsaj 18 mesecev.
Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details see section 5.3).
Študije pri podganah v laktaciji so pokazale izločanje perampanela in/ali njegovih presnovkov v materino mleko (za podrobnosti glejte poglavje 5.3).
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Bolnike (in negovalce bolnikov) je treba opozoriti, da poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnih misli ali vedenja.
Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na etiketi plastenke in škatli.
Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Priprava: vtisljiv nastavek za plastenko (PIBA), ki je priložen kartonski škatli z zdravilom, pred uporabo čvrsto vstavite v vrat plastenke, kjer naj ostane, dokler boste plastenko uporabljali.
At doses of 12 mg/day Fycompa may decrease the effectiveness of progestative-containing hormonal contraceptives; in this circumstance additional non-hormonal forms of contraception are recommended when using Fycompa (see section 4.5).
Pri odmerkih 12 mg/dan lahko zdravilo Fycompa zmanjša učinkovitost hormonskih kontraceptivov, ki vsebujejo progestagen; v tem primeru se pri uporabi zdravila Fycompa priporočajo dodatne oblike nehormonske kontracepcije (glejte poglavje 4.5).
Open label extension study
Odprta podaljšana študija
Use in patients with moderate or severe renal impairment or patients undergoing haemodialysis is not recommended.
Uporaba pri bolnikih z zmerno ali hudo okvaro ledvic ali pri bolnikih na hemodializi se ne priporoča.
Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations and the potential for higher plasma concentrations of reactive metabolites in their presence has not been excluded.
Pričakuje se, da bodo močni induktorji citokroma P450, kot sta rifampicin in šentjanževka, zmanjšala koncentracije perampanela in možnost višjih plazemskih koncentracij reaktivnih presnovkov v njihovi prisotnosti ni bila izključena.
In in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that perampanel is a noncompetitive AMPA receptor antagonist.
V študijah in vitro perampanel ni tekmoval z AMPA za vezavo na receptorje AMPA, je pa vezavo perampanela izpodrinil nekompetitivni antagonist receptorja AMPA, kar nakazuje na to, da je perampanel nekompetitiven antagonist receptorja AMPA.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
V času predpisovanja je treba bolnike opozoriti na znake in simptome kožnih reakcij ter jih skrbno spremljati glede njihovega pojava.
Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Plastenko obrnite navzdol in izvlecite predpisano količino zdravila Fycompa iz plastenke.
It is not known whether perampanel is excreted in human milk.
Ni znano, ali se perampanel izloča v materino mleko.
In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 subjects have received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.
V vseh kontroliranih in nekontroliranih preskušanjih pri bolnikih z napadi parcialnega izvora je 1.639 oseb prejelo perampanel; 1.147 med njimi je bilo zdravljenih 6 mesecev in 703 dlje kot 12 mesecev.
The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Prehajanje skozi placento je bilo relativno nizko; v plodu so odkrili 0,09 % danega odmerka ali manj.
Taking Fycompa with certain other medicines may cause side effects or affect how they work.
Jemanje zdravila Fycompa z nekaterimi drugimi zdravili lahko povzroči neželene učinke ali vpliva na način njihovega delovanja.
In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
V retrospektivni študiji klinične prakse je 51 bolnikov z epilepsijo, ki so prejemali perampanel kot adjuvantno zdravilo, prešlo na monoterapijo s perampanelom.
Dose increases in patients with mild and moderate hepatic impairment should be based on clinical response and tolerability.
Povečevanje odmerkov pri bolnikih z blago in zmerno okvaro jeter mora temeljiti na kliničnem odzivu in prenašanju.
These data were consistent with those for percent change in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time from about week 26 through the end of year 2.
Ti podatki so bili konsistentni s tistimi o odstotni spremembi pogostnosti napadov in so pokazali, da je bila 50 % stopnja odziva pri primarnih generaliziranih napadih s tonično-kloničnimi krči na splošno stabilna ves čas od približno 26. tedna do konca 2. leta.
Fycompa contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Zdravilo Fycompa vsebuje laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Ninety-seven percent of the patients who completed the randomised trials in patients with partial-onset seizures were enrolled in the open label extension study (n = 1186).
Sedemindevetdeset odstotkov bolnikov, ki so končali randomizirano preskušanje pri bolnikih z napadi parcialnega izvora, je bilo vključenih v podaljšek odprte študije (n = 1.186).
Open label extension phase
Odprta podaljšana faza
Interactions between Fycompa and other anti-epileptic medicinal products
Medsebojno delovanje zdravila Fycompa in drugih antiepileptičnih zdravil:
In both analyses, perampanel exposure is correlated with reduction in seizure frequency.
Pri obeh analizah je izpostavljenost perampanelu sovpadala z zmanjšanjem pogostnosti epileptičnih napadov.
The usual starting dose is 2 mg once a day before you go to bed.
Običajni začetni odmerek je 2 mg enkrat na dan pred spanjem.
Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy in people aged 12 years and older.
Zdravilo Fycompa se v povezavi z drugimi zdravili za epilepsijo uporablja za zdravljenje nekaterih oblik epilepsije pri osebah, starih 12 let ali več.
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Če je bolnik prekinil uporabo perampanela za neprekinjeno obdobje, daljše kot 5 razpolovnih časov, se priporoča upoštevanje uporabe zgoraj navedenega začetnega odmerka.
The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are breast-feeding.
Zdravnik bo ocenil razmerje tveganja in koristi za vašega otroka, če jemljete zdravilo Fycompa med dojenjem.
Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months.
Štiriintrideset (34) bolnikov so spremljali vsaj 6 mesecev dolgo, od njih je 24 bolnikov (71 %) ostalo na monoterapiji s perampanelom vsaj 6 mesecev.
Caution should be exercised when combining Fycompa oral suspension with other antiepileptic medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect absorption of some drugs.
Pri kombiniranju peroralne suspenzije zdravila Fycompa z drugimi antiepileptičnimi zdravili, ki vsebujejo sorbitol, je potrebna previdnost, ker skupen vnos več kot 1 grama sorbitola lahko vpliva na absorpcijo nekaterih zdravil.
In healthy subjects, the CYP3A4 inhibitor ketoconazole (400 mg once daily for 10 days) increased perampanel AUC by 20% and prolonged perampanel half--life by 15% (67.8 h vs 58.4 h).
Pri zdravih prostovoljcih je zaviralec CYP3A4 ketokonazol (400 mg enkrat na dan za 10 dni) povečal AUC perampanela za 20 % in podaljšal razpolovni čas perampanela za 15 % (67,8 ure v primerjavi z 58,4 ure).
In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
V populacijski farmakokinetični analizi bolnikov z epilepsijo je perampanel zmanjšal očistek okskarbazepina za 26 %.
The European Medicines Agency has deferred the obligation to submit the results of studies with Fycompa in one or more subsets of the paediatric population in treatment-resistant epilepsies (localisation-related and age-related epilepsy syndromes) (see section 4.2 for information on adolescent use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Fycompa za eno ali več podskupin pediatrične populacije pri epilepsiji, odporni na zdravljenje (epileptični sindromi, odvisni od lokacije in starosti) (za podatke o uporabi pri mladostnikih glejte poglavje 4.2).
Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each bottle contains 340 ml of suspension in an outer cardboard carton.
Plastenka iz polietilen tereftalata (PET) z za otroke varno polipropilensko (PP) zaporko; ena plastenka vsebuje 340 ml suspenzije v zunanji kartonski škatli.
The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe.
Če se pojavijo taki simptomi, je treba odmerek perampanela zmanjšati ali ga takoj ukiniti, če so simptomi resni.
During a 6-week baseline period, subjects were required to have more than five seizures with no seizure-free period exceeding 25 days.
V 6-tedenskem obdobju od izhodišča je bil pogoj več kot pet napadov brez obdobja, v katerem dlje kot 25 dni ni bilo napadov.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures.
Priporoča se postopno zmanjševanje za zmanjšanje možnosti povratnih epileptičnih napadov.
In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and UGT1A9 among major hepatic CYPs and UGTs.
V človeških jetrnih mikrosomih je imel perampanel (30 µmol/l) šibek zaviralni učinek na CYP2C8 in UGT1A9 med pomembnejšimi jetrnimi encimi CYP in UGT.
Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects.
Karbamazepin, znani močan induktor encimov, je v študiji, opravljeni pri zdravih prostovoljcih, zmanjšal ravni perampanela za dve tretjini.
In the Extension Phase, 73.7% of subjects have a modal daily perampanel dose of greater than 4 to 8 mg/day and 16.7% had a modal daily dose of greater than 8 to 12 mg/day.
V fazi podaljšanja je 73,7 % oseb imelo modalni dnevni odmerek perampanela med 4 in 8 mg/dan, 16,7 % oseb pa je imelo modalni dnevni odmerek med 8 in 12 mg/dan.
The effect of perampanel on monohydroxycarbazepine concentrations is not known.
Učinek perampanela na koncentracije monohidroksikarbazepina ni znan.
Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - občutek omotičnosti - občutek zaspanosti (dremavost ali zaspanost)
What Fycompa is and what it is used for
Kaj je zdravilo Fycompa in za kaj ga uporabljamo
Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary.
Zdravila Fycompa ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen če je nujno potrebno.
Nervous system disorders
Bolezni živčnega sistema
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients taking perampanel metabolism-inducing AEDs (see section 4.5)), consideration should be given to re-start treatment from the last dose level.
Če bolnik izpusti več kot 1 odmerek v neprekinjenem obdobju, krajšem kot 5 razpolovnih časov (3 tedne za bolnike, ki ne jemljejo antiepileptičnih zdravil (AEZ), ki inducirajo presnovo perampanela, 1 teden za bolnike, ki jemljejo AEZ, ki inducirajo presnovo perampanela (glejte poglavje 4.5)), je treba razmisliti o ponovnem začetku zdravljenja z ravnijo zadnjega odmerka.
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see section 4.7).
Perampanel lahko povzroči omotico in zaspanost, zato lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.7).
Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo.
V dveh študijah (študiji 304 in 305) so primerjali odmerke perampanela 8 in 12 mg/dan s placebom in v tretji študiji (študija 306) so primerjali odmerke perampanela 2, 4 in 8 mg/dan s placebom.
There is no available specific antidote to the effects of perampanel.
Za učinke perampanela ni specifičnega antidota.
In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required.
Rezultati v kombinaciji z razliko izpostavljenosti perampanelu, nepovezani s starostjo, kažejo, da odmerka pri starejših bolnikih ni treba prilagajati.
Do not stop unless your doctor advises you to.
Ne prenehajte jemati zdravila, če vam tako ne svetuje vaš zdravnik.
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial-onset seizures and primary generalised tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Na podlagi podatkovne zbirke kliničnih preskušanj s 196 mladostniki, ki so bili izpostavljeni perampanelu v dvojno slepih študijah zaradi napadov s parcialnim izvorom in primarnih generaliziranih tonično-kloničnih napadov, je bil celotni varnostni profil pri mladostnikih podoben kot pri odraslih, razen agresivnosti, ki so jo pogosteje ugotavljali pri mladostnikih kot pri odraslih.
During the Titration Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 2 mg/day to the target dose.
V fazi titriranja se je zdravljenje v vseh treh preskušanjih začelo z odmerkom 2 mg/dan, nato pa se je odmerek vsak teden povečal za 2 mg/dan do ciljnega odmerka.
Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly.
Bolnike je treba pri dodajanju ali odstranjevanju spodbujevalcev ali zaviralcev citokroma P450 skrbno spremljati za prenašanje in klinični odziv, saj se lahko ravni perampanela v plazmi zmanjšajo ali povečajo; odmerek perampanela bo morda treba ustrezno prilagoditi.
In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast Cancer Resistance Protein (BCRP).
Študije in vitro kažejo, da perampanel ni substrat ali pomemben zaviralec organskih anionskih transportnih polipeptidov (OATP) 1B1 in 1B3, organskih anionskih transporterjev (OAT) 1, 2, 3 in 4, organskih kationskih transporterjev (OCT) 1, 2 in 3 in efluksnih transporterjev P-glikoproteina in proteina dovzetnosti za raka dojke (BCRP - Breast Cancer Resistance Protein).
No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).
Po 104 tednih zdravljenja niso opazili nikakršnih učinkov telesno maso, telesno višino in spolni razvoj (n = 114).
Fycompa has moderate influence on the ability to drive and use machines.
Zdravilo Fycompa ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
Majhno število oseb, ki se zdravilo z antiepileptiki, je imelo misli o samopoškodovanju ali samomoru.
However, population pharmacokinetic analysis demonstrated that under simulated steady state exposure conditions, Cmax and AUC, of perampanel oral suspension were bioequivalent to the tablet formulation under both fasted and fed conditions.
Vendar pa je populacijska farmakokinetična analiza pokazala, da sta bili v razmerah simuliranega stanja ravnovesja Cmax in AUC peroralne suspenzije perampanela biološko enakovredni zdravilu v obliki tablet tako na tešče kot po zaužitju hrane.
Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4).
Perampanel je treba pri starejših uporabljati previdno in upoštevati možne interakcije zdravila pri bolnikih, ki prejemajo več zdravil (glejte poglavje 4.4).
- If you have mild or moderate liver problems, your dose should not be more than 8 mg each day and your dose increases should be at least 2 weeks apart.
- Če imate blage do zmerne težave z jetri, ne uporabite več kot 8 mg na dan, med povečanji odmerkov pa morata preteči vsaj 2 tedna.
The usual starting dose is 2 mg (4 ml) once a day before you go to bed.
Običajni začetni odmerek je 2 mg (4 ml) enkrat na dan pred spanjem.
You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa.
Pri jemanju zdravila Fycompa uporabljajte druge oblike varne in učinkovite kontracepcije (npr. kondom ali maternični vložek).