FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur.
Slovenian: Raven natrija je treba preveriti tudi, če se pojavijo klinični znaki hiponatriemije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of multipacks (without blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Vmesna škatla pri skupnem pakiranju (brez "blue box" podatkov)
English: The percentage of subjects with ≥50% reduction (1581 analyzed) in seizure frequency in the phase III studies was 19.3% for placebo, 20.8% for eslicarbazepine acetate 400 mg, 30.5% for eslicarbazepine acetate 800 mg and 35.3% for eslicarbazepine acetate 1,200 mg daily.
Slovenian: Odstotek bolnikov, pri katerih je prišlo do ≥ 50-odstotnega zmanjšanja (1.581 analiziranih) pogostnosti epileptičnih napadov v študijah III. faze, je 19,3 % za placebo, 20,8 % za eslikarbazepinacetat 400 mg, 30,5 % za eslikarbazepinacetat 800 mg in 35,3 % za eslikarbazepinacetat 1.200 mg na dan.
English: HLA-A*3101 allele- European descent and Japanese populations
Slovenian: Alel HLA-A*3101- pri populacijah evropskega porekla in populacijah japonske narodnosti
English: • Allergy;
Slovenian: • alergija,
English: Evidence of nephrotoxicity was observed in repeated dose-toxicity studies in the rat, but was not seen in studies in mice or dogs, and is consistent with an exacerbation of spontaneous chronic progressive nephropathy in this species.
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah so opazili znake nefrotoksičnosti, vendar jih v študijah pri miših in psih niso opazili, kar je skladno s poslabšanjem spontane kronične progresivne nefropatije pri tej živalski vrsti.
English: Of the 183 patients who completed parts I and II of the study, 152 patients were enrolled into part III.
Slovenian: Od 183 bolnikov, ki so dokončali I. in II.
English: Zebinix has been given to you by your doctor to reduce your number of seizures.
Slovenian: Zdravilo Zebinix vam je zdravnik predpisal za zmanjševanje števila epileptičnih napadov.
English: • Slower or irregular heart beat;
Slovenian: • počasnejši ali nereden srčni utrip,
English: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
Slovenian: • monoterapija pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih z na novo diagnosticirano epilepsijo,
English: Other medicines and Zebinix
Slovenian: Druga zdravila in zdravilo Zebinix
English: In studies with eslicarbazepine in fresh human hepatocytes a mild induction of UGT1A1 mediated glucuronidation was observed.
Slovenian: V študijah z eslikarbazepinom na svežih hepatocitih človeka so opazili blago indukcijo glukuronidacije, pri kateri sodeluje UGT1A1.
English: If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated.
Slovenian: Če se pojavijo znaki ali simptomi preobčutljivosti, je treba zdravljenje z eslikarbazepinacetatom takoj prekiniti in uvesti drugačno zdravljenje.
English: The mechanism by which bone metabolism is affected has not been identified.
Slovenian: Mehanizem vpliva na presnovo kosti še ni opredeljen.
English: Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, druge derivate karboksamida (npr. karbamazepin, okskarbazepin) ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The bottle can be closed with the closure with the bottle adapter still in place.
Slovenian: Steklenico lahko z zaporko zaprete tudi s prilagodilnikom v njej.
English: Liver centrilobular hypertrophy was seen in repeated-dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov pri miših in podganah so opazili centrilobularno hipertrofijo jeter, v študijah kancerogenosti pri miših pa so opazili zvečano pogostnost jetrnih tumorjev; te ugotovitve so skladne z indukcijo mikrosomskih encimov v jetrih, kar je učinek, ki ga pri bolnikih, ki so prejemali eslikarbazepinacetat, niso opazili.
English: However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage-gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing.
Slovenian: Vendar elektrofiziološke študije in vitro kažejo, da eslikarbazepinacetat in njegovi presnovki stabilizirajo neaktivirano stanje natrijevih napetostnih kanalčkov, pri čemer preprečujejo, da bi se vrnili v aktivirano stanje in posledično preprečujejo ponavljajoče se sprožanje nevronov.
English: Each cardboard box contains a 10 ml polypropylene graduated syringe with 0.2 ml graduations, and a copolymer push-in bottle adapter.
Slovenian: Vsaka škatla vsebuje 10 ml polipropilensko graduirano injekcijsko brizgo z graduacijami po 0,2 ml in kopolimerski nastavek za steklenico.
English: Long-term safety data in the paediatric population obtained from open label extensions of the phase III study was consistent with the known safety profile of the product with no new findings of concern.
Slovenian: Podatki o dolgoročni varnosti pri pediatrični populaciji, pridobljeni v nezaslepljenih podaljšanih obdobjih študije III. faze, so bili skladni z znanim varnostnim profilom zdravila.
English: Contents of the pack and other information What Zebinix contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zebinix
English: The other ingredients are xanthan gum (E415), macrogol-100 stearate, methyl parahydroxybenzoate (E218), saccharin sodium (E954), flavour tutti-frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water.
Slovenian: • Druge sestavine so ksantanski gumi (E415), makrogol-100 stearat, metilparahidroksibenzoat (E218), natrijev saharinat (E954), umetna aroma tutti frutti (vsebuje maltodekstrin, propilenglikol, naravne in umetne arome in arabski gumi (E414), prekrivni okus (vsebuje propilenglikol, vodo in naravne ter umetne arome) in prečiščena voda.
English: To ease the process you should mark the desired volume in the syringe by moving the plunger.
Slovenian: 4. korak: Za poenostavitev postopka označite želeno količino v brizgi s premikom bata.
English: Based on individual response, the dose of eslicarbazepine acetate may need to be increased and the dose of phenytoin may need to be decreased.
Slovenian: Glede na odziv posameznika bo morda treba odmerek eslikarbazepinacetata povečati in odmerek fenitoina zmanjšati.
English: 90 tablets.
Slovenian: 90 tablet.
English: Once inserted, the bottle adapter must not be removed from the bottle.
Slovenian: Vstavljenega prilagodilnika ne smete odstraniti iz steklenice.
English: Based on individual response, the dose may be increased to 1,200 mg once daily Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).
Slovenian: Glede na odziv posameznika se odmerek lahko zveča do 1.200 mg enkrat na dan. Nekateri bolniki na monoterapiji kot režimu zdravljenja imajo lahko večjo korist pri odmerku 1.600 mg enkrat na dan (glejte poglavje 5.1).
English: • Dehydration;
Slovenian: • dehidracija,
English: Always use the oral syringe provided to take your medicine.
Slovenian: Za jemanje zdravila vedno uporabite priloženo odmerno brizgo.
English: Caution should be exercised in the treatment of patients, adult and children above 6 years of age, with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows: - CLCR >60 ml/min: no dose adjustment required.
Slovenian: Pri zdravljenju bolnikov, odraslih in otrok, starih več kot 6 let, z ledvično okvaro je potrebna previdnost, odmerek pa je treba prilagoditi glede na kreatininski očistek (CLCR) na naslednji način: - CLCR > 60 ml/min: prilagajanje odmerka ni potrebno;
English: • Abnormal sense of touch;
Slovenian: • pekoč občutek, • nenormalen občutek za dotik,
English: The safety of Zebinix in children aged 6 years and below has not yet been established.
Slovenian: Varnost zdravila Zebinix pri otrocih, starih 6 let ali manj, ni bila ugotovljena.
English: • Hair loss;
Slovenian: • izguba las,
English: There was no effect on the Rwarfarin pharmacokinetics or on coagulation.
Slovenian: Učinka na farmakokinetiko R-varfarina ali na koagulacijo ni bilo.
English: What you need to know before you take Zebinix Do not take Zebinix:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zebinix Ne jemljite zdravila Zebinix:
English: • Feeling extremely sleepy;
Slovenian: • izjemna zaspanost,
English: If you are taking Zebinix on its own your doctor may consider you can benefit of a dose of 1,600 mg once daily.
Slovenian: Če zdravilo Zebinix jemljete samostojno, bo zdravnik morda presodil, da bo korist večja pri odmerku 1.600 mg enkrat na dan.
English: (increase of ≥25%) compared to Baseline Parts III-V was 25.7%.
Slovenian: ≥ 25 %) v primerjavi z izhodiščno vrednostjo delov III do V je bil 25,7 %.
English: Amongst these, when excluding patients aged 6 years and younger, 14 (48.3%) and 11 (30.6%) of patients in the eslicarbazepine acetate and placebo group, respectively, were responders (p=0.1514).
Slovenian: Med njimi je bilo po izključitvi bolnikov, starih 6 let ali manj, odzivnih 14 (48,3 %) in 11 (30,6 %) v skupini z eslikarbazepinacetatom oz. v skupini s placebom (p = 0,1514).
English: Eslicarbazepine acetate was tested at doses of 20 and 30 mg/kg/day, up to a maximum of 1,200 mg/day.
Slovenian: Eslikarbazepinacetat so testirali v odmerku 20 in 30 mg/kg/dan, do največ 1.200 mg/dan.
English: Ask your doctor or pharmacist.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom.
English: Zebinix is for oral use.
Slovenian: Zdravilo Zebinix je za peroralno uporabo.
English: • Urticaria (skin rash with itching).
Slovenian: • urtikarija (koprivnica; srbeč kožni izpuščaj).
English: Symptoms include tremors, pain, cramping;
Slovenian: Simptomi vključujejo tresenje, bolečine in krče,
English: • Mood changes or hallucinations;
Slovenian: • spremembe razpoloženja ali blodnje,
English: Seizure-free rates during the entire 10-week monotherapy period were 7.6% (1,600 mg) and 8.3 % (1,200 mg) in one study and 10.0% (1,600 mg) and 7.4 % (1,200 mg) in the other study, respectively.
Slovenian: Eslikarbazepinacetat so preskušali v odmerkih 1.200 mg in 1.600 mg z odmerjanjem enkrat na dan. Deleži preskušancev brez napadov v celotnem 10-tedenskem obdobju monoterapije so bili 7,6 % (1.600 mg) in 8,3 % (1.200 mg) v eni študiji ter 10,0 % (1.600 mg) in 7,4 % (1.200 mg) v drugi študiji.
English: There are no data on the effects of eslicarbazepine acetate on human fertility.
Slovenian: Podatkov o učinkih eslikarbazepinacetata na plodnost pri ljudeh ni.
English: Of these, 65 patients had received ESL and 87 patients had received placebo during the double-blind part of the study.
Slovenian: del študije, je bilo 152 bolnikov vključenih v III. del. Od teh je 65 bolnikov prejemalo eslikarbazepinacetat in 87 bolnikov placebo v dvojno slepem delu študije.
English: The maximum dose is 1,200 mg once daily.
Slovenian: Največji odmerek je 1.200 mg enkrat na dan.
English: Eslicarbazepine acetate was not teratogenic in the rat or rabbit, but did induce skeletal abnormalities in the mouse.
Slovenian: Eslikarbazepinacetat ni bil teratogen pri podganah ali kuncih, a je pri miših izzval nenormalnosti okostja.
English: The adverse reaction profile of eslicarbazepine acetate is generally similar across age goups.
Slovenian: Profil neželenih učinkov eslikarbazepinacetata je na splošno podoben v vseh starostnih skupinah.
English: • Blood tests showing that you have low levels of sodium in your blood;
Slovenian: • krvne preiskave, ki kažejo nizke ravni natrija v krvi,
English: In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions.
Slovenian: V kliničnih študijah (dodatno zdravljenje in monoterapija) so z eslikarbazepinacetatom zdravili 2.434 bolnikov s parcialnimi epileptičnimi napadi (1.983 odraslih bolnikov in 451 pediatričnih bolnikov), od katerih je 51 % imelo neželene učinke.
English: 400 mg once daily for one or two weeks, before increasing to the maintenance dose.
Slovenian: 400 mg enkrat na dan en ali dva tedna, nato se odmerek zveča na vzdrževalni odmerek.
English: Eslicarbazepine acetate adversely interacts with oral contraceptives.
Slovenian: Eslikarbazepinacetat ima neželeno medsebojno delovanje s peroralnimi kontraceptivi.
English: • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Slovenian: • dodatno zdravljenje pri odraslih, mladostnikih in otrocih, starih več kot 6 let, s parcialnimi epileptičnimi napadi s sekundarno generalizacijo ali brez nje.
English: HLA-B* 1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing the severe cutaneous reactions known as Stevens Johnson syndrome (SJS) when treated with carbamazepine.
Slovenian: Pokazalo se je, da je prisotnost HLA-B* 1502 pri posameznikih Han kitajske ali tajske narodnosti, ki prejemajo karbamazepin, tesno povezana s tveganjem za razvoj hudih kožnih reakcij, znanih kot Stevens-Johnsonov sindrom (SJS).
English: There are some data that suggest HLA-A*3101 is associated with an increased risk of carbamazepine induced cutaneous adverse drug reactions including SJS, TEN, Drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis (AGEP) and maculopapular rash in people of European descent and the Japanese.
Slovenian: Nekateri podatki nakazujejo, da je HLA-A*3101 povezan z večjim tveganjem kožnih neželenih učinkov, ki jih povzroči karbamazepin, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN), izpuščajem zaradi zdravila z eozinofilijo ali manj hudo akutno generalizirano eksantematozno pustulozo in makulopapularnim izpuščajem pri populacijah evropskega porekla in japonske narodnosti.
English: The total median standardised seizure frequency was 6.1 (decreasing from 7.0 (weeks 1-4) to 4.0 (weeks > 40), resulting in a median relative change compared to the baseline period of -46.7%).
Slovenian: Skupna mediana standardizirana pogostnost epileptičnih napadov je bila 6,1 (ki se je znižala s 7,0 (1.-4. teden) na 4,0 (> 40. teden), kar pomeni mediano relativno spremembo
English: Zebinix tablets may be taken with or without food.
Slovenian: Tablete Zebinix lahko jemljete s hrano ali brez nje.
English: • simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;
Slovenian: • simvastatin (zdravilo za zniževanje koncentracije holesterola v krvi), kajti morda bo treba prilagoditi odmerek;
English: What Zebinix is and what it is used for
Slovenian: Kaj je zdravilo Zebinix in za kaj ga uporabljamo
English: Population pharmacokinetics indicate that comparable eslicarbazepine exposure is observed between 20 and 30 mg/kg/day in children above 6 years old and adults with 800 and 1200 mg of eslicarbazepine acetate once-daily, respectively (see section 4.2).
Slovenian: Populacijska farmakokinetika kaže, da so primerljivo izpostavljenost eslikarbazepinu opazili pri odmerkih eslikarbazepinacetata med 20 in 30 mg/kg/dan pri otrocih, starih več kot 6 let, ter pri 800 mg in 1200 mg enkrat dnevno pri odraslih (glejte poglavje 4.2).
English: If you forget to take Zebinix
Slovenian: Če ste pozabili vzeti zdravilo Zebinix
English: The efficacy of eslicarbazepine acetate as adjunctive therapy has been demonstrated in four phase III double-blind placebo-controlled studies in 1,703 randomized adult patients with partial epilepsy refractory to treatment with one to three concomitant antiepileptic medicinal products.
Slovenian: Učinkovitost eslikarbazepinacetata kot dodatno zdravljenje so pokazali v štirih dvojno slepih, s placebom nadzorovanih študijah III. faze pri 1.703 randomiziranih odraslih bolnikih s parcialno epilepsijo, ki se odziva na zdravljenje z enim do tremi antiepileptiki.
English: 3 years.
Slovenian: 2 leti
English: In placebo-controlled studies involving patients aged from 2 to 18 years with partial-onset seizures (238 patients treated with eslicarbazepine acetate and 189 with placebo), 35.7% of patients treated with eslicarbazepine acetate and 19% of patients treated with placebo experienced adverse reactions.
Slovenian: V študijah, nadzorovanih s placebom, v katere so bili vključeni bolniki, stari od 2 do 18 let s parcialnimi napadi (238 bolnikov, zdravljenih z eslikarbazepinacetatom, in 189 s placebom), je 35,7 % bolnikov, zdravljenih z eslikarbazepinacetatom, in 19 % bolnikov, zdravljenih s placebom,
English: If you accidently take more Zebinix than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster.
Slovenian: Če po nesreči vzamete več zdravila Zebinix, kot bi smeli, se pri vas lahko poveča število epileptičnih napadov ali pa boste morda čutili, da je vaš srčni utrip nereden ali hitrejši.
English: 7 tablets 14 tablets 28 tablets
Slovenian: 7 tablet 14 tablet 28 tablet
English: Impairment of fertility was observed in female rats; decreases in implantations and live embryos seen in the mouse fertility study may also indicate effects on female fertility, however, corpora lutea counts were not evaluated.
Slovenian: Pri podganjih samicah so opazili vpliv na plodnost; zmanjšanje implantacij in živih embrijev so opazili v študiji plodnosti pri miših, kar lahko kaže tudi na učinek na plodnost pri ženskah, vendar števila rumenih telesc niso ocenjevali.
English: Study 208 included 2 additional subsequent long-term, open-label extensions (1 year in part II and 2 years in part III) and Study 305 included 4 subsequent long-term, open-label extension periods (1 year in Parts II, III and IV and 2 years in Part V).
Slovenian: delu in 2 leti v III. delu) in študija 305 je zajemala 4 poznejša dolgotrajna nezaslepljena podaljšana obdobja (1 leto v II., III. in IV. delu ter 2 leti v V. delu).
English: Two clusters of ADRs were identified in context of overdose cases - epilepsy/seizures/status epilepticus and cardiac events, mainly arrhythmias.
Slovenian: Na podlagi primerov prevelikega odmerjanja so ugotovili dve skupini neželenih učinkov zdravila, in sicer epilepsijo/epileptične napade/epileptični status in srčne dogodke, večinoma aritmije.
English: The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v s placebom kontroliranih študijah dodatnega zdravljenja pri odraslih bolnikih z epilepsijo in v z aktivnim zdravilom kontrolirani študiji monoterapije, kjer so primerjali eslikarbazepinacetat s karbamazepinom z nadzorovanim sproščanjem, so bili omotica, zaspanost, glavobol in navzea.
English: Take special care with Zebinix:
Slovenian: Pri zdravilu Zebinix bodite posebno previdni:
English: Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.
Slovenian: Uporaba eslikarbazepinacetata je povezana z nekaterimi neželenimi učinki v osrednjem živčevju, kot sta omotica in somnolenca, ki lahko povečajo pogostnost nezgodnih poškodb.
English: Zebinix is not recommended in patients with severe renal disease.
Slovenian: Zebinix ni priporočeno pri bolnikih s hudo ledvično boleznijo.
English: Therefore, women of childbearing potential must use adequate contraception during treatment with Zebinix, and up to the end of the current menstruation cycle after the treatment has been discontinued (see section 4.6).
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom Zebinix in do konca trenutnega menstrualnega cikla po prekinitvi zdravljenja uporabljati ustrezno kontracepcijo (glejte poglavje 4.6).
English: As a risk to the breast-fed child cannot be excluded breastfeeding should be discontinued during treatment with eslicarbazepine acetate.
Slovenian: Tveganja za dojenčka ni mogoče izključiti, zato je treba med zdravljenjem z eslikarbazepinacetatom dojenje prekiniti.
English: As clinical data are limited in patients with mild to moderate hepatic impairment and pharmacokinetic and clinical data are missing in patients with severe hepatic impairment, eslicarbazepine acetate should be used with caution in patients with mild to moderate hepatic impairment and is not recommended in patients with severe hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno jetrno okvaro je kliničnih podatkov malo, pri bolnikih s hudo jetrno okvaro pa farmakokinetičnih in kliničnih podatkov ni, zato je treba pri bolnikih z blago do zmerno jetrno okvaro eslikarbazepinacetat uporabljati previdno, pri bolnikih s hudo jetrno okvaro pa njegova uporaba ni priporočena.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for eslicarbazepine acetate, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za eslikarbazepinacetat je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: If clinically-relevant hyponatraemia develops, eslicarbazepine acetate should be discontinued.
Slovenian: Če se pojavi klinično pomembna hiponatriemija, je treba uporabo eslikarbazepinacetata prekiniti.
English: Blood pressure decreased, weight decreased, blood pressure increased, blood sodium decreased, blood chloride decreased, osteocalcin increased, haematocrit decreased, haemoglobin decreased, transaminases increased
Slovenian: Preiskave povečana telesna masa znižan krvni tlak, zmanjšana telesna masa, zvišan krvni tlak, znižan natrij v krvi, znižana raven kloridov v krvi, zvišana raven osteokalcina, znižan hematokrit, znižan hemoglobin, zvišane transaminaze
English: Glucuronidation is the major metabolic pathway for both eslicarbazepine and lamotrigine and therefore, an interaction could be expected.
Slovenian: Glavna presnovna pot eslikarbazepina in lamotrigina je glukuronidacija, zato bi lahko pričakovali interakcije.
English: In the age group from 6 to 11 years of age, the most common adverse reaction observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
Slovenian: V starostni skupini od 6 do 11 let so bili najpogostejši neželeni učinki, ki so jih opazili pri več kot dveh bolnikih, zdravljenih z eslikarbazepinacetatom, diplopija (9,5 %), somnolenca (7,4 %), omotičnost (6,3 %), konvulzija (6,3 %) in navzea (3,2 %); v starostni skupini od 12 do 18 let pa somnolenca (7,4 %), bruhanje (4,2 %), diplopija (3,2 %) in utrujenost (3,2 %).