FrancophonIA/ELRC3.0 huggingface dataset:
English: If at any time you have these thoughts, when taking Zebinix, contact your doctor immediately.
Slovenian: Če boste kadar koli med jemanjem zdravila Zebinix imeli takšne misli, takoj obvestite zdravnika.
English: If patients of these ethnic origins are tested positive for HLA- B*1502 allele, the use of eslicarbazepine acetate may be considered if the benefits are thought to exceed risks.
Slovenian: Če so testi pri bolnikih tega porekla pozitivni za alel HLA- B*1502, je mogoče o uporabi eslikarbazepinacetata razmisliti, če so pričakovane koristi večje od tveganj.
English: If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Zebinix should be carefully re-evaluated.
Slovenian: Če ženska, ki prejema eslikarbazepinacetat, zanosi ali če načrtuje zanositev, je treba uporabo zdravila Zebinix znova pozorno oceniti.
English: • Attention deficit/ hyperactivity disorder;
Slovenian: • motnje pomanjkanja pozornosti s hiperaktivnostjo,
English: The chemical structure of eslicarbazepine acetate is similar to that of carbamazepine, and it is possible that patients who are positive for HLA-B*1502 may also be at risk for SJS after treatment with eslicarbazepine acetate.
Slovenian: Kemična struktura eslikarbazepinacetata je podobna kot pri karbamazepinu, zato je možno, da obstaja pri bolnikih, pozitivnih na HLA-B*1502, tveganje za SJS tudi po zdravljenju z eslikarbazepinacetatom.
English: Based on this outcome, update of section 4.8 of the SmPC to add ‘weight increased' with the frequency common (calculation based on clinical trial data) is recommended.
Slovenian: Na podlagi tega se priporoča posodobitev poglavja 4.8 povzetka glavnih značilnosti zdravila, tako da se doda »povečana telesna masa« s pogostnostjo »pogosti« (izračun temelji na podatkih iz kliničnih preskušanj).
English: If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and contact your doctor or seek medical attention immediately.
Slovenian: Če se pri vas pojavijo hud izpuščaj ali drugi kožni simptomi (glejte poglavje 4), takoj nehajte jemati zdravilo Zebinix in se posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: During the reporting period, the MAH detected a signal of overdose.
Slovenian: V obdobju poročanja je imetnik dovoljenja za promet zaznal signal za preveliko odmerjanje.
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Slovenian: Tveganja, povezana z epilepsijo in antiepileptiki na splošno Raziskave so pokazale, da je pri potomcih žensk z epilepsijo razširjenost malformacij dve- do trikrat večja kot pri splošni populaciji, kjer je 3-odstotna.
English: PR interval
Slovenian: Interval PR
English: Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing eslicarbazepine acetate were warranted.
Slovenian: Na podlagi podatkov, predstavljenih v pregledanem PSUR, odbor PRAC meni, da so spremembe informacij o zdravilu za zdravila, ki vsebujejo eslikarbazepin, utemeljene.
English: • Crying, feeling depressed, nervous or confused, lack of interest or emotion;
Slovenian: • jok, potrtost, živčnost ali zmedenost, pomanjkanje zanimanja ali občutkov,
English: Zebinix is indicated as:
Slovenian: Zdravilo Zebinix je indicirano kot:
English: Should your doctor decide to stop your treatment with Zebinix your dose will usually be reduced gradually.
Slovenian: Če se zdravnik odloči, da morate prekiniti zdravljenje z zdravilom Zebinix, bo odmerek postopoma zmanjšal.
English: • tricyclic antidepressants e.g. amitriptyline;
Slovenian: • triciklične antidepresive, npr. amitriptilin;
English: Eslicarbazepine Cmax is attained at 2 to 3 hours post-dose (tmax).
Slovenian: Cmax eslikarbazepina nastopi 2 do 3 ure po odmerku (tmax).
English: Other form of this medicine, like oral suspension, maybe more suitable for children.
Slovenian: Morda so za otroke bolj primerne druge oblike tega zdravila, na primer peroralna suspenzija.
English: Be careful, do not push the plunger down when removing the oral syringe from the bottle.
Slovenian: Bodite previdni, da bata ne potisnete navzdol, ko odmerno brizgo odstranjujete iz steklenice.
English: Very common (may affect more than 1 in 10 people) side effects are: • Feeling dizzy or sleepy.
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov) so: • občutek omotice ali zaspanosti.
English: Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness.
Slovenian: Izsledki kliničnih študij pri bolnikih kažejo, da sočasno zdravljenje zveča tveganje za naslednje neželene učinke: diplopija, nenormalna koordinacija in omotica.
English: Palpitations, bradycardia
Slovenian: Srčne bolezni palpitacije, bradikardija
English: Uncommon (may affect up to 1 in 100 people) side effects are:
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri do 1 od 100 bolnikov) so:
English: Studies in animals have shown impairment of fertility after treatment with eslicarbazepine acetate (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na plodnost po zdravljenju z eslikarbazepinacetatom (glejte poglavje 5.3).
English: The information currently provided in section 4.9 of the SmPC is limited and does not reflect a potential cardiac risk of eslicarbazepine acetate overdose or the risk of seizure induction.
Slovenian: Informacije, ki so trenutno podane v poglavju 4.9 povzetka glavnih značilnosti zdravila, so omejene in ne odražajo možnega tveganja za srčne dogodke pri prevelikem odmerjanju eslikarbazepina ali tveganja za povzročitev epileptičnih napadov.
English: Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal.
Slovenian: Angioedem v kontekstu preobčutljivostne/anafilaktične reakcije, povezane z laringealnim edemom, je lahko smrten.
English: Off-white to white suspension.
Slovenian: peroralna suspenzija Belkasta do bela suspenzija.
English: • Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
Slovenian: • huda alergijska reakcija, ki povzroči otekanje obraza, grla, dlani, stopal, gležnjev ali spodnjega dela nog,
English: Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.
Slovenian: Zdravilo Zebinix peroralna suspenzija vsebuje metilparahidroksibenzoat (E218), ki lahko povzroči alergijske reakcije (možno tudi zakasnjene), in sulfite, ki lahko redko povzročijo preobčutljivostne reakcije in bronhospazem.
English: The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment (see sections 4.4 and 5.2) and use in these patients is, therefore, not recommended.
Slovenian: Pri bolnikih s hudo jetrno okvaro farmakokinetike eslikarbazepinacetata niso ocenili (glejte poglavji 4.4 in 5.2), zato uporaba pri teh bolnikih ni priporočljiva.
English: When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity.
Slovenian: Ob začetku ali prenehanju zdravljenja z zdravilom Zebinix, ali pri spreminjanju njegovega odmerka, lahko doseganje nove ravni encimske aktivnosti traja 2 do 3 tedne.
English: • Difficulty in speaking;
Slovenian: • težave pri govoru,
English: • Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;
Slovenian: • krvne preiskave, ki kažejo, da imate nizke ravni soli (vključno s kloridi) v krvi ali zmanjšano število eritrocitov,
English: Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Slovenian: Zdravilo Zebinix spada v skupino zdravil, imenovanih antiepileptiki, uporablja pa se za zdravljenje epilepsije, bolezni, pri kateri imajo bolniki ponavljajoče se epileptične napade.
English: At 1 year, the probability for subjects to withdraw due to either adverse reactions or lack of efficacy was 0.26 for eslicarbazepine acetate and 0.21 for carbamazepine controlled release.
Slovenian: Po enem letu je bila verjetnost, da preskušanec izstopi iz študije zaradi neželenih učinkov ali pomanjkanja učinkovitosti, 0,26 za eslikarbazepinacetat in 0,21 za karbamazepin z nadzorovanim sproščanjem.
English: Since the relationship between exposure and drug activity is unclear, the monitoring of response to therapy (e.g., cholesterol levels) is recommended.
Slovenian: Ker je povezava med izpostavljenostjo in delovanjem zdravila nejasna, se priporoca spremljanje odziva na zdravljenje (npr. kontrola koncentracije holesterola v krvi).
English: Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate.
Slovenian: Neželeni učinki so bili navadno blagi do zmerni, pojavljali pa so se predvsem v prvih tednih zdravljenja z eslikarbazepinacetatom.
English: • do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known whether it is safe to take these medicines together.
Slovenian: • ne jemljite okskarbazepina (zdravila za zdravljenje epilepsije) skupaj z zdravilom Zebinix, saj ni znano, ali je sočasno jemanje teh dveh zdravil varno.
English: • Seeing double or blurred vision;
Slovenian: • dvojni ali zamegljen vid,
English: On the basis of the scientific conclusions for eslicarbazepine acetate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing eslicarbazepine acetate is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za eslikarbazepinacetat skupina CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) eslikarbazepinacetat, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Adverse reactions observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of eslicarbazepine acetate).
Slovenian: Neželeni učinki, ki so jih opazili v študijah pri živalih, so se pojavili pri ravneh izpostavljenosti, ki so bile znatno nižje kot klinične ravni izpostavljenosti eslikarbazepinu (glavnemu in farmakološko aktivnemu presnovku eslikarbazepinacetata).
English: Therefore, their occurrence after treatment with eslicarbazepine acetate cannot be excluded.
Slovenian: Zato njihovega pojava po zdravljenju z zdravilom eslikarbazepinacetatom ni mogoče izključiti.
English: • Eye movement changes, fuzzy vision or red eye;
Slovenian: • spremembe premikanja oči, zamegljen vid ali rdeče oči,
English: Interactions with other antiepileptic medicinal products
Slovenian: Interakcije z drugimi antiepileptiki
English: If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate).
Slovenian: Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravilo Zebinix takoj ukiniti in razmisliti o drugačnem zdravljenju (skladno s potrebami).
English: Population pharmacokinetics indicate that in the subgroup of children aged from 2 to 6 years, doses of 27.5 mg/kg/day and 40 mg/kg/day are required in order to achieve exposures that are equivalent to the therapeutic doses of 20 and 30 mg/kg/day in children above 6 years of age.
Slovenian: Populacijska farmakokinetika kaže, da so v podskupini otrok, starih od 2 do 6 let, potrebni odmerki 27,5 mg/kg/dan in 40 mg/kg/dan, da se dosežejo izpostavljenosti, enakovredne terapevtskim odmerkom 20 in 30 mg/kg/dan pri otrocih, starih več kot 6 let.
English: Second or third degree atrioventricular (AV) block.
Slovenian: Atrioventrikularni (AV) blok druge ali tretje stopnje.
English: On the other hand effective antiepileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.
Slovenian: Po drugi strani se zdravljenje z antiepileptiki ne sme prekiniti, saj je poslabšanje bolezni lahko škodljivo za mater in nerojenega otroka.
English: Based on comparative bioavailability data for the tablet and the suspension formulations, switching patients from one formulation to the other can be done.
Slovenian: Na podlagi komparativnih podatkov o biološki razpoložljivosti za tableto in suspenzijo je bolniku mogoče zamenjati farmacevtsko obliko.
English: Your doctor should be able to advise if a blood test is necessary before taking Zebinix.
Slovenian: Vaš zdravnik vam bo svetoval, ali je pri vas treba opraviti krvni test, preden začnete uporabljati zdravilo Zebinix.
English: Studies in animals have shown reproductive toxicity (see Fertility).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte Plodnost).
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Slovenian: Skupina CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
English: Concomitant use of eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Slovenian: Sočasna uporaba eslikarbazepinacetata z okskarbazepinom ni priporočljiva, saj lahko povzroči preveliko izpostavljenost aktivnim presnovkom.
English: • Low blood pressure or a fall in blood pressure on standing up;
Slovenian: • nizek krvni tlak ali padec krvnega tlaka ob vstajanju,
English: In the analysis of treatment failure (seizure risk) based on time to event analysis (Kaplan-Meier analysis and Cox regression), the Kaplan-Meier estimates of seizure risk at the end of the evaluation period was 0.06 with carbamazepine and 0.12 with eslicarbazepine acetate and by the end of 1 year with an additional increased risk to 0.11 with carbamazepine and 0.19 with eslicarbazepine acetate (p=0.0002).
Slovenian: V analizi neuspešnosti zdravljenja (tveganje za epileptični napad) na osnovi analize časa, ki je pretekel do dogodka (Kaplan-Meierjeva analiza in Coxova regresija), je bila ocena tveganja za epileptični napad po Kaplan-Meierjevi metodi ob zaključku evalvacijskega obdobja 0,06 za karbamazepin in 0,12 za eslikarbazepinacetat, ob preteku enega leta pa se je tveganje dodatno zvišalo na 0,11 za karbamazepin in 0,19 za eslikarbazepinacetat (p = 0,0002).
English: In addition, there are six post-marketing cases of ‘weight increase' for which the causality was assessed as possibly related to eslicarbazepine acetate by the MAH.
Slovenian: Poleg tega je bilo v obdobju trženja šest primerov »povečanja telesne mase«, pri katerih je imetnik dovoljenja za promet ocenil, da je možna vzročna povezava z eslikarbazepinacetatom.
English: • if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
Slovenian: • če ste alergični na eslikarbazepinacetat, druge derivate karboksamida (npr. karbamazepin ali okskarbazepin, zdravili za zdravljenje epilepsije) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Eslicarbazepine is a weak inducer of CYP3A4 and has inhibiting properties with respect to CYP2C19 (as stated in section 4.5).
Slovenian: Eslikarbazepin je šibak induktor encima CYP3A4 in ima zaviralno deluje na CYP2C19 (kot je navedeno v poglavju 4.5).
English: If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency.
Slovenian: Če je treba uporabo zdravila Zebinix prekiniti, je to priporočljivo storiti postopoma, da se zmanjša možnost zvečane pogostnosti epileptičnih napadov.
English: Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies.
Slovenian: Okskarbazepin in felbamat v teh študijah nista bila dovoljena kot sočasno zdravljenje.
English: Contact a doctor or go to a hospital immediately if you experience any of the above symptoms.
Slovenian: Takoj poiščite zdravniški nasvet ali pojdite na oddelek za nujno zdravstveno pomoč, če opazite katerega koli od teh simptomov.
English: Whenever possible, these individuals should be screened for this allele before starting treatment with carbamazepine or chemically-related active substances.
Slovenian: Če je le mogoče, je treba pri posameznikih teh narodnosti opraviti presejalni pregled za ta alel, preden se začnejo zdraviti s karbamazepinom ali sorodnimi učinkovinami.
English: The safety and efficacy of eslicarbazepine acetate in children aged 6 years and below has not yet been established.
Slovenian: Varnost in učinkovitost eslikarbazepinacetata pri otrocih, starih do 6 let, še nista bili dokazani.
English: Insert the tip of the oral syringe into the bottle adapter opening, keeping the bottle upright.
Slovenian: Konico odmerne brizge vstavite v odprtino prilagodilnika steklenice, pri tem pa držite steklenico ravno.
English: Step 5: Hold the oral syringe in place and turn the bottle upside down.
Slovenian: 5. korak: Držite odmerno brizgo in obrnite steklenico navzdol.
English: Take special care when taking Zebinix to avoid accidental injury, such as fall.
Slovenian: Med jemanjem zdravila Zebinix bodite posebno previdni, da preprečite nezgodne poškodbe, kot so padci.
English: From the 815 randomized patients, 401 patients were treated with eslicarbazepine acetate once-daily [271 patients (67.6%) remained at dose of 800 mg, 70 patients (17.5%) remained at dose of 1,200 mg and 60 patients (15.0%) were treated with 1,600 mg].
Slovenian: Od 815 randomiziranih bolnikov je bil 401 bolnik zdravljen z eslikarbazepinacetatom enkrat na dan [271 bolnikov (67,6 %) je ostalo pri odmerku 800 mg, 70 bolnikov (17,5 %) je ostalo pri odmerku 1.200 mg in 60 bolnikov (15,0 %) je bilo zdravljenih z odmerkom 1.600 mg].
English: • Sweating or having dry skin;
Slovenian: • potenje ali suha koža,
English: Zebinix is not to be given to children aged 6 years and below.
Slovenian: Zdravilo Zebinix se ne sme dajati otrokom, starim 6 let ali manj.
English: The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects.
Slovenian: Tveganja, ki so jih ugotovili za zdravilo Zebinix, so pretežno od odmerka odvisni neželeni učinki, ki so značilni za to skupino zdravil.
English: Pharmacodynamic effect
Slovenian: Farmakodinamični učinki
English: In patients with pre-existing renal disease leading to hyponatraemia, or in patients concomitantly treated with medicinal products which may themselves lead to hyponatraemia (e.g. diuretics, desmopressin, carbamazepine), serum sodium levels should be examined before and during treatment with eslicarbazepine acetate.
Slovenian: Pri bolnikih z obstoječo boleznijo ledvic, ki vodi v hiponatriemijo, ali pri bolnikih, ki sočasno prejemajo zdravila, ki lahko sama povzročajo hiponatriemijo (npr. diuretiki, dezmopresin, karbamazepin), je treba pred zdravljenjem z eslikarbazepinacetatom in med njim preveriti raven natrija.
English: Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy
Slovenian: Zdravilo Zebinix se uporablja: • samostojno (monoterapija) pri odraslih bolnikih z na novo diagnosticirano epilepsijo.
English: A population pharmacokinetics analysis of phase III studies in epileptic adult patients indicated that concomitant administration with valproate or levetiracetam did not affect the exposure to eslicarbazepine but this has not been verified by conventional interaction studies.
Slovenian: Valproat in levetiracetam Analiza populacijske farmakokinetike v študijah III. faze pri odraslih bolnikih z epilepsijo je pokazala, da sočasno dajanje valproata ali levetiracetama ne vpliva na izpostavljenost eslikarbazepinu, vendar to ni bilo potrjeno z običajnimi študijami interakcij.
English: Each ml of oral suspension contains 2.0 mg of methyl parahydroxybenzoate (E218) and approximately 0.00001 mg of sulphites.
Slovenian: En ml peroralne suspenzije vsebuje 2,0 mg metilparahidroksibenzoata (E218) in približno 0,00001 mg sulfitov.
English: Rare adverse reactions such as bone marrow depression, anaphylactic reactions, systemic lupus erythematosus or serious cardiac arrhythmias did not occur during the placebo-controlled studies of the epilepsy program with eslicarbazepine acetate.
Slovenian: Redki neželeni učinki, kot so depresija kostnega mozga, anafilaktične reakcije, sistemski erimatozni lupus ali hude srčne aritmije, se med študijami, nadzorovanimi s placebom programa zdravljenja epilepsije z eslikarbazepinacetatom, niso pojavile.
English: • hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective;
Slovenian: • hormonski kontraceptivi (kot je kontracepcijska tabletka), saj lahko zdravilo Zebinix povzroči zmanjšano učinkovitost;
English: If you take more Zebinix than you should
Slovenian: Če ste vzeli večji odmerek zdravila Zebinix, kot bi smeli
English: In the subsequent 3 open-label extensions (ITT set N=148), the overall responder rate was 26.6% when compared to baseline Parts III-V (i.e. the last 4 weeks in part II).
Slovenian: V poznejših 3 nezaslepljenih podaljšanih obdobjih (nabor ITT N = 148) je bila splošna stopnja odziva 26,6 % v primerjavi z izhodiščno vrednostjo delov III do V (tj. zadnjimi 4 tedni II.
English: Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature;
Slovenian: Simptomi vključujejo zmanjšane ravni ščitničnega hormona (to pokažejo krvne preiskave) slabo prenašanje mraza, povečanje jezika, tenke in krhke nohte ali lase ter nizko telesno temperaturo,
English: Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac arrhythmia).
Slovenian: Simptomi, ki jih opazimo pri prevelikem odmerjanju eslikarbazepinacetata, so primarno povezani s simptomi osrednjega živčevja (npr. vse vrste epileptičnih napadov, epileptični status) in srčnimi boleznimi (npr. srčna aritmija).
English: 14 patients (9.2%) completed open-label treatment with ESL through Part V. The most common reason for withdrawal during any part of the study was sponsor request (30 patients in part III [19.7% of the patients who entered part III], 9 in part IV [9.6% of the patients who entered part IV], and 43 in part V [64.2% of the patients who entered Part V]).
Slovenian: Najpogostejši razlog za izstop v katerem koli delu študije je bila zahteva sponzorja (30 bolnikov v III. delu [19,7 % bolnikov, ki so vstopili v III. del], 9 bolnikov v IV. delu [9,6 % bolnikov, ki so vstopili v IV. del] in 43 bolnikov v V. delu [64,2 % bolnikov, ki so vstopili v V. del]).
English: The efficacy and safety of eslicarbazepine acetate as adjunctive therapy for partial-onset seizures in children was evaluated in one phase II study in children aged from 6 to 16 years (N=123) and one phase III study in children aged from 2 to 18 years (N=304).
Slovenian: Pediatrična populacija Učinkovitost in varnost eslikarbazepinacetata kot dodatnega zdravljenja pri otrocih s parcialno epilepsijo so ocenili v eni študiji faze II pri otrocih, starih od 6 do 16 let (N = 123) in eni študiji faze III pri otrocih, starih od 2 do 18 let (N = 304).
English: The overall median relative decrease in Part I was greater in patients treated with ESL (-25.8%) than in patients treated with placebo (-16.4%).
Slovenian: Splošno mediano relativno zmanjšanje v I. delu je bilo večje pri bolnikih, zdravljenih z eslikarbazepinacetatom (-25,8 %), kot pri bolnikih, zdravljenih s placebom (-16,4 %).