FrancophonIA/ELRC3.0 huggingface dataset:
English: Eslicarbazepine is a weak inducer of CYP3A4 and has inhibiting properties with respect to CYP2C19 (as stated in section 4.5).
Croatian: Eslikarbazepin je slabi induktor enzima CYP3A4 i ima inhibirajući učinak na CYP2C19 (kako je navedeno u dijelu 4.5).
English: Zebinix oral suspension may be taken with or without food.
Croatian: Oralna suspenzija Zebinix može se uzimati s hranom ili bez nje.
English: The pharmacokinetics and metabolism of eslicarbazepine acetate were evaluated in healthy subjects and moderately liver-impaired patients after multiple oral doses.
Croatian: Farmakokinetika i metabolizam eslikarbazepinacetata su ispitivani u zdravih ispitanika i u bolesnika s umjerenim oštećenjem jetre nakon ponovljenih oralnih doza.
English: In children above 6 years, 36 patients (35.0%) in the eslicarbazepine acetate group compared to 29 patients (30.2%) in the placebo group were responders (p=0.4759) and the least square mean reduction in standardised seizure frequency was higher in the eslicarbazepine acetate group compared to placebo (-24.4% versus -10.5%); however, the difference of 13.9% was not statistically significant (p=0.1040).
Croatian: U djece starije od 6 godina, 36 bolesnika (35,0%) u skupini eslikarbazepinacetata u usporedbi s 29 bolesnika (30,2%) u skupini placeba, odgovorilo je na liječenje (p = 0,4759) i smanjenje srednje vrijednosti dobivene metodom najmanjeg kvadrata za standardiziranu učestalost napadaja bilo je veće u skupini skupini eslikarbazepinacetata u usporedbi s placebom (-24,4% u usporedbi s -10,5%); ipak, razlika od 13,9% nije bila statistički značajna (p = 0,1040).
English: There was an average decrease of 36-39% in systemic exposure in healthy subjects when co-administered with eslicarbazepine acetate 1,200 mg once daily.
Croatian: Primijećeno je prosječno smanjenje sustavne izloženosti od 36-39% u zdravih ispitanika pri istovremenoj primjeni s 1200 mg eslikarbazepinacetata jedanput dnevno.
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.
Croatian: 6.1 Popis pomoćnih tvari ksantanska guma (E415) makrogol[100]stearat metilparahidroksibenzoat (E218) saharinnatrij (E954) umjetna aroma Tutti-Frutti (sadrži maltodekstrin, propilenglikol, prirodne i umjetne arome, arapsku gumu (E414) maskirajuća aroma (sadrži propilenglikol, vodu i prirodne i umjetne arome)
English: Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine.
Croatian: Na temelju individualnog odgovora, dozu eslikarbazepinacetata možda može biti potrebno povećati, ako se koristi istovremeno s karbamazepinom.
English: Turn the bottle upright and remove the entire oral syringe from the bottle.
Croatian: 7. korak: Uspravite bocu i cijelu štrcaljku za usta izvadite iz boce.
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).
Croatian: žene u generativnoj dobi moraju koristiti odgovarajuću kontracepciju tijekom liječenja Zebinixom, a sve do kraja tekućeg ciklusa menstruacije nakon što je liječenje prekinuto (vidjeti dio 4.6).
English: An increase of the simvastatin dose may be required when used concomitantly with eslicarbazepine acetate.
Croatian: Povećanje doze simvastatina može biti potrebno, ako se koristi istodobno s eslikarbazepinacetatom.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
Croatian: Metaboliti eslikarbazepinacetata se eliminiraju iz sistemske cirkulacije primarno izlučivanjem putem bubrega, u nepromijenjenom obliku i u obliku konjugata glukuronida.
English: A study in healthy subjects showed an average decrease of 50% in systemic exposure to simvastatin when co-administered with eslicarbazepine acetate 800 mg once daily, most likely caused by an induction of CYP3A4.
Croatian: Studija u zdravih ispitanika pokazala je prosječno smanjenje od 50% u sistemskoj izloženosti simvastatinu kada se primjenjuje zajedno sa eslikarbazepinacetatom u dozi od 800 mg jednom dnevno, najvjerojatnije uzrokovano indukcijom CYP3A4.
English: There are no data from the use of eslicarbazepine acetate in pregnant women.
Croatian: Nema podataka o primjeni eslikarbazepinacetata u trudnica.
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.
Croatian: Ako je test na prisutnost alela HLA-B*1502 u bolesnika ovog etničkog porijekla pozitivan, primjena eslikarbazepinacetata može se uzeti u obzir ako se smatra da korist njegove primjene nadmašuje moguće rizike.
English: Weight increased
Croatian: Porast tjelesne težine
English: Hypoacusis, tinnitus
Croatian: Vrtoglavica Hipoakuzija, tinitus
English: Patients with kidney problems
Croatian: Bolesnici s bolestima bubrega
English: BIAL -Portela & Cª, S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Croatian: BIAL - Portela & Cª, S.A., À Av. da Siderurgia Nacional 4745-457 S.
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin).
Croatian: In vivo eslikarbazepin izaziva indicirajući učinak na metabolizam lijekova, koji se uglavnom eliminiraju metabolizmom putem CYP3A4 (npr. simvastatin).
English: Each cardboard box contains a 10 ml polypropylene graduated syringe with 0.2 ml graduations, and a copolymer push-in bottle adapter.
Croatian: Svaka kartonska kutija sadrži polipropilensku graduiranu štrcaljku od 10 ml s gradacijama po 0,2 ml i kopolimerni nastavak koji se utisne u grlo boce.
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.
Croatian: Budući da su klinički podaci ograničeni u bolesnika s blagim do umjerenim oštećenjem jetre a farmakokinetički i klinički podaci nedostaju u bolesnika s teškim oštećenjem jetre, eslikarbazepinacetat treba koristiti s oprezom u bolesnika s blagim do umjerenim oštećenjem jetre i ne preporučuje se u bolesnika s teškim oštećenjem jetre.
English: In patients concomitantly treated with carbamazepine and eslicarbazepine acetate in placebocontrolled studies, the following adverse reactions were observed: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine), see section 4.5.
Croatian: U bolesnika istodobno liječenih karbamazepinom i eslikarbazepinacetatom u placebom kontroliranim studijama primijećene su sljedeće nuspojave: diplopija (11,4% ispitanika koji su istodobno primali karbamazepin, 2,4% ispitanika koji nisu istodobno primali karbamazepin), poremećaj koordinacije (6,7% s istodobnom primjenom karbamazepina, 2,7% bez istodobne primjene karbamazepina), i omaglica (30,0% s istodobnom primjenom karbamazepina, 11,5% bez istodobne primjene karbamazepina), vidjeti dio 4.5.
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.
Croatian: U kliničkim ispitivanjima (kao dodatna terapija i kao monoterapija), 2434 bolesnika s parcijalnim napadajima liječeno je eslikarbazepinacetatom (1983 odraslih i 451 pedijatrijski bolesnik), 51% tih bolesnika imalo je nuspojave.
English: 200 ml bottle oral syringe (10 ml) (outer pack only)
Croatian: oralna suspenzija boca od 200 ml štrcaljka za usta (10 ml) (samo vanjsko pakiranje)
English: Zebinix may be taken with or without food.
Croatian: Zebinix se može uzimati s hranom ili bez nje.
English: Zebinix contains methyl parahydroxybenzoate (E218) and sulphites
Croatian: Zebinix sadrži metilparahidroksibenzoat (E218) i sulfite
English: • Disturbances in the sense of smell;
Croatian: • Smetnje osjeta mirisa;
English: The median relative change was larger in the previous placebo group (-51.4%) than in the previous ESL group (
Croatian: Median relativne promjene bio je veći u prethodnoj placebo skupini (-51,4%) nego u prethodnoj ESL skupini (-40,4%).
English: The most common adverse reaction in the group treated with eslicarbazepine acetate were diplopia (5.0%), somnolence (8.0%) and vomiting (4.6%).
Croatian: Najčešće nuspojave u skupini liječenoj eslikarbazepinacetatom bile su diplopija (5,0%), somnolencija
English: Hypertension (including hypertensive crisis), hypotension, orthostatic hypotension, flushing, peripheral coldness
Croatian: (uključujući hipertenzivnu krizu), hipotenzija, ortostatska hipotenzija, navale crvenila, periferna hladnoća
English: Urticaria and angioedema cases have been reported in patients taking Zebinix.
Croatian: Prijavljeni su slučajevi urtikarije i angioedema u bolesnika koji su uzimali Zebinix.
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).
Croatian: (Kaplan-Meierova analiza i Coxova regresija), Kaplan-Meierova procjena za rizik pojave napadaja na kraju razdoblja evaluacije iznosila je 0,06 u skupini liječenoj karbamazepinom i 0,12 u skupini liječenoj eslikarbazepinacetatom, a nakon 1 godine s dodatnim povećanjem rizika na 0,11 u skupini liječenoj karbamazepinom i 0,19 u skupini liječenoj eslikarbazepinacetatom (p = 0,0002).
English: • Medicine toxicity;
Croatian: • Toksičnost lijeka;
English: Liver disorder
Croatian: Poremećaji jetre
English: • Irritability;
Croatian: • Nespretnost;
English: 20 tablets 30 tablets 60 tablets 90 tablets
Croatian: 20 tableta 30 tableta 60 tableta 90 tableta
English: Zebinix tablets may be taken with or without food.
Croatian: Tablete Zebinix se mogu uzimati s hranom ili bez nje.
English: A study in healthy subjects showed no effect of eslicarbazepine acetate 1,200 mg once daily on digoxin pharmacokinetics, suggesting that eslicarbazepine acetate has no effect on the transporter Pglycoprotein.
Croatian: Studija u zdravih ispitanika nije pokazala utjecaj eslikarbazepinacetata 1200 mg jednom dnevno na farmakokinetiku digoksina, sugerirajući da eslikarbazepinacetat nema nikakav utjecaj na transporter Pglikoprotein.
English: Zebinix is not recommended if you have severe kidney problems.
Croatian: Zebinix se ne preporučuje ako imate tešku bolest bubrega.
English: The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment.
Croatian: Farmakokinetika eslikarbazepinacetata nije ispitivana u bolesnika s teškim oštećenjima jetre.
English: • Feeling unsteady or having a sensation of spinning or floating;
Croatian: • Osjećaj nestabilnosti ili osjećaj vrtnje ili plutanja; • Mučnina ili povraćanje;
English: What you need to know before you take Zebinix 3.
Croatian: Što morate znati prije nego počnete uzimati Zebinix
English: Zebinix 50 mg/ml oral suspension Eslicarbazepine acetate
Croatian: Zebinix 50 mg/ml oralna suspenzija eslikarbazepinacetat
English: Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
Croatian: Stoga se savjetuje da, dok uzimate Zebinix, koristite druge oblike sigurne i učinkovite kontracepcije sve do kraja tekućeg menstrualnog ciklusa nakon prekida liječenja.
English: Similar to adults, eslicarbazepine acetate is extensively converted to eslicarbazepine.
Croatian: Slično kao u odraslih, eslikarbazepinacetat se opsežno pretvara u eslikarbazepin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS ALU/ALU blister
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER Al/Al blister
English: Uncommon (may affect up to 1 in 100 people) side effects are:
Croatian: Manje česte (mogu se javiti kod do 1 na 100 osoba) nuspojave su:
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).
Croatian: U 3 otvorena nastavka ispitivanja (ITT N = 148) koja su uslijedila, ukupna stopa bolesnika koja je imala odgovor na terapiju iznosila je 26,6% u usporedbi s početnim vrijednostima u dijelovima III-V (tj. u 4 posljednja tjedna dijela II).
English: Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
Croatian: poremećaji apatija, depresija, nervoza, agitacija, razdražljivost, deficit pažnje/ hiperaktivni poremećaj, konfuzno stanje, promjene raspoloženja, plač,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER PVC/Al blister
English: HPDE bottles carton and HPDE bottles of 90 tablets
Croatian: Kutija s HPDE bocama i HPDE boce s 90 tableta
English: Minor metabolites in plasma are Rlicarbazepine and oxcarbazepine, which were shown to be active, and the glucuronic acid conjugates of eslicarbazepine acetate, eslicarbazepine, R-licarbazepine and oxcarbazepine.
Croatian: Manji metaboliti u plazmi su R-likarbazepin i okskarbazepin, koji su aktivni te konjugati glukuronske kiseline s eslikarbazepinacetatom, eslikarbazepin, R-likarbazepin i okskarbazepin.
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.
Croatian: (1200 mg) u jednom, odnosno 10,0% (1600 mg) i 7,4% (1200 mg) u drugom ispitivanju.
English: Take special care with Zebinix:
Croatian: Budite posebno oprezni kada uzimate Zebinix:
English: Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day,based on individual response.
Croatian: Dozu treba povećavati svakog tjedna ili svaka dva tjedna za 10 mg/kg/dan do najviše 30 mg/kg/dan, ovisno o individualnom odgovoru.
English: How to take Zebinix
Croatian: Kako uzimati Zebinix
English: Common (may affect up to 1 in 10 people) side effects are:
Croatian: Česte (mogu se javiti kod do 1 na 10 osoba) nuspojave su:
English: Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; rash and hyponatraemia were less common in children than in adults.
Croatian: Omaglica, somnolencija, vrtoglavica, astenija, poremećaj hoda, tremor, ataksija, poremećaj ravnoteže, zamućen vid, proljev, osip i hiponatrijemija bili su manje česti u djece nego u odraslih.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija s 20, 30, 60 ili 90 tableta
English: • Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome);
Croatian: • U početku simptomi slični gripi, osip po licu koji se potom širi, visoka tjelesna temperatura, porast razine jetrenih enzima, odstupanja u rezultatima krvnih pretraga (eozinofilija), povećani limfni čvorovi i zahvaćenost drugih organa (osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima, poznata i kao DRESS ili sindrom preosjetljivosti na lijek);
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%).
Croatian: U dobnoj skupini od 6 do 11 godina najčešće nuspojave primijećene u više od dva bolesnika liječena eslikarbazepinacetatom bile su diplopija (9,5%), somnolencija (7,4%), omaglica (6,3%), konvulzije (6,3%) i mučnina (3,2%); u dobnoj skupini od 12 do 18 godina bile su to somnolencija (7,4%), povraćanje (4,2%), diplopija (3,2%) i umor (3,2%).
English: Children with a body weight of 60 kg or more should be given the same dose as for adults.
Croatian: Djeci tjelesne težine 60 kg ili više potrebno je davati iste doze kao i odraslima.
English: The efficacy of eslicarbazepine acetate as conversion to monotherapy was evaluated in 2 double-blind, randomized controlled studies in 365 adult patients with partial-onset seizures.
Croatian: Djelotvornost eslikarbazepinacetata kod prelaska na monoterapiju procjenjivana je u 2 dvostruko slijepa, randomizirana, kontrolirana ispitivanja na 365 odraslih bolesnika s parcijalnim napadajima.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation.
Croatian: Eslikarbazepinacetat se opsežno konvertira u eslikarbazepin, koji se uglavnom eliminira putem glukuronidacije.
English: BIAL - Portela & Cª , SA
Croatian: BIAL - Portela & Cª , S.A.
English: Amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Croatian: Boce od smeđeg stakla s HDPE zatvaračem sigurnim za djecu koje sadrže 200 ml oralne suspenzije, u kartonskim kutijama.
English: • phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
Croatian: • fenitoin (lijek za liječenje epilepsije) jer će možda biti potrebno prilagoditi dozu.
English: Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases.
Croatian: Eslikarbazepin može in vivo imati inducirajući učinak na metabolizam lijekova koji se uglavnom eliminiraju konjugacijom putem UDP-glukuronil transferaze.
English: HPDE bottles carton and HPDE bottles of 60 tablets
Croatian: Kutija sa HPDE bocama i HPDE boce sa 60 tableta
English: • blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
Croatian: • Stvaranje mjehurića po koži ili ljuštenje kože i/ili sluznica, osip, poteškoće gutanja ili disanja, oticanje usana, lica, vjeđa, grla ili jezika.
English: Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis , melaena, toothache
Croatian: Konstipacija, dispepsija, gastritis, bol u abdomenu, suha usta, nelagoda u abdomenu, distenzija abdomena, gingivitis, melena, zubobolja
English: 400 mg (or 10 mg/kg in children above 6 years)every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years).
Croatian: - CLCR 30-60 ml/min: početna doza od 200 mg (ili 5 mg/kg u djece starije od 6 godina) jedanput dnevno ili 400 mg (ili 10 mg/kg u djece starije od 6 godina) svaki drugi dan kroz 2 tjedna, nakon toga jedanput dnevno doza od 400 mg (ili 10 mg/kg u djece starije od 6 godina).
English: It is unknown whether eslicarbazepine acetate is excreted in human milk.
Croatian: Nije poznato izlučuje li se eslikarbazepinacetat u majčino mlijeko kod ljudi.
English: PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
Croatian: PVC/aluminij blisteri u kartonskim kutijama koje sadrže 20 ili 60 tableta.
English: Although the robustness of these post-hoc subgroup analyses is limited, the data suggest an age and dose dependent increase in effect size.
Croatian: Iako je robusnost ovih post-hoc analiza podskupina ograničena,
English: • simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;
Croatian: • simvastatin (lijek za smanjenje razine kolesterola) jer će možda biti potrebno prilagoditi Vašu dozu.
English: The least square mean reduction in standardised seizure frequency from baseline to maintenance period was significantly (p<0.001) higher with eslicarbazepine acetate (-34.8%) compared to placebo (13.8%).
Croatian: Smanjenje srednje vrijednosti dobivene metodom najmanjih kvadrata za standardiziranu učestalost napadaja, od početnih vrijednosti do razdoblja održavanja, bilo je značajno veće (p<0,001) za eslikarbazepinacetat (-34,8%) u usporedbi s placebom (-13,8%).
English: Tel: + 39 02 518 1401
Croatian: Eisai S.r.l. Tel: + 39 02 518 1401
English: The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data).
Croatian: Korištena je sljedeća konvencija za klasifikaciju pojave nuspojava: vrlo često ≥1/10, često ≥1/100 i <1/10,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 7, 14 ili 28 tableta
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Croatian: Nakon peroralne primjene, plazmatske razine eslikarbazepinacetata obično ostaju ispod granice kvantifikacije.
English: Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Croatian: Aluminij/aluminij ili PVC/aluminij blisteri u kartonskim kutijama koje sadrže 7, 14 ili 28 tableta.
English: • Anxiety.
Croatian: • Tjeskoba.
English: The most frequent individual adverse reactions were dizziness (12.5% of subjects), somnolence (9.7%), fatigue, convulsion and hyponatraemia (8.3%, each), nasopharyngitis (6.9%) and upper respiratory tract infection (5.6%).
Croatian: Najčešće pojedinačne nuspojave bile su omaglica (12,5% ispitanika), somnolencija (9,7%), umor, konvulzije i hiponatrijemija (svaka 8,3%), nazofaringitis (6,9%) i infekcija gornjih dišnih puteva (5,6%).
English: In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 hours and 13-20 hours, respectively.
Croatian: U ispitivanjima u zdravih ispitanika prividni poluvijek eslikarbazepina je od 10-20 sati, odnosno u epileptičkih odraslih bolesnika, 13-20 sati.
English: HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations
Croatian: Prisutnost alela HLA-B*1502 u populacijama pripadnika kineskog naroda Han, pripadnika naroda Tai i pripadnika drugih azijskih naroda
English: Always use the oral syringe provided to take your medicine.
Croatian: Za uzimanje lijeka uvijek koristite priloženu štrcaljku za usta.
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an 18% decrease in exposure to topiramate, most likely caused by a reduced bioavailability of topiramate.
Croatian: U ispitivanju u zdravih ispitanika, istodobna primjena eslikarbazepinacetata 1200 mg jednom dnevno i topiramata nije pokazala značajne promjene u izloženosti eslikarbazepinu, nego 18% smanjenu ekspoziciju topiramatu, najvjerojatnije uzrokovanu smanjenom bioraspoloživosti topiramata.