FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation.
Croatian: U ispitivanju u zdravih ispitanika, istodobna primjena eslikarbazepinacetata 800 mg jednom dnevno i karbamazepina 400 mg dva puta dnevno rezultirala je u prosjeku padom od 32% u izloženosti aktivnom metabolitu eslikarbazepinu, najvjerojatnije uzrokovan indukcijom glukuronidacije.
English: Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from in clinical studies and post-marketing surveillance
Croatian: Tablica 1: Nuspojave nastale tijekom liječenja povezane s primjenom Zebinixa tijekom kliničkih ispitivanja i praćenja nakon stavljanja lijeka u promet
English: • Feeling extremely sleepy;
Croatian: • Osjećaj izrazite pospanosti;
English: Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and postmarketing surveillance are tabulated below.
Croatian: Tablični prikaz nuspojava Nuspojave povezane s eslikarbazepinacetatom prikupljene tijekom kliničkih ispitivanja i praćenjem lijeka nakon njegovog stavljanja u promet, prikazane su u tablici u nastavku.
English: Method and route of administration Zebinix is for oral use.
Croatian: Način i put primjene Zebinix se uzima kroz usta.
English: Replace the closure on the bottle by turning it clock-wise (to the right).
Croatian: 8. korak: Vratite zatvarač na bocu i zakrenite ga u smjeru kazaljke na satu (prema desno).
English: Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy
Croatian: • sam (kao monoterapija) u odraslih bolesnika s novodijagnosticiranom epilepsijom
English: • Burning sensation;
Croatian: • Osjećaj žarenja;
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
Croatian: Metaboliti eslikarbazepinacetata su eliminirani iz sistemske cirkulacije primarno preko bubrega.
English: Eslicarbazepine acetate was tested at doses of 20 and 30 mg/kg/day, up to a maximum of 1,200 mg/day.
Croatian: Eslikarbazepinacetat ispitan je u dozama od 20 i 30 mg/kg/dan, do maksimalne doze od 1200 mg/dan.
English: EU/1/09/514/021 20 tablets - PVC/ALU blister EU/1/09/514/022 60 tablets - PVC/ALU blister
Croatian: EU/1/09/514/021 20 tableta - PVC/Al blister EU/1/09/514/022 60 tableta - PVC/Al blister
English: Zebinix is not recommended in patients with severe liver problems.
Croatian: Zebinix se ne preporučuje u bolesnika s teškim bolestima jetre.
English: • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
Croatian: • Žgaravica, nadražaj želuca, bol u trbuhu, nadimanja i nelagoda u trbuhu ili suha usta;
English: Children with a body weight of ≥60 kg Children with a body weight of 60 kg or more should be given the same dose as for adults.
Croatian: Djeca tjelesne težine ≥60 kg Djeca tjelesne težine 60 kg i više trebaju uzimati doze jednake onima za odrasle.
English: CONDITIONS O R RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: Myalgia, bone metabolism disorder, muscular weakness, pain in extremity
Croatian: slabost u mišićima, bol u ekstremitetima
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets or in multipacks containing 180 (2x90) tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Croatian: Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 20, 30, 60 ili 90 tableta ili višestruka pakovanja koja sadrže 180 (2x90) tableta, i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 90 tableta.
English: 20 tablets 60 tablets
Croatian: 20 tableta 60 tableta
English: There was no effect on the Rwarfarin pharmacokinetics or on coagulation.
Croatian: Nije bilo nikakvog utjecaja na farmakokinetiku R
English: During treatment with Zebinix dose adjustment is recommended in patients, adult and children above 6 years of age with creatinine clearance <60 ml/min (see section
Croatian: Tijekom liječenja Zebinixom, preporučuje se prilagodba doze u bolesnika, odraslih i djece starije od 6 godina, s klirensom kreatinina <60 ml/min (vidjeti dio 4.2).
English: 30 tablets 60 tablets
Croatian: 30 tableta 60 tableta
English: Alopecia, dry skin, hyperhidrosis, erythema, skin disorder, pruritus, dermatitis allergic
Croatian: Alopecija, suha koža, hiperhidroza, eritem,
English: Zebinix is not recommended in patients with severe renal disease.
Croatian: Zebinix se ne preporučuje kod bolesnika sa teškim bolestima bubrega.
English: • Migraine;
Croatian: • Glavobolja;
English: Be careful, do not push the plunger down when removing the oral syringe from the bottle.
Croatian: Pazite da dok vadite štrcaljku za usta ne pritisnite klip prema dolje.
English: • Skin rash;
Croatian: • Osip kože;
English: Step 4.
Croatian: Prilog IV.
English: EU/1/09/514/012 20 tablets - ALU/ALU blister EU/1/09/514/013 30 tablets - ALU/ALU blister EU/1/09/514/014 60 tablets - ALU/ALU blister EU/1/09/514/015 90 tablets - ALU/ALU blister EU/1/09/514/016 20 tablets - PVC/ALU blister EU/1/09/514/017 30 tablets - PVC/ALU blister EU/1/09/514/018 60 tablets - PVC/ALU blister EU/1/09/514/019 90 tablets - PVC/ALU blister
Croatian: EU/1/09/514/012 20 tableta - Al/Al blister EU/1/09/514/013 30 tableta - Al/Al blister EU/1/09/514/014 60 tableta - Al/Al blister EU/1/09/514/015 90 tableta - Al/Al blister EU/1/09/514/016 20 tableta - PVC/Al blister EU/1/09/514/017 30 tableta - PVC/Al blister EU/1/09/514/018 60 tableta - PVC/Al blister EU/1/09/514/019 90 tableta - PVC/Al blister
English: Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 tablets.
Croatian: Aluminij/aluminij ili PVC/aluminij blisteri u kartonskim kutijama koje sadrže 30 ili 60 tableta.
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.
Croatian: Najčešće prijavljene nuspojave, tijekom placebom kontroliranih ispitivanja dodatne terapije u odraslih bolesnika s epilepsijom i u aktivno kontroliranom ispitivanju monoterapije u kojem se eslikarbazepinacetat uspoređivao s karbamazepinom s kontroliranim oslobađanjem, bile su omaglica, somnolencija, glavobolja i mučnina.
English: • Seeing double or blurred vision;
Croatian: • Dvostruke slike ili zamućenje vida;
English: • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure).
Croatian: • zajedno s drugim antiepilepticima (kao dodatna terapija) u odraslih bolesnika, adolescenata i djece starije od 6 godina, kojiimaju napadaje koji zahvaćaju jedan dio mozga (parcijalni napadaji).
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%).
Croatian: 25,8%) nego u bolesnika koji su primali placebo (-16,4%).
English: • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age who are experiencing seizures that affect one part of the brain (partial seizure).
Croatian: • zajedno s drugim antiepilepticima (kao dodatna terapija) u odraslih bolesnika, adolescenata i djece starije od 6 godina koji imaju napadaje koji zahvaćaju jedan dio mozga (parcijalni napadaji).
English: The efficacy of eslicarbazepine acetate as monotherapy has been demonstrated in a double-blind, active controlled (carbamazepine controlled release) study, involving 815 randomized adult patients with newly diagnosed partial-onset seizures.
Croatian: Djelotvornost eslikarbazepinacetata kao monoterapije dokazana je u dvostruko slijepom, aktivno kontroliranom (karbamazepin s kontroliranim oslobađanjem) ispitivanju, koje je uključivalo 815
English: Two clusters of ADRs were identified in context of overdose cases - epilepsy/seizures/status epilepticus and cardiac events, mainly arrhythmias.
Croatian: napadaji / status epileptikus i kardijalni događaji, uglavnom aritmije.
English: Package leaflet: Information for the user Zebinix 50 mg/ml oral suspension
Croatian: Uputa o lijeku: Informacije za korisnika Zebinix 50 mg/ml oralna suspenzija eslikarbazepinacetat
English: Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients.
Croatian: U 1,2% ukupne populacije liječene Zebinixom u kliničkim ispitivanjima u epileptičkih bolesnika kao nuspojava se pojavio osip.
English: zebinix 50 mg/ml (outer pack only)
Croatian: zebinix 50 mg/ml (samo vanjsko pakiranje)
English: Risk related to epilepsy and antiepileptic medicinal products in general
Croatian: 4.6 Plodnost, trudnoća i dojenje Rizici vezani za epilepsiju i antiepileptičke lijekove općenito
English: Do not use this medicine after the expiry date, which is stated on the blister, bottle and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, boci i kutiji iza „Rok valjanosti“.
English: • if you have 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: • imate mjehuriće po koži ili Vam se ljušti koža i/ili sluznice, imate osip, smetnje gutanja ili smetnje disanja, oticanje usana, lica, vjeđa, grla ili jezika.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka,, obratite se svom liječniku ili ljekarniku.
English: Toxic epidermal necrolysis, StevensJohnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, urticaria
Croatian: Johnsonov sindrom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS) angioedem, urtikarija
English: How to store Zebinix
Croatian: Kako čuvati Zebinix
English: Blood pressure decreased, weight decreased, blood pressure increased, blood sodium decreased, blood chloride decreased, osteocalcin increased, haematocrit decreased, haemoglobin decreased, transaminases increased
Croatian: smanjeni natrij u krvi, smanjeni kloridi u krvi, povišeni osteokalcin, smanjeni hematokrit, smanjeni hemoglobin,
English: Forty-one patients (30.6%) in the eslicarbazepine acetate group compared to 40 patients (31.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a non-significant difference (p=0.9017).
Croatian: bolesnika (31,0%) u skupini placeba odgovorilo je na liječenje (≥ 50% smanjenja standarizirane učestalosti napadaja), što je rezultiralo ne značajnom razlikom (p=0,9017).
English: • Feeling low in energy or tired;
Croatian: • Osjećaj nedostatka energije ili umora;
English: The adverse reaction profile of eslicarbazepine acetate is generally similar across age goups.
Croatian: Profil nuspojava eslikarbazepinacetata općenito je bio sličan u svim dobnim skupinama.
English: Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
Croatian: Jedna ml oralne suspenzije sadrži 50 mg eslikarbazepinacetata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija s 30 ili 60 tableta
English: The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 60 tablets.
Croatian: Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 20 ili 60 tableta i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 60 tableta.
English: The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Croatian: Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 30 ili 60 tableta i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 90 tableta.
English: Zebinix 400 mg tablets are white, circular and biconvex.
Croatian: Zebinix 400 mg tablete su bijele, okrugle i bikonveksne.
English: Insert the bottle adapter in the bottle neck opening.
Croatian: 3. korak: Umetnite nastavak u otvor grla boce.
English: Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paraesthesia, migraine
Croatian: hipersomnija, sedacija, afazija, disestezija, distonija, letargija, parosmija, cerebelarni sindrom, konvulzije, periferna neuropatija,
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
English: Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4).
Croatian: Teške kožne nuspojave (SCARS), uključujući Stevens-Johnsonov sindrom (SJS) / toksičnu epidermalnu nekrolizu (TEN) i osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS) zabilježene su kod liječenja Zebinixom nakon stavljanja lijeka na tržište (vidjeti dio 4.4).
English: Zebinix is for oral use.
Croatian: Zebinix se uzima kroz usta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20 or 60 tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 20 ili 60 tableta
English: • Hearing difficulty;
Croatian: • Poteškoće sa sluhom;
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].
Croatian: Od 815 randomiziranih bolesnika, 401 bolesnik je liječen eslikarbazepinacetatom jednom dnevno [271 bolesnik (67,6%) ostao je pri dozi od 800 mg, 70 bolesnika (17,5%) ostalo je pri dozi od 1200 mg i 60 bolesnika (15,0%) liječeno je dozom od 1600 mg]. U primarnoj analizi djelotvornosti, u kojoj su ispitanici koji su napustili ispitivanje smatrani ispitanicima bez odgovora, 71,1% ispitanika klasificirano je kao „bez napadaja“ u skupini s eslikarbazepinacetatom, a 75,6% u skupini s karbamazepinom s kontroliranim oslobađanjem, tijekom razdoblja evaluacije od 26 tjedana
English: The most common treatment-emergent 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.
Croatian: Najčešće prijavljene nuspojave, tijekom placebom kontroliranih ispitivanja dodatne terapije u odraslih bolesnika s epilepsijom, i u aktivno kontroliranom ispitivanju monoterapije u kojem se eslikarbazepinacetat uspoređivao s karbamazepinom s kontroliranim oslobađanjem, bile su omaglica,
English: • Muscle pain, pain in limbs, muscular weakness;
Croatian: • Bolovi u mišićima, bol u udovima, slabost u mišićima; • Poremećaj metabolizma kostiju;
English: Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with Zebinix.
Croatian: Ozbiljne i potencijalno po život opasne kožne nuspojave uključujući Stevens-Johnsonov sindrom / toksičnu epidermalnu nekrolizu i osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS), zabilježene su u bolesnika liječenih Zebinixom nakon stavljanja lijeka na tržište.
English: Eisai S.r.l.
Croatian: Eisai B.V.
English: The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Croatian: Prevalencija nositelja HLA-B*1502 u populacijama pripadnika kineskog naroda
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Croatian: Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
English: Do not use this medicine after the expiry date, which is stated on the bottle and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza „Rok valjanosti“.
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.
Croatian: Postoje podaci koji upućuju da je HLA-A*3101 udružen s povećanim rizikom za nastanak kožnih nuspojava induciranih karbamazepinom, uključujući SJS, TEN, osip s eozinofilijom izazvan lijekom
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.
Croatian: Tai snažno je povezan s rizikom od razvoja teške kožne reakcije poznate kao Stevens-Johnsonov sindrom (SJS), kada se oni liječe karbamazepinom.
English: Eisai B.V. Tél/Tel: + 31 (0) 900 575 3340
Croatian: Tel: + 31 (0) 900 575 3340
English: The tablets have ‘ESL 600'engraved on one side and are scored on the other side, with a length of 17.3 mm.
Croatian: Tablete imaju utisnuto "ESL 600" na jednoj strani i urez na drugoj strani, dužine su 17,3 mm.
English: In the double-blind period of the phase III study, the least square mean reduction in standardised seizure frequency with eslicarbazepine acetate (-18.1% versus baseline) was different to placebo (8.6% versus baseline) but not statistically significant (p=0.2490).
Croatian: U dvostruko slijepom razdoblju ispitivanja faze III smanjenje srednje vrijednosti dobivene metodom najmanjih kvadrata za standardiziranu učestalost napadaja za eslikarbazepinacetat (-18,1% u odnosu na početne vrijednosti) razlikovalo se od placeba (-8,6% u odnosu na početne vrijednosti), ali nije bilo statistički značajno (p=0,2490). 41 bolesnik (30,6%) u skupini eslikarbazepinacetata u usporedbi s 40
English: Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „Rok valjanosti“.
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.
Croatian: Oralna suspenzija Zebinix sadrži metilparahidroksibenzoat (E218) koji može izazvati alergijske reakcije
English: Step 1.
Croatian: K1.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Croatian: Apsorpcija Eslikarbazepinacetat se opsežno pretvara u eslikarbazepin.
English: • Urticaria (skin rash with itching).
Croatian: • Koprivnjača (kožni osip praćen svrbežom)
English: HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Croatian: HDPE bočice s polipropilenskim zatvaračem sigurnim za djecu, smještene u kartonske kutije koje sadrže 90 tableta.
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.
Croatian: (npr. diuretici, dezmopresin, karbamazepin), serumska razina natrija treba biti ispitana prije i tijekom liječenja eslikarbazepinacetatom.
English: HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Croatian: HDPE boce s polipropilenskim zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 60 tableta.
English: Forty-two patients (50.6%) in the eslicarbazepine acetate group compared to 10 patients (25.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a significant difference (p=0.009).
Croatian: 42 bolesnika (50,6%) u skupini eslikarbazepinacetata u usporedbi s 10 bolesnika (25,0%) u skupini placeba imalo je odgovor na liječenje
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Croatian: Bijele duguljaste tablete s utisnutim "ESL 600" na jednoj strani i urezom na drugoj strani, dužine 17,3 mm.
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Croatian: Tablete imaju utisnuto "ESL 800" na jednoj strani i urez na drugoj strani, dužine su 19 mm.
English: • Thermal burn;
Croatian: • Toplinske opekline;
English: Contact a doctor or go to a hospital immediately if you experience any of the above symptoms.
Croatian: Ako iskusite neki od gore navedenih simptoma odmah se obratite liječniku ili otiđite u hitni odjel bolnice.
English: Adult population
Croatian: Doziranje Odrasli
English: EU/1/09/514/001 7 tablets - ALU/ALU blister EU/1/09/514/002 14 tablets - ALU/ALU blister EU/1/09/514/003 28 tablets - ALU/ALU blister EU/1/09/514/004 7 tablets - PVC/ALU blister EU/1/09/514/005 14 tablets - PVC/ALU blister EU/1/09/514/006 28 tablets - PVC/ALU blister
Croatian: - Al/Al blister EU/1/09/514/003 28 tableta - Al/Al blister EU/1/09/514/004 7 tableta - PVC/Al blister EU/1/09/514/005 14 tableta - PVC/Al blister EU/1/09/514/006 28 tableta - PVC/Al blister
English: White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Croatian: Bijele duguljaste tablete s utisnutim "ESL 200" na jednoj strani i urezom na drugoj strani, dužine 11 mm.
English: 2 What you need to know before you take Zebinix Do not take Zebinix:
Croatian: Što je Zebinix i za što se koristi Što morate znati prije nego počnete uzimati Zebinix Kako uzimati Zebinix
English: Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinylestradiol, respectively, most likely caused by an induction of CYP3A4.
Croatian: Primjena eslikarbazepinacetata 1200 mg jednom dnevno kod ženskih ispitanica koje koriste kombinirane oralne kontraceptive, pokazala je prosječno smanjenje od 37% u sistemskoj izloženosti levonorgestrelu i
English: Croscarmellose sodium Magnesium stearate
Croatian: Toksična epidermalna nekroliza, Stevens
English: • Swelling in your legs and arms;
Croatian: • Otekline nogu ili ruku;
English: • Severe pain in the back and stomach (caused by inflamation of the pancreas);
Croatian: • Smanjenje broja krvnih pločica što povećava opasnost od krvarenja ili stvaranja modrica; • Jaki bolovi u leđima i trbuhu (uzrokovani upalom gušterače);
English: Eslicarbazepine acetate
Croatian: poremećaji hoda, astenija
English: Nausea, vomiting, diarrhoea
Croatian: diazepama, digoksina, fenitoina i tolbutamida.
English: • Abnormal sense of touch;
Croatian: • Poremećaj osjeta dodira;
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.
Croatian: smatra da su promjene u informacijama o lijeku lijekova koji sadrže eslikarbazepinacetat opravdane.