FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Zebinix
Croatian: Ako prestanete uzimati Zebinix
English: Urinary tract infection
Croatian: Infekcija urinarnog trakta
English: Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives, ATC code: N03AF04
Croatian: Farmakoterapijska skupina: Antiepileptici, derivati karboksamida, ATK oznaka: N03AF04
English: Ossification delays, reduced foetal weights, an increase in minor skeletal and visceral anomalies were observed at maternal toxic doses in embryotoxicity studies in mice, rats and rabbits.
Croatian: Zakašnjela osifikacija, smanjena fetalna težina, porast manjih abnormalnosti skeleta ili unutarnjih organa primijećeni su pri maternalnim toksičnim dozama u ispitivanjima embriotoksičnosti na miševima, štakorima i kunićima.
English: • Difficulty in speaking;
Croatian: • Poteškoće govora;
English: Depending on how you respond to Zebinix, your dose may be increased to 1,200 mg once daily.
Croatian: Ovisno o tome kako reagirate na Zebinix, doza se može povećati na 1200 mg jednom dnevno.
English: Contact your doctor immediately:
Croatian: Obavijestite odmah Vašeg liječnika ako:
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).
Croatian: Primijećene nuspojave u studijama na životinjama pojavljuju se na razini izloženosti znatno nižoj od razine kliničke izloženosti eslikarbazepinu (glavni i farmakološki aktivni metabolit eslikarbazepinacetata).
English: • Allergy;
Croatian: • Alergija;
English: • Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
Croatian: • Ozbiljne alergijske reakcije koje uzrokuju oteknuće lica, grla, šaka, stopala, skočnih zgova ili potkoljenica;
English: 2D barcode carrying the unique identifier included.
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom. (samo za vanjsko pakiranje)
English: The pharmacokinetic profile of eslicarbazepine acetate is unaffected in the elderly patients with creatinine clearance >60 ml/min (see section 4.2).
Croatian: Farmakokinetički profil eslikarbazepinacetata je nepromijenjen u starijih bolesnika s klirensom kreatinina >60 ml/min (vidjeti dio 4.2).
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);
Croatian: • ste alergični na eslikarbazepinacetat, druge derivate karboksamida (npr. karbamazepin ili okskarbazepin, lijekove za liječenje epilepsije) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: No dose adjustment is recommended in patients with mild to moderate liver impairment (see section 4.2).
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim do umjerenim oštećenjem jetre (vidjeti dio 4.2).
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.
Croatian: Potreban je oprez u liječenju bolesnika, odraslih i djece starije od 6 godina, s oštećenjem bubrega i dozu treba prilagoditi prema klirensu kreatinina (CLCR) kako slijedi: - CLCR >60 ml/min: nije potrebna prilagodba doze.
English: Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives, ATC code: N03AF04 Mechanism of action
Croatian: Farmakoterapijska skupina: Antiepileptici, derivati karboksamida, ATK oznaka: N03AF04 Mehanizam djelovanja
English: The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval.
Croatian: Uzimanje Zebinixa je povezano s nepravilnosti u EKG-u (elektrokardiogram) koja se zove produljeni PR interval.
English: Insert the tip of the oral syringe into the bottle adapter opening, keeping the bottle upright.
Croatian: Umetnite vrh štrcaljke za usta u otvor nastavka za bocu, držeći bocu uspravno.
English: Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.
Croatian: Mogu nastupiti nuspojave povezane s tim abnormalnim EKG nalazom (npr. padanje u nesvijest i usporenje otkucaja srca).
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.
Croatian: Rijetke nuspojave kao što su depresija koštane srži, anafilaktičke reakcije, sistemski lupus eritematosus ili ozbiljne srčane aritmije nisu se pojavile tijekom placebom kontroliranih studija programa epilepsije sa eslikarbazepinacetatom.
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.
Croatian: Kemijska struktura eslikarbazepinacetata slična je strukturi karbamazepina, i moguće je da u bolesnika pozitivnih na HLA-B*1502 postoji rizik za nastanak SJS-a nakon liječenja eslikarbazepinacetatom.
English: A study in adult patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Croatian: Studija u odraslih bolesnika s blagim do teškim oštećenjem bubrega pokazala je da klirens ovisi o bubrežnoj funkciji.
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.
Croatian: Podaci o dugoročnoj sigurnosti primjene u pedijatrijskoj populaciji prikupljeni u otvorenom produžetku ispitivanja faze III bili su u skladu s već poznatim sigurnosnim profilom lijeka, bez značajnih novih spoznaja.
English: Visual impairment, oscillopsia, binocular eye movement disorder, ocular hyperaemia
Croatian: Oštećenje vida, oscilopsija, poremećaji binokularnog kretanja očiju, očna hiperemija
English: In the subsequent 1-year open-label extension (Part II) of the phase III study (ITT set N=225) the total responder rate was 46.7% (steadily increasing from 44.9% (weeks 1-4) to 57.5% (weeks > 40)).
Croatian: U jednogodišnjem otvorenom nastavku ispitivanja (dio II) faze III (ITT N = 225) koje je nastavno uslijedilo, ukupna stopa bolesnika koji su imali odgovor na terapiju iznosila je 46,7% (kontinuirani porast s 44,9% (u tjednima 1-4) na 57,5% (u tjednima > 40).
English: • Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
Croatian: • Crvenkaste mrlje nalik meti ili kružne mrlje često s mjehurom u sredini smještene po trupu, koža koja se ljušti, vrijedovi u ustima, grlu, nosu, genitalijama i očima, crvene i otečene oči čemu prethodi vrućica i/ili simptomi slični gripi (Steven-johnsonov sindrom / toksična epidermalna nekroliza);
English: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (see section 4.2).
Croatian: Potreban je oprez u liječenju bolesnika s oštećenjem bubrega i dozu treba prilagoditi prema klirensu kreatinina (vidjeti dio 4.2).
English: Symptoms include tremors, pain, cramping;
Croatian: Simptomi su drhtanje, bolovi i grčevi;
English: • Flushing, cold limbs;
Croatian: • Naleti crvenila, hladni udovi;
English: The safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients were evaluated in one non-controlled study, with a duration of 26 weeks, in 72 elderly (aged ≥ 65 years).
Croatian: Sigurnost i djelotvornost eslikarbazepinacetata kao dodatne terapije za parcijalne napadaje u starijih bolesnika ispitana je u nekontroliranom ispitivanju u trajanju od 26 tjedana na 72 starije osobe (u dobi ≥ 65 godina).
English: • the blood thinner - warfarin;
Croatian: • lijekove protiv zgrušavanja krvi - varfarin.
English: Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies.
Croatian: U tim ispitivanjima nisu bili dozvoljeni okskarbazepin i felbamat kao istodobni lijekovi.
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.
Croatian: Smanjenje plodnosti primijećeno je u ženki štakora; smanjen broj implantacija i živih embrija primijećen u ispitivanjima plodnosti miševa može također ukazivati na utjecaj na plodnost ženki, međutim nije ispitivan broj žutih tijela.
English: • if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval.
Croatian: • ako uzimate bilo koji lijek koji može izazvati nepravilnosti u EKG-u (elektrokardiogramu) nazvane produljenje PR intervala.
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).
Croatian: Među njima, kada se isključe bolesnici u dobi od 6 godina i mlađi, 14 (48,3%) bolesnika u skupini eslikarbazepinactata, odnosno 11 (30,6%) u skupini placeba, odgovorili su na liječenje (p = 0,1514).
English: Co-administration of eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%), but statistically significant decrease in exposure to S-warfarin.
Croatian: Istodobna primjena eslikarbazepinacetata 1200 mg jednom dnevno s varfarinom pokazala je mali (23%), ali statistički značajan pad u izloženosti S-varfarinu.
English: If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time.
Croatian: U bolesnika kod kojih su se pojavile ove reakcije, s liječenjem Zebinixom se ne smije više nikad započeti.
English: 90 tablets.
Croatian: 90 tableta.
English: Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment.
Croatian: Zebinix može kod Vas prouzročiti omaglicu i/ili omamljenost, osobito na početku liječenja.
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;
Croatian: Simptomi obuhvaćaju snižene razine tiroidnog hormona (utvrđene pretragama krvi), nepodnošenje hladnoće, veliki jezik, tanke i lomljive nokte ili kosu i nisku tjelesnu temperaturu ;
English: If you forget to take Zebinix
Croatian: Ako ste zaboravili uzeti Zebinix
English: This is so the doctor knows what you have taken.
Croatian: Ponesite sa sobom pakiranje lijeka, kako bi liječnik znao što ste uzeli.
English: Outer carton / bottle
Croatian: Kutija/boca
English: No dose adjustment is needed in the elderly population provided that the renal function is not disturbed.
Croatian: U starije populacije nije potrebna prilagodba doze pod uvjetom da je bubrežna funkcija očuvana.
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.
Croatian: Preosjetljivost na djelatnu tvar, druge derivate karboksamida (npr. karbamazepin, okskarbazepin) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
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.
Croatian: U placebom kontroliranim ispitivanjima koja su uključivala bolesnike u dobi od 2 do 18 godina s parcijalnim napadajima (238 bolesnika liječenih eslikarbazepinacetatom i 189 placebom), nuspojave su se javile kod 35,7% bolesnika liječenih eslikarbazepinacetatom i kod 19% bolesnika koji su primali placebo.
English: Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin).
Croatian: Stoga, mogu nastati interakcije kada su istodobno primjenjivane visoke doze eslikarbazepinacetata s lijekovima koji se uglavnom metaboliziraju putem CYP2C19 (npr. fenitoin).
English: Eslicarbazepine acetate was tested at doses of 400 mg (in -301 and -302 studies only), 800 mg and 1,200 mg, once daily.
Croatian: Eslikarbazepinacetat je ispitan u dozama od 400 mg (samo u studiji 301 i studiji 302), 800 mg i 1200 mg, jedanput dnevno.
English: The tablets are packaged in blisters in cardboard boxes containing 7, 14 or 28 tablets.
Croatian: Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 7, 14 ili 28 tableta.
English: • Crying, feeling depressed, nervous or confused, lack of interest or emotion;
Croatian: • Loše pamćenje ili zaboravnost; • Plač, depresivnost, nervoza ili zbunjenost, nedostatak interesa ili osjećaja;
English: Other form of this medicine, like oral suspension, maybe more suitable for children.
Croatian: Za liječenje djece može biti prikladniji drugi farmaceutski oblik ovog lijeka, npr. oralna suspenzija.
English: If clinically-relevant hyponatraemia develops, eslicarbazepine acetate should be discontinued.
Croatian: Ako se razvije klinički značajna hiponatrijemija, eslikarbazepinacetat treba ukinuti.
English: • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Croatian: • dodatna terapija u odraslih, adolescenata i djece starije od 6 godina s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
English: Headache, disturbance in attention, tremor, ataxia, balance disorder
Croatian: Glavobolja, smetnje u pozornosti, tremor, ataksija,
English: Eslicarbazepine has inhibiting properties with respect to CYP2C19.
Croatian: Eslikarbazepin ima inhibirajuća svojstva na CYP2C19.
English: Eslicarbazepine acetate does not affect its own metabolism or clearance.
Croatian: Eslikarbazepinacetat ne utječe na svoj metabolizam ili klirens.
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Croatian: À Av. da Siderurgia Nacional 4745-457 S.
English: The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects.
Croatian: Rizici utvrđeni za Zebinix uglavnom su nuspojave povezane s ovom skupinom lijekova i ovisne o dozi.
English: Zebinix 50 mg/ml is an off-white to white oral suspension.
Croatian: Zebinix 50 mg/ml je bjelkasta do bijela oralna suspenzija.
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.
Croatian: Djelotvornost eslikarbazepinacetata kao dodatne terapije je dokazana u četiri dvostruko slijepa placebom kontrolirana ispitivanja faze III u 1703 randomiziranih odraslih bolesnika sa parcijalnom epilepsijom refraktornom na liječenje s jednim do tri istodobna antiepileptička lijeka.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga ove bolesnike treba nadzirati u smislu pojave znakova suicidalne ideacije i suicidalnog ponašanja te razmotriti potrebu uvođenja odgovarajuće terapije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of multipacks (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Međupakiranje višestrukog pakiranja (bez plavog okvira)
English: Frequency of hyponatraemia increased with increasing eslicarbazepine acetate dose.
Croatian: Učestalost hiponatrijemije se povećava s povećanjem doze eslikarbazepinacetata.
English: The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before increasing to the maintenance dose.
Croatian: Početna doza je 10 mg po kilogramu tjelesne težine jedanput dnevno tijekom jednog ili dva tjedna, prije povećanja na dozu održavanja.
English: Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate.
Croatian: Stoga, može biti potrebno povećanje doze lijekova koji se uglavnom metaboliziraju putem CYP3A4, kada se koriste istodobno sa eslikarbazepinacetatom.
English: • Inflamed gums or toothache;
Croatian: • Upaljeno zubno meso ili zubobolja;
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]).
Croatian: Najčešći razlog povlačenja iz ispitivanja tijekom bilo kojeg dijela ispitivanja bio je na zahtjev naručitelja ispitivanja (30 bolesnika u dijelu III [19,7% bolesnika koji su uključeni u dio III ispitivanja], 9 u dijelu IV [9,6% bolesnika koji su uključeni u dio IV ispitivanja], i 43 u dijelu V (64,2% bolesnika koji su uključeni u dio
English: A study in healthy subjects with eslicarbazepine acetate 1,200 mg once daily showed a minor average pharmacokinetic interaction (exposure of lamotrigine decreased 15%) between eslicarbazepine acetate and lamotrigine and consequently no dose adjustments are required.
Croatian: Studija u zdravih ispitanika s eslikarbazepinacetatom 1200 mg jednom dnevno pokazala je manju prosječnu farmakokinetičku interakciju (izloženost lamotriginu je smanjena 15%) između eslikarbazepinacetata i lamotrigina, te posljedično nije potrebna prilagodba doze.
English: Haemodialysis removes eslicarbazepine acetate metabolites from plasma.
Croatian: Hemodijaliza uklanja metabolite eslikarbazepinacetata iz plazme.
English: Moderate hepatic impairment did not affect the pharmacokinetics of eslicarbazepine acetate.
Croatian: Umjereno oštećenje jetre nije utjecalo na farmakokinetiku eslikarbazepinacetata.
English: Taking into account that more eslicarbazepine acetate-treated patients experienced weight increase than weight decrease during the open label extension of the Phase III studies the current labelling is not considered adequate.
Croatian: Uzimajući u obzir da je kod više bolesnika liječenih eslikarbazepinacetatom tijekom otvorenog nastavka ispitivanja faze III došlo do porasta nego do pada tjelesne težine, trenutni opis lijeka ne smatra se odgovarajućim.
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem jetre.
English: The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded.
Croatian: Ne može se isključiti opasnost od povećanja specifičnih nuspojava uzrokovanih istodobnom primjenom karbamazepina i eslikarbazepinacetata.
English: Zebinix 50 mg/ml oral suspension
Croatian: Zebinix 50 mg/ml oralna suspenzija
English: Aluminium / Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets and in multi-packs containing 180 (2 packs of 90) tablets.
Croatian: Aluminij/aluminij ili PVC/aluminij blisteri u kartonskim kutijama koje sadrže 20, 30, 60 ili 90 tableta i u višestrukim pakiranjima koja sadrže 180 (2 pakiranja od 90) tableta.
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).
Croatian: Populacijska farmakokinetika ukazuje da je primijećena usporediva izloženost eslikarbazepinu između djece starije od 6 godina nakon primjene doze od 20 i 30 mg/kg/dan, i odraslih nakon primjene doze od 800 odnosno 1200 mg eslikarbazepinacetata jedanput dnevno (vidjeti dio 4.2).
English: There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with the structurally related antiepileptic drugs carbamazepine and oxcarbazepine.
Croatian: Postoje izvješća o smanjenoj mineralnoj gustoći kostiju, osteopeniji, osteoporozi i frakturama kod bolesnika na dugotrajnoj terapiji strukturno povezanim antiepilepticima karbamazepinom i okskarbazepinom.
English: 7 tablets 14 tablets 28 tablets
Croatian: 7 tableta 14 tableta 28 tableta
English: The maximum dose is 1,200 mg once daily.
Croatian: Maksimalna doza iznosi 1200 mg jedanput dnevno.
English: The treatment effect observed during the 26-week evaluation period was maintained over 1 year of treatment with 64.7 % eslicarbazepine acetate subjects and 70.3 % carbamazepine controlled release subjects classified as seizure free (average risk difference -5.46%, 95% confidence interval: [-11.88; 0.97].
Croatian: Učinak liječenja zamijećen tijekom 26-tjednog razdoblja evaluacije bio je održan preko godine dana liječenja, pri čemu je 64,7% ispitanika liječenih eslikarbazepinacetatom i 70,3% bolesnika liječenih karbamazepinom s kontroliranim oslobađanjem klasificirano kao „bez napadaja“ (prosječna razlika rizika -5,46%, CI 95%: [-11,88; 0,97].
English: The maximum dose is 1,200 mg once daily (see section 5.1).
Croatian: Maksimalna doza je 1200 mg jedanput dnevno (vidjeti dio 5.1).
English: (Португалия)
Croatian: (Portugalija)
English: There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine.
Croatian: Postoje izvješća o poremećajima kosti uključujući osteopeniju i osteoporozu (stanjivanje kosti) te o lomovima uslijed uzimanja strukturno sličnih antiepileptičkih lijekova kao što je karbamazepin i oksakarbazepin.
English: • Reduction in white blood cells which makes infections more likely;
Croatian: • Smanjenje broja bijelih krvnih stanica što dovodi do lakše pojave infekcija;
English: Hyponatraemia has been reported as an adverse reaction in 1.5% of patients treated with Zebinix.
Croatian: Hiponatrijemija Hiponatrijemija je prijavljena nuspojava u 1,5% bolesnika liječenih Zebinixom.
English: The target dose was 30 mg/kg/day in study 208 and 20 mg/kg/day in study 305.
Croatian: Ciljna doza u ispitivanju 208 bila je 30 mg/kg/dan, a u ispitivanju 305 bila je 20 mg/kg/dan.
English: Malaise, chills, oedema peripheral
Croatian: Malaksalost, zimica, periferni edem
English: Studies in healthy subjects and patients showed that pharmacokinetics of eslicarbazepine acetate were not affected by gender.
Croatian: Studije u zdravih ispitanika i bolesnika su pokazale da farmakokinetika eslikarbazepinacetata ne ovisi o spolu.
English: As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn.
Croatian: Kao preventivna mjera u posljednjih nekoliko tjedana trudnoće i u novorođenčeta bi trebalo primijeniti vitamin K1.
English: During the reporting period, the MAH detected a signal of overdose.
Croatian: Tijekom izvještajnog razdoblja, nositelj odobrenja za stavljanje lijeka u promet primio je signal o predoziranju.
English: The total median standardised seizure frequency was 2.4 (resulting in a median relative change from Baseline Part III-V of -22.9%).
Croatian: Sveukupni medijan standardizirane učestalosti napadaja iznosio je 2,4 (s medijanom relativne promjene u odnosu na početne vrijednosti u dijelovima III-V od -22,9/).
English: Place the oral syringe into the mouth against the inside of the cheek.
Croatian: 9. korak: Štrcaljku za usta stavite u usta uz unutrašnju stranu obraza.