FrancophonIA/ELRC3.0 huggingface dataset:
English: This will create pressure inside the bottle that will help the dosing of the suspension, forcing it to leave from the bottle to the oral syringe.
Croatian: Time će se u boci stvoriti tlak koji će olakšati doziranje suspenzije tako da ona iz boce prijeđe u štrcaljku za usta.
English: However, due to inter-individual variability in the interaction, special attention on monitoring of INR should be performed the first weeks after initiation or ending concomitant treatment of warfarin and eslicarbazepine acetate.
Croatian: Međutim, zbog interindividualne varijabilnosti u interakciji, posebnom pažnjom treba pratiti INR prvih tjedana nakon početka ili završetka istodobnog liječenja varfarinom i eslikarbazepinacetatom.
English: HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
Croatian: Alel HLA-A*3101 ima prevalenciju 2% do 5% u europskim populacijama i oko 10% u japanskoj populaciji.
English: If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Zebinix should be carefully re-evaluated.
Croatian: Ako žene koje primaju eslikarbazepinacetat postanu trudne ili namjeravaju zatrudniti, treba pažljivo ponovo procijeniti primjenu Zebinixa.
English: Bleeding disorders in the newborn caused by antiepileptic medicinal products have been reported.
Croatian: Prijavljeni su poremećaji krvarenja u novorođenčadi uzrokovani antiepileptičkim lijekovima.
English: Dose when you start treatment
Croatian: Doza kod započinjanja liječenja
English: • Tingling and/or feeling numb in any part of your body;
Croatian: • Osjećaj trnaca i/ili utrnulosti u bilo kojem dijelu tijela;
English: The mechanism for this reduction is unknown, but could be due to interference of transporter activity for rosuvastatin alone or in combination with induction of its metabolism.
Croatian: Mehanizam ovog smanjenja je nepoznat ali razlog može biti utjecaj na sposobnost transporta rosuvastatina sam ili u kombinaciji s indukcijom njegovog metabolizma.
English: Post-hoc subgroup analyses for the phase III study were conducted by age strata and above 6 years, as well as by dose.
Croatian: Provedene su post-hoc analize za ispitivanje faze III po podskupinama po dobi i iznad 6 godina starosti, kao i po dozi.
English: Of these, 65 patients had received ESL and 87 patients had received placebo during the double-blind part of the study.
Croatian: Od njih, 65 ih je primilo ESL a 87 ih je primilo placebo tijekom dvostrukoslijepog dijela ispitivanja.
English: If you forget to take a tablet, take it as soon as you remember and carry on as usual.
Croatian: Ako ste zaboravili uzeti tabletu, uzmite tabletu čim se sjetite i nastavite uobičajeno dalje.
English: Monoamino Oxidase Inhibitors (MAOIs)
Croatian: Inhibitori monoaminooksidaze (inhibitori MAO)
English: Because of the prevalence of this allele in other Asian populations (e.g, above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
Croatian: Zbog prevalencije ovog alela u drugim azijskim narodima (npr. iznad 15% kod Filipinaca i Malezijaca, može biti potrebno razmotriti potrebu genetičkog testiranja na prisutnost HLA-B*1502 u populacijama pod rizikom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zebinix in one or more subsets of the paediatric population in the treatment of epilepsy with partial onset seizures (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Zebinix u jednoj ili više podskupina pedijatrijske populacije za liječenje epilepsije s parcijalnim napadajima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Dermatitis allergic (uncommon, 0.8%) was reported only in the paediatric population.
Croatian: Alergijski dermatitis (manje često, 0,8%) zabilježen je samo u pedijatrijskoj populaciji.
English: Other medicines and Zebinix
Croatian: Drugi lijekovi i Zebinix
English: Hyponatraemia is asymptomatic in most cases, however, it may be accompanied by clinical symptoms like worsening of seizures, confusion, decreased consciousness.
Croatian: Hiponatrijemija je u većini slučajeva asimptomatska, međutim ona može biti popraćena kliničkim simptomima kao što su pogoršanje napadaja, konfuzija i smanjena svijest.
English: 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.
Croatian: Dokazano je da je u potomstvu žena sa epilepsijom, prevalencija malformacija 2-3 puta veća od stope od oko 3 % u općoj populaciji.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications.
Croatian: Suicidalne ideacije i suicidalno ponašanje zabilježeni su u bolesnika liječenih antiepileptičkim djelatnim tvarima kod nekoliko indikacija.
English: • Skin changes (e.g. red skin);
Croatian: • Promjene kože (npr. crvena koža);
English: Furthermore, a role of age independently of weight with regards to clearance of eslicarbazepine acetate could not be excluded, in particular for the youngest age group (2-6 years).
Croatian: Nadalje, uloga dobi neovisno o tjelesnoj težini u odnosu na klirens eslikarbazepinacetata ne može se isključiti, osobito za najmlađu dobnu skupinu (2-6 godina).
English: Body weight was shown to have an effect on volume of distribution and clearance.
Croatian: Utvrđeno je da tjelesna težina ima učinka na volumen distribucije i klirens.
English: Symptomatic and supportive treatment should be administered as appropriate.
Croatian: Treba dati odgovarajuće simptomatsko i suportivno liječenje.
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.
Croatian: Ako se kod Vas javi ozbiljan osip ili drugi kožni simptomi (vidjeti dio 4), prestanite uzimati Zebinix i obratite se svome liječniku ili odmah potražite medicinsku pomoć.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane prema smanjenju ozbiljnosti.
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Croatian: Metaanaliza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala mali porast rizika za suicidalne ideacije i suicidalno ponašanje.
English: Whenever possible, these individuals should be screened for this allele before starting treatment with carbamazepine or chemically-related active substances.
Croatian: Kad god je to moguće ove pojedince treba testirati na ovaj alel prije početka liječenja karbamazepinom ili kemijski srodnim djelatnim tvarima.
English: Take special care when taking Zebinix to avoid accidental injury, such as fall.
Croatian: Posebnu pozornost kod uzimanja Zebinixa treba posvetiti izbjegavanju slučajne ozljede, kao što je pad.
English: These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Croatian: Ovi napadaji mogu, ali ne moraju biti praćeni napadajima koji zahvaćaju cijeli mozak (sekundarna generalizacija).
English: Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population.
Croatian: Budući da su podaci o primjeni režima monoterapije u dozi od 1600 mg u starijih osoba ograničeni, ova se doza ne preporučuje u toj populaciji.
English: Zebinix is not to be given to children aged 6 years and below.
Croatian: Zebinix se ne smije davati djeci u dobi od 6 godina i mlađoj.
English: • Slower or irregular heart beat;
Croatian: • Spori ili nepravilni otkucaji srca;
English: Therefore, patients should be advised that their physical and/or mental abilities needed for operating machinery or driving may be impaired and they are recommended not to do so until it has been established that their ability to perform such activities is not affected.
Croatian: Stoga bolesnike treba savjetovati da im fizičke i/ili mentalne sposobnosti za upravljanje strojevima ili vožnju mogu biti smanjene i ne preporučuje im se upravljati strojevima ili vozilima dok se ne utvrdi da njihova sposobnost za obavljanje takvih aktivnosti nije ograničena.
English: In total, eslicarbazepine and its glucuronide correspond to more than 90% of total metabolites excreted in urine, approximately two thirds in the unchanged form and one third as glucuronide conjugate.
Croatian: Ukupno, eslikarbazepin i njegovi glukuronidi čine više od 90% ukupnih metabolita izlučenih u mokraći, približno dvije trećine u nepromijenjenom obliku, a jedna trećina kao konjugat glukuronida.
English: • Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;
Croatian: • Pretrage krvi pokazuju smanjenje razine soli (uključujući kloride) u krvi ili smanjenje crvenih krvnih stanica;
English: No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures which could have serious consequences for both mother and child.
Croatian: Ne treba naglo prekidati terapiju antiepileptičkim lijekovima, jer to može dovesti do napadaja, koji bi mogli imati ozbiljne posljedice po majku i dijete.
English: The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent from concentration.
Croatian: Vezanje eslikarbazepina za proteine plazme relativno je nisko (<40%) i neovisno o koncentraciji.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for eslicarbazepine acetate, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za eslikarbazepinacetat, znanstveni zaključci CHMP-a su sljedeći:
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Croatian: U bolesnika s CLCR <30 ml/min ne preporučuje se koristiti zbog nedostatka podataka.
English: A total of 39% patients in study 305 were up titrated to the maximum possible dose (30 mg/kg/day).
Croatian: U ispitivanju 305 ukupno je 39% bolesnika bilo titrirano do maksimalno moguće doze (30 mg/kg/dan).
English: PVC/ALU blister
Croatian: PVC/AL blister
English: If they happen to you stop taking Zebinix and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:
Croatian: Ako nastupe kod Vas, odmah prestanite uzimati Zebinix i odmah se obratite svom liječniku ili otiđite u bolnicu, jer Vam može biti potrebna hitna medicinska pomoć:
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.
Croatian: S druge strane, djelotvorno liječenje epilepsije se ne smije prekinuti, jer je pogoršanje bolesti štetno i za majku i za nerođeno dijete.
English: Only a few subjects (N=27) aged above 65 years were treated with eslicarbazepine acetate in monotherapy study.
Croatian: Samo nekoliko bolesnika (N=27) starijih od 65 godina liječeno je eslikarbazepinacetatom u ispitivanju primjene monoterapije.
English: If at any time you have these thoughts, when taking Zebinix, contact your doctor immediately.
Croatian: Ako se ikada dogodi da imate takve misli dok uzimate Zebinix, odmah se obratite svom liječniku.
English: Both studies were double-blind and placebo controlled with a duration of maintenance of 8 weeks (study 208) and 12 weeks (study 305), respectively.
Croatian: Oba ispitivanja bila su dvostruko slijepa placebom kontrolirana ispitivanja s trajanjem faze održavanja od 8 tjedana (ispitivanje 208) odnosno 12 tjedana (ispitivanje 305).
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnike (i njihove skrbnike) potrebno je savjetovati da potraže liječnički savjet u slučaju pojave znakova suicidalne ideacije odnosno suicidalnog ponašanja.
English: • Eye movement changes, fuzzy vision or red eye;
Croatian: • Promjene kretanja oka, nejasna slika ili crveno oko;
English: Electrolyte imbalance, dehydration, hypochloraemia
Croatian: Neravnoteža elektrolita, dehidracija, hipokloremija
English: What Zebinix looks like and contents of the pack
Croatian: Kako Zebinix izgleda i sadržaj pakiranja
English: Your doctor should be able to advise if a blood test is necessary before taking Zebinix.
Croatian: Vaš bi Vas liječnik trebao obavijestiti ako su krvne pretrage neophodne prije početka uzimanja Zebinixa.
English: Very common (may affect more than 1 in 10 people) side effects are: • Feeling dizzy or sleepy.
Croatian: Vrlo česte (mogu se javiti kod više od 1 na 10 osoba) nuspojave su: • Osjećaj omaglice ili pospanosti
English: • Blood tests showing that you have low levels of sodium in your blood;
Croatian: • Pretrage krvi koje pokazuju da imate niske razine natrija u krvi;
English: • hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective;
Croatian: • hormonalna kontracepcijska sredstva (poput pilule za kontracepciju) jer Zebinix može smanjiti njihovu učinkovitost.
English: • Mood changes or hallucinations;
Croatian: • Razdražljivost; • Promjene raspoloženja ili halucinacije;
English: If you forget to take a dose, take it as soon as you remember and carry on as usual.
Croatian: Ako ste zaboravili uzeti dozu, uzmite tabletu čim se sjetite i nastavite uobičajeno dalje.
English: The safety profile of eslicarbazepine acetate was generally similar between adult and paediatric patients, except for agitation (common, 1.3%) and abdominal pain (common, 2.1%) which were more common in children than in adults.
Croatian: Sigurnosni profil eslikarbazepinacetata bio je općenito sličan u odraslih i u pedijatrijskih bolesnika, osim za agitaciju (često, 1,3%) i bol u abdomenu (često, 2,1%) koje su bili češće u djece nego u odraslih.
English: Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur.
Croatian: Također serumsku razinu natrija treba odrediti ako se pojave klinički znakovi hiponatrijemije.
English: Zebinix may make hormonal contraceptives such as the contraceptive pill less effective.
Croatian: Zebinix može smanjiti učinkovitost hormonalnih kontraceptiva poput pilule za kontracepciju.
English: A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves.
Croatian: Mali broj osoba liječenih antiepilepticima imao je poriv za samoozljeđivanjem ili samoubilačke misli.
English: • Charcoal (dark) stool;
Croatian: • Katranasta (tamna) stolica;
English: • Increased bone proteins;
Croatian: • Povišenu razinu koštanih proteina;
English: Children above 6 years of age
Croatian: Djeca starija od 6 godina
English: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
Croatian: • monoterapija u liječenju parcijalnih napadaja, sa ili bez sekundarne generalizacije, u odraslih s novodijagnosticiranom epilepsijom;
English: Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity to antenatal screening.
Croatian: Bolesnice treba savjetovati o mogućnosti povećanog rizika od malformacija i dati priliku za prenatalni skrining.
English: The presence of HLA-A*3101 allele may increase the risk for carbamazepine induced cutaneous reactions (mostly less severe) from 5.0% in general population to 26.0% among subjects of European ancestry, whereas its absence may reduce the risk from 5.0% to 3.8%.
Croatian: Prisutnost alela HLA-A*3101 može povećati rizik za pojavu kožnih reakcija induciranih karbamazepinom (uglavnom manje teških) od 5,0% u općoj populaciji do 26,0% među osobama koje imaju europske pretke, dok odsutnost alela može smanjiti rizik s 5,0% na 3,8%.
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.
Croatian: Analiza farmakokinetike populacije studije faze III u epileptičkih odraslih bolesnika pokazala je da istodobna primjena s valproatom ili levetiracetamom nije utjecala na izloženost eslikarbazepinu, ali to nije provjereno konvencionalnim studijama interakcija.
English: Press the plugger down slowly to release Zebinix into the mouth.
Croatian: Polako pritisnite klip i istisnite Zebinix u usta.
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.
Croatian: • nemojte uzimati okskarbazepin (lijek za liječenje epilepsije) sa Zebinixom jer nije poznato je li sigurno ove lijekove uzimati istodobno.
English: Children with a body weight of ≥60 kg
Croatian: Djeca tjelesne težine ≥60 kg
English: There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine or chemically-related compounds treatment.
Croatian: Nema dovoljno podataka koji bi govorili u prilog preporuke za provedbu probira na HLA-A*3101 prije početka liječenja karbamazepinom ili kemijski srodnim djelatnim tvarima.
English: Antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality.
Croatian: Antiepileptički lijekovi mogu pridonijeti nedostatku folne kiseline, mogućem dodatnom uzroku fetalne abnormalnosti.
English: The steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 hours.
Croatian: Koncentracija u plazmi u stanju dinamičke ravnoteže se postiže za 4 do 5 dana doziranjem jednom dnevno, u skladu sa efektivnim poluvijekom od 20-24 sata.
English: No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Croatian: Nije zabilježena promjena u izloženosti karbamazepinu ili njegovom metabolitu karbamazepinepoksidu.
English: Drug toxicity, fall, thermal burn
Croatian: Toksičnost lijeka, pad, toplinske opekline
English: Should your doctor decide to stop your treatment with Zebinix your dose will usually be reduced gradually.
Croatian: Ako liječnik odluči prekinuti liječenje Zebinixom, doza će se postupno smanjivati.
English: A total of 50 of the 72 subjects starting the study completed the 26-week treatment period that corresponds to a retention rate of 69.4% (see section 4.2 for information on elderly use).
Croatian: Ukupno 50 od 72 ispitanika koji su započeli ispitivanje dovršilo je period liječenja u trajanju od 26 tjedna, što odgovara stopi zadržavanja od 69,4% (vidjeti dio 4.2 za informacije o primjeni u starijih osoba).
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Croatian: Najčešće je izviješćeno o rascjepu usne, kardiovaskularnim malformacijama i oštećenjima neuralne cijevi.
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.
Croatian: Nakon 1 godine, vjerojatnost da će se ispitanici povući iz ispitivanja, bilo zbog nuspojava ili nedostatka djelotvornosti lijeka, bila je 0,26 za eslikarbazepinacetat i 0,21 za karbamazepin s kontroliranim oslobađanjem.
English: Genotoxicity studies with eslicarbazepine acetate indicate no special hazards for humans.
Croatian: Studije genotoksičnosti eslikarbazepinacetata ne pokazuju posebne opasnosti za ljude.
English: Pharmacodynamic effect
Croatian: Farmakodinamički učinak
English: Dizziness, somnolence
Croatian: Omaglica, somnolencija
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: U trenutku propisivanja lijeka bolesnike se mora upozoriti na znakove i simptome kožnih reakcija i pažljivo nadzirati bolesnike kako bi se uočila pojava tih reakcija.
English: Eslicarbazepine acetate and its active metabolites prevented the development of seizures in nonclinical models predictive of anticonvulsant efficacy in man.
Croatian: Eslikarbazepinacetat i njegovi aktivni metaboliti sprečavaju razvoj napadaja u nekliničkim modelima predviđanja antikonvulzivne djelotvornosti u ljudi.
English: If patients of European descent or Japanese origin are known to be positive for HLA-A*3101 allele, the use of carbamazepine or chemically-related compounds may be considered if the benefits are thought to exceed risks.
Croatian: Ako se za bolesnike europskog ili japanskog podrijetla zna da su pozitivni na HLA-A*3101 alel, primjenu karbamazepina ili kemijski srodnih spojeva može se uzeti u obzir ako se smatra da korist od njegove primjene nadmašuje moguće rizike.
English: Store the bottle and the oral syringe together in the carton until next use.
Croatian: Bocu i štrcaljku za usta čuvajte zajedno u istoj kutiji do sljedeće uporabe.
English: • tricyclic antidepressants e.g. amitriptyline;
Croatian: • tricikličke antidepresive npr. amitriptilin.
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.
Croatian: Populacijska farmakokinetika ukazuje da su u podskupini djece u dobi od 2 do 6 godina potrebne doze od 27,5 mg/kg/dan i 40 mg/kg/dan, da bi se postigla izloženost koja je ekvivalentna terapijskim dozama od 20 i 30 mg/kg/dan u djece starije od 6 godina.
English: Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Croatian: Zebinix spada u skupinu lijekova, antiepileptika, koji se koriste za liječenje epilepsije, stanja pri kojem se javljaju ponavljani napadaji.
English: (≥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: manje često ≥1/1000 i <1/100 i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Considering that changes in body weight can influence the treatment decision and are of particular importance in epilepsy which itself may be associated with overweight/obesity this information should adequately be reflected in SmPC and PIL.
Croatian: Smatrajući da promjena tjelesne težine može utjecati na odluku o liječenju i da je od osobite važnosti kod epilepsije koja sama po sebi može biti povezana s prekomjernom tjelesnom težinom / pretilosti, ovaj se podatak na odgovarajući način mora navesti u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not known whether it passes into breast milk.
Croatian: Nije poznato prelazi li u majčino mlijeko.
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.
Croatian: Podaci koji se trenutno nalaze u dijelu 4.9 sažetka opisa svojstava lijeka su ograničeni i ne odražavaju mogući kardijalni rizik kod predoziranja eslikarbazepinacetatom ili rizik od izazivanja napadaja.
English: • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures.
Croatian: • Neurološki poremećaj pokreta gdje se Vaši mišići stežu uzrokujući izvrtanje i ponavljajuće pokrete ili abnormalno držanje tijela.
English: Zebinix is indicated as:
Croatian: Zebinix je indiciran kao: