FrancophonIA/ELRC3.0 huggingface dataset:
English: Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Croatian: Preporučuje se napraviti kompletnu krvnu sliku u bolesnika koji imaju značajnu slabost, vrućicu, ponavljajuće infekcije ili poremećaje koagulacije (dio 4.8).
English: The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Croatian: Levetiracetam se uglavnom izlučuje putem urina, i to 95 % doze (približno 93 % doze izluči se za 48 sati).
English: Weight
Croatian: Težina
English: However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Croatian: Međutim, nisu poznati dugoročni učinci kod djece na učenje, inteligenciju, rast, endokrinu funkciju, pubertet i reproduktivnu sposobnost.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neki drugi pirolidonski derivat ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Croatian: Mora se omogućiti prikladno kliničko vođenje trudnica koje uzimaju levetiracetam.
English: Push the plunger in slowly and allow the child to swallow the content of the syringe.
Croatian: Polako potisnite klip tako da dijete može progutati sadržaj štrcaljke.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove http://www.ema.europa.eu
English: Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Croatian: Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla;
English: Before starting the measuring procedure make sure that the transparent dosing body of the syringe as well as the white plunger are in the bottom most position.
Croatian: Prije početka mjerenja provjerite da su prozirno graduirano tijelo štrcaljke i njen bijeli klip u najnižem položaju.
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Croatian: Nakon akutnog predoziranja želudac se može isprazniti gastričnom lavažom ili izazivanjem povraćanja.
English: Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed.
Croatian: Levetiracetam se može koristiti u trudnoći ako se nakon pažljive procjene smatra da je to klinički neophodno.
English: Take the oral solution following your doctor's instructions.
Croatian: Uzmite oralnu otopinu prema uputama liječnika.
English: Dose in children 50 kg or greater is the same as in adults.
Croatian: Doza u djece od 50 kg ili više jednaka je kao u odraslih.
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Croatian: Taj je utjecaj bio izraženiji u mlađe dojenčadi i s porastom dobi je slabio, a oko 4. godine života postao je zanemariv.
English: It is therefore recommended to adjust the maintenance daily dose of Levetiracetam Actavis Group, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Croatian: Stoga se preporučuje prilagođavanje dnevne doze održavanja lijeka Levetiracetam Actavis Group s obzirom na klirens kreatinina u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
English: This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
Croatian: To pakiranje treba propisivati djeci u dobi od 4 godine i starijoj, adolescentima i odraslima.
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Croatian: U dojenčadi i djece u dobi od 1 mjeseca do manje od 4 godine, razdražljivost (vrlo često, 11,7%) i poremećaji koordinacije (često, 3,3%) bili su prijavljeni češće nego u drugim dobnim skupinama ili u cjelokupnom sigurnosnom profilu.
English: In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Croatian: Kod ljudi je njegova aktivnost u stanjima i parcijalne i generalizirane epilepsije (epileptiformno izbijanje/fotoparoksizmalni odgovor) potvrdila širok spektar farmakološkog profila levetiracetama.
English: In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
Croatian: U kulturi ljudskih hepatocita levetiracetam je imao malen utjecaj ili nije imao utjecaja na CYP1A2, SULT1E1 ili UGT1A1.
English: The content of the syringe can also be emptied in a glass of water or baby´s bottle.
Croatian: Sadržaj štrcaljke može se također isprazniti u čašu vode ili dječju bočicu.
English: Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Croatian: Levetiracetam štiti od napadaja kod velikog broja životinjskih modela parcijalnih i primarno generaliziranih napadaja te nema prokonvulzijske učinke.
English: Alopecia, eczema, pruritus,
Croatian: Alopecija, ekcem, pruritus
English: This leaflet was last revised in {month/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {mjesec/GGGG} Ostali izvori informacija
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Croatian: Dostupni su samo ograničeni podaci o neurološkom razvoju djece izložene monoterapiji levetiracetamom in utero.
English: Infants and children (1 month to 4 years)
Croatian: Dojenčad i djeca (1 mjesec do 4 godine)
English: This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
Croatian: Vezno je mjesto sinaptički vezikularni protein 2A, za koji se smatra da je uključen u fuziju vezikula i egzocitozu neurotransmitera.
English: The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 24% of the dose, respectively during the first 48 hours.
Croatian: Kumulativno izlučivanje levetiracetama i njegovog glavnog metabolita urinom iznosi 66 % odnosno 24 % doze tijekom prvih 48 sati.
English: End-stage renal disease patients undergoing dialysis (1)
Croatian: Bolesnici u završnoj fazi bubrežne bolesti na dijalizi (1)
English: Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga se kod bolesnika moraju pratiti znakovi depresije i/ili samoubilačke ideje i ponašanje te razmotriti prikladan oblik liječenja.
English: Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Croatian: Sigurnosni rezultati u pedijatrijskih bolesnika u placebom kontroliranim kliničkim ispitivanjima bili su u skladu sa sigurnosim profilom levetiracetama u odraslih osim za nuspojave ponašanja i psihijatrijske nuspojave koje su bile češće u djece nego u odraslih.
English: The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Croatian: Kod ljudi poluvrijeme života levetiracetama u plazmi iznosi 7±1 sati i ne varira ovisno o dozi, putu primjene ili ponovljenoj primjeni.
English: The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
Croatian: Rizik anoreksije veći je ako se levetiracetat uzima istodobno s topiramatom.
English: The majority of patients presented with juvenile myoclonic epilepsy.
Croatian: Većina bolesnika imala je juvenilnu miokloničnu epilepsiju.
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Croatian: Farmakokinetički podaci upućuju da je poluvrijeme života (5,3 h) kraće nego u odraslih (7,2 h), a prividni klirens (1,5 ml/min/kg) brži je nego u odraslih (0,96 ml/min/kg).
English: • swelling of the face, lips, tongue and throat (Quincke's oedema);
Croatian: • oticanje lica, usana, jezika i grla (Quinckeov edem)
English: Rhabdomyolysis and blood creatine phosphokinase increased*
Croatian: Rabdomioliza i povišena kreatin fosfokinaza u krvi*
English: • elevated/abnormal values in a liver function test;
Croatian: • povišene/promijenjene vrijednosti testova jetrene funkcije nalazi funkcije jetre;
English: • uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
Croatian: • nekontrolirani mišićni grčevi koji zahvaćaju glavu, trup i udove, teškoće u kontroliranju pokreta, hiperkinezija (hiperaktivnost);
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Croatian: Sigurnosni profil levetiracetama uglavnom je sličan u svim starosnim skupinama (odrasli i pedijatrijski bolesnici) i u svim odobrenim indikacijama epilepsije.
English: Infection
Croatian: Infekcija
English: Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
Croatian: Levetiracetam se može koristiti u trudnoći samo ako nakon pažljive procjene Vaš liječnik smatra da je to potrebno.
English: • weight decrease, weight increase;
Croatian: • gubitak tjelesne težine, povećanje tjelesne težine;
English: Empty the contents of the syringe in a glass of water by pushing down the plunger.
Croatian: Ispraznite sadržaj štrcaljke u čašu vode potiskivanjem klipa do dna štrcaljke.
English: The extent of absorption is dose-independent and is not altered by food.
Croatian: Opseg apsorpcije ne ovisi o dozi, niti se mijenja u prisutnosti hrane.
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Croatian: Nastajanje primarnog metabolita, ucb L057, nije ovisno o izoformama jetrenog citokroma P450.
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Croatian: Na temelju retrospektivne ocjene farmakokinetičkih interakcija u djece i adolescenata s epilepsijom (4 do 17 godina) potvrđeno je da dodatno oralno liječenje levetiracetamom ne utječe na ravnotežne serumske koncentracije istodobno primijenjenog karbamazepina i valproata.
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Croatian: Epilepsija je stanje u kojem bolesnici imaju ponavljane epileptičke napadaje, Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju u jednoj strani mozga, ali se nakon toga mogu proširiti na veće područje u obje strane mozga (parcijalni napadaj sa ili bez sekundarne generalizacije).
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Croatian: • puno teži oblik osipa koji uzrokuje ljuštenje kože u više od 30 % površine tijela (toksična epidermalna nekroliza)
English: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Croatian: • rabdomioliza (oštećenje mišićnog tkiva) i povezano povećanje kreatin fosfokinaze u krvi.
English: Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95 % CI: -7.8 8.2).
Croatian: 73,0 % bolesnika liječenih levetiracetamom i 72,8 % bolesnika liječenih karbamazepinom s kontroliranim otpuštanjem (CR) bilo je šest mjeseci bez napadaja: prilagođena apsolutna razlika između liječenja bila je 0,2 % (95% CI: -7,8 8,2).
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Croatian: Dodatno, 101 dojenče mlađe od 12 mjeseci bilo je izloženo lijeku u ispitivanju sigurnosti primjene lijeka nakon stavljanja lijeka u promet.
English: Therefore there is no need for plasma level monitoring of levetiracetam.
Croatian: Stoga nije potrebno praćenje razine levetiracetama u plazmi.
English: Dose in adults and adolescents (12 to 17 years):
Croatian: Doza u odraslih i adolescenata (12 do 17 godina):
English: Thrombocytopenia, leukopenia
Croatian: Trombocitopenija, leukopenija
English: The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response.
Croatian: Doza se može dalje povećavati za po 250 mg dva puta na dan svaka dva tjedna, ovisno o kliničkom odgovoru.
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP:.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „EXP“.
English: • weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
Croatian: • slabost, osjećaj ošamućenosti ili vrtoglavice ili poteškoće s disanjem, budući da to mogu biti znakovi ozbiljne alergične (anafilaktičke) reakcije
English: In the population pharmacokinetic analysis conducted in patients from 1 month to 16 years of age, body weight was significantly correlated to apparent clearance (clearance increased with an increase in body weight) and apparent volume of distribution.
Croatian: Farmakokinetička analiza populacije obavljena u bolesnika u dobi od 1. mjeseca do 16. godine života pokazala je značajnu korelaciju tjelesne težine s prividnim klirensom (klirens se povećavao s porastom tjelesne težine) i s prividnim volumenom distribucije.
English: (2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Croatian: (2) Nakon dijalize preporučuje se dopunska doza od 250 ili 500 mg.
English: Injury
Croatian: Ozljeda
English: Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Croatian: Vršna koncentracija u plazmi (Cmax) postiže se 1,3 sata nakon uzimanja lijeka.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to
Croatian: Nuspojave su prikazane u padajućem nizu s obzirom na ozbiljnost i njihova učestalost je definirana na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, the following formula:
Croatian: Klirens kreatinina u ml/min može se procijeniti iz serumskog kreatinina (mg/dl), za odrasle i adolescente teške 50 kg ili više, pomoću sljedeće formule:
English: For adult patients, refer to the following table and adjust the dose as indicated.
Croatian: Za odrasle bolesnike prilagodite dozu prema sljedećoj tablici.
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Croatian: Rezultati kliničkih ispitivanja na odraslim bolesnicima prije stavljanja lijeka u promet pokazuju da levetiracetam ne utječe na serumske koncentracije postojećih antiepileptika (fenitoin, karbamazepin, valproična kiselina, fenobarbital, lamotrigin, gabapentin i primidon) te da ti antiepileptici ne utječu na farmakokinetiku levetiracetama.
English: Propylene glycol (E1520)
Croatian: Propilenglikol (E1520)
English: • If you notice any slow down in the growth or unexpected puberty development of your child,
Croatian: • Ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Croatian: Dvostruko slijepo i placebom kontrolirano pedijatrijsko ispitivanje o sigurnosti s neinferiornim dizajnom ocijenilo je kognitivne i neuropsihološke učinke levetiracetama u djece od 4. do 16. godine života s parcijalnim napadajima.
English: • sudden decrease in kidney function;
Croatian: • iznenadno smanjenje bubrežne funkcije;
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Croatian: Liječnik treba propisati najprikladniji farmaceutski oblik, vrstu pakiranja i jačinu lijeka u skladu s dobi, tjelesnom težinom i dozom.
English: For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Croatian: Kod djece s oštećenjem bubrega treba prilagoditi dozu levetiracetama s obzirom na bubrežnu funkciju jer je klirens levetiracetama povezan s bubrežnom funkcijom.
English: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
Croatian: Pri istodobnoj primjeni levetiracetama i metotreksata prijavljeno je smanjenje klirensa metotreksata što uzrokuje povišenu/zadržanu koncentraciju metotreksata u krvi do potencijalno toksičnih razina.
English: The dose level of 1,800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies.
Croatian: Doza od 1800 mg/kg/dan izazvala je znatnu maternalnu toksičnost i smanjenje fetalne težine, povezane s povećanom pojavnošću fetusa s anomalijama srčano-žilnog sustava i kostura.
English: Push the plunger in slowly to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 7).
Croatian: Polako potisnite klip do oznake koja odgovara količini u mililitrima (ml) koju je propisao Vaš liječnik
English: The apparent body clearance was 1.1 ml/min/kg.
Croatian: Prividni tjelesni klirens bio je 1,1 ml/min/kg.
English: Pull the plunger down and fill the syringe with a quantity of solution slightly beyond the prescribed dose (Figure 5).
Croatian: Izvucite klip i napunite štrcaljku s količinom otopine koja je malo veća od propisane doze (slika 5).
English: The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
Croatian: In vitro i in vivo podaci o interakciji s oralnim kontraceptivima, digoksinom i varfarinom upućuju na to da nije očekivana značajna indukcija enzima in vivo.
English: • delirium;
Croatian: • delirij;
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Croatian: Djelatna tvar, levetiracetam, jest derivat pirolidona (S-enantiomer α-etil-2-okso-1-pirolidinacetamida), kemijski različit od postojećih antiepileptičnih djelatnih tvari.
English: In most subjects with severe hepatic impairment, the clearance of levetiracetam was reduced by more than 50% due to a concomitant renal impairment (see section 4.2).
Croatian: U većine osoba s teškim oštećenjem jetre klirens levetiracetama smanjen je za više od 50 % uslijed popratnog oštećenja bubrega (vidjeti dio 4.2).
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Croatian: Profil nuspojava opisan niže temelji se na analizi zbirnih placebom konroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je levetiracetamom liječeno ukupno 3416 bolesnika.
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/ kg twice daily every two weeks).
Croatian: Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata tjelesne težine veće od 50 kg: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u dojenčadi starije od 6 mjeseci, djece i adolescenata tjelesne težine manje od 50 kg: smanjenje doze ne smije biti veće od 10 mg/kg dva puta na dan svaka dva tjedna; u dojenčadi (mlađe od 6
English: In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Croatian: . U bolesnika s teško oštećenom jetrenom funkcijom treba odrediti funkciju bubrega prije odabira doze (vidjeti dio 4.2).
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Croatian: Nuspojave značajne za kliničku primjenu koje nisu primijećene tijekom kliničkih studija, a koje su nađene kod štakora i u manjoj mjeri kod miševa izloženih razinama sličnim razinama izloženosti kod ljudi, bile su promjene jetre koje su upućivale na prilagodbeni odgovor kao na primjer povećana težina i centrilobularna hipertrofija, masna infiltracija jetre i povišene razine jetrenih enzima u plazmi.
English: At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Croatian: Pri dozi od 3600 mg/kg/dan samo je u jednom od dva EFD ispitivanja uočeno blago smanjenje fetalne težine povezano s marginalnim porastom varijacija kostura/malih anomalija.
English: The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Croatian: Bubrežni klirens levetiracetama i ucb L057 jest 0,6, odnosno 4,2 ml/min/kg, što ukazuje da se levetiracetam izlučuje glomerularnom filtracijom nakon čega dolazi do tubularne reapsorpcije te da se glavni metabolit osim glomerularnom filtracijom izlučuje i aktivnom tubularnom sekrecijom.
English: This recommendation is based on a study in adult renally impaired patients.
Croatian: Ta preporuka zasnovana je na ispitivanju u odraslih bolesnika s oštećenjem bubrega.