natgillin/translations-raw huggingface dataset:
Epilepsy is a condition where the patients have repeated fits (seizures). 
Epilepsija je stanje u kojem bolesnici imaju ponavljajuće epileptične epizode (napadaje).
General dose: between 1,000 mg and 3,000 mg each day. 
Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. 
Ti podaci dopunjeni su s podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i postmarketinškim iskustvima.
Somnolence, headache 
Somnolencija, glavobolja
Package Leaflet: Information for the patient 
Uputa o lijeku: Informacije za korisnika
You can switch from the filmcoated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. 
Možete se prebaciti s filmom obloženih tableta ili s oralne otopine na intravenski oblik ili obrnuto bez prilagodbe doze.
Levetiracetam has been given to you by your doctor to reduce the number of fits. 
Levetiracetam Vam je propisao Vaš liječnik s namjenom smanjivanja broja napadaja.
• swelling of the face, lips, tongue and throat (Quincke's oedema) 
• oticanje lica, usana, jezika i grla (Quinckeov edem)
Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use. 
Budući da je izloženost levetiracetamu za intravensku primjenu bila ograničena i budući da su peroralna i intravenska formulacija bioekvivalentne, sigurnosne informacije za intravenski levetiracetam se oslanjaju na levetiracetam za peroralnu primjenu.
Talk to your doctor before you are given Levetiracetam Hospira: 
Obratite se svom liječniku prije nego uzmete Levetiracetam Hospira:
Should your doctor decide to stop your Levetiracetam Hospira treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Hospira. 
Ako Vaš liječnik odluči prekinuti liječenje Levetiracetam Hospirom, pružiti će Vam informacije o postupnom prekidu liječenja Levetiracetam Hospirom.
• a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme) 
• kožni osip koji može tvoriti mjehure i izgledati poput malih meta (središnje tamne mrlje okružene svijetlim područjem, s tamnim prstenom oko ruba) (multiformni eritem)
What Levetiracetam Hospira is and what it is used for What you need to know before you are given Levetiracetam Hospira How Levetiracetam Hospira is given Possible side effects 
Što je Levetiracetam Hospira i za što se koristi Što morate znati prije nego počnete primjenjivati Levetiracetam Hospira Kako primjenjivati Levetiracetam Hospira Moguće nuspojave
A meta-analysis of randomized placebo-controlled trials of antiepileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. 
Metaanaliza randomiziranih placebom kontroliranih studija antiepileptičkih lijekova pokazala je mali porast rizika od samoubilačkih misli i ponašanja.
This medicinal product is for single use only, any unused solution should be discarded. 
Ovaj lijek namijenjen je samo za jednokratnu uporabu, neupotrebljenu otopinu treba baciti.
• elevated/abnormal values in a liver function test; 
• povišeni/nenormalni nalazi funkcije jetre;
Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients; 
Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla.
nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache. 
• nazofaringitis (infekcija nosa ili grla); • somnolencija (pospanost), glavobolja.
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1. 
Preosjetljivost na djelatnu tvar ili druge pirolidonske derivate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy. 
Nisu pronađena nikakva nova sigurnosna pitanja za levetiracetam u dojenčadi mlađoj od 12 mjeseci starosti s epilepsijom.
• Lactated Ringer's solution for injection 
• otopina Ringerovog laktata za injekciju
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures (fits) in epilepsy). 
Levetiracetam je antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).
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). 
Levetiracetam se uglavnom izlučuje putem urina, i to 95% doze (približno 93% doze izluči se za 48 sati).
Levetiracetam Hospira may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. 
Levetiracetam Hospira može narušiti Vašu sposobnost upravljanja vozilima ili alatima ili strojevima jer može uzrokovati osjećaj pospanosti.
Box of 10 or 25 vials 
Kutija sa 10 ili 25 bočica
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 24% of the dose, respectively during the first 48 hours. 
Kumulativno izlučivanje levetiracetama i njegovog glavnog metabolita urinom iznosi 66% odnosno 24% doze tijekom prvih 48 sati.
It is therefore recommended to adjust the maintenance daily dose of levetiracetam, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2). 
Stoga se preporučuje prilagođavanje dnevne doze održavanja levetiracetama s obzirom na klirens kreatinina u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. 
Stoga se kod bolesnika moraju pratiti znakovi depresije i/ili samoubilačke ideje i ponašanje te razmotriti prikladan oblik liječenja.
The risk of anorexia is higher when levetiracetam is co-administered with topiramate. 
Rizik anoreksije je veći ako se levetiracetam uzima istodobno s topiramatom.
The majority of patients presented with juvenile myoclonic epilepsy. 
Većina bolesnika imala je juvenilnu miokloničku epilepsiju.
The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration. 
Kod ljudi poluvijek levetiracetama u plazmi iznosi 7±1 sati i ne varira ovisno o dozi, putu primjene ili ponovljenoj primjeni.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities. 
In vitro je pokazano da levetiracetam i njegov glavni metabolit ne inhibiraju aktivnost glavnih izoformi humanog citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 i 1A2), glukuronil transferaze (UGT1A1 i UGT1A6) i epoksid hidroksilaze.
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity); 
• nekontrolirani mišićni grčevi koji zahvaćaju glavu, trup i ekstremitete, teškoće u kontroliranju pokreta, hiperkinezija (hiperaktivnost);
If you stop using Levetiracetam Hospira: 
Ako prestanete uzimati Levetiracetam Hospira:
• Sodium chloride 9 mg/ml (0.9%) solution for injection 
• otopina natrijevog klorida 9 mg/ml (0,9 %) za injekciju
Excipient with known effect: 
Pomoćna tvar s poznatim učinkom
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) 
• rasprostranjeni osip s mjehurićima i kožom koja se ljušti, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom)
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. 
Štetni učinci koji nisu zabilježeni u kliničkim ispitivanjima, ali su zapaženi u štakora i u manjoj mjeri u miševa pri razinama izloženosti sličnim razinama izloženosti kod ljudi i s mogućom važnošću za kliničku primjenu, 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.
In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid. 
Nadalje, levetiracetam ne utječe na glukuronidaciju valproatne kiseline in vitro.
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 
U studiji koja je bila odraz kliničke prakse bilo je moguće prekinuti istodobno antiepileptičko liječenje u ograničenog broja bolesnika koji su odgovorili na dodatno liječenje levetiracetamom (36 od 69 odraslih bolesnika).
Following dialysis, a 250 to 500 mg supplemental dose is recommended. 
Nakon dijalize preporučuje se dopunska doza od 250 ili 500 mg.
Levetiracetam has minor or moderate influence on the ability to drive and use machines. 
Levetiracetam ima blagi ili umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1,500 mg intravenous infusion for 4 days with twice daily dosing. 
Vremenski neovisan farmakokinetički profil levetiracetama potvrđen je također nakon intravenske infuzije od 1500 mg tijekom 4 dana dva puta dnevno.
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. 
Djelatna tvar, levetiracetam, jest derivat pirolidona (S-enantiomer α-etil-2-okso-1-pirolidinacetamida), kemijski različit od postojećih antiepileptičkih djelatnih tvari.
The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications. 
Sigurnosni profil levetiracetama uglavnom je sličan u svim dobnim skupinama (odrasli i pedijatrijski bolesnici) i u svim odobrenim indikacijama epilepsije.
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function 
• simptome kao što je smanjen volumen mokraće, umor, mučninu, povraćanje, smetenost i oticanje u nogama, gležnjevima ili stopalima jer to može biti znak naglog smanjenja bubrežne funkcije
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). 
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).
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. 
Dvostruko-slijepa i placebom kontrolirana pedijatrijska studija o sigurnosti s neinferiornim dizajnom ocijenila je kognitivne i neuropsihološke učinke levetiracetama u djece od 4. do 16. godine života s parcijalnim napadajima.
5 ml glass vial (type I) with bromobutyl coated rubber stoppers and an aluminium flip-off seal. 
Staklena bočica (tip I) od 5 ml s gumenim čepom obloženim bromobutilom i aluminijskim flip-off zatvaračem.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. 
S mikrobiološkog stajališta, lijek se treba odmah primijeniti, osim ako metoda razrjeđivanja isključuje rizik mikrobiološke kontaminacije.
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 children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks). 
Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata teških 50 kg ili više: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u djece i adolescenanta teških manje od 50 kg: smanjenje za ne više od 10 mg/kg dva puta na dan svaka dva tjedna).
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. 
Profil nuspojava opisan niže temelji se na analizi zbirnih placebom kontroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je ukupno 3416 bolesnika liječeno levetiracetamom.
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula: 
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:
Other medicines and Levetiracetam Hospira 
Drugi lijekovi i Levetiracetam Hospira
• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction 
• slabost, osjećaj ošamućenosti ili vrtoglavice ili poteškoće s disanjem, budući da to mogu biti znakovi ozbiljne alergične (anafilaktičke) reakcije
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. 
Pri dozi od 3600 mg/kg/dan samo je u jednoj od dvije EFD studije uočeno blago smanjenje fetalne težine povezano s marginalnim porastom varijacija kostura/malih anomalija.
However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration. 
Međutim, na temelju farmakokinetičkih svojstava levetiracetama, farmakokinetike u odraslih nakon intravenske primjene i farmakokinetike u djece nakon peroralne primjene, očekuje slična izloženost (AUC) levetiracetamu u pedijatrijskih bolesnika u dobi od 4 do 12 godina nakon intravenske i peroralne primjene.
However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline. 
No u ispitanika koji su uzimali levetiracetam tijekom dugoročne, otvorene studije provedene praćenjem u prosjeku nije bilo pogoršanja bihevioralnog i emocionalnog funkcioniranja; osobito nije bilo pogoršanja pokazatelja agresivnog ponašanja u odnosu na početno stanje.
The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies. 
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.
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). 
U većine osoba s teškim oštećenjem jetre klirens levetiracetama smanjen je za više od 50% uslijed popratnog oštećenja bubrega (vidjeti dio 4.2).
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. 
Rezultati kliničkih studija na odraslim bolesnicima prije stavljanja lijeka u promet pokazuju da levetiracetam ne utječe na serumske koncentracije postojećih antiepileptika (fenitoin, karbamazepin, valproatna kiselina, fenobarbital, lamotrigin, gabapentin i primidon) te da ti antiepileptici ne utječu na farmakokinetiku levetiracetama.
The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy. 
Farmakokinetički profil zdravih dobrovoljaca i bolesnika s epilepsijom jest usporediv.
The active substance is levetiracetam. 
- Djelatna tvar je levetiracetam.
CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m 
CLcr (ml/min/1,73 m 2) = ---------------------------- x 1,73 PT bolesnika (m
Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency. 
Nuspojave zabilježene tijekom kliničkih studija (odrasli, adolescenti, djeca i dojenčad starija od 1 mjeseca) ili iskustva nakon stavljanja lijeka u promet navedene su u sljedećoj tablici s obzirom na organski sustav i učestalost.
Levetiracetam Hospira is indicated as adjunctive therapy 
Levetiracetam Hospira je indicirana kao dodatna terapija
Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor. 
Levetiracetam Hospira se može koristiti u trudnoći samo ako nakon pažljive procjene Vaš liječnik smatra da je to potrebno.
Directions for the proper use of Levetiracetam Hospira is provided in section 3. 
Upute za pravilnu primjenu Levetiracetam Hospire se nalaze u dijelu 3.
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. 
Na temelju retrospektivne procjene farmakokinetičkih interakcija u djece i adolescenata s epilepsijom (4 do 17 godina) potvrđeno je da dodatno peroralno liječenje levetiracetamom ne utječe na ravnotežne serumske koncentracije istodobno primijenjenog karbamazepina i valproata.
Levetiracetam Hospira concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6). 
Levetiracetam Hospira koncentrat je isključivo za intravensku primjenu i preporučena doza mora se razrijediti u najmanje 100 ml kompatibilnog otapala i primijeniti intravenski kao 15-minutna intravenska infuzija (vidjeti dio 6.6).
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis); 
• crvenilo kože koje može tvoriti mjehure i izgledati kao male mete (sa središnjim tamnim točkama okruženim bljeđim područjem i tamnim prstenom oko ruba) (multiformni eritem), jako rasprostranjen osip s mjehurma i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom), i mnogo teži oblik koji uzrokuje ljuštenje kože na više od 30% površine tijela (toksična epidermalna nekroliza).
There is no experience with administration of intravenous levetiracetam for longer period than 4 days. 
• Nema iskustva sa intravenskom primjenom levetiracetama za razdoblje duže od 4 dana.
What you need to know before you are given Levetiracetam Hospira 
Što morate znati prije nego počnete primjenjivati Levetiracetam Hospira
Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible. 
Levetiracetam Hospira koncentrat je alternativa za bolesnike kada peroralna primjena privremeno nije moguća.
At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. 
Na početku liječenja ili nakon povećanja doze neke od nuspojava, poput pospanosti, umora i omaglice, mogu se češće javiti.
Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1,500 mg infused over 15 minutes was 51 ± 19 micrograms/ml (arithmetic average ± standard deviation). 
Vršna koncentracija u plazmi (Cmax) izmjerena u 17 ispitanika nakon jednokratne intravenske doze od 1500 mg primijenjene infuzijom tijekom 15 minuta bila je 51 ± 19 mikrograma/ml (aritmetička sredina ± standardna devijacija).
Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed. 
Nakon ponovljene primjene peroralne doze (20 do 60 mg/kg/na dan) u djece s epilepsijom (4 do 12 godina) levetiracetam se brzo apsorbira.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes. 
Preporučena doza mora biti razrijeđena u najmanje 100 ml kompatibilnog otapala i primijenjena infuzijom tijekom 15 minuta.
Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution. 
Levetiracetam Hospira koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra, bezbojna otopina.
It was concluded that levetiracetam was not different (non-inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population. 
Zaključeno je da se levetiracetam u populaciji po protokolu nije razlikovao od placeba (nije bio manje vrijedan) s obzirom na promjene od početnih vrijednosti rezultata testiranja dobivenih ljestvicom Leiter-R Attention and Memory, Memory Screen Composite.
Levetiracetam Hospira concentrate for solution for infusion is packed in a cardboard box containing 10 or 25 vials of 5 ml. 
Levetiracetam Hospira koncentrat za otopinu za infuziju pakiran je u kutije od 10 ili 25 bočica od 5 ml.
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist). 
Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog validiranim instrumentom (CBCLAchenbach Child Behavior Checklist) na standardiziran i sistematičan način.
Each carton contains 10 or 25 vials. 
Jedna kutija sadrži 10 ili 25 bočica.
The use of levetiracetam has been very rarely associated with acute kidney injury with a time to onset ranging from a few days to several months. 
Primjena levetiracetama vrlo je rijetko bila povezana s akutnim oštećenjem bubrega, a može se pojaviti u rasponu od nekoliko dana do nekoliko mjeseci od početka primjene.
What Levetiracetam Hospira is and what it is used for 
Što je Levetiracetam Hospira za što se koristi
Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. 
Pokazalo se da istodobna primjena levetiracetama s metotreksatom smanjuje klirens metotreksata, zbog čega je koncentracija metotreksata u krvi povišena/ dugotrajno povišena do potencijalno toksičnih razina.