FrancophonIA/ELRC3.0 huggingface dataset:
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: The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
Croatian: Rizik anoreksije je veći ako se levetiracetam uzima istodobno s topiramatom.
English: The majority of patients presented with juvenile myoclonic epilepsy.
Croatian: Većina bolesnika imala je juvenilnu miokloničku epilepsiju.
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 poluvijek levetiracetama u plazmi iznosi 7±1 sati i ne varira ovisno o dozi, putu primjene ili ponovljenoj primjeni.
English: 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.
Croatian: 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.
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 ekstremitete, teškoće u kontroliranju pokreta, hiperkinezija (hiperaktivnost);
English: If you stop using Levetiracetam Hospira:
Croatian: Ako prestanete uzimati Levetiracetam Hospira:
English: • Sodium chloride 9 mg/ml (0.9%) solution for injection
Croatian: • otopina natrijevog klorida 9 mg/ml (0,9 %) za injekciju
English: Excipient with known effect:
Croatian: Pomoćna tvar s poznatim učinkom
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Croatian: • rasprostranjeni osip s mjehurićima i kožom koja se ljušti, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom)
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: 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.
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Croatian: Nadalje, levetiracetam ne utječe na glukuronidaciju valproatne kiseline in vitro.
English: 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
Croatian: 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).
English: Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Croatian: Nakon dijalize preporučuje se dopunska doza od 250 ili 500 mg.
English: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Croatian: Levetiracetam ima blagi ili umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1,500 mg intravenous infusion for 4 days with twice daily dosing.
Croatian: Vremenski neovisan farmakokinetički profil levetiracetama potvrđen je također nakon intravenske infuzije od 1500 mg tijekom 4 dana dva puta dnevno.
English: 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.
Croatian: Djelatna tvar, levetiracetam, jest derivat pirolidona (S-enantiomer α-etil-2-okso-1-pirolidinacetamida), kemijski različit od postojećih antiepileptičkih djelatnih tvari.
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 dobnim skupinama (odrasli i pedijatrijski bolesnici) i u svim odobrenim indikacijama epilepsije.
English: • 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
Croatian: • 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
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: 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-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.
English: 5 ml glass vial (type I) with bromobutyl coated rubber stoppers and an aluminium flip-off seal.
Croatian: Staklena bočica (tip I) od 5 ml s gumenim čepom obloženim bromobutilom i aluminijskim flip-off zatvaračem.
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba odmah primijeniti, osim ako metoda razrjeđivanja isključuje rizik mikrobiološke kontaminacije.
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 children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Croatian: 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).
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 kontroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je ukupno 3416 bolesnika liječeno levetiracetamom.
English: 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:
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: Other medicines and Levetiracetam Hospira
Croatian: Drugi lijekovi i Levetiracetam Hospira
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: 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 jednoj od dvije EFD studije uočeno blago smanjenje fetalne težine povezano s marginalnim porastom varijacija kostura/malih anomalija.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
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: 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: 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 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.
English: The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Croatian: Farmakokinetički profil zdravih dobrovoljaca i bolesnika s epilepsijom jest usporediv.
English: The active substance is levetiracetam.
Croatian: - Djelatna tvar je levetiracetam.
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Croatian: CLcr (ml/min/1,73 m 2) = ---------------------------- x 1,73 PT bolesnika (m
English: 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.
Croatian: 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.
English: Levetiracetam Hospira is indicated as adjunctive therapy
Croatian: Levetiracetam Hospira je indicirana kao dodatna terapija
English: Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
Croatian: Levetiracetam Hospira se može koristiti u trudnoći samo ako nakon pažljive procjene Vaš liječnik smatra da je to potrebno.
English: Directions for the proper use of Levetiracetam Hospira is provided in section 3.
Croatian: Upute za pravilnu primjenu Levetiracetam Hospire se nalaze u dijelu 3.
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 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.
English: 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).
Croatian: 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).
English: • 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);
Croatian: • 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).
English: There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Croatian: • Nema iskustva sa intravenskom primjenom levetiracetama za razdoblje duže od 4 dana.
English: What you need to know before you are given Levetiracetam Hospira
Croatian: Što morate znati prije nego počnete primjenjivati Levetiracetam Hospira
English: Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Croatian: Levetiracetam Hospira koncentrat je alternativa za bolesnike kada peroralna primjena privremeno nije moguća.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Croatian: Na početku liječenja ili nakon povećanja doze neke od nuspojava, poput pospanosti, umora i omaglice, mogu se češće javiti.
English: 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).
Croatian: 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).
English: Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Croatian: Nakon ponovljene primjene peroralne doze (20 do 60 mg/kg/na dan) u djece s epilepsijom (4 do 12 godina) levetiracetam se brzo apsorbira.
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Croatian: Preporučena doza mora biti razrijeđena u najmanje 100 ml kompatibilnog otapala i primijenjena infuzijom tijekom 15 minuta.
English: Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution.
Croatian: Levetiracetam Hospira koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra, bezbojna otopina.
English: 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.
Croatian: 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.
English: Levetiracetam Hospira concentrate for solution for infusion is packed in a cardboard box containing 10 or 25 vials of 5 ml.
Croatian: Levetiracetam Hospira koncentrat za otopinu za infuziju pakiran je u kutije od 10 ili 25 bočica od 5 ml.
English: 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).
Croatian: 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.
English: Each carton contains 10 or 25 vials.
Croatian: Jedna kutija sadrži 10 ili 25 bočica.
English: 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.
Croatian: 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.
English: What Levetiracetam Hospira is and what it is used for
Croatian: Što je Levetiracetam Hospira za što se koristi
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: 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.
English: Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue.
Croatian: Nadalje, studijama in vitro pokazano je da se levetiracetam veže za specifično mjesto u moždanom tkivu glodavaca.
English: The patients were randomized to carbamazepine CR 400-1,200 mg/day or levetiracetam 1,000-3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Croatian: Bolesnici su randomizirani za dobivanje 400 - 1200 mg karbamazepina s kontroliranim otpuštanjem (CR) na dan ili 1000 - 3000 mg levetiracetama na dan, liječenje je trajalo do 121 tjedna, ovisno o odgovoru.
English: What Levetiracetam Hospiralooks like and contents of the pack
Croatian: Kako Levetiracetam Hospira izgleda i sadržaj pakiranja
English: 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Croatian: U djece i adolescenata u dobi 4 do 16 godina povraćanje (vrlo često, 11,2%), agitacija (često, 3,4%), promjene raspoloženja (često, 2,1%), nestabilnost afekta (često, 1,7%), agresija (često, 8,2%), poremećaj ponašanja (često, 5,6%) i letargija (često, 3,9%) bili su prijavljeni češće nego u drugim dobnim rasponima ili u cjelokupnom sigurnosnom profilu.
English: 1,500 twice daily Children 25 kg or less should preferably start the treatment with levetiracetam 100 mg/ml oral solution.
Croatian: 1500 mg dva puta na dan U djece od 25 kg ili manje liječenje je najbolje započeti oralnom otopinom levetiracetama od 100 mg/ml.
English: If stopping treatment, as with other antiepileptic medicines, Levetiracetam Hospira should be discontinued gradually to avoid an increase of seizures.
Croatian: Ako prekidate liječenje Levetiracetam Hospirom, kao i u slučaju drugih antiepileptika, prekid mora biti postupan kako bi se izbjeglo pojačanje napadaja.
English: • flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]).
Croatian: • simptome nalik gripi i osip na licu popraćen proširenim osipom s visokom tjelesnom temperaturom, povećane vrijednosti jetrenih enzima u krvnim testovima, povećanje posebne vrste bijelih krvnih stanica (eozinofilija) i povećane limfne čvorove (reakcija na lijek s eozinofilijom i sistemskim simptomima [DRESS]).
English: No tissue distribution data are available in humans.
Croatian: Nema podataka o distribuciji ovog lijeka u tkivima kod ljudi.
English: 58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
Croatian: 58,3% bolesnika liječenih levetiracetamom i 23,3% bolesnika koji su dobivali placebo imalo je barem 50%-tno smanjenje broja dana s miokloničkim napadajima tjedno.
English: In this study, the patients received levetiracetam as a fixed dose of 60 mg/kg/day (with twice a day dosing).
Croatian: Bolesnici su u toj studiji dobivali konstantnu dozu od 60 mg/kg/dan (doziranje dva puta na dan).
English: Levetiracetam Hospira concentrate was found to be physically compatible and chemically stable when mixed with the following diluents:
Croatian: Utvrđeno je da je Levetiracetam Hospira koncentrat fizički kompatibilan i kemijski stabilan ako se miješa sa sljedećim otapalima:
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type
Croatian: Studije in vitro pokazuju da levetiracetam utječe na razinu Ca u neuronima na način da djelomično inhibira
English: Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Croatian: Nakon primjene jedne peroralne doze (20 mg/kg) u djece s epilepsijom (6 do 12 godina), poluvijek levetiracetama bio je 6,0 sati.