FrancophonIA/ELRC3.0 huggingface dataset:
English: Then CLcr is adjusted for body surface area (BSA) as follows:
Slovenian: Nato se CLcr prilagodi glede na telesno površino takole:
English: ks= 0.45 in term infants to 1 year old; ks= 0.55 in children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Slovenian: ks = 0,45 pri donošenih dojenčkih do 1 leta starosti, ks = 0,55 pri otrocih, mlajših od 13 let, in pri mladostnicah, ks = 0,7 pri mladostnikih
English: Antiepileptic medicinal products
Slovenian: Antiepileptična zdravila
English: The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Slovenian: Farmakokinetični profil pri zdravih prostovoljcih in bolnikih z epilepsijo je primerljiv.
English: The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Slovenian: Farmakokinetični profil je linearen, z majhno intra- in interindividualno variabilnostjo.
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Slovenian: Poleg tega delno odpravi zmanjšanje z GABA in glicinom uravnavanih tokov, povzročenih s cinkom ß-karbolini.
English: The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: • Do not stop your treatment without your doctor's advice as this could increase your seizures.
Slovenian: • Ne prekinite zdravljenja, ne da bi se posvetovali z zdravnikom, ker se vam epileptični napadi lahko stopnjujejo.
English: Levetiracetam Actavis Group must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Slovenian: Zdravilo Levetiracetam Actavis Group je treba vzeti dvakrat na dan, enkrat zjutraj in enkrat zvečer,
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.
Slovenian: Uporaba levetiracetama je bila zelo redko povezana z akutno poškodbo ledvic, ki se lahko pojavi v razponu od nekaj dni do nekaj mesecev od uporabe.
English: • If you suffer from kidney problems, follow your doctor's instructions.
Slovenian: • Če imate težave z ledvicami, upoštevajte zdravnikova navodila.
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 behavior were not worse than baseline.
Slovenian: Vendar se preiskovancem, ki so jemali levetiracetam v dolgoročni, odprti spremljevalni študiji, v povprečju vedenjsko in čustveno delovanje ni poslabšalo; še zlasti mere agresivnega vedenja niso bile slabše kot izhodiščno.
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 69).
Slovenian: V študiji, ki odraža klinično prakso, je bilo mogoče antiepileptično zdravilo opustiti pri manjšem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 odraslih bolnikov od 69).
English: Two minor metabolites were also identified.
Slovenian: Ugotovljena sta še dva manj pomembna presnovka.
English: A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Slovenian: Veliko podatkov, pridobljenih v obdobju trženja, o nosečnicah, ki so bile izpostavljene samostojnemu zdravljenju z levetiracetamom (več kot 1800, od katerih jih je bilo več kot 1500 izpostavljenih med prvim trimesečjem), ne kažejo na povečanje tveganja za večje prirojene malformacije.
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Slovenian: • znake resnih mentalnih sprememb ali če kdo okoli vas opazi znake zmedenosti, somnolence (zaspanost), amnezije (izguba spomina), oslabljen spomin (pozabljivost), neobičajno vedenje ali druge nevrološke znake vključno z nehotenim ali nenadzorovanim gibanjem.
English: • limp or difficulty walking.
Slovenian: • šepanje ali težave pri hoji
English: Push the plunger in slowly and allow the child to swallow the content of the syringe.
Slovenian: Počasi potisnite bat, da bo otrok lahko pogoltnil vsebino brizge.
English: Normal
Slovenian: Normalno
English: • elevated/abnormal values in a liver function test;
Slovenian: • povišane/nenormalne vrednosti testov jetrnih funkcij
English: The daily dose must be individualised according to renal function.
Slovenian: Dnevni odmerek je treba individualno prilagoditi glede na delovanje ledvic.
English: If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and pull it back again.
Slovenian: Če se v brizgi pojavijo mehurčki, naj stekleničke ostane obrnjena na glavo; rahlo potisnite bat navznoter in ga nato znova potegnite ven.
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
Slovenian: Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
English: This recommendation is based on a study in adult renally impaired patients.
Slovenian: Priporočilo temelji na študiji pri odraslih bolnikih z okvaro ledvic.
English: In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
Slovenian: V obeh starostnih skupinah pediatričnih bolnikov so podatki dopolnjeni s postmarketinškimi izkušnjami pri uporabi levetiracetama.
English: The apparent body clearance was 1.1 ml/min/kg.
Slovenian: Navidezni telesni očistek je bil 1,1 ml/min/kg.
English: Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Slovenian: Zato se makrogola ne sme vzeti eno uro pred zaužitjem levetiracetama in še eno uro po zaužitju.
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Slovenian: V več primerih alopecije so opažali njeno izginotje po prenehanju uporabe levetiracetama.
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.
Slovenian: Predmarketinški podatki iz kliničnih študij pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo obstoječih antiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona) in da ta antiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
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.
Slovenian: Pri človeku je delovanje pri parcialnih in generaliziranih epileptičnih motnjah (epileptiformna sprožitev/fotoparoksizmalni odziv) potrdilo široki predklinično ugotovljeni farmakološki profil levetiracetama.
English: To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Slovenian: Za uporabo te odmerne preglednice je treba oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
English: <1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000).
Slovenian: (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Slovenian: Če imate kakšne simptome depresije in/ali razmišljate o samomoru, se posvetujte z zdravnikom.
English: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced.
Slovenian: Hrana ni spremenila deleža absorpcije levetiracetama, je pa rahlo zmanjšala hitrost absorpcije.
English: In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Slovenian: Poskusi in vitro in in vivo kažejo, da levetiracetam ne spreminja osnovnih značilnosti celic in normalnega živčnega prenosa.
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).
Slovenian: Stanje 6 mesecev brez napadov je doseglo 73,0 % prejemnikov levetiracetama in 72,8 % prejemnikov karbamazepina CR; korigirana absolutna razlika med zdraviloma je bila 0,2 % (95 % IZ: -7,8, 8,2).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih poškodba
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Slovenian: Levetiracetam je antiepileptično zdravilo (zdravilo za zdravljenje napadov pri epilepsiji).
English: Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Slovenian: Zato je pri priporočljiva previdnost pri bolnikih, ki izvajajo dejavnosti, pri katerih je potrebna pozornost, npr. upravljajo vozila ali stroje.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilno razmišljanje ali vedenje.
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Slovenian: Zdravnik mora predpisati najprimernejšo farmacevtsko obliko, pakiranje in jakost glede na starost, telesno maso in odmerek.
English: Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed.
Slovenian: Levetiracetam se lahko uporablja med nosečnostjo, če se po skrbnem pretehtanju ugotovi, da je to klinično potrebno.
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).
Slovenian: Farmakokinetični rezultati kažejo, da je razpolovni čas krajši (5,3 ure) kot pri odraslih (7,2 ure), navidezni očistek pa je hitrejši (1,5 ml/min/kg) kot pri odraslih (0,96
English: A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Slovenian: Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptičnih zdravil je pokazala tudi majhno povečanje tveganja samomorilnih misli in vedenja.
English: Do not use after 7 months of first opening the bottle.
Slovenian: Zdravila ne smete uporabljati več kot 7 mesece po prvem odprtju stekleničke.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni 'brez natrija'.
English: Repeat until there are no bubbles in the syringe (Figure 6).
Slovenian: To ponavljajte, dokler v brizgi ne več mehurčkov (slika 6).
English: Infants and children (1 month to 4 years)
Slovenian: Dojenčki in otroci (od 1 meseca do 4 let)
English: Oral contraceptives and other pharmacokinetics interactions
Slovenian: Peroralni kontraceptivi in druga farmakokinetična medsebojna delovanja
English: No tissue distribution data are available in humans.
Slovenian: Podatkov o porazdelitvi v tkiva pri človeku ni.
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Slovenian: Bolniki so smeli imeti le neizzvane napade parcialnega izvora ali generalizirane tonično-klonične napade.
English: The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Slovenian: Plazemski razpolovni čas pri odraslih je 7 ± 1 ura in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
English: • A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves.
Slovenian: • Pri majhnem številu oseb, ki so dobivale zdravila proti epilepsiji, kakršno je levetiracetam, se je pojavilo razmišljanje o samopoškodovanju ali samomoru.
English: • decreased number of all blood cell types;
Slovenian: • okužba • zmanjšano število vseh tipov krvnih celic
English: End-stage renal disease patients undergoing dialysis (1)
Slovenian: Bolniki s končno odpovedjo ledvic na dializi (1)
English: The total daily dose was administered twice daily.
Slovenian: Celotni dnevni odmerek je bil razdeljen na uporabo dvakrat na dan.
English: Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight.
Slovenian: Zaradi popolne in linearne absorpcije je mogoče koncentracijo v plazmi predvideti na podlagi peroralnega odmerka levetiracetama, izraženega v mg/kg telesne mase.
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.
Slovenian: Ugotovila je, da se levetiracetam v populaciji-po-protokolu ni razlikoval (ni bil inferioren) od placeba, kar zadeva spremembo sestavljene ocene Leiter-R Attention and Memory, Memory Screen Composite.
English: The majority of patients presented with juvenile myoclonic epilepsy.
Slovenian: Večina bolnikov je imela juvenilno mioklonično epilepsijo.
English: 3 years.
Slovenian: 4 leta in več.
English: If stopping treatment, Levetiracetam Actavis Group should be discontinued gradually to avoid an increase of seizures.
Slovenian: V primeru prenehanja zdravljenja je treba zdravilo Levetiracetam Actavis Group nehati uporabljati postopoma, da bi preprečili stopnjevanje napadov.
English: The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Slovenian: Navidezni, za telesno maso korigirani očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.
English: • injury.
Slovenian: • poškodba
English: Breast-feeding is not recommended during treatment.
Slovenian: Dojenje med zdravljenjem ni priporočljivo.
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).
Slovenian: Pri večini preiskovancev s hudo okvaro jeter se je očistek levetiracetama zaradi sočasne okvare ledvic zmanjšal za več kot 50 % (glejte poglavje 4.2).
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.
Slovenian: Preden začnete postopek merjenja, se prepričajte, da sta prozorno telo odmerne brizge in njen beli bat v najnižjem položaju.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino, kakšen drug pirolidonski derivat ali katero od pomožnih snovi, navedeno v poglavju 6.1.
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Slovenian: • hujšo obliko izpuščaja, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza)
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Slovenian: Poleg tega levetiracetam in vitro ne vpliva na glukuronidacijo valprojske kisline.
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50% reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Slovenian: Primarna mera učinkovitosti je bil delež odzivnih bolnikov (bolnikov, ki so dosegli ≥ 50 % zmanjšanje povprečne dnevne pogostnosti napadov parcialnega izvora), kot ga je ocenil slepljen centralni pregledovalec z uporabo 48-urnega video EEG.
English: Dose in adults and adolescents (12 to 17 years):
Slovenian: Odmerek pri odraslih in mladostnikih (od 12 do 17 let):
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Slovenian: Ti podatki so dopolnjeni s podatki iz ustreznih odprtih, razširjenih študij o uporabi levetiracetama ter s postmarketinškimi podatki.
English: After oral administration the bitter taste of levetiracetam may be experienced.
Slovenian: Po peroralnem dajanju se lahko okusi grenak okus levetiracetama.
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Slovenian: Reykjavíkurvegur 76-78
English: The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food.
Slovenian: Način uporabe Peroralno raztopino je mogoče razredčiti v kozarcu vode ali dojenčkovi steklenički; zdravilo se lahko vzame s hrano ali brez hrane.
English: • swelling of the face, lips, tongue and throat (Quincke's oedema);
Slovenian: • otekanje obraza, ustnic, jezika in žrela (Quinckejev edem)
English: Elderly (65 years and older)
Slovenian: Posebne skupine bolnikov Starejši (65 let in več)
English: • sudden decrease in kidney function;
Slovenian: • nenadno zmanjšanje delovanja ledvic
English: He/she may decide if your dose should be adjusted.
Slovenian: Zdravnik se lahko odloči, da vam bo odmerek prilagodil.
English: The extent of absorption is dose-independent and is not altered by food.
Slovenian: Obseg absorpcije ni odvisen od odmerka; hrana ga ne spremeni.
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Slovenian: Analiza učinkovitosti je zajela 109 bolnikov, ki so tako izhodiščno kot med obdobjem ocenjevanja imeli vsaj 24-urni video EEG.
English: For adults and children aged 4 years and older
Slovenian: Za odrasle in otroke, stare 4 leta in več
English: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Slovenian: • rabdomioliza (razpad mišičnega tkiva) in z njo povezano zvišanje kreatin fosfokinaze v krvi.
English: However, data suggested a 20 % higher levetiracetam clearance in children taking enzymeinducing antiepileptic medicinal products.
Slovenian: So pa podatki pokazali 20 % večji očistek levetiracetama pri otrocih, zdravljenih z antiepileptičnimi zdravili, ki inducirajo encime.
English: This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
Slovenian: To vezavno mesto je sinaptična vezikularna beljakovina 2A, domnevno vključena v fuzijo veziklov in eksocitozo nevrotransmiterjev.
English: Push the plunger in slowly to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (Figure 7).
Slovenian: Bat počasi potisnite do odmerne oznake, ki ustreza količini v mililitrih (ml), kakršno je predpisal zdravnik (slika 7).
English: Levetiracetam Actavis Group may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Slovenian: Zdravilo Levetiracetam Actavis Group vam lahko poslabša sposobnost upravljanja vozil in strojev, ker lahko povzroči zaspanost.
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.
Slovenian: V populacijski farmakokinetični analizi pri bolnikih, starih od 1 mesec do 16 let, je telesna masa statistično značilno korelirala z navideznim očistkom (očistek se je povečeval z naraščanjem telesne mase) in navideznim volumnom porazdelitve.
English: This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
Slovenian: To pakiranje je treba predpisati otrokom, starim 4 leta ali več, mladostnikom in odraslim.
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.
Slovenian: Poročali so, da sočasna uporaba levetiracetama in metotreksata zmanjša očistek metotreksata, zaradi česar je koncentracija metotreksata v krvi povišana/podaljšana do potencialno toksična.
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Slovenian: Študije in vitro so pokazale, da levetiracetam vpliva na raven Ca2+ v nevronu z delnim zavrtjem tokov Ca2+ tipa N in z zmanjšanjem sproščanja Ca2+ iz zalog v nevronu.
English: The content of the syringe can also be emptied in a glass of water or baby´s bottle.
Slovenian: Vsebino brizge lahko izpraznite tudi v kozarec vode ali v dojenčkovo stekleničko.
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Slovenian: Poleg tega je bilo v obdobju po začetku trženja zdravila, 101 dojenčkov, mlajših od 12 mesecev, vključenih v varnostno študijo.
English: More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Slovenian: Več kot polovica preiskovancev je ostala brez napadov 12 mesecev (56,6 % prejemnikov levetiracetama in 58,5 % prejemnikov karbamazepina CR).
English: Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Slovenian: Levetiracetam zavaruje pred napadi v širokem spektru živalskih modelov parcialnih in primarno generaliziranih napadov in ne deluje prokonvulzivno.
English: Management of overdose
Slovenian: Obvladovanje prevelikega odmerjanja
English: Propylene glycol (E1520)
Slovenian: Propilenglikol (E1520)
English: Nevertheless, the concentration of this metabolite remains low.
Slovenian: Kljub temu ostane koncentracija primarnega presnovka majhna.
English: Acute kidney injury
Slovenian: Akutna poškodba ledvic
English: After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis.
Slovenian: Po akutnem prevelikem odmerjanju je mogoče želodec izprazniti z izpiranjem želodca ali sprožitvijo bruhanja.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
Slovenian: • široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom)