natgillin/translations-raw huggingface dataset:
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with twice daily dosing. 
Potrjen je bil tudi časovno neodvisen farmakokinetični profil levetiracetama pri intravenski infuziji 1500 mg dvakrat dnevno 4 dni.
Levetiracetam SUN is packed in colorless tubular glass vial (type I) with 20 mm grey bromobutyl rubber stopper sealed with white flip-top aluminum seal. 
Levetiracetam SUN je pakiran v brezbarvnih steklenih vialah (tip I) z 20 mm sivimi bromobutilnimi gumijastimi zamaški, zapečatenih z belo aluminijasto/polipropilensko zaporko (flip top).
From a microbiological point of view, the product should be used immediately after dilution. 
Z mikrobiološkega vidika je zdravilo treba uporabiti takoj po redčenju.
Levetiracetam SUN is for intravenous use. 
Zdravilo Levetiracetam SUN je za intravensko uporabo.
Monotherapy for adults and adolescents from 16 years of age 
Samostojno zdravljenje za odrasle in mladostnike od 16. leta starosti
If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor. 
Če imate kakršnekoli simptome depresije ali misli o samomoru ali oboje, se posvetujte z zdravnikom.
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. 
Retrospektivna ocena o farmakokinetičnih interakcijah pri otrocih in mladostnikih z epilepsijo (od 4 do 17 let) je potrdila, da dopolnilna terapija s peroralno vzetim levetiracetamom ni vplivala na koncentracije v serumu v stanju dinamičnega ravnotežja pri sočasnem dajanju karbamazepina in valproata.
- A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves. 
- pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Levetiracetam SUN, so se pojavile misli na samopoškodovanje ali samomor.
At 3600 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 3.600 mg/kg/dan se je samo v eni od dveh študij embrio-fetalnega razvoja telesna masa plodu rahlo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes. 
Priporočen odmerek se mora razredčiti v vsaj 100 ml kompatibilnega topila in infundirano15 minut.
(2) Following dialysis, a 250 to 500 mg supplemental dose is recommended. 
Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
If stopping treatment, as with other antiepileptic medicines, Levetiracetam SUN should be discontinued gradually to avoid an increase of seizures. 
Če ste prenehali uporabljati zdravilo Levetiracetam SUN Tako kot pri vseh protiepileptičnih zdravilih je tudi pri zdravilu Levetiracetam SUN treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines. 
Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalčkov povzročeno z Zn2+ in β- karbolini.
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. 
Podatki pred prihodom zdravila na tržišče, pridobljeni iz kliničnih študij izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo drugih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona), in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
What Levetiracetam SUN looks like and contents of the pack Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid. 
Izgled zdravila Levetiracetam SUN in vsebina pakiranja Levetiracetam SUN koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna, tekočina.
In use shelf life: from a microbiological point of view, the product should be used immediately after dilution. 
Rok uporabnosti po redčenju: z mikrobiološkega vidika je zdravilo treba uporabiti takoj po redčenju.
Oral contraceptives and other pharmacokinetics interactions Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified. 
Peroralni kontraceptivi in druge farmakokinetične interakcije Levetiracetam v odmerku 1.000 mg na dan ni vplival na farmakokinetiko peroralnih kontraceptivov (etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
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). 
Če je treba zdravljenje z levetiracetamom prekiniti je priporočljivo zdravljenje opustiti postopno (npr. pri odraslih in mladostnikih, težkih več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna.
Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily not feasible. 
Koncentrat zdravila Levetiracetam SUN je alternativa za bolnike, pri katerih peroralna uporaba začasno ni mogoča.
The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies. 
Odmerki 1.800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase plodov, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
The intravenous formulation is an alternative to the oral formulation. 
Intravenska oblika je alternativa vaši peroralni uporabi.
INFORMATION IN BRAILLE Justification for not including Braille accepted 
PODATKI V BRAILLOVI PISAVI Razlog za nedostopnost v Braillovi pisavi zaveden.
In the elderly, the half-life is increased by about 40 % (10 to 11 hours). 
Zaradi zmanjšanega delovanja ledvic se pri starejših razpolovni čas podaljša za približno 40 % (10 do 11 ur) (glejte poglavje 4.2).
This medicinal product is for single use only, any unused solution should be discarded. 
Zdravilo je samo za enkratno uporabo, neporabljeno raztopino je treba zavreči.
In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6% for patients on placebo. 
Delež bolnikov iz zbranih analiz, pri katerih je bilo doseženo 50 ali več odstotno zmanjšanje pogostnosti parcialnih napadov na teden pri stalnem odmerku (12/14 tednov), je bil 27,7 % pri bolnikih, ki so prejemali 1.000 mg, 31,6 % pri bolnikih, ki so prejemali 2.000 mg in 41,3 % pri bolnikih, ki so prejemali 3.000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
Levetiracetam therapy can be initiated with either intravenous or oral administration. 
Zdravljenje z zdravilom Levetiracetam lahko začnemo z intravensko ali peroralno uporabo.
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. 
Vendar je na osnovi farmakokinetičnih značilnosti levetiracetama, farmakokinetike pri odraslih po intravenskem dajanju in farmakokinetike pri otrocih po peroralnem dajanju, pričakovati pri otrocih, od 4 do 12 let, podobno razpoložljivost (AUC) levetiracetama po intravenskem in peroralnem dajanju.
In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks. 
Pri odraslih je bila učinkovitost levetiracetama dokazana v 3 dvojno slepih, s placebom nadzorovanih študijah s 1.000 mg, 2.000 mg ali 3.000 mg/dan, razdeljenih na dva odmerka, ter s trajanjem zdravljenja do 18 tednov.
How to store Levetiracetam SUN Contents of the pack and other information 
Shranjevanje Levetiracetama SUN Vsebina pakiranja in dodatne informacije
Levetiracetam SUN 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). 
Koncentrat zdravila Levetiracetam SUN je samo za intravensko uporabo, priporočeni odmerek mora biti razredčen v vsaj 100 ml kompatibilnega topila in uporabljen intravensko kot 15-minutna intravenska infuzija (glejte poglavje 6.6).
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. 
Zaradi majhne uporabe zdravila levetiracetama za intravensko uporabo in bioekvivalence med peroralno in intravensko obliko se informacije o varnosti za zdravilo levetiracetama za intravensko uporabo navezujejo na zdravilo levetiracetama za peroralno uporabo.
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite but not of levetiracetam. 
Ugotovili so, da probenecid (500 mg štirikrat na dan), ki preprečuje ledvično tubularno sekrecijo, zavre ledvični očistek primarnega presnovka, ne pa levetiracetama.
The risk of anorexia is higher when levetiracetam is coadministered with topiramate. 
Tveganje za pojav anoreksije je večje pri sočasni uporabi levetiracetama in topiramata.
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. 
Ugotovili so, da se levetiracetam pri populaciji v skladu s protokolom ne razlikuje (ni manjvreden) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
Levetiracetam and related analogues show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy. 
Levetiracetam in sorodni analogi kažejo vrstni red afinitete za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo protiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for young adolescents and children using the following formula (Schwartz formula): 
CLcr v ml/min/1,73 m2 je pri mlajših mladostnikih, otrocih in dojenčkih, mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) z uporabo naslednje formule (po Schwartz-evi formuli):
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. 
Zdravilna učinkovina levetiracetama je pirolidonski derivat (S-enantiomer α-etil-2-okso1- pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
Dose in children 50 kg or greater is the same as in adults. 
Pri otrocih, ki s telesno maso 50 kg ali več, je odmerjanje enako kot pri odraslih.
The patients were randomized to carbamazepine CR 400 - 1200 mg/day or levetiracetam 1000 - 3000 mg/day, the duration of the treatment was up to 121 weeks depending on the response. 
Bolniki so randomizirano prejemali 400-1200 mg karbamazepina z nadzorovanim sproščanjem (CR) na dan ali 1.000-3.000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov odvisno od odziva.
For doctors and nurses, more detailed direction for the proper use of Levetiracetam SUN is provided in section 6. 
Za zdravnike in medicinske sestre so podrobna navodila za uporabo zdravila Levetiracetam SUN navedena v poglavju 6.
This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial). 
To zdravilo vsebuje 2,5 mmol (ali 57 mg) natrija v največjem enkratnem odmerku (0,8 mmola (ali 19 mg) na vialo).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg/5 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 mg/5 ml
Creatinine clearance (ml/min/1.73 m2) 
Očistek kreatinina (ml/min/1,73m2)
Infusion Time 
Čas infuzije Pogostost uporabe
There is no experience with administration of intravenous levetiracetam for longer period than 4 days. 
Trajanje zdravljenja Ni izkušenj z intravensko uporabo levetiracetama za obdobje daljše od 4 dni.
In children and adolescents aged 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. 
Pogosteje kot v drugih starostnih skupinah ali v skupnem varnostnem profilu so pri otrocih in mladostnikih, starih od 4 do 16 let, poročali o bruhanju (zelo pogosto, 11,2 %), agitaciji (pogosto, 3,4 %), nihanjih razpoloženja (pogosto, 2,1 %), čustveni labilnosti (pogosto, 1,7 %), agresiji (pogosto, 8,2 %), nenormalnem vedenju (pogosto, 5,6 %) in letargiji (pogosto, 3,9 %).
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam. 
Tako kot pri odraslih, tudi pri pediatričnih bolnikih, ki so prejemali do 60 mg/kg/dan levetiracetama, ni jasnih dokazov o klinično značilnem medsebojnem delovanju z zdravili.
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1800 mg/kg/day. 
Peri- in postnatalno študijo razvoja so izvedli pri podganah z odmerki levetiracetama od 70, 350 in 1.800 mg/kg/dan.
Levetiracetam SUN is used - on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. 
Zdravilo Levetiracetam SUN se uporablja: - samostojno za zdravljenje pri odraslih in mladostnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated. 
Ovrednotena je bila intravenska uporaba odmerkov do 4.000 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 15 minut in odmerkov do 2.500 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 5 minut.
One vial of Levetiracetam SUN concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml). 
Ena viala koncentrata zdravila Levetiracetam SUN vsebuje 500 mg levetiracetama (5 ml koncentrata po 100 mg/ml).
Diluents: - Sodium chloride 9 mg/ml (0.9%) solution for injection - Lactated Ringer's solution for injection - Dextrose 50 mg/ml (5%) solution for injection 
Raztopine: - natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje - Ringerjeva raztopina z laktatom za injiciranje - dekstroza 50 mg/ml (5 %) raztopina za injiciranje
A single dose of 1500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1500 mg levetiracetam oral intake, given as three 500 mg tablets. 
Enkratni odmerek 1.500 mg levetiracetama, razredčen v 100 ml kompatibilnega topila in 15 minut intravensko infundiran, je bioekvivalenten 1.500 mg peroralnega levetiracetama, to so 3 tablete po 500 mg.
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day. 
Dve študiji embrio-fetalnega razvoja pri podganah so izvedli z odmerki 400, 1.200 in 3.600 mg/kg/dan.
Adjustment of the dose is recommended in elderly patients with compromised renal function (see "Renal impairment" below). 
Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj »Bolniki z ledvično okvaro«).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Druga zdravila in zdravilo Levetiracetam SUN Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). 
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra, brezbarvna tekočina.
Uncommon: may affect up to 1 in 100 people - decreased number of blood platelets, decreased number of white blood cells - weight decrease, weight increase - suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, 
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - zmanjšano število krvnih ploščic, zmanjšano število belih krvnih celic - zmanjšanje telesne mase, povečanje telesne mase - poskus samomora in razmišljanje o samomoru, duševne motnje, nenormalno vedenje,
(impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration) - diplopia (double vision), vision blurred - elevated/abnormal values in a liver function test - hair loss, eczema, pruritus - muscle weakness, myalgia (muscle pain) - injury 
(motena usklajenost mišičnih gibov), parestezija (mravljinčenje), motnje pozornosti (izguba koncentracije) - diplopija (dvojni vid), zamegljen vid - povišane/nenormalne vrednosti testov jetrnih funkcij - izguba las, ekcem, pruritus - šibkost mišic, mialgija (bolečina v mišicah) - poškodba
The maximum dose is 1500 mg twice daily. 
Največji odmerek je 1.500 mg dvakrat na dan.
(2) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended. 
(2) Po dializi je priporočljiv dodatni odmerek od 5 to 10 mg/kg (0,05 do 0,10 ml/kg).
Levetiracetam SUN concentrate for solution for infusion can be used when administration of oral levetiracetam is temporarily impossible. 
Zdravilo Levetiracetam SUN koncentrat za raztopino za infundiranje se lahko uporablja, kadar uporaba peroralnega protiepileptičnega zdravila Levetiracetam začasno ni mogoča.
- weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction - swelling of the face, lips, tongue and throat (Quincke's oedema) - 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]) - 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 - 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) - a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) - a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis) - 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. 
- šibkost, vrtoglavico ali omotico ali težave z dihanjem, saj so to lahko znaki resne alergijske (anafilaktične) reakcije - otekanje obraza, ustnic, jezika in žrela (Quinckejev edem) - gripi podobne simptome in izpuščaj na obrazu, ki se v nadaljevanju razširi in ga spremlja visoka temperatura, zvišane vrednosti jetrnih encimov pri krvnih testih in povečanje števila določenega tipa belih krvnih celic (eozinofilija) ter povečane bezgavke (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi [DRESS] - simptome kot so nizek volumen urina, utrujenost, slabost, bruhanje, zmedenost in otekanje nog, gležnjev ali stopal saj so lahko to znaki nenadnega zmanjšanja delovanja ledvic - kožni izpuščaj, ki lahko tvori mehurčke in po videzu spominja na majhne tarče (na sredini temne pike, obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem) - široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) - hujšo obliko, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza) - 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.
Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg 
Dopolnilno zdravljenje za otroke (od 4 do 11 let) in mladostnike (od 12 do 17 let), s telesno maso manjšo od 50 kg
Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero. 
O nevrološkem razvoju otrok, ki so bili in utero izpostavljeni zdravilu z levetiracetamom, uporabljenim samostojno, so na voljo samo omejeni dokazi.
Levetiracetam SUN concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25°C. 
Koncentrat zdravila Levetiracetam SUN je fizikalno kompatibilen in kemijsko stabilen vsaj 24 ur pri mešanju z naslednjimi raztopinami ter shranjen v PVC vrečah pri kontrolirani sobni temperaturi 15 °C do 25 °C.
Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes. 
Učinkovitost levetiracetama je bila dokazana v dvojno slepi, s placebom nadzorovani 16-tedenski študiji pri bolnikih, od 12 leta starosti, z idiopatsko generalizirano epilepsijo z miokloničnimi napadi pri različnih sindromih.
Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day. 
Štiri študije embrio-fetalnega razvoja pri kuncih so izvedli z odmerki 200, 600, 800, 1.200 in 1.800 mg/kg/dan.
Levetiracetam SUN concentrate for solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25°C. 
Zdravilo Levetiracetam SUN koncentrat za raztopino za infundiranje je fizikalno kompatibilen in kemijsko stabilen vsaj 24 ur pri mešanju z naslednjimi raztopinami ter shranjen v PVC vrečah pri kontrolirani sobni temperaturi 15 °C do 25 °C.