FrancophonIA/ELRC3.0 huggingface dataset:
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]).
Slovenian: • 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])
English: See the package leaflet for further information.
Slovenian: Za podrobnejše informacije glejte priloženo navodilo za uporabo.
English: Levetiracetam Hospira concentrate for solution for infusion is packed in a cardboard box containing 10 or 25 vials of 5 ml.
Slovenian: Zdravilo Levetiracetam Hospira koncentrat za raztopino za infundiranje je pakirano v škatle po 10 ali 25 5 ml vial.
English: In this study, the patients received levetiracetam as a fixed dose of 60 mg/kg/day (with twice a day dosing).
Slovenian: V tej študiji so bolniki prejemali stalen odmerek 60 mg/kg/dan (odmerjanje dvakrat na dan).
English: Add-on therapy for infants and children less than 4 years The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Slovenian: Dopolnilno zdravljenje za dojenčke in otroke, mlajše od 4 let Varnost in učinkovitost levetiracetama v obliki koncentrata za raztopino za infundiranje pri dojenčkih in pri otrocih, mlajših od 4 let, nista bili dokazani.
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of
Slovenian: V študiji, ki je odražala klinično prakso, je bilo mogoče pri omejenem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 od 69 odraslih bolnikov), prekiniti sočasno antiepileptično zdravljenje.
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).
Slovenian: 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).
English: If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Slovenian: Ne uporabljajte zdravila Levetiracetam Hospira če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: There is no evidence for any relevant gender, race or circadian variability.
Slovenian: Med spoloma, rasami ali cirkadiano ni znakov pomembne variabilnosti.
English: Levetiracetam Hospira 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.
Slovenian: Zdravilo Levetiracetam Hospira se uporablja: samostojno za zdravljenje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
English: The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Slovenian: Farmakokinetični profil pri bolnikih z epilepsijo je primerljiv s farmakokinetičnim profilom pri zdravih prostovoljcih.
English: 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.
Slovenian: Ugotovili so, da probenecid (500 mg štirikrat na dan), ki preprečuje ledvično tubularno sekrecijo, zavre ledvični očistek primarnega presnovka, ne pa levetiracetama.
English: This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
Slovenian: Ta odkritja kažejo, da bi lahko interakcija med levetiracetamom in sinaptičnim vezikularnim proteinom 2A prispevala k antiepileptičnemu delovanju zdravila.
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: Ugotovili so, da se levetiracetam pri populaciji po protokolu ne razlikuje (ni manjvredno) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
English: In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter je pred izbiro odmerka priporočljivo oceniti delovanje ledvic (glejte poglavje 4.2).
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je zdravilo treba uporabiti takoj, razen, če metoda redčenja izključuje tveganje za mikrobiološko kontaminacijo.
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Slovenian: CLcr v ml/min/1,73 m2 je pri mlajših mladostnikih in otrocih mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) z uporabo naslednje formule (po Schwartzevi formuli):
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat)
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Slovenian: Priporočeni odmedrek se mora razredčiti v vsaj 100 ml kompatibilnega topila in infundirati 15 minut.
English: 10 vials 25 vials
Slovenian: 10 vial 25 vial
English: The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
Slovenian: Tveganje za pojav anoreksije je večje pri sočasni uporabi levetiracetama in topiramata.
English: The pharmacokinetics in paediatric patients has not been investigated after intravenous administration.
Slovenian: Pri otrocih niso raziskovali farmakokinetike po intravenskem dajanju.
English: 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.
Slovenian: Levetiracetam in sorodni analogi kažejo vrstni red afinitete za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo antiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
English: Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution.
Slovenian: Zdravilo Levetiracetam Hospira koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna raztopina.
English: This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial).
Slovenian: To zdravilo vsebuje 2,5 mmol (ali 57 mg) natrija v največjem enkratnem odmerku (0,8 mmol (ali 19 mg) na vialo).
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Slovenian: V tej študiji je bil odmerek levetiracetama za odrasle in mladostnike 3.000 mg na dan, za otroke pa 60 mg/kg/dan, razdeljen na dva odmerka.
English: Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
Slovenian: Zdravilo Levetiracetam Hospira se lahko med nosečnostjo uporablja samo, če zdravnik po skrbni oceni ugotovi, da je to potrebno.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Slovenian: [140 - starost (leta)] x masa (kg) CLcr (ml/min) = ---------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl)
English: Levetiracetam therapy can be initiated with either intravenous or oral administration.
Slovenian: Zdravljenje z levetiracetamom lahko začnemo z intravensko ali peroralno uporabo.
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Slovenian: Peri- in postnatalne razvojne študije z levetiracetamom pri podganah so izvedli pri odmerkih od 70, 350 in 1.800 mg/kg/dan.
English: • anorexia (loss of appetite);
Slovenian: anoreksija (izguba teka);
English: Dose in children and adolescents 50 kg or more is the same as in adults.
Slovenian: Pri otrocih in mladostnikih, težkih 50 kg ali več, je odmerjanje enako kot pri odraslih.
English: If stopping treatment, as with other antiepileptic medicines, Levetiracetam Hospira should be discontinued gradually to avoid an increase of seizures.
Slovenian: Tako kot pri vseh protiepileptičnih zdravilih je tudi pri zdravilu Levetiracetam Hospira treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
English: The total daily dose and frequency of administration should be maintained.
Slovenian: Celokupni dnevni odmerek in pogostost uporabe morata ostati enaka.
English: 35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
Slovenian: 35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih < 6 mesecev, je bilo vključenih v placebo kontrolirane klinične študije.
English: The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the creatinine clearance.
Slovenian: Navidezni telesni očistek levetiracetama in njegovega primarnega presnovka korelira z očistkom kreatinina.
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.
Slovenian: Dvojno slepa, s placebom nadzorovana pediatrična študija o varnosti z modelom o enakovrednosti zdravljenja je pokazala kognitivne in nevropsihološke učinke levetiracetama pri pediatričnih bolnikih, starih od 4 do 16 let s parcialnimi napadi.
English: • pancreatitis (inflammation of the pancreas);
Slovenian: • pankreatitis (vnetje trebušne slinavke);
English: • Dextrose 50 mg/ml (5%) solution for injection
Slovenian: • glukoza 50 mg/ml (5 %) raztopina za injiciranje
English: The intravenous administration of doses up to 4,000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2,500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Slovenian: 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.
English: No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Slovenian: Pri dojenčkih z epilepsijo, mlajših od 12 mesecev, niso ugotovili nobenih novih pomislekov glede varnosti za levetiracetam.
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Slovenian: Dve študiji embriofetalnega razvoja pri podganah so izvedli pri odmerkih 400, 1.200 in 3.600 mg/kg/dan.
English: The active substance is levetiracetam.
Slovenian: Učinkovina je levetiracetam.
English: Periodic Safety Update Reports
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR)
English: With continued long-term treatment, 47.4% of the patients were free of tonic-clonic seizures for at least 6 months and 31.5% were free of tonic-clonic seizures for at least 1 year.
Slovenian: Z nadaljevanjem dolgotrajnega zdravljenja je bilo 47,4 % bolnikov brez tonično-kloničnih napadov vsaj 6 mesecev, 31,5 % pa jih je bilo brez tonično-kloničnih napadov vsaj 1 leto.
English: Renal impairment The daily dose must be individualised according to renal function.
Slovenian: Bolniki z ledvično okvaro Dnevni odmerek je treba prilagoditi individualno glede na delovanje ledvic.
English: The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Slovenian: Frakcijska odstranitev levetiracetama med tipično 4-urno dializo je bila 51 %.
English: A single dose of 1,500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1,500 mg levetiracetam oral intake, given as three 500 mg tablets.
Slovenian: 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.
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.
Slovenian: Po uporabi posamičnega peroralnega odmerka (20 mg/kg) pri otrocih z epilepsijo (od 6 do 12 let) je bil razpolovni čas levetiracetama 6,0 ur.
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Slovenian: V nekaterih primerih alopecije so po prekinitvi zdravljenja z levetiracetamom opazili izboljšanje.
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Slovenian: Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj "Bolniki z ledvično okvaro").
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 12 mesecev ni imela napadov (56,6 % preiskovancev, ki so prejemali levetiracetam, in 58,5 % preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Slovenian: O nevrološkem razvoju otrok, ki so bili in utero izpostavljeni levetiracetamu, uporabljenim samostojno, so na voljo samo omejeni dokazi.
English: Levetiracetam Hospira concentrate was found to be physically compatible and chemically stable when mixed with the following diluents:
Slovenian: Zdravilo Levetiracetam Hospira koncentrat je fizikalno kompatibilno in kemijsko stabilno pri mešanju z naslednjimi redčili:
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.
Slovenian: 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 %).
English: 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.
Slovenian: Učinkovitost levetiracetama je bila dokazana v dvojno slepi, s placebom nadzorovani 16-tedenski študiji pri bolnikih, od 12 leta starosti in starejših, z idiopatsko generalizirano epilepsijo z miokloničnimi napadi pri različnih sindromih.
English: • Lactated Ringer's solution for injection
Slovenian: • Ringerjev laktat raztopina za injiciranje
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1,200 and 1,800 mg/kg/day.
Slovenian: Štiri študije embriofetalnega razvoja pri kuncih so izvedli pri odmerkih 200, 600, 800, 1.200 in 1.800 mg/kg/dan.
English: • weight decrease, weight increase;
Slovenian: • zmanjšanje telesne mase, povečanje telesne mase;
English: Levetiracetam is a highly soluble and permeable compound.
Slovenian: Levetiracetam je zelo lahko topna in permeabilna snov.
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Slovenian: • parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti, z epilepsijo.
English: There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Slovenian: Trajanje zdravljenja: • Ni izkušenj z intravensko uporabo levetiracetama za obdobje, daljše od 4 dni.
English: With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Slovenian: Z nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napada vsaj 6 mesecev, 7,2 % pa jih je bilo brez napada vsaj 1 leto.
English: Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Slovenian: V času nosečnosti so opazili zmanjšano koncentracijo levetiracetama v plazmi.
English: Levetiracetam Hospira concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic levetiracetammedicine by mouth is temporarily not feasible.
Slovenian: Zdravilo Levetiracetam Hospira koncentrat je alternativa za bolnike, ko uporaba peroralnega antiepileptičnega zdravila z levetiracetamom začasno ni mogoča.
English: One vial of Levetiracetam Hospira concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Slovenian: Ena viala zdravila Levetiracetam Hospira koncentrat vsebuje 500 mg levetiracetama (5 ml koncentrata po 100 mg/ml).
English: One maximum single dose of Levetiracetam Hospira concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial).
Slovenian: Največji enkratni odmerek zdravila Levetiracetam Hospira koncentrat vsebuje 2,5 mmol (ali 57 mg) natrija (0,8 mmol (ali 19 mg) natrija na vialo).
English: Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Slovenian: Zdravilo Levetiracetam Hospira koncentrat je alternativa za bolnike, pri katerih peroralna uporaba začasno ni mogoča.
English: Other medicines and Levetiracetam Hospira
Slovenian: Druga zdravila in zdravilo Levetiracetam Hospira
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
Slovenian: Z nadaljevanjem dolgotrajnega zdravljenja je bilo 28,6 % bolnikov brez miokloničnih napadov vsaj 6 mesecev, 21,0 % pa jih je bilo brez miokloničnih napadov vsaj 1 leto.
English: Levetiracetam concentrate for solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents:
Slovenian: Levetiracetam koncentrat za raztopino za infundiranje je fizikalno kompatibilen in kemijsko stabilen pri mešanju z naslednjimi redčili:
English: For adult patients, refer to the following table and adjust the dose as indicated.
Slovenian: Sklicujoč se na spodnjo preglednico se odmerek za odrasle bolnike prilagodi, kot je navedeno.
English: In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours during interdialytic and intradialytic periods, respectively.
Slovenian: Pri anuričnih odraslih osebah s končno ledvično odpovedjo je bil razpolovni čas v obdobju med eno in drugo dializo približno 25 ur, med samo dializo pa približno 3,1 ure.
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Slovenian: Tako kot pri odraslih tudi pri otrocih, ki so prejemali do 60 mg/kg/dan levetiracetama, ni jasnih dokazov o klinično značilnem medsebojnem delovanju z zdravili.
English: Levetiracetam Hospira is indicated as adjunctive therapy
Slovenian: Zdravilo Levetiracetam Hospira je indicirano za dopolnilno zdravljenje:
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Slovenian: Pogosteje kot v drugih starostnih skupinah ali v skupnem varnostnem profilu so pri dojenčkih in otrocih, starih od 1 meseca do manj kot 4 leta, poročali o razdražljivosti (zelo pogosto, 11,7 %) in poslabšani koordinaciji (pogosto, 3,3 %).
English: • vertigo (sensation of rotation);
Slovenian: • vrtoglavica (občutek vrtenja);
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type
Slovenian: In vitro študije so pokazale, da levetiracetam vpliva na nivo Ca znotraj nevrona preko delne inhibicije Ca kanalčkov tipa N in zmanjšanjem sproščanja Ca iz zalog znotraj nevrona.
English: Monotherapy for adults and adolescents from 16 years of age The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks.
Slovenian: Samostojno zdravljenje za odrasle in mladostnike od 16. leta starosti Priporočeni začetni odmerek je 250 mg dvakrat na dan, ki ga po dveh tednih povečamo na začetni terapevtski odmerek 500 mg dvakrat na dan. Odmerek se lahko poveča za 250 mg dvakrat na dan vsaka dva tedna glede na klinični odziv.
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Slovenian: razširjenih študij o uporabi levetiracetama ter s postmarketinškimi podatki.
English: 72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater decrease in the frequency of PGTC seizures per week.
Slovenian: Pri 72,2 % bolnikov, ki so se zdravili z levetiracetamom, in 45,2 % bolnikov, ki so prejemali placebo, je bilo 50 ali več odstotno zmanjšanje pogostnosti PGTC napadov na teden.
English: Each vial contains 19 mg of sodium.
Slovenian: Ena viala vsebuje 19 mg natrija.
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 preiskovancih z blago in zmerno jetrno okvaro se očistek levetiracetama ni pomembno spremenil, pri večini preiskovancev s hudo jetrno okvaro pa se je zaradi sočasne okvare ledvic zmanjšal za več kot 50 % (glejte poglavje 4.2).
English: Levetiracetam Hospira 100 mg/ml sterile concentrate levetiracetam
Slovenian: Levetiracetam Hospira 100 mg/ml sterilni koncentrat levetiracetam i.v.
English: This dose can be started on the first day of treatment.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.