natgillin/translations-raw huggingface dataset:
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. 
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 z napadi parcialnega izvora.
The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. 
Neželeni učinki, o katerih so najpogosteje poročali, so nazofaringitis, somnolenca (zaspanost), glavobol, utrujenost in omotica.
Creatinine clearance (ml/min/1.73 m2) 
skupina očistek kreatinina (ml/min/1,73m2)
Levetiracetam Actavis is not indicated in children and adolescents below 16 years on its own (monotherapy). 
Zdravilo Levetiracetam Actavis, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days. 
Pri pediatričnih bolnikih (od 1 meseca do manj kot 4. leta starosti) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 116 bolnikov in je trajala 5 dni.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy. 
Učinkovitost levetiracetama za samostojno zdravljenje je bila dokazana pri vzporednih skupinah, v dvojno slepi študiji, ki dokazuje da levetiracetam po učinkovitosti ni nič slabši od karbamazepina z nadzorovanim sproščanjem (CR), pri 576 bolnikih, starih 16 let ali več, z na novo ali nedavno diagnosticirano epilepsijo.
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 % 
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR) je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95 % CI: 7,8-8,2).
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”).
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). 
Več kot polovica preiskovancev 12 mesecev ni imela napadov (56,6 % preiskovancev, ki so prejemali levetiracetam, in 58,5 %
If stopping treatment, Levetiracetam Actavis should be discontinued gradually to avoid an increase of seizures. 
Pri zdravilu Levetiracetam Actavis je potrebno zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
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). 
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).
Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: 
Odmerjanje pri dojenčkih (od 1 meseca do 23 mesecev), otrocih (od 2 do 11 let) in mladostnikih (od 12 do 17 let), lažjih od 50 kg
Actavis treatment for as long as your doctor has told you. 
Zdravljenje z zdravilom Levetiracetam Actavis morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
Other medicines and Levetiracetam Actavis 
Druga zdravila in zdravilo Levetiracetam Actavis
The fractional removal of levetiracetam was 51 % during a typical 4-hour dialysis session. 
Frakcijska odstranitev levetiracetama med značilno 4-urno dializo je bila 51 %.
Contains colouring agent sunset yellow (E110). 
Vsebuje barvilo sončno rumeno FCF (E110).
Perforated unit dose blisters: 60 x 1 film-coated tablets. 
Perforiranem pretisnem omotu za enkratni odmerek: 60 x 1fimsko obloženih tablet.
(1) An oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. 
(1) Pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se priporočenega odmerjanja zato ne more doseči z večimi tabletami in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti peroralno raztopino.
- If you have any further questions, ask your doctor or pharmacist. 
− Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali s farmacevtom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Aluminium/PVC blisters 
PODATKI NA ZUNANJI OVOJNINI Škatla za pretisne omote iz Al/PVC
For children 6 years and above, an oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. 
Za otroke, stare 6 let in več, se mora pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se zato priporočenega odmerjanja ne more doseči z večimi tabletami in pri bolnikih, ki ne morejo požirati tablet, uporabiti zdravilo Levetiracetam Actavis peroralna raztopina.
If you stop taking Levetiracetam Actavis 
Če ste prenehali jemati zdravilo Levetiracetam Actavis
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 otrocih, ki so prejemali do 60 mg/kg/dan levetiracetama, ni jasnih dokazov o klinično značilnem medsebojnem delovanju z zdravili.
Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1,200 and 1,800 mg/kg/day. 
Štiri študije embrio-fetalnega razvoja pri kuncih so izvedli pri odmerkih 200, 600, 800, 1200 in
Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam Actavis 1,000 mg film-coated tablets 
Levetiracetam Actavis 250 mg filmsko obložene tablete Levetiracetam Actavis 500 mg filmsko obložene tablete Levetiracetam Actavis 750 mg filmsko obložene tablete Levetiracetam Actavis 1.000 mg filmsko obložene tablete
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. 
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.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala, ne kažejo posebnega tveganja za človeka.
What Levetiracetam Actavis looks like and contents of the pack 
Izgled zdravila Levetiracetam Actavis in vsebina pakiranja
Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening). 
Dopolnilno zdravljenje primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo Učinkovitost levetiracetama je bila dokazana v 24-tedenski dvojno slepi, s placebom nadzorovani študiji, ki je vključevala odrasle, mladostnike in omejeno število otrok z idiopatsko generalizirano epilepsijo s primarno generaliziranimi tonično-kloničnimi (PGTC) napadi pri različnih sindromih (juvenilna mioklonična epilepsija, juvenilna epilepsija z absencami, otroška epilepsija z absencami ali epilepsija z grand mal napadi pri prebujanju).
The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established. 
Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost levetiracetama nista bili dokazani.
The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis). 
mg/kg/dan za samice in 200 mg/kg/dan za zarodke (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2).
Crospovidon, povidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol-part. hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), colourants*. 
Pomožne snovi so: krospovidon, povidon, brezvodni koloidni silicijev dioksid, magnezijev stearat, polivinilalkohol - delno hidroliziran, makrogol 4000, smukec, titanov dioksid (E171), barvila*.
750 mg tablet: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172). 
750 mg tableta: indigotin (E132), sončno rumeno FCF (E110), rdeči železov oksid (E172)
A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six month and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 month to less than 4 years old, was used in this study. 
V tej študiji so pri dojenčkih, od 1. meseca do manj kot 6. meseca starosti, uporabljali odmerek 20 mg/kg/dan titriran do 40 mg/kg/dan, za dojenčke in otroke, od 6. meseca do manj kot 4. leta starosti, pa odmerek 25 mg/kg/dan titriran do 50 mg/kg/dan.
Oral absolute bioavailability is close to Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing. 
Največjo koncentracijo v plazmi (Cmax) dosežemo 1,3 ure po odmerku.
In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. 
Poleg tega jakosti tablet, ki so na voljo, niso primerne za začetno zdravljenje pri otrocih, težkih manj kot 25 kg,
Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function 
Prilagoditev odmerjanja pri dojenčkih, otrocih in mladostnikih s telesno maso, manjšo kot 50 kg, z okvarjenim delovanjem ledvic:
The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. 
Dnevni odmerek se lahko poveča do 1500 mg dvakrat na dan glede na klinični odziv in toleranco.
The NOAEL was ≥ 1,800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis). 
≥1800 mg/kg/dan za F0 samice in za preživetje, rast in razvoj F1 mladičev do prenehanja dojenja (6
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10%). 
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy. 
Dopolnilno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo
Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam. 
peroralnimi kontraceptivi in varfarinom ni vplivala na njegovo farmakokinetiko.
No tissue distribution data are available in humans. 
Porazdelitev Pri ljudeh ni podatkov o porazdelitvi levetiracetama v tkivih.
The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. 
Pri prevelikem odmerjanju levetiracetama so opažali somnolenco, agitiranost, agresivnost, zmanjšano stopnjo zavesti, depresijo dihanja in komo.
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets 60 x 1 film-coated tablets 
20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 120 filmsko obloženih tablet 200 filmsko obloženih tablet 60 x 1 filmsko obloženih tablet
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function 
Prilagoditev odmerjanja pri odraslih in mladostnikih s telesno maso, večjo kot 50 kg, z okvarjenim delovanjem ledvic:
Take the number of tablets following your doctor´s instructions. 
Vzemite toliko tablet, kot vam je predpisal zdravnik.
Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland 
Reykjavikurvegur 76-78 220 Hafnarfjordur Islandija
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland 
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Islandija
Nasopharyngitis 
• nazofaringitis
- This medicine has been prescribed for you only. 
− Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Peak concentrations (Cmax) are typically 31 and 43 μg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively. 
Po posamičnem 1000 mg odmerku je največja koncentracija (Cmax) ponavadi 31 µg/ml, po ponavljajočih odmerkih 1000 mg dvakrat na dan pa 43 µg/ml.
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. 
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.
C. 
Z
How to take Levetiracetam Actavis 
Kako jemati zdravilo Levetiracetam Actavis
The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo. 
In vitro podatki in in vivo podatki medsebojnega delovanja peroralnih kontraceptivov, digoksina in varfarina kažejo, da ni pričakovati pomembne in vivo encimske indukcije, zato je malo možnosti za interakcije med zdravilom Levetiracetam Actavis in drugimi snovmi oz. obratno.
30 film-coated tablets 100 film-coated tablets 200 film-coated tablets 
30 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet
Steady-state is achieved after two days of a twice daily administration schedule. 
Ob uporabi dvakrat na dan dosežemo stanje dinamičnega ravnovesja v dveh dneh.
Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours. 
Otroci (od 4 do 12 let) 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.
In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule. 
V tej študiji so bolnikom glede na njihovo starost predpisali shemo titriranja dnevnega odmerka peroralne raztopine po 20 mg/kg, 25 mg/kg, 40 mg/kg ali 50 mg/kg.
Levetiracetam Actavis is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. 
Zdravilo Levetiracetam Actavis je indicirano za samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo.
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose. 
Zdravnik vam bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko levetiracetama.
Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland 
Reykjavikurvegur 76-78, 220 Hafnarfjordur, Islandija
With continued long-term treatment, 8.6 % of the patients were seizurefree for at least 6 months and 7.8 % were seizure-free for at least 1 year. 
Pri nadaljnjem dolgotrajnem zdravljenju je bilo 8,6 % bolnikov brez napadov najmanj 6 mesecev in 7,8 % bolnikov najmanj 1 leto.
In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses. 
V tej študiji je bil odmerek levetiracetama 3000 mg na dan, razdeljen na dva odmerka.
500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 
500 do 1500 mg dvakrat na dan 500 do 1000 mg dvakrat na dan 250 do 750 mg dvakrat na dan huda ledvična okvara končna ledvična odpoved bolniki na dializi (1)
20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets 
20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 120 filmsko obloženih tablet 200 filmsko obloženih tablet
Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. 
Samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo
The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66 % and 24 % of the dose, respectively during the first 48 hours. 
V prvih 48 urah se s kumulativnim izločanjem z urinom izloči 66 % odmerka levetiracetama ter 24 %
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišična oslabelost,
Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1,800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis). 
V študijah pri novorojenčkih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/kg/dan (6-kratna do 17-kratna vrednost največjega priporočenega odmerka pri ljudeh glede na mg/m2) ni bilo neželenih učinkov na običajna obdobja razvoja in dozorevanja.
In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2). 
Pri bolnikih z okvarjenim delovanjem jeter je pred izbiro odmerka priporočljivo oceniti delovanje ledvic
Levetiracetam Actavis 750 mg tablets contain Sunset Yellow (E110) 
Zdravilo Levetiracetam Actavis 750 mg tablete vsebuje barvilo sončno rumeno FCF (E110)
Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg 
Dopolnilno zdravljenje za dojenčke, stare od 6 do 23 mesecev, otroke (od 2 do 11 let) in mladostnike
Each film-coated tablet contains 0.156 mg sunset yellow E110. 
Pomožne snovi z znanim učinkom: Ena filmsko obložena tableta vsebuje 0,156 mg barvila sončno rumeno FCF (E110).
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl) 
Višina (cm) x ks CLcr (ml/min/1,73 m2) =----------------------------------------------------------koncentracija kreatinina v serumu (mg/dl)
• 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 (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis). 
široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in hujša oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza).
With continued longterm treatment, 11.4 % of the patients were seizure-free for at least 6 months and 7.2 % were seizurefree for at least 1 year. 
nadaljevanjem dolgotrajnega zdravljenja je bilo 11,4 % bolnikov brez napada vsaj 6 mesecev, 7,2 % pa jih je bilo brez napada vsaj 1 leto.
Aluminium/PVC blister packs. 
Pretisni omoti Al/PVC.
in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. 
• primarno generaliziranih tonično-kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo.
10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5) 
10 do 20 mg/kg (0,10 do 0,20 ml/kg) enkrat na dan (3) (5)
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. 
do 17 let) je potrdila, da dopolnilna terapija s peroralno vzetim levetiracetamom ni vplivala na koncentracije v serumu v stanju dinamičnega ravnovesja pri sočasnem dajanju karbamazepina in valproata.
Should your doctor decide to stop your Levetiracetam Actavis treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Actavis. 
Actavis, vam bo dal napotke o postopni ukinitvi zdravila Levetiracetam Actavis.
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. 
starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji tabeli po organskih sistemih in pogostnosti.
One tablet of Levetiracetam Actavis 1,000 mg contains 1,000 mg of levetiracetam. 
Ena tableta zdravila Levetiracetam Actavis 1000 mg vsebuje 1000 mg levetiracetama.
Levetiracetam Actavis 1,000 mg film-coated tablets Each film-coated tablet contains 1,000 mg levetiracetam. 
Levetiracetam Actavis 1.000 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1.000 mg levetiracetama.
The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. 
Način uporabe Filmsko obložene tablete se zaužijejo peroralno z dovolj tekočine.
Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2. 
Če je očistek kreatinina < 60 ml/min/1,73 m2, je priporočljivo zmanjšati dnevni vzdrževalni odmerek za
Excretion via faeces accounted for only 0.3 % of the dose. 
Z blatom se izloči le 0,3 % odmerka.
One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam. 
Ena tableta zdravila Levetiracetam Actavis 500 mg vsebuje 500 mg levetiracetama.
One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam. 
Ena tableta zdravila Levetiracetam Actavis 250 mg vsebuje 250 mg levetiracetama.
250 to 500 mg twice daily 
250 do 500 mg dvakrat na dan 500 do 1000 mg enkrat na dan(2)
Contact your doctor if you took more tablets than you should. 
Če ste vzeli več tablet kot bi morali, se posvetujte s svojim zdravnikom.
• 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 Actavis se uporablja: • za samostojno zdravljenje pri odraslih in mladostnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
Peak plasma concentration was observed 0.5 to 1.0 hour after dosing. 
Največja plazemska koncentracija je bila dosežena med 0,5