natgillin/translations-raw huggingface dataset:
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 kanalov povzročeno z Zn2+ in β - karbolini.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Delovanje na parcialne in generalizirane epileptične napade (epileptiformno proženje/ fotoparoksizmalen odgovor) potrjuje njegov širok spekter farmakološkega profila levetiracetama pri ljudeh.
Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy:
Dopolnilno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih in otrocih, od 4. leta starosti, z epilepsijo
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 1000 mg, 2000 mg ali 3000 mg/ dan, razdeljenih na dva odmerka, ter s trajanjem zdravljenja do 18 tednov.
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 napadov parcialnega izvora na teden pri stalnem odmerku (12/ 14 tednov), je bil 27, 7% pri bolnikih, ki so prejemali 1000 mg, 31, 6% pri bolnikih, ki so prejemali 2000 mg in 41, 3% pri bolnikih, ki so prejemali 3000 mg levetiracetama, ter 12, 6% pri bolnikih, ki so prejemali placebo.
In pediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Pri otrocih (od 4 do 16 let) je bila učinkovitost levetiracetama dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je vključevala 198 bolnikov in trajala 14 tednov.
In this study, the patients received levetiracetam as a fixed dose of 60 mg/ kg/ day (with twice a day dosing).
V tej študiji so bolniki prejemali stalen odmerek 60 mg/ kg/ dan (odmerjanje dvakrat na dan).
8 44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Pri 44, 6% bolnikov, ki so se zdravili z levetiracetamom, in 19, 6% bolnikov, ki so prejemali placebo, je bilo 50 ali več odstotno zmanjšanje pogostnosti napadov parcialnega izvora na teden.
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.
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.
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.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Bolniki so morali imeti neizzvane napade parcialnega izvora ali samo generalizirane tonično- klonične napade.
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 sproščanje (CR) na dan ali 1000- 3000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov oziroma odvisno od odziva.
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).
Več kot polovica preiskovancev
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).
8 12 mesecev ni imela napadov (56, 6% preiskovancev, ki so prejemali levetiracetam, in 58, 5% preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
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 in starejših, z idiopatsko generalizirano epilepsijo z miokloničnimi napadi pri različnih sindromih.
In this study, levetiracetam, dose was 3000 mg/ day given in 2 divided doses.
V tej študiji je bil odmerek levetiracetama 3000 mg na dan, razdeljen na dva odmerka.
58.3% of the levetiracetam treated patients and 23.3% of the patients on placebo had at least a 50% reduction in myoclonic seizure days per week.
58, 3% bolnikov, ki so se zdravili z levetiracetamom, in 23, 3% bolnikov, ki so prejemali placebo, je imelo vsaj 50- odstotno zmanjšanje števila dni z miokloničnimi napadi na teden.
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.
Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Dopolnilno zdravljenje primarno generaliziranih tonično- kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo
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).
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).
In this study, levetiracetam dose was 3000 mg/ day for adults and adolescents or 60 mg/ kg/ day for children, given in 2 divided doses.
V tej študiji je bil odmerek levetiracetama za odrasle in mladostnike 3000 mg na dan, za otroke pa 60 mg/ kg/ dan, razdeljen na dva odmerka.
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.
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.
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.
The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Ima linearni farmakokinetični profil, z majhno intra - in interindividualno variabilnostjo.
There is no modification of the clearance after repeated
Očistek se po ponavljajočem dajanju ne spremeni.
Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/ kg bodyweight.
Zaradi popolne in linearne absorpcije je koncentracijo levetiracetama v plazmi mogoče predvideti na podlagi peroralnega odmerka, izraženega v mg/ kg telesne mase.
Therefore there is no need for plasma level monitoring of levetiracetam.
Koncentracije levetiracetama v plazmi zato ni potrebno kontrolirati.
A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/ plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Pri odraslih in otrocih so pokazali pomembno povezavo med koncentracijo v plazmi in slini (razmerje koncentracij slina/ plazma se giblje med 1 in 1, 7 za tableto in peroralno raztopino 4 ure po odmerku).
Oral absolute bioavailability is close to 100%.
Absolutna biološka uporabnost peroralno uporabljenega zdravila je skoraj 100%.
Peak plasma concentrations (Cmax) are achieved at 1.3 hours after dosing.
Največjo koncentracijo v plazmi (Cmax) dosežemo 1, 3 ure po odmerku.
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 1. 000- mg odmerku je največja koncentracija (Cmax) ponavadi 31 µg/ ml, po ponavljajočih odmerkih 1. 000 mg dvakrat na dan pa 43 µg/ ml.
The extent of absorption is dose-independent and is not altered by food.
9 Obseg absorpcije ni odvisen od odmerka; hrana ga ne spremeni.
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 (< 10%).
The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/ kg, a value close to the total body water volume.
Volumen porazdelitve levetiracetama je približno 0, 5 do 0, 7 l/ kg, kar je blizu vrednosti celotnega volumna vode v telesu.
The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Glavna presnovna pot (24% odmerka) je encimska hidroliza acetamidne skupine.
One was obtained by hydroxylation of the pyrrolidone ring (1.6% of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose).
Eden nastane s hidroksilacijo pirolidonskega obroča (1, 6% odmerka), drugi z odprtjem pirolidonskega obroča (0, 9% odmerka).
Other unidentified components accounted only for 0.6% of the dose.
Druge, neidentificirane sestavine predstavljajo le 0, 6% odmerka.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 AND UGT1A6]) and epoxide hydroxylase activities.
In vitro so pokazali, da levetiracetam in njegov primarni presnovek ne zavirata aktivnosti glavnih izooblik človeškega jetrnega citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 in 1A2), glukuronil- transferaze (UGT1A1 in UGT1A6) in epoksid- hidroksilaze.
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 Keppro in drugimi snovmi oz. obratno.
Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.
Izločanje
Elimination 10 The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Plazemski razpolovni čas pri odraslih je 7 ± 1 ur in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
The mean total body clearance was 0.96 ml/ min/ kg.
Povprečni skupni telesni očistek je 0, 96 ml/ min/ kg.
The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Glavna pot izločanja je z urinom, s katerim se izloči povprečno 95% odmerka (približno 93% odmerka se izloči v 48 urah).
Excretion via faeces accounted for only 0.3% of the dose.
Z blatom se izloči le 0, 3% odmerka.
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% odmerka njegovega primarnega presnovka.
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/ min/ kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Ledvični očistek levetiracetama 0, 6 ml/ min/ kg in njegovega primarnega presnovka ucb L057 4, 2 ml/ min/ kg kažeta na to, da se levetiracetam izloča z glomerulno filtracijo, ki ji sledi tubularna reabsorpcija, primarni presnovek pa se poleg glomerulne filtracije izloča tudi z aktivno tubularno sekrecijo.
This is related to the decrease in renal function in this population (see section 4.2).
Zaradi zmanjšanega delovanja ledvic se pri starejših razpolovni čas podaljša za približno 40% (10 do 11 ur) (glejte poglavje 4. 2).
Following single oral dose administration (20 mg/ kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
10 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.
The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Navidezni telesni očistek je bil približno 30% večji kot pri odraslih z epilepsijo.
Following repeated oral dose administration (20 to 60 mg/ kg/ day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Po uporabi večkratnega peroralnega odmerka (od 20 do 60 mg/ kg/ dan) pri otrocih z epilepsijo (od 4 do 12 let) se je levetiracetam hitro absorbiral.
Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Največja plazemska koncentracija je bila dosežena med 0, 5 in 1 uro po odmerku.
The apparent body clearance was 1.1 ml/ min/ kg.
Navidezni telesni očistek je bil 1, 1 ml/ min/ kg.
Following single dose administration (20 mg/ kg) of a 100 mg/ ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Po uporabi posamičnega odmerka (20 mg/ kg) 100 mg/ ml peroralne raztopine pri otrocih z epilepsijo (od 1 meseca do 4 let) se je levetiracetam hitro absorbiral in plazemska koncentracija je bila dosežena približno 1 uro po odmerku.
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).
Farmakokinetični rezultati kažejo, da je bil razpolovni čas (5, 3 ure) krajši kot pri odraslih (7, 2 ure) in navidezni očistek večji (1, 5 ml/ min/ kg) kot pri odraslih (0, 96 ml/ min/ kg).
It is therefore recommended to adjust the maintenance daily dose of Keppra, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Zato je priporočljivo dnevni vzdrževalni odmerek Keppre pri bolnikih z zmerno in hudo ledvično okvaro prilagoditi očistku kreatinina (glejte poglavje 4. 2).
In anuric end-stage renal disease adult subjects the half-life was approximately 25 and 3.1 hours during interdialytic and intradialytic periods, respectively.
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.
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%.
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).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenosti, ne kažejo posebnega tveganja za človeka.
In reproductive toxicity studies in the rat, levetiracetam induced developmental toxicity (increase in skeletal variations/ minor anomalies, retarded growth, increased pup mortality) at exposure levels similar to or greater than the human exposure.
V študijah reprodukcijske toksičnosti pri podganah je levetiracetam v podobnih ali večjih koncentracijah, kot so jim bili izpostavljeni ljudje, povzročil razvojne toksične učinke (številnejše variacije/ blažje anomalije okostja, upočasnjeno rast, večjo umrljivost mladičev).
In the rabbit foetal effects (embryonic death, increased skeletal anomalies, and increased malformations) were observed in the presence of maternal toxicity.
Pri kuncih so v primeru toksičnosti pri materi opažali učinke na plod (smrt zarodkov, številnejše anomalije okostja in številnejše malformacije).
The systemic exposure at the observed no effect level in the rabbit was about 4 to 5 times the human exposure.
Pri kuncih je bila sistemska izpostavljenost pri koncentracijah, pri katerih niso opazili učinkov, približno 4 - do 5- krat večja od izpostavljenosti pri ljudeh.
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 1800 mg/ kg/ day corresponding to 30 times the maximum recommended human dose.
V študijah pri novojorenčih in mladičih živali so dokazali, da pri podganah in psih, pri odmerkih do 1800 mg/ kg/ dan, ki ustrezajo 30- kratnemu največjemu priporočenemu odmerku pri ljudeh, ni bilo neželenih učinkov na običajna obdobja razvoja in dozorevanja.
6.1 List of excipients
11 6. 1 Seznam pomožnih snovi
Sodium croscarmellose Macrogol 6000 Colloidal anhydrous silica Magnesium stearate
Jedro: premreženi natrijev karmelozat, makrogol 6000, brezvodni koloidni silicijev dioksid, magnezijev stearat
Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350 Talc Indigo carmine aluminium lake (E132)
Filmska obloga Opadry 85F20694: delno hidroliziran polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, indigotin (E132).
Keppra 250 mg film-coated tablets are packaged in aluminium/ PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 and 200 film-coated tablets.
Keppra 250 mg filmsko obložene tablete so pakirane v pretisnih omotih aluminij/ PVC, v kartonskih škatlah po 20, 30, 50, 60, 100 in 200 filmsko obloženih tablet.
Allée de la Recherche 60 B-1070 Bruxelles Belgium
UCB Pharma SA Allée de la Recherche 60 B- 1070 Bruxelles Belgija
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILJKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET 12 Datum pridobitve dovoljenja za promet:
29 September 2000 Date of last renewal:
29. september 2000 Datum zadnjega podaljšanja dovoljenja za promet:
08 July 2005
8. julij 2005
Keppra 500 mg film-coated tablets.
Keppra 500 mg filmsko obložene tablete
Yellow, oblong, scored and debossed with the code “ ucb” and “ 500” on one side.
Rumena, podolgovata, z zarezo tableta z vtisnjeno oznako “ ucb˝ in ˝500 ” na eni strani.
• Add-on therapy Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more
• Dopolnilno zdravljenje Odrasli (≥ 18 let) in mladostniki (od 12 do 17 let), težki 50 kg in več
14 Adjustment of the dose is recommended in elderly patients with compromised renal function (see “ Patients with renal impairment ” below).
Pri starejših bolnikih z okvarjenim delovanjem ledvic je priporočljiva prilagoditev odmerka (glejte spodaj “ Bolniki z ledvično okvaro ”).
The initial therapeutic dose is 10 mg/ kg twice daily.
14 Začetni terapevtski odmerek je 10 mg/ kg dvakrat na dan.
15 Dosing adjustment for adult patients with impaired renal function
Prilagoditev odmerjanja pri odraslih bolnikih z okvarjenim delovanjem ledvic
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
15 Pri otrocih z ledvično okvaro je treba odmerek levetiracetama prilagoditi glede na delovanje ledvic, kajti z njihovim delovanjem je povezan tudi očistek levetiracetama.
The mechanism of this risk is not known.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov Mehanizem tveganja še ni znan.
16 Therefore patients should be monitored for signs of depression and/ or suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
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
17 No studies on the effects on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Pri nekaterih bolnikih se lahko zaradi različne individualne občutljivosti predvsem na začetku zdravljenja ali po povečanju odmerka pojavi zaspanost ali drugi simptomi povezani s centralnim živčnim sistemom.
Pooled safety data from clinical studies conducted with Keppra oral formulations in adult patients with partial onset seizures showed that 46.4% of the patients in the Keppra group and 42.2% of the patients in the placebo group experienced undesirable effects.
Kumulativni varnostni podatki iz kliničnih študij izvedenih pri odraslih bolnikih z napadi parcialnega izvora, ki so prejemali peroralne oblike Keppre, kažejo, da so se neželeni učinki pojavili pri 46, 4% bolnikov, ki so prejemali Keppro, in 42, 2% bolnikov, ki so prejemali placebo.
In monotherapy 49.8% of the subjects experienced at least one drug related undesirable effect.
17 Pri monoterapiji je 49, 8% bolnikov doživelo vsaj en neželeni učinek, povezan z zdravilom.