natgillin/translations-raw huggingface dataset:
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.
Tabelirani seznam neželenih učinkov Neželeni učinki, opisani v kliničnih študijah (pri odraslih, mladostnikih, otrocih in dojenčkih, starejših od 1 meseca) in med obdobjem trženja, so navedeni v spodnji preglednici po organskih sistemih in pogostnosti.
Levetiracetam and related analogs 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 ranžirno razvrstitev afinitete za vezavo na sinaptično vezikularno beljakovino 2A, ki korelira z jakostjo antiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Da bi zagotovili točnost odmerjanja, je treba to pakiranje predpisati dojenčkom v starosti od 1 meseca do manj kot 6 mesecev.
The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Frakcijska odstranitev levetiracetama med tipično 4-urno dializo je 51 %.
Dose in children 50 kg or greater is the same as in adults.
Odmerek za otroke s telesno maso 50 kg ali več je enak kot za odrasle.
Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks.
Spremembe odmerka ne smejo preseči povečanja ali zmanjšanja 10 mg/kg dvakrat na dan vsaka dva tedna.
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1,200 and 3,600 mg/kg/day.
Pri podganah sta bili opravljeni dve študiji embrio-fetalnega razvoja z odmerki 400, 1.200 in 3.600 mg/kg/dan.
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.
V tej študiji je bil odmerek levetiracetama 3.000 mg/dan za odrasle in mladostnike ter 60 mg/kg/dan za otroke; uporabljen je bil v 2 deljenih odmerkih.
Turn the bottle the right way up and remove the syringe (Figure 8).
Stekleničko zdaj obrnite v pokončen položaj in odstranite brizgo (slika 8).
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 so bile opravljene na kuncih v odmerkih 200, 600, 800, 1.200 in
Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
Sočasna uporaba z digoksinom, peroralnimi kontraceptivi in varfarinom ni vplivala na farmakokinetiko levetiracetama.
• muscle weakness, myalgia (muscle pain);
• šibkost mišic, mialgija (bolečina v mišicah)
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali s farmacevtom .
Sixty of these patients were treated with levetiracetam in placebo-controlled studies.
Od tega so 60 bolnikov zdravili z levetiracetamom v s placebom nadzorovanih študijah.
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Ugotovili so linearna in odmerku sorazmerna povečanja največje koncentracije v plazmi in površine pod krivuljo.
No enantiomeric interconversion was evidenced in vivo for either levetiracetam or its primary metabolite.
In vivo niso ugotovili enantiomerne interkonverzije ne pri levetiracetamu ne pri njegovem primarnem presnovku.
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 ugotovljena v 24-tedenski dvojno slepi, s placebom kontrolirani študiji, ki je zajela odrasle, mladostnike in majhno število otrok z idiopatsko generalizirano epilepsijo s primarno generaliziranimi tonično kloničnimi (PGTC) napad v različnih sindromih (juvenilna monoklonična epilepsija, juvenilna epilepsija z absencami, otroška epilepsija z absencami ali epilepsija z napadi grand mal ob prebujanju).
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.
Dokazano je, da levetiracetam in njegov primarni presnovek in vitro ne zavirata aktivnosti glavnih izooblik človeškega jetrnega citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 in 1A2),
Pull the syringe by the dosing body out of the bottle (Figure 2).
Brizgo za njeno telo potegnite iz stekleničke (slika 2).
The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50 kg or more, the following formula:
Clcr v ml/min je mogoče pri odraslih in mladostnikih s telesno maso 50 kg ali več oceniti iz koncentracije kreatinina v serumu (mg/dl) po naslednji formuli:
Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Po večkratni peroralni uporabo (odmerki od 20 do 60 mg/kg/dan) pri otrocih z epilepsijo (starih od 4 do 12 let) se je levetiracetam hitro absorbiral.
Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Učinkovitost levetiracetama v monoterapiji je bila ugotovljena v dvojno slepi študiji vzporednih skupin za oceno neinferiornosti s karbamazepinom z nadzorovanim sproščanjem (CR - controlled release) pri 576 bolnikih, starih 16 let ali več z novoodkrito ali nedavno odkrito epilepsijo.
• 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);
• 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)
• hair loss, eczema, pruritus;
• izguba las, ekcem, pruritus
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 kontrolirana pediatrična študija varnosti (z načrtom ugotavljanja neinferiornosti) je ocenila kognitivne in nevropsihološke učinke levetiracetama pri otrocih, starih od 4
The administration of levetiracetam to patients with renal impairment may require dose adjustment.
Bolniki z ledvično okvaro V primeru uporabe levetiracetama pri bolnikih z okvaro ledvic je lahko potrebna prilagoditev odmerka.
The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Profil neželenih učinkov levetiracetama je v splošnem podoben v vseh starostnih skupinah in pri vseh odobrenih indikacijah za zdravljenje epilepsije.
What Levetiracetam Actavis Group is and what it is used for
Kaj je zdravilo Levetiracetam Actavis Group in za kaj ga uporabljamo
Maltitol liquid
Tekoči maltitol
Levetiracetam Actavis Group 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.
0,20 ml/kg) enkrat na dan (1) Zdravilo Levetiracetam Actavis Group peroralna raztopina je treba uporabljati za odmerke, manjše od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se priporočenega odmerjanja zato ne more doseči z večimi tabletami in za bolnike, ki ne morejo pogoltniti tablet.
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 prejemajo do 60 mg levetiracetama na kilogram na dan, ni dokazov o klinično pomembnem medsebojnem delovanju z zdravili.
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).
NOAEL je bila ≥ 1.800 mg/kg/dan za samice F0 in za preživetje, rast in razvoj potomstva F1 do prenehanja dojenja (6-kratni največji priporočeni odmerek za človeka glede na mg/m2).
Each ml contains 100 mg of levetiracetam.
En mililiter vsebuje 100 mg levetiracetama.
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 levetiracetamu, uporabljenem samostojno, so na voljo samo omejeni dokazi.
• weight decrease, weight increase;
• zmanjšanje telesne mase, povečanje telesne mase
Levetiracetam Actavis Group is not indicated in children and adolescents below 16 years on its own (monotherapy).
Zdravilo Levetiracetam Actavis Group pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
Ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje za bolnike, stare 4 leta in več.
Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks.
Spremembe odmerka ne smejo preseči zvečanja ali zmanjšanja za 7 mg/kg dvakrat na dan vsaka dva tedna.
In paediatric 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 pediatričnih bolnikih (starih od 4 do 16 let) je bila učinkovitost levetiracetama ugotovljena z dvojno slepo, s placebom kontrolirano študijo, ki je zajela 198 bolnikov in v kateri je zdravljenje trajalo 14 tednov.
In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
Pri preiskovancih z zmerno okvaro jeter se očistek levetiracetama ni pomembno spremenil.
Treatment of an overdose will be symptomatic and may include haemodialysis.
Specifičnega antidota za levetiracetam ni. Zdravljenje prevelikega odmerjanja je simptomatsko in lahko vključuje hemodializo.
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 (starih od 1 mesec do manj kot 4 leta) je bila učinkovitost levetiracetama ugotovljena v dvojno slepi, s placebom kontrolirani študiji, ki je zajela 116 bolnikov in v kateri je zdravljenje trajalo 5 dni.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (I), ODGOVOREN ZA SPROŠČANJE SERIJ
The maximum dose is 1,500 mg twice daily.
Največji odmerek je 1.500 mg dvakrat na dan.
General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1,500 mg).
Splošen odmerek: zdravilo Levetiracetam Actavis Group se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 5 ml (500 mg) do 15 ml (1500 mg).
Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg of propyl parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965), 3,26 mg propylene glycol (E 1520) and 0.25 mg of sodium.
En mililiter vsebuje 1,50 mg metilparahidroksibenzoata (E218), 0,15 mg propilparahidroksibenzoata (E216), 290 mg tekočega maltitola (E965), 3,26 mg propilenglikola (E 1520) in 0,25 mg natrija.
BSA subject (m2)
telesna površina osebe (m2)
• delirium;
• delirij
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 s končno odpovedjo ledvic je bil razpolovni čas v obdobju med eno in drugo dializo približno 25 ur, med samo dializo pa približno 3,1 ure.
The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
Tveganje neješčnosti je večje, če je hkrati z levetiracetamom uporabljen topiramat.
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 enega odmerka (20 mg/kg) peroralne raztopine 100 mg/ml pri otrocih z epilepsijo (starih od 1 do 4 mesece) se je levetiracetam hitro absorbiral in največja koncentracija v plazmi je bila dosežena približno 1 uro po uporabi.
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) Levetiracetam Actavis Group 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216) Zdravilo Levetiracetam Actavis Group 100 mg/ml peroralna raztopina vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročita alergijske reakcije (lahko zapoznele).
The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
60 % in primarnega presnovka 74 %.
Push the plunger down slowly to introduce air inside the bottle (Figure 3).
Potisnite bat navzdol, da boste v stekleničko potisnili zrak (slika 3).
Dose in adults and adolescents from 16 years of age:
Odmerek za odrasle in mladostnike od 16. leta starosti:
Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Prilagoditev odmerka pri odraslih in mladostnikih s telesno maso nad 50 kg in okvarjenim delovanjem ledvic:
Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520).
Vsebuje E216, E218, tekoči maltitol (E965) in propilenglikol (E1520).
Discontinuation
Prekinitev
In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
V humanih jetrnih celicah v kulturi je levetiracetam na CYP1A2, SULT1E1 in UGT1A1 vplival le malo ali sploh ne, blago pa je induciral CYP2B6 in CYP3A4.
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Neželeni učinki, o katerih so najpogosteje poročali, so bili nazofaringitis, somnolenca, glavobol, utrujenost in omotica.
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 infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/ kg twice daily every two weeks).
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 dojenčkih, starejših od 6 mesecev, otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna;
Creatinine clearance (ml/min/1.73m2)
(ml/min/1,73m2)
Levetiracetam Actavis Group treatment for as long as your doctor has told you.
Levetiracetam Actavis Group morate jemati toliko časa, kot vam naroči zdravnik.
The 300 ml glass bottle of Levetiracetam Actavis Group (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml).
300-ml steklenica zdravila Levetiracetam Actavis Group (za otroke, stare 4 leta in več, mladostnike in odrasle) je pakirana v kartonski škatli, v kateri je tudi 10-ml peroralna brizga (z odmernimi oznakami na 0,25 ml).
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Starejšim bolnikom s slabšim delovanjem ledvic je odmerek priporočljivo prilagoditi (glejte "Okvara ledvic", spodaj).
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).
Študije na novorojenih in mladih podganah in psih niso pokazale nobenih neželenih učinkov na noben standardni opazovani dogodek razvoja ali dozorevanja v odmerkih do 1.800 mg/kg/dan (6- do
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.
35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih < 6 mesecev,
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.
Največja koncentracija (Cmax) je po enkratnem odmerku 1.000 mg praviloma 31 µg/ml in po večkratnem odmerjanju 1.000 mg dvakrat na dan 43 µg/ml.
Levetiracetam Actavis Group oral solution also contains maltitol.
Zdravilo Levetiracetam Actavis Group peroralna raztopina vsebuje tudi maltitol.
Hepatic failure, hepatitis
• odpoved jeter, hepatitis
The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
NOAEL je bila < 200 mg/kg/dan za samice matere in 200 mg/kg/dan za plodove (to je enako največjemu priporočenemu odmerek za človeka glede na mg/m2).
Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Med nosečnostjo so opažali znižanje koncentracije levetiracetama v plazmi.
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.
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 %).
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 ugotovljena v 16-tedenski dvojno slepi, s placebom kontrolirani študiji pri bolnikih, starih 12 let ali več, ki so imeli idiopatsko generalizirano epilepsijo z miokloničnimi napadi v različnih sindromih.
Not applicable.
nista ugotovljeni.
Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Izooblike jetrnega citokroma P450 ne sodelujejo pri nastajanju primarnega presnovka ucb L057.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
5.3 Predklinični podatki o varnosti Predklinični podatki na temelju običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala, ne kažejo posebnega tveganja za človeka.
The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for young adolescents, children and infants, using the following formula (Schwartz formula):
CLcr v ml/min/1,73 m2 je mogoče pri odraslih, otrocih in dojenčkih oceniti iz koncentracije kreatinina v serumu (mg/dl) po naslednji formuli (Schwartzova formula): telesna višina (cm) x ks CLcr (ml/min/1,73 m2) = -----------------------------------kreatinin v serumu (mg/dl)
Take the syringe and pull back the plunger a little way (Figure 2).
Vzemite brizgo in nekoliko izvlecite njen bat (slika 2).
A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
V tej študiji so pri dojenčkih, starih od 1 mesec do manj kot 6 mesecev, uporabili odmerek 20 mg/kg/dan s titriranjem do 40 mg/kg/dan, pri dojenčkih in otrocih, starih od 6 mesecev do manj kot 4 leta, pa odmerek 25 mg/kg/dan s titriranjem do 50 mg/kg/dan.
500 to 1,000 mg once daily (2)
500 do 1.000 mg enkrat na dan (2)
28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
28 mg (0,3 ml) dvakrat na dan 84 mg (0,85 ml) dvakrat na dan
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.
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
For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Za otroke, stare 4 let in več, ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje.
Instruction for use for 1 ml and 3 ml syringes with an adaptor
Navodilo za uporab 1-ml in 3-ml brizge z nastavkom
Levetiracetam Actavis Group is indicated as adjunctive therapy
Zdravilo Levetiracetam Actavis Group je indicirano kot dopolnilno zdravilo
Infants should start the treatment with Levetiracetam Actavis Group 100 mg/ml oral solution.
Pri dojenčkih je treba zdravljenje začeti z zdravilom Levetiracetam Actavis Group 100 mg/ml peroralna raztopina.
Contents of the pack and other information What Levetiracetam Actavis Group contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Levetiracetam Actavis Group
Levetiracetam Actavis Group 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 Group je indicirano kot monoterapija za zdravljenje epileptičnih napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih od 16. leta starosti z novoodkrito epilepsijo.
The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1,200 mg/kg/day for fetuses.
Raven brez opaženih neželenih učinkov (NOAEL - No Observed Adverse Effect Level) je bila pri brejih podganah 3.600 mg/kg/dan (12-kratni največji priporočeni odmerek za človeka glede na mg/m2) in pri plodovih 1.200 mg/kg/dan.
In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses.
V tej študiji je bil odmerek levetiracetama 3.000 mg/dan, uporabljen v 2 deljenih odmerkih.
Levetiracetam Actavis Group 100 mg/ml oral solution contains 3,26 mg propylene glycol (E1520) in each ml.
Vsak mililiter zdravila Levetiracetam Actavis Group 100 mg/ml peroralna raztopina vsebuje 3,26 mg propilenglikola (E1520).
• 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.
• za zdravljenje epileptičnih napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, ki imajo epilepsijo.
The oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Peroralna raztopina ima prednost pri dojenčkih in otrocih, mlajših od 6 let.
Levetiracetam has been given to you by your doctor to reduce the number of fits.
Zdravnik vam je predpisal levetiracetam z namenom zmanjšanja števila krčev.
• asthenia/fatigue (tiredness).
• astenija/izčrpanost (utrujenost)