FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • 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);
Slovenian: • 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)
English: • hair loss, eczema, pruritus;
Slovenian: • izguba las, ekcem, pruritus
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 kontrolirana pediatrična študija varnosti (z načrtom ugotavljanja neinferiornosti) je ocenila kognitivne in nevropsihološke učinke levetiracetama pri otrocih, starih od 4
English: The administration of levetiracetam to patients with renal impairment may require dose adjustment.
Slovenian: Bolniki z ledvično okvaro V primeru uporabe levetiracetama pri bolnikih z okvaro ledvic je lahko potrebna prilagoditev odmerka.
English: The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Slovenian: Profil neželenih učinkov levetiracetama je v splošnem podoben v vseh starostnih skupinah in pri vseh odobrenih indikacijah za zdravljenje epilepsije.
English: What Levetiracetam Actavis Group is and what it is used for
Slovenian: Kaj je zdravilo Levetiracetam Actavis Group in za kaj ga uporabljamo
English: Maltitol liquid
Slovenian: Tekoči maltitol
English: 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.
Slovenian: 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.
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 pediatričnih bolnikih, ki prejemajo do 60 mg levetiracetama na kilogram na dan, ni dokazov o klinično pomembnem medsebojnem delovanju z zdravili.
English: 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).
Slovenian: 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).
English: Each ml contains 100 mg of levetiracetam.
Slovenian: En mililiter vsebuje 100 mg levetiracetama.
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, uporabljenem samostojno, so na voljo samo omejeni dokazi.
English: • weight decrease, weight increase;
Slovenian: • zmanjšanje telesne mase, povečanje telesne mase
English: Levetiracetam Actavis Group is not indicated in children and adolescents below 16 years on its own (monotherapy).
Slovenian: Zdravilo Levetiracetam Actavis Group pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija).
English: Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
Slovenian: Ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje za bolnike, stare 4 leta in več.
English: Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks.
Slovenian: Spremembe odmerka ne smejo preseči zvečanja ali zmanjšanja za 7 mg/kg dvakrat na dan vsaka dva tedna.
English: 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.
Slovenian: 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.
English: In subjects with mild and moderate hepatic impairment, there was no relevant modification of the clearance of levetiracetam.
Slovenian: Pri preiskovancih z zmerno okvaro jeter se očistek levetiracetama ni pomembno spremenil.
English: Treatment of an overdose will be symptomatic and may include haemodialysis.
Slovenian: Specifičnega antidota za levetiracetam ni. Zdravljenje prevelikega odmerjanja je simptomatsko in lahko vključuje hemodializo.
English: 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.
Slovenian: 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.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (I), ODGOVOREN ZA SPROŠČANJE SERIJ
English: The maximum dose is 1,500 mg twice daily.
Slovenian: Največji odmerek je 1.500 mg dvakrat na dan.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: BSA subject (m2)
Slovenian: telesna površina osebe (m2)
English: • delirium;
Slovenian: • delirij
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 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.
English: The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
Slovenian: Tveganje neješčnosti je večje, če je hkrati z levetiracetamom uporabljen topiramat.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Slovenian: 60 % in primarnega presnovka 74 %.
English: Push the plunger down slowly to introduce air inside the bottle (Figure 3).
Slovenian: Potisnite bat navzdol, da boste v stekleničko potisnili zrak (slika 3).
English: Dose in adults and adolescents from 16 years of age:
Slovenian: Odmerek za odrasle in mladostnike od 16. leta starosti:
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Slovenian: Prilagoditev odmerka pri odraslih in mladostnikih s telesno maso nad 50 kg in okvarjenim delovanjem ledvic:
English: Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520).
Slovenian: Vsebuje E216, E218, tekoči maltitol (E965) in propilenglikol (E1520).
English: Discontinuation
Slovenian: Prekinitev
English: In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
Slovenian: 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.
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili nazofaringitis, somnolenca, glavobol, utrujenost in omotica.
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 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).
Slovenian: 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;
English: Creatinine clearance (ml/min/1.73m2)
Slovenian: (ml/min/1,73m2)
English: Levetiracetam Actavis Group treatment for as long as your doctor has told you.
Slovenian: Levetiracetam Actavis Group morate jemati toliko časa, kot vam naroči zdravnik.
English: 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).
Slovenian: 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).
English: Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Slovenian: Starejšim bolnikom s slabšim delovanjem ledvic je odmerek priporočljivo prilagoditi (glejte "Okvara ledvic", spodaj).
English: 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).
Slovenian: 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
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,
English: 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.
Slovenian: 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.
English: Levetiracetam Actavis Group oral solution also contains maltitol.
Slovenian: Zdravilo Levetiracetam Actavis Group peroralna raztopina vsebuje tudi maltitol.
English: Hepatic failure, hepatitis
Slovenian: • odpoved jeter, hepatitis
English: 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).
Slovenian: 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).
English: Decrease in levetiracetam plasma concentrations has been observed during pregnancy.
Slovenian: Med nosečnostjo so opažali znižanje koncentracije levetiracetama v plazmi.
English: 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.
Slovenian: 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 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.
English: Not applicable.
Slovenian: nista ugotovljeni.
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Slovenian: Izooblike jetrnega citokroma P450 ne sodelujejo pri nastajanju primarnega presnovka ucb L057.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na temelju običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenega potenciala, ne kažejo posebnega tveganja za človeka.
English: 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):
Slovenian: 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)
English: Take the syringe and pull back the plunger a little way (Figure 2).
Slovenian: Vzemite brizgo in nekoliko izvlecite njen bat (slika 2).
English: 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.
Slovenian: 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.
English: 500 to 1,000 mg once daily (2)
Slovenian: 500 do 1.000 mg enkrat na dan (2)
English: 28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Slovenian: 28 mg (0,3 ml) dvakrat na dan 84 mg (0,85 ml) dvakrat na dan
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
English: For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Slovenian: Za otroke, stare 4 let in več, ustrezen odmerek izmerite z uporabo 10-mililitrske brizge, vključene v pakiranje.
English: Instruction for use for 1 ml and 3 ml syringes with an adaptor
Slovenian: Navodilo za uporab 1-ml in 3-ml brizge z nastavkom
English: Levetiracetam Actavis Group is indicated as adjunctive therapy
Slovenian: Zdravilo Levetiracetam Actavis Group je indicirano kot dopolnilno zdravilo
English: Infants should start the treatment with Levetiracetam Actavis Group 100 mg/ml oral solution.
Slovenian: Pri dojenčkih je treba zdravljenje začeti z zdravilom Levetiracetam Actavis Group 100 mg/ml peroralna raztopina.
English: Contents of the pack and other information What Levetiracetam Actavis Group contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Levetiracetam Actavis Group
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In this study, levetiracetam, dose was 3,000 mg/day given in 2 divided doses.
Slovenian: V tej študiji je bil odmerek levetiracetama 3.000 mg/dan, uporabljen v 2 deljenih odmerkih.
English: Levetiracetam Actavis Group 100 mg/ml oral solution contains 3,26 mg propylene glycol (E1520) in each ml.
Slovenian: Vsak mililiter zdravila Levetiracetam Actavis Group 100 mg/ml peroralna raztopina vsebuje 3,26 mg propilenglikola (E1520).
English: • 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.
Slovenian: • 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.
English: The oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Slovenian: Peroralna raztopina ima prednost pri dojenčkih in otrocih, mlajših od 6 let.
English: Levetiracetam has been given to you by your doctor to reduce the number of fits.
Slovenian: Zdravnik vam je predpisal levetiracetam z namenom zmanjšanja števila krčev.
English: • asthenia/fatigue (tiredness).
Slovenian: • astenija/izčrpanost (utrujenost)
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Slovenian: Neželeni učinki, ki jih niso opažali v kliničnih študijah, opazili pa so jih pri podganah in v manjši meri pri miših ob izpostavljenosti, podobni izpostavljenosti pri človeku (in torej potencialno pomembni za klinično uporabo), so jetrne spremembe.
English: Levetiracetam Actavis Group contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, propylene glycol and sodium.
Slovenian: Zdravilo Levetiracetam Actavis Group vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, maltitol, propilenglikol in natrij
English: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Slovenian: Običajni odmerek: zdravilo Levetiracetam Actavis Group se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,1 ml (10 mg) do 0,3 ml (30 mg) na kg telesne mase otroka (za primere odmerkov glejte spodnjo preglednico).
English: Depending upon the clinical response and tolerability, the dose can be increased up to 21 mg/kg twice daily.
Slovenian: Glede na klinični odziv in prenašanje je mogoče dnevni odmerek povečati do 21 mg/kg dvakrat na dan.
English: Dose in infants (1 month to less than 6 months):
Slovenian: Odmerek za dojenčke (od 1 meseca do manj kot 6 mesecev):
English: How to store Levetiracetam Actavis Group Contents of the pack and other information
Slovenian: Shranjevanje zdravila Levetiracetam Actavis Group Vsebina pakiranja in dodatne informacije
English: Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily.
Slovenian: Glede na klinični odziv in prenašanje je mogoče dnevni odmerek povečati do 30 mg/kg dvakrat na dan.
English: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Slovenian: Splošen odmerek: zdravilo Levetiracetam Actavis Group se jemlje dvakrat na dan v dveh enakih odmerkih, pri čemer vsak posamezni odmerek znaša od 0,07 ml (7 mg) do 0,21 ml (21 mg) na kg telesne mase dojenčka (za primere odmerkov glejte spodnjo preglednico).
English: Dose recommendations for infants aged from 1 month to less than 6 months:
Slovenian: Priporočila za odmerjanje pri dojenčkih v starosti od 1 meseca do manj kot 6 mesecev:
English: • somnolence (sleepiness), headache.
Slovenian: • nazofaringitis • somnolenca (zaspanost), glavobol
English: 49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
Slovenian: 49 mg (0,5 ml) dvakrat na dan 147 mg (1,5 ml) dvakrat na dan
English: Other medicines and Levetiracetam Actavis Group
Slovenian: Druga zdravila in zdravilo Levetiracetam Actavis Group
English: • vertigo (sensation of rotation);
Slovenian: • vrtoglavica (občutek vrtenja)
English: Wash the syringe with water after use and close the bottle with the plastic screw cap (Figure 10).
Slovenian: Po uporabi brizgo izperite z vodo in jo zaprite s plastičnim navojnim pokrovčkom (slika 10).
English: Dosing adjustment for infants, children and adolescent patients weighing less than 50 kg with impaired renal function:
Slovenian: Prilagoditev odmerka pri dojenčkih, otrocih in mladostnikih s telesno maso manj kot 50 kg in okvarjenim delovanjem ledvic Skupina
English: For children aged 1 month to less than 6 months.
Slovenian: Za otroke, stare od 1 meseca do manj kot 6 mesecev.
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Slovenian: • poskus samomora in razmišljanje o samomoru, duševne motnje, nenormalno vedenje,