natgillin/translations-raw huggingface dataset:
The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Učinkovina levetiracetam je pirolidonski derivat (S-enantiomer -etil-2-okso-1-pirolidinacetamida), ki kemično ni podoben drugim antiepileptičnim učinkovinam.
Levetiracetam is not extensively metabolised in humans.
Levetiracetam se pri ljudeh ne presnavlja obsežno.
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• široko razširjen izpuščaj z mehurji in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom)
Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP:.
Levetiracetam Hospira is for intravenous use.
Zdravilo Levetiracetam Hospira je za intravensko uporabo.
What you need to know before you are given Levetiracetam Hospira
Kaj morate vedeti, preden boste prejeli zdravilo Levetiracetam Hospira
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.
It is therefore recommended to adjust the maintenance daily dose of levetiracetam, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Zato je priporočljivo dnevni vzdrževalni odmerek levetiracetama pri bolnikih z zmerno in hudo ledvično okvaro prilagoditi očistku kreatinina (glejte poglavje 4.2).
• 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 (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• kožni izpuščaj, ki lahko tvori mehurčke in izgleda kot majhne tarče (na sredini temne pike, obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem), široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in bolj huda oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza);
5 ml glass vial (type I) with bromobutyl coated rubber stoppers and an aluminium flip-off seal.
5 ml steklena viala (tip I) z bromobutilnim gumijastim zamaškom in aluminijasto zaporko s ploščico.
• Sodium chloride 9 mg/ml (0.9%) solution for injection
• natrijev klorid 9 mg/ml (0,9 %) raztopina za injiciranje
The patients were randomized to carbamazepine CR 400-1,200 mg/day or levetiracetam 1,000-3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response.
Bolniki so randomizirano prejemali 400-1.200 mg karbamazepina z nadzorovanim sproščanjem (CR) na dan ali 1.000-3.000 mg levetiracetama na dan, trajanje zdravljenja pa je bilo do 121 tednov oziroma odvisno od odziva.
• 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 mehurje in po videzu spominja na majhne tarče (na sredini temne pike, obkrožene s svetlejšim delom in s temnim krogom na robu) (multiformni eritem)
Each carton contains 10 or 25 vials.
Ena škatla vsebuje 10 ali 25 vial.
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 (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.
The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Profil neželenih učinkov, ki je opisan spodaj, temelji na analizi združenih s placebom nadzorovanih kliničnih preskušanj za vse preučevane indikacije, v katerih so z levetiracetamom zdravili 3416 bolnikov.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Pri otrocih z ledvično okvaro je treba odmerek levetiracetama prilagoditi glede na delovanje ledvic, kajti z njihovim delovanjem je povezan tudi očistek levetiracetama.
• diplopia (double vision), vision blurred;
• diplopija (dvojni vid), zamegljen vid;
The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Odmerki 1.800 mg/kg/dan so sprožili izrazito toksičnost pri samicah in zmanjšanje telesne mase zarodka, povezano s povečanjem pogostnosti zarodkov s kardiovaskularnimi/skeletnimi anomalijami.
You can switch from the filmcoated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Prehod od filmsko obloženih tablet ali od peroralne raztopine k intravenski obliki ali obratno, je lahko neposreden brez prilagajanja odmerka.
If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Če imate kakršne koli simptome depresije ali misli o samomoru ali oboje, se posvetujte z zdravnikom.
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures (fits) in epilepsy).
Levetiracetam je zdravilo proti epilepsiji (zdravilo za zdravljenje epileptičnih napadov).
Breast-feeding is not recommended during treatment.
Med zdravljenjem ni priporočljivo dojiti.
For doctors and nurses, more detailed direction for the proper use of Levetiracetam Hospira is provided in section 6.
Za zdravnike in medicinske sestre so podrobna navodila za uporabo zdravila Levetiracetam Hospira navedena v poglavju 6.
Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Levetiracetam v odmerku 1.000 mg na dan ni vplival na farmakokinetiko peroralnih kontraceptivov (etinilestradiola in levonorgestrela); endokrini parametri (luteinizirajoči hormon in progesteron) se niso spremenili.
However, based on the pharmacokinetic characteristics of levetiracetam, the pharmacokinetics in adults after intravenous administration and the pharmacokinetics in children after oral administration, the exposure (AUC) of levetiracetam is expected to be similar in paediatric patients aged 4 to 12 years after intravenous and oral administration.
Vendar je na osnovi farmakokinetičnih znaličnosti levetiracetama, farmakokinetike pri odraslih po intravenskem dajanju in farmakokinetike pri otrocih po peroralnem dajanju, pričakovati pri otrocih od 4 do 12 let podobno razpoložljivost (AUC) levetiracetama po intravenskem in peroralnem dajanju.
Vial of 5 ml
Viala s 5 ml
Dose in children 50 kg or greater is the same as in adults.
Pri otrocih, ki so težki 50 kg ali več, je odmerjanje enako kot pri odraslih.
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• depresija, sovražnost ali agresivnost, anksioznost, nespečnost, živčnost ali razdražljivost;
• decreased blood sodium concentration;
• znižana koncentracija natrija v krvi;
Following repeated oral dose administration (20 to 60 mg/kg/day) to epileptic children (4 to 12 years), levetiracetam was rapidly absorbed.
Po uporabi večkratnih peroralnih odmerkov (od 20 do 60 mg/kg/dan) pri otrocih z epilepsijo (od 4 do 12 let) se je levetiracetam hitro absorbiral.
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.
In the elderly, the half-life is increased by about 40% (10 to 11 hours).
Zaradi zmanjšanega delovanja ledvic se pri starejših razpolovni čas podaljša za približno 40 % (10 do 11 ur) (glejte poglavje 4.2).
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 1,000, 2,000 or 3,000 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 parcialnih napadov na teden pri stalnem odmerku (12/14 tednov), je bil 27,7 % pri bolnikih, ki so prejemali 1.000 mg, 31,6 % pri bolnikih, ki so prejemali 2.000 mg in 41,3 % pri bolnikih, ki so prejemali 3.000 mg levetiracetama, ter 12,6 % pri bolnikih, ki so prejemali placebo.
• flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]).
• gripi podobne simptome in izpuščaj na obrazu, ki se v nadaljevanju razširi in ga spremlja visoka temperatura, zvišane vrednosti jetrnih encimov pri krvnih testih in povečanje števila določenega tipa belih krvnih celic (eozinofilija) ter povečane bezgavke (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi [DRESS])
See the package leaflet for further information.
Za podrobnejše informacije glejte priloženo navodilo za uporabo.
Levetiracetam Hospira concentrate for solution for infusion is packed in a cardboard box containing 10 or 25 vials of 5 ml.
Zdravilo Levetiracetam Hospira koncentrat za raztopino za infundiranje je pakirano v škatle po 10 ali 25 5 ml vial.
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).
Add-on therapy for infants and children less than 4 years The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Dopolnilno zdravljenje za dojenčke in otroke, mlajše od 4 let Varnost in učinkovitost levetiracetama v obliki koncentrata za raztopino za infundiranje pri dojenčkih in pri otrocih, mlajših od 4 let, nista bili dokazani.
In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of
V študiji, ki je odražala klinično prakso, je bilo mogoče pri omejenem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 od 69 odraslih bolnikov), prekiniti sočasno antiepileptično zdravljenje.
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
Če je treba zdravljenje z levetiracetamom prekiniti, je priporočljivo zdravljenje opustiti postopno (npr. pri odraslih in mladostnikih, težkih več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna).
If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Ne uporabljajte zdravila Levetiracetam Hospira če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
There is no evidence for any relevant gender, race or circadian variability.
Med spoloma, rasami ali cirkadiano ni znakov pomembne variabilnosti.
Levetiracetam Hospira is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Zdravilo Levetiracetam Hospira se uporablja: samostojno za zdravljenje pri odraslih in mladostnikih od 16. leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje določene oblike epilepsije.
The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Farmakokinetični profil pri bolnikih z epilepsijo je primerljiv s farmakokinetičnim profilom pri zdravih prostovoljcih.
Probenecid (500 mg four times daily), a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam.
Ugotovili so, da probenecid (500 mg štirikrat na dan), ki preprečuje ledvično tubularno sekrecijo, zavre ledvični očistek primarnega presnovka, ne pa levetiracetama.
This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
Ta odkritja kažejo, da bi lahko interakcija med levetiracetamom in sinaptičnim vezikularnim proteinom 2A prispevala k antiepileptičnemu delovanju zdravila.
It was concluded that levetiracetam was not different (non-inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Ugotovili so, da se levetiracetam pri populaciji po protokolu ne razlikuje (ni manjvredno) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
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 (glejte poglavje 4.2).
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je zdravilo treba uporabiti takoj, razen, če metoda redčenja izključuje tveganje za mikrobiološko kontaminacijo.
The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
CLcr v ml/min/1,73 m2 je pri mlajših mladostnikih in otrocih mogoče oceniti iz koncentracije kreatinina v serumu (mg/dl) z uporabo naslednje formule (po Schwartzevi formuli):
Concentrate for solution for infusion (sterile concentrate).
koncentrat za raztopino za infundiranje (sterilni koncentrat)
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.
Priporočeni odmedrek se mora razredčiti v vsaj 100 ml kompatibilnega topila in infundirati 15 minut.
10 vials 25 vials
10 vial 25 vial
The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
Tveganje za pojav anoreksije je večje pri sočasni uporabi levetiracetama in topiramata.
The pharmacokinetics in paediatric patients has not been investigated after intravenous administration.
Pri otrocih niso raziskovali farmakokinetike po intravenskem dajanju.
Levetiracetam and related analogues show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Levetiracetam in sorodni analogi kažejo vrstni red afinitete za vezavo na sinaptični vezikularni protein 2A, ki korelira z jakostjo antiepileptične zaščite pri mišjem audiogenem modelu epilepsije.
Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution.
Zdravilo Levetiracetam Hospira koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna raztopina.
This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial).
To zdravilo vsebuje 2,5 mmol (ali 57 mg) natrija v največjem enkratnem odmerku (0,8 mmol (ali 19 mg) na vialo).
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 za odrasle in mladostnike 3.000 mg na dan, za otroke pa 60 mg/kg/dan, razdeljen na dva odmerka.
Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
Zdravilo Levetiracetam Hospira se lahko med nosečnostjo uporablja samo, če zdravnik po skrbni oceni ugotovi, da je to potrebno.
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
[140 - starost (leta)] x masa (kg) CLcr (ml/min) = ---------------------------------------------------- (x 0,85 za ženske) 72 x koncentracija kreatinina v serumu (mg/dl)
Levetiracetam therapy can be initiated with either intravenous or oral administration.
Zdravljenje z levetiracetamom lahko začnemo z intravensko ali peroralno uporabo.
A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Peri- in postnatalne razvojne študije z levetiracetamom pri podganah so izvedli pri odmerkih od 70, 350 in 1.800 mg/kg/dan.
• anorexia (loss of appetite);
anoreksija (izguba teka);
Dose in children and adolescents 50 kg or more is the same as in adults.
Pri otrocih in mladostnikih, težkih 50 kg ali več, je odmerjanje enako kot pri odraslih.
If stopping treatment, as with other antiepileptic medicines, Levetiracetam Hospira should be discontinued gradually to avoid an increase of seizures.
Tako kot pri vseh protiepileptičnih zdravilih je tudi pri zdravilu Levetiracetam Hospira treba zdravljenje opustiti postopoma, da se število napadov ne bi povečalo.
The total daily dose and frequency of administration should be maintained.
Celokupni dnevni odmerek in pogostost uporabe morata ostati enaka.
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, je bilo vključenih v placebo kontrolirane klinične študije.
The apparent body clearance of both levetiracetam and of its primary metabolite is correlated to the creatinine clearance.
Navidezni telesni očistek levetiracetama in njegovega primarnega presnovka korelira z očistkom kreatinina.
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 s parcialnimi napadi.
• pancreatitis (inflammation of the pancreas);
• pankreatitis (vnetje trebušne slinavke);
• Dextrose 50 mg/ml (5%) solution for injection
• glukoza 50 mg/ml (5 %) raztopina za injiciranje
The intravenous administration of doses up to 4,000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2,500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Ovrednotena je bila intravenska uporaba odmerkov do 4.000 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 15 minut, in odmerkov do 2.500 mg, razredčenih v 100 ml 0,9 % natrijevega klorida, infundiranih 5 minut.
No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Pri dojenčkih z epilepsijo, mlajših od 12 mesecev, niso ugotovili nobenih novih pomislekov glede varnosti za levetiracetam.
Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Dve študiji embriofetalnega razvoja pri podganah so izvedli pri odmerkih 400, 1.200 in 3.600 mg/kg/dan.
The active substance is levetiracetam.
Učinkovina je levetiracetam.
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.
Renal impairment The daily dose must be individualised according to renal function.
Bolniki z ledvično okvaro Dnevni odmerek je treba prilagoditi individualno glede na delovanje ledvic.
The fractional removal of levetiracetam was 51% during a typical 4-hour dialysis session.
Frakcijska odstranitev levetiracetama med tipično 4-urno dializo je bila 51 %.
A single dose of 1,500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1,500 mg levetiracetam oral intake, given as three 500 mg tablets.
Enkratni odmerek 1.500 mg levetiracetama, razredčen v 100 ml kompatibilnega topila in 15 minut intravensko infundiran, je bioekvivalenten 1.500 mg peroralnega levetiracetama, to so 3 tablete po 500 mg.
Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
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 several cases of alopecia, recovery was observed when levetiracetam was discontinued.
V nekaterih primerih alopecije so po prekinitvi zdravljenja z levetiracetamom opazili izboljšanje.
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 % preiskovancev, ki so prejemali karbamazepin z nadzorovanim sproščanjem).
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, uporabljenim samostojno, so na voljo samo omejeni dokazi.
Levetiracetam Hospira concentrate was found to be physically compatible and chemically stable when mixed with the following diluents:
Zdravilo Levetiracetam Hospira koncentrat je fizikalno kompatibilno in kemijsko stabilno pri mešanju z naslednjimi redčili:
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.
Pogosteje kot v drugih starostnih skupinah ali v skupnem varnostnem profilu so pri otrocih in mladostnikih, starih od 4 do 16 let, poročali o bruhanju (zelo pogosto, 11,2 %), agitaciji (pogosto, 3,4 %), nihanjih razpoloženja (pogosto, 2,1 %), čustveni labilnosti (pogosto, 1,7 %), agresiji (pogosto, 8,2 %), nenormalnem vedenju (pogosto, 5,6 %) in letargiji (pogosto, 3,9 %).