natgillin/translations-raw huggingface dataset:
This is related to the decrease in renal function in this population (see section 4.2).
To je povezano z zmanjšanim delovanjem ledvic v tej populaciji (glejte poglavje 4.2).
The lowest effective dose should be used.
Uporabiti je treba najmanjši učinkoviti odmerek.
No impact on fertility was detected in animal studies (see section 5.3).
V študijah na živalih niso ugotovili vpliva na plodnost (glejte poglavje 5.3).
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
*Prevalenca je bistveno višja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki.
Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Zagotoviti je treba ustrezno klinično vodenje nosečnic, zdravljenih z levetiracetamom.
Suicide
Samomor
The mechanism of action of levetiracetam still remains to be fully elucidated.
Mehanizem delovanja Mehanizem delovanja levetiracetama še ni povsem pojasnjen.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati.
Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Hidroliza acetamidne skupine je merljiva v številnih tkivih, tudi v krvnih celicah.
However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Vendar dolgoročni vplivi na učenje, inteligenco, rast, endokrino delovanje, puberteto in zmožnost imeti otroke pri otrocih ostajajo neznani.
No data are available.
Na razpolago ni nobenih podatkov..
There is no evidence for any relevant gender, race or circadian variability.
Ni znakov pomembne variabilnosti med spoloma, med rasami ali cirkadiano.
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.
There was no effect on embryomortality and no increased incidence of malformations.
Vpliva na umrljivost zarodkov ni bilo, prav tako se ni povečala incidenca malformacij.
However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Če pa je zdravljenje z levetiracetamom med obdobjem dojenja potrebno, je treba koristi in tveganja takšnega zdravljenja pretehtati upoštevaje pomen dojenja.
The results are consistent across age group.
Rezultati po starostnih skupinah se skladajo.
The metabolite ucb L057 is pharmacologically inactive.
Presnovek ucb L057 je farmakološko neaktiven.
• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
• Če ste alergični na levetiracetam, pirolidonske derivate ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
as an add-on to other antiepileptic medicines to treat:
• kot dodatek drugim antiepileptičnim zdravilom za zdravljenje:
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction],
• hude alergijske reakcije (DRESS, anafilaktična reakcija [huda in pomembna alergijska reakcija],
Be sure to drink the whole contents of the glass.
Poskrbite, da boste popili celotno vsebino kozarca.
Your doctor will establish the best possible treatment of overdose.
Zdravnik bo določil najustreznejše zdravljenje prevelikega odmerjanja.
Therefore, the interaction of levetiracetam with other substances, or vice versa, is unlikely.
Zato medsebojno delovanje levetiracetama drugimi snovmi ali drugih snovi z njim ni verjetno.
Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP:.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli in na steklenički poleg oznake EXP.
CLcr (ml/min) = ----------------------------------------- (x 0.85 for women)
CLcr (ml/min) = ----------------------------------------- (x 0,85 za ženske)
Nervous system Somnolence,
Bolezni živčevja somnolenca,
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravila vi ali vaš otrok natančno preberite navodilo, ker vsebuje za vaju pomembne podatke!
No data on the interaction of levetiracetam with alcohol are available.
Podatkov o interakciji levetiracetama z alkoholom ni.
Physiological changes during pregnancy may affect levetiracetam concentration.
Fiziološke spremembe lahko med nosečnostjo vplivajo na koncentracijo levetiracetama.
For adult patients, refer to the following table and adjust the dose as indicated.
Za odrasle bolnike glejte naslednjo preglednico in prilagodite odmerek, kot je označeno.
This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Ta učinek je bil izrazit pri mladih dojenčkih in se je s povečevanjem starosti manjšal, tako da je okrog 4. leta postal zanemarljiv.
• decreased number of blood platelets, decreased number of white blood cells;
• zmanjšano število krvnih ploščic, zmanjšano število belih krvnih celic
Other unidentified components accounted only for 0.6% of the dose.
Na račun drugih, neidentificiranih sestavin gre le 0,6 % odmerka.
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Bolnikom je treba naročiti, naj ne vozijo in ne uporabljajo strojev, dokler se ne izkaže, da njihova sposobnost za opravljanje takšnih dejavnosti ni prizadeta.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.
Ne jemljite makrogola (učinkovina, ki se uporablja kot laksativ) eno uro pred in eno uro po jemanju levetiracetama, ker lahko zmanjša učinek levetiracetama.
72 x serum creatinine (mg/dl)
72 x kreatinin v serumu (mg/dl)
Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Pogostnost je bistveno višja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, mislite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX14
[140-age (years)] x weight (kg)
[140-starost (let)] x masa (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 v urinu; tako se izloči povprečno 95 % odmerka (približno 93 % odmerka se izloči v 48 urah).
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.
Ker se individualna občutljivost razlikuje, se lahko nekaterim bolnikom pojavijo zaspanost ali drugi simptomi, povezani z osrednjim živčevjem, zlasti na začetku zdravljenja ali po povečanju odmerka.
Epilepsy is a condition where the patients have repeated fits (seizures).
Epilepsija je stanje, kjer imajo bolniki ponavljajoče krče (napade).
Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Levetiracetam ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
When you will first start taking Levetiracetam Actavis Group, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Na začetku jemanja zdravila Levetiracetam Actavis Group vam bo zdravnik prva dva tedna predpisal manjši odmerek, preden vam bo dal najmanjši splošni odmerek.
220 Hafnarfjörður Iceland
220 Hafnarfjörđur
For young children gently put the tip of the syringe into the child´s mouth to the inside of the cheek.
Pri majhnih otrocih previdno dajte konico brizge v otrokova usta, na notranjo stran lica.
Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Priporoča se določitev celotne krvne slike pri bolnikih, ki imajo močno slabost, pireksijo, ponavljajoče okužbe ali motnje v koagulaciji (poglavje 4.8).
You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Ne upravljajte vozil ali strojev, dokler se ne izkaže, da vaša sposobnost za takšne dejavnosti ni prizadeta.
Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Levetiracetam se uporablja pri vrsti epilepsije, kjer krči v začetku prizadanejo eno stran možganov, kasneje pa se lahko razširijo na večje površine na obeh straneh možganov (parcialni napadi s sekundarno generalizacijo ali brez nje).
There is no modification of the clearance after repeated administration.
Očistek se po ponavljajoči se uporabi ne spremeni.
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).
Then CLcr is adjusted for body surface area (BSA) as follows:
Nato se CLcr prilagodi glede na telesno površino takole:
ks= 0.45 in term infants to 1 year old; ks= 0.55 in children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
ks = 0,45 pri donošenih dojenčkih do 1 leta starosti, ks = 0,55 pri otrocih, mlajših od 13 let, in pri mladostnicah, ks = 0,7 pri mladostnikih
Antiepileptic medicinal products
Antiepileptična zdravila
The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy.
Farmakokinetični profil pri zdravih prostovoljcih in bolnikih z epilepsijo je primerljiv.
The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Farmakokinetični profil je linearen, z majhno intra- in interindividualno variabilnostjo.
In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Poleg tega delno odpravi zmanjšanje z GABA in glicinom uravnavanih tokov, povzročenih s cinkom ß-karbolini.
The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
• Do not stop your treatment without your doctor's advice as this could increase your seizures.
• Ne prekinite zdravljenja, ne da bi se posvetovali z zdravnikom, ker se vam epileptični napadi lahko stopnjujejo.
Levetiracetam Actavis Group must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Levetiracetam Actavis Group je treba vzeti dvakrat na dan, enkrat zjutraj in enkrat zvečer,
The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Uporaba levetiracetama je bila zelo redko povezana z akutno poškodbo ledvic, ki se lahko pojavi v razponu od nekaj dni do nekaj mesecev od uporabe.
• If you suffer from kidney problems, follow your doctor's instructions.
• Če imate težave z ledvicami, upoštevajte zdravnikova navodila.
However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Vendar se preiskovancem, ki so jemali levetiracetam v dolgoročni, odprti spremljevalni študiji, v povprečju vedenjsko in čustveno delovanje ni poslabšalo; še zlasti mere agresivnega vedenja niso bile slabše kot izhodiščno.
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 69).
V študiji, ki odraža klinično prakso, je bilo mogoče antiepileptično zdravilo opustiti pri manjšem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 odraslih bolnikov od 69).
Two minor metabolites were also identified.
Ugotovljena sta še dva manj pomembna presnovka.
A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Veliko podatkov, pridobljenih v obdobju trženja, o nosečnicah, ki so bile izpostavljene samostojnemu zdravljenju z levetiracetamom (več kot 1800, od katerih jih je bilo več kot 1500 izpostavljenih med prvim trimesečjem), ne kažejo na povečanje tveganja za večje prirojene malformacije.
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
• znake resnih mentalnih sprememb ali če kdo okoli vas opazi znake zmedenosti, somnolence (zaspanost), amnezije (izguba spomina), oslabljen spomin (pozabljivost), neobičajno vedenje ali druge nevrološke znake vključno z nehotenim ali nenadzorovanim gibanjem.
• limp or difficulty walking.
• šepanje ali težave pri hoji
Push the plunger in slowly and allow the child to swallow the content of the syringe.
Počasi potisnite bat, da bo otrok lahko pogoltnil vsebino brizge.
• elevated/abnormal values in a liver function test;
• povišane/nenormalne vrednosti testov jetrnih funkcij
The daily dose must be individualised according to renal function.
Dnevni odmerek je treba individualno prilagoditi glede na delovanje ledvic.
If any bubbles appear in the syringe keep the bottle upside down and slightly push in the plunger and pull it back again.
Če se v brizgi pojavijo mehurčki, naj stekleničke ostane obrnjena na glavo; rahlo potisnite bat navznoter in ga nato znova potegnite ven.
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to
Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
This recommendation is based on a study in adult renally impaired patients.
Priporočilo temelji na študiji pri odraslih bolnikih z okvaro ledvic.
In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
V obeh starostnih skupinah pediatričnih bolnikov so podatki dopolnjeni s postmarketinškimi izkušnjami pri uporabi levetiracetama.
The apparent body clearance was 1.1 ml/min/kg.
Navidezni telesni očistek je bil 1,1 ml/min/kg.
Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.
Zato se makrogola ne sme vzeti eno uro pred zaužitjem levetiracetama in še eno uro po zaužitju.
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
V več primerih alopecije so opažali njeno izginotje po prenehanju uporabe levetiracetama.
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Predmarketinški podatki iz kliničnih študij pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo obstoječih antiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona) in da ta antiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Pri človeku je delovanje pri parcialnih in generaliziranih epileptičnih motnjah (epileptiformna sprožitev/fotoparoksizmalni odziv) potrdilo široki predklinično ugotovljeni farmakološki profil levetiracetama.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Za uporabo te odmerne preglednice je treba oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
<1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000).
(≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Če imate kakšne simptome depresije in/ali razmišljate o samomoru, se posvetujte z zdravnikom.
The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced.
Hrana ni spremenila deleža absorpcije levetiracetama, je pa rahlo zmanjšala hitrost absorpcije.
In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Poskusi in vitro in in vivo kažejo, da levetiracetam ne spreminja osnovnih značilnosti celic in normalnega živčnega prenosa.
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).
Stanje 6 mesecev brez napadov je doseglo 73,0 % prejemnikov levetiracetama in 72,8 % prejemnikov karbamazepina CR; korigirana absolutna razlika med zdraviloma je bila 0,2 % (95 % IZ: -7,8, 8,2).
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih poškodba
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam je antiepileptično zdravilo (zdravilo za zdravljenje napadov pri epilepsiji).
Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Zato je pri priporočljiva previdnost pri bolnikih, ki izvajajo dejavnosti, pri katerih je potrebna pozornost, npr. upravljajo vozila ali stroje.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Bolnikom (in skrbnikom bolnikov) je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilno razmišljanje ali vedenje.
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Zdravnik mora predpisati najprimernejšo farmacevtsko obliko, pakiranje in jakost glede na starost, telesno maso in odmerek.
Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed.
Levetiracetam se lahko uporablja med nosečnostjo, če se po skrbnem pretehtanju ugotovi, da je to klinično potrebno.
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 razpolovni čas krajši (5,3 ure) kot pri odraslih (7,2 ure), navidezni očistek pa je hitrejši (1,5 ml/min/kg) kot pri odraslih (0,96
A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptičnih zdravil je pokazala tudi majhno povečanje tveganja samomorilnih misli in vedenja.
Do not use after 7 months of first opening the bottle.
Zdravila ne smete uporabljati več kot 7 mesece po prvem odprtju stekleničke.
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni 'brez natrija'.
Repeat until there are no bubbles in the syringe (Figure 6).
To ponavljajte, dokler v brizgi ne več mehurčkov (slika 6).
Infants and children (1 month to 4 years)
Dojenčki in otroci (od 1 meseca do 4 let)
Oral contraceptives and other pharmacokinetics interactions
Peroralni kontraceptivi in druga farmakokinetična medsebojna delovanja
No tissue distribution data are available in humans.
Podatkov o porazdelitvi v tkiva pri človeku ni.
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Bolniki so smeli imeti le neizzvane napade parcialnega izvora ali generalizirane tonično-klonične napade.
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 ura in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
• A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves.
• Pri majhnem številu oseb, ki so dobivale zdravila proti epilepsiji, kakršno je levetiracetam, se je pojavilo razmišljanje o samopoškodovanju ali samomoru.
• decreased number of all blood cell types;
• okužba • zmanjšano število vseh tipov krvnih celic
End-stage renal disease patients undergoing dialysis (1)
Bolniki s končno odpovedjo ledvic na dializi (1)
The total daily dose was administered twice daily.
Celotni dnevni odmerek je bil razdeljen na uporabo dvakrat na dan.
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 mogoče koncentracijo v plazmi predvideti na podlagi peroralnega odmerka levetiracetama, izraženega v mg/kg telesne mase.
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.
Ugotovila je, da se levetiracetam v populaciji-po-protokolu ni razlikoval (ni bil inferioren) od placeba, kar zadeva spremembo sestavljene ocene Leiter-R Attention and Memory, Memory Screen Composite.
The majority of patients presented with juvenile myoclonic epilepsy.
Večina bolnikov je imela juvenilno mioklonično epilepsijo.
3 years.
4 leta in več.
If stopping treatment, Levetiracetam Actavis Group should be discontinued gradually to avoid an increase of seizures.
V primeru prenehanja zdravljenja je treba zdravilo Levetiracetam Actavis Group nehati uporabljati postopoma, da bi preprečili stopnjevanje napadov.
The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Navidezni, za telesno maso korigirani očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.
• injury.
• poškodba
Breast-feeding is not recommended during treatment.
Dojenje med zdravljenjem ni priporočljivo.