natgillin/translations-raw huggingface dataset:
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah; ks = 0,7 pri mladostnikih moškega spola
• elevated/abnormal values in a liver function test;
• povišane/nenormalne vrednosti testov jetrnih funkcij;
Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
Pogostnost je bistveno večja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki;
The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Glavna pot izločanja je z urinom, s katerim se izloči povprečno 95 % odmerka (približno 93 % odmerka se izloči v 48 urah).
This recommendation is based on a study in adult renally impaired patients.
To priporočilo temelji na študiji pri odraslih bolnikih z ledvično okvaro.
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 <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
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 (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila vi ali vaš otrok natančno preberite navodilo, ker vsebuje za vaju pomembne podatke!
The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Bolniki so morali imeti neizzvane parcialne napade ali samo generalizirane tonično-klonične napade.
Your total daily dose and frequency of administration remain identical.
Vaš celokupni dnevni odmerek in pogostost uporabe ostaneta enaki.
There is no modification of the clearance after repeated administration.
Očistek se po ponavljajočem dajanju 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).
Oral contraceptives and other pharmacokinetics interactions
Peroralni kontraceptivi in druge farmakokinetične interakcije
Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Ti bolniki morajo biti zato previdni pri izvajanju zahtevnih opravil, npr. pri vožnji vozil ali upravljanju strojev.
Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Bolnikom svetujemo, naj ne vozijo ali upravljajo s stroji, dokler ni potrjeno, da ni vpliva na njihovo sposobnost izvajanja teh dejavnosti.
Levetiracetam caused mild induction of CYP2B6 and CYP3A4.
Levetiracetam je povzročil blago indukcijo CYP2B6 in CYP3A4.
There was no effect on embryomortality and no increased incidence of malformations.
Umrljivosti zarodka in povečanje pojava malformacij ni bilo.
The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Navidezni telesni očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.
The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Volumen porazdelitve levetiracetama je približno 0,5 do 0,7 l/kg, kar je blizu vrednosti celotnega volumna vode v telesu.
• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• hujšo obliko izpuščaja, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza)
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX14.
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)
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 s stroji.
However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Če je zdravljenje z levetiracetamom v obdobju dojenja potrebno, se mora pretehtati razmerje med koristjo in tveganjem zdravljenja glede na pomembnost dojenja.
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 svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki depresije in/ali samomorilnega razmišljanja in vedenja.
• decreased number of all blood cell types;
• zmanjšano število vseh vrst krvnih celic;
The metabolite ucb L057 is pharmacologically inactive.
Presnovek ucb L057 ni farmakološko aktiven.
When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.
Na začetku jemanja zdravila Levetiracetam Hospira vam bo zdravnik, preden vam bo predpisal najnižji običajni odmerek, za dva tedna predpisal nižji odmerek.
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.
You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Ne smete voziti ali upravljati strojev, dokler ni potrjeno, da zdravilo ne vpliva na vašo sposobnost izvajanja teh dejavnosti.
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
• hude alergijske reakcije (DRESS, anafilaktična reakcija [huda in pomembna alergijska reakcija], Quinckejev edem [otekanje obraza, ustnic, jezika in žrela]);
nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache.
nazofaringitis (okužba nosu ali žrela); somnolenca (zaspanost), glavobol.
Therefore patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Infusion Time Frequency of administration
Čas infuzije Pogostost uporabe
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
Conversion to or from oral to intravenous administration can be done directly without titration.
Prehod na ali od peroralne k intravenski uporabi je lahko neposreden brez titracije.
What Levetiracetam Hospira is and what it is used for What you need to know before you are given Levetiracetam Hospira How Levetiracetam Hospira is given Possible side effects
Kaj je zdravilo Levetiracetam Hospira in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Levetiracetam Hospira Kako se daje zdravilo Levetiracetam Hospira Možni neželeni učinki
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 behaviour were not worse than baseline.
Kljub temu pa se osebam, ki so jemale levetiracetam med dolgotrajno, odprto, sledilno študijo, v povprečju niso poslabšale njihove vedenjske in emocionalne funkcije; natančneje, rezultati meritev agresivnega obnašanja niso bili slabši od začetnih vrednosti.
• 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.
• znaki resnih duševnih 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.
A large amount of post-marketing 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.
In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.
V kulturi človeških hepatocitov je imel levetiracetam majhen učinek ali pa ni imel učinka na CYP1A2, SULT1E1 ali UGT1A1.
At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kot so na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
Nevertheless, the concentration of this metabolite remains low.
Kljub temu ostane koncentracija primarnega presnovka nizka.
This medicinal product is for single use only, any unused solution should be discarded.
Zdravilo je samo za enkratno uporabo, neuporabljeno raztopino je treba zavreči.
A doctor or a nurse will administer you Levetiracetam Hospira as an intravenous infusion.
Zdravnik ali medicinska sestra vam bo zdravilo Levetiracetam Hospira dal kot intravensko infuzijo.
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali druge pirolidonske derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Plazemski razpolovni čas pri odraslih je 7  1 ur in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
• swelling of the face, lips, tongue and throat (Quincke's oedema)
• otekanje obraza, ustnic, jezika in žrela (Quinckejev edem)
If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
če ste pri otroku opazili počasnejšo rast ali nepričakovan razvoj v puberteti, se posvetujte z zdravnikom.
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Zdravnik mora glede na starost, telesno maso in odmerek predpisati najustreznejšo farmacevtsko obliko, velikost pakiranja in jakost.
• decreased number of blood platelets, decreased number of white blood cells;
zmanjšano število krvnih ploščic, zmanjšano število belih krvnih celic;
The dialyser extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
Učinkovitost dializne ekstrakcije levetiracetama je 60 %, primarnega presnovka pa 74 %.
CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
CLcr (ml/min/1,73 m 2) = ----------------------- x 1,73 BSA bolnika (m
Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
Withdrawal Volume Volume of Diluent
Odmerek Odvzeti volumen Volumen redčila
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Rezultati povezani z vedenjskimi in emocionalnimi funkcijami kažejo pri bolnikih, ki se zdravijo z levetiracetamom, poslabšanje agresivnega obnašanja, ki se izmeri na standardiziran in sistematičen način z uporabo validiranega merskega instrumenta (CBCL - Achenbach Child Behavior Checklist).
Levetiracetam Hospira may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Zdravilo Levetiracetam Hospira lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko zdravilo Levetiracetam Hospira povzroči zaspanost.
In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalov povzročeno z Zn in β- karbolini.
Furthermore, levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue.
Nadalje se je za levetiracetam v in vitro študijah pokazalo, da se veže na specifično mesto v možganskem tkivu glodalcev.
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.
Neželeni učinki, o katerih so poročali v kliničnih študijah (odrasli, mladostniki, otroci in dojenčki, starejši od 1 meseca) in v postmarketinškem obdobju, so navedeni v spodnji preglednici po organskih sistemih in pogostnosti.
Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Pri nekaterih bolnikih se lahko zaradi različne individualne občutljivosti predvsem na začetku zdravljenja ali po povečanju odmerka pojavi somnolenca ali drugi simptomi, povezani s centralnim živčnim sistemom.
Box of 10 or 25 vials
Škatla z 10 ali 25 vialami
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, izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo drugih antiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona), in da ta antiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
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).
73,0 % bolnikov, ki so se zdravili z levetiracetamom, in 72,8 % bolnikov, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem (CR) je bilo šest mesecev brez napadov; prilagojena absolutna razlika med zdravljenjema je bila 0,2 % (95-% CI: 7,8-8,2).
Пфайзер Люксембург САРЛ, Клон България Тел.
Пфайзер Люксембург САРЛ, Клон БългарияHospira UK Limited Тел.
This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis.
To vezavno mesto je sinaptični vezikularni protein 2A, ki naj bi bil udeležen pri fuziji veziklov in eksocitozi nevrotransmiterjev.
Directions for the proper use of Levetiracetam Hospira is provided in section 3.
Navodila za pravilno uporabo zdravila Levetiracetam Hospira se nahajajo v poglavju 3.
Should your doctor decide to stop your Levetiracetam Hospira treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Hospira.
Če se bo vaš zdravnik odločil za prekinitev zdravljenja z zdravilom Levetiracetam Hospira, vam bo dal napotke o postopni ukinitvi zdravila Levetiracetam Hospira.
In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
In vitro so pokazali, da levetiracetam in njegov primarni presnovek ne zavirata aktivnosti glavnih izooblik človeškega jetrnega citokroma P450 (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 in 1A2), glukuronil-transferaze (UGT1A1 in UGT1A6) in epoksid-hidroksilaze.
General dose: between 1,000 mg and 3,000 mg each day.
Običajni odmerek: med 1.000 mg in 3.000 mg na dan.
If you stop using Levetiracetam Hospira:
Če ste prenehali uporabljati zdravilo Levetiracetam Hospira:
Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use.
Zaradi omejene izpostavljenosti intravenski uporabi levetiracetama in zaradi bioekvivalence med peroralno in intravensko obliko informacije o varnosti intravenske uporabe levetiracetama temeljijo na peroralni uporabi levetiracetama.
A small number of people being treated with antiepileptics such as Levetiracetam Hospira have had thoughts of harming or killing themselves.
pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Levetiracetam Hospira, so se pojavile misli na samopoškodovanje ali samomor.
• sudden decrease in kidney function;
• nenadno zmanjšanje delovanja ledvic;
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• nekontrolirani mišični spazmi, ki prizadenejo glavo, trup in okončine, težave pri nadzoru gibanja, hiperkinezija (hiperaktivnost);
However, data suggested a 20% higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Vendar pa podatki nakazujejo, da je pri otrocih, ki jemljejo antiepileptična zdravila, ki inducirajo encime, povečan očistek levetiracetama za 20 %.
Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect.
Levetiracetam povzroči zaščito pred parcialnimi in primarno generaliziranimi napadi pri širokem spektru živalskih modelov in nima prokonvulzivnega učinka.
• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
• šibkost, vrtoglavico ali omotico ali težave z dihanjem, saj so to lahko znaki resne alergijske (anafilaktične) reakcije
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Za uporabo te preglednice je treba predhodno oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Ima linearni farmakokinetični profil, z majhno intra- in interindividualno variabilnostjo.
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
• rabdomioliza (razgradnja mišičnega tkiva) in z njo povezano zvišanje kreatin fosfokinaze v krvi.
The intravenous formulation is an alternative to your oral administration.
Intravenska oblika je alternativa vaši peroralni uporabi.
In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam.
Delovanje na parcialne in generalizirane epileptične napade (epileptiformno proženje/fotoparoksizmalen odgovor) potrjuje njegov širok spekter farmakološkega profila levetiracetama pri ljudeh.
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Retrospektivna ocena o farmakokinetičnih interakcijah pri otrocih in mladostnikih z epilepsijo (od 4 do 17 let) je potrdila, da dopolnilna terapija s peroralno uporabljenim levetiracetamom ni vplivala na koncentracije v serumu v stanju dinamičnega ravnovesja pri sočasnem dajanju karbamazepina in valproata.
The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1,500 mg intravenous infusion for 4 days with twice daily dosing.
Potrjen je bil tudi časovno neodvisen farmakokinetični profil levetiracetama pri intravenski infuziji 1.500 mg dvakrat dnevno 4 dni.
The primary metabolite is inactive.
Njegov primarni presnovek ni aktiven.
What Levetiracetam Hospira is and what it is used for
Kaj je zdravilo Levetiracetam Hospira in za kaj ga uporabljamo
This is more likely at the beginning of treatment or after an increase in the dose.
Zaspanost se največkrat pojavlja na začetku zdravljenja ali po povečanju odmerka.
Two minor metabolites were also identified.
Odkrili so še dva manj pomembna presnovka.
5 How to store Levetiracetam Hospira 6 Contents of the pack and other information
5 Shranjevanje zdravila Levetiracetam Hospira 6 Vsebina pakiranja in dodatne informacije
The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Ledvični očistek levetiracetama 0,6 ml/min/kg in njegovega primarnega presnovka ucb L057 4,2 ml/min/kg kažeta na to, da se levetiracetam izloča z glomerulno filtracijo, ki ji sledi tubularna reabsorpcija, primarni presnovek pa se poleg glomerulne filtracije izloča tudi z aktivno tubularno sekrecijo.
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• simptome kot so majhen volumen urina, utrujenost, slabost, bruhanje, zmedenost in otekanje nog, gležnjev ali stopal saj so lahko to znaki nenadnega zmanjšanja delovanja ledvic
In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Levetiracetam in vitro prav tako ne vpliva na glukuronidacijo valprojske kisline.
Levetiracetam Hospira concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Zdravilo Levetiracetam Hospira koncentrat je samo za intravensko uporabo, priporočeni odmerek mora biti razredčen v vsaj 100 ml kompatibilnega topila in uporabljen intravensko kot 15-minutna intravenska infuzija (glejte poglavje 6.6).
At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Pri 3.600 mg/kg/dan se je samo v eni od dveh študij embriofetalnega razvoja telesna masa plodu zanemarljivo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.