natgillin/translations-raw huggingface dataset:
These are common in people taking Trobalt, and can lead to not being able to pass urine at all.
Te so pri osebah, ki jemljejo zdravilo Trobalt, pogoste in lahko povzročijo, da oseba sploh ne more odvajati urina.
If breakthrough seizures occur towards the end of dialysis then an additional supplemental dose may be considered at the start of subsequent dialysis sessions.
V primeru izbruha napadov proti koncu dialize pride v poštev uporaba dodatnega odmerka na začetku vseh nadaljnjih dializ.
What is in this leaflet What Trobalt is and what it is used for What you need to know before you take Trobalt
Kaj je zdravilo Trobalt in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trobalt
The cumulative incidences of an event at 1 year, 2 years, 3 years, 4 years and 5 years of exposure are approximately 1%, 1.8%, 4.4%, 10.2% and 16.7% respectively.
Kumulativne incidence tega učinka so: 1 % po 1 letu, 1,8 % po 2 letih, 4,4 % po 3 letih, 10,2 % po 4 letih in 16,7 % po 5 letih izpostavljenosti.
In vitro data indicated a low potential for interaction with other antiepileptic medicinal products (see section 5.2).
Podatki in vitro so pokazali majhno možnost medsebojnega delovanja z drugimi antiepileptiki (glejte poglavje 5.2).
Marketing Authorisation Holder Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
Imetnik dovoljenja za promet Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS, Velika Britanija.
Read the package leaflet before use Oral use
Pred uporabo preberite priloženo navodilo.
Therefore Trobalt may be taken with or without food.
Zato se lahko zdravilo Trobalt jemlje s hrano ali brez nje.
Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Starejši bolniki imajo lahko večje tveganje za pojave v centralnem živčnem sistemu, retence urina in atrijske fibrilacije.
Like all medicines, Trobalt can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Trobalt neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
There was no effect on sleep time induced by halothane or methohexital sodium.
Na čas spanja, povzročenega s halotanom ali natrijevim metoheksitalatom, ni vplival.
Tell your doctor as soon as possible if you get any of these symptoms.
Zdravniku morate čim prej povedati, če se vam pojavi kateri od teh simptomov.
A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
V celoti se v urinu pojavi približno 84 % odmerka, vključno z N-acetilnim presnovkom (18 %), N-glukuronidi matične učinkovine in N-acetilnega presnovka (24 %) ali matične učinkovine (36 %).
Trobalt must be used with caution in patients at risk of urinary retention, and it is recommended that patients are advised about the risk of these possible effects.
Zdravilo Trobalt je treba previdno uporabljati pri bolnikih, ki imajo tveganje za pojav retence urina; bolnike je priporočljivo seznaniti o tveganju za pojav takih neželenih učinkov.
Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Sočasna uporaba etanola (1,0 g/kg) in retigabina (200 mg) je pri zdravih prostovoljcih povzročila povečanje zamegljenosti vida.
In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment.
Na podlagi kumulativnih podatkov o varnosti iz treh multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih študij so bili neželeni učinki na splošno blagi do zmerni in so bili najpogosteje opisani v prvih 8 tednih zdravljenja.
It is not known whether the active substance of Trobalt can pass into breast-milk.
Ni znano, ali lahko zdravilna učinkovina zdravila Trobalt prehaja v materino mleko.
Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Retigabin se presnovi tudi v N-acetilni presnovek (NAMR), ki se nato prav tako glukuronira.
Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Farmakokinetika retigabina pri otrocih mlajših od 12 let ni raziskana.
In addition, retigabine was effective in preventing status epilepticus seizures in rodents with cobalt-induced epileptogenic lesions, and inhibiting tonic extensor seizures in genetically susceptible mice.
Poleg tega je retigabin učinkovito preprečil napade statusa epilepticusa pri glodalcih, ki so imeli s kobaltom povzročene epileptogene lezije, in je zavrl tonične ekstenzorske napade pri genetsko dovzetnih miših.
In rats, retigabine and/or its metabolites crossed the placenta resulting in tissue concentrations that were similar in dams and foetuses.
Pri podganah retigabin in/ali njegovi presnovki prehajajo skozi placento in dosežejo pri samicah in plodovih podobne tkivne koncentracije.
Weight increased Increased appetite
večji apetit
− The need to inform patients that TROBALT may cause pigment changes in ocular tissues, including the retina, and also in the skin, lips and/or nails, as well as a distinct form of macular abnormality with features of vitelliform maculopathy;
- Bolnike je treba obvestiti, da lahko zdravilo TROBALT povzroča pigmentne spremembe v očesnih tkivih, vključno z mrežnico, pa tudi na koži, ustnicah in/ali nohtih, kot tudi posebno obliko nenormalnosti makule z značilnostmi viteliformne makulopatije.
Tell your doctor immediately if you get any of these symptoms.
Zdravniku morate takoj povedati, če se vam pojavi kateri od teh simptomov.
Approximately 30-40% of clinical trial subjects who were being treated with retigabine and underwent a skin and/or ophthalmological examination had findings of discolouration of nails, lips, skin and/or mucosa or non-retinal ocular pigmentation, and approximately 15-30% of clinical trial subjects who were being treated with retigabine and underwent an ophthalmological examination had retinal pigmentation findings.
Približno 30 do 40 % preiskovancev kliničnih preskušanj, ki so prejemali retigabin in so opravili pregled kože in/ali oftalmološki pregled, je imelo spremembe barve nohtov, ustnic, kože in/ali sluznic ali nemrežnične pigmentacije v očesu, približno 15 do 30 % preiskovancev kliničnih preskušanj, ki so prejemali retigabin in so opravili oftalmološki pregled, pa je imelo pigmentacije mrežnice.
Don't chew, crush or split the tablet.
Ne grizite je, ne drobite in ne lomite.
When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
V primeru prenehanja zdravljenja z zdravilom Trobalt je treba odmerek zmanjševati postopoma v obdobju vsaj 3 tednov (glejte poglavje 4.4).
There are no adequate data from the use of retigabine in pregnant women.
Za uporabo retigabina pri nosečnicah ni zadostnih podatkov.
Don't stop unless your doctor advises you to.
Ne nehajte ga jemati, razen če vam to svetuje zdravnik.
Distension of the gall bladder was seen in studies with dogs, but there was no evidence of cholestasis or other signs of gall bladder dysfunction, and bile ejection volume was unchanged.
Pri psih so ugotovili razširitev žolčnika, ni pa bilo znakov holestaze ali drugih znakov motenega delovanja žolčnika; tudi iztisni volumen žolča ni bil spremenjen.
This analysis also showed no clinically significant effect of the inducers (phenytoin, carbamazepine and phenobarbital) on retigabine clearance.
Ta analiza tudi ni pokazala klinično pomembnega učinka induktorjev (fenitoina, karbamazepina in fenobarbitala) na očistek retigabina.
Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Spremenjena barva kože, nohtov, ustnic in oči ter težave z očmi, ki jih povzročajo spremembe v centru mrežnice (makulopatija).
84 film-coated tablets Component of a multipack, can't be sold separately
84 filmsko obloženih tablet Sestavina skupnega pakiranja, ni za ločeno prodajo.
• tingling or numbness of the hands or feet
• mravljinčenje ali omrtvelost v dlaneh in stopalih,
The MAH shall ensure that, at launch and after launch, neurologists, ophthalmologists and other healthcare professionals (according to national requirements) are provided with a physician information pack containing the following elements:
Imetnik dovoljenja za promet mora zagotoviti, da ob prihodu zdravila na trg in po prihodu zdravila na trg, nevrologi, oftalmologi in drugi zdravstveni delavci (skladno z nacionalnimi zahtevami), prejmejo izobraževalno gradivo za zdravnike, ki vključuje naslednje elemente: • Povzetek glavnih značilnosti zdravila
For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day.
Bolniki z ledvično okvaro v končnem stadiju, ki so na hemodializi, naj vzamejo na dan dialize dnevni odmerek kot ponavadi.
In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
V študiji peri- in postnatalnega razvoja pri podganah je bil retigabin po uporabi med brejostjo povezan z večjo perinatalno umrljivostjo.
It is unknown whether retigabine is excreted in human breast milk.
Ni znano, ali se retigabin pri človeku izloča v materinem mleku.
Do not take Trobalt • if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6).
• če ste alergični na retigabin ali katerokoli drugo sestavino zdravila Trobalt (naštete so v poglavju 6).
If you forget to take Trobalt
Če ste pozabili vzeti zdravilo Trobalt
It may take a few weeks to find the right dose of Trobalt for you.
Mine lahko nekaj tednov, preden se ugotovi odmerek zdravila Trobalt, ki je pravi za vas.
Pharmacodynamic effects
Farmakodinamski učinki
Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
če je zdravilo Trobalt predpisano z zdravili, ki podaljšajo interval QT, in pri bolnikih z znanim podaljšanim QT intervalom, kongestivnim srčnim popuščanjem, hipertrofijo prekatov, hipokaliemijo ali hipomagneziemijo in pri bolnikih, ki začenjajo zdravljenje in so stari 65 let ali več.
Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Poročali so o motnjah vida (zoženje vidnega polja, izguba centralne občutljivosti in zmanjšana ostrina vida).
However, efficacy and safety of retigabine have not been determined in adolescents.
Učinkovitost in varnost pri mladostnikih še nista bili ugotovljeni.
You can take Trobalt with or without food.
Zdravilo Trobalt lahko vzamete s hrano ali brez nje.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Trobalt is for oral use.
Zdravilo Trobalt je za peroralno uporabo.
A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
Pri starejših bolnikih je priporočljivo zmanjšati začetni in vzdrževalni odmerek zdravila Trobalt.
Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Bolnike so randomizirali na placebo ali na 600, 900 ali 1.200 mg retigabina na dan (glejte preglednico 1).
The drug interaction potential was, therefore, evaluated based on a pooled analysis across clinical studies and whilst not considered as robust as stand-alone clinical interaction studies, the results support the in vitro data.
Možnost medsebojnega delovanja je bila zato ocenjena na podlagi kumulativne analize kliničnih študij; ti rezultati sicer ne veljajo za tako trdne kot rezultati samostojne klinične študije medsebojnega delovanja, vendar podpirajo podatke, dobljene in vitro.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA (BREZ MODREGA OKENCA - SAMO SKUPNO PAKIRANJE)
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Varnost in učinkovitost retigabina pri otrocih, mlajših od 18 let, še nista ugotovljeni (glejte poglavje
Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation).
(parcialni napad), ki se lahko ali ne širi na večja področja obeh strani možganov (sekundarna generalizacija).
• if you have an existing heart problem • if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in your
• če imate nizek kalij (hipokaliemija) ali nizek magnezij (hipomagneziemija) v krvi,
After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed.
Po zaužitju izpuščenega odmerka morajo preteči vsaj 3 ure, preden vzame naslednji odmerek; nato mora zdravilo jemati naprej po običajni shemi.
In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis (n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine (100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
V drugi študiji enkratnih odmerkov pri preiskovancih s končno odpovedjo ledvic na kronični hemodializi (n = 8) je začetek dialize približno 4 ure po enkratnem odmerku retigabina (100 mg) povzročil mediano znižanje koncentracije retigabina v plazmi od začetka do konca dialize za 52 %.
− The need to inform patients that TROBALT may cause or potentiate symptoms of urinary retention/urinary hesitation
− Bolnike je treba obvestiti, da zdravilo TROBALT lahko povzroči ali potencira simptome retence urina/zastajanja curka urina.
Drinking alcohol with Trobalt can make your vision blurred.
Pitje alkohola hkrati z jemanjem zdravila Trobalt lahko povzroči zamegljen vid.
After both single and multiple oral doses, retigabine is rapidly absorbed with median tmax values generally between 0.5 and 2 hours.
Retigabin se po enem in večkratnih peroralnih odmerkih hitro absorbira in mediana tmax je na splošno med 0,5 in 2 uri.
Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
Obvestite svojega zdravnika, če med zdravljenjem z zdravilom Trobalt opazite kakršne koli spremembe vida.
In these patients it is recommended that an electrocardiogram (ECG) is recorded before initiation of treatment with Trobalt and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose.
Takšnim bolnikom je pred začetkom zdravljenja z zdravilom Trobalt priporočljivo posneti elektrokardiogram (EKG); tistim, ki imajo korigirani interval QT izhodiščno > 440 ms, je treba EKG
Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow).
Če kaj od tega velja za vas, ali če opazite kakšne nenavadne spremembe srčnega ritma (npr. prehitro ali prepočasno bitje srca), morate to povedati zdravniku.
An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
Pričakovani učinkoviti vzdrževalni odmerek je med 600 mg/dan in 1.200 mg/dan.
Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Ugotovljeno je, da retigabin moti klinične laboratorijske teste bilirubina v serumu in urinu; posledica so lahko lažno zvišane vrednosti.
It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal (see section 4.2).
Odmerek zdravila Trobalt je priporočljivo zmanjševati v obdobju vsaj 3 tednov, razen če je zaradi varnostnih razlogov potrebna nenadna prekinitev (glejte poglavje 4.2).
If you stop taking Trobalt
Če ste prenehali jemati zdravilo Trobalt
Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Potem je treba celotni dnevni odmerek povečevati po največ 150 mg na teden, upoštevaje bolnikov odziv in prenašanje.
Data from an in vitro study showed that the N-acetyl metabolite of retigabine (NAMR) inhibited P-glycoprotein-mediated transport of digoxin in a concentration-dependent manner.
Podatki iz študije in vitro so pokazali, da N-acetilni presnovek retigabina (NAMR) od koncentracije odvisno zavre transport digoksina, posredovan s P-glikoproteinom.
Interaction with anaesthetics
Medsebojno delovanje z anestetiki
In a range of seizure models, retigabine increased the threshold for seizure induction produced by maximal electroshock, pentylenetetrazol, picrotoxin and N-methyl-D-aspartate (NMDA).
V različnih modelih napadov je retigabin zvišal prag sprožitve napadov, izzvanih z največjim elektrošokom, pentilentetrazolom, pikrotoksinom in N-metil-D-aspartatom (NMDA).
A blue-grey discolouration of the skin, lips or nails: this is very common in people taking Trobalt for several years.
Modro-sive spremembe barve kože, ustnic ali nohtov: To je zelo pogosto pri bolnikih, ki jemljejo zdravilo Trobalt več let.
Do not stop treatment without discussing it with your doctor.
Ne prekinite zdravljenja, ne da bi se prej posvetovali s svojim zdravnikom.
Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
Ugotovljeno je, da hemodializa za približno 50 % zniža koncentracijo retigabina in NAMR v plazmi.
Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Največje odmerke v študijah toksičnosti ponavljajočih se odmerkov so omejili čezmerni farmakološki učinki retigabina (vključno z ataksijo, hipokinezijo in tremorjem).
The effect of retigabine on human fertility has not been established.
Vpliv retigabina na plodnost pri človeku ni ugotovljen.
The requirements for submission of periodic safety updates reports 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 webportal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
The gall bladder distension in the dog resulted in focal compression of the liver.
Razširitev žolčnika pri psih je povzročila fokalno kompresijo jeter.
Retigabine pharmacokinetics are essentially linear over the single-dose range of 25 to 600 mg in healthy volunteers and up to 1,200 mg daily in patients with epilepsy, with no unexpected accumulation following repeated administration.
Farmakokinetika retigabina je v bistvu linearna v območju enkratnega odmerka od 25 do 600 mg pri zdravih prostovoljcih ter do 1.200 mg na dan pri bolnikih z epilepsijo.
Non-clinical data reveal no special hazard for humans based on studies of genotoxicity or carcinogenic potential.
Neklinični podatki na osnovi običajnih študij genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
Croscarmellose sodium Hypromellose Magnesium stearate Microcrystalline cellulose.
Jedro tablete premreženi natrijev karmelozat hipromeloza magnezijev stearat mikrokristalna celuloza
However, there was no apparent gender difference in weight-normalized clearance, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of gender.
Vendar se za telesno maso normalizirani očistek med spoloma ni očitno razlikoval; ker titriranje retigabina poteka glede na odziv in prenašanje posameznega bolnika, prilagajanje odmerka glede na spol ni potrebno.
If you are not sure what to do, ask your doctor or pharmacist.
Če niste prepričani, kaj storiti, se posvetujte s svojim zdravnikom ali farmacevtom.
In retigabine-treated patients in the pooled dataset, confusional state was reported in 9% of patients, hallucinations in 2% of patients and psychotic disorders in 1% of patients (see section 4.4).
V kumulativnem naboru podatkov je bilo pri bolnikih, zdravljenih z retigabinom, stanje zmedenosti zabeleženo pri 9 % bolnikov, halucinacija pri 2 % bolnikov in psihotične motnje pri 1 % bolnikov (glejte poglavje 4.4).
Peripheral oedema
periferni edemi
The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.
Celotni začetni dnevni odmerek je 150 mg; med obdobjem titriranja je priporočljivo celotni dnevni odmerek povečevati po 50 mg na teden do največjega celotnega odmerka 600 mg/dan.
Don't take any more Trobalt than your doctor has recommended.
Ne vzemite več zdravila Trobalt, kot vam je naročil zdravnik.
Trobalt must be withdrawn gradually to minimise the potential for rebound seizures.
Zdravilo Trobalt je treba opustiti postopoma, da bi čim bolj zmanjšali možnost pojava odtegnitvenih napadov ("rebound").
Trobalt 50 mg film-coated tablets Trobalt 100 mg film-coated tablets Trobalt 200 mg film-coated tablets Trobalt 300 mg film-coated tablets Trobalt 400 mg film-coated tablets
Trobalt 50 mg filmsko obložene tablete Trobalt 100 mg filmsko obložene tablete Trobalt 200 mg filmsko obložene tablete Trobalt 300 mg filmsko obložene tablete Trobalt 400 mg filmsko obložene tablete retigabin
The maximum total maintenance dose is 1,200 mg/day.
Največji celotni vzdrževalni odmerek je 1.200 mg/dan.
The primary efficacy endpoints were: - percentage change in the 28-day total partial seizure frequency from baseline to the double-blind phase (titration and maintenance phases combined) in all three studies - responder rate (defined as the percentage of patients with a ≥50% reduction in 28-day total partial seizure frequency) from baseline to the maintenance phase (Studies 301 and 302 only).
Primarna opazovana dogodka učinkovitosti sta bila: - odstotna sprememba 28-dnevne celotne pogostnosti parcialnih napadov od izhodišča do dvojno slepe faze (kombinirani fazi titriranja in vzdrževanja) v vseh treh študijah, - delež odzivnih bolnikov (opredeljen kot odstotek bolnikov s ≥ 50 % zmanjšanjem 28-dnevne celotne pogostnosti parcialnih napadov) od izhodišča do vzdrževalne faze (samo študiji 301 in
Retigabine and its metabolites are eliminated principally by renal excretion.
Retigabin in njegovi presnovki se v glavnem izločijo skozi ledvice.
There is no information about the safety of Trobalt in pregnant women.
Ni podatkov o varnosti za zdravilo Trobalt pri nosečnicah.
In a single-dose study, retigabine was eliminated more slowly by healthy elderly volunteers (66 to 82 years of age) relative to healthy young adult volunteers, resulting in a higher AUC (approximately 40 to 50%) and longer terminal half-life (30%) (see section 4.2).
V študiji enega odmerka je bilo odstranjevanje retigabina počasnejše pri zdravih starejših prostovoljcih (starih od 66 do 82 let) kot pri zdravih mlajših odraslih prostovoljcih; posledica sta bili večja AUC (približno 40 do 50 %) in daljši terminalni razpolovni čas (30 %) (glejte poglavje 4.2).