FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pri tem razvrstitev posameznega neželenega učinka v ustrezno kategorijo pogostnosti temelji na naslednjem dogovoru: 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); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you use more Ultibro Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Slovenian: Če ste uporabili večji odmerek zdravila Ultibro Breezhaler, kot bi smeli Če ste vdihnili preveč tega zdravila ali če kdo drug pomotoma uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno pomoč.
English: If a dose is missed, it should be taken as soon as possible on the same day.
Slovenian: V primeru izpuščenega odmerka je treba zdravilo vzeti čimprej še isti dan.
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Slovenian: Po intravenski infuziji je bil volumen porazdelitve indakaterola v obdobju končne faze izločanja 2.557 litrov, kar kaže na obsežno porazdelitev.
English: Do not give this medicine to children or adolescents below the age of 18 years.
Slovenian: Tega zdravila ne dajajte otrokom ali mladostnikom, ki so stari manj kot 18 let, ker uporaba zdravila v tej starostni skupini ni bila proučena.
English: Pierce capsule by firmly pressing both side buttons at the same time.
Slovenian: Kapsulo predrete tako, da oba stranska gumba istočasno močno stisnete.
English: Shortening of electrocardiograph intervals and decreased systolic and diastolic blood pressure were also apparent.
Slovenian: Opažali so tudi krajšanje intervalov pri elektrokardiografiji ter zniževanje sistoličnega in diastoličnega krvnega tlaka.
English: FEV1 AUC:
Slovenian: AUC vrednosti FEV1:
English: Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Slovenian: Tega zdravila ne uporabljajte za zdravljenje nenadnih napadov zadihanosti ali piskajočega dihanja.
English: • Do not blow into the mouthpiece.
Slovenian: • Ne pihajte v ustnik.
English: There was no attenuation of the bronchodilator effect over time.
Slovenian: Bronhodilatatoren učinek se s časom ni zmanjševal.
English: The apparent volume of distribution in the terminal phase following inhalation was almost 20-fold larger, which reflects the much slower elimination after inhalation.
Slovenian: Po inhalaciji je bil navidezni volumen porazdelitve v terminalni fazi skoraj 20-krat večji, kar odraža precej počasnješe izločanje učinkovine po inhalaciji.
English: Inhalation powder, hard capsule
Slovenian: prašek za inhaliranje, trda kapsula
English: When compared with the serum clearance of indacaterol of 23.3 litres/hour, it is evident that renal clearance plays a minor role (about 2 to 5% of systemic clearance) in the elimination of systemically available indacaterol.
Slovenian: Primerjava s serumskim očistkom indakaterola 23,3 litra/uro jasno kaže, da ima izločanje preko ledvic le majhno vlogo (približno 2 do 5 % sistemskega očistka) pri izločanju sistemsko razpoložljivega indakaterola.
English: In case such effects occur with this medicinal product, treatment may need to be discontinued.
Slovenian: Če pride do takega vpliva pri uporabi tega zdravila, je včasih treba zdravljenje prekiniti.
English: Repeat steps 3a to 3c.
Slovenian: Ponovite korake 3a do 3c.
English: • One or more blister cards, each containing either
Slovenian: • en ali več pretisnih omotov, vsak vsebuje 6 ali
English: In four of these studies patients were enrolled who had a clinical diagnosis of moderate to severe COPD.
Slovenian: V štiri od navedenih študij so bili vključeni bolniki, ki so imeli klinično diagnozo zmerne do hude KOPB.
English: Rare (may affect up to 1 in 1000 people) • tingling or numbness.
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) • mravljinčenje ali odrevenelost
English: Glycopyrronium bromide (including its metabolites) was excreted into the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam.
Slovenian: Glikopironijev bromid se je (vključno s presnovki) izločal v mleko doječih podgan in je v mleku dosegal do 10-krat višjo koncentracijo kot v krvi samice.
English: To be taken into account with concomitant use
Slovenian: Pri sočasni uporabi je treba vzeti v obzir
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Slovenian: Koncentracija indakaterola v serumu upada v več fazah s povprečnim končnim razpolovnim časom v razponu od 45,5 do 126 ur.
English: In clinical studies, the amount of indacaterol excreted unchanged via urine was generally lower than 2.5% of the delivered dose.
Slovenian: V kliničnih študijah je bil delež nespremenjenega indakaterola, ki se je izločil z urinom, večinoma manjši od 2,5 % prejetega odmerka.
English: This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
Slovenian: To zdravilo zmanjša napetost teh mišic v pljučih, tako da zrak laže vstopi v pljuča in izstopi iz njih.
English: Why didn't the inhaler make a noise when I inhaled?
Slovenian: Zakaj med inhalacijo ni bilo slišati brnenja inhalatorja?
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja pri klinično pomembnih izpostavljenostih zdravilu (glejte poglavje 5.3).
English: Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue.
Slovenian: Čiščenje inhalatorja Ustnik z notranje in zunanje strani očistite s čisto, suho krpico, ki ne pušča vlaken, da odstranite ostanke praška.
English: The capsules must be administered only using the Ultibro Breezhaler inhaler (see section 6.6).
Slovenian: Kapsule so namenjene samo uporabi z inhalatorjem Ultibro Breezhaler (glejte poglavje 6.6).
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit, or you may notice visual disturbances, feel constipated or have difficulty when passing urine.
Slovenian: Morda boste opažali, da vam srce bije hitreje kot običajno, morda vas bo bolela glava ali pa boste zaspani, vam bo slabo ali vas bo sililo na bruhanje, morda pa boste opažali motnje vida, zaprtost ali oteženo odvajanje urina.
English: All these findings occurred at exposures sufficiently in excess of those anticipated in humans.
Slovenian: Do vseh navedenih sprememb je prišlo pri izpostavljenosti, ki je v zadostni meri presegala predvideno izpostavljenost pri ljudeh.
English: • crushing chest pain with increased sweating - this may be a serious heart problem (ischaemic heart disease).
Slovenian: • stiskajoča bolečina v prsih s povečanim znojenjem - lahko gre za resne težave s srcem (za ishemično bolezen srca);
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ultibro Breezhaler contains lactose”).
Slovenian: - Drugi sestavini inhalacijskega praška sta laktoza monohidrat in magnezijev stearat (glejte poglavje 2 pod “Zdravilo Ultibro Breezhaler vsebuje laktozo”).
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler 90 x 1 capsules + 1 inhaler
Slovenian: 6 x 1 kapsula + 1 inhalator 10 x 1 kapsul + 1 inhalator 12 x 1 kapsula + 1 inhalator 30 x 1 kapsula + 1 inhalator 90 x 1 kapsula + 1 inhalator
English: If this happens, carefully loosen the capsule by tapping the base of the inhaler.
Slovenian: Če se to zgodi, previdno sprostite kapsulo z rahlim trkanjem ob spodnji del inhalatorja.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.
Slovenian: Priporočeni odmerek je inhalacija vsebine ene kapsule enkrat na dan z uporabo inhalatorja Ultibro Breezhaler.
English: Gender, smoking status and baseline FEV1 had no apparent effect on systemic exposure.
Slovenian: Spol, status kajenja in izhodiščna vrednost FEV1 niso imeli opaznega vpliva na sistemsko izpostavljenost.
English: In Phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
Slovenian: V študijah faze III so bronhodilatatoren učinek opažali v prvih 5 minutah po prvem odmerku, pri čemer se je učinek ohranil v celotnem 24-urnem intervalu po prvem odmerku.
English: The mean terminal elimination half-life was much longer after inhalation (33 to 57 hours) than after intravenous (6.2 hours) and oral (2.8 hours) administration.
Slovenian: Povprečni terminalni razpolovni čas izločanja je precej daljši po inhaliranju zdravila (33 do 57 ur) kot po intravenski (6,2 ure) in peroralni aplikaciji (2,8 ure).
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Slovenian: Če karkoli od zgoraj navedenega velja za vas (oziroma o tem niste prepričani), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete uporabljati to zdravilo.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Slovenian: Poleg tega so za agoniste beta-2 adrenergičnih receptorjev poročali, da povzročajo elektrokardiografske (EKG) spremembe, na primer zmanjševanje vala T, podaljšanje intervala QT in depresijo segmenta ST, vendar klinični pomen teh opažanj ni znan.
English: An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding.
Slovenian: Preveliko odmerjanje lahko povzroča prekomerno izražene učinke, ki so sicer značilni za stimulanse beta-2-adrenergičnega sistema, in sicer: tahikardijo, tremor, palpitacije, glavobol, navzeo, bruhanje, zaspanost, ventrikularne aritmije, presnovno acidozo, hipokaliemijo in hiperglikemijo, oziroma lahko sproži antiholinergične učinke, kot so zvišan intraokularni tlak (ki povzroča bolečine, motnje vida ali rdečino očesa), obstipacijo ali težave pri uriniranju.
English: The in vitro human serum and plasma protein binding was about 95%.
Slovenian: In vitro je bila vezava na proteine v humanem serumu in plazmi približno 95 %.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ultibro Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ultibro Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Do not use Ultibro Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Ultibro Breezhaler - če ste alergični na indakaterol, glikopironij ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Close the inhaler and repeat steps 3a to 3c.
Slovenian: Zaprite inhalator in ponovite korake 3a do 3c.
English: Excipient(s) with known effect Each capsule contains 23.5 mg lactose (as monohydrate).
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 23,5 mg laktoze (v obliki monohidrata).
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with indacaterol in clinical studies of up to one year at doses up to twice the maximum recommended indacaterol dose.
Slovenian: Povečanje izpostavljenosti zaradi interakcij ni zaskrbljujoče, in sicer zaradi izkušenj glede varnosti pri uporabi indakaterola v kliničnih študijah s trajanjem do enega leta v odmerkih, ki so dosegali tudi dvakratni najvišji priporočeni odmerek indakaterola.
English: Systemic exposure to indacaterol increased with increasing (delivered) dose (120 micrograms to 480 micrograms) in a dose proportional manner.
Slovenian: Sistemska izpostavljenost indakaterolu se je povečevala z zviševanjem (prejetega) odmerka (120 mikrogramov do 480 mikrogramov) sorazmerno z višino odmerka.
English: Administration of Ultibro Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Slovenian: Odmerjanje zdravila Ultibro Breezhaler lahko povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
English: Pre-clinical studies included in vitro and in vivo safety pharmacology assessments, repeated-dose inhalation toxicity studies in rats and dogs and an inhalation embryo-foetal development study in rats.
Slovenian: Predklinične študije so obsegale študije farmakološke varnosti in vitro in in vivo, študije toksičnosti pri ponavljajočih se inhalacijskih odmerkih na podganah in psih ter inhalacijsko študijo embrio-fetalnega razvoja na podganah.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.2 litres/hour.
Slovenian: Ledvični očistek indakaterola je bil v povprečju med 0,46 in 1,20 litra/uro.
English: After intravenous dosing, the steady-state volume of distribution of glycopyrronium was 83 litres and the volume of distribution in the terminal phase was 376 litres.
Slovenian: Po intravenskem odmerjanju je znašal volumen porazdelitve glikopironija v stanju dinamičnega ravnovesja 83 litrov, volumen porazdelitve v terminalni fazi pa je bil 376 litrov.
English: The capsule may be stuck in the capsule chamber.
Slovenian: Kapsula se je morda zataknila v vdolbini.
English: Cimetidine or other inhibitors of organic cation transport In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
Slovenian: Cimetidin in drugi zaviralci transporta organskih kationov V klinični študiji z zdravimi prostovoljci je cimetidin, zaviralec transporta organskih kationov, ki je domnevno vpleten v izločanje glikopironija preko ledvic, povečal skupno izpostavljenost (AUC) glikopironiju za 22 %, ledvični očistek pa zmanjšal za 23 %.
English: If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Slovenian: Če pride do znakov, ki kažejo na alergijsko reakcijo, zlasti če pride do angioedema (oteženega dihanja ali požiranja, otekanja jezika, ustnic in obraza), urtikarije ali izpuščaja, je treba zdravljenje takoj ukiniti in ga nadomestiti z drugim zdravljenjem.
English: • painful and frequent urination - these may be signs of a urinary tract infection called cystitis.
Slovenian: • boleče in pogosto uriniranje - to sta lahko znaka okužbe sečil, ki se imenuje cistitis
English: 3H]-labelled glycopyrronium bromide, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Slovenian: 3H] označenega glikopironijevega bromida se je v 48 urah v urinu izločilo povprečno 85 % radioaktivno označenega odmerka.
English: - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Slovenian: - V škatli boste našli inhalator in kapsule (v pretisnih omotih), ki vsebujejo zdravilo v obliki praška za inhaliranje.
English: Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 1).
Slovenian: Neželeni učinki, ki so jih zaznali v kliničnih preskušanjih in na podlagi virov iz obdobja po prihodu zdravila na trg, so navedeni po MedDRA klasifikaciji organskih sistemov (preglednica 1).
English: COPD is a long-term disease and you should use Ultibro Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Slovenian: - KOPB je dolgotrajna bolezen in zdravilo Ultibro Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
English: Instructions for handling and use
Slovenian: Navodila za rokovanje in uporabo
English: The effective half-life, calculated from the accumulation of indacaterol after repeated dosing ranged from 40 to 52 hours which is consistent with the observed time-to-steady state of approximately 12-15 days.
Slovenian: Efektivni razpolovni čas, izračunan iz kopičenja indakaterola po večkratnem odmerjanju, je znašal od 40 do 52 ur, kar se ujema z ugotovljenim časom do stanja dinamičnega ravnovesja, ki je približno 12-15 dni.
English: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.
Slovenian: Rezultati študij vpliva na sposobnost razmnoževanja in drugi podatki iz študij na živalih ne vzbujajo pomislekov glede plodnosti tako pri moških kot pri ženskah.
English: • palpitations - signs of abnormal heart beat.
Slovenian: • palpitacije - znak nepravilnega bitja srca
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z “BLUE BOX” PODATKI)
English: If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba nadaljevati z uporabo tega zdravila, se pogovorite z zdravnikom ali farmacevtom.
English: Ask your doctor or pharmacist for advice before using any medicine.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: The safety experience with Ultibro Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Slovenian: Izkušnje glede varnosti pri uporabi zdravila Ultibro Breezhaler so pridobljene pri izpostavljenosti zdravilu v trajanju do 15 mesecev v priporočenem terapevtskem odmerku.
English: A population pharmacokinetic analysis showed that there is no clinically relevant effect of age (adults up to 88 years), sex, weight (32-168 kg) or race on the pharmacokinetics of indacaterol.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da starost (pri odraslih do 88. leta starosti), spol, telesna masa (32-168 kg) in rasa nimajo klinično pomembnega vpliva na farmakokinetiko indakaterola.
English: In patients with COPD, pharmacokinetic steady-state of glycopyrronium was reached within one week of the start of treatment.
Slovenian: Pri bolnikih s KOPB je do farmakokinetičnega stanja dinamičnega ravnovesja glikopironija prišlo v enem tednu od začetka zdravljenja.
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Slovenian: Znižana koncentracija kalija v serumu je običajno le prehodna in zaradi nje ni treba nadomeščati kalija.
English: • feeling tired or very thirsty, having an increased appetite without gaining weight and passing more urine than usual - these may be signs of high level of sugar in the blood (hyperglycaemia).
Slovenian: • občutek utrujenosti ali hude žeje, povečan apetit brez povečanja telesne mase in odvajanje večjih količin urina kot običajno - to so lahko znaki zvišane ravni sladkorja v krvi (hiperglikemije).
English: Metabolic and transporter based interactions
Slovenian: Interakcije na podlagi presnove in prenašalcev
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “Uporabno do”/“EXP”.
English: Never wash your inhaler with water.
Slovenian: Inhalatorja nikoli ne umivajte z vodo.
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: Their presence in the heart raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects.
Slovenian: Zaradi njihove prisotnosti v srcu obstaja možnost, da celo visoko selektivni agonisti beta-2 adrenergičnih receptorjev lahko vplivajo na srce.
English: Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
Slovenian: Kadar je potrebno, je treba izbrati kardioselektivne antagoniste beta adrenergičnih receptorjev, vendar jih je treba uporabljati previdno.
English: Treatment for 90 days [90 x 1 capsules + 1 inhaler only].
Slovenian: za inhaliranje zdravljenje za 90 dni [90 x 1 kapsula + samo 1 inhalator].
English: Ultibro Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Slovenian: Zdravilo Ultibro Breezhaler, ki so ga odmerjali zjutraj, je zmanjšalo dinamično hiperinflacijo pljuč in podaljšalo čas, ko so bolniki lahko izvajali vajo, in sicer od prvega odmerka dalje.
English: Therefore, Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Slovenian: Iz tega razloga se sme zdravilo Ultibro Breezhaler v nosečnosti uporabiti samo v primeru, da pričakovana korist za bolnico upravičuje potencialno tveganje za plod.
English: When inhaled, indacaterol acts locally in the lung as a bronchodilator.
Slovenian: Inhaliran indakaterol deluje lokalno v pljučih kot bronhodilatator.
English: Hydroxylation resulting in a variety of mono- and bis-hydroxylated metabolites and direct hydrolysis resulting in the formation of a carboxylic acid derivative (M9) were seen.
Slovenian: Opažali so hidroksilacijo, s katero nastajajo različni monohidroksilirani in dihidroksilirani presnovki, in direktno hidrolizo, s katero nastaja derivat s karboksilno kislino (M9).
English: Ultibro Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Slovenian: Zdravila Ultibro Breezhaler se ne sme uporabljati za zdravljenje astme, saj o uporabi pri tej indikaciji ni na voljo nobenih podatkov.
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.
Slovenian: Glede na velikost teh sprememb ni pričakovati klinično pomembnih interakcij pri sočasni uporabi glikopironija in cimetidina ali drugih zaviralcev transporta organskih kationov.
English: Ultibro Breezhaler is recommended to be administered at the same time of the day each day.
Slovenian: Zdravilo Ultibro Breezhaler je priporočeno uporabiti vsak dan ob istem času.