FrancophonIA/ELRC3.0 huggingface dataset:
English: Zuprevo is used in cattle to treat and prevent bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: Zuprevo se koristi u goveda za liječenje i sprječavanje goveđih dišnih bolesti (BRD-a) povezanog s Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: What is the risk associated with Zuprevo?
Croatian: Koji su rizici povezani s lijekom Zuprevo?
English: Zuprevo should only be used when the bacteria are sensitive to tildipirosin.
Croatian: Zuprevo treba primjenjivati samo u slučajevima kada su bakterije osjetljive na tildipirosin.
English: What is Zuprevo?
Croatian: Što je Zuprevo?
English: During severe outbreaks of SRD Zuprevo can also be used metaphylactically which means to treat at the same time both diseased pigs and those clincially healthy pigs in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
Croatian: Tijekom nekoliko izbijanja SED-a, Zuprevo se može također koristiti za metafilaksu što znači za liječenje dok su bolesne svinje i klinički zdrave svinje u bliskom kontaktu kako bi se spriječilo razvijanje kliničkih znakova u svinja te daljnje širenje bolesti.
English: medical advice should be sought immediately and the package leaflet or the label should be shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja potrebno je odmah potražiti liječnički savjet te pokazati uputu o lijeku ili etiketu liječniku.
English: The studies in SRD included pigs between three and 21 weeks of age, and those in BRD included cattle between one and 24 months of age.
Croatian: Ispitivanja u slučaju SRD-a obuhvatila su svinje starosti od tri do 21 tjedna starosti, te goveda u starosti od jednog do 24 mjeseca starosti u slučaju BRD-a.
English: Zuprevo is given as a single injection, into muscle for pigs, and under the skin for cattle.
Croatian: Zuprevo se primjenjuje kao jedna injekcija u mišić za svinje te subkutano za goveda.
English: When using the antibiotic Zuprevo, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Croatian: Kod primjene antibiotika Zuprevo moraju se strogo slijediti upute o lijeku kako bi se razvoj rezistencije na antibiotike sveo na najmanju moguću mjeru.
English: The effectiveness of Zuprevo was shown to be comparable to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD.
Croatian: Utvrđeno je da je djelotvornost VMP-a Zuprevo usporediva s djelotvornosti tulatrolicina ili florfenikola u terapiji SRD-a. te za liječenje i prevenciju BRD-a.
English: What is Zuprevo used for?
Croatian: Za što se Zuprevo koristi?
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a i prije klanja životinje i korištenja mesa za prehranu ljudi.
English: What benefit has Zuprevo shown during the studies?
Croatian: Koje su koristi lijeka Zuprevo dokazane u ispitivanjima?
English: Laboratory as well as field studies were conducted to look at the use of Zuprevo in both the treatment and metaphylaxis of SRD and the treatment and prevention of BRD.
Croatian: Provedena su laboratorijska kao i terenska ispitivanja kako bi se istražila primjena lijeka Zuprevo kako za potrebe terapije tako i metafilakse SRD-a te za terapiju i liječenje BRD-a.
English: Special caution should be taken to avoid accidental self-injection, as laboratory studies in dogs showed cardiovascular effects after intramuscular injection of high doses of tildipirosin.
Croatian: U toksikološkim ispitivanjima u laboratoriju, životinje su pokazale kardiovaskularne učinke nakon intramuskularne primjene tildipirosina.
English: Tildipirosin may cause sensitisation by skin contact.
Croatian: U dodiru s kožom tildipirosin može izazvati preosjetljivost.
English: How does Zuprevo work?
Croatian: Kako djeluje Zuprevo?
English: How has Zuprevo been studied?
Croatian: Kako je Zuprevo ispitivan?
English: Date of first authorisation: 27 May 2015
Croatian: Datum prvog odobrenja: 27. svibnja 2015
English: Drinking enough water
Croatian: Piti dovoljno vode
English: Your doctor will be able to decide what is suitable for you.
Croatian: Vaš liječnik će odlučiti što je prikladno za Vas.
English: • allergic reactions (see above)
Croatian: • alergijske reakcije (vidjeti iznad)
English: If this happens to you, do not drive or use any tools or machines.
Croatian: Ako se to dogodi i Vama, nemojte voziti ni koristiti bilo kakve alate ili strojeve.
English: Smoking and alcohol
Croatian: Pušenje i alkohol
English: The lower dose is taken 8 hours later.
Croatian: Manja doza se uzima 8 sati kasnije.
English: Patients were treated for up to 3 years.
Croatian: Bolesnici su liječeni do 3 godine.
English: • Advice if such symptoms occur
Croatian: • savjeti za slučaj da se takvi simptomi pojave
English: The second daily dose can be taken with or without food.
Croatian: Druga dnevna doza može se uzeti s hranom ili bez nje.
English: Due to the increased urine production it is also important that you always have access to a toilet.
Croatian: Zbog pojačanog stvaranja mokraće također je važno da uvijek imate pristup toaletu.
English: 1 Quarter 2026
Croatian: I. kvartala 2026.
English: • difficulty sleeping
Croatian: • poteškoće sa spavanjem
English: DO NOT take a double dose to make up for forgotten individual doses.
Croatian: NEMOJTE uzeti dvostruku dozu kako biste nadoknadili pojedinačne zaboravljene doze.
English: 1101 CT, Amsterdam Netherlands
Croatian: 1101 CT, Amsterdam Nizozemska
English: Not known: frequency cannot be estimated from the available data
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: In particular let your doctor know if you are taking:
Croatian: Posebno obavijestite svog liječnika ako uzimate:
English: Recommended guidelines for permanent discontinuation include:
Croatian: Preporučene smjernice za trajno ukidanje uključuju:
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Croatian: Ne zaboravite ponijeti sa sobom pakiranje lijeka tako da bude jasno što ste uzeli.
English: If you take the higher dose very late in the day you may have to go to the toilet at night more frequently.
Croatian: Ako uzmete veću dozu vrlo kasno tijekom dana možda ćete tijekom noći morati češće ići u toalet.
English: If you forget to take your medicine you should take the dose as soon as you remember on the same day.
Croatian: Ako zaboravite uzeti svoj lijek, trebate uzeti dozu čim se sjetite, u istom danu.
English: In particular this applies to patients with inadequately controlled type II diabetes.
Croatian: To se posebice odnosi na bolesnike s neodgovarajuće kontroliranim dijabetesom tipa 2.
English: Your medicine is supplied in the following pack sizes:
Croatian: Vaš lijek isporučuje se u sljedećim veličinama pakiranja:
English: • Patients who cannot perceive or respond to thirst
Croatian: • Bolesnici koji ne osjećaju ili ne mogu odgovoriti na žeđ.
English: Liver transplantation was necessary.
Croatian: Bila je neophodna transplantacija jetre.
English: The advice of a hepatologist is recommended.
Croatian: Preporučuje se savjetovanje s hepatologom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i lijekove koje ste nabavili bez recepta.
English: Patients have to be carefully monitored during treatment.
Croatian: Bolesnike je potrebno pažljivo pratiti tijekom liječenja.
English: Uncommon Not known*
Croatian: Manje često Nepoznato*
English: Stop taking Jinarc and immediately contact a doctor or go to the nearest hospital if you:
Croatian: Prestanite uzimati Jinarc i odmah se obratite svome liječniku ili otiđite u najbližu bolnicu ako:
English: • if your kidneys do not work (no urine production)
Croatian: • ako Vam bubrezi ne rade (nema stvaranja urina).
English: Jinarc with food and drink Do not drink grapefruit juice when taking Jinarc.
Croatian: Jinarc s hranom i pićem Nemojte piti sok od grejpa kada uzimate Jinarc.
English: • if you do not realise when you are thirsty
Croatian: • ako ne osjećate žeđ.
English: To find the best dose your doctor will regularly check how well you are tolerating a prescribed dose.
Croatian: Kako bi Vam odredio najbolju dozu, Vaš će liječnik redovito provjeravati koliko dobro podnosite preporučenu dozu.
English: • if you cannot drink enough water (see “drinking enough water” below) or if you have to restrict your fluid intake.
Croatian: • ako ne možete popiti dovoljno vode (vidjeti "Piti dovoljno vode") ili ako morate ograničiti unos tekućine.
English: Jinarc has not been studied in children and adolescents (under age 18) and its use is therefore not recommended in these age groups.
Croatian: Jinarc nije ispitan u djece i adolescenata (mlađih od 18 godina) i zato se njegova primjena u tim dobnim skupinama ne preporučuje.
English: If you take more Jinarc than you should
Croatian: Ako uzmete više Jinarca nego što ste trebali
English: During long-term treatment electrolytes have to be monitored at least every three months.
Croatian: Tijekom dugotrajnog liječenja, elektrolite treba provjeriti najmanje svaka 3 mjeseca.
English: Tolvaptan is only a minor component in plasma (3 %).
Croatian: Tolvaptan čini samo manji dio u plazmi (3 %).
English: If you do not take your tablets on one day, take your normal dose on the next day.
Croatian: Ako jedan dan ne uzmete svoje tablete, sljedećeg dana uzmite svoju uobičajenu dozu.
English: Prior to launch of Jinarc in each Member State the Marketing Authorisation Holder must agree the content and format of the educational programme, including communication media and distribution modalities with each National Competent Authority.
Croatian: Prije puštanja Jinarca u promet u svakoj zemlji članici, nositelj odobrenja mora usuglasiti sadržaj i oblik edukacijskog programa, uključujući komunikacijske medije i modalitet distribucije sa svakim nadležnim državnim tijelom.
English: 30 mg (further reduction to 15 mg if 30 mg are not well tolerated)
Croatian: 30 mg (daljnje smanjenje na 15 mg ako se 30 mg ne podnosi dobro)
English: If you notice any of the following side effects, you may need urgent medical attention.
Croatian: Ako primijetite bilo koju od sljedećih nuspojava možda ćete trebati hitnu medicinsku njegu.
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Croatian: Manje od 1 % čiste djelatne tvari izlučuje se nepromijenjeno urinom.
English: Consequently, the frequency of these adverse events is qualified as "not known".
Croatian: Posljedično tome, učestalost ovih nuspojava navodi se kao „nepoznato“.
English: OUTER CARTON (blisters in wallet card)
Croatian: VANJSKA KUTIJA (blisteri u kartonskom ovitku)
English: This type of reaction occurred after the first administration of tolvaptan.
Croatian: Ova vrsta reakcija nastupila je nakon prve primjene tolvaptana.
English: A non-interventional post-authorisation safety study (PASS) to investigate the risks of:
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): kako bi se istražio rizik od:
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Croatian: Ako ste uzeli više tableta nego što Vam je propisano, pijte puno vode i odmah se obratite svome liječniku ili u lokalnu bolnicu.
English: The use of any of these medicines together with Jinarc is to be avoided because this may reduce the effects of Jinarc.
Croatian: Primjenu bilo kojeg od ovih lijekova zajedno s Jinarcom treba izbjegavati jer to može umanjiti učinke Jinarca.
English: Fluid and electrolyte status must be monitored in all patients.
Croatian: Status tekućine i elektrolita mora se nadzirati u svih bolesnika.
English: Therefore, you should only stop taking Jinarc if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.
Croatian: Zato bi trebali prestati uzimati Jinarc samo ako primijetite nuspojave koje zahtijevaju hitnu medicinsku njegu (vidjeti dio 4) ili ako Vam Vaš liječnik kaže da prestanete.
English: The table is based on adverse events reported during clinical trials and/or post-marketing use.
Croatian: Tablica se temelji na štetnim događajima prijavljenima tijekom kliničkih ispitivanja i/ili nakon stavljanja lijeka u promet.
English: Bilirubin increased
Croatian: Povišen bilirubin
English: • the importance of pregnancy prevention, before and during treatment with Jinarc
Croatian: • važnost prevencije trudnoće, prije i tijekom liječenja Jinarcom
English: What Jinarc is and what it is used for
Croatian: Što je Jinarc i za što se koristi
English: Following an additional 2 years of tolvaptan treatment, resulting in a total of 5 years on tolvaptan therapy no new safety signals were identified.
Croatian: Nakon dodatne 2 godine liječenja tolvaptanom, tj., nakon ukupno 5 godina terapije tolvaptanom, nisu opaženi nikakvi novi sigurnosni signali.
English: • diuretics or other medicines for the treatment of high blood pressure.
Croatian: • diuretici ili drugi lijekovi za liječenje visokog krvnog tlaka.
English: Other potential causes of renal dysfunction or dehydration must be evaluated and addressed.
Croatian: Drugi mogući uzroci renalne disfunkcije ili dehidracije moraju se procijeniti i zbrinuti.
English: The daily amount of Jinarc is split into two doses, one bigger than the other.
Croatian: Dnevna količina Jinarca uzima se podijeljena u dvije doze, jednu veću i drugu manju.
English: It is therefore of greatest importance that patients have access to water and are able to drink sufficient amounts of fluids.
Croatian: Zato je od najveće važnosti da bolesnici imaju pristup vodi i da mogu piti dovoljne količine tekućina.
English: • if you have a condition which is associated with a very low blood volume (e.g. severe dehydration or bleeding)
Croatian: • ako patite od stanja koje je povezano s vrlo niskim volumenom krvi (npr. teška dehidracija ili krvarenje).
English: • jaundice (yellowing of skin or eyes)
Croatian: • žutica (žuta boja kože ili očiju)
English: If you take other medicines which can increase the effects of Jinarc you may receive lower doses.
Croatian: Ako uzimate druge lijekove koji mogu pojačati učinke Jinarca, možete primati niže doze.
English: 7 tablets 28 tablets
Croatian: 7 tableta 28 tableta
English: The MAH must ensure that all healthcare professionals and patients/carers who are expected to prescribe and/or use JINARC have access to/are provided with the following educational package
Croatian: Nositelj odobrenja mora osigurati da svi zdravstveni djelatnici i bolesnici/njegovatelji za koje se očekuje da će propisivati i/ili primjenjivati JINARC imaju pristup/dobiju sljedeći edukacijski paket
English: Tablets must be swallowed without chewing and with a glass of water.
Croatian: Tablete se moraju progutati bez žvakanja i s čašom vode.
English: There is no specific antidote for tolvaptan intoxication.
Croatian: Nema specifičnog antidota za trovanje tolvaptanom.
English: Only the oxobutyric acid metabolite is present at greater than 10 % of total plasma radioactivity; all others are present at lower concentrations than tolvaptan.
Croatian: Samo metabolit oksobutiratna kiselina sudjeluje u više od 10 % ukupne radioaktivnosti plazme; svi drugi prisutni su u nižim koncentracijama nego tolvaptan.
English: It may still be alright for you to take these medicines and Jinarc together.
Croatian: Ipak, može biti dobro za Vas da uzimate ove lijekove zajedno s Jinarcom.
English: Other medicines and Jinarc
Croatian: Drugi lijekovi i Jinarc
English: • if you suffer from liver disease.
Croatian: • ako patite od bolesti jetre.
English: Prescribing physicians must comply fully with the safety measures required below.
Croatian: Ordinirajući liječnik mora se u potpunosti pridržavati niže navedenih sigurnosnih mjera.
English: Tolvaptan binds reversibly (98 %) to plasma proteins.
Croatian: Tolvaptan se reverzibilno veže (98 %) za proteine plazme.
English: • raised levels of liver enzymes in the blood
Croatian: • povišene razine jetrenih enzima u krvi
English: During the first 18 months of treatment, Jinarc can only be supplied to patients whose physician has determined that liver function supports continued therapy.
Croatian: Tijekom prvih 18 mjeseci liječenja, Jinarc se može isporučiti samo za bolesnike čiji su liječnici utvrdili da funkcija njihove jetre može podržati kontinuiranu terapiju.
English: 4) worsening albuminuria
Croatian: 4) pogoršanje albuminurije
English: The phase 3 pivotal trial (TEMPO 3:4, 156-04-251) included subjects from 129 centres in the Americas, Japan, Europe and other countries.
Croatian: Pivotalno ispitivanje faze 3 (TEMPO 3:4, 156-04-251) uključilo je ispitanike iz 129 centara u Sjevernoj i Južnoj Americi, u Japanu, Europi i drugim zemljama.
English: All ADRs are listed by system organ class and frequency; 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Sve nuspojave navedene su prema klasifikaciji organskih sustava i učestalosti; vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (<10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti ili kancerogenog potencijala.
English: The safety and efficacy of tolvaptan in children and adolescents has not yet been established.
Croatian: Sigurnost i djelotvornost tolvaptana u djece i adolescenata nisu još ustanovljene.
English: This condition must be excluded prior and during treatment with tolvaptan.
Croatian: Ovo se stanje mora isključiti prije i tijekom liječenja tolvaptanom.
English: • if you have difficulties urinating or have an enlarged prostate.
Croatian: • ako imate poteškoća s mokrenjem ili uvećanu prostatu.
English: Urinary output must be secured.
Croatian: Mora se osigurati protok urina.
English: The educational programme is aimed at ensuring awareness about the potential risk of hepatotoxicity and providing guidance on how to manage this risk and the importance of pregnancy prevention prior to the initiation and during the treatment with Jinarc.
Croatian: Cilj edukacijskog programa je osiguravanje informiranosti o mogućem riziku od hepatotoksičnosti te pružanje smjernica za zbrinjavanje tog rizika i o važnosti prevencije trudnoće prije početka i tijekom liječenja Jinarcom.
English: Dialysis may not be effective in removing tolvaptan because of its high binding affinity for human plasma protein (> 98 %).
Croatian: Dijaliza možda neće biti učinkovita u uklanjanju tolvaptana zbog njegovog visokog afiniteta vezanja za ljudske proteine plazme (> 98 %).
English: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD United Kingdom
Croatian: Almac House, 20 Seagoe Industrial Estate Craigavon - BT63 5QD Ujedinjeno Kraljevstvo
English: Fourteen metabolites have been identified in plasma, urine and faeces; all but one were also metabolised by CYP3A.
Croatian: Identificirano je 14 metabolita u plazmi, urinu i fecesu; svi osim jednog također se metaboliziraju putem CYP3A.
English: A pre-specified subgroup analysis suggested that tolvaptan had less of an effect in patients older than 55 years of age, a small subgroup with a notably slower rate of eGFR decline.
Croatian: Unaprijed definirana analiza podskupina ukazala je na to da je tolvaptan imao manji učinak u bolesnika starijih od 55 godina, male podskupine sa znatno manjom brzinom smanjenja eGFR-a.
English: Your treatment will normally start with a dose of 45 mg in the morning and 15 mg eight hours later.
Croatian: Vaše liječenje će uobičajeno započeti s dozom od 45 mg ujutro i 15 mg osam sati kasnije.
English: The absolute bioavailability of tolvaptan is about 56 %.
Croatian: Apsolutna bioraspoloživost tolvaptana je otprilike 56 %.
English: In total, 14 clinical trials involving tolvaptan have been completed worldwide in support of the ADPKD indication, including 8 trials in the US, 1 in the Netherlands, 3 in Japan, 1 in Korea, and the multinational phase 3 pivotal trial.
Croatian: Ukupno je diljem svijeta provedeno 14 kliničkih ispitivanja koja su uključivala tolvaptan, a koja su potvrdila indikaciju ADPBB-a, uključujući 8 ispitivanja u SAD-u, 1 u Nizozemskoj, 3 u Japanu, 1 u Koreji i multinacionalno pivotalno ispitivanje faze 3.
English: The higher dose should be taken in the morning when you wake up, at least 30 minutes before the morning meal.
Croatian: Veću dozu potrebno je uzeti ujutro kada se probudite, najmanje 30 minuta prije jutarnjeg obroka.
English: Information in braille:
Croatian: Podaci na brailleovom pismu:
English: There are no adequate data from the use of tolvaptan in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni tolvaptana u trudnica.
English: However, the safety and effectiveness of tolvaptan in ADPKD patients aged over 50 years has not yet been established.
Croatian: Ipak, sigurnost i učinkovitost tolvaptana u oboljelih od ADPBB-a u dobi iznad 50 godina nisu još ustanovljene.
English: The most frequent adverse reactions are related to water loss.
Croatian: Najčešće nuspojave povezane su uz gubitak tekućine.
English: What Jinarc looks like and contents of the pack
Croatian: Kako Jinarc izgleda i sadržaj pakiranja
English: Fluid and electrolyte balance
Croatian: Ravnoteža tekućine i elektrolita
English: • ALT or AST > 5-times ULN for more than 2 weeks
Croatian: • ALT ili AST > 5 puta GGN tijekom više od 2 tjedna
English: Two fertility studies in rats showed effects on the parental generation (decreased food consumption and body weight gain, salivation), but tolvaptan did not affect reproductive performance in males and there were no effects on the foetuses.
Croatian: Dva ispitivanja plodnosti u štakora pokazala su učinke na roditeljsku generaciju (smanjeno uzimanje hrane i porast tjelesne težine, salivacija), ali tolvaptan nije utjecao na reproduktivne sposobnosti u mužjaka i nije bilo utjecaja na fetuse.
English: No clinical trials in subjects with a creatinine clearance < 10 mL/min or in patients undergoing dialysis have been conducted.
Croatian: Nisu provedena klinička ispitivanja na ispitanicima s klirensom kreatinina < 10 ml/min ili na bolesnicima koji su na dijalizi.
English: In this case your doctor may prescribe you Jinarc tablets with 30 mg or 15 mg tolvaptan which have to be taken once a day in the morning.
Croatian: U tom slučaju Vaš liječnik Vam može propisati Jinarc tablete s 30 mg ili 15 mg tolvaptana koje se uzimaju jednom na dan, ujutro.
English: These data also showed significant benefit from tolvaptan vs. placebo (p < 0.0001).
Croatian: Ti su podaci također pokazali značajnu korist od tolvaptana naspram placeba (p < 0,0001).
English: Women of childbearing age must use reliable contraceptive measures during use of this medicine.
Croatian: Žene reproduktivne dobi moraju koristiti pouzdanu kontracepciju tijekom primjene ovog lijeka.
English: • full or bloated or uncomfortable feeling in the stomach
Croatian: • osjećaj punoće, napuhnutosti ili nelagode u trbuhu
English: Your doctor may gradually increase your dose up to a maximum combination of 90 mg on waking and 30 mg after 8 hours.
Croatian: Vaš liječnik zatim može postupno povećavati Vašu dozu do najviše kombinacije od 90 mg nakon buđenja i 30 mg nakon 8 sati.