FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/12/2016
Croatian: Datum prvog odobrenja: 08/12/2016
English: However, even taking as worst case reference the limits for genotoxic and carcinogenic impurities, the risk related to the trace amounts of 1,10-phenanthroline in SomaKit TOC formulation is considered negligible at the dose to be administered in patients: the exposure to 1,10-phenanthroline (5 µg/dose) is 24 fold lower than the acceptable daily intake for a genotoxic impurity (120 µg/day for exposures <1 month).
Croatian: Međutim, čak i uzimajući u obzir u najgorem slučaju kao referencu granice za genotoksična i kancerogena onečišćenja, rizik povezan s količinom 1,10-fenantrolina u tragovima u pripravku SomaKit TOC smatra se zanemarivim u dozi koja se primjenjuje u bolesnika: izlaganje 1,10-fenantrolinu (5 µg/doza) je 24 puta manje od prihvatljivog dnevnog unosa genotoksičnih onečišćenja (120 µg dnevno za izlaganja kraća od mjesec dana).
English: SomaKit TOC must not be used if there are visible signs of deterioration.
Croatian: SomaKit TOC ne smije se koristiti ako postoje vidljivi znakovi odstupanja u kakvoći.
English: edotreotide PET scan correlated with the tumour-absorbed doses per injected activity of the subsequent first treatment cycle, differed between those lesions classified as responding and nonresponding after three PRRT cycles, and helped to separate hepatic metastases from normal liver tissue.
Croatian: PRRT-a odgovarala dozama koje je apsorbirao tumor po ubrizganoj aktivnosti prvog terapijskog ciklusa koji je slijedio, razlikovala se između tumora klasificiranih kao oni s odgovorom i oni bez odgovora nakon tri ciklusa PRRT-a, te pomogla razlikovati jetrene metastaze od zdravog tkiva jetre.
English: 13040 Saluggia (VC) Italy
Croatian: Via Crescentino 13040 Saluggia (VC) Italija
English: Gallbladder wall Lower large intestine wall Small intestine Stomach wall Upper large intestine wall Heart wall
Croatian: Stijenka gornjeg debelog crijeva Stijenka srca
English: Τηλ: +30 22920 63900
Croatian: ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Τηλ: +30 22920 63900
English: Elute the generator directly into the Vial 1 (through the needle) according to the generator manufacturer instructions for use, in order to reconstitute the powder with the eluate.
Croatian: Eluirajte generator izravno u bočicu 1 (kroz iglu) u skladu s uputama za uporabu proizvođača generatora, kako biste rekonstituirali prašak eluensom.
English: Local tolerance assessment resulted in mild to moderate inflammation signs in the perivascular region of some animals which can be attributed to the acidic pH of the solution.
Croatian: Lokalna procjena podnošljivosti rezultirala je blagim do umjerenim znakovima upale u perivaskularnom području u nekih životinja, što se može pripisati niskom pH otopine.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Croatian: Ovaj je lijek radiofarmaceutski proizvod samo za dijagnostičku primjenu.
English: Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
Croatian: Testirajte radioaktivnost bočice odgovarajućim sustavom kalibracije radioaktivnosti i zabilježite rezultat.
English: For administration, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Croatian: Za primjenu, otopinu treba izvući kroz čep koristeći jednodoznu štrcaljku opremljenu odgovarajućim zaštitnim pokrovom i sterilnu iglu za jednokratnu uporabu ili uz pomoć odobrenog automatiziranog sustava za primjenu.
English: The gallium (68Ga) edotreotide solution must be prepared in accordance with radioprotection and pharmaceutical quality standards, especially concerning aseptic technique.
Croatian: Otopina galijevog [68Ga] edotreotida mora se pripremiti u skladu sa standardima zaštite od zračenja i farmaceutske kvalitete, osobito u odnosu na aseptičku tehniku.
English: - The other ingredients are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections.
Croatian: - Ostali sastojci su: 1,10-fenantrolin, gentizinska kiselina, manitol, mravlja kiselina, natrijev hidroksid, voda za injekcije.
English: Add the reaction buffer previously dosed in the 1 ml sterile syringe.
Croatian: Dodajte reakcijski pufer koji ste prethodno dozirali u sterilnoj štrcaljki od 1 ml.
English: The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection.
Croatian: Preporučena aktivnost za odraslu osobu koja teži 70 kg je 100 do 200 MBq, primijenjeno izravnom, polaganom intravenskom injekcijom.
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and fœtus.
Croatian: Zbog toga se tijekom trudnoće smiju provoditi samo neophodne pretrage, pri kojima vjerojatna korist od primjene uvelike premašuje rizik za majku i fetus.
English: Radioactive waste must be disposed of in accordance with relevant national regulations.
Croatian: Radioaktivni otpad mora se zbrinuti u skladu s odgovarajućim nacionalnim propisima.
English: Use within 4 hours after radiolabelling.
Croatian: Upotrijebiti u roku od 4 sata nakon radioaktivnog obilježavanja.
English: Report the activity value, the calibration time, the batch number and the expiry time on the shield label included in the pack to be applied on the lead shielding container after radiolabelling.
Croatian: Zabilježite vrijednost aktivnosti, vrijeme kalibracije, broj serije i rok valjanosti na naljepnicu zaštitnog spremnika uključenu u pakiranje koja se postavlja na olovni zaštitni spremnik nakon radioaktivnog obilježavanja.
English: Regarding the novel excipient (1,10-phenanthroline), during the toxicity study conducted with the kit formulation of SomaKit TOC including 1,10-phenanthroline at a dose 400 fold higher than the human dose, no toxicity signs were observed.
Croatian: Što se tiče nove pomoćne tvari (1,10-fenantrolina), za vrijeme ispitivanja toksičnosti provedenog sa setom za pripravu SomaKit TOC koji je uključivao 1,10-fenantrolin u 400 puta većoj dozi od one za ljudsku primjenu, nisu zabilježeni znakovi toksičnosti.
English: For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja lijeka nakon radioaktivnog obilježavanja vidjeti u dijelu 6.3.
English: An increased uptake of gallium (68Ga) edotreotide is not specific for GEP-NET.
Croatian: Povećana apsorpcija galijevog [68Ga] edotreotida nije specifična za GEP-NET.
English: No data are available regarding the use of this product during pregnancy.
Croatian: Nema podataka o primjeni ovog lijeka u trudnoći.
English: The peptide is excreted via kidneys as intact compound.
Croatian: Peptid se izlučuje iz bubrega kao netaknuti spoj.
English: Non-clinical data did not reveal any special hazard for gallium (68Ga) edotreotide in humans.
Croatian: Neklinički podaci nisu otkrili nikakvu posebnu opasnost od galijevog [68Ga] edotreotida u ljudi.
English: Radiopharmaceuticals should be received, used and administered only by authorized persons in designated clinical settings.
Croatian: Radiofarmaceutike moraju preuzimati, koristiti i primjenjivati samo ovlaštene osobe u za to određenim kliničkim uvjetima.
English: The dosimetry of gallium (68Ga) edotreotide was calculated by Sandstrom et al. (2013), using
Croatian: Dozimetriju galijevog [68Ga] edotreotida izračunali su Sandstrom i sur. (2013), koristeći softver
English: Driving and using machines It is considered unlikely that SomaKit TOC will affect your ability to drive or to use machines.
Croatian: Smatra se kako nije vjerojatno da će Somakit TOC utjecati na vašu sposobnost upravljanja vozilima ili rukovanja strojevima.
English: The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration.
Croatian: Dozu u bolesnika treba izmjeriti odgovarajućim sustavom kalibracije radioaktivnosti neposredno prije primjene u bolesnika.
English: Symptoms may include: warm flush, redness of the skin, swelling, itching, nausea and difficulty breathing.
Croatian: Simptomi uključuju: valove vrućine, crvenilo kože, otekline, svrbež, mučninu i otežano disanje.
English: Your nuclear medicine doctor will inform you if you need to take any other special precaution before or after using SomaKit TOC.
Croatian: Liječnik specijalist nuklearne medicine obavijest će vas ako morate poduzeti bilo kakve posebne mjere opreza prije ili poslije primjene lijeka SomaKit TOC.
English: The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Croatian: Sigurnost i djelotvornost galijevog [68Ga] edotreotida nisu ustanovljene za pedijatrijsku populaciju u kojoj bi efektivna doza mogla biti drugačija nego u odraslih osoba.
English: In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and by frequent micturition.
Croatian: U slučaju primjene prevelike doze zračenja, dozu koju je bolesnik apsorbirao potrebno je, kad je to moguće, smanjiti ubrzavanjem izlučivanja radionuklida iz tijela pojačanom hidratacijom i učestalim mokrenjem.
English: The labelling efficiency is calculated by integration of peak with Rf = 0 to 0.1 that must be ≤ 3%.
Croatian: Djelotvornost obilježavanja računa se integracijom vršne vrijednosti s faktorom Rf = 0 do 0,1 koja mora biti ≤ 3 %.
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Croatian: Te će osobe biti posebno oprezne kako bi lijek primijenile na siguran način i govorit će vam što u pojedinom trenutku rade.
English: The labelling efficiency is calculated by integration of peak with Rf = 0.9 to 1.0 that must be ≤ 2%.
Croatian: Djelotvornost obilježavanja računa se integracijom vršne vrijednosti s faktorom Rf = 0,9 do 1,0 koja mora biti ≤ 2 %.
English: SomaKit TOC contains sodium (see section 2).
Croatian: SomaKit TOC sadržava natrij (pogledajte dio 2.).
English: You must inform the nuclear medicine doctor before the administration of SomaKit TOC if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Croatian: Morate obavijestiti liječnika specijalista nuklearne medicine prije primjene lijeka SomaKit TOC ako postoji mogućnost da ste trudni, ako vam je izostala mjesečnica ili ako dojite.
English: Should you have any further questions on the use of SomaKit TOC, please ask the nuclear medicine doctor who supervises the procedure.
Croatian: Imate li kakvih dodatnih pitanja o primjeni lijeka SomaKit TOC, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: OTHER Do not store above 25ºC
Croatian: Ne čuvati na temperaturi iznad 25ºC
English: Clear solutions free of visible particles
Croatian: Bistre otopine bez vidljivih čestica
English: Drinking and emptying your bladder frequently will help remove the radioactive substance from your body more quickly.
Croatian: Redoviti unos tekućine i pražnjenje mjehura doprinijet će bržem uklanjaju radioaktivne tvari iz vašeg tijela.
English: Precautions to be taken before handling or administration of the medicinal product For instructions on radiolabelling of the medicinal product before administration, see section 12.
Croatian: Mjere opreza koje treba poduzeti prije rukovanja ili primjene lijeka Za upute o radioaktivnom obilježavanju lijeka prije primjene vidjeti dio 12.
English: The medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine diagnostic agents and only in a designated nuclear medicine facility.
Croatian: Lijek smiju primjenjivati samo educirani zdravstveni radnici koji su stručni u uporabi i rukovanju dijagnostičkim sredstvima u djelatnosti nuklearne medicine te isključivo u određenom prostoru odjela nuklearne medicine.
English: Only clear solutions, free from visible particles should be used.
Croatian: Smiju se koristiti samo bistre otopine bez vidljivih čestica.
English: Radiolabelled SomaKit TOC is suitable for PET medical imaging.
Croatian: Radioaktivno obilježeni SomaKit TOC prikladan je za medicinsko oslikavanje PET-om.
English: Other medicines and SomaKit TOC
Croatian: Drugi lijekovi i SomaKit TOC
English: Radiolabelling of carrier molecules with gallium (68Ga) chloride is very sensitive to the presence of trace metal impurities.
Croatian: Radioaktivno obilježavanje molekula nosača galijevim [68Ga] kloridom vrlo je osjetljivo na prisutnost metalnih onečišćenja u tragovima.
English: Gallium (68Ga) edotreotide has no or negligible influence on the ability to drive and use machines.
Croatian: Galijev [68Ga] edotreotid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The following information is intended for healthcare professionals only: The complete SmPC of SomaKit TOC is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Croatian: Cijeli sažetak opisa svojstva lijeka Somakit TOC dostupan je kao zaseban dokument u pakiranju lijeka, s ciljem pružanja ostalih dodatnih znanstvenih i praktičnih informacija o primjeni i uporabi ovog radiofarmaceutika zdravstvenim radnicima.
English: The gallium (68Ga) edotreotide solution for intravenous injection must be prepared according to aseptic procedure, local regulation and the following instructions.
Croatian: Otopina galijevog [68Ga] edotreotida za intravensku injekciju mora se pripremiti u skladu s aseptičnim postupkom, lokalnim propisima i sljedećim uputama.
English: Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling the radiolabelled SomaKit TOC to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
Croatian: Sigurnost pri zračenju - rukovanje lijekom Koristite vodootporne rukavice, djelotvornu zaštitu od zračenja i odgovarajuće mjere sigurnosti prilikom rukovanja radioaktivno obilježenim lijekom SomaKit TOC kako biste izbjegli nepotrebno ozračivanje bolesnika, zaposlenika, kliničkog osoblja i drugih osoba.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 micrograms
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mikrograma
English: After radiolabelling, store below 25°C.
Croatian: Nakon radioaktivnog obilježavanja čuvati na temperaturi ispod 25°C.
English: This medicinal product must not be mixed with other products except those mentioned in section 12.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 12. 6.3. Rok valjanosti
English: At the end of the elution, disconnect the generator from the Vial 1 withdrawing the needle from the rubber septum and immediately add the reaction buffer previously dosed in the 1 ml sterile syringe.
Croatian: Na kraju eluacije razdvojite generator od bočice 1 izvlačenjem igle iz gumenog čepa i odmah dodajte reakcijski pufer koji je prethodno doziran u sterilnoj štrcaljki od 1 ml.
English: Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium (68Ga) chloride to make gallium (68Ga) edotreotide (this procedure is called radiolabelling).
Croatian: Prije nego što se može upotrijebiti, prašak u bočici miješa se s radioaktivnom tvari koja se naziva galijev [68Ga] klorid kako bi nastao galijev [68Ga] edotreotid (taj se postupak naziva radioaktivno obilježavanje).
English: Please ask your nuclear medicine doctor when you can resume breast-feeding.
Croatian: Pitajte liječnika specijalista nuklearne medicine kada možete nastaviti dojiti.
English: What SomaKit TOC is and what it is used for 2.
Croatian: Što je SomaKit TOC i za što se koristi 2.
English: SomaKit TOC must not be used after the expiry date which is stated on the carton.
Croatian: SomaKit TOC se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: SomaKit TOC must not be used - if you are allergic to edotreotide or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na edotreotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Recommended method for determining labelling efficiency of gallium (68Ga) edotreotide:
Croatian: Preporučena metoda za određivanje djelotvornosti obilježavanja galijevim [68Ga] edotreotidom:
English: Due to the acidic pH of the radiolabelled gallium (68Ga) edotreotide solution, accidental extravasation may cause local irritation.
Croatian: Zbog niskog pH radioaktivno obilježene otopine galijevog [68Ga] edotreotida, slučajna ekstravazacija može izazvati lokalni nadražaj.
English: A prospective intra-individual comparison showed that gallium (68Ga) edotreotide is able to detect lesions better than indium (111In) pentetreotide.
Croatian: Prospektivna intraindividualna usporedba pokazala je da galijev [68Ga] edotreotid može otkriti tumore bolje od indij (111In) pentetreotida.
English: If you have been given more SomaKit TOC than you should An overdose is unlikely because you will only receive a single dose under controlled conditions by the nuclear medicine doctor supervising the procedure.
Croatian: Predoziranje nije vjerojatno jer ćete primiti samo jednu dozu u kontroliranim uvjetima, a primijenit će je liječnik specijalist nuklearne medicine koji nadgleda postupak.
English: Set the temperature of the shielded dry bath at 95°C and wait for the temperature to reach the set point and stabilize.
Croatian: Postavite temperaturu zaštićene suhe kupelji na 95°C te pričekajte da dosegne zadanu vrijednost i stabilizira se.
English: What SomaKit TOC is and what it is used for
Croatian: Što je SomaKit TOC i za što se koristi
English: The content of the kit before radiolabelling is not radioactive.
Croatian: Sadržaj seta nije radioaktivan prije radioaktivnog obilježavanja.
English: 13040 Saluggia (VC)
Croatian: Via Crescentino, 13040 Saluggia (VC)
English: Only essential investigations should be carried out during pregnancy, when the likely benefit far exceeds any risk to the mother and foetus.
Croatian: Tijekom trudnoće je potrebno provoditi samo neophodne pretrage, pri kojima vjerojatna korist od primjene uvelike premašuje rizik za majku i plod.
English: However, after gallium (68Ga) chloride solution is added, adequate shielding of the final preparation must be maintained.
Croatian: Međutim, nakon dodavanja otopine galijevog [68Ga] klorida nužna je primjerena zaštita završnog pripravka.
English: A schematic representation of the radiolabelling procedure is shown in Figure 2.
Croatian: Shematski prikaz postupka radioaktivnog obilježavanja prikazan je na Slici 2.
English: Although no side effects have been reported, a potential risk of allergic reactions (hypersensitivity) exists with SomaKit TOC.
Croatian: Iako nisu zabilježene nuspojave, s lijekom SomaKit TOC povezana je potencijalna opasnost od alergijskih reakcija (preosjetljivost).
English: - Reaction buffer: the vial contains a clear, colourless solution.
Croatian: - Reakcijski pufer: bočica sadržava bistru, bezbojnu otopinu.
English: The injection of gallium (68Ga) edotreotide must be administered intravenously in order to avoid local extravasation resulting in inadvertent radiation to the patient and imaging artefacts.
Croatian: Injekciju galijevog [68Ga] edotreotida mora se primijeniti intravenskim putem kako bi se izbjegla lokalna ekstravazacija čija je posljedica nenamjerno ozračivanje bolesnika i pojava artefakata na slikama.
English: The use of SomaKit TOC involves exposure to small amounts of radioactivity.
Croatian: Primjena lijeka SomaKit TOC uključuje izlaganje maloj količini radioaktivnosti.
English: Product administration data should also be recorded.
Croatian: Također bi trebalo zabilježiti podatke o primjeni lijeka.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovaj lijek primjenjuju i njime rukuju samo osobe obučene i kvalificirane za njegovu sigurnu primjenu.
English: At the end of the elution, first withdraw the needle from the vacuum vial in order to establish atmospheric pressure into Vial 1, then disconnect Vial 1 from the generator by removing the needle from the rubber septum.
Croatian: Na kraju eluacije prvo izvucite iglu iz vakuumske bočice radi uspostave atmosferskog tlaka u bočici 1, potom uklanjanjem igle iz gumenog čepa razdvojite bočicu 1 s generatora.
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Zato se moraju poduzeti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips Mobile phase: sodium Citrate 0.1 M (pH 5) in water
Croatian: • ITCL papir od staklenog vlakna (npr. Agilent ITLC SGI001) koji je prethodno narezan na trakice od 1 cm x 12 cm Mobilna faza: natrijev citrat 0,1 M (pH 5) u vodi
English: EXP: ________ Time/Date
Croatian: Rok valjanosti: ________ vrijeme/datum
English: Distribution After intravenous injection, gallium (68Ga) edotreotide is rapidly cleared from the blood following bi exponential elimination of activity with half-lives of 2.0 ± 0.3 min and 48 ± 7 min respectively.
Croatian: Ga] edotreotid brzo se eliminira iz krvi uslijed bieksponencijalne eliminacije aktivnosti uz poluvijek od 2,0 ± 0,3 min i 48 ± 7 min.
English: (70%) and discrepancies in 14 patients (30%) presenting 9 with progressive disease and 5 with remission.
Croatian: edotreotida pokazale su podudarnost kod 32 bolesnika (70%) te nepodudarnost kod 14 bolesnika (30%), od kojih je 9 bilo u progresiji bolesti i 5 u remisiji.
English: It contains the active substance edotreotide.
Croatian: Sadržava djelatnu tvar edotreotid.
English: The three remaining retrospective studies recruited small samples (ranging from 20 to 28 GEP-NET patients or those with cancer of unknown origin) and found that semiquantitative uptake in the pre-PRRT gallium (68Ga)
Croatian: Tri preostala retrospektivna ispitivanja uključila su mali broj bolesnika (u rasponu od 20 do 28 bolesnika s GEP-NET-om ili onih s karcinomom nepoznatog primarnog sijela) te su pokazala da je semikvantitativna apsorpcija na PET prikazu dobivenom primjenom galijevog [68Ga] edotreotida prije
English: The quality controls should be performed under a shielded screen for radioprotection purposes.
Croatian: Kontrole kvalitete trebalo bi izvoditi sa zaštitnom maskom radi zaštite od zračenja.
English: Table 1: Dosimetry of gallium (68Ga) edotreotide
Croatian: Tabela 1.: Dozimetrija galijevog [68Ga] edotreotida
English: After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Croatian: Nakon radioaktivnog obilježavanja otopinom galijevog [68Ga] klorida, dobivena otopina galijevog [68Ga] edotreotida indicirana je za prikaz prekomjerne ekspresije somatostatinskih receptora pozitronskom emisijskom tomografijom (PET) u odraslih bolesnika s potvrđenom dijagnozom ili sumnjom na dobro diferencirane gastroenteropankreatične neuroendokrine tumore (GEP-NET) sa svrhom lokaliziranja primarnih tumora i njihovih metastaza.
English: As the effective dose is about 4.5 mSv when the maximal recommended activity of 200 MBq is administered, these adverse reactions are expected to occur with a low probability.
Croatian: Budući da kod primjene maksimalne preporučene aktivnosti od 200 MBq efektivna doza iznosi 4,5 mSv, pojava nuspojava je malo vjerojatna.