FrancophonIA/ELRC3.0 huggingface dataset:
English: A response was seen in around 90% of patients who could not use imatinib or it had not worked, and in 94% of newly diagnosed patients.
Croatian: Odgovor je utvrđen u oko 90 % bolesnika koji nisu mogli uzimati imatinib ili kod kojih imatinib nije djelovao te u 94 % bolesnika s novodijagnosticiranom bolesti.
English: How does Sprycel work?
Croatian: Kako djeluje Sprycel?
English: Sprycel is used when other treatments do not work or cause troublesome side effects.
Croatian: Sprycel se primjenjuje kada druga liječenja ne djeluju ili uzrokuju ozbiljne nuspojave.
English: Sprycel contains the active substance dasatinib.
Croatian: Sprycel sadržava djelatnu tvar dasatinib.
English: Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).
Croatian: Dva su ispitivanja provedena na bolesnicima s kroničnim KML-om (198 i 36 bolesnika), jedno je uključivalo bolesnike s ubrzanim KML-om (120 bolesnika), jedno ispitivanje obuhvatilo je bolesnike s mijeloblastičnim KML-om (80 bolesnika) te jedno bolesnike s Ph+ ALL-om i limfoblastičnim KML-om (81 bolesnik).
English: Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated.
Croatian: U još jednom glavnom ispitivanju ispitana je učinkovitost lijeka Sprycel u 113 djece s Ph+ KML-om u kroničnoj fazi, uključujući 29 bolesnika u kojih se nije mogao primijeniti imatinib ili kod kojih imatinib nije djelovao, kao i 84 djece s novodijagnosticiranom bolesti koja prethodno nisu bila liječena.
English: • newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
Croatian: • s novodijagnosticiranim Ph+ KML-om u „kroničnoj” fazi ili djece koja imaju Ph+ KML kada ne mogu primiti drugo liječenje, uključujući imatinib, ili kada drugo liječenje ne djeluje;
English: In the larger main study of patients with chronic phase CML, blood levels of platelets and white blood cells returned to within normal values in 90% of the patients.
Croatian: U većem glavnom ispitivanju bolesnika s KML-om u kroničnoj fazi broj trombocita i leukocita vratio se na normalne vrijednosti u 90 % bolesnika.
English: What benefits of Sprycel have been shown in studies?
Croatian: Koje su koristi lijeka od Sprycel utvrđene u ispitivanjima?
English: A further study involving 519 patients compared Sprycel with imatinib in treating newly diagnosed Ph+ patients with chronic phase CML who had not received any previous treatment.
Croatian: U daljnjem ispitivanju, koje je uključivalo 519 bolesnika, uspoređen je lijek Sprycel s imatinibom u liječenju bolesnika s novodijagnosticiranim Ph+ KML-om u kroničnoj fazi koji prethodno nisu bili liječeni.
English: For the full list of side effects and restrictions with Sprycel, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih prilikom primjene lijeka Sprycel potražite u uputi o lijeku.
English: How is Sprycel used?
Croatian: Kako se Sprycel primjenjuje?
English: Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL.
Croatian: Jedno je ispitivanje uključivalo 670 bolesnika s KML-om u kroničnoj fazi, a drugo 611 bolesnika s KML-om u uznapredovaloj fazi ili Ph+ ALL-om.
English: Blood transfusions were rarely required.
Croatian: Transfuzije krvi bile su rijetko potrebne.
English: Other incompatibilities may also exist.
Croatian: Mogu postojati i druge inkompatibilnosti.
English: - age over 75 years
Croatian: • dob veća od 75 godina
English: Each pack contains:
Croatian: Svako pakiranje sadrži:
English: 2 needles 19 G1
Croatian: 2 igle 19 G1
English: • if you have had external heart massage within the past 10 days.
Croatian: • ako ste imali vanjsku masažu srca u posljednjih 10 dana
English: Do not add any other medicines.
Croatian: Nemojte dodavati neke druge lijekove.
English: 20014 Nerviano (Milan) Italy
Croatian: 20014 Nerviano (Milan) Italija
English: Therefore tell the medical staff immediately if you
Croatian: Stoga odmah obavijestite medicinsko osoblje ako
English: 10 U reteplase
Croatian: 10 U reteplaze
English: Use aseptic technique throughout.
Croatian: Cijelo vrijeme primjenjujte aseptičku tehniku.
English: Therefore it should not be used except in life-threatening situations.
Croatian: Stoga se ne smije primjenjivati, osim u situacijama opasnima po život.
English: Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006
Croatian: Datum posljednje obnove: 29. kolovoza 2006.
English: Rapilysin is usually given in a hospital.
Croatian: Rapilysin se uglavnom daje u bolnici.
English: For further information see section 4.4, section bleeding.
Croatian: Za dodatne informacije vidjeti dio 4.4, dio o krvarenju.
English: These events can be life-threatening and may lead to death.
Croatian: Ti događaji mogu biti opasni po život i mogu uzrokovati smrt.
English: Injury, poisoning and procedural
Croatian: Ozljede, trovanja i proceduralne komplikacije
English: This leaflet was last revised in <{MM/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}
English: It is given within 12 hours after the onset of symptoms.
Croatian: Primjenjuje se unutar 12 sati od pojave simptoma.
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France
Croatian: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois Francuska
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti prije uporabe odgovornost su korisnika.
English: The fibrinogen level normalises within 2 days.
Croatian: Razina fibrinogena normalizira se tijekom 2 dana.
English: • any other condition in which bleeding might be especially dangerous or might occur at a site where it would be difficult to control
Croatian: • bilo koje drugo stanje u kojem krvarenje može biti osobito opasno ili se može pojaviti na mjestu koje je teško nadzirati.
English: 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Instructions for use/handling
Croatian: Upute za uporabu/rukovanje
English: • if you have severe uncontrolled high blood pressure (hypertension).
Croatian: • ako imate teški, nekontrolirani, povišeni krvni tlak (hipertenziju)
English: As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days.
Croatian: Kao i kod drugih aktivatora plazminogena dolazi do fenomena povratne sprege tijekom kojega razina fibrinogena dostiže maksimum u razdoblju od 9 dana i ostaje povišena i do 18 dana.
English: Be sure to tell hospital staff immediately if any of these symptoms appear.
Croatian: Odmah obavijestite medicinsko osoblje ako se javi bilo koji od ovih simptoma.
English: • if you have in the past 3 months had severe bleeding, a major injury or major surgery (e.g.
Croatian: • ako ste u posljednja 3 mjeseca imali teško krvarenje, veću ozljedu ili veći kirurški zahvat (npr.
English: In case of incompatibility an adaptor can be used and removed together with the glass syringe immediately after administration
Croatian: U slučaju inkompatibilnosti može se primijeniti adapter i ukloniti zajedno sa staklenom štrcaljkom odmah nakon primjene.
English: Each injection should be given slowly within 2 minutes.
Croatian: Svaka se injekcija mora ubrizgavati polako, u trajanju od 2 minute.
English: The requirements for submission of periodic safety update 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 published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: The risks of Rapilysin treatment may be increased if you have any of the following conditions:
Croatian: Rizici liječenja lijekom Rapilysin mogu se povećati ako imate neko od sljedećih stanja:
English: This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid.
Croatian: Ovaj lijek se ne smije miješati s heparinom i/ili acetilsalicilatnom kiselinom.
English: The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age.
Croatian: Rizik od intrakranijalnog krvarenja i smrtonosnog intrakranijalnog krvarenja povećava se s dobi.
English: After reconstitution (“when dissolved”), the solution must be used immediately.
Croatian: Nakon pripreme za primjenu („kada je otopljena“), otopina se mora odmah primijeniti.
English: • if you have other tumours associated with an increased risk of bleeding.
Croatian: • ako imate druge tumore povezane s povećanim rizikom od krvarenja
English: Reconstituted product:
Croatian: Rekonstituirani lijek:
English: * Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
Croatian: * Jakost reteplaze izražava se u jedinicama (U) korištenjem referentnog standarda koji je specifičan za reteplazu i ne može se uspoređivati s jedinicama korištenim za druge trombolitičke lijekove.
English: Contents of the pack and other information What Rapilysin contains
Croatian: Sadržaj pakiranja i druge informacije Što Rapilysin sadrži
English: • if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na reteplazu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions (see section 5.3).
Croatian: Jedini dostupni relevantni podaci dobiveni ispitivanjima na životinjama odnose se na ispitivanja provedena na kunićima koja su pokazala pojavu vaginalnog krvarenje povezanog s pobačajima (vidjeti dio 5.3).
English: White powder and clear colourless liquid (water for injections).
Croatian: Bijeli prašak i bistra bezbojna tekućina (voda za injekcije).
English: In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e.g. coagulation factor V) with a consequent risk of bleeding.
Croatian: U slučaju predoziranja može se očekivati deplecija fibrinogena i drugih komponenti zgrušavanja krvi (npr. koagulacijski faktor V), s posljedičnim rizikom od krvarenja.
English: In the alteplase group 33.0 % were fatal and 39.8 % were disabling.
Croatian: U skupini koja je primala alteplazu 33,0% bilo je smrtonosno, a 39,8% uzrokovalo je invalidnost.
English: Hypersensitivity reactions (e.g. allergic reactions)1
Croatian: Reakcije preosjetljivosti (primjerice, alergijske reakcije)1
English: 220 Hafnarfjordur Iceland.
Croatian: 220 Hafnarfjordur
English: The dose is now ready for intravenous administration
Croatian: Doza je sada spremna za intravensku primjenu.
English: In dogs repeated dosing of the human peptide reteplase led to immunologic-allergic reactions.
Croatian: Ponovljeno doziranje ljudske peptidne reteplaze u pasa rezultiralo je imunološko-alergijskim reakcijama.
English: The frequency of adverse reactions reported is listed in the following table.
Croatian: Učestalost prijavljenih nuspojava navedena je u sljedećoj tablici.
English: Attention should be paid to this effect especially during periods of low plasma fibrinogen (up to about 2 days after fibrinolytic therapy of AMI).
Croatian: Potrebno je obratiti pažnju na taj učinak, posebno tijekom razdoblja niske razine fibrinogena u plazmi (do 2 dana nakon liječenja akutnog infarkta miokarda fibrinoliticima).
English: Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use.
Croatian: Zbog toga, kompatibilnost staklene štrcaljke i intravenskog pristupa mora biti osigurana prije primjene.
English: What Rapilysin is and what it is used for
Croatian: Što je Rapilysin i za što se koristi
English: Your doctor can tell you the risks and benefits of using Rapilysin during pregnancy.
Croatian: Liječnik će Vam objasniti rizike i koristi od primjene lijeka Rapilysin tijekom trudnoće.
English: Pay careful attention to all possible bleeding sites (e.g. injection sites).
Croatian: Osobitu pozornost obratite na sva mjesta mogućeg krvarenja (npr. mjesta davanja injekcije).
English: What Rapilysin looks like and contents of the pack
Croatian: Kako Rapilysin izgleda i sadržaj pakiranja
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥
Croatian: Učestalosti su definirane kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i <
English: Plasminogen activator inhibitor 1 (PAI-1) activity can be reduced to around zero, but rapidly normalises within two hours showing a rebound phenomenon.
Croatian: Aktivnost inhibitora aktivatora plazminogena 1 (PAI-1) može se smanjiti na oko nule, ali ubrzo se normalizira, tijekom dva sata, pokazujući fenomen povratne sprege.
English: The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding.
Croatian: Liječnik će Vam prije primjene lijeka Rapilysin postaviti pitanja kako bi saznao postoji li povećani rizik od krvarenja.
English: Reteplase (10+10 U) dose-dependently reduces plasma fibrinogen levels by about 60 to 80 %.
Croatian: Ovisno o dozi, reteplaza (10+10 U) smanjuje razinu fibrinogena u plazmi za oko 60% do 80%.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah.
English: Safety and effectiveness of Rapilysin in children have not been established.
Croatian: Sigurnosti i djelotvornost lijeka Rapilysin u djece nisu još ustanovljene.
English: Pharmacotherapeutic group: antithrombotic agent, ATC Code: B01AD07
Croatian: Farmakoterapijska skupina: antitrombotik, ATK oznaka: B01AD07
English: Discuss with your doctor when you can take up breast-feeding again.
Croatian: Savjetujte se s liječnikom o tome kada možete ponovno početi dojiti.
English: Subacute toxicity studies did not reveal any unexpected adverse events.
Croatian: Ispitivanjima subakutne toksičnosti nisu otkriveni štetni događaji.
English: - septic thrombophlebitis or occluded arteriovenous cannula at seriously infected site
Croatian: - septički tromboflebitis ili začepljena arteriovenska kanila na ozbiljno inficiranom mjestu
English: Each bolus is administered as a slow intravenous injection within 2 minutes.
Croatian: Svaki bolus primjenjuje se kao spora intravenska injekcija u trajanju od 2 minute.
English: Experiments in rats indicate that the liver and the kidneys are the main organs of active uptake and lysosomal degradation.
Croatian: Eksperimenti na štakorima pokazuju da su jetra i bubrezi glavni organi aktivne pohrane i lizosomske razgradnje.
English: Each patient being considered for therapy with reteplase should be carefully evaluated.
Croatian: Svakog bolesnika kojeg se namjerava liječiti reteplazom potrebno je pažljivo procijeniti.
English: The reconstituted solution contains 1 U reteplase per ml.
Croatian: Rekonstituirana otopina sadrži 1 U reteplaze po ml.
English: An additional increase of half-life of activity in patients with myocardial infarction and severely impaired liver and renal function cannot be excluded, but no clinical data of pharmacokinetics of reteplase in these patients are available.
Croatian: Dodatno produljenje poluvijeka aktivnosti u bolesnika s infarktom miokarda i teškim oštećenjem funkcije jetre i bubrega ne može se isključiti, ali klinički podaci o farmakokinetičkim svojstvima reteplaze u tih bolesnika nisu dostupni.
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Croatian: Aritmije Koronarna tromboliza može uzrokovati aritmije povezane s reperfuzijom.
English: Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions.
Croatian: Ishemijski ili hemoragijski cerebrovaskularni događaji mogu doprinijeti stanju ili biti podležeće stanje.
English: This event has been reported for the therapeutic class of thrombolytic agents.
Croatian: Ovaj je događaj prijavljen za terapijsku skupinu trombolitičkih lijekova.
English: - cerebrovascular disease
Croatian: - cerebrovaskularna bolest
English: The lyophilisate is reconstituted with the contents of the accompanying syringe.
Croatian: Liofilizat se rekonstituira sadržajem priložene štrcaljke.
English: Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported.
Croatian: Prijavljene su inkompatibilnosti nekih napunjenih staklenih štrcaljki (uključujući Rapilysin) s određenim spojnicama bez igala.
English: • high likelihood of a blood clot in the heart (e.g. as a result of narrowing of a heart valve or atrial fibrillation)
Croatian: • velika vjerojatnost od pojave krvnog ugruška u srcu (npr. kao rezultat sužavanja srčanog zaliska ili fibrilacije atrija)
English: ** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
Croatian: ** Rekombinantni aktivator plazminogena proizveden je tehnologijom rekombinantne DNK na bakteriji Escherichia coli.
English: If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Croatian: Ako se pojavi anafilaktoidna reakcija, odmah treba prestati ubrizgavati injekciju i započeti s odgovarajućim liječenjem.
English: Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.
Croatian: Liječenje lijekom Rapilysin 10 U potrebno je početi što prije nakon pojave simptoma srčanog udara.
English: Overall stroke rates were 1.64 % in the reteplase and 1.79 % in the alteplase group.
Croatian: Ukupna stopa moždanog udara iznosila je 1,64% u skupini koja je primala reteplazu i 1,79% u skupini koja je primala alteplazu.
English: The predominant acute symptom after single high doses of reteplase in rats and rabbits was transient apathy shortly after injection.
Croatian: Najizraženiji akutni simptom nakon pojedinačne visoke doze reteplaze primijećen na štakorima i zečevima bila je prolazna apatija ubrzo nakon ubrizgavanja.
English: Additional studies in human plasma samples in vitro suggest that complexation with C1-inactivator, α2-antiplasmin and α2-antitrypsin contributes to the inactivation of reteplase in plasma.
Croatian: Dodatna ispitivanja na uzorcima ljudske plazme in vitro upućuju da stvaranje kompleksa s C1inaktivatorom, α2-antiplazminom i α2-antitripsinom pridonosi inaktivaciji reteplazme u plazmi.
English: • if you have had a stroke.
Croatian: • ako ste imali moždani udar
English: Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients with acute myocardial infarction.
Croatian: Retrospektivne analize kliničkih ispitivanja nisu otkrile klinički značajne interakcije s lijekovima primjenjivanima istodobno s reteplazom u bolesnika s akutnim infarktom miokarda.
English: A large comparative mortality trial (INJECT) in approx. 6000 patients showed that reteplase reduced the incidence of heart failure (secondary efficacy criterion) in a significant manner and was at least equally effective in terms of reducing mortality (primary efficacy criterion) when compared to streptokinase.
Croatian: Veliko usporedno ispitivanje smrtnosti (INJECT) na oko 6000 bolesnika pokazalo je da reteplaza značajno smanjuje učestalost zatajenja srca (sekundarni kriterij djelotvornosti) i da je barem jednako djelotvorna u smanjivanju smrtnosti (primarni kriterij djelotvornosti) u usporedbi sa streptokinazom.
English: Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack.
Croatian: Rapilysin se primjenjuje nakon akutnog infarkta miokarda (srčanog udara) da bi razgradio krvne ugruške koji uzrokuju srčani udar.
English: Prothrombin activation fragment 1 levels and thrombin-antithrombin III-complexes increase during thrombolysis indicating thrombin production of which the clinical relevance is unknown.
Croatian: Vrijednosti fragmenta 1 aktivacije protrombina i kompleksa trombin-antitrombin III povećavaju se tijekom trombolize upućujući na proizvodnju trombina, čiji je klinički značaj nepoznat.
English: Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin.
Croatian: Reteplaza je rekombinantni aktivator plazminogena koji katalizira cijepanje endogenog plazminogena za tvorbu plazmina.
English: This plasminogenolysis occurs preferentially in the presence of fibrin.
Croatian: Plazminogenoliza se odvija uglavnom u prisutnosti fibrina.
English: Reductions of plasma levels of plasminogen and α2-antiplasmin normalise within 1 to 3 days.
Croatian: Smanjene razine plazminogena i α2-antiplazmina u plazmi normaliziraju se tijekom 1 do 3 dana.
English: In rabbits, vaginal bleedings and abortions possibly associated to prolonged haemostasis, but no foetal abnormalities were noted.
Croatian: Vaginalno krvarenje i pobačaji u zečeva vjerojatno su povezani s produženom hemostazom, ali nisu zabilježene deformacije fetusa.
English: You should not breast-feed your baby during treatment with Rapilysin as it is not known whether Rapilysin is excreted into mother's milk.
Croatian: Tijekom liječenja lijekom Rapilysin ne smijete dojiti dijete jer nije poznato izlučuje li se Rapilysin u majčino mlijeko.
English: Death or permanent disability are not uncommon in patients who have a stroke (including bleeding in the brain) or other serious bleeding problem.
Croatian: Smrt ili trajna invalidnost nisu rijetke u bolesnika koji su pretrpjeli moždani udar (uključujući krvarenje u mozgu) ili druga teška krvarenja.
English: There are no adequate data on the use of reteplase in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni reteplaze u trudnica.
English: In the following conditions the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits:
Croatian: Rizik od liječenja reteplazom može se povećati u sljedećim stanjima te ga je potrebno procijeniti u odnosu na očekivanu korist:
English: Animal data show that in case of severely impaired renal function with a pronounced increase in serum creatinine and serum urea an increase in half-life of reteplase has to be expected.
Croatian: Podaci dobiveni ispitivanjima na životinjama pokazuju da se u slučaju oštećene funkcije bubrega s naglašeno povećanim serumskim kreatininom i urejom može očekivati produljenje poluvijeka reteplaze.
English: Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package.
Croatian: Prije primjene prašak za injekciju mora se otopiti u vodi za injekciju, koja se nalazi u napunjenoj štrcaljki u pakiranju.
English: Reproductive toxicity studies were performed in rats (fertility and embryo-foetotoxicity study including a littering phase) and in rabbits (embryo-foetotoxicity study, dose-range finding only).
Croatian: Ispitivanja reproduktivne toksičnosti provedena su na štakorima (ispitivanja plodnosti te embrioksičnosti i fetotoksičnosti, uključujući fazu okota) i na zečevima (ispitivanja embrioksičnosti i fetotoksičnosti, samo rezultati ispitivanja raspona doze).