FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no adequate data from use of abatacept in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni abatacepta u trudnica.
English: What ORENCIA is and what it is used for
Croatian: Što je ORENCIA i za što se koristi
English: ORENCIA increases the risk of getting infections.
Croatian: ORENCIA povećava rizik od infekcija.
English: Proportion of patients with a clinically meaningful improvementd
Croatian: Udio bolesnika s klinički značajnim poboljšanjemd
English: Avoid prolonged or vigorous agitation.
Croatian: Izbjegavajte dugotrajno i žustro protresanje.
English: Complete ALL steps to deliver your full dose of the medicine
Croatian: Morate dovršiti SVE korake da biste primijenili punu dozu lijeka
English: The safety of ORENCIA in individuals with latent tuberculosis is unknown.
Croatian: Sigurnost primjene lijeka ORENCIA u osoba s latentnom tuberkulozom nije poznata.
English: Don't try to self-inject until you are sure that you understand how to prepare and give the injection.
Croatian: Nemojte si pokušavati sami davati injekciju dok niste sigurni da razumijete kako treba pripremiti i primijeniti injekciju.
English: It is very important to use ORENCIA exactly as prescribed by your doctor.
Croatian: Vrlo je važno da primjenjujete lijek ORENCIA točno onako kako Vam je propisao liječnik.
English: The significance of the higher incidence in the 2 to 5 year age cohort is unknown, taking into account the difference in sample size.
Croatian: Značaj veće incidencije u kohorti od 2 do 5 godina starosti nije poznat, uzimajući u obzir razliku u veličini uzorka.
English: Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click.
Croatian: Potvrdite: nakon završetka injekcije štitnik će prekriti iglu i možda ćete čuti 'klik'.
English: Check with your doctor before you are given any vaccines.
Croatian: Provjerite sa svojim liječnikom prije nego što primite bilo koje cjepivo.
English: Let your skin dry before injecting.
Croatian: Pustite da se koža osuši prije injekcije.
English: You may use the same thigh for weekly injections, as long as each injection site is approximately 2.5 cm away from where you last injected.
Croatian: Možete koristiti isto bedro svakog tjedna ako je svako mjesto injekcije udaljeno približno 2,5 cm od mjesta prethodne injekcije.
English: However, you and your doctor may decide that you can inject ORENCIA yourself.
Croatian: Međutim, Vi i Vaš liječnik možete odlučiti da si injekcije lijeka ORENCIA možete davati sami.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA24
Croatian: Farmakoterapijska skupina: Imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA24
English: If you use more ORENCIA than you should
Croatian: Ako primijenite više lijeka ORENCIA nego što ste trebali
English: c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating,
Croatian: c Upitnik za procjenu zdravlja: 0 = najbolje, 3 = najgore; 20 pitanja, 8 kategorija: odijevanje i njega, ustajanje, hranjenje, hod,
English: Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86.
Croatian: Abatacept selektivno inhibira taj put kostimulacije tako što se specifično vezuje za CD80 i CD86.
English: Inadequate response to MTX
Croatian: Nedovoljan odgovor na MTX
English: STEP 2: Choose and prepare your injection site
Croatian: KORAK 2: Odaberite i pripremite mjesto injiciranja
English: Treatment with immunosuppressive therapy, such as ORENCIA, may be associated with progressive multifocal leukoencephalopathy (PML).
Croatian: Liječenje imunosupresivnim lijekovima, kakav je ORENCIA, može biti povezano s progresivnom multifokalnom leukoencefalopatijom (PML).
English: The overall safety profile with respect to adverse reactions was similar between the two groups over the 24-month period.
Croatian: Ukupan sigurnosni profil s obzirom na nuspojave bio je sličan u obje skupine tijekom 24-mjesečnog razdoblja.
English: The active substance is abatacept.
Croatian: Djelatna tvar je abatacept.
English: c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period.
Croatian: c Značajan klinički odgovor definiran je kao postizanje odgovora ACR70 tijekom kontinuiranog razdoblja od 6 mjeseci.
English: Get to know your Pre-filled Syringe There are 3 types of pre-filled syringes:
Croatian: Upoznajte svoju napunjenu štrcaljku Postoje 3 vrste napunjenih štrcaljki:
English: ORENCIA can cause serious side effects, which may need treatment.
Croatian: ORENCIA može uzrokovati ozbiljne nuspojave, koje će možda trebati liječiti.
English: Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 USA
Croatian: Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 SAD
English: Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities.
Croatian: Reumatoidni artritis je dugotrajna progresivna sustavna bolest koja, ako se ne liječi, može dovesti do ozbiljnih posljedica, kao što su razaranje zglobova, povećana onesposobljenost i otežano obavljanje svakodnevnih aktivnosti.
English: Study SC-II: abatacept versus adalimumab
Croatian: Ispitivanje SC-II: abatacept naspram adalimumaba
English: Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes.
Croatian: Izvadite jednu brizgalicu iz hladnjaka i ostavite je na sobnoj temperaturi (približno 25°C) 30 minuta.
English: ORENCIA is intended for use under the guidance of a healthcare professional.
Croatian: ORENCIA je namijenjena za primjenu pod vodstvom zdravstvenog radnika.
English: Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal.
Croatian: Za potpuno aktiviranje T-limfocita potrebna su dva signala koja daju stanice koje prezentiraju antigen: prepoznavanje specifičnog antigena od strane T-staničnog receptora (signal 1) i drugi, kostimulatorni signal.
English: Have the syringe ready for use immediately after you have prepared your injection site.
Croatian: Neka Vam štrcaljka bude spremna za uporabu odmah nakon što ste pripremili mjesto injiciranja.
English: Keep this card with you for 3 months after the last ORENCIA dose, since side effects may occur a long time after your last dose of ORENCIA.
Croatian: Nosite ovu karticu sa sobom još 3 mjeseca nakon posljednje doze lijeka ORENCIA jer se nuspojave mogu pojaviti dugo vremena nakon posljednje doze lijeka ORENCIA.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving abatacept.
Croatian: Nema podataka o sekundarnom prijenosu infekcije s osobe koja je primila živo cjepivo na bolesnike koji primaju abatacept.
English: Step 6: After the Injection
Croatian: KORAK 6: NAKON INJEKCIJE
English: Position the ClickJect Pen so you can see the viewing window and it's at a 90º angle to the injection site.
Croatian: Namjestite brizgalicu ClickJect tako da možete vidjeti prozor za provjeru i tako da bude pod kutom od 90º u odnosu na mjesto injekcije.
English: walking, hygiene, reach, grip, and activities.
Croatian: higijena, dosezanje stvari, držanje stvari i aktivnosti.
English: Abdomen, avoid 5 cm around navel
Croatian: Trbuh, izbjegavajte područje 5 cm oko pupka
English: Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.
Croatian: Moguće ozbiljne nuspojave su ozbiljne infekcije, zloćudne bolesti (rak) i alergijske reakcije, kako je navedeno u nastavku.
English: b 61% of patients were previously treated with TNF inhibitor.
Croatian: b 61% bolesnika prethodno je bilo liječeno TNF-inhibitorom.
English: Healthcare professionals will monitor you while you receive your ORENCIA infusion.
Croatian: Zdravstveni radnici će Vas nadzirati dok primate infuziju lijeka ORENCIA.
English: Safety and structural damage assessments were conducted at one and two years.
Croatian: Procjene sigurnosti i strukturnog oštećenja provedene su nakon jedne i nakon dvije godine liječenja.
English: Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek dok primate lijek ORENCIA.
English: ORENCIA should NOT be used with siliconised syringes (see section 6.6).
Croatian: ORENCIA se NE SMIJE primjenjivati silikoniziranim štrcaljkama (vidjeti dio 6.6).
English: The occurrence of anaphylaxis remained rare during the double blind and the cumulative period.
Croatian: Pojava anafilaksije je bila rijetko zabilježena tijekom dvostruko slijepog i kumulativnog razdoblja.
English: Of the 54 patients withdrawn from ORENCIA during the doubleblind period for up to 6 months, none had an infusion reaction upon re-initiation of ORENCIA.
Croatian: Od 54 bolesnika koji nisu primali lijek ORENCIA tijekom dvostruko slijepe faze u trajanju do 6 mjeseci, niti jedan nije imao infuzijsku reakciju kod ponovnog uvođenja lijeka ORENCIA.
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats).
Croatian: Istraživanja na štakorima izloženima abataceptu pokazala su abnormalnosti u imunološkom sustavu, uključujući nisku incidenciju smrtonosnih infekcija (u mladih štakora).
English: It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Croatian: Povećana osjetljivost na oportunističke infekcije opažena u mladih štakora vjerojatno je povezana s izlaganjem abataceptu prije razvoja memorijskih odgovora.
English: Abatacept was shown to cross the placenta in rats and rabbits.
Croatian: Pokazalo se da abatacept prolazi kroz placentu u štakora i kunića.
English: Patients with known malignancies were not included in these clinical trials.
Croatian: Bolesnici s postojećom zloćudnom bolešću nisu bili uključeni u ta klinička ispitivanja.
English: The type of pre-filled syringe you receive depends on the dose prescribed by your doctor.
Croatian: Koju ćete vrstu napunjene štrcaljke dobiti ovisi o tome koju Vam je dozu propisao Vaš liječnik.
English: The rate is consistent with previous experience, and there was no effect of immunogenicity on pharmacokinetics, safety, or efficacy.
Croatian: Ta je stopa u skladu s ranijim iskustvom, a imunogenost nije utjecala na farmakokinetiku, sigurnost i djelotvornost.
English: Placebo group in Period B
Croatian: Placebo skupina u Razdoblju B
English: Structural response
Croatian: Strukturni odgovor
English: ORENCIA will be given to you under the supervision of an experienced doctor.
Croatian: Lijek ORENCIA ćete primiti pod nadzorom iskusnog liječnika.
English: 1,000 mg a Approximating 10 mg/kg.
Croatian: 1000 mg a približno 10 mg/kg.
English: Treatment with ORENCIA should not be initiated in patients with active infections until infections are controlled.
Croatian: Ne smije se započinjati liječenje lijekom ORENCIA u bolesnika s aktivnim infekcijama dok se infekcija ne stavi pod kontrolu.
English: Do not fan or blow on the clean area.
Croatian: Nemojte mahati ili puhati po očišćenom području.
English: This was mostly due to non-serious upper respiratory tract infections in the 2 to 5 year age cohort.
Croatian: To je uglavnom bilo zbog neozbiljnih infekcija gornjih dišnih putova u kohorti 2 do 5 godina starosti.
English: What ORENCIA contains
Croatian: Što ORENCIA sadrži
English: If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered (see section 5.1).
Croatian: Ako se odgovor na abatacept ne postigne unutar 6 mjeseci liječenja, treba razmisliti o nastavku liječenja (vidjeti dio 5.1).
English: Immunogenicity and safety of abatacept upon withdrawal and restart of treatment
Croatian: Imunogenost i sigurnost abatacepta nakon prekida i ponovnog uvođenja liječenja
English: Choose a different injection site for each new injection.
Croatian: Za svaku novu injekciju odaberite drugo mjesto injekcije.
English: Similar efficacy was observed in these patients and in younger patients.
Croatian: U tih je bolesnika zabilježena podjednaka djelotvornost kao u mlađih bolesnika.
English: At 10 mg/kg, the mean terminal half-life was 13.1 days, ranging from 8 to 25 days.
Croatian: Pri dozi od 10 mg/kg, prosječan terminalni poluvijek bio je 13,1 dan, a kretao se od 8 do 25 dana.
English: - Any unused portion in the vials must be immediately discarded in accordance with local requirements.
Croatian: - - Neiskorišteni dio u bočicama mora se odmah zbrinuti u skladu s lokalnim propisima.
English: Reductions in serum TNFα were also observed.
Croatian: Opaženo je i sniženje vrijednosti TNFα u serumu.
English: Patients continued abatacept treatment in an ongoing open-label extension, which assessed long-term safety and efficacy for an additional 20 months.
Croatian: Bolesnici su nastavili liječenje abataceptom u otvorenom produžetku ispitivanja koje je trenutno u tijeku, a u kojem su se ocjenjivale dugoročna sigurnost i djelotvornost tijekom dodatnih 20 mjeseci.
English: The exposure adjusted incidence rate (expressed per 100 person-years) remained stable over the treatment duration.
Croatian: Stopa incidencije prilagođena prema izloženosti (izraženo kao 100 osoba-godina) ostala je stabilna tijekom cijelog trajanja liječenja.
English: Consequently, these infants may be at increased risk of infection.
Croatian: Zbog toga u te novorođenčadi može postojati povećan rizik od infekcije.
English: The types of infections were consistent with those commonly seen in outpatient paediatric populations.
Croatian: Vrste infekcija bile su u skladu s onima koje se uobičajeno vide u ambulantnoj pedijatrijskoj populaciji.
English: if you become pregnant while using ORENCIA, tell your doctor.
Croatian: ako zatrudnite dok primate lijek ORENCIA, obavijestite svog liječnika.
English: Clinical responses in controlled trials Percent of patients Intravenous administration
Croatian: Klinički odgovori u kontroliranim ispitivanjima Postotak bolesnika Intravenska primjena
English: The time to and proportion of patients with the relapse of the disease observed between the two groups were similar.
Croatian: Vrijeme do relapsa i udio bolesnika s relapsom bolesti bili su podjednaki u obje skupine.
English: Look at the liquid in the syringe (Figure 2).
Croatian: Pogledajte tekućinu u štrcaljki (Slika 2).
English: Use your thumb to push the plunger down, pressing firmly until the plunger will go no further, and all of the medicine has been injected (Figure 6).
Croatian: Palcem gurnite klip i pritišćite ga čvrsto sve dok ne dođe do kraja i dok niste injicirali sav lijek (Slika 6).
English: ORENCIA should not be used during pregnancy unless the clinical condition of the woman requires treatment with abatacept.
Croatian: ORENCIA se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje abataceptom.
English: Don't shake the syringe, as this may damage the ORENCIA medicine.
Croatian: Nemojte tresti štrcaljku jer to može oštetiti lijek ORENCIA.
English: Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections.
Croatian: Mnoge ozbiljne infekcije javile su se u bolesnika na istodobnoj imunosupresivnoj terapiji, koja ih je, uz postojeću bolest, mogla dodatno predisponirati za infekcije.
English: Combination with other medicinal products that affect the immune system and with vaccinations
Croatian: Kombinacija s drugim lijekovima koji djeluju na imunološki sustav i s cijepljenjima
English: Combination with TNF-inhibitors
Croatian: Kombinacija s TNF-inhibitorima
English: ORENCIA has not been studied in these patient populations.
Croatian: ORENCIA nije ispitivana u ovim populacijama bolesnika.
English: HOW TO USE
Croatian: KAKO SE KORISTI
English: Before you use the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist shows you the right way to use it.
Croatian: Prije nego što prvi puta upotrijebite napunjenu štrcaljku pobrinite se da Vam liječnik, medicinska sestra ili ljekarnik pokažu kako je pravilno koristiti.
English: By finding the right treatment plan for you, you may be able to slow down this disease process, which may help reduce long-term joint damage, as well as pain and fatigue and improve your overall quality of life.
Croatian: Ako se pronađe odgovarajući plan liječenja za Vas, taj se proces može usporiti, čime se mogu umanjiti dugotrajno oštećenje zglobova, bolovi i umor te poboljšati ukupna kvaliteta života.
English: If you miss your dose by more than three days, ask your doctor when to take your next dose.
Croatian: Ako propustite dozu za više od 3 dana, upitajte svog liječnika kada trebate primijeniti sljedeću dozu.
English: Inadequate response to TNF Inhibitor
Croatian: Nedovoljan odgovor na TNF-inhibitor
English: The powder is a white to off-white whole or fragmented cake.
Croatian: Prašak je bijeli do bjelkasti, cjelovit ili rascjepkan kolačić.
English: In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints.
Croatian: U osoba s reumatoidnim artritisom njihov vlastiti imunološki sustav napada normalna tkiva, što izaziva bolove i oticanje zglobova.
English: - You must not be treated with ORENCIA if you have severe infection.
Croatian: Ne smijete se liječiti lijekom ORENCIA ako imate tešku infekciju.
English: Response rates at the end of the short-term exposure are summarised in Table 9:
Croatian: Stope odgovora na kraju kratkoročnog izlaganja sažeto su prikazane su Tablici 9:
English: Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic Tlymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
Croatian: Abatacept je fuzijski protein koji se sastoji od izvanstanične domene antigena 4 povezanog s ljudskim citotoksičnim T-limfocitom ( CTLA-4) vezane na modificirani dio Fc ljudskog imunoglobulina G1 (IgG1).
English: The mean distribution volume (Vss) was 0.07 L/kg and ranged from 0.02 to 0.13 L/kg.
Croatian: Prosječan volumen distribucije (Vss) iznosio je 0,07 l/kg, a kretao se od 0,02 do 0,13 l/kg.
English: Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
Croatian: Abatacept selektivno modulira ključni kostimulacijski signal potreban za potpuno aktiviranje T-limfocita koji eksprimiraju CD28.
English: Study IV did not require any specific number of tender or swollen joints.
Croatian: U ispitivanju IV nije se tražio određen broj bolnih ili otečenih zglobova.
English: Rheumatoid arthritis (RA) affects everyone differently.
Croatian: Reumatoidni artritis svakoga pogađa na drugačiji način.
English: In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased.
Croatian: Dodatno, smanjene su i serumske koncentracije matriks metaloproteinaze-3 koja izaziva razaranje hrskavice i preoblikovanje tkiva.
English: After reconstitution and dilution, the infusion solution is stable for 24 hours in a refrigerator, but for bacteriological reasons, it is to be used immediately.
Croatian: Nakon pripreme i razrjeđivanja, otopina za infuziju je stabilna 24 sata u hladnjaku, ali se zbog bakterioloških razloga mora odmah primijeniti.
English: Before you use the ClickJect Pen for the first time, make sure your healthcare provider shows you the right way to use it.
Croatian: Prije nego što prvi puta upotrijebite brizgalicu ClickJect, pobrinite se da Vam zdravstveni radnik pokaže kako je pravilno koristiti.
English: Press a cotton ball over the injection site and hold for 10 seconds.
Croatian: Pritisnite mjesto injekcije pamučnom vatom i držite 10 sekundi.
English: leflunomide, azathioprine, gold, and anakinra.
Croatian: leflunomid, azatioprin, zlato i anakinru.
English: After 1 year of treatment, the maintenance of remission was assessed by the relapse of the disease.
Croatian: Nakon 1 godine liječenja održanje remisije ocijenjeno je s obzirom na relaps bolesti.
English: Proportion (%) of polyarticular JIA patients with ACRP responses or inactive disease at end of short-term period (4 months) Ages 2 to 17 years n=219
Croatian: Udio (%) bolesnika s poliartikularnim JIA-om i ACRP odgovorima ili neaktivnom bolešću na kraju kratkoročnog razdoblja (4 mjeseca) Dob od 2 do 17 godina n=219
English: Check the liquid
Croatian: Pregledajte tekućinu
English: The absence of concomitant methotrexate did not appear to be associated with a higher rate of seropositivity.
Croatian: Čini se da izostanak istodobne primjene metotreksata nije bio povezan s višom stopom seropozitivnosti.
English: Of the 219 patients treated, 205 completed the short-term period and 200 entered the ongoing longterm extension period.
Croatian: Od 219 liječenih bolesnika, njih 205 završilo je kratkoročno razdoblje, a 200 bolesnika ušlo je u dugoročni produžetak ispitivanja, koji je još u tijeku.
English: Other medicines: ORENCIA should not be mixed with other medicines or infused concomitantly in the same intravenous line with other medicines.
Croatian: Drugi lijekovi: ORENCIA se ne smije miješati s drugim lijekovima niti istodobno primjenjivati u istoj infuzijskoj liniji s drugim lijekovima.
English: Comparison of incidence rates across different assays is not appropriate, as the ECL assay was developed to be more sensitive and drug tolerant than the previous ELISA assay.
Croatian: Nije primjereno uspoređivati stope incidencije dobivene različitim testovima jer je ECL test razvijen kako bi bio osjetljiviji i tolerantniji na lijek od prethodnog ELISA testa.
English: The median duration of abatacept treatment in Period C was 1815 days (range 57-2,415 days; nearly 61 months).
Croatian: Medijan trajanja liječenja abataceptom u Razdoblju C bio je 1815 dana (raspon 57-2415 dana, gotovo 61 mjesec).
English: Don't speed the warming process in any way, such as using the microwave or placing the syringe in warm water.
Croatian: Nemojte ni na koji način ubrzavati zagrijavanje, primjerice u mikrovalnoj pećnici ili tako da štrcaljku stavite u toplu vodu.
English: This means, even if you're on treatment, whether or not you're still having symptoms, RA could be continuing to damage your joints.
Croatian: To znači da, čak i kada se liječite, bez obzira na to jesu li simptomi još uvijek prisutni, reumatoidni artritis može i dalje oštećivati Vaše zglobove.
English: * No active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL.
Croatian: * Bez aktivnih zglobova, težina bolesti ≤ 10 mm prema globalnoj ocjeni liječnika i CRP ≤ 0,6 mg/dl.
English: OTHER SPECIAL WARNING(S), IF NECESSARY 8.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO 8. ROK VALJANOSTI
English: Common adverse reactions: pyrexia Uncommon adverse reactions: haematuria, otitis (media and externa).
Croatian: Česte nuspojave: pireksija Manje česte nuspojave: hematurija, otitis (media i externa).
English: Should you have any questions, ask your pharmacist.
Croatian: Ako imate bilo kakvih pitanja, obratite se svom ljekarniku.
English: Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
Croatian: Teške i nekontrolirane infekcije poput sepse i oportunističkih infekcija (vidjeti dio 4.4).
English: Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.
Croatian: Ostavite štrcaljku na sobnoj temperaturi 30 do 60 minuta prije injiciranja.
English: d After 6 months, patients were given the opportunity to enter an open-label study.
Croatian: d Nakon 6 mjeseci bolesnici su dobili priliku za ulazak u otvoreno ispitivanje.