FrancophonIA/ELRC3.0 huggingface dataset:
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
Croatian: • Moguće znakove raka koji uključuju, ali nisu ograničeni na oticanje limfnih čvorova, gubitak tjelesne težine, vrućicu, neuobičajene kvržice na koži, promjene izgleda madeža ili boje kože ili neuobičajeno krvarenje iz rodnice.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Croatian: Infliksimab se povezuje s akutnim reakcijama vezanima uz infuziju, uključujući anafilaktički šok te reakcije kasne preosjetljivosti (vidjeti dio 4.8).
English: Limited experience from re-treatment following disease flare by a re-induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment (see section 4.8).
Croatian: Ograničeno iskustvo ponovne primjene lijeka zbog novog izbijanja bolesti ponavljanjem uvodnog režima liječenja, pokazuje veću incidenciju reakcija vezanih uz infuziju, uključujući i ozbiljne reakcije, u odnosu na terapiju održavanja svakih 8 tjedana (vidjeti dio 4.8).
English: Use of antituberculosis therapy should also be considered before the initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Croatian: Primjenu antituberkulozne terapije treba razmotriti prije početka liječenja lijekom Remicade i u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi da su bili liječeni na odgovarajući način.
English: Radiographic changes were assessed in IMPACT 2.
Croatian: U ispitivanju IMPACT 2 praćene su radiografske promjene zglobova.
English: Heart problems
Croatian: Problemi sa srcem
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, further treatment with Remicade must not be given (see section 4.8).
Croatian: Ako bolesnik nakon liječenja lijekom Remicade razvije simptome koji ukazuju na sindrom sličan lupusu i ako ima pozitivan nalaz protutijela na dvolančanu DNK, ne smije nastaviti liječenje lijekom Remicade (vidjeti dio 4.8).
English: At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Croatian: U 102. tjednu infliksimab je i dalje primalo 80 ispitanika, od kojih je 71 (89%) imalo klinički odgovor ASAS 20.
English: A population-based retrospective cohort study using data from Swedish national health registries found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age.
Croatian: Populacijsko retrospektivno kohortno ispitivanje, koje je koristilo podatke iz Švedskih nacionalnih zdravstvenih registara, pokazalo je povećanu incidenciju raka cerviksa u žena s reumatoidnim artritisom liječenih infliksimabom u usporedbi s bolesnicama koje nisu bile liječene biološkim lijekovima ili općom populacijom, uključujući i one starije od 60 godina.
English: Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
Croatian: Znakovi uključuju bol u zglobovima ili osip na obrazima ili rukama osjetljiv na sunce.
English: • Some patients who have received TNF-blockers, including Remicade have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Croatian: • U nekih bolesnika koji su liječeni TNF-blokatorima uključujući Remicade razvio se rijedak oblik raka zvan hepatosplenički limfom T-stanica.
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Croatian: Potreban je oprez kada se razmatra liječenje TNF-blokatorom u bolesnika koji su bolovali od zloćudne bolesti odnosno kada se razmatra nastavak liječenja bolesnika u kojih se razvila zloćudna bolest.
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal antiinflammatory drugs (NSAIDs) was permitted.
Croatian: U oba je ispitivanja bila dopuštena istodobna primjena ustaljenih doza folatne kiseline, peroralnih kortikosteroida (≤ 10 mg na dan) i/ili nesteroidnih protuupalnih lijekova.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT infliximab
Croatian: Tablica 3 Učinci na ACR20, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu, ATTRACT
English: Most aminotransferase abnormalities were transient; however, a small number of patients experienced more prolonged elevations.
Croatian: Poremećaji vrijednosti aminotransferaza većinom su bili prolaznog karaktera, iako je u manjeg broja bolesnika povišenje koncentracije tih enzima trajalo dulje.
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given
Croatian: • Obavijestite svog liječnika ako imate neprirodne otvore na koži (fistule) prije nego počnete primati Remicade.
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Croatian: U istraživanju razvojne toksičnosti provedenom na miševima pomoću analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα, nije bilo znakova toksičnosti za majku, embriotoksičnosti ni teratogenosti (vidjeti dio 5.3).
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
Croatian: U drugom ispitivanju (IMPACT 2), djelotvornost i sigurnost primjene infliksimaba ispitivane su u 200 bolesnika s aktivnim psorijatičnim artritisom (≥ 5 otečenih zglobova i ≥ 5 bolnih zglobova).
English: p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Croatian: p = 0,030 za skupinu koja je primala dozu od 3 mg/kg i p < 0,001 za skupinu koja je primala dozu od 6 mg/kg u usporedbi s placebo + MTX.
English: At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Croatian: U 102. tjednu infliksimab je i dalje primalo 49 ispitanika, od kojih je 30 (61%) imalo klinički odgovor BASDAI 50.
English: Remicade treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Croatian: Liječenje lijekom Remicade uvodi se i provodi pod nadzorom liječnika specijaliste s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa, upalnih bolesti crijeva, ankilozantnog spondilitisa, psorijatičnog artritisa ili psorijaze.
English: Abnormal skin openings
Croatian: Neprirodni otvori na koži
English: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p = 0.017).
Croatian: Zabilježeno je značajno manje kolektomija tijekom 3 mjeseca od infuzije ispitivanog lijeka u bolesnika koji su primili jednu dozu infliksimaba od 5 mg/kg u odnosu na bolesnike koji su primili placebo (29,2% naspram 66,7%, p = 0,017).
English: What Remicade contains
Croatian: Što Remicade sadrži
English: If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see section 4.3).
Croatian: Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Remicade (vidjeti dio 4.3).
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use before your baby is given any vaccine.
Croatian: • Važno je obavijestiti pedijatra Vašeg djeteta i druge zdravstvene radnike o Vašem primanju lijeka Remicade prije nego što Vaše dijete primi bilo koje cjepivo.
English: Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Croatian: Potreban je oprez kad se razmatra mogućnost primjene lijeka Remicade u bolesnika s kroničnim ili rekurirajućim infekcijama, uključujući one koji istodobno primaju imunosupresive.
English: Symptoms included, but were not limited to, dyspnea, urticaria, facial oedema, and hypotension.
Croatian: Simptomi su uključivali, ali nisu bili ograničeni na dispneju, urtikariju, edem lica i hipotenziju.
English: What Remicade looks like and contents of the pack Remicade is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Croatian: Remicade je dostupan u staklenoj bočici koja sadrži prašak za koncentrat za otopinu za infuziju.
English: Administration of Remicade should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Croatian: Ako bolesnik razvije novu ozbiljnu infekciju ili sepsu, treba prekinuti liječenje lijekom Remicade i uvesti odgovarajuću antimikrobnu ili antimikotičku terapiju sve dok infekcija ne bude pod kontrolom.
English: All patients were on stable methotrexate doses (median 15 mg/wk) for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Croatian: Svi su bolesnici uzimali ustaljenu dozu metotreksata (medijan 15 mg na tjedan) tijekom 6 mjeseci prije uključenja u ispitivanje i trebali su nastaviti s uzimanjem istih doza tijekom čitavog ispitivanja.
English: Store at 2 °C - 8 °C.
Croatian: Čuvati na temperaturi od 2°C-8°C.
English: In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Croatian: U prvom kliničkom ispitivanju (IMPACT) ispitivane su djelotvornost i sigurnost primjene infliksimaba u 104 bolesnika s aktivnim poliartikularnim psorijatičnim artritisom.
English: However, before Remicade is given to you, it is mixed with a solution that contains sodium.
Croatian: Međutim, prije primjene lijek Remicade se pomiješa s otopinom koja sadrži natrij.
English: Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Croatian: U bolesnika liječenih infliksimabom bilo je vidljivo značajno poboljšanje u funkcionalnoj sposobnosti koja se procjenjivala HAQ-om.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including Remicade in the post-marketing setting.
Croatian: Zloćudne bolesti, neke sa smrtnim ishodom, prijavljene su u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Croatian: Oštećenje strukture zgloba (erozije i sužavanje zglobnog prostora) kako na šakama tako i na stopalima mjerilo se u odnosu na početne vrijednosti prema van der Heijdeovoj modifikaciji Sharpove bodovne skale (0-440).
English: • Your doctor will test you to see if you have TB.
Croatian: • Liječnik će provesti testove da utvrdi imate li tuberkulozu.
English: Administer the infusion solution over a period of not less than the infusion time recommended.
Croatian: Primijenite otopinu za infuziju tijekom razdoblja koje ne smije biti kraće od preporučenog.
English: ≥ 5 x ULN
Croatian: ≥ 5 x GGN
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]).
Croatian: U ovom je ispitivanju bilo više bolesnika u dobnoj skupini od 12 do 17 godina (45/60 [75,0%]) nego u dobnoj skupini od 6 do 11 godina (15/60 [25,0%]).
English: The overall incidence of infections in C0168T72 was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Croatian: Ukupna incidencija infekcija u ispitivanju C0168T72 bila je 13/22 (59%) u skupini koja je primala terapiju održavanja svakih 8 tjedana, a 14/23 (60,9%) u skupini koja je tu terapiju primala svakih 12 tjedana.
English: Following administration of 5 mg/kg Remicade every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Croatian: Nakon primjene lijeka Remicade u dozi od 5 mg/kg svakih 8 tjedana, predviđena izloženost infliksimabu u stanju dinamičke ravnoteže (područje pod krivuljom koncentracija-vrijeme u stanju dinamičke ravnoteže, AUCss) u pedijatrijskih bolesnika u dobi od 6 do 17 godina bila je približno 20% niža nego predviđena izloženost lijeku u stanju dinamičke ravnoteže u odraslih.
English: During Remicade treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised.
Croatian: Tijekom liječenja lijekom Remicade treba optimalno prilagoditi istodobnu terapiju drugim lijekovima, primjerice kortikosteroidima i imunosupresivima.
English: Available data do not support further infliximab treatment in children and adolescents not responding within the first 10 weeks of treatment (see section 5.1).
Croatian: Na temelju dostupnih podataka ne preporučuje se daljnje liječenje infliksimabom u djece i adolescenata koji nisu odgovorili na terapiju u prvih 10 tjedana (vidjeti dio 5.1).
English: Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Croatian: Remicade je indiciran za liječenje teškog, aktivnog ankilozantnog spondilitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju.
English: In Crohn's disease patients who received maintenance treatment, antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving immunosuppressants.
Croatian: Među bolesnicima s Crohnovom bolešću koji su primali terapiju održavanja ukupno je 3,3% bolesnika koji su primali imunosupresive i 13,3% bolesnika koji nisu primali imunosupresive razvilo protutijela na infliksimab.
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Croatian: Primarna mjera ishoda ispitivanja bila je klinička remisija bez primjene kortikosteroida u 26. tjednu, što je značilo da bolesnik u kliničkoj remisiji (CDAI < 150) najmanje 3 tjedna nije uzimao peroralne sustavne kortikosteroide (prednizon ili slično) ni budezonid u dozi od > 6 mg/dan.
English: At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
Croatian: Na posljednjem pregledu nakon 12 tjedana, 13 od 27 (48%) bolesnika liječenih infliksimabom i dalje je pokazivalo klinički odgovor na liječenje.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Remicade.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte s Vašim liječnikom ili ljekarnikom prije nego primite Remicade.
English: Infusion reactions following re-administration of Remicade A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Croatian: Reakcije na infuziju nakon ponovne primjene lijeka Remicade Provedeno je kliničko ispitivanje bolesnika s umjerenom do teškom psorijazom kako bi se ocijenile djelotvornost i sigurnost dugotrajne terapije održavanja u odnosu na ponovno davanje uvodnog režima liječenja lijekom Remicade (najviše četiri infuzije u 0., 2., 6. i 14. tjednu) nakon ponovnog izbijanja bolesti.
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Croatian: • oticanje jetre (hepatitis) ili žučne vrećice, oštećenje jetre
English: Tell your doctor straight away if you notice any of the following:
Croatian: Odmah obavijestite liječnika ako primijetite neki od sljedećih simptoma:
English: In the Phase IIIb trial in Crohn's disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Croatian: U kliničkom ispitivanju faze IIIb u Crohnovoj bolesti, pod nazivom SONIC, bolesnici u placebo skupini primali su AZA u dozi od 2,5 mg/kg/dan kao aktivnu kontrolu uz placebo infuzije infliksimaba.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2°C-8°C).
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Croatian: U istraživanju razvojne toksičnosti provedenom na miševima pomoću analognog protutijela koje selektivno inhibira funkcionalnu aktivnost mišjeg TNFα, nije bilo znakova toksičnosti za majku, embriotoksičnosti ni teratogenosti.
English: While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group.
Croatian: Iako je broj bolesnika u svakoj podskupini premalen da bi omogućio donošenje konačnih zaključaka o utjecaju dobi na sigurnost primjene, u mlađoj je dobnoj skupini bio veći udio bolesnika s ozbiljnim štetnim događajima zbog primjene lijeka kao i veći udio onih koji su prekinuli liječenje zbog tih događaja nego u starijoj skupini.
English: • Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
Croatian: • nedostatna opskrba tijela kisikom preko krvi, poremećaji cirkulacije kao što je suženje krvnih žila
English: Some of those had a fatal outcome.
Croatian: Neke od njih završile su smrtnim ishodom.
English: Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
Croatian: Mogu se razviti protutijela na infliksimab koja su povezana s povećanom učestalošću reakcija vezanih uz infuziju.
English: Remicade infliximab
Croatian: Remicade infliksimab
English: In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Croatian: U kontroliranim dijelovima kliničkih ispitivanja TNF-blokatora zabilježeno je više slučajeva zloćudnih bolesti, uključujući limfome, u bolesnika koji su primali TNF-blokator u odnosu na kontrolnu skupinu bolesnika.
English: The incidence of serious infections in Remicade-treated patients 65 years and older was greater than in those under 65 years of age.
Croatian: Incidencija ozbiljnih infekcija u bolesnika u dobi od 65 ili više godina koji su liječeni lijekom Remicade bila je veća nego u bolesnika mlađih od 65 godina.
English: Repeated administration of infliximab (5 mg/kg at 0, 2 and 6 weeks in fistulising Crohn's disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Croatian: Ponovna primjena infliksimaba (5 mg/kg u 0., 2. i 6. tjednu u fistulirajućem obliku Crohnove bolesti, 3 ili 10 mg/kg svakih 4 ili 8 tjedana u bolesnika s reumatoidnim artritisom) dovela je do blage akumulacije infliksimaba u serumu nakon druge doze.
English: Remicade was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Croatian: Kliničko ispitivanje lijeka Remicade provedeno je u 120 bolesnika (dobni raspon: 4-17 godina) s aktivnim juvenilnim reumatoidnim artritisom usprkos liječenju metotreksatom.
English: Limited experience from re-treatment with one single Remicade dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Croatian: Ograničeno iskustvo ponovne primjene lijeka u bolesnika s psorijazom davanjem jedne doze lijeka Remicade nakon 20 tjedana ukazuje na smanjenu djelotvornost i povećanu incidenciju blagih do umjereno jakih reakcija vezanih uz infuziju u odnosu na one tijekom prvobitne primjene uvodnog režima liječenja (vidjeti dio 5.1).
English: • Reactions at the injection site such as pain, swelling, redness or itching
Croatian: • reakcije na mjestu davanja injekcije kao što su bol, oteklina, crvenilo ili svrbež
English: Side effects may also occur after your treatment with Remicade has stopped.
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja lijekom Remicade.
English: Powder for concentrate for solution for infusion 1 vial 100 mg
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica sa 100 mg
English: Most side effects are mild to moderate.
Croatian: Većina nuspojava su blage do umjereno teške.
English: In both studies, physical function and quality of life as measured by the BASFI and the physical component score of the SF-36 were also improved significantly.
Croatian: U oba su se ispitivanja značajno poboljšale funkcionalna sposobnost i kvaliteta života mjerene pomoću upitnika BASFI, kao i rezultat na fizičkoj komponenti upitnika SF-36.
English: Also at week 4, 13/27 (48%) of infliximab-treated patients achieved a clinical remission (CDAI < 150) vs. 1/25 (4%) of placebo-treated patients.
Croatian: Također, u 4. je tjednu 13 od 27 (48%) bolesnika liječenih infliksimabom postiglo kliničku remisiju bolesti (CDAI < 150), naspram jednog od 25 (4%) bolesnika koji su primili placebo.
English: The combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept, is not recommended (see section 4.4).
Croatian: Ne preporučuje se primjena lijeka Remicade u kombinaciji s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i Remicade, uključujući anakinru i abatacept (vidjeti dio 4.4)
English: Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Croatian: U bolesnika koji su razvili protutijela na infliksimab vjerojatnost pojave reakcija vezanih uz infuziju bila je veća (približno 2 do 3 puta).
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, or modification of concomitant therapy.
Croatian: Bolesnici s povišenim ALT-om i AST-om u pravilu nisu imali simptoma, a odstupanja bi se smanjila ili vratila na normalne vrijednosti bilo s nastavkom ili prekidom davanja lijeka Remicade ili modifikacijom istodobno primijenjenih lijekova.
English: Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Croatian: Podaci za 98. tjedan ispitivanja IMPACT uključuju i bolesnike koji su prebačeni sa liječenja placebom i one koji su primali infliksimab i ušli u fazu otvorenog ispitivanja.