FrancophonIA/ELRC3.0 huggingface dataset:
English: However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumour lesion size.
Croatian: Međutim, velika varijabilnost razine CL2 između pojedinih bolesnika utvrđena je i nakon izuzimanja CD19pozitivnih stanica i veličine tumorskih lezija.
English: Median EFS: 36 Not reached p < 0.0001
Croatian: Medijan EFS: 36 Nije dostignuto p < 0,0001
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Croatian: Klinička slika anafilaksije može nalikovati kliničkoj slici sindroma otpuštanja citokina (opisan prethodno).
English: Body system
Croatian: Organski sustav
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
Croatian: U 28. mjesecu teški je relaps (definiran kao ponovni nastup kliničkih i/ili laboratorijskih znakova aktivnosti vaskulitisa [BVAS > 0] koji bi mogao dovesti do zatajenja ili oštećenja organa odnosno ugroziti život) nastupio u 3 bolesnika (5%) u skupini liječenoj lijekom rituksimab i 17 bolesnika (29%) u skupini liječenoj azatioprinom (p = 0,0007).
English: The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported.
Croatian: Ukupan sigurnosni profil odgovarao je dobro poznatom sigurnosnom profilu lijeka rituksimab kod RA i GPA/MPA te nije prijavljena nijedna nova nuspojava lijeka.
English: B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials.
Croatian: Razine B-stanica u ljudske novorođenčadi nakon izloženosti majke lijeku rituksimaba nisu ispitivane u kliničkim ispitivanjima.
English: • The active ingredient in Ritemvia is called rituximab.
Croatian: • Djelatna tvar u lijeku Ritemvia zove se rituksimab.
English: During rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Croatian: Tijekom terapije održavanja rituksimabom u trajanju do najviše dvije godine leukopenija (5 % u odnosu na 2 %, stupanj 3/4) i neutropenija (10 % u odnosu na 4 %, stupanj 3/4) su prijavljene učestalije nego u opservacijskoj skupini.
English: For the 60 re-treatments on study, the
Croatian: U 60 ponovljenih liječenja u ispitivanju
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Croatian: Ukupna stopa odgovora nakon osmog ciklusa iznosila je 76,2 % u skupini liječenoj R-CHOP-om, a 62,4 % u skupini liječenoj CHOP-om (p = 0,0028).
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.
Croatian: Akutno zatajenje dišnog sustava mogu pratiti poremećaji kao što su infiltracija plućnog intersticija ili edem pluća, koji su vidljivi na radiografskoj snimci prsnog koša.
English: Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Croatian: Stoga treba pomno nadzirati bolesnike koji u anamnezi imaju bolest srca i/ili kardiotoksičnu kemoterapiju.
English: Serious cardiac reactions were reported at a rate of 1.3 per 100 patient years in the rituximab treated patients compared to 1.3 per 100 patient years in placebo treated patients.
Croatian: Ozbiljne srčane nuspojave prijavljene su po stopi od 1,3 na 100 bolesnik-godina u bolesnika liječenih rituksimabom u usporedbi s 1,3 na 100 bolesnik-godina u bolesnika koji su primali placebo.
English: The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicentre trial (Trial 1).
Croatian: Djelotvornost i sigurnost rituksimaba u ublažavanju simptoma i znakova reumatoidnog artritisa u bolesnika u kojih nije postignut zadovoljavajući odgovor na liječenje TNF-inhibitorima dokazane su u pivotalnom, randomiziranom, kontroliranom, dvostruko slijepom, multicentričnom kliničkom ispitivanju (Ispitivanje 1).
English: Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomisation.
Croatian: Doza prednizona postupno se smanjivala, a potom održavala na niskoj razini (približno 5 mg na dan) tijekom najmanje 18 mjeseci nakon randomizacije.
English: Median PFS: 28.8 Not reached p < 0.0001
Croatian: Medijan PFS: 28,8 Nije dostignuto p < 0,0001
English: Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4).
Croatian: Bolesnike treba pažljivo nadzirati zbog mogućnosti pojave sindroma otpuštanja citokina (vidjeti dio 4.4).
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Croatian: • ako imate teško zatajenje srca ili tešku nekontroliranu srčanu bolest i imate granulomatozu s poliangiitisom, mikroskopski poliangiitis ili obični pemfigus.
English: The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Croatian: Najčešće prijavljena ozbiljna infekcija u skupini liječenoj lijekom rituksimab bila je blagi ili umjereni bronhitis.
English: late neutropenia2
Croatian: odgođena neutropenija2
English: The majority of patients were ANCApositive at diagnosis or during the course of their disease; had histologically confirmed necrotizing small-vessel vasculitis with a clinical phenotype of GPA/MPA, or renal limited ANCA-associated vasculitis; or both.
Croatian: Većina je bolesnika bila ANCA-pozitivna pri dijagnozi ili tijekom bolesti te je imala histološki potvrđen nekrotizirajući vaskulitis malih krvnih žila i klinički fenotip GPA/MPA, ANCA vaskulitis ograničen na bubrege ili oboje.
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Croatian: Treba određivati neutrofile u krvi prije svakog ciklusa lijeka rituksimaba, redovito tijekom najdulje 6 mjeseci nakon prestanka liječenja te po pojavi znakova ili simptoma infekcije (vidjeti dio 4.8).
English: 2) Last tumour response as assessed by the investigator.
Croatian: 1) Procjene su izračunate prema omjerima hazarda 2) Zadnji tumorski odgovor koji je procijenio ispitivač.
English: Subsequent infusions
Croatian: Daljnje infuzije
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Croatian: Antitijelo se proizvodi na kulturi stanične suspenzije sisavaca (jajnika kineskog hrčka) te se pročišćava afinitetnom kromatografijom i izmjenom iona, uključujući specifične postupke inaktivacije i uklanjanja virusa.
English: • low numbers of platelets in the blood
Croatian: • nizak broj krvnih pločica
English: Corticosteroids will usually be given by injection before the start of Ritemvia treatment.
Croatian: Obično će se prije početka liječenja lijekom Ritemvia primijeniti injekcija kortikosteroida.
English: Patients received 2 x 1000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Croatian: Bolesnici su intravenskom infuzijom primili 2 x 1000 mg rituksimaba ili placebo u kombinaciji s metotreksatom.
English: Reactivation of hepatitis B infection has also been very rarely reported in rheumatoid arthritis patients receiving rituximab (see section 4.4).
Croatian: Reaktivacija infekcije hepatitisom B prijavljena je vrlo rijetko u bolesnika s reumatoidnim artritisom koji primaju rituksimab (vidjeti dio 4.4).
English: Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Croatian: Liječenje rituksimabom u kombinaciji s metotreksatom u više ciklusa dovelo je do trajnih poboljšanja kliničkih znakova i simptoma reumatoidnog artritisa, što je vidljivo prema ACR, DAS28-ESR i EULAR odgovorima u svim populacijama bolesnika koje su obuhvaćene ispitivanjem (Slika 2).
English: After adjusting for BSA, male subjects had a larger volume of distribution and a faster clearance than female subjects.
Croatian: Nakon prilagodbe s obzirom na tjelesnu površinu muški su ispitanici imali veći volumen raspodjele i brži klirens nego ispitanice.
English: Results from other supportive studies using rituximab in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Croatian: Rezultati iz ostalih ispitivanja u kojima se primjenjivao rituksimab u kombinaciji s drugim kemoterapijskim protokolima (uključujući CHOP, FCM, PC, PCM, bendamustin i kladribin) u liječenju prethodno neliječenih bolesnika i/ili bolesnika s relapsirajućim/refraktornim KLL-om također su pokazali visoke stope ukupnog odgovora i korist liječenja u smislu PFS stopa, iako s nešto višom toksičnošću (posebno mijelotoksičnošću).
English: IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
Croatian: Reakcije povezane s infuzijom mogu se javiti kao posljedica preosjetljivosti i/ili mehanizma djelovanja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with autoimmune arthritis.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s autoimunim artritisom.
English: All of these arrhythmias either occurred in the context of a rituximab infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Croatian: Sve su se te aritmije pojavile vezano uz infuziju rituksimaba ili su bile povezane s predisponirajućim stanjima kao što su vrućica, infekcija, akutni infarkt miokarda ili postojeća bolest dišnog i kardiovaskularnog sustava.
English: Treatment with Ritemvia uses four separate infusions given at weekly intervals.
Croatian: Liječenje lijekom Ritemvia obuhvaća četiri zasebne infuzije koje se daju u razmacima od tjedan dana.
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose).
Croatian: Svi su bolesnici bili praćeni do 28. mjeseca (10 mjeseci nakon posljednje infuzije lijeka rituksimab odnosno 6 mjeseci nakon posljednje doze azatioprina).
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Croatian: overall response rate, ORR) u populaciji svih randomiziranih bolesnika (engl. intent-to-treat, ITT) iznosila je 48 % (95 % CI 41 % - 56 %), od čega 6 % otpada na potpun odgovor (engl. complete response, CR), a 42 % na djelomičan odgovor (engl. partial response, PR).
English: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Croatian: Rituksimab je kimerno mišje/ljudsko monoklonsko antitijelo proizvedeno genetičkim inženjerstvom, koje predstavlja glikozilirani imunoglobulin s konstantnim regijama ljudskog IgG1 i varijabilnim nizovima mišjih lakih i teških lanaca.
English: If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
Croatian: Postoji li dvojba, treba razmotriti provođenje daljnjih pretraga, uključujući MR oslikavanje, po mogućnosti s kontrastnim sredstvom, ispitivanje cerebrospinalnog likvora na DNK JC virusa i ponavljanje neuroloških pretraga.
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Croatian: Infekcije (pretežno bakterijske i virusne) nastupile su tijekom kliničkih ispitivanja u približno 30-55 % bolesnika s NHL-om te u 30-50 % bolesnika tijekom kliničkog ispitivanja bolesnika s KLL-om.
English: PK parameters for rituximab were comparable over the two treatment courses.
Croatian: Farmakokinetički parametri za rituksimab bili su slični tijekom dva ciklusa liječenja.
English: Three of the patients had received two courses of rituximab before enrolment and thus were given a third course in the study.
Croatian: Tri su bolesnika već primila dva ciklusa liječenja rituksimabom prije uključivanja u ispitivanje te su u ispitivanju bila podvrgnuta trećem ciklusu liječenja.
English: The overall safety profile was consistent with the well-established safety profile for rituximab in approved autoimmune indications, including GPA/MPA.
Croatian: Ukupan sigurnosni profil bio je u skladu s dobro poznatim sigurnosnim profilom lijeka rituksimab u odobrenim indikacijama za liječenje autoimunih bolesti, uključujući GPA/MPA.
English: None of the 99 rituximab-treated patients were ADA positive at screening.
Croatian: Nijedan od 99 bolesnika liječenih rituksimabom nije bio pozitivan na antitijela na lijek pri probiru.
English: All patients in the cyclophosphamide arm received azathioprine maintenance therapy during follow-up.
Croatian: Svi bolesnici u skupini liječenoj ciklofosfamidom primali su terapiju održavanja azatioprinom tijekom razdoblja praćenja.
English: If a patient develops PML, the dosing of rituximab must be permanently discontinued.
Croatian: Ako se u bolesnika razvije PML, primjena lijeka rituksimaba mora se trajno obustaviti.
English: For mixing the solution, gently invert the bag in order to avoid foaming.
Croatian: Lagano preokrenite vrećicu kako bi se izmiješao sadržaj i izbjeglo pjenjenje.
English: 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Croatian: 1 uključuje reaktivaciju i primarne infekcije; učestalost se temelji na R-FC režimu u relapsirajućem/refraktornom KLL-u
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Croatian: Analizom djelotvornosti obuhvaćeno je ukupno 810 bolesnika (403 R-FC, 407 FC) u ispitivanju prve linije liječenja (Tablica 10a i Tablica 10b) i 552 bolesnika (276 R-FC, 276 FC) u ispitivanju relapsirajuće/refraktorne bolesti (Tablica 11).
English: The most commonly reported events considered as ADRs were infusion-related reactions and infections.
Croatian: Najčešće prijavljeni događaji koji su se smatrali nuspojavama lijeka bile su reakcije povezane s infuzijom i infekcije.
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the long-term benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table
Croatian: Podaci prikupljeni tijekom produljenog praćenja bolesnika u ispitivanju (medijan praćenja 9 godina) potvrdili su dugoročnu korist terapije održavanja lijekom rituksimab s obzirom na PFS, EFS, TNLT i
English: Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Croatian: Neutropenija se može javiti i nekoliko mjeseci nakon primjene rituksimaba (vidjeti dio 4.4).
English: Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Croatian: Human Anti-Mouse Antibody, HAMA) ili antitijela na lijek (engl. anti-drug antibody, ADA) mogu nastupiti alergijske reakcije ili reakcije preosjetljivosti prilikom primjene drugih dijagnostičkih ili terapijskih monoklonskih antitijela.
English: Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, mišje proteine ili neku od ostalih pomoćnih tvari navedenih u dijelu 6.1.
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Croatian: Prijavljeni su vrlo rijetki slučajevi progresivne multifokalne leukoencefalopatije (PML) sa smrtnim ishodom nakon primjene rituksimaba u liječenju reumatoidnog artritisa i autoimunih bolesti uključujući sistemski lupus eritematodes (SLE) i vaskulitis.
English: Remission-induction therapy included IV prednisone, administered as per the investigator's discretion, preceded in some patients by methylprednisolone pulses, and pulse cyclophosphamide until remission was attained after 4 to 6 months.
Croatian: Terapija za poticanje remisije uključivala je i.v. prednizon, koji se primjenjivao prema odluci ispitivača i kojem je u nekih bolesnika prethodila pulsna terapija metilprednizolonom, te pulsnu terapiju ciklofosfamidom do postizanja remisije nakon 4 - 6 mjeseci.
English: The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of rituximab.
Croatian: Incidencija simptoma povezanih s infuzijom znatno se smanjuje u sljedećim infuzijama te nakon osam doza rituksimaba iznosi manje od 1 %.
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Croatian: U dugoročnom opservacijskom ispitivanju sigurnosti, 97 bolesnika s GPA-om/MPA-om primalo je lijek rituksimab (srednja vrijednost broja infuzija: 8 [raspon: 1 - 28]) tijekom razdoblja do 4 godine, sukladno standardnoj praksi i odluci njihovih liječnika.
English: In clinical trials with rituximab monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Croatian: U kliničkim ispitivanjima primjene rituksimaba u monoterapiji kroz 4 tjedna hematološki poremećaji su se pojavili u manjeg broja bolesnika i obično su bili blagi i reverzibilni.
English: Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Croatian: Infuzije rituksimaba primjenjivane su nakon intravenske infuzije 100 mg metilprednizolona; bolesnici su također peroralno primali prednizon u trajanju od 15 dana.
English: Rituximab + Prednisone N=38
Croatian: Rituksimab + prednizon N=38
English: If you are being treated for granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: Ako se liječite od granulomatoze s poliangitisom, mikroskopskog poliangitisa ili običnog pemfigusa, ove ćete informacije naći i u Kartici za bolesnika koju Vam je dao liječnik.
English: These studies support the use of rituximab with any chemotherapy.
Croatian: Ova ispitivanja podupiru primjenu rituksimaba s bilo kojom kemoterapijom.
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Croatian: Budući da ne cirkulira plazmom kao slobodni antigen, CD20 se ne natječe za vezanje antitijela.
English: The proportion of patients experiencing an infusion-related reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Croatian: Udio bolesnika koji su imali reakciju povezanu s infuzijom iznosio je 29% (11 bolesnika) kod prve infuzije, 40% (15 bolesnika) kod druge, 13% (5 bolesnika) kod treće i 10% (4 bolesnika) kod četvrte infuzije.
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Croatian: Liječnici trebaju provjeriti bolesnikov status cijepljenja i slijediti važeće smjernice o cijepljenju prije terapije lijekom rituksimaba.
English: • The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Croatian: • Bolesnicima treba objasniti rizik od infekcija i PML-a, uključujući simptome kojih moraju biti svjesni i napomenuti im da se odmah obrate svom liječniku ako primijete neki od njih.
English: Patients treated with Ritemvia must be given the patient alert card with each infusion.
Croatian: Bolesnici koji se liječe lijekom Ritemvia moraju kod svake infuzije dobiti karticu s upozorenjima za bolesnika.
English: You will always be given Ritemvia as a drip (intravenous infusion).
Croatian: Lijek Ritemvia ćete uvijek primiti ukapavanjem u venu (intravenskom infuzijom).
English: Rarely fatal cases reported 5 signs and symptoms of cranial neuropathy.
Croatian: 5 Znakovi i simptomi kranijalne neuropatije.
English: After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 8).
Croatian: Nakon medijana vremena promatranja od 31 mjeseca za bolesnike randomizirane u indukcijsku fazu, R-CHOP je u usporedbi s CHOP-om znatno poboljšao ishod bolesti u bolesnika s relapsirajućim/refraktornim folikularnim limfomom (vidjeti Tablicu 8).
English: Clinical laboratory finding
Croatian: Klinički laboratorijski nalazi
English: Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Croatian: Bolesnike s velikom zahvaćenošću tumorom ili visokim brojem (≥ 25 x 109/l) cirkulirajućih zloćudnih stanica, kao što su bolesnici s KLL-om, u kojih može postojati povećan rizik od osobito teškog sindroma otpuštanja citokina, smije se liječiti samo uz izniman oprez.
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Croatian: Analizom podskupina pokazalo se da je ORR bio veći u bolesnika s histološkim podtipovima IWF B, C i D u odnosu na podtip IWF A (58 % u odnosu na 12 %), veći u bolesnika u kojih je najdulji promjer najvećih lezija bio < 5 cm u odnosu na > 7 cm (53 % u odnosu na 38 %) i veći u bolesnika u relapsu koji su odgovorili na kemoterapiju u odnosu na kemorezistentne bolesnike (definirane trajanjem odgovora < 3 mjeseca) u relapsu (50 % u odnosu na 22 %).
English: Rituximab was administered on the first day of the treatment cycle.
Croatian: Rituksimaba je primijenjena prvog dana ciklusa liječenja.