FrancophonIA/ELRC3.0 huggingface dataset:
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Croatian: Sljedeće su nuspojave prijavljene tijekom kliničkih ispitivanja, no njihova je incidencija bila slična ili manja u skupinama koje su primale rituksimab u odnosu na kontrolne skupine: hematotoksičnost, neutropenijska infekcija, infekcija mokraćnih puteva, poremećaj osjeta, vrućica.
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001).
Croatian: Završna analiza potvrdila je da je liječenje R-CHOPom povezano s klinički relevantnim i statističkim značajnim poboljšanjem trajanja preživljenja bez pojave događaja (primarni parametar djelotvornosti; događajem se smatrala smrt, relaps ili progresija limfoma odnosno početak novog liječenja limfoma) (p = 0,0001).
English: The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Croatian: Infekcije Ukupna stopa infekcija iznosila je približno 94 na 100 bolesnik-godina u bolesnika koji su primali rituksimab.
English: Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either rituximab and low-dose prednisone or standard-dose prednisone.
Croatian: Bolesnici su bili stratificirani prema težini bolesti na početku ispitivanja (umjerena ili teška) te su bili randomizirani u omjeru 1:1 za primanje lijeka rituksimab i niske doze prednizona ili standardne doze prednizona.
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with rituximab and patients closely monitored during administration.
Croatian: Stoga se u bolesnika s anamnezom srčanih poremećaja i onih koji su ranije imali nuspojave na srcu i plućima prije liječenja lijekom rituksimaba mora razmotriti rizik od razvoja kardiovaskularnih komplikacija kao posljedice reakcije na infuziju te ih se mora pažljivo nadzirati tijekom liječenja.
English: Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4 weekly doses.
Croatian: Početni broj CD19-pozitivnih stanica i veličina mjerljivih tumorskih lezija pridonijeli su nekim varijabilnostima CL2 rituksimaba u podacima prikupljenima od 161 bolesnika koji su primali 375 mg/m2 lijeka intravenskom infuzijom jedanput tjedno tijekom 4 tjedna.
English: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Croatian: Staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 500 mg rituksimaba u 50 ml.
English: The incidence of IRR decreased with subsequent courses (see section 4.8).
Croatian: Incidencija reakcija povezanih s infuzijom smanjivala se u daljnjim ciklusima (vidjeti dio 4.8).
English: No pharmacokinetic data are available in patients with hepatic or renal impairment.
Croatian: Nema farmakokinetičkih podataka o bolesnicima s oštećenjem jetre ili bubrega.
English: The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Croatian: Minimal Clinically Important Difference, MCID) u HAQ-DI (definirano kao smanjenje pojedinačnog ukupnog rezultata za > 0,22) bio je veći nego udio takvih bolesnika koji su primali samo metotreksat (Tablica 14).
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post-marketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab
Croatian: Tablica 2 Sažetak nuspojava prijavljenih u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet u bolesnika s reumatoidnim artritisom koji su primali rituksimab
English: CHVP-IFN, R-CHVPIFN, 175
Croatian: CHVP-IFN: R-CHVP-IFN:
English: Peripheral B cell counts declined below normal following completion of the first dose of rituximab.
Croatian: Broj perifernih B-stanica nakon primjene prve doze rituksimaba smanjio se ispod granice normale.
English: Patient subpopulations - rituximab monotherapy
Croatian: Podskupine bolesnika - monoterapija rituksimabom
English: The most frequent reported or observed serious adverse drug reactions were:  IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Croatian: Najčešće prijavljene ili opažene ozbiljne nuspojave bile su: • reakcije povezane s infuzijom (uključujući sindrom otpuštanja citokina i sindrom lize tumora),
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Croatian: Mogući mehanizmi stanične lize posredovane efektorom uključuju citotoksičnost ovisnu o komplementu, nastalu kao rezultat vezanja C1q, i staničnu citotoksičnost ovisnu o antitijelima, posredovanu jednim ili više Fcγ receptora na površini granulocita, makrofaga i NK-stanica.
English: The benefit of rituximab maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (Table 9).
Croatian: Korist od terapije održavanja rituksimabom potvrđena je u svim analiziranim podskupinama neovisno o uvodnom režimu liječenja (CHOP ili R-CHOP) i kvaliteti odgovora na uvodno liječenje (CR ili PR)
English: The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Croatian: Djelotvornost i sigurnost lijeka rituksimab u kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida (prednizona) ocjenjivale su se u novodijagnosticiranih bolesnika s umjerenim do teškim pemfigusom (74 bolesnika s običnim pemfigusom [PV] i 16 bolesnika koji su imali pemphigus foliaceus [PF]) u randomiziranom, otvorenom, kontroliranom, multicentričnom ispitivanju.
English: Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
Croatian: Liječnik Vam za liječenje Vaše bolesti može u bilo kojem trenutku propisati kortikosteroide koji se uzimaju kroz usta.
English: Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Croatian: Bolesnici su praćeni dulje od 24 tjedna radi utvrđivanja dugoročnih mjera ishoda, uključivo i radiološku procjenu u
English: Persistent depressive disorder Major depression Irritability
Croatian: Psihijatrijski poremećaji perzistentan depresivni poremećaj velika depresija razdražljivost
English: The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Croatian: Završna analiza djelotvornosti obuhvatila je sve randomizirane bolesnike (197 CHOP, 202 R-CHOP),
English: Ritemvia should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Croatian: Ritemvia se treba primijeniti u obliku dvije i.v. infuzije od 500 mg u razmaku od dva tjedna, nakon čega se primjenjuje doza od 500 mg i.v. infuzijom svakih 6 mjeseci.
English: • swelling of the stomach.
Croatian: • bol u trbuhu
English: Maintenance doses of 500 mg IV were administered at months 12 and 18.
Croatian: Doza održavanja od 500 mg i.v. primijenjena je u 12. i 18. mjesecu.
English: Rituximab was administered at a dosage of 375 mg/m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/m2 on day 1 of each subsequent treatment cycle.
Croatian: Rituksimab se primjenjivao u dozi od 375 mg/m2 u prvom ciklusu jedan dan prije kemoterapije i u dozi od 500 mg/m2 prvog dana svakog sljedećeg ciklusa.
English: Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Croatian: Odluke o postupnom smanjenju doze prednizona i prekidu njegove primjene nakon 18 mjeseci donosio je ispitivač.
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6month primary endpoint.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije, koje je obuhvatilo 99 bolesnika liječenih rituksimabom, ukupna stopa infekcija iznosila je približno 237 na 100 bolesnik-godina (95 % CI 197-285) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: Experience from pemphigus vulgaris
Croatian: Obični pemfigus (pemphigus vulgaris, PV)
English: Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Croatian: Ako je potrebno cijepljenje neživim cjepivom tijekom primjene lijeka rituksimaba, ono se mora dovršiti najmanje 4 tjedna prije početka sljedećeg ciklusa lijeka rituksimaba.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Croatian: Pneumocystic jirovecii tijekom i nakon liječenja lijekom Ritemvia, prema potrebi i u skladu s lokalnim smjernicama za kliničku praksu.
English: The emergence of ADA was not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Croatian: Pojava antitijela na lijek u većine bolesnika nije bila povezana s kliničkim pogoršanjem ni povećanim rizikom od reakcija na daljnje infuzije.
English: Clinical experience in rheumatoid arthritis
Croatian: Klinička iskustva u liječenju reumatoidnog artritisa
English: They will watch you closely while you are being given this medicine.
Croatian: Pažljivo će Vas nadzirati dok budete primali lijek kako bi uočili pojavu mogućih nuspojava.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
Croatian: 1 Kategorija učestalosti dodijeljena na temelju laboratorijskih vrijednosti prikupljenih tijekom rutinskih laboratorijskih kontrola u kliničkim ispitivanjima
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: natrijev klorid, natrijev citrat dihidrat, polisorbat 80, voda za injekcije.
English: Metabolism and nutritional disorders hypercholesterolemia
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemija
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu lijeka rituksimaba u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim stanjima koje ih mogu dodatno predisponirati za ozbiljne infekcije (vidjeti dio 4.8).
English: ACR70 EULAR Response (Good/Moderate)
Croatian: ACR20 ACR50 ACR70 EULAR odgovor (dobar/umjeren) Srednja vrijednost promjene rezultata aktivnosti bolesti (DAS)
English: Whether rituximab is excreted in human milk is not known.
Croatian: Nije poznato izlučuje li se rituksimab u majčino mlijeko u ljudi.
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Croatian: U nerandomiziranom ispitivanju, bolesnici u relapsu NHL-a niskog stupnja malignosti koji su primali monoterapiju rituksimabom su u usporedbi sa zdravim neliječenim kontrolnim ispitanicima imali nižu stopu odgovora na cijepljenje antigenom tetanusa (16 % u odnosu na 81 %) i Keyhole Limpet Haemocyanin (KLH) neoantigenom (4 % u odnosu na 76 % kada se mjerilo više nego dvostruko povećanje titra antitijela).
English: Patients treated with rituximab may receive non-live vaccinations.
Croatian: Bolesnici liječeni lijekom rituksimaba mogu primiti neživa cjepiva.
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients.
Croatian: U kliničkom ispitivanju primjene lijeka za terapiju održavanja incidencija neutropenije bilo kojeg stupnja iznosila je 0% u bolesnika liječenih lijekom rituksimab te 5% u bolesnika liječenih azatioprinom.
English: • Fever or cough all the time
Croatian: stalnu vrućicu ili kašalj
English: • Information on the Patient Alert Card
Croatian: Informacije o lijeku Informacije za liječnike Informacije za bolesnike Karticu s upozorenjima za bolesnika
English: Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest X-ray.
Croatian: Bolesnicima s ne-Hodgkinovim limfomom tada treba procijeniti stanje zbog mogućeg sindroma lize tumora, što uključuje odgovarajuće laboratorijske pretrage te radiološko snimanje prsnog koša radi otkrivanja moguće plućne infiltracije.
English: Bulky disease
Croatian: Zloćudne bolesti
English: Infections and infestations upper respiratory tract infection, urinary tract infections bronchitis, sinusitis, gastroenteritis, tinea pedis
Croatian: Infekcije i infestacije infekcija gornjih dišnih puteva, infekcije mokraćnih puteva bronhitis, sinusitis, gastroenteritis, tinea pedis
English: Patients received 2 × 1000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Croatian: Bolesnici su primali 2 x 1000 mg rituksimaba u razmacima od dva tjedna kao dodatak metotreksatu (10 do 25 mg na tjedan).
English: Mean change DAS28-ESR ‐1.97** Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Croatian: Razine značajnosti definirane su kao * p < 0,05, **p < 0,001, ***p < 0,0001
English: Excipients: This medicinal product contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Croatian: Pomoćne tvari: Ovaj lijek sadrži 11,5 mmol (ili 263,2 mg) natrija po bočici od 50 ml.
English: The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
Croatian: Preporučena doza je 375 mg/m2 tjelesne površine, a primjenjuje se prvog dana svakog ciklusa kemoterapije nakon intravenske infuzije glukokortikoidne komponente CHOP-a, tijekom 8 ciklusa.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2 mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Croatian: Bolesnici su u omjeru 1:1 randomizirani da primaju ili peroralni ciklofosfamid (2 mg/kg na dan) svakodnevno tijekom 3-6 mjeseci ili rituksimab (375 mg/m2) jedanput tjedno tijekom 4 tjedna.
English: • Relapsed/refractory follicular lymphoma
Croatian: • Relapsirajući/refraktorni folikularni limfom
English: Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the rituximab intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first rituximab intravenous infusion.
Croatian: Pri primjeni rituksimaba u formulaciji za intravensku primjenu nakon njezina stavljanja u promet prijavljene su teške reakcije na infuziju sa smrtnim ishodom, koje su nastupile 30 minuta do 2 sata nakon početka prve intravenske infuzije rituksimaba.
English: Seropositive (n=506)
Croatian: Seropozitivni (n = 506)
English: Psychiatric disorders depression, nervousness,
Croatian: Psihijatrijsk i poremećaji depresija, nervoza
English: Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Croatian: U osoba koje su primale rituksimab prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući fulminantni hepatitis sa smrtnim ishodom.
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to <1% on observation.
Croatian: Srčani događaji su prijavljeni kao ozbiljne nuspojave (uključujući fibrilaciju atrija, infarkt miokarda, zatajenje lijeve klijetke i ishemiju miokarda) u 3 % bolesnika liječenih rituksimabom u usporedbi s < 1 % bolesnika u opservacijskoj skupini.
English: The Patient information about Ritemvia should contain the following key elements:
Croatian: Informacije za bolesnike o lijeku Ritemvia moraju sadržavati sljedeće ključne elemente:
English: In a further clinical study, a total of 57 severe active GPA and MPA patients in disease remission were treated with rituximab for the maintenance of remission (see section 5.1)
Croatian: U dodatnom je kliničkom ispitivanju ukupno 57 bolesnika s teškim aktivnim GPA-om i MPA-om kod kojih je bolest bila u remisiji primalo lijek rituksimab za održavanje remisije (vidjeti dio 5.1).
English: You must also do this for 12 months after your last treatment with Ritemvia.
Croatian: Morate to činiti i još 12 mjeseci nakon posljednje primjene lijeka
English: There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
Croatian: Nakon sniženja razina IgG-a ili IgM-a nije se povećala stopa ukupnih infekcija niti ozbiljnih infekcija (vidjeti dio 4.4).
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Croatian: Nuspojave navedene u Tablici 3 su sve nuspojave koje su se javile s incidencijom od ≥ 5 % u skupini koja je primala rituksimab i s većom učestalošću nego u usporednoj skupini.
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the rituximab arm experienced infections.
Croatian: U kliničkom ispitivanju primjene lijeka za terapiju održavanja infekcije su zabilježene u 30/57 (53%) bolesnika liječenih lijekom rituksimab.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety dysgeusia peripheral neuropathy, facial nerve palsy5
Croatian: Poremećaji živčanog sustava parestezija, hipoestezija, agitacija, nesanica, vazodilatacija, omaglica, anksioznost disgeuzija periferna neuropatija, paraliza facijalnog živca5
English: • The importance of sharing this information with their partner or caregiver
Croatian: • Važno je da te informacije podijele sa svojim partnerom ili skrbnikom • Informaciju o Kartici s upozorenjima za bolesnika
English: Maintenance and relapse infusions were administered no sooner than 16 weeks following the previous infusion.
Croatian: Infuzije za terapiju održavanja ili liječenje relapsa primjenjivale su se najranije 16 tjedana nakon prethodne infuzije.
English: Infusion-related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
Croatian: U 77 % bolesnika liječenih rituksimabom primijećene su nuspojave vezane uz primjenu infuzije (uključujući sindrom otpuštanja citokina praćen hipotenzijom i bronhospazmom u 10 % bolesnika), vidjeti dio 4.8.
English: Hepatitis B Infections
Croatian: Infekcije virusom hepatitisa B
English: Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median observation time) Efficacy parameter
Croatian: Tablica 11 Liječenje relapsirajuće/refraktorne kronične limfocitne leukemije - pregled rezultata djelotvornosti za rituksimab + FC u odnosu na samo FC (medijan vremena promatranja je 25,3 mjeseca) Parametar djelotvornosti
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Croatian: U ispitivanju u prvoj liniji liječenja, nakon medijana promatranja od 48,1 mjeseca, medijan preživljenja bez progresije bolesti (PFS) iznosio je 55 mjeseci u R-FC skupini i 33 mjeseca u FC skupini (p < 0,0001, log-rang test).
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP
Croatian: Tablica 8 Indukcijska faza: pregled rezultata djelotvornosti CHOP-a i R-CHOP-a (medijan vremena promatranja je 31 mjesec) CHOP R-CHOP p-vrijednost Smanjenje rizika1)
English: In the majority of these cases, rituximab was administered with chemotherapy.
Croatian: U većini tih slučajeva rituksimab je primijenjen u kombinaciji s kemoterapijom.
English: In the clinical trial on induction of remission, the incidence of malignancy in rituximab-treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije incidencija zloćudnih bolesti u bolesnika liječenih rituksimabom u kliničkom ispitivanju u indikacijama granulomatoze s poliangiitisom i mikroskopskog poliangiitisa iznosila je 2,00 na 100 bolesnik-godina na dan završetka ispitivanja (kada je posljednji bolesnik dovršio razdoblje praćenja).
English: The two treatment groups were well balanced with regard to baseline characteristics and disease status.
Croatian: Dvije su terapijske skupine bile dobro uravnotežene u pogledu osnovnih karakteristika i stanja bolesti.
English: Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with preexisting Kaposi's sarcoma.
Croatian: Progresija Kaposijeva sarkoma primijećena je u bolesnika izloženih rituksimabu koji su imali Kaposijev sarkom prije početka liječenja.
English: s r.o Tel: +420 227 129 111
Croatian: EGIS Praha, spol. s r.o Tel: +420 227 129 111
English: Worst case imputation is applied for patients with missing data
Croatian: Za bolesnike za koje nedostaju podaci primjenjuje se pretpostavka najgoreg slučaja
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Croatian: U populaciji bolesnika s PV-om, 5 (13%) bolesnika liječenih lijekom rituksimab i 3 (8%) bolesnika liječena standardnom dozom prednizona imala su umjereni oblik bolesti, dok su 33 (87%) bolesnika liječena lijekom rituksimab i 33 (92%) bolesnika liječena standardnom dozom prednizona imala težak oblik bolesti prema Harmanovim kriterijima za ocjenu težine bolesti.