FrancophonIA/ELRC3.0 huggingface dataset:
English: The prepared infusion solution of rituximab in 5% glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Croatian: Pripremljena infuzijska otopina rituksimaba u 5%-tnoj otopini glukoze fizikalno je i kemijski stabilna 24 sata na temperaturi od 2 °C do 8 °C, a nakon toga još 12 sati na sobnoj temperaturi (ne višoj od 30 °C).
English: The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Croatian: Ukupan sigurnosni profil rituksimaba u reumatoidnom artritisu temelji se na podacima o bolesnicima iz kliničkih ispitivanja i praćenju nakon stavljanja lijeka u promet.
English: In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of rituximab.
Croatian: U ispitivanju osmišljenom da ocijeni sigurnost primjene brže infuzije rituksimaba u bolesnika s reumatoidnim artritisom, bolesnici s umjerenim do teškim aktivnim reumatoidnim artritisom koji nisu imali ozbiljnu reakciju povezanu s infuzijom tijekom ili unutar 24 sata od prve ispitivane infuzije smjeli su primiti 2-satnu intravensku infuziju rituksimaba.
English: Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
Croatian: Obični pemfigus je autoimuna bolest koja uzrokuje stvaranje bolnih mjehura na koži i sluznici usta, nosa, grla i spolnih organa.
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije kod teškog aktivnog GPA i MPA reakcije povezane s infuzijom su definirane su se kao bilo koji štetni događaj koji je nastupio unutar 24 sata od infuzije i koji je ispitivač populacije u ispitivanju sigurnosti lijeka smatrao povezanim s infuzijom.
English: • memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
Croatian: • gubitak pamćenja, smetnje pri razmišljanju, poteškoće pri hodu ili gubitak vida - ove nuspojave mogu biti posljedica vrlo rijetke i ozbiljne infekcije mozga koja može završiti smrću
English: In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
Croatian: U ispitivanju relapsirajućeg/refraktornog KLL-a trombocitopenija stupnja 3/4 prijavljena je u 11 % bolesnika u skupini koja je primala R-FC u usporedbi s 9 % bolesnika u skupini koja je primala FC.
English: • The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections.
Croatian: • Drugi sastojci su: natrijev klorid, natrijev citrat dihidrat, polisorbat 80 i voda za injekcije.
English: In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije, u 24 % bolesnika koji su primali lijek rituksimab (jedan ciklus) i 23 % bolesnika u skupini liječenoj ciklofosfamidom razvila se neutropenija 3. ili višeg stupnja prema CTC kriterijima.
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Croatian: Najčešće prijavljena ozbiljna infekcija u skupini koja je primala rituksimab bila je upala pluća, s učestalošću od 4 %.
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Croatian: Farmakokinetički profil rituksimaba kada se primjenjuje u 6 infuzija u dozi od 375 mg/m2 u kombinaciji sa 6 ciklusa CHOP kemoterapije sličan je profilu rituksimaba kada se primjenjuje samostalno.
English: An analysis of overall survival confirmed the significant benefit of rituximab maintenance over observation (p=0.0039 log-rank test).
Croatian: Analiza ukupnog preživljenja potvrdila je značajnu korist terapije održavanja rituksimabom u odnosu na opservacijsku skupinu (p = 0,0039, log-rang test).
English: Seropositive (n=514)
Croatian: Seropozitivni (n = 514)
English: Seronegative (n=101)
Croatian: Seronegativni (n = 101)
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4).
Croatian: Broj bolesnika liječenih rituksimabom i niskom dozom prednizona koji nisu primali ili su primali minimalnu dozu prednizona (10 mg ili manje na dan) u odnosu na bolesnike koji su primali standardnu dozu prednizona tijekom 24-mjesečnog razdoblja liječenja pokazuje poštedni učinak lijeka rituksimab na primjenu steroida (Slika 4).
English: In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Croatian: U bolesnika s KLL-om čini se da istodobna primjena rituksimaba nije utjecala na farmakokinetiku fludarabina niti ciklofosfamida.
English: This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Croatian: Ne-Hodgkinov limfom je bolest limfnog tkiva (dijela imunološkog sustava) koja jednu vrstu bijelih krvnih stanica zahvaća B-limfocite.
English: Rituximab+MTX (2 x 1000 mg)
Croatian: Rituksimab+MTX (2 x 1000 mg)
English: CHOP, 205 R-CHOP,
Croatian: GLSG'00 CHOP: 205 R-CHOP: 223
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.
Croatian: Liječnik će pažljivo nadzirati bolesnike koji su imali infekciju virusom hepatitisa B kako bi uočio moguće znakove infekcije.
English: Among the 3189 patients treated with rituximab, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Croatian: Od 3189 bolesnika liječenih rituksimabom, njih je 1135 (36 %) imalo barem jednu reakciju povezanu s infuzijom, a 733/3189 (23 %) bolesnika imalo je reakciju povezanu s infuzijom nakon prve infuzije pri prvom izlaganju rituksimabu.
English: Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Croatian: Tablica 7 Pregled rezultata djelotvornosti terapije održavanja lijekom rituksimab u odnosu na opservacijsku skupinu u primarnoj analizi prema planu ispitivanja i nakon medijana od 9 godina praćenja (završna analiza)
English: 48-months p = 0.0096
Croatian: 48 mjeseci p = 0,0096
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 follicular lymphoma and chronic lymphocytic leukaemia.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s folikularnim limfomom i KLL-om.
English: Your doctor may prescribe Ritemvia for the treatment of:
Croatian: Vam može propisati lijek Ritemvia za liječenje sljedećih bolesti:
English: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UK
Croatian: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park
English: • bacterial or viral infections, bronchitis
Croatian: bakterijske ili virusne infekcije, upala bronha (bronhitis)
English: In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Croatian: U skupini liječenoj rituksimabom 48 % bolesnika postiglo je potpunu remisiju nakon 12 mjeseci, a 39 % bolesnika postiglo je potpunu remisiju nakon 18 mjeseci.
English: The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Croatian: Postotak bolesnika koji su prijavili nuspojave nakon ponovnog liječenja dodatnim ciklusima rituksimaba bio je sličan postotku bolesnika koji su prijavili nuspojave nakon početnog liječenja (nuspojave svih stupnjeva i nuspojave stupnja 3/4).
English: Some vaccines should not be given at the same time as Ritemvia or in the months after you receive Ritemvia.
Croatian: Neka se cjepiva ne smiju davati istodobno s lijekom Ritemvia ili nekoliko mjeseci nakon liječenja lijekom Ritemvia.
English: Figure 4: Number of patients who were off or minimal corticosteroid (≤ 10mg/day) therapy over time
Croatian: Slika 4: Broj bolesnika koji nisu primali kortikosteroide ili su primali minimalnu dozu kortikosteroida (≤ 10 mg na dan) tijekom vremena
English: Cyclophosphamide (n = 98)
Croatian: Ciklofosfamid (n = 98)
English: Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001
Croatian: Značajna razlika u odnosu na placebo + metotreksat u trenutku primarne mjere ishoda: ***p ≤ 0,0001
English: The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30 °C).
Croatian: Pripremljena infuzijska otopina rituksimaba u 0.9%-tnoj otopini natrijeva klorida fizikalno je i kemijski stabilna 30 dana na temperaturi od 2 °C do 8 °C, a nakon toga još 24 sati na sobnoj temperaturi (ne višoj od 30 °C).
English: In patients treated with cyclophosphamide (followed by azathioprine for maintenance of complete remission), 39% of patients achieved CR at 12 months, and 33% of patients achieved CR at 18 months.
Croatian: Od bolesnika liječenih ciklofosfamidom (te zatim azatioprinom radi održavanja potpune remisije) njih je 39 % postiglo potpunu remisiju nakon 12 mjeseci, a 33 % bolesnika postiglo je potpunu remisiju nakon 18 mjeseci.
English: Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Croatian: Infekcije i infestacije infekcija virusom herpesa herpes zoster oralni herpes konjunktivitis
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Croatian: U ispitivanju relapsirajućeg/refraktornog KLL-a medijan preživljenja bez progresije bolesti (primarna mjera ishoda) bio je 30,6 mjeseci u skupini R-FC i 20,6 mjeseci u skupini FC (p = 0,0002, log-rang test).
English: All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Croatian: Svi su bolesnici istodobno peroralno primali prednizon u dozi od 60 mg od 2. do 7. dana te u dozi od 30 mg od 8. do 14. dana nakon prve infuzije.
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Croatian: Prisutnost antitijela na lijek nije imala primjetnog negativnog utjecaja na sigurnost ili djelotvornost u kliničkom ispitivanju primjene lijeka za terapiju održavanja.
English: The PK parameters of rituximab in these patients appear similar to what has been observed in rheumatoid arthritis patients.
Croatian: Čini se da su farmakokinetički parametri rituksimaba u tih bolesnika slični onima opaženima u bolesnika s reumatoidnim artritisom.
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both.
Croatian: Bolesnici seropozitivni na reumatoidni faktor (RF) i/ili antitijela na cikličke citrulinirane peptide (antiCCP) koji su liječeni rituksimabom i metotreksatom na liječenje su odgovorili bolje nego bolesnici koji su bili negativni na oba antitijela.
English: Psychiatric disorders depression, anxiety
Croatian: Psihijatrijski poremećaji depresija, tjeskoba
English: How to store Ritemvia
Croatian: Kako čuvati lijek Ritemvia
English: Time to new CLL treatment
Croatian: Vrijeme do novog liječenja
English: The most common infusion-related reaction symptoms/Preferred Terms included headaches, chills, high blood pressure, nausea, asthenia and pain.
Croatian: Najčešći simptomi reakcija povezanih s infuzijom/preporučeni pojmovi uključivali su glavobolju, zimicu, visok krvni tlak, mučninu, asteniju i bol.
English: This can be fatal.
Croatian: PML može biti smrtonosan.
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
Croatian: Isto tako, nije uočeno da fludarabin i ciklofosfamid utječu na farmakokinetiku rituksimaba.
English: Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Croatian: Dodatne reakcije prijavljene u nekim slučajevima bile su infarkt miokarda, fibrilacija atrija, plućni edem i akutna reverzibilna trombocitopenija.
English: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Croatian: Preporučena početna brzina infuzije je 50 mg/sat; nakon prvih 30 minuta može se povećavati za
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Croatian: Rituksimaba se ne smije primijeniti bolesnicima s aktivnom teškom infekcijom (npr. tuberkulozom, sepsom i oportunističkim infekcijama, vidjeti dio 4.3) ili teško imunokompromitiranim bolesnicima (npr. kada su razine CD4 ili CD8 stanica vrlo niske).
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2).
Croatian: Najčešće nuspojave nakon primitka rituksimaba u kliničkim ispitivanjima bile su reakcije povezane s infuzijom (vidjeti Tablicu 2).
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Croatian: HBsAg ili HBcAb) trebaju prije početka liječenja konzultirati stručnjake za jetrene bolesti te ih treba nadzirati i liječiti sukladno lokalnim standardima s ciljem prevencije reaktivacije hepatitisa B.
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Croatian: Promjena DAS28-ESR indeksa od početne vrijednosti, prema početnom statusu autoantitijela
English: Kaplan-Meier estimated progression-free rates at 12 months were 78% in the rituximab maintenance group vs. 57% in the observation group.
Croatian: Prema Kaplan-Meierovoj procjeni, stope bez progresije bolesti nakon 12 mjeseci iznosile su 78 % u skupini koja je primala terapiju održavanja rituksimabom u usporedbi s 57 % u opservacijskoj skupini.
English: Table 1 ADRs reported in clinical trials or during post-marketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy
Croatian: Tablica 1 Nuspojave prijavljene u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka u promet u bolesnika s NHL-om i KLL-om koji su rituksimab primali kao monoterapiju/terapiju održavanja ili u kombinaciji s kemoterapijom
English: Observation (N = 167)
Croatian: Opservacijska skupina (N = 167)
English: cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Croatian: pokazala znakove povrata B stanica, uz vrijednosti od > 10 stanica/µl do 12. mjeseca, što se povećalo na 87 % bolesnika do 18. mjeseca.
English: Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients.
Croatian: Istodobna primjena s metrotreksatom nije imala utjecaja na farmakokinetiku rituksimaba u bolesnika s reumatoidnim artritisom.
English: Rituximab binding to CD20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Croatian: Također se pokazalo da vezanje rituksimaba na antigen CD20 na B-limfocitima može inducirati staničnu smrt putem apoptoze.
English: Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Croatian: Terapija održavanja lijekom Ritemvia indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma koji su odgovorili na uvodnu terapiju.
English: The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Croatian: Sigurnost imunizacije živim virusnim cjepivima nakon liječenja lijekom rituksimaba nije ispitivana u bolesnika s NHL-om i KLL-om pa se cijepljenje živim virusnim cjepivima ne preporučuje.
English: Progressive multifocal leukoencephalopathy (PML)
Croatian: (progresivna multifokalna leukoencefalopatija ili PML).
English: Safety and efficacy of Ritemvia have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Croatian: Sigurnost i djelotvornost lijeka Ritemvia u kombinaciji s drugim kemoterapijskim protokolima u liječenju difuznog ne-Hodgkinovog limfoma velikih B-stanica nisu ustanovljene.
English: Studies of rituximab in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
Croatian: U ispitivanjima primjene lijeka rituksimaba u bolesnika s ranim artritisom (bolesnika koji prethodno nisu liječeni metotreksatom i bolesnika koji nisu dovoljno dobro odgovorili na metotreksat, no još nisu liječeni inhibitorima TNF-alfa) postignute su primarne mjere ishoda.
English: If you get any of these, tell a doctor or nurse straight away.
Croatian: Ako primijetite bilo što od navedenog, odmah o tome obavijestite liječnika ili medicinsku sestru.
English: Prednisone tapering was to be completed by 6 months from the start of study treatment.
Croatian: Postupno smanjivanje doze prednizona moralo se dovršiti do isteka 6 mjeseci od prve primjene ispitivanog lijeka.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Of the 99 patients treated with rituximab, 12 (12%) experienced at least one IRR.
Croatian: Od 99 bolesnika liječenih lijekom rituksimabom, njih 12 (12%) imalo je barem jednu reakciju povezanu s infuzijom.
English: The clinical relevance of ADA formation in rituximab-treated PV patients is unclear.
Croatian: Klinički značaj pojave antitijela na lijek u bolesnika s PV-om liječenih lijekom rituksimab nije jasan.
English: Median TTF/PFS/ EFS mo
Croatian: Medijan TTF/PFS/EFS, mjeseci stope OS,
English: Non-Hodgkin's lymphoma (NHL)
Croatian: Ne-Hodgkinov limfom (NHL)
English: Infections were predominately mild to moderate.
Croatian: Infekcije su pretežno bile blage do umjerene težine.
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of rituximab-containing treatment.
Croatian: Incidencija pojave simptoma povezanih s infuzijom znatno se smanjila u narednim infuzijama te je do osmog ciklusa terapije koja je sadržavala rituksimab iznosila < 1 %.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Croatian: Tijekom terapije održavanja incidencija srčanih poremećaja stupnja 3/4 bila je slična u bolesnika liječenih rituksimabom i onih u opservacijskoj skupini.
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Croatian: U ispitivanju prve linije liječenja KLL-a, bolesnici u stadiju C bolesti prema Binetovoj klasifikaciji koji su primali R-FC imali su više nuspojava u usporedbi s onima koji su primali FC (R-FC 83 % u odnosu na FC 71 %).
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Croatian: ORR u bolesnika prethodno liječenih autolognom transplantacijom koštane srži iznosio je 78 % u odnosu na 43 % u bolesnika koji nisu bili podvrgnuti tom postupku.
English: Limited experience with doses higher than the approved dose of intravenous rituximab formulation is available from clinical trials in humans.
Croatian: Iz kliničkih ispitivanja u ljudi dostupno je ograničeno iskustvo s primjenom većih doza intravenske formulacije rituksimaba od odobrenih.
English: Neurologic disorders
Croatian: Neurološki poremećaji
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs. 0% FC.
Croatian: U bolesnika s relapsirajućim/refraktornim KLL-om incidencija hepatitis B infekcije stupnja 3/4 (reaktivacija i primarna infekcija) iznosila je 2 % kod primjene R-FC terapije u odnosu na 0 % kod primjene FC terapije.
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Croatian: Medijan odgovora iznosio je 37,7 mjeseci u skupini liječenoj R-CVP-om i 13,5 mjeseci u skupini liječenoj CVP-om (p < 0,0001, log-rang test).
English: Investigations decreased IgM levels4
Croatian: Pretrage snižene razine IgM-a4
English: Seronegative (n=106)
Croatian: Seronegativni (n = 106)
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg rituximab separated by a 14 day interval.
Croatian: U oboljelih od reumatoidnog artritisa uočena je trenutna deplecija B-stanica u perifernoj krvi nakon dvije infuzije od 1000 mg rituksimaba u razmaku od 14 dana.
English: EGIS Polska Sp. z o.o.
Croatian: EGIS SLOVAKIA spol. s r.o
English: The Patient Alert Card for Ritemvia in non-oncology indications should contain the following key elements:
Croatian: Kartica s upozorenjima za bolesnika za lijek Ritemvia u neonkološkim indikacijama mora sadržavati sljedeće ključne elemente:
English: Median TTF: years Not reached p < 0.001
Croatian: Medijan TTF: 2,6 godina Nije dostignuto p < 0,001
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the rituximab group (12%) and eight patients in the azathioprine group (14%).
Croatian: Blagi relapsi (koji nisu bili opasni po život niti su doveli do većeg oštećenja organa) zabilježeni su u 7 bolesnika u skupini liječenoj lijekom rituksimab (12%) i 8 bolesnika u skupini liječenoj azatioprinom (14%).