FrancophonIA/ELRC3.0 huggingface dataset:
English: In a prospective, open label, international, multicentre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP
Croatian: U prospektivnom, otvorenom, međunarodnom, multicentričnom ispitivanju faze III 1193 bolesnika s prethodno neliječenim uznapredovalim folikularnim limfomom primalo je početnu terapiju R-CHOP
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving rituximab were IRRs which occurred in the majority of patients during the first infusion.
Croatian: Najčešće opažene nuspojave u bolesnika liječenih rituksimabom bile su reakcije povezane s infuzijom, koje su se u većine bolesnika pojavile pri prvoj infuziji.
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, e.g. hypogammaglobulinaemia (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu lijeka rituksimaba u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim bolestima koje ih mogu dodatno predisponirati za ozbiljne infekcije, primjerice hipogamaglobulinemijom (vidjeti dio 4.8).
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Croatian: To uključuje primjenu u reumatoidnom artritisu i neodobrenim indikacijama za liječenje autoimunih bolesti kao što su sistemski lupus eritematodes i vaskulitis.
English: The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Croatian: Sigurnosni profil lijeka rituksimab kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida u liječenju bolesnika s običnim pemfigusom ispitivao se u randomiziranom, kontroliranom, multicentričnom, otvorenom ispitivanju faze 3 među bolesnicima s pemfigusom, u kojem je 38 bolesnika s običnim pemfigusom (PV) bilo randomizirano u skupinu liječenu lijekom rituksimab.
English: Inhibition of the rate of progressive joint damage was also observed long term.
Croatian: Promatralo se i dugoročno usporavanje napredovanja oštećenja zglobova.
English: The pharmacokinetics of rituximab were assessed following two IV doses of 500 mg and 1000 mg upon re-treatment in the second course.
Croatian: Ispitana su farmakokinetička svojstva rituksimaba nakon dvije intravenske doze od 500 mg i 1000 mg primijenjene u ponovnom liječenju u drugom ciklusu.
English: Ritemvia monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Croatian: Monoterapija lijekom Ritemvia indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije.
English: For intravenous use after dilution
Croatian: Za primjenu u venu nakon razrjeđivanja
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections.
Croatian: Ograničeni podaci iz jednog ispitivanja u bolesnika s relapsirajućim/refraktornim KLLom ukazuju da liječenje rituksimabom može također pogoršati ishod primarne infekcije hepatitisom B. Sve bolesnike mora se prije početka liječenja lijekom rituksimaba testirati na virus hepatitisa B (HBV).
English: The Physician information about Ritemvia should contain the following key elements:
Croatian: Informacije za liječnike o lijeku Ritemvia moraju sadržavati sljedeće ključne elemente:
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Croatian: R-CVP se u odnosu na CVP pokazao bitno boljim u postizanju primarne mjere ishoda, vremena do prestanka učinka liječenja (27 mjeseci u odnosu na 6,6 mjeseci, p < 0,0001, log-rang test).
English: Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Croatian: Rituksimab je primijenjen intravenskom infuzijom u dozi od 375 mg/m2 u prvom ciklusu, koja je povećana na 500 mg/m2 u svakom od narednih pet ciklusa, u kombinaciji s fludarabinom i ciklofosfamidom u bolesnika s KLL-om.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.
Croatian: Tijekom kliničkih ispitivanja prijavljene su infekcije donjih dišnih puteva (uključujući upalu pluća), a incidencija im je bila slična u skupinama koje su primale rituksimab i u kontrolnim skupinama.
English: This medicine contains 52.6 mg sodium (main component of cooking/table salt) in each 10 mL vial.
Croatian: Ovaj lijek sadrži 52,6 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočicu od 10 mL.
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion.
Croatian: Budući da tijekom infuzije rituksimaba može doći do hipotenzije, treba razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije primjene infuzije lijeka rituksimaba.
English: • The need to check, prior to Ritemvia treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Croatian: imunosupresiju, prethodnu/trenutačnu primjenu lijekova koji djeluju na imunološki sustav te nedavna ili planirana cijepljenja.
English: Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Croatian: Seropozitivni bolesnici također su pokazali značajno veće smanjenje indeksa DAS28-ESR (engl.
English: The recommended dosage of Ritemvia for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Croatian: Preporučena doza lijeka Ritemvia za poticanje remisije granulomatoze s poliangitisom i mikroskopskog poliangitisa iznosi 375 mg/m2 tjelesne površine primijenjeno intravenskom infuzijom jedanput tjedno tijekom 4 tjedna (ukupno četiri infuzije).
English: Rituximab (n=57)
Croatian: Rituksimab (n=57)
English: 53-months p=0.029
Croatian: 53 mjesec a p = 0,029
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Croatian: Pogoršanja već postojećih srčanih poremećaja, npr. angine pektoris i kongestivnog zatajenja srca, ili teški srčani događaji (zatajenje srca, infarkt miokarda, fibrilacija atrija), plućni edem, višeorgansko zatajenje, sindrom lize tumora, sindrom otpuštanja citokina, zatajenje bubrega i zatajenje dišnog sustava prijavljeni su s manjom ili nepoznatom učestalošću.
English: This medicine contains 263.2 mg sodium (main component of cooking/table salt) in each 50 mL vial.
Croatian: Ovaj lijek sadrži 263,2 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočicu od 50 mL.
English: Cardiac disorders angina pectoris, atrial fibrillation, heart failure,
Croatian: Srčani poremećaji angina pektoris, fibrilacija atrija, zatajenje srca, infarkt undulacija atrija
English: Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
Croatian: Rjeđe se u nekih bolesnika mogu pojaviti bol na mjestu infuzije, plikovi, svrbež, mučnina, umor, glavobolja, otežano disanje, povišen krvni tlak, piskanje pri disanju, nelagoda u grlu, natečenost jezika ili grla, svrbež ili curenje nosa, povraćanje, crvenilo praćeno osjećajem vrućine ili osjećaj lupanja srca, srčani udar ili malen broj krvnih pločica (trombocita).
English: 14 patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Croatian: Infekcije povezane s liječenjem zabilježene su u 14 bolesnika (37%) u skupini liječenoj lijekom rituksumab te 15 bolesnika (42%) u skupini liječenoj standardnom dozom prednizona.
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Croatian: Ukupno je 197 bolesnika u dobi od 15 ili više godina s teškom aktivnom granulomatozom s poliangiitisom (75 %) i mikroskopskim poliangiitisom (24 %) sudjelovalo i liječeno u randomiziranom,
English: The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Croatian: Najčešće infekcije u skupini koja je primala lijek rituksimab bile su herpes simplex i herpes zoster, bronhitis, infekcije mokraćnih putova, gljivične infekcije i konjunktivitis.
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Croatian: Sigurnost cijepljenja živim virusnim cjepivima nakon terapije lijekom rituksimaba nije ispitivana.
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Croatian: Reakcije povezane s infuzijom u bolesnika s granulomatozom s poliangiitisom, mikroskopskim poliangiitisom i običnim pemfigusom odgovarale su onima opaženima u bolesnika s reumatoidnim artritisom u kliničkim ispitivanjima (vidjeti dio 4.8).
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Croatian: U bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom broj perifernih B stanica smanjio se na < 10 stanica/µl nakon dvije tjedne infuzije rituksimaba u dozi od 375 mg/m2 i održao na toj razini u većine bolesnika do trenutka mjere ishoda nakon 6 mjeseci.
English: What you need to know before you use Ritemvia Do not take Ritemvia if:
Croatian: Što morate znati prije nego počnete primati lijek Ritemvia
English: Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).
Croatian: Terapija održavanja rituksimabom dovela je do klinički relevantnih i statistički značajnih poboljšanja u primarnoj mjeri ishoda, što je bio PFS (vrijeme od randomizacije na terapiju održavanja do relapsa, progresije bolesti ili smrti), u usporedbi s opservacijskom skupinom (p < 0,0001, log-rang test).
English: The incidence, types and severity of IRRs were consistent with that observed historically.
Croatian: Incidencija, vrste i težina reakcija povezanih s infuzijom bile su u skladu s onima primijećenima u ranijim ispitivanjima.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Ritemvia infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Croatian: U bolesnika s granulomoatozom s poliangitisom (Wegenerovom granulomatozom), mikroshkopskim poliangitisom ili običnim pemfigusom kod kojih je bolest u remisiji treba primijeniti premedikaciju metilprednizolonom u dozi od 100 mg intravenski radi smanjenja incidencije i težine reakcija povezanih s infuzijom, a primjena mora završiti 30 minuta prije početka infuzije lijeka Ritemvia.
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Croatian: Poremećaji uha i labirinta tinitus, bol u ušima gubitak sluha5
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Croatian: alergijske reakcije koje su najvjerojatnije tijekom infuzije, ali se mogu javiti do 24 sata nakon infuzije dugotrajna depresija opadanje kose
English: % HAQ‐DI MCID Mean change in FACIT‐T
Croatian: % bolesnika s HAQ-DI MCID Srednja vrijednost promjene FACIT-T
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Croatian: Farmakokinetika rituksimaba ispitana je nakon dvije intravenske doze od 500 mg i 1000 mg, primijenjene 1. i 15. dana u četiri ispitivanja.
English: Although subgroups were small, rituximab maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Croatian: Iako su podskupine bile male, terapija održavanja rituksimabom donijela je značajnu korist u smislu ukupnog preživljenja kako bolesnicima koji su odgovorili na
English: Severe cytokine release syndrome is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.
Croatian: Teški oblik sindroma otpuštanja citokina očituje se teškom dispnejom, često popraćenom bronhospazmom i hipoksijom, uz vrućicu, zimicu, tresavicu, urtikariju i angioedem.
English: Progression-free survival (median)
Croatian: Progression Free Survival)
English: In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Croatian: U bolesnika liječenih rituksimabom primijećena je pojava simptoma već postojeće ishemijske bolesti srca, poput angine pektoris te fibrilacija i undulacija atrija.
English: Induction of remission
Croatian: Poticanje remisije
English: Overall survival (median)
Croatian: Overall Survival rates)
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1×109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1×109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Croatian: Ispitivanjima prethodno neliječenog i relapsirajućeg/refraktornog KLL-a utvrdilo se da je u do 25 % bolesnika koji su primali R-FC neutropenija bila produljena (definirano kao broj neutrofila koji je ostao niži od 1 x 109/l između 24. i 42. dana od posljednje doze) ili se pojavila kasnije (definirano kao broj neutrofila niži od 1 x 109/l nakon više od 42 dana od posljednje doze u bolesnika koji ranije nisu imali produljenu neutropeniju ili u onih koji su se oporavili prije 42. dana) nakon liječenja rituksimabom u kombinaciji s FC-om.
English: Mean change in HAQ‐DI
Croatian: Srednja vrijednost promjene HAQ-DI
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of rituximab in NHL and CLL (see section 4.8).
Croatian: Nakon stavljanja rituksimaba u promet prijavljeni su vrlo rijetki slučajevi progresivne multifokalne leukoencefalopatije (PML) u bolesnika s NHL-om i KLL-om (vidjeti dio 4.8).
English: Skin and subcutaneous tissue disorders alopecia toxic epidermal necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Croatian: Poremećaji kože i potkožnog tkiva alopecija toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
English: Immune system disorders infusion related reactions4, angioedema hypersensitivit y anaphylaxi s tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytope nia4
Croatian: Poremećaji imunološko g sustava reakcije povezane s infuzijom4, angioedem preosjetljivost anafilaksija sindrom lize tumora, sindrom otpuštanja citokina4, serumska bolest akutna reverzibilna trombocitopenij a povezana s infuzijom4
English: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland
Croatian: Block 7, City North Business Campus, Stamullen, Co.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Croatian: Udio bolesnika s tumorskim odgovorom (CR, CRu (nepotvrđen potpuni odgovor, od engl. complete response/unconfirmed) ili PR) bio je značajno veći (p < 0,0001, hi-kvadrat test) u skupini liječenoj RCVP-om (80,9 %) nego u skupini liječenoj CVP-om (57,2 %).
English: Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test).
Croatian: Liječenje R-CVP-om je u usporedbi s liječenjem CVP-om značajno produljilo vrijeme do progresije bolesti ili smrti na 33,6 mjeseci u odnosu na 14,7 mjeseci (p < 0,0001, log-rang test).
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Croatian: “Primarni” statistički test za “odgovor” bio je trend test: CR u odnosu na PR u odnosu na izostanak odgovora (p < 0,0001)
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 × 500 mg dose and ranged from 21 to 22 days for the 2 × 1000 mg dose.
Croatian: Srednje terminalno poluvrijeme eliminacije nakon druge infuzije i drugog ciklusa iznosilo je 19 dana za dozu od 2 x 500 mg te od 21 do 22 dana za dozu od 2 x 1000 mg.
English: Date of most recent infusion:
Croatian: Datum posljednje infuzije:_______________
English: The projected median time to progression (TTP) for responding patients was 13.0 months.
Croatian: U bolesnika koji su odgovorili na liječenje procijenjeni medijan vremena do progresije bolesti (engl. time to progression, TTP) iznosio je 13,0 mjeseci.
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Croatian: Nakon primjene rituksimaba u dozi od 375 mg/m2 u obliku intravenske infuzije, osam puta u u razmacima od tjedan dana u 37 bolesnika s NHL-om, srednja vrijednost Cmax povećavala se sa svakom sljedećom infuzijom, a vrijednosti su se kretale od prosječnih 243 µg/ml (raspon 16-582 µg/ml) nakon prve infuzije do 550 µg/ml (raspon 171-1177 µg/ml) nakon osme infuzije.
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Croatian: Na temelju populacijske farmakokinetičke analize u 298 bolesnika s NHL-om koji su primili jednu ili više infuzija rituksimaba, samog ili u kombinaciji s CHOP terapijom (primijenjene doze rituksimaba bile su u rasponu od 100 do 500 mg/m2), procjene za tipičnu populaciju bolesnika bile su: za nespecifični klirens (CL1) 0,14 l/dan, specifični klirens (CL2) kojemu su vjerojatno pridonijele
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Croatian: Preporučuje se prije početka liječenja lijekom rituksimaba odrediti razine imunoglobulina.
English: Infusion related reactions
Croatian: Reakcije povezane s infuzijom
English: In a randomised trial, patients with rheumatoid arthritis treated with rituximab and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after rituximab as compared to patients only receiving methotrexate.
Croatian: U randomiziranom ispitivanju bolesnici s reumatoidnim artritisom koji su liječeni rituksimabom i metotreksatom imali su, u usporedbi s bolesnicima koji su primali samo metotreksat, usporedive stope odgovora na antigen tetanusa (39 % u odnosu na 42 %), a umanjene stope odgovora na pneumokokno polisaharidno cjepivo (43 % u odnosu na 82 % za najmanje dva serotipa pneumokoknih antitijela) i KLH neoantigen (47 % u odnosu na 93 %), koji su primijenjeni 6 mjeseci nakon rituksimaba.
English: Most adverse events in the rituximab arm were mild or moderate in intensity.
Croatian: Većina štetnih događaja u skupini bolesnika liječenih lijekom rituksimab bila je blagog ili umjerenog intenziteta.
English: 1 mL contains 10 mg of rituximab.
Croatian: 1 ml sadrži 10 mg rituksimaba.
English: In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with rituximab treatment.
Croatian: Nadalje, tijekom liječenja rituksimabom prijavljene su druge ozbiljne virusne infekcije, bilo da se radi o novima, reaktivaciji ili egzacerbaciji postojećih infekcija, od kojih su neke imale smrtni ishod.
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Croatian: Dob, spol i procjena sposobnosti za svakodnevan život prema kriterijima Svjetske zdravstvene organizacije nisu utjecali na farmakokinetiku rituksimaba.
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Croatian: European League Against Rheumatism) odgovor postiglo znatno više bolesnika liječenih rituksimabom i metotreksatom nego onih koji su liječeni samo metotreksatom (Tablica 12).
English: These symptoms mainly comprised fever, chills and rigors.
Croatian: Simptomi su najčešće obuhvaćali vrućicu, zimicu i tresavicu.
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Ritemvia treatment.
Croatian: 1 mg/kg na dan (ne više od 80 mg na dan i što brže postupno smanjivati dozu, ovisno o kliničkoj potrebi).
English: The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Croatian: Sigurnosni profil lijeka rituksimab u bolesnika s PV-om odgovarao je onome opaženome u bolesnika s reumatoidnim artritisom i GPA-om/MPA-om.