FrancophonIA/ELRC3.0 huggingface dataset:
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: Rixathon 100 mg concentrate for solution for infusion EU/1/17/1185/001
Croatian: Rixathon 100 mg koncentrat za otopinu za infuziju EU/1/17/1185/001
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Croatian: Terapija održavanja rituksimabom donijela je dosljednu korist u svim unaprijed definiranim ispitanim podskupinama: s obzirom na spol (muški, ženski), dob (< 60 godina, ≥ 60 godina), FLIPI indeks (≤ 1, 2 ili ≥ 3) i početnu terapiju (R-CHOP, R-CVP ili R-FCM) te bez obzira na kvalitetu odgovora na početnu terapiju (CR/CRu ili PR).
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: % HAQ-DI MCID Mean change in FACIT-T
Croatian: % bolesnika s HAQ-DI MCID Srednja vrijednost promjene FACIT-T
English: CR2) PR2)
Croatian: PR2)
English: In patients where the treatment is working, Rixathon may be used as a maintenance treatment for 2 years after completing the initial treatment.
Croatian: U bolesnika u kojih se liječenje pokaže djelotvornim, Rixathon se može primjenjivati kao terapija održavanja tijekom 2 godine nakon završetka početnog liječenja.
English: You should also tell them about your Rixathon treatment.
Croatian: Recite im i da se liječite lijekom Rixathon.
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Croatian: Iako rituksimab primijenjen u monoterapiji nema mijelosupresivan učinak, potreban je oprez kada se razmatra liječenje bolesnika s brojem neutrofila < 1,5 × 109/l i/ili brojem trombocita < 75 × 109/l jer je kliničko iskustvo u liječenju takvih bolesnika ograničeno.
English: The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Croatian: Najčešće prijavljena ozbiljna infekcija u skupini liječenoj rituksimabom bila je blagi ili umjereni bronhitis.
English: A total of 1,078 patients responded to induction therapy, of which 1,018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Croatian: Na početno liječenje odgovorilo je ukupno 1078 bolesnika, od kojih je njih 1018 randomizirano u skupinu koja je primala terapiju održavanja rituksimabom (n = 505) ili u opservacijsku skupinu (n = 513).
English: • heart problems - such as reduced heart rate or chest pain (angina)
Croatian: • srčane tegobe - kao što su usporeno kucanje srca ili bol u prsnom košu (angina)
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 podudarao se s dobro poznatim sigurnosnim profilom rituksimaba kod RA i GPA/MPA te nije prijavljena nijedna nova nuspojava lijeka.
English: B lymphocytes are involved in the cause of some of the symptoms you have.
Croatian: B-limfociti sudjeluju u nastanku nekih simptoma koje možda imate.
English: Placebo+MTX Rituximab+MTX (2 x 1,000 mg)
Croatian: Placebo + MTX Rituksimab + MTX (2 × 1000 mg)
English: If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1,000 mg Rixathon administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Croatian: Ako bolesnici nisu razvili ozbiljnu reakciju na infuziju tijekom prve ili neke od sljedećih infuzija doze od 1000 mg lijeka Rixathon primijenjene prema standardnom rasporedu primjene, druga ili sljedeće infuzije mogu se dati većom brzinom, uz istu koncentraciju kao i u prethodnim infuzijama (4 mg/ml u volumenu od 250 ml).
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 rituksimaba odnosno 6 mjeseci nakon posljednje doze azatioprina).
English: The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Croatian: Stopa svih infekcija i ozbiljnih infekcija nije se povećala nakon pojave niskih vrijednosti IgA, IgG ili
English: In placebo-controlled periods of clinical trials, 0.94% (13/1,382) of rituximab treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Croatian: U placebom kontroliranim razdobljima kliničkih ispitivanja u 0,94 % (13/1382) bolesnika liječenih rituksimabom te 0,27 % (2/731) bolesnika koji su primali placebo razvila se teška neutropenija.
English: If you respond well to treatment, you may be given Rixathon as a maintenance treatment.
Croatian: Ako dobro reagirate na liječenje, možda ćete primati lijek Rixathon kao terapiju održavanja.
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 grudnog koša.
English: • Infections such as pneumonia (bacterial)
Croatian: • infekcije kao što je upala pluća (bakterijska)
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)
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)
English: Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Croatian: Recite liječniku ili medicinskoj sestri ako uzimate ili ste ranije uzimali lijekove koji mogu utjecati na imunološki sustav,
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Croatian: Udio bolesnika s razinom IgG-a ispod donje granice normalnih vrijednosti bio je oko 60 % u skupini koja je primala rituksimab tijekom cjelokupnog dvogodišnjeg razdoblja liječenja, dok se u opservacijskoj skupini smanjio (36 % nakon
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, multicenter 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: Rixathon in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Croatian: Rixathon je u kombinaciji s metotreksatom indiciran za liječenje odraslih bolesnika s teškim oblikom aktivnog reumatoidnog artritisa koji nisu dovoljno dobro odgovorili na druge antireumatske lijekove koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drugs, DMARDs), uključujući jedan ili više inhibitora faktora nekroze tumora (TNF), ili ih nisu podnosili.
English: Rixathon should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Croatian: Rixathon se treba primijeniti prvog dana svakog kemoterapijskog ciklusa, nakon intravenske primjene glukokortikoidne komponente kemoterapije, ako je liječenje obuhvaća.
English: The highest intravenous dose of rituximab tested in humans to date is 5,000 mg (2,250 mg/m²), tested in a dose escalation study in patients with chronic lymphocytic leukaemia.
Croatian: Najviša do sada ispitivana intravenska doza rituksimaba u ljudi iznosi 5000 mg (2250 mg/m2), a testirana je u sklopu ispitivanja postupnog povećanja doze u bolesnika s KLL-om.
English: NR: not reached; a: only applicable to patients achieving a CR
Croatian: ND ND: nije dostignuto; a: primjenjivo samo u bolesnika koji su postigli CR
English: Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (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: 50 mL vial - Pack of 1 or 2 vials.
Croatian: Bočica od 50 ml - pakiranje od 1 ili 2 bočice.
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) (Tablica 9).
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.
Croatian: Dostupni su samo ograničeni podaci o djelotvornosti i sigurnosti za bolesnike prethodno liječene monoklonskim antitijelima uključujući rituksimab, kao i za bolesnike refraktorne na prethodno liječenje rituksimabom u kombinaciji s kemoterapijom.
English: In the maintenance therapy clinical trial, no clinically meaningful differences between the two treatment arms or decreases in total immunoglobulin, IgG, IgM or IgA levels were observed throughout the trial.
Croatian: U kliničkom ispitivanju terapije održavanja ni u jednom trenutku nisu opažene klinički značajne razlike između dviju liječenih skupina kao ni sniženja vrijednosti ukupnog imunoglobulina, IgG, IgM ni IgA
English: B lymphocytes are involved in the cause of these conditions.
Croatian: B limfociti igraju ulogu u izazivanju tih bolesti.
English: 4.04 years
Croatian: 4,04 godine
English: None of the 99 rituximab-treated patients were ADA positive at screening.
Croatian: Niti jedan od 99 bolesnika liječenih rituksimabom nije bio pozitivan na antitijela na lijek pri probiru.
English: Figure 4: Number of patients who were off or on 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: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to Rixathon therapy.
Croatian: Liječnici trebaju provjeriti bolesnikov status cijepljenja i slijediti važeće smjernice o cijepljenju prije terapije lijekom Rixathon.
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Croatian: * Reakcije povezane s infuzijom uključivale su simptome prijavljene pri sljedećem planiranom posjetu nakon svake infuzije te nuspojave koje su se pojavile na dan primjene infuzije ili jedan dan nakon njezine primjene.
English: Ljubljana Verovškova 57
Croatian: Lek Pharmaceuticals d.d. Ljubljana Verovškova 57
English: Patients with active hepatitis B disease should not be treated with Rixathon.
Croatian: Bolesnici s aktivnim hepatitisom B ne smiju se liječiti lijekom Rixathon.
English: • if you are taking medicines for high blood pressure.
Croatian: Osobito je važno da kažete liječniku: • ako uzimate lijekove za liječenje visokog krvnog tlaka.
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
Croatian: U kliničkom ispitivanju terapije održavanja 7/57 (12 %) bolesnika u skupini liječenoj rituksimabom imalo je najmanje jednu reakciju povezanu s infuzijom.
English: • infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
Croatian: • infekcije kao što su infekcije u prsima, infekcije mokraćnih putova (bol pri mokrenju), prehlade i herpes
English: Patients with active hepatitis B disease should not be treated with rituximab.
Croatian: Bolesnici s aktivnim hepatitisom B ne smiju se liječiti rituksimabom.
English: The incidence of infusionrelated 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: Before giving a subsequent course of Rixathon treatment, patients should be re-evaluated for any potential risk for infections.
Croatian: Prije primjene sljedećeg ciklusa lijeka Rixathon treba ponovno procijeniti stanje bolesnika kako bi se utvrdio potencijalni rizik od infekcija.
English: • damage to the intestinal wall (perforation)
Croatian: • oštećenje stijenke crijeva (perforacija)
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“ ili „Rok valjanosti“.
English: Medicines given before each Rixathon administration
Croatian: Lijekovi koji se daju prije svake primjene lijeka Rixathon
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 x 109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1 x 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 × 109/l između 24. i 42. dana od posljednje doze) ili se pojavila kasnije (definirano kao broj neutrofila niži od 1 × 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: 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 leukopatije (PML) sa smrtnim ishodom nakon primjene rituksimaba u liječenju reumatoidnog artritisa i autoimunih bolesti uključujući sistemski lupus eritematodes (SLE) i vaskulitis.
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 rituksimabom (12 %) i 8 bolesnika u skupini liječenoj azatioprinom (14 %).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i vrlo rijetko (< 1/10 000).
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Rixathon.
Croatian: Ovisno o težini infuzijske reakcije i potrebnim intervencijama valja privremeno ili trajno prekinuti primjenu lijeka
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, DAS28-ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Croatian: Dugoročna djelotvornost višekratnih ciklusa terapije 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: Talk to your doctor, pharmacist or nurse before you are given Rixathon if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Rixathon:
English: This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections, all of which were more frequent in the first 6 months of treatment.
Croatian: Za to su uglavnom zaslužne reakcije povezane s infuzijom (najčešće tijekom prvog ciklusa liječenja), egzacerbacija reumatoidnog artritisa i infekcije, jer su se sve one javljale češće tijekom prvih 6 mjeseci liječenja.
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 infusionrelated by investigators in the safety population.
Croatian: Reakcije povezane s infuzijom U kliničkom ispitivanju poticanja remisije kod teškog aktivnog GPA i MPA reakcije povezane s infuzijom definirale 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: No dose reductions of Rixathon are recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka Rixathon.
English: In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
Croatian: U istraživanjima opće toksičnosti na makaki majmunima nisu primijećeni štetni učinci na reproduktivne organe mužjaka niti ženki.
English: Hazard ratio (95% CI)
Croatian: Broj bolesnika Omjer hazarda (95 % CI)
English: Rituximab was administered on the first day of the treatment cycle.
Croatian: Rituksimab je primijenjen prvog dana ciklusa liječenja.
English: +Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Croatian: +infarkt miokarda4 i 6, aritmija, +fibrilacija atrija, tahikardija,
English: Initiate at a rate of 250 mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Croatian: Infuzija se započinje brzinom od 250 mg/sat tijekom prvih 30 minuta, a nastavlja brzinom od 600 mg/sat tijekom sljedećih 90 minuta.
English: Trials 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 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: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Croatian: Incidencija nuspojava svih stupnjeva i nuspojava stupnja 3/4 bila je slična u starijih i mlađih bolesnika (< 65 godina).
English: Of the ninety nine patients treated with rituximab, 12 (12%) experienced at least one IRR.
Croatian: Od devedeset i devet bolesnika liječenih rituksimabom 12 (12 %) imalo je barem jednu reakciju povezanu s infuzijom.
English: Rituximab may make you feel dizzy and may affect your ability to drive or use any tools or machines.
Croatian: Rituksimab može uzrokovati osjećaj omaglice i utjecati na Vašu sposobnost upravljanja vozilima ili rada s alatima i strojevima.
English: Rixathon is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Croatian: Rixathon je bistra, bezbojna do blago žućkasta otopina, dostupna u obliku koncentrata za otopinu za infuziju.
English: All patients in the cyclophosphamide arm received azathioprine maintenance therapy in during follow-up.
Croatian: Svi bolesnici u skupini liječenoj ciklofosfamidom primali su terapiju održavanja azatioprinom tijekom razdoblja praćenja.
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Croatian: Nuspojave navedene u Tablici 5 predstavljaju štetne događaje čija je stopa među bolesnicima s PV-om liječenima rituksimabom iznosila ≥ 5 % i za koje je apsolutna razlika u incidenciji između skupine liječene rituksimabom i skupine liječene standardnom dozom prednizona iznosila ≥ 2 % do 24. mjeseca.
English: Rituximab + Prednisone N=38
Croatian: Rituksimab + prednizon N = 38
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 zahvaća jednu vrstu bijelih krvnih stanica zvanih B-limfociti.
English: You must also do this for 12 months after your last treatment with Rixathon.
Croatian: Morate to činiti i još 12 mjeseci nakon posljednje primjene lijeka Rixathon.
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 rituksimaba u odobrenim indikacijama za liječenje autoimunih bolesti, uključujući GPA/MPA.
English: Subsequent doses of Rixathon can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Croatian: Sljedeće doze lijeka Rixathon mogu se dati početnom brzinom infuzije od 100 mg/sat, a brzina se može povećavati za 100 mg/sat u razmacima od 30 minuta, do najviše 400 mg/sat.
English: Patients received 2 x 1,000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Croatian: Bolesnici su intravenskom infuzijom primili 2 × 1000 mg rituksimaba ili placebo u kombinaciji s metotreksatom.
English: 10 mL vial - Pack of 2 or 3 vials.
Croatian: Bočica od 10 ml - pakiranje od 2 ili 3 bočice.