FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients randomised to the rituximab group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Croatian: Bolesnici randomizirani u skupinu liječenu lijekom rituksimab primili su početnu dozu od 1000 mg i.v. na 1. dan ispitivanja i drugu dozu od 1000 mg i.v. na 15. dan ispitivanja.
English: Therefore vaccination with live virus vaccines is not recommended whilst on rituximab or whilst peripherally B cell depleted.
Croatian: Stoga se ne preporučuje cijepljenje živim virusnim cjepivima za vrijeme primjene lijeka rituksimaba odnosno dok je prisutna deplecija B-stanica u perifernoj krvi.
English: The incidence of all grade infections was similar between the arms.
Croatian: Incidencija infekcija bilo kojeg stupnja težine bila je slična u obje liječene skupine.
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Croatian: Tablica 9 Faza održavanja: pregled rezultata djelotvornosti rituksimaba u odnosu na opservacijsku skupinu (medijan vremena promatranja je 28 mjeseci) Parametar djelotvornosti
English: The incidence of IRRs declined with subsequent infusions.
Croatian: nakon prve infuzije te se smanjivala s narednim infuzijama.
English: 42-months p = 0.029
Croatian: 42 mjesec a p = 0,029
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the rituximab infusion.
Croatian: S obzirom da tijekom primjene lijeka rituksimaba može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije davanja infuzije lijeka rituksimaba.
English: Significant benefit from maintenance treatment with rituximab was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Croatian: U primarnoj je analizi uočena i značajna korist od terapije održavanja rituksimabom u pogledu sekundarnih mjera ishoda: preživljenja bez pojave događaja (EFS), vremena do sljedećeg liječenja limfoma (engl. time to next anti-lymphoma treatment, TNLT), vremena do sljedeće kemoterapije (engl. time to next chemotherapy, TNCT) te stope ukupnog odgovora (ORR) (Tablica 7).
English: Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Croatian: Granulomatoza s poliangiitisom i mikroskopski poliangiitis Ritemvia je u kombinaciji s glukokortikoidima indicirana za liječenje odraslih bolesnika s teškom aktivnom granulomatozom s poliangitiisom (Wegenerova granulomatoza) (GPA) i mikroskopskim poliangiitisom (MPA).
English: Ritemvia is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Croatian: Ritemvia je dostupna u sterilnim, jednokratnim apirogenim bočicama, bez konzervansa.
English: In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the rituximab group.
Croatian: IgG-a potom povisio iznad donje granice normalnih vrijednosti, dok je u skupini koja je primala rituksimab ostao nepromijenjen.
English: In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR.
Croatian: Manje od 1 % (17/3189) bolesnika u kliničkim ispitivanjima imalo je ozbiljnu reakciju povezanu s infuzijom.
English: Ritemvia is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Croatian: Ritemvia je indicirana za liječenje bolesnika s umjerenim do teškim oblikom običnog pemfigusa (PV).
English: At this time, the infusion can be initially resumed at not more than one-half the previous rate.
Croatian: Tada se može nastaviti infuzija, ali brzinom koja iznosi najviše polovicu brzine prethodne infuzije.
English: In addition to adverse reactions seen in RA clinical trials for rituximab, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Croatian: Uz nuspojave rituksimaba zabilježene u kliničkim ispitivanjima reumatoidnog artritisa, nakon stavljanja lijeka u promet prijavljene su progresivna multifokalna leukoencefalopatija (PML) (vidjeti dio 4.4) i reakcija nalik serumskoj bolesti.
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Croatian: U ispitivanjima primjene rituksimaba u kombinaciji s kemoterapijom incidencija pojave srčanih aritmija stupnja 3 i 4, uglavnom supraventrikularnih aritmija kao što su tahikardija i undulacija/fibrilacija atrija, bila je veća u skupini liječenoj kombinacijom R-CHOP (14 bolesnika,
English: 7 includes fatal cases
Croatian: Uključuje slučajeve sa smrtnim ishodom
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcije povezane s infuzijom2
English: You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, o tome morate obavijestiti svog liječnika ili medicinsku sestru.
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Croatian: Najčešći simptomi bile su alergijske reakcije, kao što su glavobolja, svrbež, iritacija grla, navale crvenila, osip, urtikarija, hipertenzija i vrućica.
English: Nervous system disorders headache paraesthesia, migraine, dizziness, sciatica
Croatian: Poremećaji živčanog sustava glavobolja parestezija, migrena, omaglica, išijas
English: During the treatment course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Croatian: 3/4 (R-CHOP 88 % u odnosu na CHOP 79 %, R-FC 23 % u odnosu na FC 12 %), neutropenija (RCVP 24 % u odnosu na CVP 14 %; R-CHOP 97 % u odnosu na CHOP 88 %, R-FC 30 % u odnosu na FC 19 % u prethodno neliječenom KLL-u) i pancitopenija (R-FC 3 % u odnosu na FC 1 % u prethodno neliječenom KLL-u).
English: Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Croatian: Bolesnicima u skupini liječenoj lijekom rituksimab koji su doživjeli relaps mogla se primijeniti dodatna infuzija lijeka rituksimab u dozi od 1000 mg te ponovno uvesti prednizon ili povećati njegovu dozu.
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Croatian: Razlike u V1 s obzirom na razlike u tjelesnoj površini (od 1,53 do 2,32 m2) odnosno istodobnu CHOP terapiju bile su relativno male (27,1 % odnosno 19,0 %).
English: The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Croatian: Najčešće infekcije u skupini liječenoj lijekom rituksimab uključivale su infekcije gornjih dišnih putova, gastroenteritis, infekcije mokraćnih putova i herpes zoster.
English: albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Croatian: ekstranodalna sijela, zahvaćenost koštane srži) omjer rizika za preživljenje bez događaja (R-CHOP u odnosu na CHOP) bio je manji od 0,83, a za ukupno preživljenje manji od 0,95.
English: Similar effects have been observed in animal studies (see section 5.3).
Croatian: Slični su učinci primijećeni i u istraživanjima na životinjama
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Croatian: Pomoćne tvari: Ovaj lijek sadrži 2,3 mmol (52,6 mg) natrija po bočici od 10 ml.
English: Three patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Croatian: U 3 bolesnika (8%) iz skupine liječene lijekom rituksimabf zabilježeno je ukupno 5 ozbiljnih infekcija (pneumonija koju je uzrokovao Pneumocystis jirovecii, infektivna tromboza, infekcija intervertebralnog diska, plućna infekcija, stafilokokna sepsa), dok je u skupini liječenoj standardnom dozom prednizona ozbiljnu infekciju (pneumoniju koju je uzrokovao Pneumocystis jirovecii) imao jedan bolesnik (3%).
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a haematopoietic stem cell transplant.
Croatian: Većina je bolesnika primala rituksimab u kombinaciji s kemoterapijom ili u sklopu presađivanja hematopoetskih matičnih stanica.
English: Maintenance infusions of rituximab 500 mg were administered at months 12 and 18.
Croatian: Infuzije lijeka rituksimab u dozi od 500 mg za terapiju održavanja primijenjene su u 12. i 18. mjesecu.
English: Rituximab +MTX 2 × 1000 mg
Croatian: Rituksimab + metotreksat 2 x 1000 mg
English: Injury, Poisoning and Procedural Complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcije povezane s infuzijom*
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Croatian: Značajna razlika u odnosu na placebo u primarnoj vremenskoj točki: * p < 0,05, **p < 0,001, ***p ≤ 0,0001 MCID HAQ
English: 99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Croatian: U kliničkom je ispitivanju 99 bolesnika liječeno lijekom rituksimabom (375 mg/m2, jedanput tjedno tijekom 4 tjedna) i glukokortikoidima za poticanje remisije GPA i MPA (vidjeti dio 5.1).
English: Ritemvia is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Croatian: Ritemvia se u kombinaciji s kortikosteroidima primjenjuje za poticanje remisije granulomatoze s poliangiitisom (ranije se zvala Wegenerova granulomatoza) i mikroskopskog poliangiitisa.
English: • The need to provide patients with the Patient Alert Card with each infusion
Croatian: • Bolesnici moraju kod svake infuzije dobiti Karticu s upozorenjima za bolesnika.
English: Infusion-related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Croatian: Događaji su se smatrali nuspojavama lijeka tek nakon što je provedena temeljita ocjena i utvrđena barem razumna mogućnost uzročne povezanosti između lijeka i štetnog događaja.
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Croatian: U kliničkim ispitivanjima je nakon terapije rituksimabom ukupno 392/3095 (12,7 %) oboljelih od reumatoidnog artritisa bilo pozitivno na antitijela na lijek.
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or rituximab in combination with FC (R-FC).
Croatian: U dva otvorena randomizirana klinička ispitivanja ukupno je 817 prethodno neliječenih bolesnika i 552 bolesnika s relapsirajućim/refraktornim KLL-om randomizirano da primaju FC kemoterapiju (fludarabin 25 mg/m2, ciklofosfamid 250 mg/m2, prva tri dana) svaka 4 tjedna kroz 6 ciklusa, ili rituksimab kombinaciji s FC kemoterapijom (R-FC).
English: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Croatian: Staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 100 mg rituksimaba u
English: log-rank p value hazard ratio (95% CI) risk reduction Overall response rate* chi-squared test p value odds ratio (95% CI)
Croatian: log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika Stopa ukupnog odgovora* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI) Stopa potpunog odgovora (CR/CRu)* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI)
English: % SF‐36 PHS MCID
Croatian: Srednja vrijednost promjene SF-36 PHS % bolesnika sa SF-36 PHS MCID
English: Rituximab was administered as two IV infusions separated by an interval of 15 days.
Croatian: Rituksimab su primali u obliku dvije zasebne intravenske infuzije u razmaku od 15 dana.
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Croatian: medijan preživljenja bez događaja iznosio je 35 mjeseci za R-CHOP skupinu, odnosno 13 mjeseci za CHOP skupinu, što predstavlja smanjenje rizika za 41 %.
English: • Previously untreated follicular lymphoma
Croatian: • Prethodno neliječeni folikularni limfom
English: Cardiac disorders
Croatian: Kardiovaskularne nuspojave
English: Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Croatian: Vrsta i težina simptoma reakcija povezanih s infuzijom bile su slične kao i kod bolesnika s reumatoidnim artritisom i GPA-om/MPA-om.
English: A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Croatian: Ukupno je 23/99 (23 %) bolesnika liječenih rituksimabom u ispitivanju primjene lijeka za poticanje remisije do 18.
English: s r.o Tel: +421 2 3240 9422
Croatian: EGIS SLOVAKIA spol. s r.o Tel: +421 2 3240 9422
English: V1 varied by body surface area (BSA) and CHOP therapy.
Croatian: V1 se mijenjao ovisno o tjelesnoj površini i primjeni
English: Following reconstitution of the immune system in immunocompromised patients with PML,
Croatian: Opažena je stabilizacija ili poboljšanje ishoda nakon ponovne uspostave funkcije imunološkog sustava u imunokompromitiranih bolesnika s PML-om.
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Croatian: Bolesnici randomizirani u skupinu liječenu standardnom dozom prednizona primali su prednizon u početnoj peroralnoj dozi od 1 mg/kg na dan, koja se postupno smanjivala tijekom 12 mjeseci ako su imali umjerenu bolest, odnosno u početnoj peroralnoj dozi od 1,5 mg/kg na dan, koja se postupno smanjivala tijekom 18 mjeseci ako su imali tešku bolest.
English: lung infiltration
Croatian: infiltracija pluća
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Croatian: Liječenje R-CHOPom dovelo je do poboljšanja ishoda i za visokorizične i za niskorizične bolesnike prema dobno prilagođenom međunarodnom prognostičkom indeksu.
English: levels4
Croatian: a4
English: In the induction of remission clinical trial, at 6 months, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG and IgM levels, respectively, compared to 25%, 50% and 46% in the cyclophosphamide group.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije su nakon 6 mjeseci u skupini koja je primala lijek rituksimab vrijednosti IgA, IgG i IgM bile snižene u 27%, 58% odnosno 51% bolesnika koji su na početku ispitivanja imali normalne vrijednosti imunoglobulina, u usporedbi s 25%, 50% odnosno 46% bolesnika u skupini koja je primala ciklofosfamid.
English: This is because side effects can develop several months after you have had treatment.
Croatian: Naime, nuspojave se mogu pojaviti i mjesecima nakon liječenja.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Lijekovi koji se primjenjuju parenteralno moraju se prije primjene vizualno provjeriti na prisutnost čestica i promjenu boje.
English: The recommended dosage of Ritemvia for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Croatian: Preporučena doza lijeka Ritemvia za liječenje običnog pemfigusa iznosi 1000 mg primijenjeno intravenskom infuzijom, a potom se nakon dva tjedna primjenjuje druga doza od 1000 mg intravenskom infuzijom u kombinaciji s glukokortikoidima čija se doza postupno smanjuje.
English: Rituximab N=505
Croatian: N=505
English: The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Croatian: U 24. mjesecu ispitivanja kombinacija lijeka rituksimab i niske doze prednizona ostvarila je statistički značajne rezultate u odnosu na standardnu dozu prednizona s obzirom na postizanje potpune remisije bez primjene kortikosteroida tijekom ≥ 2 mjeseca u bolesnika s PV-om (vidjeti Tablicu 18).
English: Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections.
Croatian: Infekcije su pretežno bile blage do umjerene i uglavnom su obuhvaćale infekcije gornjih dišnih puteva, herpes zoster i infekcije mokraćnih puteva.
English: Event free survival Response rate (CR, nPR, or PR) CR rates
Croatian: Stopa odgovora (CR, nPR, ili PR) CR stope n.p. n.p.
English: 3 see also section haematologic adverse reactions below
Croatian: 3 Vidjeti i dio o hematološkim nuspojavama u nastavku.
English: A total of 6/34 (18%) of rituximab-treated patients from the maintenance therapy clinical trial developed ADA.
Croatian: U ukupno 6/34 (18%) bolesnika liječenih lijekom rituksimab u sklopu kliničkog ispitivanja primjene lijeka za terapiju održavanja razvila su se antitijela na lijek.
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the induction of the remission trial.
Croatian: Prisutnost antitijela na lijek nije imala primjetnog negativnog utjecaja na sigurnost ili djelotvornost u ispitivanju primjene lijeka za poticanje remisije.
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Svim bolesnicima s reumatoidnim artritisom, granulomatozom s poliangiitisom, mikroskopskim poliangiitisom ili običnim pemfigusom koji se liječe lijekom rituksimaba potrebno je uz svaku infuziju dati karticu s upozorenjima za bolesnika.
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Croatian: ORR je iznosio 57 % (95 % CI 41 % - 73 %; CR 14 %, PR 43 %), a procijenjeni medijan TTP-a u bolesnika koji su odgovorili na liječenje bio je 19,4 mjeseci (raspon od 5,3 do 38,9 mjeseci).
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ovaj lijek ako ste Vi ili
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Croatian: Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije terapija održavanja rituksimabom u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj.
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose.
Croatian: Nakon druge se infuzije prosječni Cmax kretao između 183 i 198 µg/ml pri dozi od 2 x 500 mg, odnosno između 355 i 404 µg/ml pri dozi od 2 x 1000 mg.
English: Read the leaflet for further information.
Croatian: Za više informacija pročitajte uputu o lijeku.
English: Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Croatian: Poremećaji probavnog sustava dispepsija, proljev, gastroezofagealni refluks, vrijed usta, bol u gornjem abdomenu
English: Rituximab, administered as an intravenous infusion at a dose of 375 mg/m2 at weekly intervals for 4 doses to 203 patients with NHL naive to rituximab, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Croatian: Srednja vrijednost Cmax nakon četvrte intravenske infuzije rituksimaba u dozi od 375 mg/m2, u razmacima od tjedan dana u 203 bolesnika s NHL-om koji prethodno nisu primali rituksimab, iznosila je 486 µg/ml (raspon od 77,5 do 996,6 µg/ml).
English: Thrombocytopenia
Croatian: Ciklofosfamid
English: Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.
Croatian: Ovisno o tome kako odgovorite na lijek, liječnik će Vam možda produljiti liječenje lijekom Ritemvia (do 5 godina).
English: The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Croatian: 3. stupnja prema CTC kriterijima i reakcija povezanih s infuzijom koje su dovele do prekida liječenja smanjivao se nakon svakog ciklusa i takvi su događaji bili su rijetki od 3. ciklusa nadalje.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
Croatian: log-rang test stratificiran prema centru): stope preživljenja nakon 53 mjeseca bile su 80,9 % za bolesnike u R-CVP skupini, u usporedbi sa 71,1 % za bolesnike u CVP skupini.
English: Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Croatian: Kontraindikacije za primjenu kod reumatoidnog artritisa, granulomatoze s poliangiitisom mikroskopskog poliangiitisa i običnog pemfigusa Preosjetljivost na djelatnu tvar, mišje proteine ili neku od ostalih pomoćnih tvari navedenih u dijelu 6.1.
English: Experience from rheumatoid arthritis
Croatian: Iskustva s primjenom u reumatoidnom artritisu