FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 vials of 10 mL
Croatian: 2 bočice od 10 ml
English: MabThera 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: MabThera 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
English: Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether MabThera was administered as monotherapy or in combination with methotrexate.
Croatian: B-stanica u perifernoj krvi počinje se povećavati od 24. tjedna, a dokaz repopulacije stanica u većine se bolesnika zamjećuje do 40. tjedna, pri monoterapiji lijekom MabThera i u kombinaciji s metotreksatom.
English: • feeling dizzy or anxious
Croatian: • osjećaj omaglice ili tjeskobe
English: Patients treated with MabThera must be given the patient alert card with each infusion.
Croatian: Bolesnici koji se liječe lijekom MabThera moraju kod svake infuzije dobiti karticu s upozorenjima za bolesnika.
English: The clinical relevance of ADA formation in MabThera-treated PV patients is unclear.
Croatian: Klinički značaj pojave antitijela na lijek u bolesnika s PV-om liječenih lijekom MabThera nije jasan.
English: In SAWYER (BO25341), severe administration-related reactions (Grade ≥3) were reported in four patients (5%) following MabThera subcutaneous administration.
Croatian: U ispitivanju SAWYER (BO25341), teške reakcije povezane s primjenom (≥ stupnja 3) prijavljene su u četiri bolesnika (5%) nakon primjene supkutane formulacije lijeka MabThera.
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Croatian: Stoga se u bolesnika s anamnezom srčanih poremećaja i onih koji su ranije imali nuspojave na srcu i plućima prije liječenja lijekom MabThera mora razmotriti rizik od razvoja kardiovaskularnih komplikacija kao posljedice reakcije na infuziju te ih se mora pažljivo nadzirati tijekom liječenja.
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.
Croatian: · ako ste ikada imali srčane tegobe (poput angine pektoris, osjećaja lupanja srca ili zatajenja srca) ili dišne tegobe.
English: Treatment with MabThera 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 lijekom MabThera 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
English: Medicines given before each MabThera administration Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Croatian: Prije nego primite lijek MabThera, primit ćete druge lijekove (premedikaciju) koji sprječavaju ili ublažavaju moguće nuspojave.
English: The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Croatian: Farmakokinetički profil lijeka MabThera kada se primjenjuje u 6 infuzija u dozi od 375 mg/m2 u kombinaciji sa 6 ciklusa CHOP kemoterapije sličan je profilu lijeka MabThera kada se primjenjuje samostalno.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or MabThera (375 mg/m2) once weekly for 4 weeks.
Croatian: Bolesnici su u omjeru 1:1 randomizirani da primaju ili peroralni ciklofosfamid (2 mg/kg na dan) svakodnevno tijekom 3-6 mjeseci ili lijek Mabthera (375 mg/m2) jedanput tjedno tijekom 4 tjedna.
English: The majority of these patients were also exposed to cytotoxic chemotherapy.
Croatian: Većina je tih bolesnika bila izložena i citotoksičnoj kemoterapiji.
English: No incompatibilities between MabThera subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed.
Croatian: Nisu zamijećene inkompatibilnosti između lijeka MabThera u formulaciji za supkutanu primjenu i polipropilenskih ili polikarbonatnih materijala za štrcaljke kao ni igala za izvlačenje i injiciranje od nehrđajućeg čelika i polietilenskih „Luer cone“ čepova.
English: The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
Croatian: Lokalne kožne reakcije zabilježene nakon primjene formulacije lijeka MabThera za supkutanu primjenu većinom su bile blage ili umjerene težine i povukle su se bez posebnoga liječenja.
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the MabThera arm experienced infections.
Croatian: U kliničkom ispitivanju primjene lijeka za terapiju održavanja infekcije su zabilježene u 30/57 (53%) bolesnika liječenih lijekom MabThera.
English: The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Croatian: Preporučena doza lijeka MabThera je 1000 mg primijenjeno intravenskom infuzijom, a potom drugih 1000 mg intravenskom infuzijom nakon dva tjedna.
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: • If you are having MabThera alone
Croatian: · ako se liječite samo lijekom MabThera
English: Repeated treatment courses with MabThera are possible.
Croatian: Ciklusi liječenja lijekom MabThera mogu se ponavljati.
English: Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of MabThera in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4
Croatian: Početni broj CD19-pozitivnih stanica i veličina mjerljivih tumorskih lezija pridonijeli su nekim varijabilnostima CL2 lijeka MabThera u podacima prikupljenima od 161 bolesnika koji su primali 375 mg/m2 lijeka intravenskom infuzijom jedanput tjedno tijekom 4
English: decreased IgG levels4
Croatian: snižene razine IgG-a4
English: MabThera should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Croatian: MabThera se treba primijeniti u obliku dvije i.v. infuzije od 500 mg u razmaku od dva tjedna, nakon čega se primjenjuje doza od 500 mg i.v. infuzijom svakih 6 mjeseci.
English: Table 5 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Croatian: Tablica 5 Indukcijska faza: pregled rezultata djelotvornosti CHOP-a i R-CHOP-a (medijan vremena promatranja je 31 mjesec) CHOP R-CHOP p-vrijednost Smanjenje rizika1)
English: What MabThera is
Croatian: Što je MabThera
English: These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Croatian: One uključuju bol, oticanje, nastanak modrica, krvarenje, crvenilo kože, svrbež i osip.
English: • Fever or cough all the time
Croatian: · stalnu vrućicu ili kašalj
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Croatian: Tablica 8 Indukcijska faza: pregled rezultata djelotvornosti CHOP-a i R-CHOP-a (medijan vremena promatranja je 31 mjesec) CHOP R-CHOP p-vrijednost Smanjenje rizika1)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg / 10 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 100 mg/10 ml
English: MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
Croatian: MabThera 1400 mg se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: • tremors (shakiness, often in the hands)
Croatian: • tremor (drhtanje, često šaka) • poteškoće sa spavanjem (nesanica)
English: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
Croatian: • oslabljen imunitet - posljedica niskih razina protutijela zvanih „imunoglobulini“ (IgG) u krvi; imunoglobulini pomažu u zaštiti od infekcije
English: The incidence of treatment-induced/enhanced anti-rHuPH20 antibodies, only measured in patients in the subcutaneous arm was 12%.
Croatian: Incidencija liječenjem izazvanog/pospješenog stvaranja antitijela na rHuPH20, koja se određivala samo u bolesnika liječenih supkutanom formulacijom, iznosila je 12%.
English: Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion, using MabThera intravenous formulation (see section 4.4).
Croatian: Prije početka primjene supkutanih injekcija lijeka MabThera, svi bolesnici uvijek moraju najprije intravenskom infuzijom primiti cijelu dozu lijeka MabThera u formulaciji za intravensku primjenu (vidjeti dio 4.4).
English: • After aseptic dilution in sodium chloride solution The prepared infusion solution of MabThera in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C plus an additional 24 hours at ≤ 30 °C.
Croatian: • Nakon aseptičkog razrjeđivanja u otopini natrijeva klorida Pripremljena infuzijska otopina lijeka MabThera u 0,9% tnoj otopini natrijeva klorida fizički je i kemijski stabilna 30 dana na temperaturi od 2°C do 8°C, a nakon toga još dodatna 24 sata na temperaturi ≤ 30°C.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following MabThera treatment, as appropriate according to local clinical practice guidelines.
Croatian: Pneumocystic jirovecii tijekom i nakon liječenja lijekom MabThera, prema potrebi i u skladu s lokalnim smjernicama za kliničku praksu.
English: Ctrough values at pre-dose cycle 8
Croatian: Ctrough prije doziranja u 8. ciklusu µg/ml
English: MabThera maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Croatian: Terapija održavanja lijekom MabThera značajno je produljila medijan PFS-a u bolesnika koji su odgovorili na uvodnu terapiju CHOP-om (medijan PFS-a 37,5 mjeseci naspram 11,6 mjeseci, p < 0,0001) kao i u onih koji su odgovorili na indukciju R-CHOP-om (medijan PFS-a 51,9 mjeseci naspram 22,1 mjesec, p = 0,0071).
English: The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Croatian: Minimal Clinically Important Difference, MCID) u HAQ-DI (definirano kao smanjenje pojedinačnog ukupnog rezultata za > 0,22) bio je veći nego udio takvih bolesnika koji su primali samo metotreksat (Tablica 14).
English: d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis Treatment with MabThera uses four separate infusions given at weekly intervals.
Croatian: d) Bolesnici koji se liječe od granulomatoze s poliangitisom ili mikroskopskog poliangitisa Liječenje lijekom MabThera obuhvaća četiri zasebne infuzije koje se daju u razmacima od tjedan dana.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with MabThera and observation.
Croatian: Tijekom terapije održavanja incidencija srčanih poremećaja stupnja 3/4 bila je slična u bolesnika liječenih lijekom MabThera i onih u opservacijskoj skupini.
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for MabTheratreated patients vs 5% for azathioprine treated patients.
Croatian: U kliničkom ispitivanju primjene lijeka za terapiju održavanja incidencija neutropenije bilo kojeg stupnja iznosila je 0% u bolesnika liječenih lijekom MabThera te 5% u bolesnika liječenih azatioprinom.
English: MabThera can be given alone or with other medicines called “chemotherapy”.
Croatian: MabThera se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Croatian: Nakon primjene lijeka MabThera 283 bolesnika s reumatoidnim artritisom nastavila su terapiju nekim biološkim DMARD-om.
English: Patients in the MabThera group who relapsed could receive an additional infusion of MabThera 1000 mg in combination with reintroduced or escalated prednisone dose.
Croatian: Bolesnicima u skupini liječenoj lijekom MabThera koji su doživjeli relaps mogla se primijeniti dodatna infuzija lijeka MabThera u dozi od 1000 mg te ponovno uvesti prednizon ili povećati njegovu dozu.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of MabThera and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Croatian: Istodobna/sekvencijska primjena drugih DMARD-a u liječenju reumatoidnog artritisa Istodobna primjena lijeka MabThera i antireumatskih lijekova koji nisu navedeni u poglavljima o indikaciji i doziranju za reumatoidni artritis se ne preporučuje.
English: All clearance and volume parameters increased with BSA.
Croatian: Svi parametri za klirens i volumen povećavali su se s površinom tijela.
English: Patients should be instructed to contact their treating physician immediately if symptoms that are suggestive of severe hypersensitivity or cytokine release syndrome occur at any time after medicinal product administration.
Croatian: Bolesnike treba uputiti da se odmah obrate liječniku koji ih liječi ako se u bilo kojem trenutku nakon primjene lijeka pojave simptomi koji ukazuju na tešku preosjetljivost ili sindrom otpuštanja citokina.
English: Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Croatian: Bolesnike s velikom zahvaćenošću tumorom ili visokim brojem (≥ 25 x 109/l) cirkulirajućih zloćudnih stanica, poput bolesnika s KLL-om, u kojih može postojati povećan rizik od osobito teškog sindroma otpuštanja citokina, treba liječiti uz izniman oprez.
English: Rituximab exposure increased dose proportional over the 375 mg/m2 to 800 mg/m2 subcutaneous dose range.
Croatian: Izloženost rituksimabu povećavala se proporcionalno dozi u rasponu supkutanih doza od 375 mg/m2 do 800 mg/m2.
English: Patient subpopulations - MabThera monotherapy
Croatian: Podskupine bolesnika - monoterapija lijekom MabThera
English: A two-stage phase III, international, multi-centre, randomised, controlled, open-label trial was conducted in patients with previously untreated follicular lymphoma, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with CHOP or CVP versus MabThera intravenous formulation in combination with CHOP or CVP.
Croatian: Međunarodno, multicentrično, randomizirano, kontrolirano, otvoreno ispitivanje faze III u dva dijela provedeno je u bolesnika s prethodno neliječenim folikularnim limfomom kako bi se ispitale neinferiornost farmakokinetičkog profila te sigurnost i djelotvornost lijeka MabThera u formulaciji za supkutanu primjenu u kombinaciji s CHOP-om ili CVP-om u odnosu na lijek MabThera u formulaciji za intravensku primjenu u kombinaciji s CHOP-om ili CVP-om.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Progression of Kaposi's sarcoma has been observed in MabThera-exposed patients with pre-existing Kaposi's sarcoma.
Croatian: Progresija Kaposijeva sarkoma primijećena je u bolesnika izloženih lijeku MabThera koji su imali Kaposijev sarkom prije početka liječenja.
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with MabThera compared to <1% on observation.
Croatian: Srčani događaji su prijavljeni kao ozbiljne nuspojave (uključujući fibrilaciju atrija, infarkt miokarda, zatajenje lijeve klijetke i ishemiju miokarda) u 3% bolesnika liječenih lijekom MabThera u usporedbi s < 1%
English: The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
Croatian: Nužno je strogo se pridržavati sljedećih smjernica povezanih s uporabom i odlaganjem štrcaljki i drugih oštrih medicinskih predmeta: · Igle i štrcaljke nikada se ne smiju ponovno upotrijebiti.
English: The overall safety profile of MabThera in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Croatian: Ukupan sigurnosni profil lijeka MabThera u liječenju ne-Hodgkinova limfoma i KLL-a temelji se na podacima o bolesnicima koji su sudjelovali u kliničkim ispitivanjima i praćenju nakon stavljanja lijeka u promet.
English: Each mL contains 120 mg of rituximab.
Croatian: Jedan ml sadrži 120 mg rituksimaba.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Croatian: Ukupna stopa odgovora nakon osmog ciklusa iznosila je 76,2% u skupini liječenoj R-CHOP-om, a 62,4% u skupini liječenoj CHOP-om (p = 0,0028).
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 2b).
Croatian: Korist u smislu PFS-a dosljedno se opažala u većini podskupina bolesnika analiziranih prema početnom riziku bolesti (Binet stadiji A-C) (Tablica 2b).
English: After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 7 minutes.
Croatian: Nakon toga ćete lijek MabThera primati injekcijom pod kožu (supkutana injekcija) tijekom otprilike 7 minuta.
English: You should also tell them about your
Croatian: Recite im i da se liječite lijekom
English: There was no impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety, efficacy or PK of MabThera.
Croatian: Prisutnost antitijela na rituksimab ili rHuPH20 nije imala utjecaja na sigurnost, djelotvornost ni farmakokinetiku lijeka MabThera.
English: Following two intravenous infusions of MabThera at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 l (range, 1.7 to 7.51 L).
Croatian: Nakon dvije intravenske infuzije lijeka MabThera u dozi od 1000 mg u razmaku od dva tjedna prosječan terminalni poluvijek bio je 20,8 dana (raspon 8,58 do 35,9 dana), prosječan sistemski klirens 0,23 l/dan (raspon 0,091 do 0,67 l/dan), a prosječan volumen raspodjele u stanju dinamičke ravnoteže 4,6 l (raspon od 1,7 do 7,51 l).
English: The clinical relevance of the development of anti-rituximab antibodies or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Croatian: Klinički značaj razvoja antitijela na rituksimab ili antitijela na rHuPH20 nakon liječenja formulacijom lijeka MabThera za supkutanu primjenu nije poznat.
English: MARKETING AUTHORISATION NUMBER(S) MabThera 100 mg concentrate for solution for infusion EU/1/98/067/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MabThera 100 mg koncentrat za otopinu za infuziju EU/1/98/067/001
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Croatian: Najčešće opažene nuspojave u bolesnika liječenih lijekom MabThera bile su reakcije povezane s infuzijom, koje su se u većine bolesnika pojavile pri prvoj infuziji.
English: Local cutaneous reactions, including injection site reactions were very common in patients receiving MabThera subcutaneous formulation.
Croatian: Lokalne kožne reakcije, uključujući reakcije na mjestu primjene injekcije, bile su vrlo česte u bolesnika koji su primali formulaciju lijeka MabThera za supkutanu primjenu.
English: A total of 23/99 (23%) MabThera-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Croatian: Ukupno je 23/99 (23%) bolesnika liječenih lijekom MabThera u ispitivanju primjene lijeka za poticanje remisije do 18. mjeseca bilo pozitivno na antitijela na lijek.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given MabThera.
Croatian: Ako se nešto od gore navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku,
English: Clinical experience of MabThera concentrate for solution for infusion in CLL
Croatian: Klinička iskustva s primjenom MabThera koncentrata za otopinu za infuziju u liječenju KLL-a
English: InSABRINA, severe administration-related reactions (grade≥3) were reported in two patients (2%) following administration of MabThera subcutaneous formulation.
Croatian: U ispitivanju SABRINA, teške reakcije povezane s primjenom (≥ stupnja 3) prijavljene su u dva bolesnika (2%) nakon primjene formulacije lijeka MabThera za supkutanu primjenu.
English: MabThera has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Croatian: MabThera je primijenjena u 21 bolesnika s autolognom transplantacijom koštane srži i drugim rizičnim skupinama bolesnika s pretpostavljenom smanjenom funkcijom koštane srži, a da nije došlo do mijelotoksičnosti.
English: The Patient Alert Card for MabThera in non-oncology indications should contain the following key elements:
Croatian: Kartica s upozorenjima za bolesnika za lijek MabThera u neonkološkim indikacijama mora sadržavati sljedeće ključne elemente:
English: The emergence of ADAwas not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Croatian: Pojava antitijela na lijek u većine bolesnika nije bila povezana s kliničkim pogoršanjem ni povećanim rizikom od reakcija na daljnje infuzije.
English: Fourteen patients (37%) in the MabThera 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 MabThera te 15 bolesnika (42%) u skupini liječenoj standardnom dozom prednizona.