natgillin/translations-raw huggingface dataset:
All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion. 
Vsi bolniki so sočasno peroralno prejemali 60 mg prednizona od 2. do 7. dne in 30 mg od 8. do 14. dne po prvi infuziji.
Ritemvia is a biosimilar medicinal product. 
Zdravilo Ritemvia je podobno biološko zdravilo.
4.04 years 
4,04 let
4 see also section infusion-related reactions below. 
4 Glejte tudi poglavje reakcije, povezane z infuzijo, spodaj.
ACR70 EULAR Response (Good/Moderate) 
Odziv po EULAR (dober/zmeren)
The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3-15). 
Delež resnih srčnih dogodkov je bil 2,1 na 100 bolnik-let (95-% interval zaupanja, 3-15).
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab. 
Povprečni predterapevtski titri protiteles proti naboru antigenov (Streptococcus pneumoniae, influenca A, mumps, rdečke, norice) so se ohranili najmanj 6 mesecev po zdravljenju z rituksimabom.
In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following rituximab. 
Pri bolnikih z revmatodnim artritisom jih je 283 po zdravljenju z rituksimabom prejelo nadaljnje zdravljenje z biološkim DMARD.
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). 
Korist vzdrževalnega zdravljenja z rituksimabom so potrdili v vseh analiziranih podskupinah, ne glede na indukcijsko shemo (CHOP ali R-CHOP) ali vrsto odgovora na indukcijsko zdravljenje (CR ali PR) (preglednica 9).
In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed. 
V študijah splošne toksičnosti pri opicah Cynomolgus niso opažali škodljivih učinkov na reproduktivne organe samcev ali samic.
In the post-marketing setting five cases of rituximab overdose have been reported. 
Po prihodu zdravila na trg je bilo opisanih pet primerov prevelikega odmerjanja rituksimaba.
Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the rituximab intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first rituximab intravenous infusion. 
Hude, z infuzijo povezane reakcije s smrtnim izidom, so bile opisane med obdobjem trženja z intravensko obliko rituksimaba; pojavile so se od 30 minut do 2 uri po začetku prve intravenske infuzije rituksimaba.
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. 
Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi rituksimab pri RA in GPA/MPA; poročali niso o nobenih novih neželenih učinkih zdravila.
The primary outcome measure was achievement of complete remission at 6 months defined as a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 0, and off glucocorticoid therapy. 
Merilo primarnega opazovanega dogodka je bila dosežena popolna remisija po 6 mesecih, opredeljena kot ocena BVAS/WG (Birmingham Vasculitis Activity Score for Wegener's Granulomatosis) 0 in brez glukokortikoidnega zdravljenja.
In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg rituximab separated by a 14 day interval. 
Pri bolnikih z revmatoidnim artritisom so takojšen upad števila celic B v periferni krvi opazili po dveh infuzijah 1.000 mg rituksimaba v presledku 14 dni.
• asthma, too little oxygen reaching the body organs 
astma, telesne organe doseže premalo kisika, oteklost trebuha.
All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose). 
Vse bolnike so spremljali do 28. meseca (10 mesecev po zadnji infuziji rituksimab ali 6 mesecev po zadnjem odmerku azatioprina).
Serious cardiac reactions were reported at a rate of 1.3 per 100 patient years in the rituximab treated patients compared to 1.3 per 100 patient years in placebo treated patients. 
Delež resnih neželenih učinkov, povezanih s srcem, je bil 1,3 na 100 bolnik-let pri bolnikih, ki so se zdravili z rituksimabom, v primerjavi z 1,3 na 100 bolnik-let pri bolnikih, ki so prejemali placebo.
Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab. 
Študije razvojne toksičnosti so izvajali na opicah Cynomologus z odmerki do 100 mg/kg (zdravljenje od 20. do 50. gestacijskega dne) in niso pokazale znakov toksičnosti za plod zaradi rituksimaba.
The incidence of ADRs of any grade was similar in these two groups. 
Incidenca neželenih učinkov katere koli stopnje je bila v obeh skupinah podobna.
All patients in the cyclophosphamide arm received azathioprine maintenance therapy during follow-up. 
Vsi bolniki v skupini s ciklofosfamidom so med obdobjem spremljanja prejemali vzdrževalno zdravljenje z azatioprinom.
Clinical laboratory findings 
Klinični laboratorijski rezultati
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%). 
Blažji recidivi (takšni, ki niso bili življenjsko ogrožajoči in niso vključevali okvare pomembnega organa) so se pojavili pri sedmih bolnikih v skupini z zdravilom rituksimab (12 %) in pri osmih bolnikih v skupini z azatioprinom (14 %).
• flushing or redness of the skin 
• pordevanje ali rdečina kože,
The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively. 
Delež bolnikov, ki se jim je pojavila z infundiranjem povezana reakcija, je bil po prvem infundiranju 29% (11 bolnikov), po drugem 40% (15 bolnikov), po tretjem 13% (5 bolnikov) in po četrtem 10% (4 bolniki).
Treatment with Ritemvia uses four separate infusions given at weekly intervals. 
Zdravljenje z zdravilom Ritemvia obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
Ask your pharmacist how to throw away medicines that you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Very rarely, severe blistering skin conditions that can be life-threatening may occur. 
Zelo redko se lahko pojavijo huda stanja z mehurji na koži, ki so lahko življenjsko ogrožujoča.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. 
Parenteralna zdravila je treba pred dajanjem vizualno podrobno pregledati glede prisotnosti delcev in obarvanja.
The proportions of rituximab 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). 
Tudi delež z rituksimabom zdravljenih bolnikov, pri katerih se je pojavila minimalna klinično pomembna razlika (MCID, Minimal Clinically Important Difference) v HAQ-DI (opredeljena kot zmanjšanje individualne celotne ocene za > 0,22), je bil večji kot pri bolnikih, ki so prejemali samo metotreksat (preglednica 14).
1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data. 
1Pogostnost pridobljena iz laboratorijskih vrednosti zbranih v okviru rutinskega laboratorijskega spremljanja v kliničnih preskušanjih.
Adverse reactions are listed in Table 2. 
Neželeni učinki so navedeni v preglednici 2.
Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies. 
Bolniki s prisotnimi humanimi protimišjimi protitelesi (HAMA) ali protitelesi proti zdravilu (ADA) imajo lahko alergijske ali preobčutljivostne reakcije, če jih zdravimo z drugimi diagnostičnimi ali terapevtskimi monoklonskimi protitelesi.
Sustained improvement in physical function as indicated by the HAQ-DI score and the proportion of patients achieving MCID for HAQ-DI were observed. 
Ugotovljeno je bilo stalno izboljšanje funkcijske zmogljivosti, ki sta ga pokazala ocena HAQ-DI in delež bolnikov z doseženo MCID v HAQ-DI.
Safety and efficacy of Ritemvia have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma. 
Varnosti in učinkovitosti zdravila Ritemvia v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
Each course of treatment is made up of two separate infusions which are given 2 weeks apart. 
Vsak cikel zdravljenja obsega dve ločeni infuziji, ki ju boste dobili v presledku 2 tednov.
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ritemvia. 
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Ritemvia.
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167). 
Skupno je bilo 334 bolnikov, ki so po indukcijskem zdravljenju dosegli popolni ali delni odgovor, randomiziranih v drugi del zdravljenja, v katerem so prejemali vzdrževalno zdravljenje z rituksimabom (n=167), ali v opazovano skupino (n=167).
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the rituximab group. 
V opazovani skupini se je mediana koncentracije IgG postopno povečevala nad spodnjo mejo normalne vrednosti, v skupini, ki je prejemala rituksimab pa je ostala nespremenjena.
V1 varied by body surface area (BSA) and CHOP therapy. 
V1 se je razlikoval glede na telesno površino in zdravljenje s CHOP.
There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%). 
Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov 3. ali 4. stopnje kot bolniki brez obsežne bolezni (25,6% v primerjavi s 15,4%).
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). 
Pomembna korist vzdrževalnega zdravljenja z rituksimabom se je pokazala tudi pri sekundarnih opazovanih dogodkih - preživetju brez dogodkov (event-free survival - EFS), času do naslednjega zdravljenja limfoma (time to next anti-lymphoma treatment - TNLT), času do naslednje kemoterapije (time to next chemotherapy - TNCT) in celokupnem odgovoru (overall response rate - ORR) v primarni analizi (preglednica 7).
Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days. 
Infuzija rituksimaba je sledila intravenski infuziji 100 mg metilprednizolona; bolniki so 15 dni tudi peroralno jemali prednizon.
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test). 
Mediano trajanje odgovora je bilo 37,7 meseca v skupini z R-CVP in 13,5 meseca v skupini s CVP (p < 0,0001, log-rang test).
In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with rituximab treatment. 
Poleg tega so med zdravljenjem z rituksimabom opisane druge resne virusne okužbe, bodisi novonastale, ponovitve ali poslabšanja; nekatere so bile smrtne.
What Ritemvia looks like and contents of the pack 
Izgled zdravila Ritemvia in vsebina pakiranja
6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 
6 Opaženi v glavnem pri bolnikih z obstoječimi boleznimi srca in/ali kardiotoksično kemoterapijo ter pretežno v zvezi z reakcijami, povezanimi z infuzijo.
Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose. 
Bolniki v skupini z rituksimab, ki se jim je pojavil recidiv, so lahko prejeli dodatno infuzijo 1.000 mg rituksimab v kombinaciji s ponovno uvedenim prednizonom ali povečanjem odmerka prednizona.
This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes. 
Ne-Hodgkinov limfom je bolezen limfatičnega tkiva (ta je del imunskega sistema), ki prizadene vrsto belih krvnih celic, limfocite B.
In clinical trials more than 3100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2400 patients received two or more courses of treatment with over 1000 having received 5 or more courses. 
V kliničnih preskušanjih je več kot 3100 bolnikov prejelo najmanj en cikel zdravljenja, po tem so jih spremljali od 6 mesecev do več kot 5 let; približno 2.400 bolnikov je prejelo dva ali več ciklov zdravljenja, od teh pa več kot 1000 bolnikov 5 ali več ciklov zdravljenja.
• lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) 
zmanjšana imunost - zaradi manjše koncentracije protiteles, imenovanih imunoglobulini
Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both. 
Bolniki, serološko pozitivni za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP), ki so prejemali rituksimab v kombinaciji z metotreksatom, so imeli izrazitejši odziv kot bolniki, negativni za oba.
Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1). 
Glede na mehanizem delovanja zdravila rituksimab in dejstvo, da imajo celice B pomembno vlogo pri vzdrževanju normalnega imunskega odziva, imajo lahko bolniki, ki se zdravijo z zdravilom rituksimab, povečano tveganje za okužbe (glejte poglavje 5.1).
The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients (< 65 years). 
Incidenca neželenih učinkov vseh stopenj ter učinkov 3. ali 4. stopnje je bila pri starejših bolnikih podobna kot pri mlajših (< 65 let).
Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma 
Povzetek ključnih rezultatov štirih randomiziranih preskušanj III. faze, ki so ocenjevala korist rituksimaba v kombinaciji z različnimi shemami kemoterapije pri folikularnih limfomih
Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4). 
Bolnike moramo zaradi možnosti pojava sindroma sproščanja citokinov (glejte poglavje 4.4) natančno opazovati.
When Ritemvia is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied. 
Če zdravilo Ritemvia uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected. 
Opazili pa so od odmerka odvisen farmakološki upad števila celic B v limfatičnih organih ploda, ki je trajal tudi postnatalno, spremljalo ga je tudi znižanje IgG pri pri prizadetih mladičih.
4.06 years 
4,06 let
What Ritemvia is and what it is used for What Ritemvia is 
Kaj je zdravilo Ritemvia in za kaj ga uporabljamo Kaj je zdravilo Ritemvia
The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone. 
Farmakokinetični profil rituksimaba, dajanega v 6 infuzijah po 375 mg/m2 v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega rituksimaba.
Medicines given before each Ritemvia administration 
Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila Ritemvia
The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray. 
Akutno odpoved dihal lahko spremljajo spremembe, kot je infiltracija pljučnega intersticija ali pljučni edem, vidne na rentgenogramu prsnih organov.
Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001 
Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001
Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients. 
Simptomi z infundiranjem povezanih reakcij so bili po vrsti in izrazitosti podobni simptomom, opaženim pri bolnikih z RA in GPA/MPA.
1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below 
1 Vključuje reaktivacijo in primarne okužbe; pogostnost temelji na režimu R-FC pri bolnikih s KLL, pri katerih se je bolezen ponovila, ali pri neodzivnih bolnikih.
Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of rituximab. 
Zdravila za zdravljenje reakcij preobčutljivosti, npr. adrenalin, antihistaminiki in glukokortikoidi, morajo biti na voljo za takojšnjo uporabo, če bi se med dajanjem zdravila rituksimab pojavile alergijske reakcije.
Rituximab was administered on the first day of each treatment cycle. 
Rituksimab je bil uporabljen prvi dan vsakega cikla zdravljenja.
Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported. 
Med infuzijo sta se pojavili tudi aritmija 3. ali 4. stopnje (vključno z ventrikularno in supraventrikularno tahikardijo) in angina pektoris.
If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered. 
V primeru dvoma je smiselno nadaljnje ovrednotenje, vključno z magnetnoresonančno preiskavo (MR), po možnosti s kontrastom, določanjem prisotnosti DNK virusa JC v cerebrospinalni tekočini in ponovno nevrološko oceno.
Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score. 
Strukturno okvaro sklepov so ocenili radiološko in jo izrazili kot spremembo ocene po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
Rituximab +MTX 2 × 1000 mg 
Rituksimab + metotreksat 2 × 1.000 mg
Rituximab+MTX (2 x 1000 mg) 
Rituksimab + metotreksat (2 x 1.000 mg)
If you are being treated for granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. 
Če se zdravite zaradi granulomatoze s poliangiitisom, mikroskopskega poliangiitisa ali navadnega pemfigusa, boste te podatke našli tudi na opozorilni kartici za bolnika, ki vam jo je dal vaš zdravnik.
Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK 
Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Velika Britanija
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. 
V kliničnem preskušanju vzdrževalnega zdravljenja med celotnim preskušanjem niso ugotovili pomembnih razlik med obema terapevtskima skupinama ali znižanja koncentracije celokupnih imunoglobulinov, IgG, IgM ali IgA.
For intravenous use after dilution. 
Za intravensko uporabo po razredčitvi.
• If you are having Ritemvia with chemotherapy Ritemvia will be given to you on the same day as your chemotherapy. 
Če prejemate zdravilo Ritemvia skupaj s kemoterapijo, ga boste dobili isti dan kot kemoterapijo.
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Ritemvia (the last dose of methylprednisolone may be given on the same day as the first infusion of Ritemvia). 
Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila Ritemvia priporočljiva intravenska uporaba metilprednizolona, ki se ga daje od 1 do 3 dni v odmerku 1000 mg na dan (zadnji odmerek metilprednizolona je lahko uporabljen na dan prve infuzije zdravila Ritemvia).
Patients with active hepatitis B disease should not be treated with rituximab. 
Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z zdravilom rituksimab.
Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. 
Vzdrževalno zdravljenje z zdravilom Ritemvia je indicirano za zdravljenje bolnikov s folikularnimi limfomi, ki se odzovejo na indukcijsko zdravljenje.
Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either rituximab and low-dose prednisone or standard-dose prednisone. 
Bolnike so stratificirali glede na izhodiščno izrazitost bolezni (zmerno ali hudo) in jih v razmerju 1:1 randomizirali ali na prejemanje zdravila rituksimab in majhnega odmerka prednizona ali na prejemanje standardnega odmerka prednizona.
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 (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR). 
Vzdrževalno zdravljenje z rituksimabom je pokazalo konsistentno korist pri vseh preiskovanih, vnaprej opredeljenih podskupinah glede na spol (moški, ženski), starost (< 60 let, ≥ 60 let), oceno po indeksu FLIPI (Follicular Lymphoma International Prognostic Index) (≤ 1, 2 ali ≥ 3), indukcijsko zdravljenje (R-CHOP, R-CVP ali R-FCM) in ne glede na odgovor na indukcijsko zdravljenje (CR/CRu ali PR).
A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy. 
V analizo učinkovitosti je bilo vključenih skupno 810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 10a ter 10b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 11).
Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%). 
Vzdrževalno zdravljenje z rituksimabom je zmanjšalo tveganje za smrt za 56 % (95-% interval zaupanja: 22-75 %).
If a patient develops PML, the dosing of rituximab must be permanently discontinued. 
Če se pri bolniku razvije PML, je treba uporabo zdravila rituksimab dokončno ukiniti.