natgillin/translations-raw huggingface dataset:
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported. 
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS,
The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients. 
Pri bolnikih, ki so se zdravili z rituksimabom, je bil celokupni delež okužb približno 94 na 100 bolnik let.
Corticosteroids will usually be given by injection before the start of Rixathon treatment. 
Pred začetkom zdravljenja z zdravilom Rixathon boste ponavadi dobili kortikosteroide v injekciji.
• swelling of the hands or ankles 
• otekanje rok ali gležnjev.
The most frequent adverse reactions considered due to receipt of rituximab IRRs. 
Najpogostejši neželeni učinki, za katere so menili, da so nastali zaradi prejetja rituksimaba, so bile reakcije, povezane z infuzijo.
Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension. 
O kardiovaskularnih neželenih učinkih so med kliničnimi preskušanji rituksimab kot samostojnega zdravila poročali pri 18,8 % bolnikov.
You should also tell them about your Rixathon treatment. 
Povejte, da se zdravite z zdravilom Rixathon.
Vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation 
hipotenzija, rinitis, okorelost, tahikardija, utrujenost, orofaringealna bolečina,
% HAQ-DI MCID Mean change in FACIT-T 
% bolnikov z MCID v HAQ-DI
• coughing or shortness of breath 
• kašelj ali kratka sapa,
Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171-1,177 µg/mL) after the eighth infusion. 
Pri 37 bolnikih z ne-Hodgkinovim limfomom, ki so prejeli 375 mg/m2 rituksimaba z intravensko infuzijo v osmih odmerkih enkrat na teden, se je povprečna Cmax povečala z vsako naslednjo infuzijo, tako da se je iz povprečne vrednosti 243 µg/ml (od 16 do 582 µg/ml) po prvi infuziji povečala na
See the Rixathon package leaflet for more information. 
Shranjevanje zdravila Rixathon Vsebina pakiranja in dodatne informacije
• Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision. 
• Znaki PML vključujejo: - zmedenost, izgubo spomina ali težave pri mišljenju,
500 mg / 50 mL 
100 mg/h na 50 mg/h).
The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended. 
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z rituksimabom pri bolnikih z NHL in
Other medicines and Rixathon 
Shranjevanje zdravila Rixathon
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome. 
utrujenost, glavobol, draženje žrela, rinitis, srbenje, bolečina, tahikardija, hipertenzija, hipotenzija, dispneja, dispepsija, astenija in značilnosti sindroma razpada tumorja.
You must also do this for 12 months after your last treatment with Rixathon. 
Učinkovito kontracepcijsko zaščito morate nadaljevati še 12 mesecev po zadnjem odmerku zdravila Rixathon.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rixathon. 
Pred uporabo zdravila Rixathon mora bolnik vedno dobiti premedikacijo, ki obsega antipiretik in antihistaminik, npr. paracetamol in difenhidramin.
Anaphylaxis Tumour lysis syndrome, cytokine release syndrome4, serum sickness 
Bolezni imunskega sistema z infuzijo povezane reakcije4, angioedem preobčutljivo st anafilaksija sindrom lize tumorja, sindrom sproščanja citokinov4, serumska bolezen z infuzijo povezana akutna reverzibilna trombocitopeni ja4
Musculoskeletal and Connective Tissue Disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišično-skeletna bolečina
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. 
A, mumps, rdečke, norice) so se ohranili najmanj 6 mesecev po zdravljenju z rituksimabom.
Consultation with a Neurologist should be considered as clinically indicated. 
Glede na klinično stanje pride v poštev posvet z nevrologom.
Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3). 
Zdravila Rixathon se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo,
For the 60 re-treatments on study, the ORR was 38% (CI95% 26% - 51%; CR 10%, PR 28%) with a projected median TTP for responding patients of 17.8 months (range 5.4-26.6). 
Za 60 ponovnih zdravljenj je bil celokupen odgovor na zdravljenje 38 % (95-% interval zaupanja 26-51 %; 10 %
This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial. 
To zdravilo vsebuje 2,3 mmol (ali 52,6 mg) natrija na 10-ml vialo.
This medicinal product contains 2.3 mmol (52.6 mg) sodium per 10 mL vial. 
To zdravilo vsebuje 2,3 mmol (52,6 mg) natrija na 10-ml vialo.
How to store Rixathon 
Kako se daje zdravilo Rixathon
In a multi-centre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses. 
V multicentričnem preskušanju brez primerjalne skupine je 37 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, prejemalo osem odmerkov po 375 mg/m2 rituksimaba v obliki intravenske infuzije enkrat na teden.
This medicine contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial. 
To zdravilo vsebuje 11,5 mmol (ali 263,2 mg) natrija na 50-ml vialo.
Experience from non-Hodgkin's lymphoma and chronic lymphocytic leukaemia 
Izkušnje pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji
The recommended dosage of Rixathon 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. 
Priporočeni odmerek zdravila Rixathon za zdravljenje navadnega pemfigusa je 1.000 mg v intravenski infuziji, ki ji čez dva tedna sledi druga intravenska infuzija 1.000 mg; uporablja se v kombinaciji z glukokortikoidi, katerih odmerke postopoma zmanjšujemo.
In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of rituximab, were re-treated with 375 mg/m2 of rituximab as intravenous infusion weekly for four doses. 
V multicentričnem preskušanju brez primerjalne skupine je 58 bolnikov, pri katerih se je nizko maligni ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo ter so dosegli objektivni klinični odgovor na predhodno zdravljenje z rituksimabom, ponovno prejelo
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). 
Študija je pri doseganju CRoff ≥ 2 meseca po 24 mesecih pri bolnikih z navadnim pemfigusom pokazala statistično značilno razliko med shemo rituksimaba in majhnega odmerka prednizona ter shemo s standardnim odmerkom prednizona (glejte preglednico 18).
• being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion 
• bruhanje, driska, bolečine v trebuhu, draženje ali razjede v žrelu in ustih, težave s požiranjem,
Patients in both arms received 1,000 mg of pulse intravenous methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day). 
Bolniki v obeh terapevtskih skupinah so prejemali 1.000 mg metilprednizolona (ali drugega glukokortikoida v enakovrednem odmerku) na dan pulzno intravensko (i.v.)
Rixathon 500 mg concentrate for solution for infusion rituximab 
Rixathon 500 mg koncentrat za raztopino za infundiranje Rituximabum (rituksimab)
Regular full blood counts, including neutrophil and platelet counts, should be performed during Rixathon therapy. 
Med zdravljenjem z zdravilom Rixathon je treba redno kontrolirati celotno krvno sliko, vključno s številom nevtrofilcev in trombocitov.
Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, 
Bolezni dihal, prsnega koša in mediastinalne ga prostora bronhospaze m4, bolezen dihal,
• Fever or persistent cough 
• zvišana telesna temperatura ali trdovraten kašelj,
Rixathon 100 mg concentrate for solution for infusion rituximab 
Rixathon 100 mg koncentrat za raztopino za infundiranje Rituximabum (rituksimab)
Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Rixathon je dobavljeno v sterilnih, apirogenih vialah brez konzervansov za enkratno uporabo.
For retreatment with Rixathon monotherapy for patients who have responded to previous treatment with rituximab monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1). 
Priporočeni odmerek zdravila Rixathon za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z rituksimabom po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
Hypertension, orthostatic hypotension, hypotension 
Bolezni živčevja parestezije, hipestezija, agitiranost,
• bald spots on the scalp, chills, headache 
• plešasti predeli na lasišču, mrzlica, glavobol,
The Patient Alert Card for Rixathon contains the following key elements: - The need to carry the card at all times and to show the card to all treating health care professionals - Warning on the risk of infections and PML, including the symptoms - The need for patients to contact their health care professional if symptoms occur 
- informacije o nujnosti svetovanja bolnikom glede tveganja za okužbe in PML, vključno s simptomi, na katere naj bodo pozorni, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od simptomov, - informacije o nujnosti, da opozorilno kartico izročijo bolniku ob vsakem infundiranju.
This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial. 
To zdravilo vsebuje 11,5 mmol (263,2 mg) natrija na 50-ml vialo.
+pancytopenia, +granulocytopenia disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy increase in serum IgM levels3 
hemolitična anemija, limfadenopatija prehodno zvečanje koncentrac ije IgM v serumu3
Follicular non-Hodgkin's lymphoma 
Ne-Hodgkinov limfom Folikularni ne-Hodgkinov limfom
The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study. 
Klinične izkušnje pri navadnem pemfigusu V randomizirani, odprti, kontrolirani multicentrični študiji so učinkovitost in varnost rituksimaba v kombinaciji s kratkotrajnim zdravljenjem z majhnim odmerkom glukokortikoida (prednizon) ocenili pri novodiagnosticiranih bolnikih z zmernim do hudim pemfigusom (74 z navadnim pemfigusom
All indications 
DRUGI PODATKI
• flushing or redness of the skin 
• omotica ali občutek tesnobe,
Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections. 
Omejeni podatki iz ene študije pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, kažejo, da lahko zdravljenje z rituksimabom poslabša tudi izid primarnih okužb z virusom hepatitisa B. Pri vseh bolnikih je treba pred začetkom zdravljenja z zdravilom Rixathon narediti presejalni test na virus hepatitisa B. To vključuje najmanj določanje statusa HBsAg in HBcAb, ki ju lahko dopolnimo z ostalimi primernimi označevalci v skladu z lokalnimi smernicami.
• hives, increased sweating, night sweats 
+alopecija urtikarija, znojenje,
Rituximab in combination with methotrexate significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 12). 
20-% izboljšanje glede na ACR oceno v primerjavi z bolniki, ki so se zdravili samo z metotreksatom (preglednica 12).
neutropenia3 
pozna nevtropenija3
Dizziness Tremor 
Razredčena raztopina
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses 
TTP: čas do napredovanja bolezni ali smrti (Time to progression or death)
Metabolism and nutrition disorders 
Presnovne in prehranske motnje hiperholesterolemija
Packs of 2 or 3 vials. 
V škatli sta 2 viali ali 3 viale.
, leucopenia, +febrile neutropenia, +thrombocyt openia 
+febrilna okužba, +herpes zoster, +okužbe dihal,
Table 13 Radiographic outcomes at 1 year (mITT population) 
Radiološki izidi po 1 letu v študiji 1 (populacija, ki so jo nameravali zdraviti) Placebo + metotreksat
Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12). 
Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001 V vseh študijah je bilo pri bolnikih, ki so se zdravili z rituksimabom in metotreksatom, zmanjšanje aktivnosti bolezni (DAS28, Disease Activity Score) pomembno večje kot pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 12).
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections 
6.1 Seznam pomožnih snovi natrijev citrat polisorbat 80 natrijev klorid natrijev hidroksid klorovodikova kislina voda za injekcije
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
OTHER 
Vse
• skin rashes, including acne or spots 
• kožni izpuščaji, vključno z aknami ali lisami, • pordevanje ali rdečina kože,
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 x 500 mg dose and 317 to 370 μg/mL for 2 x 1,000 mg dose. 
170 do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction 
TNLT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Severe infections were reported in about 4% of patients treated with rituximab monotherapy. 
Pri 4 % bolnikov, ki so prejemali rituksimab kot samostojno zdravljenje, so opazili hude okužbe.
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC). 
tako v študiji v prvi liniji zdravljenja (4 % R-FC, 3 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4 % R- FC, 4 % FC).
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 
Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
ORR2) 
Primarna učinkovitost ORR2)
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions. 
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
Asthma, bronchiolitis obliterans, lung disorder, 
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis. 
Domena rituksimaba Fab se veže na antigen CD20 na B-limfocitih in prek domene Fc sproži imunska dogajanja, ki privedejo do razgradnje celic B. Mogoča mehanizma celične razgradnje sta od komplementa odvisna citotoksičnost (complement-dependent cytotoxicity - CDC,), ki je posledica vezave C1q, in od protiteles odvisna celična citotoksičnost (antibody-dependent cellular cytotoxicity
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/10 ml
You might get infections more easily during your treatment with Rixathon. 
Med zdravljenjem z zdravilom Rixathon ste lahko bolj nagnjeni k okužbam.
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (< 65 years), with previously untreated or relapsed/refractory CLL. 
ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki (< 65 let).
The recommended dose of Rixathon monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks. 
• Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Rixathon za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
Rixathon is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion. 
Zdravilo Rixathon je bistra, brezbarvna do rumenkasta raztopina.
In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test). 
FC in 20,6 meseca v skupini FC (p = 0,0002, test log rank).
Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm. 
Vzdrževalno zdravljenje z rituksimabom je klinično pomembno in statistično značilno izboljšalo primarni cilj - preživetje brez napredovanja bolezni (progression free survival - PFS) (čas od randomizacije v vzdrževalno zdravljenje do ponovitve bolezni, napredovanja bolezni ali smrti) v primerjavi z opazovano skupino (p < 0,0001, test log-rank).
In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia. 
pojavila pri 24 % prejemnikov rituksimaba (en cikel) in pri 23 % prejemnikov ciklofosfamida.
Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris. 
e) navadnega pemfigusa Zdravilo Rixathon se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction 
TNCT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy. 
Pri primerih PRES/RPLS, o katerih so poročali, so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo,
• Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, 
• zvečana koncentracija holesterola v krvi, • nenormalni občutki v koži, kot je otrplost, mravljinčenje, zbadanje ali žarjenje, išias, migrena,
They were characterised by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8). 
drgetanja, hipotenzije, urtikarije, angioedema in drugih simptomov (glejte poglavje 4.8).
Secondary efficacy Overall survival (median) log-rank p value hazard ratio (95% CI) risk reduction 
Celokupno preživetje (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Duration of response * Disease free survival (DFS)** Time to new CLL treatment 
TTF: čas do neuspeha zdravljenja (Time to Treatment Failure)
Packs of 1 or 2 vials. 
V škatli sta 1 viala ali 2 viali.
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established. 
Uporaba rituksimaba pri bolnikih, ki še niso prejemali metotreksata, ni priporočljiva, ker ni bilo dokazano ugodno razmerje med koristjo in tveganji.
Event-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction 
Preživetje brez dogodka (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%) 
Popolna remisija po 6 mesecih glede na stanje bolezni Rituksimab
• Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth 
• slaba prebava, driska, zgaga, vnetje in/ali razjede v žrelu in ustih,
Renal failure4 
odpoved dihal4
Measure blood neutrophils prior to each course of Rixathon, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8). 
6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion. 
povezano z infuzijo na katero koli biološko zdravilo ali na rituksimab, ne smejo prejeti hitrejše infuzije.
Infusion site pain 
bolečina na mestu infundiranja