natgillin/translations-raw huggingface dataset:
150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p <0.05, ** p < 0.001.
150 bolnikov, ki so v preskušanju 1 sprva prejemali placebo + metotreksat, je do enega leta prejelo vsaj en cikel rituksimaba + metotreksata * p < 0,05; ** p < 0,001.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Zdravnik mora oceniti bolnika, da bi ugotovil, ali simptomi kažejo na nevrološko disfunkcijo, in če je tako, ali so lahko povezani s PML.
In all these studies, rituximab pharmacokinetics were dose proportional over the limited dose range studied.
V vseh preskušanjih je bila farmakokinetika rituksimaba sorazmerna odmerku v omejenem območju odmerkov, ki so ga preučevali.
Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Pregled učinkovitosti zdravljenja z rituksimabom v primerjavi z opazovanjem v času primarne analize, določene s protokolom, in po mediani spremljanja 9 let (končna analiza)
Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin's lymphoma.
Perforacijo prebavil, ki je v nekaterih primerih povzročila smrt, so opazili pri bolnikih, ki so prejemali rituksimab za zdravljenje ne-Hodgkinovega limfoma.
The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Priporočena začetna hitrost infundiranja je 50 mg/h; po prvih 30 minutah jo lahko vsakih 30 minut povečujemo po 50 mg/h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/h.
Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Preobčutljivost na učinkovino ali mišje beljakovine ali na katero koli drugo pomožno snov, navedeno v poglavju 6.1.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicentre trial (Trial 1).
Učinkovitost in varnost rituksimaba v lajšanju simptomov in znakov revmatoidnega artritisa pri bolnikih, ki niso zadostno odgovorili na zdravljenje z zaviralci TNF, sta bili dokazani v ključnem randomiziranem, kontroliranem, dvojno slepem, multicentričnem preskušanju (preskušanje 1).
• infections such as herpes infections and eye infection
okužbe, kot so okužbe z virusom herpes in očesne okužbe,
Significant improvement in health related quality of life was also demonstrated with significant improvement in both the physical health score (PHS) and mental health score (MHS) of the SF-36.
Ugotovljeno je bilo tudi značilno izboljšanje zdravstvenih kazalcev kakovosti življenja z značilnim izboljšanjem ocene telesnega zdravja (PHS, Physical Health Score) in duševnega zdravja (MHS, Mental
Duration of response* Disease free survival (DFS)** Time to new treatment
Trajanje odgovora* Preživetje brez bolezni** Čas do novega zdravljenja
This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Ritemvia treatment.
Temu mora slediti 1 mg/kg/dan prednizona peroralno (odmerek ne sme preseči 80 mg/dan in ga je treba zmanjšati, kolikor hitro je mogoče glede na klinične potrebe) med in po 4-tedenskem indukcijskem zdravljenjem z zdravilom Ritemvia in po njem.
A total of 1078 patients responded to induction therapy, of which 1018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Na indukcijsko zdravljenje se je odzvalo 1.078 bolnikov, od teh jih je bilo 1.018 randomiziranih v vzdrževalno zdravljenje z rituksimabom (n=505) ali v opazovanje (n=513).
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following rituximab (see section 4.5).
Iz kliničnih preskušanj ni zadostnih podatkov za popolno oceno varnosti uporabe drugih DMARD (vključno z zaviralci TNF in drugimi biološkimi zdravili), ki sledijo zdravljenju z zdravilom rituksimab (glejte poglavje 4.5).
Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Nevtropenija se lahko pojavi več mesecev po dajanju rituksimaba (glejte poglavje 4.4).
At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Po 24 tednih so imeli bolniki, ki so bili izhodiščno seropozitivni za RF in/ali anti-CCP, značilno večjo verjetnost, da dosežejo odziv ACR20 in 50, v primerjavi s seronegativnimi bolniki (p=0,0312 in p=0,0096) (preglednica 15).
Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Infekcijske in parazitske bolezni okužba z virusom herpes herpes zoster oralni herpes konjunktivitis
Therefore vaccination with live virus vaccines is not recommended whilst on rituximab or whilst peripherally B cell depleted.
Cepljenje z živimi virusnimi cepivi zato ni priporočljivo med zdravljenjem z zdravilom rituksimab ali medtem, ko je število perifernih celic B zmanjšano.
The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Preskušanje je dokazalo neinferiornost rituksimaba v primerjavi s ciklofosfamidom glede popolne remisije po 6 mesecih (preglednica 16).
The healthcare provider should also consider resuming or increasing the patient's glucocorticoid dose based on clinical evaluation.
Zdravnik mora na podlagi klinične ocene razmisliti tudi o ponovni uvedbi ali povečanju bolnikovega odmerka glukokortikoida.
The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Delež bolnikov s koncentracijo IgG pod spodnjo mejo normalne vrednosti je bil med 2-letnim zdravljenjem približno 60% v skupini, ki je prejemala rituksimab, v opazovani skupini pa se je zmanjšal (36% po dveh letih).
A statistically significant correlation was noted between response rates and bone marrow involvement.
Statistično značilno korelacijo so opazili med deležem odgovorov in infiltracijo kostnega mozga.
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Pri bolnikih je treba redno spremljati pojave novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
Abbreviation: NS, non significant
Kratica: NS, ni značilno (Not Significant).
There was no difference between the treatment groups in the incidence of other thromboembolic events.
Incidenca drugih trombemboličnih dogodkov se med terapevtskima skupinama ni razlikovala.
Event free survival Response rate (CR, nPR, or PR)
Preživetje brez dogodka Odgovor (CR, nPR ali PR)
The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Mediana PFS je bila 42,2 meseca v skupini, ki je prejemala vzdrževalno zdravljenje z rituksimabom, in 14,3 meseca v opazovani skupini.
In rheumatoid arthritis most infusion-related events reported in clinical trials were mild to moderate in severity.
Pri revmatoidnem artritisu je bila večina z infuzijo povezanih dogodkov, o katerih so poročali v kliničnih preskušanjih, po resnosti blagih do zmernih.
Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
O preobčutljivostnih reakcijah so poročali redkeje kot o reakcijah zaradi sproščanja citokinov.
Rituximab 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.
Rituksimab so uporabili pri 21 bolnikih po avtologni transplantaciji kostnega mozga in pri drugih rizičnih skupinah, pri katerih je pričakovano zmanjšano delovanje kostnega mozga, ne da bi se pojavila mielotoksičnost.
The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Celokupna incidenca z infuzijo povezanih reakcij je v kliničnih preskušanjih znašala 23 % pri prvi infuziji in se je pri nadaljnjih infuzijah zmanjšala.
Talk to your doctor, pharmacist or nurse before you are given Ritemvia if:
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Ritemvia:
There was no cumulative toxicity in terms of infections reported over a 2-year treatment period.
Pri okužbah, o katerih so poročali med dveletnim zdravljenjem, kumulativne toksičnosti ni bilo.
Rituximab 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).
Zdravila rituksimab se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3) ali hudo imunokompromitiranim bolnikom (npr. pri zelo nizkih vrednostih CD4 ali CD8).
Results from three other randomised trials using rituximab in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Rezultati treh drugih randomiziranih preskušanj z uporabo rituksimaba v kombinaciji z drugimi shemami kemoterapije (CHOP, MCP, CHVP/interferon alfa), in ne CVP, so prav tako pokazali značilna izboljšanja deležev odgovora, od časa odvisnih parametrov in celokupnega preživetja.
Observation (N = 167)
Opazovanje (n = 167)
The highest intravenous dose of rituximab tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Največji do zdaj preizkušen intravenski odmerek rituksimaba pri človeku je 5.000 mg (2.250 mg/m2), preizkušen v študiji povečevanja odmerka pri bolnikih s kronično limfocitno levkemijo.
No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Med rituksimabom in vrečkami iz polivinilklorida ali polietilena ali infuzijskimi seti niso ugotovili inkompatibilnosti.
Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
Poročali so o posameznih primerih pozne nevtropenije, ki se je pojavila več kot 4 tedne po zadnji infuziji rituksimaba.
In studies of rituximab in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Pri bolnikih z Waldenstromovo makroglobulinemijo so v študijah z rituksimabom po začetku zdravljenja opazili prehodna zvišanja koncentracij IgM v serumu, kar pa je lahko povezano s hiperviskoznostjo in sorodnimi simptomi.
A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Skupno je bilo 392 od 3.095 (12,7%) bolnikov z revmatoidnim artritisom v kliničnih študijah zdravljenja z rituksimabom pozitivnih na ADA.
• you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
• imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus.
This is because in a few cases, Ritemvia could cause hepatitis B to become active again, which can be fatal in very rare cases.
V maloštevilnih primerih namreč lahko bolezen zaradi zdravila Ritemvia ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥ 2 months).
Primarni cilj študije je bila popolna remisija (CR - complete remission) (popolna epitelizacija in odsotnost novih in/ali razvitih lezij) po 24 mesecih brez uporabe prednizonskega zdravljenja v obdobju dveh mesecev ali več (CRoff za ≥ 2 meseca).
Ritemvia should be used in combination with CHOP chemotherapy.
Zdravilo Ritemvia je treba uporabljati v kombinaciji s kemoterapijo CHOP.
Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Nevtropenija ni bila povezana z opaznim povečanjem resnih okužb med bolniki, ki so prejemali rituksimab.
Remission-induction therapy included IV prednisone, administered as per the investigator's discretion, preceded in some patients by methylprednisolone pulses, and pulse cyclophosphamide until remission was attained after 4 to 6 months.
Zdravljenje za indukcijo remisije je vključevalo intravenski prednizon, uporabljen po raziskovalčevi presoji, (nekateri bolniki so pred tem prejemali pulze metilprednizolona) in pulzni ciklofosfamid dokler ni bila dosežena remisija po 4 do 6 mesecih.
CHVP-IFN, R-CHVPIFN, 175
CHVP-IFN: 183 R-CHVP-IFN: 175
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.