FrancophonIA/ELRC3.0 huggingface dataset:
English: If you respond well to treatment, you may be given MabThera as a maintenance treatment.
Slovenian: Če se boste na zdravilo dobro odzvali, boste lahko zdravilo MabThera prejemali kot vzdrževalno zdravljenje.
English: MabThera is not indicated for these patients, since the safety data about long-term MabThera treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Slovenian: Zdravilo MabThera ni indicirano za uporabo pri teh bolnikih zaradi nezadostnih podatkov o varnosti dolgoročnega zdravljenja z zdravilom MabThera, še posebej v zvezi s tveganjem za razvoj malignih bolezni ter PML.
English: • infections such as herpes infections and eye infection
Slovenian: · okužbe, kot so okužbe z virusom herpes in očesne okužbe,
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.
Slovenian: Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila MabThera Preden boste dobili zdravilo MabThera, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
English: Your doctor will check if you should have any vaccines before you receive MabThera.
Slovenian: Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo MabThera.
English: Patients reporting signs and symptoms of infection following MabThera therapy should be promptly evaluated and treated appropriately.
Slovenian: Bolnike, pri katerih se pojavijo znaki in simptomi okužbe po zdravljenju z zdravilom MabThera, je treba nemudoma pregledati in primerno zdraviti.
English: The rate of all ADRs following first MabThera exposure was highest during the first 6 months and declined thereafter.
Slovenian: Delež vseh neželenih učinkov, ki so se pojavili po prvi izpostavitvi zdravilu MabThera, je bil najvišji v prvih 6 mesecih in se je potem zmanjševal.
English: This analysis suggests that dose adjustment of MabThera with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Slovenian: Te analize kažejo, da prilagoditev odmerka zdravila MabThera s katerokoli od testiranih spremenljivk verjetno ne bo pomembno zmanjšala njegove farmakokinetične variabilnosti.
English: Part 2 N = 176
Slovenian: 2. del n = 176
English: Before giving a subsequent course of MabThera treatment, patients should be re-evaluated for any potential risk for infections.
Slovenian: Pred dajanjem nadaljnjega cikla zdravila MabThera je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
English: Following subcutaneous administration, the absorption of rituximab is slow, reaching maximal concentrations about 3 days after administration.
Slovenian: Po podkožni uporabi se rituksimab absorbira počasi in doseže največjo koncentracijo približno 3 dni po uporabi.
English: Table 14 Physical Function and Quality of Life outcomes at week 24 in Trial 1
Slovenian: Funkcijska zmogljivost in vpliv na kakovost življenja po 24 tednih v preskušanju 1 Izid†
English: • tight or painful muscles
Slovenian: · napete ali boleče mišice,
English: The overall trial design was identical among both stages and patients were randomized into the following two treatment groups:
Slovenian: Celotna zasnova preskušanja je bila v obeh stopnjah enaka in bolniki so bili randomizirani v naslednji terapevtski skupini:
English: key efficacy results for the pooled analysis of 410 patients in SABRINA stages 1 and 2 are shown in table 2.
Slovenian: Ključni rezultati učinkovitosti za združeno analizo 410 bolnikov iz 1. in 2. stopnje preskušanja SABRINA so prikazani v preglednici 2.
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Slovenian: Slika 2: Odzivi ACR za 4 cikle zdravljenja 24 tednov po vsakem ciklu (intraindividualno, znotraj pregledov) pri bolnikih, ki niso zadostno odgovorili zdravljenje z zaviralci TNF (n = 146)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Slovenian: Na osnovi omejenih izkušenj z zdravilom MabThera pri zdravljenju revmatoidnega artritisa (glejte poglavje 4.8) sedanji podatki ne kažejo kakršnegakoli povečanega tveganja za razvoj malignih bolezni.
English: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Slovenian: Hudo srčno popuščanje (IV. razred po klasifikaciji Newyorškega združenja za srce NYHA) ali huda, neobvladljiva bolezen srca (glejte poglavje 4.4 glede drugih srčno-žilnih bolezni).
English: MabThera will be given to you once a week for 4 weeks.
Slovenian: ga boste prejeli enkrat na teden 4 tedne.
English: A total of 176 patients with CLL were randomized into the following two treatment groups:
Slovenian: Skupno so randomizirali 176 bolnikov s KLL v naslednji terapevtski skupini:
English: In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.
Slovenian: Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče zdravilo MabThera uporabljati kot vzdrževalno zdravljenje še dve leti po dokončanju začetnega zdravljenja.
English: MabThera was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Slovenian: Zdravilo MabThera so dajali v kombinaciji z intravenskimi glukokortikoidi, ki lahko zmanjšajo incidenco in izrazitost teh učinkov.
English: Rarely, some of these side effects have been fatal.
Slovenian: Redko so bili nekateri od teh neželenih učinkov smrtni.
English: • high or low blood pressure (low blood pressure especially when standing upright)
Slovenian: · visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju)
English: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Slovenian: Bolniki so lahko dobili 1000 mg intravensko ob času recidiva (glejte poglavje 5.1).
English: This compares favourably with the TTP achieved after the prior course of MabThera (12.4 months).
Slovenian: To je lepo primerljivo s časom do napredovanja bolezni, ki je bil dosežen po predhodnem zdravljenju z zdravilom MabThera (12,4 meseca).
English: Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Slovenian: Okrajšave: NA: ni na voljo; ORR: celokupni odgovor (overall response rate); CR: popolni odgovor (complete response); PR: delni odgovor (partial response).
English: • hearing loss, loss of other senses.
Slovenian: · poslabšanje sluha, poslabšanje drugih čutov.
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with MabThera (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Slovenian: V dolgoročni opazovalni študiji varnosti je 97 bolnikov z GPA/MPA prejemalo zdravljenje z zdravilom MabThera (v povprečju 8 infuzij [razpon od 1 do 28]) do 4 leta, v skladu s standardno prakso in presojo njihovega zdravnika.
English: Of 356 patients evaluated for ADA, 1.1 % (4 patients) were positive.
Slovenian: Od 356 bolnikov, pri katerih so ocenjevali ADA, so bili pozitivni 4 bolniki (1,1 %).
English: Other medicines and MabThera
Slovenian: Druga zdravila in zdravilo MabThera
English: Key results from all four trials are summarized in table 3.
Slovenian: Ključni rezultati vseh štirih preskušanj so povzeti v preglednici 3.
English: The cells that are affected by MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera.
Slovenian: Celice, ki jih zdravilo MabThera uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo MabThera.
English: Therefore, the switch to MabThera subcutaneous formulation can only occur at the second or subsequent cycles of treatment.
Slovenian: Zato je mogoče prehod na podkožno obliko zdravila MabThera opraviti le v drugem ali nadaljnjih ciklih zdravljenja.
English: No dose reductions of MabThera are recommended.
Slovenian: Odmerka zdravila MabThera ni priporočljivo zmanjšati.
English: In the event of relapse, patients may receive 1000 mg IV.
Slovenian: V primeru recidiva lahko bolniki dobijo 1000 mg intravensko.
English: • If you respond well to treatment, you may be given MabThera as a maintenance treatment every 2 or 3 months for two years.
Slovenian: · Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo MabThera dobivali kot vzdrževalno zdravljenje na dva meseca ali tri, in sicer dve leti.
English: The hypodermic injection needle must only be attached to the syringe immediately prior to administration to avoid potential needle clogging.
Slovenian: Hipodermično injekcijsko iglo je treba namestiti na brizgo šele tik pred dajanjem zdravila, da bi preprečili možno zamašitev igle.
English: METHOD OF ADMINISTRATION Only for subcutaneous use
Slovenian: POSTOPEK UPORABE Samo za subkutano uporabo
English: In embryofetal developmental studies in mice, rHuPH20 caused reduced fetal weight and loss of implantations at systemic exposures sufficiently in excess of human therapeutic exposure.
Slovenian: V študijah embrio-fetalnega razvoja pri miših je rHuPH20 povzročil manjšo telesno maso in izgubo implantatov pri sistemskih izpostavljenostih, ki so občutno presegale terapevtsko izpostavljenost pri človeku.
English: 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).
Slovenian: 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 ³ 2 meseca).
English: 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 MabThera treatment.
Slovenian: 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 zdravljenju z zdravilom MabThera.
English: As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Slovenian: Kot je značilno za monoklonska protitelesa, so farmakokinetični parametri rituksimaba odvisni od telesne velikosti.
English: The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo MabThera, prejeli:
English: 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).
Slovenian: 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).
English: This is because side effects can develop several months after you have had treatment.
Slovenian: ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
English: Of the 99 patients treated with MabThera, 12 (12%) experienced at least one IRR.
Slovenian: Od 99 bolnikov, zdravljenih z zdravilom MabThera, se je pri 12 (12 %) pojavila vsaj ena IRR.
English: The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Slovenian: Končna analiza učinkovitosti je vključevala vse randomizirane bolnike (197 CHOP, 202 R-CHOP); mediano sledenje bolnikov je trajalo približno 31 mesecev.
English: Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Slovenian: Bolnika je treba opazovati vsaj 15 minut po podkožni uporabi zdravila MabThera.
English: Your doctor may need to take special care of you during your treatment with MabThera.
Slovenian: Zdravnik bo morda moral med zdravljenjem z zdravilom MabThera posebej poskrbeti za vas.
English: Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Slovenian: Ravni signifikantnosti so bile opredeljene kot *p < 0,05; **p < 0,001; ***p < 0,0001.
English: The safety and efficacy of MabThera in children below 18 years has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila MabThera pri otrocih do 18. leta starosti nista dokazani.
English: MabThera is indicated in adults for the following indications:
Slovenian: Zdravilo MabThera je pri odraslih indicirano za naslednje indikacije:
English: MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Slovenian: Zdravilo MabThera upočasni nastanek okvar sklepov, ki so posledica revmatoidnega artritisa, ter izboljša vašo sposobnost za opravljanje običajnih dnevnih aktivnosti.
English: Other rarely-reported side-effects due to MabThera include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Slovenian: Drugi neželeni učinki zdravila MabThera, o katerih so poročali redko, vključujejo zmanjšano število belih krvnih celic (nevtrofilcev), ki pomagajo v boju proti okužbam.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and very rare (<1/10,000).
Slovenian: Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta (≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10.000).
English: Measure blood neutrophils prior to each course of MabThera, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Slovenian: Število nevtrofilcev v krvi je treba določiti pred vsakim ciklom zdravila MabThera in redno do 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
English: MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Slovenian: Zdravilo MabThera v kombinaciji s kemoterapijo uniči te celice, ki se postopno odstranijo iz telesa z biološkimi procesi.
English: Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Slovenian: Redko lahko zdravilo MabThera povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
English: µg.day/mL
Slovenian: µg.dan/ml
English: This sticker should be removed from the vial and stuck onto the syringe prior to use.
Slovenian: To nalepko morate z viale odlepiti in jo pred uporabo nalepiti na brizgo.
English: Additionally, no effects on semen quality were shown for rHuPH20.
Slovenian: Poleg tega so ugotovili, da rHuPH20 ni vplival na kakovost semena.
English: Patient subpopulations - MabThera combination therapy Elderly patients (≥ 65 years)
Slovenian: Podskupine bolnikov - kombinirano zdravljenje z zdravilom MabThera Starejši bolniki (³ 65 let)
English: Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
Slovenian: Nekatera cepiva se ne smejo dajati sočasno z zdravilom MabThera ali nekaj mesecev po prejetju tega zdravila.
English: Initial treatment in combination with chemotherapy
Slovenian: Začetno zdravljenje v kombinaciji s kemoterapijo
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and subsequent updates of the RMP.
Slovenian: Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Table 17 Complete remission at 6-months by disease status MabThera
Slovenian: Popolna remisija po 6 mesecih glede na stanje bolezni MabThera
English: From month 12 to month 18, 8 relapses were observed in the MabThera group compared with four in the cyclophosphamide group.
Slovenian: Od 12. do 18. meseca so v skupini z zdravilom MabThera zabeležili 8 ponovitev in v skupini s ciklofosfamidom 4.
English: Immunomodulatory drugs may increase the risk of malignancy.
Slovenian: Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
English: Initiate at a rate of 250mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Slovenian: Začetna hitrost infundiranja je 250 mg/h prvih 30 minut in nato 600 mg/h naslednjih 90 minut.
English: Of 67 patients evaluated for HAMA, no responses were noted.
Slovenian: Pri 67 bolnikih, pri katerih so analizirali prisotnost HAMA, teh niso opazili.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of MabThera.
Slovenian: Pri majhnem deležu bolnikov je bil upad števila perifernih celic B dolgotrajen, trajal je 2 leti ali več po zadnjem odmerku zdravila
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Slovenian: · Vse uporabljene igle in brizge zavrzite v vsebnik za ostre odpadke (proti prebadanju varen vsebnik za enkratno uporabo).
English: In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with MabThera for the maintenance of remission (see section 5.1).
Slovenian: V nadaljnji klinični študiji so skupno 57 bolnikov s hudo aktivno GPA in MPA v remisiji bolezni zdravili z zdravilom MabThera za vzdrževanje remisije (glejte poglavje 5.1).
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
Slovenian: Podatki o varnosti, zbrani v obdobju po prihodu zdravila na trg, odražajo pričakovani profil neželenih učinkov, kot so ga opazili v kliničnih preskušanjih z zdravilom MabThera (glejte poglavje 4.4).
English: Kaplan-Meier Estimate of Median Time to Event (Months)
Slovenian: Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
English: Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
Slovenian: Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo zdravila MabThera.
English: Many patients get some local side effects where MabThera is injected.
Slovenian: Številnim bolnikom se pojavijo nekateri lokalni neželeni učinki na mestu, kjer je bilo injicirano zdravilo MabThera.
English: There was no evidence of clinically relevant dependencies of rituximab pharmacokinetics on age and sex.
Slovenian: Ni bilo dokazov, da bi bila farmakokinetika rituksimaba klinično pomembno odvisna od starosti in spola.
English: Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Slovenian: Izide učinkovitosti so pri bolnikih, zdravljenih z zdravilom MabThera, analizirali na podlagi stanja protiteles pred začetkom zdravljenja.
English: This is because MabThera may pass into breast milk.
Slovenian: Zdravilo MabThera namreč lahko prehaja v materino mleko.
English: • taste problems - such as changes in the way things taste
Slovenian: · motnje okušanja - na primer spremenjen okus stvari,
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.
Slovenian: Število perifernih celic B se je začelo povečevati od 24. tedna in znake ponovne populacije so opazili pri večini bolnikov do 40. tedna ne glede na to, ali so zdravilo MabThera prejemali kot samostojno zdravljenje ali v kombinaciji z metotreksatom.
English: These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Slovenian: 48. teden, ko je seropozitivnost prav tako značilno povečala verjetnost za doseganje odziva ACR70.
English: Ask your pharmacist how to throw away medicines that you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: All clearance and volume parameters increased with BSA.
Slovenian: Vsi očistki in volumski parametri so se povečevali s telesno površino.
English: Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Slovenian: Slika 4: Število bolnikov brez kortikosteroidnega zdravljenja ali z minimalnim kortikosteroidnim zdravljenjem (≤ 10mg/dan) glede na čas zdravljenja
English: serious viral infection2
Slovenian: resna virusna okužba2
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following MabThera therapy.
Slovenian: Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z zdravilom MabThera, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z zdravilom MabThera prejmejo biološka zdravila in/ali DMARD.
English: • The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.
Slovenian: · Druge sestavine zdravila so rekombinantna humana hialuronidaza (rHuPH20), L-histidin, L-histidin-klorid monohidrat, a,a-trehaloza-dihidrat, L-metionin, polisorbat 80 in voda za injekcije.
English: If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Slovenian: Če se pri bolniku razvije PML, je treba uporabo zdravila MabThera dokončno ukiniti.
English: • 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.
Slovenian: - zmedenost, izgubo spomina ali težave pri mišljenju, - izgubo ravnotežja ali spremembo v načinu govora ali hoje, - zmanjšano moč ali šibkost na eni strani telesa, - zamegljen vid ali izgubo vida.
English: Your doctor may prescribe MabThera for the treatment of:
Slovenian: Zdravnik vam lahko zdravilo MabThera predpiše za zdravljenje:
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 -15).
Slovenian: Delež resnih srčnih dogodkov je bil 2,1 na 100 bolnik-let (95-% interval zaupanja, 3-15).
English: MabThera + low-dose prednisone (n = 38)
Slovenian: MabThera + majhen odmerek prednizona (n = 38)
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of MabThera treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Slovenian: V kliničnih preskušanjih nadzorovanih s placebom, je pri 0,94 % (13/1382) bolnikov zdravljenih z zdravilom MabThera in pri 0,27 % (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude nevtropenije.