FrancophonIA/ELRC3.0 huggingface dataset:
English: • nerve damage in arms and legs, paralysed face
Slovenian: · okvara živcev v rokah in nogah, paraliza obraza
English: The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
Slovenian: Večina lokalnih kožnih reakcij po uporabi podkožne oblike zdravila MabThera je bila blagih ali zmernih in so minile brez posebnega zdravljenja.
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42 % partial response (PR) rate.
Slovenian: Celokupen odgovor (ORR, overall response rate) v populaciji z namenom zdraviti (ITT, the intent-totreat) je bil 48 % (95-% interval zaupanja 41−56 %), od tega popoln odgovor (CR, complete response) pri 6 %, delni odgovor (PR, partial response) pa pri 42 %.
English: Premedication with glucocorticoids should also be considered.
Slovenian: V poštev pride tudi premedikacija z glukokortikoidi.
English: Cases of fatal PML that occurred after disease progression and retreatment have also been reported in clinical trials.
Slovenian: do katerih je prišlo po napredovanju bolezni in ponovnem zdravljenju, so poročali tudi v kliničnih preskušanjih.
English: The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
Slovenian: Primerjava podatkov za predvideno mediano največje koncentracije (Cmax) za podkožno in intravensko obliko zdravila MabThera je povzeta v preglednici 7.
English: 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.
Slovenian: Bolniki s prisotnimi humanimi protimišjimi protitelesi (human anti-mouse antibody - HAMA) ali protitelesi proti zdravilu (human anti-drug antibody - ADA) imajo lahko alergijske ali preobčutljivostne reakcije, če jih zdravimo z drugimi diagnostičnimi ali terapevtskimi monoklonskimi protitelesi.
English: • Periodic Safety Update Reports
Slovenian: · Redno posodobljena poročila o varnosti zdravila (PSUR)
English: A higher proportion of patients receiving the original MabThera/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Slovenian: Prav tako pri večjem deležu bolnikov, ki so prvotno prejemali zdravilo MabThera in metotreksat, ni prišlo do napredovanja erozij v 56 tednih (preglednica 13).
English: The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Slovenian: Preskušanje je dokazalo neinferiornost zdravila MabThera v primerjavi s ciklofosfamidom glede popolne remisije po 6 mesecih (preglednica 16).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: Posodobljen RMP je treba predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: 2 vials of 10 mL
Slovenian: 2 viali po 10 ml
English: • asthma, too little oxygen reaching the body organs
Slovenian: · astma, telesne organe doseže premalo kisika · oteklost trebuha
English: Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
Slovenian: Po indukciji remisije z drugimi imunosupresivi, ki spadajo v okvir običajnega zdravljenja, je treba vzdrževalno zdravljenje z zdravilom MabThera začeti v 4-tedenskem obdobju po remisiji bolezni.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 500 mg / 50 mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 500 mg/50 ml
English: Relapsing n=51
Slovenian: Ponovitev n = 51
English: MabThera maintenance treatment reduced the risk of death by 56 % (95 % CI; 22 %-75 %).
Slovenian: Vzdrževalno zdravljenje z zdravilom MabThera je zmanjšalo tveganje za smrt za 56 % (95-% interval zaupanja: 22-75 %).
English: Conditional simulations that summarized the impact of all body size dependencies on rituximab exposure demonstrated that, while fixed subcutaneous dosing leads to larger differences in exposure (Ctrough and AUCτ) between subjects with low and high body sizes compared to body-weight-adjusted intravenous dosing, it allows to maintain Ctrough and AUCτ values for all body-size groups at the levels not lower than levels attained by intravenous dosing, thus achieving at least the same target saturation as for intravenousdosing.
Slovenian: Pogojne simulacije, v katerih so povzeli vplive vseh telesnih mer na izpostavljenost rituksimabu, so pokazale, da fiksno podkožno odmerjanje v primerjavi z intravenskim, ki je prilagojeno na telesno maso, po eni strani povzroča večje razlike v izpostavljenosti zdravilu (Ctrough in AUCτ) med bolniki z majhnimi in velikimi telesnimi merami, po drugi strani pa omogoča ohranjanje vrednosti Ctrough in AUCτ za vse bolnike ne glede na telesne mere na ravneh, ki niso nižje od tistih, ki jih dosežemo z intravenskim odmerjanjem.
English: The cumulative incidence rate curves showed that time to first major relapse was longer in patients with MabThera starting from month 2 and was maintained up to month 28 (Figure 3).
Slovenian: Krivulje kumulativnih stopenj incidence so pokazale, da je bil čas do prvega hujšega recidiva pri bolnikih, ki so prejemali zdravilo MabThera, daljši, in sicer od 2. meseca naprej; to se je ohranilo do 28. meseca (slika 3).
English: Anti-rituximab antibodies were detected in only 13 patients and did not result in any clinically relevant increase in steady-state clearance.
Slovenian: Protitelesa proti rituksimabu so ugotovili le pri 13 bolnikih in niso klinično pomembno podaljšala očistka v stanju dinamičnega ravnovesja.
English: For CLL patients similar results are assumable considering similarities between both diseases, but this has not been investigated in clinical trials.
Slovenian: Zaradi podobnosti med boleznima sklepamo, da bi bili rezultati za bolnike s KLL podobni, a tega niso preučili v kliničnem preskušanju.
English: This set of reactions which includes syndrome of cytokine release, tumor lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Slovenian: Ta skupina reakcij, ki vključuje sindrom sproščanja citokinov, sindrom razpada tumorja in anafilaktične ter preobčutljivostne reakcije, je opisana spodaj.
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
Slovenian: Na voljo so le omejeni podatki glede učinkovitosti in varnosti pri bolnikih, ki so se predhodno zdravili z monoklonskimi protitelesi, vključno z zdravilom MabThera, ali pri bolnikih, ki se na prejšnje zdravljenje z zdravilom MabThera in kemoterapijo niso odzvali.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg / 10 mL
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 100 mg/10 ml
English: 1 vial of 50 mL
Slovenian: 1 viala po 50 ml
English: MabThera infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Slovenian: Infuzija zdravila MabThera je sledila intravenski infuziji 100 mg metiprednizolona; bolniki so 15 dni tudi peroralno jemali prednizon.
English: If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg MabThera administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Slovenian: Če bolniki niso imeli resne reakcije, povezane z infuzijo, pri prvem ali nadaljnjem infundiranju odmerka 1000 mg zdravila Mabthera, ki je potekalo v skladu z originalno shemo dajanja, lahko drugo in nadaljnje infuzije prejmejo hitreje z enako koncentracijo kot v prejšnjih infuzijah (4 mg/ml v 250ml volumnu).
English: The best responses to MabThera are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP).
Slovenian: Na zdravljenje z zdravilom MabThera se najbolje odzovejo tisti bolniki, pri katerih je krvni test za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP) pozitiven.
English: A total of 64 patients with CLL were enrolled at any point prior to cycle 5 during their treatment with MabThera intravenous formulation in combination with chemotherapy.
Slovenian: Skupno so vključili 64 bolnikov s KLL na kateri koli točki pred 5. ciklom med zdravljenjem z intravensko obliko zdravila MabThera v kombinaciji s kemoterapijo.
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of MabThera.
Slovenian: Starost, spol in stanje zmogljivosti po SZO niso vplivali na farmakokinetiko zdravila MabThera.
English: Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
Slovenian: Skupno rezultati potrjujejo, da ima podkožna oblika zdravila MabThera v odmerku 1600 mg primerljivo razmerje med koristmi in tveganji kot intravenska oblika zdravila MabThera v odmerku 500 mg/m2.
English: Among the 3189 patients treated with MabThera, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to MabThera.
Slovenian: Med 3.189 bolniki, ki so prejeli zdravilo MabThera, se je vsaj ena z infuzijo povezana reakcija pojavila pri 1.135 bolnikih (36 %), od tega pa se je pri 733 od 3.189 bolnikov (23 %) reakcija pojavila po prejemu prve infuzije zdravila MabThera.
English: Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Slovenian: Med zdravljenjem z zdravilom MabThera se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
English: For subjects weighing > 90 kg, Ctrough values were the same for the intravenous and subcutaneous regimens.
Slovenian: Pri bolnikih s telesno maso > 90 kg so pri intravenskem in podkožnem režimu odmerjanja zabeležili enake Ctrough.
English: Yeonsu-gu, Incheon 21987,
Slovenian: Samsung BioLogics 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987, Koreja
English: All healthcare professionals administering MabThera subcutaneous formulation will be provided with an Educational Material (« step by step guide » and « comparison card ») to minimise the risk of off label use and administration route error.
Slovenian: Vsi zdravstveni delavci, ki dajejo zdravilo MabThera v podkožni obliki, bodo z namenom zmanjševanja tveganja neodobrene uporabe zdravila in napak zaradi nepravilne poti dajanja zdravila prejeli izobraževalno gradivo (vodnik po korakih in kartico za primerjavo).
English: The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Slovenian: Tudi delež z zdravilom MabThera 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).
English: • feeling restless, problems falling asleep
Slovenian: · nemir, bolnik težko zaspi
English: The efficacy and safety of MabThera 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, multicenter trial (Trial 1).
Slovenian: Klinične izkušnje pri revmatoidnem artritisu Učinkovitost in varnost zdravila MabThera 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).
English: Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Slovenian: Varnosti in učinkovitosti zdravila MabThera v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Slovenian: aVrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p. b 95-% interval zaupanja je korigiran Newcombov interval.
English: There was no apparent impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety or efficacy.
Slovenian: Očitnega vpliva prisotnosti protiteles proti rituksimabu ali protiteles proti rHuPH20 na varnost in učinkovitost ni bilo.
English: In the overall experience of MabThera repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Slovenian: Pri ponovnem enoletnem zdravljenju z zdravilom MabThera pri revmatoidnem artritisu so bili deleži bolnikov s pozitivnim titrom protiteles proti S. pneumoniae, influenci, mumpsu, rdečkah, noricah in tetanusnem toksoidu na splošno podobni kot izhodiščni.
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Slovenian: · kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobuliniIgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized to receive azathioprine (59 patients) or MabThera (58 patients) in a prospective, multi-center, controlled, open-label study.
Slovenian: Skupno 117 bolnikov (88 z GPA, 24 z MPA in 5 z ledvično omejenim z ANCA povezanim vaskulitisom), ki so bili v remisiji bolezni, so v prospektivni, multicentrični, kontrolirani odprti študiji randomizirali na prejemanje azatioprina (59 bolnikov) ali zdravila MabThera (58 bolnikov).
English: The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Slovenian: Priporočeni odmerek zdravila MabThera je 1000 mg z intravensko infuzijo, čemur sledi druga intravenska infuzija 1000 mg 2 tedna pozneje.
English: 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 MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila MabThera 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 MabThera).
English: Absorption parameters of subcutaneous formulation, decreased with increasing BMI.
Slovenian: Parametri absorpcije so se za podkožno obliko zdravila zmanjševali z naraščajočim indeksom telesne mase.
English: In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
Slovenian: V opazovani skupini se je mediana koncentracije IgG postopno povečevala nad spodnjo mejo normalne vrednosti, v skupini, ki je prejemala zdravilo MabThera pa je ostala nespremenjena.
English: In the SABRINA trial (BO22334) the incidence of treatment-induced/enhanced anti-rituximab antibodies was low and similar in the intravenous and subcutaneous groups (1.9% vs. 2%, respectively).
Slovenian: preskušanju SABRINA (BO22334) je bila incidenca z zdravljenjem povzročenega/okrepljenega nastajanja protiteles proti rituksimabu majhna in podobna v skupinah z intravensko in podkožno obliko zdravila (1,9 % v primerjavi z 2 %).
English: Cyclophosphamide (n = 98)
Slovenian: ciklofosfamid (n = 98)
English: In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving MabThera in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Slovenian: V preskušanju 1 je bilo pri bolnikih, ki so nezadovoljivo odgovorili na eno ali več zdravljenj z zaviralci TNF ali jih niso prenašali, in ki so prejemali zdravilo MabThera in metotreksat, po 56 tednih na posnetkih značilno manj znakov napredovanja kot pri tistih, ki so prvotno dobivali samo metotreksat.
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in -three clinical trials: SparkThera and SABRINA (the two trials in NHL) and SAWYER the CLL trial.
Slovenian: Tveganje za akutne reakcije, povezane z dajanjem podkožne oblike zdravila MabThera, so ocenili v treh kliničnih preskušanjih: SparkThera in SABRINA (preskušanji pri bolnikih z NHL) in SAWYER (preskušanje pri bolnikih s KLL).
English: arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Slovenian: aritmija, +atrijska fibrilacija, tahikardija, +srčna bolezen
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Slovenian: Incidenca trombocitopenije je bila nizka (< 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
English: The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Slovenian: Farmakokinetični profil zdravila MabThera, dajanega v 6 infuzijah po 375 mg/m2 v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega zdravila MabThera.
English: In patients with non-Hodgkin's lymphoma receiving MabThera in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin's lymphoma).
Slovenian: Pri bolnikih z ne-Hodgkinovim limfomom, ki so prejemali zdravilo MabThera v kombinaciji s citotoksično kemoterapijo, so poročali o primerih reaktivacije virusa hepatitisa B (glejte ne-Hodgkinov limfom).
English: Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Slovenian: Bolniki so prejeli 2 x 1000 mg zdravila MabThera v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
English: This is because some people have a fall in their blood pressure while they are being given MabThera.
Slovenian: Nekaterim ljudem se namreč med prejemanjem zdravila MabThera krvni tlak zniža;
English: 50 mL vial - Pack of 1 vial
Slovenian: 50-ml viale: škatla z 1 vialo
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of MabThera maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 4).
Slovenian: Podatki iz podaljšanega spremljanja bolnikov v študiji (mediana spremljanja 9 let) so potrdili dolgoročno korist vzdrževalnega zdravljenja z zdravilom MabThera glede na PFS, EFS, TNLT in TNCT (preglednica 4).
English: Keep this card with you for 2 years after your last dose of MabThera.
Slovenian: Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila MabThera,
English: Based on the mechanism of action of MabThera and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following MabThera therapy (see section 5.1).
Slovenian: Glede na mehanizem delovanja zdravila MabThera in dejstvo, da imajo celice B pomembno vlogo pri vzdrževanju normalnega imunskega odziva, imajo lahko bolniki, ki se zdravijo z zdravilom MabThera,
English: There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Slovenian: Ni dokazov, da bi sistemska izpostavljenost rHuPH20 povzročila dismorfogenezo (tj. teratogenost).
English: by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
Slovenian: do 4. četrtletja 2019 (preliminarno poročilo klinične študije) do 4. četrtletja 2020 (končno poročilo klinične študije)
English: Three patients (8%) in the MabThera group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Slovenian: V skupini z zdravilom MabThera se je pri 3 bolnikih (8 %) pojavilo 5 resnih okužb (pljučnica zaradi Pneumocystis jirovecii, infekcijska tromboza, intervertebralni disciitis, okužba pljuč, stafilokokna sepsa); v skupini s standardnim odmerkom prednizona se je resna okužba (pljučnica zaradi Pneumocystis jirovecii) pojavila pri 1 bolniku (3 %).
English: • Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Slovenian: · Kronična limfocitna levkemija (KLL) je najbolj pogosta oblika levkemije pri odraslih.
English: Patients who experience overdose or medication error with MabThera should be closely monitored.
Slovenian: Bolnike, pri katerih pride do prevelikega odmerjanja ali napake, povezane z zdravilom MabThera, je treba skrbno nadzorovati.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Slovenian: Klinični odzivi ob času primarnega cilja preskušanja 1 (populacija, ki so jo nameravali zdraviti) Izid†
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov 97 bolnikov z granulomatozo s poliangiitisom in z mikroskopskim poliangiitisom, ki so štiri tedne prejemali 375 mg/m2 zdravila MabThera enkrat na teden, je ocenjeni mediani končni razpolovni čas izločanja 23 dni (razpon: od 9 do 49 dni).
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Slovenian: Najpogosteje opaženi neželeni učinek pri prejemnikih zdravila MabThera so bile z infuzijo povezane reakcije, ki so se pri večini bolnikov pojavile med prvo infuzijo.
English: Specific studies to determine the effects of rituximab or rHuPH20 on fertility have not been performed.
Slovenian: Specifičnih študij za ugotavljanje učinkov rituksimaba ali rHuPH20 na plodnost niso izvedli.