FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Slovenian: Najpogosteje zabeležena okužba v skupini bolnikov, ki so prejemali rituksimab, je bila pljučnica; njena pogostnost je bila 4%.
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
Slovenian: Rezultati Po 28 mesecih so hujši recidiv (opredeljen kot ponoven pojav kliničnih in/ali laboratorijskih znakov aktivnosti vaskulitisa ([BVAS] > 0), ki bi lahko povzročil odpoved organa ali okvaro ali bi lahko bil življenjsko nevaren) zabeležili pri 3 bolnikih (5 %) v skupini z zdravilom rituksimab in pri 17 bolnikih (29 %) v skupini z azatioprinom (p = 0,0007).
English: Rituximab + Prednisone N=38
Slovenian: rituksimab + prednizon n = 38
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Slovenian: Starost, spol in stanje zmogljivosti po SZO niso vplivali na farmakokinetiko rituksimaba.
English: These reactions are less likely to happen after the second infusion.
Slovenian: Po drugi infuziji je pojav teh reakcij manj verjeten.
English: In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Slovenian: Pri bolnikih, ki so se zdravili z rituksimabom, so opazili simptomatiko že obstoječe ishemične bolezni srca, kot je angina pektoris, ter tudi atrijsko fibrilacijo in undulacijo.
English: Concentrate for solution for infusion 100 mg / 10 mL
Slovenian: koncentrat za raztopino za infundiranje 100 mg/10 ml
English: • feeling restless, problems falling asleep,
Slovenian: nemir, bolnik težko zaspi,
English: Seropositive (n=514)
Slovenian: Seropozitivni (n = 514)
English: Seronegative (n=101)
Slovenian: Seronegativni (n = 101)
English: Cyclophosphamide (n = 98)
Slovenian: Ciklofosfamid (n = 98)
English: The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Slovenian: Celokupen varnostni profil rituksimaba pri revmatoidnem artritisu je osnovan na podatkih bolnikov iz kliničnih preskušanj in spremljanja po prihodu zdravila na trg.
English: IgG immunoglobulins are known to cross the placental barrier.
Slovenian: Imunoglobulini IgG lahko prehajajo skozi placentno pregrado.
English: Laboratory evaluations
Slovenian: Laboratorijske preiskave
English: Observation N=513
Slovenian: Opazovanje rituksimab n = 513
English: Patients treated with Ritemvia must be given the patient alert card with each infusion.
Slovenian: Bolniki, ki prejemajo zdravilo Ritemvia, morajo ob vsaki infuziji dobiti opozorilno kartico.
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Slovenian: V preglednici 5 prikazani neželeni učinki so tisti, ki so se med bolniki z navadnim pemfigusom, zdravljenimi z zdravilom rituksimab, pojavili z ≥ 5-odstotnim deležem, absolutna razlika v njihovi pojavnosti med skupino z zdravilom rituksimab in skupino s standardnim odmerkom prednizona pa je bila do 24. meseca ≥ 2%.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of rituximab and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Slovenian: Sočasna/zaporedna uporaba drugih DMARD pri revmatoidnem artritisu Sočasna uporaba zdravila rituksimab in zdravil za zdravljenje revmatičnih bolezni, razen omenjenih v indikaciji in odmerjanju za revmatoidni artritis, ni priporočljiva.
English: The prepared infusion solution of rituximab in 5% glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Slovenian: Pripravljena infuzijska raztopina rituksimaba v 5-% raztopini D-glukoze je fizikalno in kemijsko stabilna 24 ur pri temperaturi 2 do 8 °C in nato še 12 ur pri sobni temperaturi (pri temperaturi do 30 °C).
English: Cardiac disorders angina pectoris, atrial fibrillation, heart failure,
Slovenian: Srčne bolezni angina pektoris, atrijska fibrilacija,
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Slovenian: V študiji pri bolnikih s KLL v prvi liniji zdravljenja so imeli bolniki s stopnjo C po Binetu več neželenih dogodkov v skupini R-FC v primerjavi s skupino FC (R-FC 83% proti FC 71%).
English: The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30 °C).
Slovenian: Pripravljena infuzijska raztopina rituksimaba v 0.9-% raztopini natrijevega klorida je fizikalno in kemijsko stabilna 30 dni pri temperaturi 2 do 8 °C in nato še 24 ur pri sobni temperaturi (pri temperaturi do 30 °C).
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Slovenian: motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk,
English: Following induction of remission with Ritemvia, maintenance treatment should be initiated no sooner than 16 weeks after the last Ritemvia infusion.
Slovenian: Po indukciji remisije z zdravilom Ritemvia se vzdrževalnega zdravljenja ne sme začeti prej kot 16 tednov po zadnji infuziji zdravila Ritemvia.
English: Hepatitis B Infections
Slovenian: Okužbe s hepatitisom B
English: Psychiatric disorders depression, anxiety
Slovenian: Psihiatrične motnje depresija, anksioznost
English: Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Slovenian: Zdravilo Ritemvia je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksirubicin, vinkristin, prednizolon).
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Slovenian: Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba zdravilo rituksimab ukiniti ali ga začasno prekiniti.
English: The incidence of IRRs declined with subsequent infusions.
Slovenian: Incidenca reakcij, povezanih z infuzijo, je bila pri nadaljnjih infuzijah manjša.
English: Ritemvia should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Slovenian: Zdravilo Ritemvia je treba dajati prvi dan vsakega cikla kemoterapije po uporabi glukokortikoidne sestavine kemoterapije, če jo shema vsebuje.
English: The most common infusion-related reaction symptoms/Preferred Terms included headaches, chills, high blood pressure, nausea, asthenia and pain.
Slovenian: Najpogostejši simptomi/prednostni izrazi z infundiranjem povezane reakcije so bili glavobol, mrzlica, visok krvni tlak, slabost, astenija in bolečina.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Slovenian: Primeri teh resnih virusnih okužb so okužbe, ki jih povzročajo herpesvirusi (citomegalovirus, virus varicela zoster in virus herpes simpleks), virus JC (progresivna multifokalna levkoencefalopatija) in virus hepatitisa C. O smrtnih primerih PML, do katerih je prišlo po napredovanju bolezni in ponovnem zdravljenju, so poročali tudi v kliničnih preskušanjih.
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of rituximab in NHL and CLL (see section 4.8).
Slovenian: V obdobju trženja so bili med uporabo rituksimaba pri zdravljenju NHL in KLL opisani zelo redki primeri progresivne multifokalne levkoencefalopatije (PML) (glejte poglavje 4.8).
English: Time to new lymphoma treatment
Slovenian: Čas do ponovnega protilimfomskega zdravljenja
English: Subsequent doses of Ritemvia can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Slovenian: Nadaljnje odmerke zdravila Ritemvia lahko dajemo z začetno hitrostjo 100 mg/h, ki jo lahko vsakih 30 minut povečujemo po 100 mg/h, dokler ne dosežemo največje hitrosti infundiranja 400 mg/h.
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively.
Slovenian: Povprečni očistek rituksimaba je bil 0,313 l/dan (razpon: od 0,116 do 0,726 l/dan, volumen porazdelitve pa 4,50 l (razpon: od 2,25 do 7,39 l).
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Slovenian: Med drugimi resnimi neželenimi učinki so poročali tudi o reaktivaciji virusa hepatitisa B in o PML (glejte poglavje 4.4).
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4).
Slovenian: Število bolnikov z rituksimabom in majhnim odmerkom prednizona (brez prednizonskega zdravljenja ali z minimalnim zdravljenjem (odmerek prednizona 10 mg ali manj na dan)) v primerjavi z bolniki s standardnim odmerkom prednizona v obdobju 24-mesečnega zdravljenja kaže, da zdravilo rituksimab zmanjša potrebo po kortikosteroidih (slika 4).
English: Persistent depressive disorder Major depression Irritability
Slovenian: Psihiatrične motnje dolgotrajna depresivna motnja velika depresija razdražljivost
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: The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Slovenian: Najpogosteje zabeležena resna okužba v skupini bolnikov, ki so prejemali zdravilo rituksimab, je bil blag ali zmeren bronhitis.
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom Ritemviarituksimab niso proučevali.
English: Ritemvia contains sodium
Slovenian: Zdravilo Ritemvia vsebuje natrij
English: There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
Slovenian: Potem, ko je prišlo do znižanja IgG in IgM, se delež vseh okužb ali resnih okužb ni povišal (glejte poglavje 4.4).
English: Maintenance doses of 500 mg IV were administered at months 12 and 18.
Slovenian: Vzdrževalna odmerka 500 mg intravensko sta bila uporabljena 12. in 18. mesec.
English: Rituximab was administered at a dosage of 375 mg/m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/m2 on day 1 of each subsequent treatment cycle.
Slovenian: Rituksimab so v prvem ciklu zdravljenja dajali v odmerku 375 mg/m2 en dan pred kemoterapijo in v odmerku 500 mg/m2 1. dan vsakega naslednjega cikla zdravljenja.
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups.
Slovenian: V kliničnem preskušanju za oceno vzdrževalnega zdravljenja z rituksimabom pri ponovitvi folikularnih limfomov ali neodzivni bolezni je bila mediana koncentracije IgG po indukcijskem zdravljenju pod spodnjo mejo normalne vrednosti (SMN) (< 7 g/L) tako v opazovani skupini kot v skupini z rituksimabom.
English: The clinical relevance of ADA formation in rituximab-treated PV patients is unclear.
Slovenian: Klinični pomen nastanka ADA pri bolnikih z navadnim pemfigusom, zdravljenih z rituksimab, ni jasen.
English: Clinical experience in rheumatoid arthritis
Slovenian: Klinične izkušnje pri revmatoidnem artritisu
English: 95% CIb
Slovenian: 95-% IZb
English: Investigations decreased IgM levels4
Slovenian: Preiskave zmanjšane koncentracije IgM4
English: Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test).
Slovenian: Zdravljenje z R-CVP je značilno podaljšalo čas do napredovanja bolezni ali smrti v primerjavi s CVP (33,6 meseca v primerjavi s 14,7 meseca, p < 0,0001, log-rang test).
English: In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of rituximab.
Slovenian: V študiji, osnovani za proučitev varnosti hitrejše infuzije rituksimaba pri bolnikih z revmatoidnim artritisom, so bolniki z zmerno do hudo aktivnim revmatoidnim artritisom, ki niso imeli resne reakcije, povezane z infuzijo, med ali v 24 urah po prvem infundiranju, lahko prejeli 2-urno intravensko infuzijo rituksimaba.
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Slovenian: V študijah z rituksimabom v kombinaciji s kemoterapijo je bila incidenca motenj srčnega ritma 3. ali 4. stopnje, predvsem supraventrikularnih aritmij, kot sta tahikardija in atrijska fibrilacija/undulacija, višja v skupini R-CHOP (14 bolnikov, 6,9%) kot pa v skupini CHOP (3 bolniki, 1,5%).
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000).
Slovenian: (≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10000).
English: 2) Last tumour response as assessed by the investigator.
Slovenian: 1) Ocene so izračunane z razmerjem ogroženosti 2) Zadnji odgovor na zdravljenje, ki ga je določil raziskovalec.
English: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Slovenian: Rituksimab je pri 70 do 80 % bolnikov povzročil zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
English: The overall safety profile of rituximab in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Slovenian: Celotni varnostni profil rituksimaba pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji (KLL) temelji na podatkih bolnikov iz kliničnih preskušanj in iz nadzora med obdobjem trženja.
English: • The need to check, prior to Ritemvia treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Slovenian: • informacije o nujnosti, da pred dajanjem zdravila Ritemvia preverijo, ali je bolnik morda okužen, imunsko oslabljen, ali jemlje zdravila, ki vplivajo na imunski sistem, ali jih je jemal v preteklosti, ali se je nedavno cepili oziroma to namerava,
English: 53-months p=0.029
Slovenian: 53 mesecev p = 0,029
English: % HAQ‐DI MCID Mean change in FACIT‐T
Slovenian: % bolnikov z MCID v HAQ-DI Povprečna sprememba FACIT-T
English: The rate of serious infections did not show any significant increase following multiple courses of rituximab.
Slovenian: Delež resnih okužb se z nadaljnjimi cikli zdravljenja z rituksimabom ni pomembno povečeval.
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Slovenian: Kaplan-Meierjeva ocena mediane trajanja preživetja brez dogodkov po Kaplan-Meierju je bila 35 mesecev v skupini R-CHOP v primerjavi s 13 meseci v skupini CHOP; to pomeni zmanjšanje tveganja za dogodke za 41%.
English: During this time, 81% of patients, from the original placebo group received rituximab between weeks 24 and 56, under an open label extension study protocol.
Slovenian: Med tem časom je 81% bolnikov, ki so prvotno dobivali placebo, v sklopu odprte, podaljšane faze študije prejelo rituksimab med 24. in 56. tednom.
English: Events of neutropenia were observed with rituximab treatment, the majority of which were transient and mild or moderate in severity.
Slovenian: Pri zdravljenju z rituksimabom so opazili dogodke nevtropenije, ki so bili večinoma prehodni in po resnosti blagi ali zmerni.
English: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Slovenian: neobvladljiva bolezen srca (glejte poglavje 4.4 glede drugih srčno-žilnih bolezni).
English: Whether rituximab is excreted in human milk is not known.
Slovenian: Ni znano, ali se rituksimab izloča v materino mleko.
English: In a further clinical study, a total of 57 severe active GPA and MPA patients in disease remission were treated with rituximab 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 rituksimab za vzdrževanje remisije (glejte poglavje 5.1).
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Slovenian: Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55 % bolnikov z neHodgkinovim limfomom in pri 30-50% bolnikov s KLL.
English: Seronegative (n=106)
Slovenian: Seronegativni (n = 106)
English: Infusion-related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Slovenian: 1 Dogodke so kot neželene učinke ocenili šele po natančni oceni in v primerih, v katerih je bila vzročna povezanost med zdravilom in neželenim učinkom vsaj smiselna možnost.
English: • changes in the rhythm of the heart, or the heart beating faster than normal
Slovenian: • spremembe v srčnem ritmu ali hitrejše (kot je običajno) bitje srca.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Slovenian: Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2%, v skupini CHOP pa 62,4 % (p=0,0028).
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving rituximab were IRRs which occurred in the majority of patients during the first infusion.
Slovenian: Najpogosteje opaženi neželeni učinek pri prejemnikih rituksimaba so bile z infuzijo povezane reakcije, ki so se pri večini bolnikov pojavile med prvo infuzijo.
English: 99 patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Slovenian: Devetindevetdeset bolnikov so za indukcijo remisije GPA in MPA zdravili z rituksimabom (375 mg/m2 enkrat na teden 4 tedne) in z glukokortikoidi (glejte poglavje 5.1).
English: Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course.
Slovenian: Resne z infuzijo povezane reakcije so bile občasne (0,5 % bolnikov) in so se večinoma pojavile med prvim ciklom zdravljenja.
English: Although subgroups were small, rituximab maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Slovenian: Čeprav so bile podskupine majhne, je vzdrževalno zdravljenje z rituksimabom pomembno povečalo korist v smislu celokupnega preživetja za bolnike, odzivne na CHOP in R-CHOP.
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2).
Slovenian: Najpogostejši neželeni učinki po prejemu rituksimaba v kliničnih preskušanjih so bile reakcije, povezane z infuzijo (glejte preglednico 2).
English: No patients in the rituximab arm had fatal adverse events.
Slovenian: Noben bolnik v skupini z rituksimab ni imel neželenih učinkov s smrtnim izidom.
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
Slovenian: Pri vseh bolnikih je treba pred začetkom zdravljenja z zdravilom rituksimab narediti presejalni test na virus hepatitisa B (HBV).
English: • The importance of sharing this information with their partner or caregiver
Slovenian: • pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom, • informacije o opozorilni kartici za bolnika.
English: Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Slovenian: Zdravilo Ritemvia je v kombinaciji z glukokortikoidi indicirano za zdravljenje odraslih bolnikov s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z mikroskopskim poliangiitisom (MPA).
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Slovenian: Pri bolnikih, pri katerih pride do prevelikega odmerjanja, je treba infundiranje nemudoma prekiniti; bolnike pa skrbno nadzorovati.
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Slovenian: Najpogostejši simptomi so bile alergijske reakcije, kot so glavobol, pruritus, draženje žrela, pordevanje, kožni izpuščaj, urtikarija, hipertenzija in pireksija.
English: late neutropenia2
Slovenian: pozna nevtropenija2
English: cranial neuropathy, loss of other senses5
Slovenian: kranialna nevropatija, poslabšanje drugih čutov5
English: • The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections.
Slovenian: • Druge sestavine zdravila so natrijev klorid, trinatrijev citrat dihidrat, polisorbat 80 in voda za injekcije.
English: Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Slovenian: Zdravilo rituksimab lahko povzroči reakcije, povezane z infuzijo, ki nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
English: late neutropenia2 serum sickness-like reaction
Slovenian: pozna nevtropenija2 reakcija, podobna serumski bolezni