FrancophonIA/ELRC3.0 huggingface dataset:
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: • Infections such as pneumonia (bacterial)
Slovenian: • okužbe, kot je pljučnica (bakterijska okužba),
English: If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1,000 mg Rixathon 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 1.000 mg zdravila Rixathon, 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 250
English: The best responses to Rixathon 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 Rixathon se najbolje odzovejo tisti bolniki, pri katerih je krvni test za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP) pozitiven.
English: Make sure you have a list of all your medicines when you see a health care professional.
Slovenian: Poskrbite, da boste na vsak pregled pri zdravniku prinesli seznam vseh drugih zdravil, ki jih uporabljate.
English: 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).
Slovenian: 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).
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Slovenian: Mediano trajanje odgovora je bilo 37,7 meseca v skupini z R-CVP in 13,5 meseca v skupini s CVP (p < 0,0001, log-rank test).
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 ne-Hodgkinovim limfomom in pri 30-50 % bolnikov s KLL.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rixathon, 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: Granulomatoza s poliangiitisom in mikroskopski poliangiitis Zdravilo Rixathon 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: • bacterial or viral infections, bronchitis
Slovenian: • bakterijske ali virusne okužbe, bronhitis,
English: Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin's lymphoma.
Slovenian: Varnosti in učinkovitosti rituksimaba v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
English: The Patient educational leaflet about Rixathon contains the following key elements: - Detailed information on the risk of infections and PML - Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any - The importance of sharing this information with their partner or caregiver - Information on the Patient Alert Card
Slovenian: Izobraževalni letak za bolnika o zdravilu Rixathon vsebuje naslednje ključne vsebine: - podrobne podatke o tveganju za okužbe in PML, - informacije o znakih in simptomih okužb, še posebno PML, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od znakov ali simptomov, - pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom, - informacije o opozorilni kartici za bolnika.
English: Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Slovenian: Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z rituksimabom, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla 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: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).
Slovenian: • Pomožne snovi so natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina in voda za injekcije (glejte poglavje 2).
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Slovenian: (n = 15) je bila 408 µg/ml (od 97 do 764 µg/ml) po peti infuziji 500 mg/m2, povprečni končni razpolovni čas pa je bil 32 dni (od 14 do 62 dni).
English: 2 vials of 10 mL 3 vials of 10 mL
Slovenian: 2 viali po 10 ml 3 viale po 10 ml
English: 10 mL vial - Pack of 2 or 3 vials.
Slovenian: 10-ml viale - pakiranje po 2 ali 3 viale.
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Slovenian: Drugi neželeni učinki so: a) Če se zdravite zaradi ne-Hodgkinovega limfoma ali kronične limfocitne levkemije
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Slovenian: Farmakokinetični profil rituksimaba, dajanega v 6 infuzijah po 375 mg/m2 v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega rituksimab.
English: Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Slovenian: Infuzija rituksimaba je sledila intravenski infuziji 100 mg metiprednizolona; bolniki so 15 dni tudi peroralno jemali prednizon.
English: No patients in the rituximab arm had fatal adverse events.
Slovenian: Noben bolnik v skupini z rituksimabom ni imel neželenih učinkov s smrtnim izidom.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN
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 rituximab (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 rituksimaba (58 bolnikov).
English: Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p < 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Slovenian: Vzdrževalno zdravljenje z rituksimabom je pomembno podaljšalo mediano PFS pri bolnikih, odzivnih na indukcijsko zdravljenje s CHOP (mediana PFS 37,5 meseca v primerjavi z 11,6 meseca, p < 0,0001), kot tudi pri bolnikih, odzivnih na indukcijsko zdravljenje z R-CHOP (mediana PFS 51,9 meseca v primerjavi z 22,1 meseca, p = 0,0071).
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both.
Slovenian: Bolniki, serološko pozitivni za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (antiCCP), ki so prejemali rituksimab v kombinaciji z metotreksatom, so imeli izrazitejši odziv kot bolniki, negativni za oba.
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Slovenian: diagnosticiran po merilih Ameriškega revmatološkega združenja (ACR, American College of Rheumatology).
English: This is because some people have a fall in their blood pressure while they are being given Rixathon.
Slovenian: Nekaterim ljudem se namreč med prejemanjem zdravila Rixathon krvni tlak zniža;
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Rixathon.
Slovenian: Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba zdravilo Rixathon ukiniti ali ga začasno prekiniti.
English: Following induction of remission with other standard of care immunosuppressants, Rixathon 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 Rixathon začeti v 4-tedenskem obdobju po remisiji bolezni.
English: All IRR symptoms were mild or moderate and most of them were reported from the SOCs Respiratory, Thoracic and Mediastinal Disorders and Skin and Subcutaneous Tissue disorders.
Slovenian: Vsi simptomi IRR so bili blagi ali zmerni in večina jih je bila zabeležena pri organskih sistemih "Bolezni dihal, prsnega koša in mediastinalnega prostora" in "Bolezni kože in podkožja".
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group.
Slovenian: Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rank test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
English: Elderly No dose adjustment is required in elderly patients (aged > 65 years).
Slovenian: Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Rixathon (the last dose of methylprednisolone may be given on the same day as the first infusion of Rixathon).
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila Rixathon priporočljiva intravenska uporaba metilprednizolona, ki se ga daje od 1 do 3 dni v odmerku 1.000 mg na dan (zadnji odmerek metilprednizolona je lahko uporabljen na dan prve infuzije zdravila Rixathon).
English: Rixathon is a biosimilar medicinal product.
Slovenian: Zdravilo Rixathon je podobno biološko zdravilo.
English: Patients with active hepatitis B disease should not be treated with Rixathon.
Slovenian: Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z zdravilom Rixathon.
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 rituksimabom, pojavili z ≥ 5-odstotnim deležem, absolutna razlika v njihovi pojavnosti med skupino z rituksimabom in skupino s standardnim odmerkom prednizona pa je bila do 24. meseca
English: What Rixathon looks like and contents of the pack
Slovenian: Izgled zdravila Rixathon in vsebina pakiranja
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Slovenian: Vzdrževalno zdravljenje z rituksimabom je pokazalo konsistentno korist pri vseh preiskovanih, vnaprej opredeljenih podskupinah glede na spol (moški, ženski), starost (< 60 let, ≥ 60 let), oceno po indeksu FLIPI (Follicular Lymphoma International Prognostic Index) (≤ 1, 2 ali ≥ 3), indukcijsko zdravljenje (R-CHOP, R-CVP ali R-FCM) in ne glede na odgovor na indukcijsko zdravljenje (CR/CRu ali PR).
English: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: Natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
English: The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Slovenian: Priporočeni odmerek zdravila Rixathon je 1.000 mg z intravensko infuzijo, čemur sledi druga intravenska infuzija 1.000 mg 2 tedna pozneje.
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10 - 25 mg/week).
Slovenian: Bolniki so prejeli 2 x 1.000 mg rituksimaba v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
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 rituksimab, je bil blag ali zmeren bronhitis.
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: 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 rituksimabom in pri 17 bolnikih (29 %)
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p < 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Slovenian: Delež bolnikov z odgovorom na zdravljenje (CR, CRu - nepotrjeni popolni odgovor (complete response/uncomfirmed), PR) je bil značilno večji (p < 0,0001, test hi-kvadrat) v skupini R- CVP (80,9 %) kot v skupini CVP (57,2 %).
English: Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
Slovenian: Manj pogosto se lahko pri nekaterih bolnikih pojavijo bolečina na mestu infundiranja, mehurji, srbenje, slabost (navzea), utrujenost, glavobol, težave z dihanjem, zvišan krvni tlak, piskajoče dihanje, nelagodje v grlu, otekanje jezika ali grla, srbeč ali smrkav nos, bruhanje, pordevanje ali hitro in močno utripanje srca, srčna kap ali nizko število trombocitov.
English: Cyclophosphamide (n=98)
Slovenian: ciklofosfamid (n = 98)
English: Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Slovenian: Rituksimab lahko spremljajo reakcije, povezane z infuzijo, ki morda nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH,
Slovenian: V vseh podskupinah bolnikov (spol, starost, starosti prilagojen mednarodni prognostični indeks, stadij po klasifikaciji Ann Arbor, ECOG (Eastern
English: +Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Slovenian: +miokardni infarkt4 in 6, aritmija, +atrijska fibrilacija, tahikardija,
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: 50 mL vial - Pack of 1 or 2 vials.
Slovenian: 50-ml viale - pakiranje po 1 ali 2 viali.
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 rituksimabom, ni jasen.
English: 1 vial contains 10 mg/mL rituximab.
Slovenian: 1 viala vsebuje 10 mg/ml rituksimaba.
English: Three patients (8%) in the rituximab 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 rituksimabom 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: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Slovenian: Pri bolnikih, pri katerih se v tem času ne pokažejo znaki terapevtske koristi, je treba o ponovnem zdravljenju pazljivo razmisliti.
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Slovenian: Med zdravljenjem z rituksimabom se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
English: ORR, % CR, % Median TTF/PFS/ EFS mo
Slovenian: Mediane TTF/PFS/EFS (meseci)
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 120-minutne 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: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Slovenian: • alergijske reakcije, ki se najverjetneje pojavijo med infuzijo, a se lahko pojavijo tudi do 24 ur po infuziji,
English: Medicines given before each Rixathon administration
Slovenian: Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila Rixathon
English: Event free survival Response rate (CR, nPR, or PR) CR rates n.a. n.a.
Slovenian: preživetje brez dogodka odgovor (CR, nPR ali PR) CR
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of Rixathon 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 Rixathon in zdravil za zdravljenje revmatičnih bolezni, razen omenjenih v indikaciji in odmerjanju za revmatoidni artritis, ni priporočljiva.
English: A total of 392/3,095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Slovenian: Klinični laboratorijski rezultati Skupno je bilo 392 od 3.095 (12,7 %) bolnikov z revmatoidnim artritisom v kliničnih študijah zdravljenja z rituksimabom pozitivnih na ADA.
English: 18-months p=0.016
Slovenian: 18 mesecev p = 0,016
English: • producing more tears, tear duct problems, inflamed eye (conjunctivitis)
Slovenian: • močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis),
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: In clinical trials with rituximab monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Slovenian: V kliničnih preskušanjih z rituksimabom kot samostojnim zdravilom, ki so ga bolniki prejemali 4 tedne, so se pri manjšem številu bolnikov pojavile hematološke nepravilnosti, ki pa so bile običajno blage in reverzibilne.
English: • Pain on passing water (urinary tract infection)
Slovenian: • bolečina pri uriniranju (okužba sečil),
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of rituximab.
Slovenian: Zdravila za zdravljenje preobčutljivostnih reakcij, npr. adrenalin, antihistaminiki in glukokortikoidi, morajo biti nemudoma na voljo, če bi se med dajanjem rituksimaba pojavile alergijske reakcije.
English: • Rixathon will be given to you once a week for 4 weeks.
Slovenian: ga boste prejeli enkrat na teden 4 tedne.