natgillin/translations-raw huggingface dataset:
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rixathon.
Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rixathon.
Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov,
4 see also section infusion related reactions below.
4 Glejte tudi poglavje reakcije, povezane z infuzijo, spodaj.
All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose).
Vse bolnike so spremljali do 28. meseca (10 mesecev po zadnji infuziji rituksimaba ali 6 mesecev po zadnjem odmerku azatioprina).
The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z rituksimabom niso proučevali.
1 vial of 50 mL 2 vials of 50 mL
1 viala po 50 ml 2 viali po 50 ml
In a prospective, open label, international, multi-centre, phase III trial 1,193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1.193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n = 881), R-CVP (n = 268) ali R-FCM (n = 44) po presoji raziskovalca.
• you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na rituksimab, druge podobne beljakovine ali katero koli sestavino tega zdravila
Talk to your doctor, pharmacist or nurse before you are given Rixathon if:
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rixathon:
Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Rituksimab je pri 70 do 80 % bolnikov povzročilo zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Bolniki v skupini z rituksimabom, ki se jim je pojavil recidiv, so lahko prejeli dodatno infuzijo 1.000 mg rituksimaba v kombinaciji s ponovno uvedenim prednizonom ali povečanjem odmerka prednizona.
• high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood
• velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima LDH v krvi, majhna koncentracija kalcija v krvi,
No dose reductions of Rixathon are recommended.
Odmerka zdravila Rixathon ni priporočljivo zmanjšati.
Cumulative incidence over time of first major relapse
Slika 3: Kumulativna incidenca glede na čas prvega hujšega recidiva
The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Incidenca neželenih učinkov vseh stopenj ter učinkov 3. ali 4. stopnje je bila pri starejših bolnikih podobna kot pri mlajših (< 65 let).
What Rixathon is and what it is used for What you need to know before you are given Rixathon How Rixathon is given
Kaj je zdravilo Rixathon in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Rixathon Kako se daje zdravilo Rixathon
Following induction of remission with Rixathon, maintenance treatment should be initiated no sooner than 16 weeks after the last rituximab infusion.
Po indukciji remisije z zdravilom Rixathon se vzdrževalno zdravljenje ne sme začeti prej kot 16 tednov po zadnji infuziji rituksimaba.
When Rixathon is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Če zdravilo Rixathon uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
All patients in the cyclophosphamide arm received azathioprine maintenance therapy in during follow-up.
Vsi bolniki v skupini s ciklofosfamidom so med obdobjem spremljanja prejemali vzdrževalno zdravljenje z azatioprinom.
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%.
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 %.
• Infections such as pneumonia (bacterial)
• okužbe, kot je pljučnica (bakterijska okužba),
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).
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
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).
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.
Make sure you have a list of all your medicines when you see a health care professional.
Poskrbite, da boste na vsak pregled pri zdravniku prinesli seznam vseh drugih zdravil, ki jih uporabljate.
The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of > 0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Tudi delež z rituksimabom zdravljenih bolnikov, pri katerih se je pojavila minimalna klinično pomembna razlika (MCID, Minimal Clinically Important Difference) v HAQ-DI (opredeljena kot zmanjšanje individualne celotne ocene za > 0,22), je bil večji kot pri bolnikih, ki so prejemali samo metotreksat (preglednica 14).
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).
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).
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.
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.
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).
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).
• bacterial or viral infections, bronchitis
• bakterijske ali virusne okužbe, bronhitis,
Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin's lymphoma.
Varnosti in učinkovitosti rituksimaba v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
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
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.
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.
Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z rituksimabom, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla rituksimaba.
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%).
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 %).
• The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).
• Pomožne snovi so natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina in voda za injekcije (glejte poglavje 2).
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).
(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).
2 vials of 10 mL 3 vials of 10 mL
2 viali po 10 ml 3 viale po 10 ml
10 mL vial - Pack of 2 or 3 vials.
10-ml viale - pakiranje po 2 ali 3 viale.
Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Drugi neželeni učinki so: a) Če se zdravite zaradi ne-Hodgkinovega limfoma ali kronične limfocitne levkemije
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.
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.
Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Infuzija rituksimaba je sledila intravenski infuziji 100 mg metiprednizolona; bolniki so 15 dni tudi peroralno jemali prednizon.
No patients in the rituximab arm had fatal adverse events.
Noben bolnik v skupini z rituksimabom ni imel neželenih učinkov s smrtnim izidom.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN
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.
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).
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).
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).
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.
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.
Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
diagnosticiran po merilih Ameriškega revmatološkega združenja (ACR, American College of Rheumatology).
This is because some people have a fall in their blood pressure while they are being given Rixathon.
Nekaterim ljudem se namreč med prejemanjem zdravila Rixathon krvni tlak zniža;
Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Rixathon.
Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba zdravilo Rixathon ukiniti ali ga začasno prekiniti.
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.
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.
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.
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".
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.
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 %.
Elderly No dose adjustment is required in elderly patients (aged > 65 years).
Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
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).
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).
Rixathon is a biosimilar medicinal product.
Zdravilo Rixathon je podobno biološko zdravilo.
Patients with active hepatitis B disease should not be treated with Rixathon.
Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z zdravilom Rixathon.
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.
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
What Rixathon looks like and contents of the pack
Izgled zdravila Rixathon in vsebina pakiranja
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).
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).
Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.
Natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Priporočeni odmerek zdravila Rixathon je 1.000 mg z intravensko infuzijo, čemur sledi druga intravenska infuzija 1.000 mg 2 tedna pozneje.
Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10 - 25 mg/week).
Bolniki so prejeli 2 x 1.000 mg rituksimaba v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Najpogosteje zabeležena resna okužba v skupini bolnikov, ki so prejemali rituksimab, je bil blag ali zmeren bronhitis.
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).
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 %)
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%).
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 %).
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.
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.
Cyclophosphamide (n=98)
ciklofosfamid (n = 98)
Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Rituksimab lahko spremljajo reakcije, povezane z infuzijo, ki morda nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH,
V vseh podskupinah bolnikov (spol, starost, starosti prilagojen mednarodni prognostični indeks, stadij po klasifikaciji Ann Arbor, ECOG (Eastern
+Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
+miokardni infarkt4 in 6, aritmija, +atrijska fibrilacija, tahikardija,
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.
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.
50 mL vial - Pack of 1 or 2 vials.
50-ml viale - pakiranje po 1 ali 2 viali.
The clinical relevance of ADA formation in rituximab-treated PV patients is unclear.
Klinični pomen nastanka ADA pri bolnikih z navadnim pemfigusom, zdravljenih z rituksimabom, ni jasen.
1 vial contains 10 mg/mL rituximab.
1 viala vsebuje 10 mg/ml rituksimaba.
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).
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 %).
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Pri bolnikih, pri katerih se v tem času ne pokažejo znaki terapevtske koristi, je treba o ponovnem zdravljenju pazljivo razmisliti.
Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Med zdravljenjem z rituksimabom se lahko pojavijo resne okužbe, vključno s smrtnimi (glejte poglavje 4.8).
ORR, % CR, % Median TTF/PFS/ EFS mo
Mediane TTF/PFS/EFS (meseci)