natgillin/translations-raw huggingface dataset:
Trials of rituximab in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
V preskušanjih z rituksimabom pri bolnikih z zgodnjim artritisom (bolniki, ki se še niso zdravili z metotreksatom in bolniki z nezadostnim odzivom na metotreksat, ki se še niso zdravili z zaviralci TNFalfa) so bili primarni cilji doseženi.
B-lymphocytes are involved in the cause of these conditions.
V nastanek teh bolezni so vpleteni limfociti B.
In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
V kliničnem preskušanju, v katerem so proučevali indukcijo remisije pri hudi aktivni GPA in MPA, so bile z infuzijo povezane reakcije (IRR - infusion-related reactions) opredeljene kot neželeni učinki, ki so se pojavili v 24 urah po infuziji in so jih raziskovalci v varnostni populaciji ocenili kot povezane z infuzijo.
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Ritemvia infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo), mikroskopskim poliangiitisom v remisiji ali navadnim pemfigusom je treba 30 minut pred pričetkom infundiranja zdravila Ritemvia zaključiti z intravenskim dajanjem 100 mg metilprednizolona za zmanjšanje incidence in resnosti reakcij, povezanih z infuzijo.
Patients received 2 x 1000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Bolniki so prejeli dve intravenski infuziji po 1000 mg rituksimaba ali placeba v kombinaciji z metotreksatom.
In patients treated with cyclophosphamide (followed by azathioprine for maintenance of complete remission), 39% of patients achieved CR at 12 months, and 33% of patients achieved CR at 18 months.
Med bolniki, zdravljenimi s ciklofosfamidom (ki mu je sledil azatioprin za vzdrževanje popolne remisije) je 39 % bolnikov doseglo popolno remisijo po 12 mesecih in 33 % bolnikov po 18 mesecih.
In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and 0.27% (2/731) of placebo-treated patients developed severe neutropenia.
V kliničnih preskušanjih, nadzorovanih s placebom, je pri 0,94 % (13/1382) bolnikov, zdravljenih z rituksimabom in pri 0,27 % (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude nevtropenije.
40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Na zdravljenje se je odzvalo 40 % bolnikov z infiltracijo kostnega mozga v primerjavi z 59 % bolnikov brez infiltracije kostnega mozga (p = 0,0186).
Cases of hepatitis B reactivation, have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Poročali so o reaktivaciji virusa hepatitisa B, večinoma pri bolnikih, ki so prejemali rituksimab v kombinaciji s citotoksično kemoterapijo.
During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Med obdobjem zdravljenja (faza indukcijskega zdravljenja, ki je obsegalo R-CHOP vsaj osem ciklov) so se pri štirih bolnikih (2%), zdravljenih z R-CHOP, ki so vsi imeli kardiovaskularne dejavnike tveganja,
In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6month primary endpoint.
V kliničnem preskušanju indukcije remisije, v katerega so prejeli vključili 99 bolnikov, zdravljenih rituksimab, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na 100 bolnik let (95-% interval zaupanja, 197-285).
Blood and lymphatic system disorders neutropenia1
Bolezni krvi in limfatičnega sistema nevtropenija1
• The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
• informacije o nujnosti svetovanja bolnikom glede tveganja za okužbe in PML, vključno s simptomi, na katere naj bodo pozorni, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če izkusijo katerega od simptomov,
Severe cytokine release syndrome is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.
Za hud sindrom sproščanja citokinov je značilna huda dispneja, ki jo pogosto spremljata bronhospazem in hipoksija, poleg zvišane telesne temperature, mrzlice, drgetanja, urtikarije in angioedema.
Experience from pemphigus vulgaris
Navadni pemfigus (pemphigus vulgaris)
+myocardial infarction4 and 6, arrhythmia, +atrial fibrillation,
+miokardni infarkt4 in 6, aritmija, +atrijska fibrilacija, tahikardija,
Ritemvia is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Zdravilo Ritemvia se uporablja za zdravljenje granulomatoze s poliangiitisom (prej imenovane Wegenerjeva granulomatoza) ali mikroskopskega poliangiitisa; daje se v kombinaciji s kortikosteroidi.
In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
V skupini, ki je prejemala rituksimab, je 48 % bolnikov doseglo popolno remisijo po 12 mesecih in 39 % bolnikov po 18 mesecih.
These are often colds, but there have been cases of pneumonia or urinary infections.
Te okužbe so pogosto prehladi, opisani pa so bili tudi primeri pljučnice in okužb sečil.
The overall safety profile was consistent with the well-established safety profile for rituximab in approved autoimmune indications, including GPA/MPA.
Na splošno so se varnostne značilnosti ujemale z dobro znanimi varnostnimi značilnostmi rituksimab pri odobrenih avtoimunskih indikacijah, vključno z GPA/MPA.
They were characterised by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
Značilni zanje so bili pljučni dogodki in v nekaterih primerih hiter razpad tumorja z značilnostmi sindroma razpada tumorja, poleg zvišane telesne temperature, mrzlice, drgetanja, hipotenzije, urtikarije, angioedema in drugih simptomov (glejte poglavje 4.8).
Table 13 Radiographic outcomes at 1 year (mITT population)
Radiološki izidi po 1 letu v študiji 1 (populacija, ki so jo nameravali zdraviti).
The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Najpogosteje zabeležena okužba v skupini bolnikov, ki so prejemali rituksimab, je bila pljučnica; njena pogostnost je bila 4%.
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).
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).
Rituximab + Prednisone N=38
rituksimab + prednizon n = 38
Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Starost, spol in stanje zmogljivosti po SZO niso vplivali na farmakokinetiko rituksimaba.
These reactions are less likely to happen after the second infusion.
Po drugi infuziji je pojav teh reakcij manj verjeten.
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.
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.
Concentrate for solution for infusion 100 mg / 10 mL
koncentrat za raztopino za infundiranje 100 mg/10 ml
• feeling restless, problems falling asleep,
nemir, bolnik težko zaspi,
The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Celokupen varnostni profil rituksimaba pri revmatoidnem artritisu je osnovan na podatkih bolnikov iz kliničnih preskušanj in spremljanja po prihodu zdravila na trg.
IgG immunoglobulins are known to cross the placental barrier.
Imunoglobulini IgG lahko prehajajo skozi placentno pregrado.
Laboratory evaluations
Laboratorijske preiskave
Observation N=513
Opazovanje rituksimab n = 513
Patients treated with Ritemvia must be given the patient alert card with each infusion.
Bolniki, ki prejemajo zdravilo Ritemvia, morajo ob vsaki infuziji dobiti opozorilno kartico.
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 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%.
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.
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.
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).
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).
Cardiac disorders angina pectoris, atrial fibrillation, heart failure,
Srčne bolezni angina pektoris, atrijska fibrilacija,
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%).
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%).
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).
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).
• blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk,
Following induction of remission with Ritemvia, maintenance treatment should be initiated no sooner than 16 weeks after the last Ritemvia infusion.
Po indukciji remisije z zdravilom Ritemvia se vzdrževalnega zdravljenja ne sme začeti prej kot 16 tednov po zadnji infuziji zdravila Ritemvia.
Hepatitis B Infections
Okužbe s hepatitisom B
Psychiatric disorders depression, anxiety
Psihiatrične motnje depresija, anksioznost
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.
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).
Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba zdravilo rituksimab ukiniti ali ga začasno prekiniti.
The incidence of IRRs declined with subsequent infusions.
Incidenca reakcij, povezanih z infuzijo, je bila pri nadaljnjih infuzijah manjša.
Ritemvia should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Zdravilo Ritemvia je treba dajati prvi dan vsakega cikla kemoterapije po uporabi glukokortikoidne sestavine kemoterapije, če jo shema vsebuje.
The most common infusion-related reaction symptoms/Preferred Terms included headaches, chills, high blood pressure, nausea, asthenia and pain.
Najpogostejši simptomi/prednostni izrazi z infundiranjem povezane reakcije so bili glavobol, mrzlica, visok krvni tlak, slabost, astenija in bolečina.
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.
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).
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).
Time to new lymphoma treatment
Čas do ponovnega protilimfomskega zdravljenja
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.
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.
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.
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).
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Med drugimi resnimi neželenimi učinki so poročali tudi o reaktivaciji virusa hepatitisa B in o PML (glejte poglavje 4.4).
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).
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).
Persistent depressive disorder Major depression Irritability
Psihiatrične motnje dolgotrajna depresivna motnja velika depresija razdražljivost
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.
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 %.
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 zdravilo rituksimab, je bil blag ali zmeren bronhitis.
The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom Ritemviarituksimab niso proučevali.
Ritemvia contains sodium
Zdravilo Ritemvia vsebuje natrij
There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
Potem, ko je prišlo do znižanja IgG in IgM, se delež vseh okužb ali resnih okužb ni povišal (glejte poglavje 4.4).
Maintenance doses of 500 mg IV were administered at months 12 and 18.
Vzdrževalna odmerka 500 mg intravensko sta bila uporabljena 12. in 18. mesec.
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.
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.
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.
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.
The clinical relevance of ADA formation in rituximab-treated PV patients is unclear.
Klinični pomen nastanka ADA pri bolnikih z navadnim pemfigusom, zdravljenih z rituksimab, ni jasen.
Clinical experience in rheumatoid arthritis
Klinične izkušnje pri revmatoidnem artritisu
95% CIb
95-% IZb
Investigations decreased IgM levels4
Preiskave zmanjšane koncentracije IgM4
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).
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).
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.
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.
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%).
(≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000).
(≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10000).
2) Last tumour response as assessed by the investigator.
1) Ocene so izračunane z razmerjem ogroženosti 2) Zadnji odgovor na zdravljenje, ki ga je določil raziskovalec.
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 povzročil zmanjšanje števila celic B, z zmanjšanjem koncentracije imunoglobulinov v serumu pa je bilo povezano le malo primerov.
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.
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.
• 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
• 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,
53-months p=0.029
53 mesecev p = 0,029
% HAQ‐DI MCID Mean change in FACIT‐T
% bolnikov z MCID v HAQ-DI Povprečna sprememba FACIT-T
The rate of serious infections did not show any significant increase following multiple courses of rituximab.
Delež resnih okužb se z nadaljnjimi cikli zdravljenja z rituksimabom ni pomembno povečeval.
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%.
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.
Med tem časom je 81% bolnikov, ki so prvotno dobivali placebo, v sklopu odprte, podaljšane faze študije prejelo rituksimab med 24. in 56. tednom.
Events of neutropenia were observed with rituximab treatment, the majority of which were transient and mild or moderate in severity.
Pri zdravljenju z rituksimabom so opazili dogodke nevtropenije, ki so bili večinoma prehodni in po resnosti blagi ali zmerni.
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
neobvladljiva bolezen srca (glejte poglavje 4.4 glede drugih srčno-žilnih bolezni).
Whether rituximab is excreted in human milk is not known.
Ni znano, ali se rituksimab izloča v materino mleko.
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)
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).