natgillin/translations-raw huggingface dataset:
A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 5a and Table 5b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 6) were analysed for efficacy.
V analizo učinkovitosti je bilo vključenih skupno 810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 5a ter 5b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 6).
Patients with active hepatitis B disease should not be treated with rituximab.
Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z rituksimabom.
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 proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Delež bolnikov, pri katerih so se pojavili neželeni učinki, povezani s srcem (vsi ali resni), se z nadaljnjimi cikli
Table 4 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Povzetek ključnih rezultatov štirih randomiziranih preskušanj III. faze, ki so ocenjevala korist rituksimaba v kombinaciji z različnimi shemami kemoterapije pri
These are listed below under “Other side effects”.
Naštete so spodaj pod naslovom Drugi
The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 5b).
Korist v smislu preživetja brez napredovanja bolezni so konsistentno opažali pri večini podskupin, ki so jih analizirali glede na tveganje bolezni pred vključitvijo (npr. stopnjo po Binetu A-C) (preglednica 5b).
• high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low calcium levels in the blood
velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima laktat dehidrogenaza (LDH) v krvi, majhna koncentracija kalcija v krvi,
No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets
Med rituksimabom in vrečkami iz polivinilklorida ali polietilena ali infuzijskimi seti niso ugotovili
When Rituzena is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Če zdravilo Rituzena uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
Safety and efficacy of Rituzena have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Varnosti in učinkovitosti zdravila Rituzena v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
The incidence of ADRs of any grade was similar in
Incidenca neželenih učinkov katere koli stopnje je bila v obeh skupinah podobna.
• swelling of the hands or ankles
otekanje dlani ali gležnjev.
Nervous system disorders paraesthesia, hypoaesthesia, agitation,
Bolezni živčevja parestezije, hipestezija, agitiranost,
Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Rituksimab se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3).
transient increase in serum IgM levels3
prehodno zvečanje koncentracije IgM v serumu3
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rituzena.
Če ste negotovi, se posvetuje z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rituzena.
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,
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
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).
Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Granulomatoza s poliangiitisom in mikroskopski poliangiitis Zdravilo Rituzena je v kombinaciji z glukokortikoidi indicirano za indukcijo remisije pri odraslih bolnikih s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z
• The need to check, prior to Rituzena treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned,
• informacije o nujnosti, da pred dajanjem zdravila Rituzena 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,
Non-oncology indications: The MAH must ensure that all physicians who are expected to prescribe Rituzena are provided with
Neonkološke indikacije: Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Rituzena,
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,
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-rang 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 %.
Rituzena is used for inducing remission in granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Zdravilo Rituzena se uporablja za spodbujanje umirjanja bolezni pri granulomatozi s poliangiitisom (prej imenovani Wegenerjeva granulomatoza) ali pri mikroskopskem poliangiitisu; daje se v kombinaciji s kortikosteroidi.
In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
V študijah splošne toksičnosti pri opicah Cynomolgus niso opažali škodljivih učinkov na reproduktivne organe samcev ali
Aseptically withdraw the necessary amount of Rituzena, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride9 mg/mL (0.9%) solution for injection or 5 % D-Glucose in water.
Aseptično odvzamemo potrebno količino zdravila Rituzena in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0,9-% raztopino natrijevega klorida za injiciranje (9 mg/ml) ali 5-% raztopino D-glukoze v vodi.
Medicines given before each Rituzena administration
Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila Rituzena
anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
anafilaksija sindrom lize tumorja, sindrom sproščanja citokinov4, serumska bolezen z infuzijo povezana akutna reverzibilna trombocitopenija4
This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need)
1 mg/kg/dan prednizona peroralno (odmerek ne sme preseči 80 mg/dan in ga je treba zmanjšati, kolikor hitro je mogoče glede na klinične potrebe) med zdravljenjem z zdravilom Rituzena in po njem.
Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still >25 x 109/L.
Že za prvo infuzijo pri teh bolnikih razmislimo o zmanjšanju pretoka ali delitvi odmerka na dva dneva v prvem ciklu in, če je število limfocitov še vedno večje od 25 x 109/l, tudi v vseh nadaljnjih ciklih.
Rituzena 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,
Zdravilo Rituzena je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksorubicin,
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 course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Med zdravljenjem v študijah rituksimaba v kombinaciji s kemoterapijo sta bili 3. ali 4. stopnja levkopenije (R-CHOP 88 % v primerjavi s CHOP 79 %, R-FC 23 % v primerjavi s FC 12 %), nevtropenije (R-CVP 24 % v primerjavi s CVP 14 %, R-CHOP 97 % v primerjavi s CHOP 88 %, R-FC: 30 % v primerjavi s FC 19 % pri predhodno nezdravljeni KLL), pancitopenije (R-FC: 3 % v primerjavi s FC 1 % pri predhodno nezdravljeni KLL) po navadi pogostejši kot s kemoterapijo samo.
The two adverse events that were reported were flu-like symptoms, with a dose of 1.8 g of rituximab and fatal respiratory failure, with a dose of 2 g of rituximab.
Dva opisana neželena dogodka sta bila gripi podobni simptomi (pri odmerku 1,8 g rituksimaba) in odpoved dihal s smrtnim izidom (pri odmerku 2 g
A slight but not significant improvement in overall survival was reported in the R-FC
Poročali so o rahlem, vendar ne pomembnem izboljšanju celokupnega preživetja v skupini
CLL affects B-lymphocytes, which originate in the bone marrow and develop in the lymph nodes.
Prizadene limfocite B, ki nastajajo v kostnem mozgu in se razvijajo v limfnih vozličih.
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 rituksimaba in zdravil za zdravljenje revmatičnih bolezni, razen omenjenih v indikaciji in odmerjanju za revmatoidni artritis, ni priporočljiva.
Less frequently, some patients may get pain at the infusion site, blisters, itching, sickness, tiredness, headache, breathing difficulties, 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, utrujenost, glavobol, težave z dihanjem, otekanje jezika ali grla, srbeč ali smrkav nos, bruhanje, pordevanje ali hitro in močno utripanje srca, srčna kap ali nizko število trombocitov.
1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
1Pogostnost pridobljena iz laboratorijskih vrednosti zbranih v okviru rutinskega laboratorijskega spremljanja v kliničnih
Response rate and CR rates analysed using Chi-squared Test. NR: not reached n.a. not applicable *: only applicable to patients achieving a CR, nPR, PR; **: only applicable to patients achieving a CR;
NR: nedoseženo; n.a. neaplikabilno *: aplikabilno samo za bolnike, ki so dosegli CR, nPR (nodularni delni odgovor), PR; **: aplikabilno samo za bolnike, ki so dosegli CR
Rituzena should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Zdravilo Rituzena je treba dajati prvi dan vsakega cikla kemoterapije po uporabi glukokortikoidne sestavine kemoterapije, če jo shema vsebuje.
95.1%b CI (−3.2%, 24.3%) a a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
95,1 %b IZ (−3,2 %, 24,3 %) a a Neinferiornost je bila dokazana, ker je bila spodnja meja (−3,2 %) višja od vnaprej opredeljene meje neinferiornosti (−20 %).
Corticosteroid medicine given by mouth may be started at any time by your doctor to treat your condition.
Zdravilo s kortikosteroidom, ki ga boste uživali, pa vam zdravnik lahko za zdravljenje vaše
In case of such an event with a suspected relationship to rituximab, treatment should be permanently discontinued.
Če se pojavi tak neželen učinek z možno povezavo z rituksimabom, je treba zdravljenje trajno ukiniti.
Summary of the safety profile (non-Hodgkin's lymphoma and chronic lymphocytic leukaemia)
Povzetek varnostnega profila (ne-Hodgkinov limfom in kronična limfocitna levkemija)
severe bullous skin reactions, Stevens-Johns on Syndrome toxic epidermal necrolysis (Lyell's Syndrome)7,
hude bulozne kožne reakcije, StevensJohnsonov sindrom, toksična epidermalna nekroliza (Lyellov sindrom)7
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.
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 metilprednizolona; bolniki so 15 dni tudi
From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Od 12. do 18. meseca so v skupini z rituksimabom zabeležili 8 ponovitev in v
Also do not breast-feed for 12 months after your last treatment with Rituzena.
Prav tako ne smete dojiti še 12 mesecev po zadnjem odmerku zdravila Rituzena.
Ninety nine patients were treated with rituximab and 12% experienced at least one IRR.
Z rituksimabom se je zdravilo 99 bolnikov in pri 12 % bolnikov se je pojavila vsaj ena reakcija, povezane z infuzijo.
The clinical relevance of HACA formation in rituximab-treated patients is unclear.
Klinični pomen pojava HACA pri bolnikih, zdravljenih z rituksimabom, ni
In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to <10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom se je število perifernih celic B zmanjšalo na < 10 celic/µl po dveh infundiranjih 375 mg/m2 rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
Occurred at various times up to several months after completion of rituximab
Pojavili so se različno, tudi do nekaj mesecev po končanem zdravljenju z
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
Pri vseh bolnikih je treba pred začetkom zdravljenja z rituksimabom narediti presejalni test na virus hepatitisa B (HBV).
Subsequent doses of Rituzena 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 Rituzena 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.
The complete response rate after cycle 8 was 76.2 % in the R-CHOP group and 62.4 % in the CHOP
Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2 %, v skupini CHOP pa 62,4 % (p = 0,0028).
• Detailed information on the risk of PML, the need for timely diagnosis of PML
• podrobne podatke o tveganju za PML, informacije o nujnosti njene pravočasne diagnoze in ustreznih ukrepov za diagnosticiranje te bolezni,
• If you are having Rituzena with chemotherapy Rituzena will be given to you on the same day as your chemotherapy.
Če prejemate zdravilo Rituzena skupaj s kemoterapijo, ga boste dobili isti dan kot kemoterapijo.
The consequences of long-term B cell depletion in paediatric
Posledice dolgotrajnega zmanjšanja števila celic B pri
If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
V primeru dvoma je smiselno nadaljnje ovrednotenje, vključno z magnetnoresonančno preiskavo (MR), po možnosti s kontrastom, določanjem prisotnosti DNK virusa JC v cerebrospinalni tekočini in ponovno
In the 99 rituximab patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6-month primary endpoint.
Med 99 bolniki, ki so prejeli rituksimab, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na 100 bolnik-let (95-% interval zaupanja, 197-285).
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.
Zdravila za zdravljenje reakcij preobčutljivosti, npr. adrenalin, antihistaminiki in glukokortikoidi, morajo biti na voljo za takojšnjo uporabo, če bi se med dajanjem rituksimaba pojavile alergijske reakcije.
In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
V nerandomizirani študiji so imeli bolniki, ki so prejeli samostojno zdravljenje z rituksimabom ob ponovitvi nizkomalignega NHL, v primerjavi z zdravimi kontrolnimi osebami, ki niso prejele zdravila, nižji delež odgovora na cepljenje s cepivom proti tetanusu (recall antigen) (16 % v primerjavi z 81 %) in neoantigenom KLH (Keyhole Limpet Haemocyanin) (4 % v primerjavi s 76 %, ko so določevali > 2
Of 356 patients evaluated for HACA, 1.1 % (4 patients) were positive.
Od 356 bolnikov, pri katerih so ocenjevali HACA, so bili pozitivni
R-FC (N=408)
FC (n = 409)
Package leaflet: Information for the patient Rituzena 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Navodilo za uporabo Rituzena 100 mg koncentrat za raztopino za infundiranje rituksimab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Med znaki in simptomi so bili motnje vida, glavobol, konvulzije in motnje zavesti s spremljajočo hipertenzijo ali brez nje.
Rituzena can be given alone or with other medicines called “chemotherapy”.
Zdravilo Rituzena lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo
The incidence of malignancy in rituximab treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Incidenca malignih bolezni med bolniki, ki so v klinični študiji pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom prejemali rituksimab, je bila ob končnem zaključnem datumu študije (tj. ko je zadnji bolnik dokončal obdobje spremljanja) 2,00 na 100 bolnik-let.
Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Zdravniki morajo pred zdravljenjem z rituksimabom pregledati status cepljenja bolnikov in upoštevati veljavne smernice za cepljenje.
Repeated treatment courses
Večkratno zdravljenje
In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% FC.
Pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, je bila incidenca okužbe s hepatitisom B stopnje 3 ali 4 (reaktivacija in primarna okužba) 2 % pri R-FC v primerjavi z 0 % pri FC (fludarabin in ciklofosfamid).
Progression‐free survival (PFS)
EFS: preživetje brez dogodka (Event Free Survival)
• memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
• poslabšanje spomina, motnje mišljenja, težave s hojo ali izguba vida - lahko so posledica zelo redke, resne okužbe možganov, ki je včasih smrtna (imenujemo jo progresivna multifokalna
Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion.
Ker se med infuzijo rituksimaba lahko pojavi hipotenzija, je treba premisliti o tem, da bi 12 ur pred infuzijo rituksimaba bolnik prenehal jemati zdravila proti
The pharmacokinetics of rituximab were assessed following two IV doses of 500 mg and 1000 mg upon re-treatment in the second course.
Farmakokinetiko rituksimaba so ocenili po dveh 500 mg in 1.000 mg intravenskih odmerkih pri ponovnem zdravljenju v drugem ciklu.
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p <
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-rang test).
• low number of white blood cells sometimes with fever, or low number of blood cells called
majhno število belih krvnih celic, včasih z zvišano telesno temperaturo, ali zmanjšanje števila krvnih celic, ki jih imenujemo trombociti (krvne ploščice),