natgillin/translations-raw huggingface dataset:
The proportions of MabThera 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 zdravilom MabThera 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).
• feeling restless, problems falling asleep
· nemir, bolnik težko zaspi
The efficacy and safety of MabThera in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicenter trial (Trial 1).
Klinične izkušnje pri revmatoidnem artritisu Učinkovitost in varnost zdravila MabThera v lajšanju simptomov in znakov revmatoidnega artritisa pri bolnikih, ki niso zadostno odgovorili na zdravljenje z zaviralci TNF, sta bili dokazani v ključnem randomiziranem, kontroliranem, dvojno slepem, multicentričnem preskušanju (preskušanje 1).
Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Varnosti in učinkovitosti zdravila MabThera v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
aVrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p. b 95-% interval zaupanja je korigiran Newcombov interval.
There was no apparent impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety or efficacy.
Očitnega vpliva prisotnosti protiteles proti rituksimabu ali protiteles proti rHuPH20 na varnost in učinkovitost ni bilo.
In the overall experience of MabThera repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Pri ponovnem enoletnem zdravljenju z zdravilom MabThera pri revmatoidnem artritisu so bili deleži bolnikov s pozitivnim titrom protiteles proti S. pneumoniae, influenci, mumpsu, rdečkah, noricah in tetanusnem toksoidu na splošno podobni kot izhodiščni.
• short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
· kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobuliniIgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic
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 MabThera (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 zdravila MabThera (58 bolnikov).
The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Priporočeni odmerek zdravila MabThera je 1000 mg z intravensko infuzijo, čemur sledi druga intravenska infuzija 1000 mg 2 tedna pozneje.
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila MabThera priporočljiva intravenska uporaba metilprednizolona, ki se ga daje od 1 do 3 dni v odmerku 1000 mg na dan (zadnji odmerek metilprednizolona je lahko uporabljen na dan prve infuzije zdravila MabThera).
Absorption parameters of subcutaneous formulation, decreased with increasing BMI.
Parametri absorpcije so se za podkožno obliko zdravila zmanjševali z naraščajočim indeksom telesne mase.
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
V opazovani skupini se je mediana koncentracije IgG postopno povečevala nad spodnjo mejo normalne vrednosti, v skupini, ki je prejemala zdravilo MabThera pa je ostala nespremenjena.
In the SABRINA trial (BO22334) the incidence of treatment-induced/enhanced anti-rituximab antibodies was low and similar in the intravenous and subcutaneous groups (1.9% vs. 2%, respectively).
preskušanju SABRINA (BO22334) je bila incidenca z zdravljenjem povzročenega/okrepljenega nastajanja protiteles proti rituksimabu majhna in podobna v skupinah z intravensko in podkožno obliko zdravila (1,9 % v primerjavi z 2 %).
Cyclophosphamide (n = 98)
ciklofosfamid (n = 98)
In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving MabThera in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
V preskušanju 1 je bilo pri bolnikih, ki so nezadovoljivo odgovorili na eno ali več zdravljenj z zaviralci TNF ali jih niso prenašali, in ki so prejemali zdravilo MabThera in metotreksat, po 56 tednih na posnetkih značilno manj znakov napredovanja kot pri tistih, ki so prvotno dobivali samo metotreksat.
The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in -three clinical trials: SparkThera and SABRINA (the two trials in NHL) and SAWYER the CLL trial.
Tveganje za akutne reakcije, povezane z dajanjem podkožne oblike zdravila MabThera, so ocenili v treh kliničnih preskušanjih: SparkThera in SABRINA (preskušanji pri bolnikih z NHL) in SAWYER (preskušanje pri bolnikih s KLL).
arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
aritmija, +atrijska fibrilacija, tahikardija, +srčna bolezen
The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka (< 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Farmakokinetični profil zdravila MabThera, dajanega v 6 infuzijah po 375 mg/m2 v kombinaciji s šestimi cikli kemoterapije CHOP, je bil podoben kot pri dajanju samega zdravila MabThera.
In patients with non-Hodgkin's lymphoma receiving MabThera in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin's lymphoma).
Pri bolnikih z ne-Hodgkinovim limfomom, ki so prejemali zdravilo MabThera v kombinaciji s citotoksično kemoterapijo, so poročali o primerih reaktivacije virusa hepatitisa B (glejte ne-Hodgkinov limfom).
Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Bolniki so prejeli 2 x 1000 mg zdravila MabThera v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
This is because some people have a fall in their blood pressure while they are being given MabThera.
Nekaterim ljudem se namreč med prejemanjem zdravila MabThera krvni tlak zniža;
50 mL vial - Pack of 1 vial
50-ml viale: škatla z 1 vialo
Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of MabThera maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 4).
Podatki iz podaljšanega spremljanja bolnikov v študiji (mediana spremljanja 9 let) so potrdili dolgoročno korist vzdrževalnega zdravljenja z zdravilom MabThera glede na PFS, EFS, TNLT in TNCT (preglednica 4).
Keep this card with you for 2 years after your last dose of MabThera.
Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila MabThera,
Based on the mechanism of action of MabThera and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following MabThera therapy (see section 5.1).
Glede na mehanizem delovanja zdravila MabThera in dejstvo, da imajo celice B pomembno vlogo pri vzdrževanju normalnega imunskega odziva, imajo lahko bolniki, ki se zdravijo z zdravilom MabThera,
There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Ni dokazov, da bi sistemska izpostavljenost rHuPH20 povzročila dismorfogenezo (tj. teratogenost).
by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
do 4. četrtletja 2019 (preliminarno poročilo klinične študije) do 4. četrtletja 2020 (končno poročilo klinične študije)
Three patients (8%) in the MabThera 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 zdravilom MabThera 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 %).
• Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
· Kronična limfocitna levkemija (KLL) je najbolj pogosta oblika levkemije pri odraslih.
Patients who experience overdose or medication error with MabThera should be closely monitored.
Bolnike, pri katerih pride do prevelikega odmerjanja ali napake, povezane z zdravilom MabThera, je treba skrbno nadzorovati.
Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Klinični odzivi ob času primarnega cilja preskušanja 1 (populacija, ki so jo nameravali zdraviti) Izid†
Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Na podlagi populacijske farmakokinetične analize podatkov 97 bolnikov z granulomatozo s poliangiitisom in z mikroskopskim poliangiitisom, ki so štiri tedne prejemali 375 mg/m2 zdravila MabThera enkrat na teden, je ocenjeni mediani končni razpolovni čas izločanja 23 dni (razpon: od 9 do 49 dni).
The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Najpogosteje opaženi neželeni učinek pri prejemnikih zdravila MabThera so bile z infuzijo povezane reakcije, ki so se pri večini bolnikov pojavile med prvo infuzijo.
Specific studies to determine the effects of rituximab or rHuPH20 on fertility have not been performed.
Specifičnih študij za ugotavljanje učinkov rituksimaba ali rHuPH20 na plodnost niso izvedli.
Patients should be instructed to contact their treating physician immediately if symptoms that are suggestive of severe hypersensitivity or cytokine release syndrome occur at any time after medicinal product administration.
Bolnikom je treba naročiti, naj se nemudoma obrnejo na lečečega zdravnika, če se jim kadar koli po uporabi zdravila pojavijo simptomi, ki nakazujejo hudo preobčutljivost ali sindrom sproščanja citokinov.
In the clinical trial on induction of remission, which included 99 MabThera-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
V kliničnem preskušanju indukcije remisije, v katerega so vključili 99 bolnikov, zdravljenih z zdravilom MabThera, je bil celotni delež okužb na primarni končni točki po 6 mesecih približno 237 na 100 bolnik-let (95-% interval zaupanja, 197-285).
MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Vzdrževalno zdravljenje z zdravilom MabThera je indicirano za zdravljenje bolnikov s folikularnimi limfomi, ki se odzovejo na indukcijsko zdravljenje.
• general discomfort or feeling uneasy or tired, shaking, signs of flu
· splošno nelagodje, neprijetno počutje ali utrujenost, tresenje, znaki gripe
Events of neutropenia were observed with MabThera treatment, the majority of which were transient and mild or moderate in severity.
Nevtropenija Pri zdravljenju z zdravilom MabThera so opazili dogodke nevtropenije, ki so bili večinoma prehodni in po resnosti blagi ali zmerni.
The most commonly reported serious infection in the MabThera group was mild or moderate bronchitis.
Najpogosteje zabeležena resna okužba v skupini bolnikov, ki so prejemali zdravilo MabThera, je bil blag ali zmeren bronhitis.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C do 8 °C).
It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and strength is being given to the patient, as prescribed.
Pomembno je preveriti nalepke na zdravilu in tako zagotoviti, da bolnik dobi ustrezno obliko (intravensko ali podkožno) in jakost zdravila, ki mu je bila predpisana.
Geometric mean
Geometrična sredina
Geometric mean AUC values at cycle 7 µg.day/mL
AUC, vrednosti 7. cikel µg.dan/ml
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 MabThera 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 zdravilom MabThera in pri 17 bolnikih
A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Skupno so zdravili in glede učinkovitosti analizirali 321 bolnikov (162 R-CVP, 159 CVP).
• Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
· 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,
All of these arrhythmias either occurred in the context of a MabThera infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Vse motnje srčnega ritma so se pojavile v povezavi z infuzijo zdravila MabThera ali pa so bile povezane s predispozicijskimi stanji, kot so zvišana telesna temperatura, okužba, akutni miokardni infarkt ali predhodna respiratorna ali kardiovaskularna bolezen.
Results from other supportive studies using MabThera in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Rezultati iz drugih podpornih študij z uporabo zdravila MabThera v kombinaciji z drugimi kemoterapijami (vključno s CHOP, FCM, PC, PCM, bendamustinom in kladribinom) za zdravljenje bolnikov s KLL, ki predhodno še niso bili zdravljeni in/ali pri katerih se je bolezen ponovila oziroma se na prejšnje zdravljenje niso odzvali, so prav tako pokazali visok delež celokupnih odgovorov s koristjo v smislu preživetja brez napredovanja bolezni, vendar z rahlo večjo toksičnostjo (predvsem mielotoksičnostjo).
The most frequently reported serious infection in the MabThera group was pneumonia at a frequency of 4%.
Najpogosteje zabeležena okužba v skupini bolnikov, ki so prejemali zdravilo MabThera, je bila pljučnica; njena pogostnost je bila 4 %.
Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001
Data from the development programme of MabThera subcutaneous formulation indicate that the formation of anti-rituximab antibodies after subcutaneous administration is comparable with that observed after intravenous administration.
Podatki iz razvojnega programa podkožne oblike zdravila MabThera kažejo, da je nastajanje protiteles proti rituksimabu po podkožni uporabi podobno, kot so ga opazili po intravenski uporabi.
Treatment with MabThera in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28-ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Zdravljenje z zdravilom MabThera v kombinaciji z metotreksatom v več ciklih je prineslo stalno izboljšanje kliničnih znakov in simptomov RA, kot so pokazali odzivi po ACR, DAS28-ESR in
• The importance of sharing this information with their partner or caregiver
· pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom, · informacije o opozorilni kartici za bolnika.
Stage 1 enrolled previously untreated patients (n=127) CD20-positive, Follicular Lymphoma (FL) Grade 1, 2 or 3a.
V 1. stopnjo so bili vključeni predhodno nezdravljeni bolniki (n = 127) s CD20-pozitivnimi folikularnimi limfomi gradusa 1, 2 ali 3a.
How much and how often you will receive your treatment a) If you are being treated for non-Hodgkin's Lymphoma
Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma · Če prejemate samo zdravilo MabThera,
Consultation with a Neurologist should be considered as clinically indicated.
Posvet z nevrologom pride v poštev, kot je klinično ustrezno.
The information provided in the section 4.4 pertains to the use of MabThera subcutaneous formulation in the approved indications Treatment of non Hodgkin lymphoma (strength 1400 mg) and Treatment of CLL (strength 1600 mg).
Informacije v poglavju 4.4 se nanašajo na uporabo podkožne oblike zdravila MabThera za odobreni indikaciji Zdravljenje ne-Hodgkinovega limfoma (jakost 1400 mg) in Zdravljenje kronične limfocitne levkemije (jakost 1600 mg).
The total number of cycles is of 6.
Skupno zdravljenje obsega 6 ciklov.
d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis Treatment with MabThera uses four separate infusions given at weekly intervals.
Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa Zdravljenje z zdravilom MabThera obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
The clinical relevance of the development of anti-rituximab antibodies or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Klinični pomen pojava protiteles proti rituksimabu ali protiteles proti rHuPH20 po zdravljenju s podkožno obliko zdravila MabThera ni znan.
Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera.
Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z zdravilom MabThera, mora biti zaključeno najmanj 4 tedne pred začetkom naslednjega cikla zdravila MabThera.
Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the MabThera intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first MabThera intravenous infusion.
Hude, z infuzijo povezane reakcije s smrtnim izidom, so bile opisane med obdobjem trženja z intravensko obliko zdravila MabThera; pojavile so se od 30 minut do 2 uri po začetku prve intravenske infuzije zdravila MabThera.
The majority of these patients were also exposed to cytotoxic chemotherapy.
Večina teh bolnikov je hkrati prejemala tudi citotoksično kemoterapijo.
Patients who experience overdose or medication error should be closely monitored.
Bolnike, pri katerih pride do prevelikega odmerjanja ali napake, povezane z zdravilom, je treba skrbno nadzorovati.
Maintenance infusions of MabThera 500 mg were administered at months 12 and 18.
Vzdrževalni infuziji 500 mg zdravila MabThera sta bili uporabljeni 12. in 18. mesec.
Table 7: Trial BP22333 (SparkThera): Absorption - Pharmacokinetic parameters of MabThera SC compared to MabThera IV
Preskušanje BP22333 (SparkThera): Absorpcija - farmakokinetični parametri zdravila MabThera podkožno v primerjavi z zdravilom MabThera intravensko MabThera podkožno
When you are treated with MabThera in combination with chemotherapy, you will receive a MabThera infusion on day 0 of cycle 1, then subcutaneous injections on day 1 of each subsequent cycle.
Ko se boste zdravili z zdravilom MabThera v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila MabThera 0. dan 1. cikla in nato podkožne injekcije 1. dan vsakega naslednjega cikla.
How it is given
Kako se zdravilo daje
There was no impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety, efficacy or PK of MabThera.
Vpliva prisotnosti protiteles proti rituksimabu ali protiteles proti rHuPH20 na varnost, učinkovitost ali farmakokinetiko zdravila MabThera ni bilo.
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera maintenance therapy (n=167) or observation (n=167).
334 bolnikov, ki so po indukcijskem zdravljenju dosegli popolni ali delni odgovor, randomiziranih v drugi del zdravljenja, v katerem so prejemali vzdrževalno zdravljenje z zdravilom MabThera (n = 167), ali v opazovano skupino (n = 167).
Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-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 MabThera, pojavili z ³ 5-odstotnim deležem, absolutna razlika v njihovi pojavnosti med skupino z zdravilom MabThera in skupino s standardnim odmerkom prednizona pa je bila do 24. meseca ³ 2 %.
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
O znakih in simptomih, ki bi lahko nakazovali reakcije, povezane z infuzijo, so poročali pri več kot 50 % bolnikov v kliničnih preskušanjih; večinoma so jih opazili med prvo infuzijo, po navadi v prvih dveh urah.
In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
V kliničnih preskušanjih z zdravilom MabThera 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.
MabThera should be used in combination with CHOP chemotherapy.
Zdravilo MabThera je treba uporabljati v kombinaciji s kemoterapijo CHOP.
• tumour pain
· tumorske bolečine