FrancophonIA/ELRC3.0 huggingface dataset:
English: For these reasons Rixathon should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Slovenian: Zato nosečnice ne smejo prejemati zdravila Rixathon, razen če je pričakovana korist večja od možnega tveganja.
English: Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomization.
Slovenian: Zdravljenje s prednizonom so postopoma zmanjšali in ga nato vzdrževali v majhnem odmerku (približno 5 mg na dan) vsaj 18 mesecev po randomizaciji.
English: In clinical trials more than 3,100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Slovenian: V kliničnih preskušanjih je več kot 3.100 bolnikov prejelo najmanj en cikel zdravljenja, po tem so jih spremljali od 6 mesecev do več kot 5 let; približno 2.400 bolnikov je prejelo dva ali več ciklov zdravljenja, od teh pa več kot 1.000 bolnikov 5 ali več ciklov zdravljenja.
English: Observation N=513
Slovenian: Opazovanje n = 513
English: p-value Risk reduction1)
Slovenian: R-CHOP Vrednost p Zmanjšanje tveganja1)
English: You may be asked not to take these other medicines 12 hours before you are given Rixathon.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12 ur, preden boste dobili zdravilo Rixathon.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Slovenian: 1Pogostnost pridobljena iz laboratorijskih vrednosti zbranih v okviru rutinskega laboratorijskega spremljanja v kliničnih preskušanjih.
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Slovenian: Slika 2: Odzivi ACR za 4 cikle zdravljenja 24 tednov po vsakem ciklu (intraindividualno, znotraj pregledov) pri bolnikih, ki niso zadostno odgovorili na zdravljenje z zaviralci TNF (n = 146)
English: Long-term efficacy with multiple course therapy
Slovenian: Dolgotrajna učinkovitost z več cikli zdravljenja
English: CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Slovenian: CD20 najdemo tako na običajnih kot na malignih celicah B, vendar ne na matičnih krvotvornih celicah, pro-B-celicah, normalnih plazmatkah ali drugem normalnem tkivu.
English: Vaccination should be completed at least 4 weeks prior to first administration of Rixathon.
Slovenian: Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo zdravila Rixathon.
English: In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Slovenian: Nasprotno pa so se cerebrovaskularni dogodki pojavili pri treh bolnikih (1,5 %) v skupini CHOP, vsi med obdobjem spremljanja.
English: Rixathon is usually taken together with another medicine called methotrexate.
Slovenian: Rixathon se običajno jemlje skupaj z zdravilom, imenovanim metotreksat.
English: How much and how often you will receive your treatment a) If you are being treated for non-Hodgkin's Lymphoma
Slovenian: Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma
English: Before giving a subsequent course of Rixathon treatment, patients should be re-evaluated for any potential risk for infections.
Slovenian: Pred dajanjem nadaljnjega cikla zdravila Rixathon je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
English: The HCP Alert card addressing the correct use of Rixathon contains the following key elements: - The advice that Rixathon is for intravenous use only and recommendations how to ensure this route of administration
Slovenian: Opozorilna kartica za zdravstvenega delavca, ki obravnava pravilno uporabo zdravila Rixathon, vsebuje naslednje ključne vsebine: - navedbo, da je zdravilo Rixathon namenjeno samo za intravensko uporabo, in priporočila, kako zagotoviti, da se uporablja ta pot uporabe
English: Data from extended follow up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT, and TNCT (Table 7).
Slovenian: Podatki iz podaljšanega spremljanja bolnikov v študiji (mediana spremljanja 9 let) so potrdili dolgoročno korist vzdrževalnega zdravljenja z rituksimabom glede na PFS, EFS, TNLT in TNCT
English: The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Slovenian: Neželeni učinki, ki so jih opazili samo po prihodu zdravila na trg in za katere pogostnosti ni mogoče oceniti, so navedeni v „neznana“.
English: Mild or moderate infusion-related reactions (IRR) (section 4.8) usually respond to a reduction in the rate of infusion.
Slovenian: Blage ali zmerne reakcije, povezane z infuzijo (poglavje 4.8), lahko običajno zmanjšamo z manjšim infuzijskim pretokom.
English: • taste problems - such as changes in the way things taste
Slovenian: • motnje okušanja - na primer spremenjen okus stvari,
English: Rixathon is indicated in adults for the following indications:
Slovenian: Zdravilo Rixathon je pri odraslih indicirano za naslednje indikacije:
English: Rixathon should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Slovenian: Zdravilo Rixathon je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: This antigen does not internalise upon antibody binding and is not shed from the cell surface.
Slovenian: Po vezavi s protitelesom ne vstopa v notranjost celice, niti se ne odcepi s celične površine.
English: The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥2 months).
Slovenian: Primarni cilj študije je bila popolna remisija (CR - complete remission) (popolna epitelizacija in odsotnost novih in/ali razvitih lezij) po 24 mesecih brez uporabe prednizonskega zdravljenja v obdobju dveh mesecev ali več (CRoff za ≥ 2 meseca).
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Slovenian: Slika 1: Sprememba v DAS28-ESR od izhodišča glede na izhodiščno stanje protiteles
English: Your doctor will check if you should have any vaccines before you receive Rixathon.
Slovenian: Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Rixathon.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Rixathon slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Slovenian: Zdravilo Rixathon upočasni nastanek okvar sklepov, ki so posledica revmatoidnega artritisa, ter izboljša vašo sposobnost za opravljanje običajnih dnevnih aktivnosti.
English: Table 16 Percentage of patients who achieved complete remission at 6 months (intent-to-treat population*)
Slovenian: Odstotek bolnikov, ki so po 6 mesecih dosegli popolno remisijo (populacija, ki so jo nameravali zdraviti*)
English: • tight or painful muscles
Slovenian: • napete ali boleče mišice,
English: Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood.
Slovenian: Bolniki s KLL imajo preveč nenormalnih limfocitov, ki se kopičijo predvsem v kostnem mozgu in krvi.
English: Treatment with rituximab 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).
Slovenian: Zdravljenje z rituksimabom 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 EULAR; to je bilo opazno v vseh raziskovanih populacijah bolnikov (slika 2).
English: Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Slovenian: Seropozitivni bolniki so imeli tudi značilno večje zmanjšanje v DAS28ESR kot seronegativni bolniki (slika 1).
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Slovenian: V dolgoročni opazovalni študiji varnosti je 97 bolnikov z GPA/MPA prejemalo zdravljenje z rituksimabom (v povprečju 8 infuzij [razpon od 1 do 28]) do 4 leta, v skladu s standardno prakso in presojo njihovega zdravnika.
English: In patients where the treatment is working, Rixathon may be used as a maintenance treatment for 2 years after completing the initial treatment.
Slovenian: Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče zdravilo Rixathon uporabljati kot vzdrževalno zdravljenje še dve leti po dokončanju začetnega zdravljenja.
English: • If you respond well to treatment, you may be given Rixathon as a maintenance treatment every 2 or 3 months for two years.
Slovenian: • Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo Rixathon dobivali kot vzdrževalno zdravljenje na dva meseca ali tri, in sicer dve leti.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of rituximab.
Slovenian: Pri majhnem deležu bolnikov je bil upad števila perifernih celic B dolgotrajen, trajal je 2 leti ali več po zadnjem odmerku rituksimaba.
English: 9.25 years
Slovenian: 9,25 let
English: The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Slovenian: Delež bolnikov, ki se jim je pojavila z infundiranjem povezana reakcija, je bil po prvem infundiranju 29 % (11 bolnikov), po drugem 40 % (15 bolnikov), po tretjem 13 % (5 bolnikov) in po četrtem 10 % (4 bolniki).
English: GLSG'00 CHOP, 205 R-CHOP, 223 18
Slovenian: CHOP: 205 R-CHOP: 223
English: 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) during and after the 4 week induction course of Rixathon treatment.
Slovenian: 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 in po 4-tedenskem indukcijskem zdravljenju z zdravilom Rixathon.
English: • raised blood pressure
Slovenian: • zvišan krvni tlak,
English: 2 Frequency category derived from post-marketing data.
Slovenian: 2Pogostnost pridobljena iz podatkov pridobljenih po prihodu zdravila na trg.
English: The majority of patients (81%) showed signs of B cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Slovenian: Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18. meseca pa še pri večjem, 87-% deležu bolnikov.
English: Mean change in SF-36 PHS
Slovenian: Povprečna sprememba SF-36 PHS
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Slovenian: Od bolnikov, ki so prvotno dobivali samo metotreksat, jih je 81 % dobilo rituksimab kot rešilno zdravilo (rescue) med 16. in 24. tednom ali v okviru nadaljevalne študije pred 56. tednom.
English: If a patient develops PML, the dosing of Rixathon must be permanently discontinued.
Slovenian: Če se pri bolniku razvije PML, je treba uporabo zdravila Rixathon dokončno ukiniti.
English: 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
Slovenian: Število odzivnih (delež odziva [%]) a Vrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p. b 95-% interval zaupanja je korigiran Newcombov interval.
English: The cells that are affected by Rixathon help to fight infection and you should wait until the infection has passed before you are given Rixathon.
Slovenian: Celice, ki jih zdravilo Rixathon uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Rixathon.
English: If you respond well to treatment, you may be given Rixathon as a maintenance treatment.
Slovenian: Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Rixathon prejemali kot vzdrževalno zdravljenje.
English: 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.
Slovenian: 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, med prvim ciklom zdravljenja pojavili trombembolični cerebrovaskularni dogodki.
English: The highest intravenous dose of rituximab tested in humans to date is 5,000 mg (2,250 mg/m²), tested in a dose escalation study in patients with chronic lymphocytic leukaemia.
Slovenian: Največji do zdaj preizkušen intravenski odmerek rituksimaba pri človeku je 5.000 mg (2.250 mg/m2), preizkušen v študiji povečevanja odmerka pri bolnikih s kronično limfocitno levkemijo.
English: Rituximab is not indicated for these patients, since the safety data about long-term rituximab treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Slovenian: Rituksimab ni indiciran za uporabo pri teh bolnikih zaradi nezadostnih podatkov o varnosti dolgoročnega zdravljenja z rituksimabom, še posebej v zvezi s tveganjem za razvoj malignih bolezni ter PML.
English: At week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Slovenian: Po 24 tednih so imeli bolniki, ki so bili izhodiščno seropozitivni za RF in/ali anti-CCP, značilno večjo verjetnost, da dosežejo odziv ACR20 in 50, v primerjavi s seronegativnimi bolniki (p = 0,0312 in p = 0,0096) (preglednica 15).
English: This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections, all of which were more frequent in the first 6 months of treatment.
Slovenian: To gre v glavnem pripisati reakcijam, povezanim z infuzijo (ki se najpogosteje pojavljajo v prvem ciklu zdravljenja), poslabšanju revmatoidnega artritisa in okužbam; vse našteto se je pogosteje pojavljalo v prvih 6 mesecih zdravljenja.
English: 10.49 years
Slovenian: 10,49 let
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Slovenian: 19 do 79 let in predhodno niso prejemali zdravljenja za pemfigus.
English: This is because there is not much information about the use of rituximab in children and young people.
Slovenian: O uporabi rituksimaba pri otrocih in mladostnikih namreč ni veliko informacij.
English: The incidence of thrombocytopenia was low (< 1%, grade 3/4) and was not different between treatment arms.
Slovenian: Incidenca trombocitopenije je bila nizka (< 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
English: Initiate at a rate of 250 mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Slovenian: Začetna hitrost infundiranja je 250 mg/h prvih 30 minut in nato 600 mg/h naslednjih 90 minut.
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Slovenian: Glede na mehanizem delovanja rituksimaba in dejstvo, da imajo celice B pomembno vlogo pri vzdrževanju normalnega imunskega odziva, imajo lahko bolniki, ki se zdravijo z rituksimabom, povečano tveganje za okužbe (glejte poglavje 5.1).
English: B lymphocytes are involved in the cause of some of the symptoms you have.
Slovenian: Limfociti B sodelujejo pri nastanku nekaterih simptomov, ki jih imate.
English: Rituximab N=505
Slovenian: rituksimab n = 505
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22% - 75%).
Slovenian: Vzdrževalno zdravljenje z rituksimabom je zmanjšalo tveganje za smrt za 56 % (95-% interval zaupanja: 22-75 %).
English: When should I not have Rixathon?
Slovenian: Kdaj ne smete prejeti zdravila Rixathon?
English: Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Slovenian: b) kronične limfocitne levkemije Kronična limfocitna levkemija (KLL) je najbolj pogosta oblika levkemije pri odraslih.
English: Mean change in HAQ-DI
Slovenian: Povprečna sprememba HAQ-DI
English: Other rarely-reported side-effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Slovenian: Drugi neželeni učinki rituksimaba, o katerih so poročali redko, vključujejo zmanjšano število belih krvnih celic (nevtrofilcev), ki pomagajo v boju proti okužbam.
English: Treatment difference (rituximabcyclophosphamide)
Slovenian: razlika zdravljenj (rituksimabciklofosfamid)
English: • low number of red blood cells (anaemia)
Slovenian: • nizko število rdečih krvnih celic (anemija),
English: 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).
Slovenian: V nadaljnji klinični študiji so skupno 57 bolnikov s hudo aktivno GPA in MPA v remisiji bolezni zdravili z rituksimabom za vzdrževanje remisije (glejte poglavje 5.1).
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Slovenian: * Z infundiranjem povezane reakcije so vključevale simptome, zbrane ob naslednjem načrtovanem obisku po vsaki infuziji, in neželene dogodke, ki so se pojavili na dan infuzije ali en dan po njej.
English: Therefore vaccination with live virus vaccines is not recommended whilst on Rixathon or whilst peripherally B cell depleted.
Slovenian: Cepljenje z živimi virusnimi cepivi zato ni priporočljivo med zdravljenjem z zdravilom Rixathon ali medtem, ko je število perifernih celic B zmanjšano.
English: • pain in the muscles or in the hands or feet
Slovenian: • bolečina v mišicah ali dlaneh ali stopalih,
English: Infusion-related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
Slovenian: Z infuzijo povezane neželene reakcije vseh vrst so opazili pri 77 % bolnikov, ki so se zdravili z rituksimabom (vključno s sindromom sproščanja citokinov, ki sta ga spremljala hipotenzija in bronhospazem pri 10 % bolnikov), glejte poglavje 4.8.
English: ▼This medicine is subject to additional monitoring.
Slovenian: Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Slovenian: Podatkov o varnosti rituksimaba pri bolnikih z zmernim srčnim popuščanjem (III. razred NYHA) ali hudo, neobvladljivo boleznijo srca ni.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Slovenian: Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta (≥ 1/100 do < 1/10), občasna (> 1/1.000 do ≤ 1/100) in zelo redka (≤ 1/10.000).
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab therapy.
Slovenian: Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z rituksimabom, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z rituksimabom prejmejo biološka zdravila in/ali DMARD.
English: Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Slovenian: Pregled učinkovitosti vzdrževalnega zdravljenja z rituksimabom v primerjavi z opazovanjem v času primarne analize, določene s protokolom, in po mediani spremljanja 9 let (končna analiza)
English: When you are treated with Rixathon in combination with chemotherapy, you will receive Rixathon infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Slovenian: Ko se boste zdravili z zdravilom Rixathon v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila Rixathon 0. dan 1. cikla in nato 1. dan vsakega naslednjega cikla, skupaj 6 ciklov.
English: Significant improvement in health related quality of life was also demonstrated with significant improvement in both the physical health score (PHS) and mental health score (MHS) of the SF-36.
Slovenian: Ugotovljeno je bilo tudi značilno izboljšanje zdravstvenih kazalcev kakovosti življenja z značilnim izboljšanjem ocene telesnega zdravja (PHS, Physical Health Score) in duševnega zdravja (MHS,
English: This is because Rixathon may pass into breast milk.
Slovenian: Zdravilo Rixathon namreč lahko prehaja v materino mleko.
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%).
Slovenian: Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov (3. ali 4. stopnje) kot bolniki brez obsežne bolezni (25,6 % v primerjavi s 15,4 %).
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following rituximab (see section 4.5).
Slovenian: Iz kliničnih preskušanj ni zadostnih podatkov za popolno oceno varnosti uporabe drugih DMARD (vključno z zaviralci TNF in drugimi biološkimi zdravili), ki sledijo zdravljenju z rituksimabom (glejte poglavje 4.5).
English: • heart beating faster than normal
Slovenian: • hitrejše bitje srca kot običajno.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome have been reported.
Slovenian: Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for rituximab (see section 4.4).
Slovenian: Podatki o varnosti, zbrani v obdobju po prihodu zdravila na trg, odražajo pričakovani profil neželenih učinkov, kot so ga opazili v kliničnih preskušanjih z rituksimabom (glejte poglavje 4.4).