FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (<65 years), with previously untreated or relapsed/refractory CLL.
Slovenian: Podskupine bolnikov - kombinirano zdravljenje z rituksimabom Incidenca neželenih dogodkov krvi in limfatičnega sistema 3. ali 4. stopnje je bila pri bolnikih s KLL, ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki (< 65 let).
English: Cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Slovenian: Delež pojavljanja srčnih dogodkov je bil na primarni končni točki po 6 mesecih približno 273 na 100 bolnik-let (95-% interval zaupanja, 149-470).
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and
Slovenian: V kliničnih preskušanjih, nadzorovanih s placebom, je pri 0,94 % (13/1.382) bolnikov, zdravljenih z rituksimabom in pri 0,27 % (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude
English: The limited data from the present trial preclude any conclusions regarding the efficacy of subsequent courses of rituximab in patients with granulomatosis with polyangiitis and microscopic polyangiitis.
Slovenian: Ker je podatkov iz tega preskušanja malo, ni mogoče sklepati o učinkovitosti nadaljnjih ciklov rituksimaba pri bolnikih z granulomatozo s poliangiitisom in z mikroskopskim poliangiitisom.
English: At 6 months, in the active-controlled, randomised, double-blind, multicentre, non-inferiority trial, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
Slovenian: V randomiziranem, dvojno slepem, z zdravilno učinkovino kontroliranem multicentričnem preskušanju neinferiornosti so po 6 mesecih pri bolnikih, ki so imeli izhodiščno normalne ravni imunoglobulinov, med prejemniki rituksimaba zabeležili nizke IgA, IgG in IgM pri 27 %, 58 % in 51 % (v tem zaporedju), med prejemniki ciklofosfamida pa pri 25 %, 50 % in 46 %.
English: microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Slovenian: V vseh podskupinah bolnikov (spol, starost, starosti prilagojen mednarodni prognostični indeks, stadij po klasifikaciji Ann Arbor, ECOG (Eastern Cooperative Oncology Group), koncentracija mikroglobulina ß2, koncentracija LDH, koncentracija albumina, B simptomi, obsežna bolezen, ekstranodalne lokalizacije, infiltracija kostnega mozga) je bilo razmerje tveganj za preživetje brez dogodkov za R-CHOP v primerjavi s CHOP manjše kot 0,83, za skupno preživetje pa manjše kot 0,95.
English: In the relapsed/refractory CLL study grade ¾ thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in
Slovenian: V študiji pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so o trombocitopeniji stopnje 3 ali 4 poročali pri 11 % bolnikov v skupini R-FC v primerjavi z 9 % v skupini FC.
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 x 1000 mg dose group.
Slovenian: Povprečni končni razpolovni čas izločanja je bil 15 do 16 dni za 2 x 500 mg odmerek ter 17 do 21 dni za 2 x 1.000 mg odmerek.
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's Syndrome) and Stevens-Johnson Syndrome, some with fatal outcome, have been reported (see section 4.8).
Slovenian: Poročali so o hudih kožnih reakcijah, kot sta toksična epidermalna nekroliza (Lyellov sindrom) in Stevens-Johnsonov sindrom; nekatere so se končale s smrtnim izidom (glejte poglavje 4.8).
English: Therefore vaccination with live virus vaccines is not recommended whilst on rituximab or whilst peripherally B cell depleted.
Slovenian: Cepljenje z živimi virusnimi cepivi zato ni priporočljivo med zdravljenjem z rituksimabom ali medtem, ko je
English: Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Slovenian: (HACA) imajo lahko alergijske ali preobčutljivostne reakcije, če jih zdravimo z drugimi diagnostičnimi ali terapevtskimi monoklonskimi protitelesi.
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/ m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Slovenian: je bila 408 µg/ml (od 97 do 764 µg/ml) po peti infuziji 500 mg/m2, povprečni končni razpolovni čas pa je
English: In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Slovenian: Pri KLL je bila celokupna incidenca srčnih bolezni stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4 % R-FC, 3 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4 % R-FC, 4 % FC).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih
English: The most common IRRs included cytokine release syndrome, flushing, throat irritation, and tremor.
Slovenian: Med najpogostejšimi reakcijami, povezanimi z infuzijo, so bili sindrom sproščanja citokinov, napadi rdečice, draženje žrela in tremor.
English: Table 5b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Number of patients
Slovenian: Razmerja ogroženosti za preživetje brez napredovanja bolezni glede na stopnjo po Binetu (ITT) - mediana opazovanja 48,1 meseca.
English: You may be asked not to take these other medicines 12 hours before you are given Rituzena.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12
English: This is usually given b) If you are being treated for chronic lymphocytic leukaemia
Slovenian: b) Če se zdravite zaradi kronične limfocitne levkemije
English: Very common side effects (may affect more than 1 in 10 people): • infections, such as chest infections, urinary tract infections (pain on passing water), colds
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe, npr. okužbe v prsih, okužbe sečil (bolečine pri odvajanju vode), prehladi in okužbe s herpesom, pojav alergijskih reakcij je najverjetnejši med infuzijo, a pojavijo se lahko 24 ur po infuziji, driska,
English: The Physician information about Rituzena should contain the following key elements: Information that the product should be administered as IV only to avoid administration route errors.
Slovenian: Gradivo za zdravnika o zdravilu Rituzena mora vsebovati naslednje ključne vsebine: • informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so vsi pripomočki za
English: 3infusion related reactions (generalised oedema,
Slovenian: 3reakcije, povezane z infuzijo (generalizirani edem, bronhospazem, piskanje, edem grla,
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (RCVP).
Slovenian: V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 rituksimaba v kombinaciji s CVP (R-CVP).
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Slovenian: Rituksimab se veže specifično na transmembranski antigen, CD20, neglikoziliran fosfoprotein, ki se nahaja na limfocitih pre-B in dozorelih limfocitih B. Antigen je izražen pri > 95 % vseh B-celičnih ne
English: Rituzena in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Slovenian: Zdravilo Rituzena je v kombinaciji s kemoterapijo indicirano za zdravljenje bolnikov s kronično limfocitno levkemijo, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila.
English: • The need to carry the card at all times and to show the card to all treating health
Slovenian: • informacije o nujnosti, da jo imajo bolniki s sabo ves čas in da jo pokažejo vsem zdravnikom, ki
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the2 x 500 mg dose and ranged from 355 to 404 µg/mL for the 2 x 1000 mg dose.
Slovenian: Po drugi infuziji je bila povprečna Cmax 183 do 198 μg/ml za 2 x 500 mg odmerek ter 355 do 404 μg/ml za 2 x 1.000 mg odmerek.
English: Rituzena monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Slovenian: Zdravilo Rituzena je indicirano za samostojno zdravljenje bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Slovenian: Povprečna serumska Cmax rituksimaba po prvi infuziji je bila 157 do 171 μg/ml za 2 x 500 mg odmerek ter 298 do 341 μg/ml za 2 x 1.000 mg odmerek.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.
Slovenian: V kliničnih preskušanjih so o okužbah spodnjih dihal (vključno s pljučnico) v skupini z rituksimabom poročali s podobno incidenco
English: Do not breast-feed while you are being treated with Rituzena.
Slovenian: Med zdravljenjem z zdravilom Rituzena ne smete dojiti.
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
English: You should also tell them about your Rituzena treatment.
Slovenian: Povejte, da se zdravite z zdravilom Rituzena.
English: Cmax following second infusion, was 207 µg/mL for the 2 x 500 mg dose and ranged from 377 to 386 µg/mL for the 2 x 1000 mg dose.
Slovenian: Po drugi infuziji je bila Cmax 207 μg/ml za 2 x 500 mg odmerek ter 377 do 386 μg/ml za 2 x 1.000 mg odmerek.
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 µg/mL and a mean terminal half-life of 19.2 days.
Slovenian: po enakem odmerjanju (2 x 1.000 mg, intravensko, v razmiku 2 tednov) so bili podobni s povprečno maksimalno koncentracijo v serumu 369 µg/ml in povprečnim končnim razpolovnim časom 19,2 dneva.
English: A corticosteroid medicine will usually be given by injection before the start of Rituzena treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Rituzena boste po navadi dobili zdravilo s kortikosteroidom v injekciji.
English: Toxic Epidermal Necrolysis (Lyell Syndrome) and Stevens-Johnson Syndrome, some with fatal outcome, have been reported very rarely.
Slovenian: Zelo redko sta bila opisana toksična epidermalna nekroliza (Lyellov sindrom) ali Stevens-Johnsonov sindrom, v nekaterih primerih s smrtnim izidom.
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3%
Slovenian: Pri KLL je bila celokupna incidenca bolezni živčevja stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4 % R-FC, 4 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (3 % R-FC, 3 % FC).
English: • 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
Slovenian: kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini - IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih okvara živcev v rokah in nogah, paraliza obraza, simptomi vnetja žil, vključno s tistimi, ki vodijo v kožo,
English: The recommended dose of Rituzena in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Slovenian: Priporočeni odmerek zdravila Rituzena v kombinaciji s kemoterapijo za indukcijsko zdravljenje bolnikov s folikularnimi limfomi, ki se predhodno še niso zdravili ali se na prejšnje zdravljenje niso odzvali ali se jim je bolezen ponovila, je: 375 mg/m2 telesne površine na cikel do 8 ciklov.
English: The recommended dosage of Rituzena in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Slovenian: Priporočeni odmerek zdravila Rituzena v kombinaciji s kemoterapijo pri bolnikih, ki predhodno še niso bili zdravljeni oziroma se na prejšnje zdravljenje niso odzvali ali pa se je bolezen pri njih ponovila, je 375 mg/m2 telesne površine, ki ga damo na dan 0 prvega cikla zdravljenja, v naslednjih ciklih zdravljenja pa dajemo 1. dan 500 mg/m2 telesne površine, skupaj 6 ciklov.
English: Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to rituximab.
Slovenian: (Fisherjev natančni test): starost, spol, gradus limfoma, začetna diagnoza, prisotnost ali odsotnost obsežne bolezni, normalna ali visoka koncentracija LDH ali ekstranodalna bolezen.
English: Continued immunosuppressive therapy may be especially appropriate in patients at risk for relapses (i.e. with history of earlier relapses and granulomatosis with polyangiitis, or patients with reconstitution of B-lymphocytes in addition to PR3-ANCA at monitoring).
Slovenian: za bolnike, ki so že imeli ponovitev in imajo granulomatozo s poliangiitisom ali bolnike, pri katerih so se limfociti B ponovno vzpostavili, skupaj s PR3-ANCA; ugotovljeno pri spremljanju).
English: In the active-controlled, randomised, double-blind, multicentre, non-inferiority trial of rituximab in granulomatosis with polyangiitis and microscopic polyangiitis, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Slovenian: V randomizirani, dvojno slepi, z zdravilno učinkovino kontrolirani multicentrični študiji neinferiornosti rituksimaba pri granulomatozi s poliangiitisom in mikroskopskem poliangiitisu se je nevtropenija, ki je bila 3. stopnje ali več po CTC, pojavila pri 24 % prejemnikov rituksimaba (en cikel) in pri 23 % prejemnikov ciklofosfamida.
English: Tell your doctor immediately if you get signs of an infection including:
Slovenian: Nemudoma povejte svojemu zdravniku, če se pri vas pojavi kateri od teh simptomov.
English: Rituzena 500 mg concentrate for solution for infusion
Slovenian: Rituzena 500 mg koncentrat za raztopino za infundiranje
English: • an increase in the amount of potassium in the blood • changes in the rhythm of the heart, or the heart beating faster than normal
Slovenian: • spremembe v srčnem ritmu ali hitrejše (kot je običajno) bitje srca.
English: • Weight loss
Slovenian: • izguba telesne mase,
English: Rituximab binding to CD20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Slovenian: Vezava rituksimaba na antigen CD20 na limfocitih B povzroči celično smrt v procesu
English: Psychiatric disorders depression, nervousness,
Slovenian: Psihiatrične motnje nespečnost Bolezni živčevja omotica tremor
English: You might get infections more easily during your treatment with Rituzena.
Slovenian: Med zdravljenjem z zdravilom Rituzena ste lahko bolj nagnjeni k okužbam.
English: Log-rank p value
Slovenian: Vrednost p v testu lograng
English: Rituzena is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Slovenian: Zdravilo Rituzena je bistra brezbarvna tekočina v sterilnih vialah za enkratno uporabo, apirogena in brez
English: Table 6 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median
Slovenian: Zdravljenje kronične limfocitne levkemije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje - pregled rezultatov o učinkovitosti za rituksimab v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC (mediana opazovanja 25,3 meseca).
English: A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Slovenian: Skupno so zdravili in glede učinkovitosti analizirali 321 bolnikov (162 R
English: Retreatment with rituximab
Slovenian: zdravljenih z rituksimabom.
English: Chronic lymphocytic leukaemia
Slovenian: Kronična limfocitna levkemija (KLL)
English: SUBSTANCE AND MANUFACTURERS RESPONSIBLE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OTHER CONDITIONS AND REQUIREMENTS OF THE CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALCI, B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Rituzena 100 mg concentrate for solution for infusion
Slovenian: Rituzena 100 mg koncentrat za raztopino za infundiranje
English: During rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Slovenian: Incidenci levkopenije in nevtropenije 3. ali 4. stopnje sta bili v skupini, ki je prejemala vzdrževalno zdravljenje z rituksimabom do 2 leti, višja (levkopenija: 5 %, nevtropenija: 10 %) kot v opazovani skupini (levkopenija: 2 %, nevtropenija: 4 %).
English: The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Slovenian: Celokupen odgovor je znašal 57 % (95-% interval zaupanja 41 %-73 %; popoln odgovor 14 %, delni odgovor 43 %), mediana časa do napredovanja bolezni je bila pri odzivnih bolnikih
English: None of the 99 rituximab-treated patients were HACA positive at screening.
Slovenian: Ob presejanju ni imel pozitivnega izvida HACA nobeden od 99 bolnikov,
English: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared
Slovenian: Incidenca neželenih učinkov vseh stopenj ter učinkov 3. ali 4. stopnje je bila pri starejših bolnikih podobna kot pri mlajših (< 65 let).
English: See the Rituzena package leaflet for more information.
Slovenian: Za več informacij preberite navodilo za uporabo zdravila Rituzena.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rituzena to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Slovenian: povezanih z infuzijo, in/ali sindroma sproščanja citokinov priporočljivo intravensko dati 100 mg prednizona/prednizolona malo pred infuzijo zdravila Rituzena.
English: • The need to monitor patients for infections, especially PML, during and after
Slovenian: • informacije o nujnosti, da bolnike spremljajo zaradi nastanka mogočih okužb, posebno progresivne multifokalne levkoencefalopatije (PML), med zdravljenjem z zdravilom Rituzena in
English: The Patient Alert Card for Rituzena in non-oncology indications should contain the following key
Slovenian: Opozorilna kartica za bolnika za neonkološke indikacije mora vsebovati naslednje ključne vsebine:
English: senses5
Slovenian: izguba sluha5
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Slovenian: motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk, slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost,
English: Cytokine release syndrome may be clinically indistinguishable
Slovenian: Sindrom sproščanja citokinov je lahko klinično nerazločljiv od akutnih preobčutljivostnih reakcij.
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission
Slovenian: Preskušanje je dokazalo neinferiornost rituksimaba v primerjavi s ciklofosfamidom glede popolne remisije po 6 mesecih (preglednica 7).
English: Rituzena was administered on the first day of the
Slovenian: Zdravilo Rituzena so prejeli prvi dan cikla zdravljenja.
English: Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Slovenian: O kardiovaskularnih neželenih učinkih so med kliničnimi preskušanji rituksimaba kot samostojnega zdravila poročali pri 18,8 % bolnikov.
English: Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Slovenian: Nevtropenija se lahko pojavi več mesecev po dajanju rituksimaba (glejte
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with rituximab.
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z rituksimabom in še 12 mesecev po njem uporabljati učinkovita
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Rituzena is not given in combination with glucocorticoid-containing chemotherapy.
Slovenian: Če zdravilo Rituzena za zdravljenje ne-Hodgkinovega limfoma in kronične limfocitne levkemije ni uporabljeno v kombinaciji s kemoterapijo, ki vključuje glukokortikoid, je treba razmisliti o premedikaciji
English: When sticking to the surface of this cell, rituximab causes the cell to die.
Slovenian: Zasnovana je tako, da se veže na površino vrste belih krvnih celic, limfocitov B. Ko se veže na površino teh celic, rituksimab povzroči njihovo smrt.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Žilne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance,
Slovenian: ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah: hematotoksičnost,