FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Croatian: Ozbiljne infekcije, uključujući one sa smrtnim ishodom, mogu se pojaviti tijekom terapije lijekom rituksimab (vidjeti dio 4.8).
English: The incidence of thrombocytopenia was low (<1% , grade 3/4) and was not different between treatment arms.
Croatian: Incidencija trombocitopenije bila je niska (< 1 %, stupanj 3/4) i nije se razlikovala između dviju skupina.
English: Rituzena should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see
Croatian: Rituzena se treba primjenjivati pod izravnim nadzorom iskusnog zdravstvenog radnika i u okruženju u kojem su izravno dostupni svi uređaji za oživljavanje (vidjeti dio 4.4).
English: The efficacy and safety of rituximab in maintenance therapy has not been established.
Croatian: Djelotvornost i sigurnost terapije održavanja rituksimabom nije ustanovljena.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rituzena.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Rituzena.
English: In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Croatian: Nasuprot tome, u CHOP skupini su tri bolesnika (1,5 %) doživjela cerebrovaskularne događaje, i to u razdoblju praćenja nakon liječenja.
English: Occurred at various times up to several months after completion of rituximab
Croatian: Pojavili su se u različito vrijeme do nekoliko mjeseci nakon završetka liječenja rituksimabom.
English: • Detailed information on the risk of PML, the need for timely diagnosis of PML
Croatian: • Detaljne informacije o riziku od PML-a, nužnost pravodobne dijagnoze PML-a i odgovarajuće mjere za dijagnosticiranje PML-a
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Croatian: Završna analiza potvrdila je da je liječenje R-CHOPom povezano s klinički relevantnim i statističkim značajnim poboljšanjem trajanja preživljenja bez pojave događaja (primarni parametar djelotvornosti; događajem se smatrala smrt, relaps ili progresija limfoma odnosno početak novog liječenja limfoma) (p = 0,0001).
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Croatian: No, budući da se majčin IgG izlučuje u majčino mlijeko, a rituksimab je otkriven u mlijeku majmunica u laktaciji, žene ne smiju dojiti tijekom liječenja lijekom rituksimab ni idućih 12 mjeseci nakon liječenja.
English: This is because Rituzena can transfer across the placenta and may affect your baby.
Croatian: To je potrebno zato što Rituzena može proći kroz posteljicu i naškoditi djetetu.
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.
Croatian: Anti-Mouse Antibody/Human Anti-Chimeric Antibody, HAMA/HACA) mogu nastupiti alergijske reakcije ili reakcije preosjetljivosti prilikom primjene drugih dijagnostičkih ili terapijskih monoklonskih antitijela.
English: Ninety nine patients were treated with rituximab and 12% experienced at least one IRR.
Croatian: Devedeset i devet je bolesnika liječeno rituksimabom i 12 % ih je imalo barem jednu reakciju povezanu s infuzijom.
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 %).
Croatian: U bolesnika s proširenim tumorima incidencija nuspojava stupnja 3/4 bila je veća nego u bolesnika bez proširenih tumora (25,6 % u odnosu na 15,4 %).
English: Before you are given Rituzena, you will be given other medicines (pre-medication) to prevent or
Croatian: Prije nego primite lijek Rituzena, primit ćete druge lijekove (premedikaciju) koji sprječavaju ili ublažavaju moguće nuspojave.
English: 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).
Croatian: Korist u smislu PFS-a dosljedno se opažala u većini podskupina bolesnika analiziranih prema početnom riziku bolesti (Binet stadiji A-C) (Tablica 5b).
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 5a).
Croatian: Analiza ukupnog preživljenja pokazala je značajnu korist R-FC terapije u odnosu na primjenu samo FC kemoterapije (p = 0,0319, log-rang test) (Tablica 5a).
English: When remission with rituximab has been achieved, continued immunosuppressive therapy may be considered to prevent relapse.
Croatian: Kada se postigne remisija primjenom rituksimaba, može se razmotriti nastavak imunosupresivne terapije u cilju sprječavanja relapsa.
English: What you need to know before you use Rituzena
Croatian: Što morate znati prije nego počnete primati lijek Rituzena
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Croatian: Iako rituksimab primijenjena u monoterapiji nema mijelosupresivan učinak, potreban je oprez kada se razmatra liječenje bolesnika s brojem neutrofila < 1,5 x 109/l i/ili brojem trombocita < 75 x 109/l jer je kliničko iskustvo u liječenju takvih bolesnika ograničeno.
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Croatian: Rituksimab se ne smije primijeniti bolesnicima s aktivnom teškom infekcijom (npr. tuberkulozom, sepsom i oportunističkim infekcijama, vidjeti dio 4.3).
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Croatian: Treba određivati neutrofile u krvi prije svakog ciklusa lijeka rituksimab, redovito tijekom najdulje 6 mjeseci nakon prestanka liječenja te po pojavi znakova ili simptoma infekcije (vidjeti dio 4.8).
English: No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets
Croatian: Nisu zamijećene inkompatibilnosti između rituksimaba i polivinilkloridnih ili polietilenskih vrećica ili kompleta za infuziju.
English: Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Croatian: Bolesnike u kojih se pojave znakovi i simptomi infekcije nakon terapije lijekom rituksimab treba odmah pregledati te odgovarajuće liječiti.
English: If a patient develops PML the dosing of rituximab must be permanently discontinued.
Croatian: Ako se u bolesnika razvije PML, primjena lijeka rituksimab mora se trajno obustaviti.
English: When Rituzena is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Croatian: Kad se Rituzena primjenjuje u kombinaciji s kemoterapijom, moraju se primijeniti uobičajena smanjenja doze kemoterapijskih lijekova.
English: IRRs in the GPA and MPA clinical trial were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Croatian: U kliničkom ispitivanju u indikacijama GPA i MPA reakcije povezane s infuzijom su definirane kao bilo koji štetni događaj koji je nastupio unutar 24 sata od infuzije i koji je ispitivač populacije u ispitivanju sigurnosti lijeka smatrao povezanim s infuzijom.
English: Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
Croatian: Cijepljenje treba dovršiti najmanje 4 tjedna prije prve primjene lijeka rituksimab.
English: B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials.
Croatian: Razine B-stanica u ljudske novorođenčadi nakon izloženosti majke lijeku rituksimab nisu ispitivane u kliničkim ispitivanjima.
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2
Croatian: Udio bolesnika s razinom IgG-a ispod donje granice normalnih vrijednosti bio je oko 60 % u skupini koja je primala rituksimab tijekom cjelokupnog dvogodišnjeg razdoblja liječenja, dok se u opservacijskoj skupini smanjio (36 % nakon
English: In case of such an event, with a suspected relationship to rituximab, treatment should be permanently discontinued.
Croatian: U slučaju takvog događaja, uz sumnju na povezanost s lijekom rituksimab, liječenje se mora trajno prekinuti.
English: Rituzena should be used in combination with CHOP chemotherapy.
Croatian: Rituzena se treba davati u kombinaciji s CHOP kemoterapijom.
English: Based upon investigator judgment, 15 patients received a second course of rituximab therapy for treatment of relapse of disease activity which occurred between 6 and 18 months after the first course of rituximab.
Croatian: Ponovno liječenje rituksimabom Temeljem procjene ispitivača, 15 je bolesnika primilo drugi ciklus rituksimaba za liječenje relapsa aktivnosti bolesti koji je nastupio 6 do 18 mjeseci nakon prvog ciklusa rituksimaba.
English: 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.
Croatian: overall response rate, ORR) u populaciji svih randomiziranih bolesnika (engl. intent-to-treat, ITT) iznosila je 48 % (95 % CI 41 % - 56 %), od čega 6 % otpada na potpun odgovor (engl. complete response, CR), a 42 % na djelomičan odgovor (engl. partial response, PR).
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG Ostali izvori informacija
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing
Croatian: • ako ste ikada imali srčane tegobe (poput angine pektoris, osjećaja lupanja srca ili zatajenja srca)
English: • The active ingredient in Rituzena is called rituximab.
Croatian: • Djelatna tvar u lijeku Rituzena zove se rituksimab.
English: and 6
Croatian: 4 godine
English: 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.
Croatian: Analizom djelotvornosti obuhvaćeno je ukupno 810 bolesnika (403 R-FC, 407 FC) u ispitivanju prve linije liječenja (Tablica 5a i Tablica 5b) i 552 bolesnika (276 R-FC, 276 FC) u ispitivanju relapsirajuće/refraktorne bolesti (Tablica 6).
English: 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 Rituzena (the last dose of methylprednisolone may be given on the same day as the first infusion of Rituzena).
Croatian: U bolesnika s granulomatozom s poliangitiisom (Wegenerova granulomatoza) ili mikroskopskim poliangitiisom se prije prve infuzije lijeka Rituzena preporučuje intravenska primjena metilprednizolona u dozi od 1000 mg na dan tijekom 1 do 3 dana (posljednja doza metilprednizolona može se dati istoga dana kao i prva infuzija lijeka Rituzena).
English: None of the 99 rituximab-treated patients were HACA positive at screening.
Croatian: Niti jedan od 99 bolesnika liječenih rituksimabom nije bio pozitivan na HACA-u pri probiru.
English: Medicines given before each Rituzena administration
Croatian: Lijekovi koji se daju prije svake primjene lijeka Rituzena
English: Rituzena should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Croatian: Rituzena se treba primijeniti prvog dana svakog kemoterapijskog ciklusa, nakon intravenske primjene glukokortikoidne komponente kemoterapije, ako je liječenje obuhvaća.
English: Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Croatian: Od 3189 bolesnika liječenih rituksimabom, njih je 1135 (36 %) imalo barem jednu reakciju povezanu s infuzijom, a 733/3189 (23 %) bolesnika imalo je reakciju povezanu s infuzijom nakon prve infuzije pri prvom izlaganju rituksimabu.
English: Rituzena in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Croatian: Rituzena je u kombinaciji s kemoterapijom indicirana za liječenje bolesnika s prethodno neliječenim i relapsirajućim/refraktornim KLL-om.
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Croatian: Liječnici trebaju provjeriti bolesnikov status cijepljenja i slijediti važeće smjernice o cijepljenju prije terapije lijekom rituksimab.
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
Croatian: Tablica 6 Liječenje relapsirajuće/refraktorne kronične limfocitne leukemije - pregled rezultata djelotvornosti za rituksimab + FC u odnosu na samo FC (medijan vremena promatranja je 25,3 mjeseca)
English: A slight but not significant improvement in overall survival was reported in the R-FC
Croatian: Prijavljeno je blago, ali ne značajno poboljšanje ukupnog preživljenja u R-FC skupini u usporedbi s FC skupinom.
English: For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Croatian: Manje često Rijetko Vrlo rijetko Nepoznato Za svaku se nuspojavu izračun učestalosti temelji na reakcijama svih stupnjeva težine (od blagih do teških), osim za nuspojave označene znakom „+“, za koje se izračun učestalosti temelji samo na teškim reakcijama (stupanj ≥ 3 prema općim kriterijima toksičnosti Nacionalnog instituta za rak).
English: Rituzena contains the active substance “rituximab”.
Croatian: Rituzena sadrži djelatnu tvar „rituksimab“.
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.
Croatian: Većina je bolesnika (81 %) pokazala znakove povrata B stanica, uz vrijednosti od > 10 stanica/µl do 12.
English: Do not take Rituzena if:
Croatian: Nemojte primati lijek Rituzena:
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rituzena or patients refractory to previous Rituzena plus chemotherapy.
Croatian: Dostupni su samo ograničeni podaci o djelotvornosti i sigurnosti za bolesnike prethodno liječene monoklonskim antitijelima uključujući lijek Rituzena, kao i za bolesnike refraktorne na prethodno liječenje lijekom Rituzena u kombinaciji s kemoterapijom.
English: If you have granulomatosis with polyangiitis or microscopic polyangiitis also tell your doctor
Croatian: Imate li granulomatozu s poliangiitisom ili mikroskopski poliangiitis, obavijestite svog liječnika
English: IRRs for patients with granulomatosis with polyangiitis and microscopic polyangiitis were similar to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Croatian: Reakcije povezane s infuzijom u bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom bile su slične onima opaženima u bolesnika s reumatoidnim artritisom u kliničkim ispitivanjima (vidjeti dio 4.8).
English: Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Croatian: Prije primjene sljedećeg ciklusa lijeka rituksimab treba ponovno procijeniti stanje bolesnika kako bi se utvrdio potencijalni rizik od infekcija.
English: Table 4 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Croatian: Tablica 4 Sažetak najvažnijih rezultata četiriju randomiziranih ispitivanja faze III u kojima se procjenjivala korist liječenja folikularnog limfoma rituksimabom u kombinaciji s različitim režimima kemoterapije
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).
Croatian: Nastavak imunosupresivne terapije može biti primjeren osobito za bolesnike s rizikom od relapsa (tj. one koji u anamnezi već imaju relapse i granulomatozu s poliangiitisom ili bolesnike u kojih se tijekom praćenja uz PR3-ANCA ustanovi i rekonstitucija B-limfocita).
English: 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.
Croatian: Sljedeće doze lijeka Rituzena mogu se dati početnom brzinom infuzije od 100 mg/sat, a brzina se može povećavati za 100 mg/sat u razmacima od 30 minuta, do najviše 400 mg/sat.
English: 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.
Croatian: Ako je potrebno cijepljenje neživim cjepivom tijekom primjene lijeka rituksimab, ono se mora dovršiti najmanje 4 tjedna prije početka sljedećeg ciklusa lijeka rituksimab.
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.
Croatian: U bolesnika s ne-Hodgkinovim limfomom i KLL-om potrebno je razmotriti premedikaciju glukokortikoidima ako se Rituzena ne primjenjuje u kombinaciji s kemoterapijom koja sadrži glukokortikoide.
English: 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.
Croatian: U aseptičkim uvjetima izvucite potrebnu količinu lijeka Rituzena i razrijedite do izračunate koncentracije od 1 do 4 mg/ml rituksimaba u vrećici za infuziju koja sadrži sterilnu apirogenu otopinu natrijevog klorida za injekciju od 9 mg/ml (0,9 %) ili 5 %-tnu vodenu otopinu D-glukoze.
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.
Croatian: U bolesnika s KLL-om koji imaju broj limfocita > 25 x 109/l preporučuje se primjena prednizona/prednizolona u dozi od 100 mg intravenski neposredno prije infuzije lijeka Rituzena kako bi se smanjila stopa i težina akutne infuzijske reakcije i/ili sindroma otpuštanja citokina.
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the
Croatian: Nuspojave navedene u Tablici 3 su sve nuspojave koje su se javile s incidencijom od ≥ 5 % u skupini koja je primala rituksimab.
English: 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.
Croatian: Lijekovi za liječenje reakcija preosjetljivosti, kao što su epinefrin (adrenalin), antihistaminici i glukokortikoidi, moraju biti dostupni za brzu primjenu u slučaju alergijske reakcije tijekom primjene lijeka rituksimab.
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
Croatian: • promjene srčanog ritma ili srce kuca brže nego obično
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Croatian: Ispitivanjima prethodno neliječenog i relapsirajućeg/refraktornog KLL-a utvrdilo se da je u do 25 % bolesnika koji su primali R-FC neutropenija bila produljena (definirano kao broj neutrofila koji je ostao niži od 1 x 109/l između 24. i 42. dana od posljednje doze) ili se pojavila kasnije (definirano kao broj neutrofila niži od 1 x 109/l nakon više od 42 dana od posljednje doze u bolesnika koji ranije nisu imali produljenu neutropeniju ili u onih koji su se oporavili prije 42. dana) nakon liječenja rituksimabom u kombinaciji s FC-om.
English: 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.
Croatian: Istodobna/sekvencijska primjena drugih DMARD-a u liječenju reumatoidnog artritisa Istodobna primjena lijeka rituksimab i antireumatskih lijekova koji nisu navedeni u poglavljima o indikaciji i doziranju za reumatoidni artritis se ne preporučuje.
English: Cases of hepatitis B reactivation,have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Croatian: Prijavljeni su slučajevi reaktivacije hepatitisa B, većina njih u bolesnika koji su primali rituksimab u kombinaciji s citotoksičnom kemoterapijom.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab, and at a higher frequency than the comparator group, in the
Croatian: Tablica 3 Nuspojave koje su u 6 mjeseci nastupile u ≥ 5 % bolesnika koji su primali rituksimab i s većom učestalošću nego u usporednoj skupini u pivotalnom
English: Patients treated with rituximab may receive non-live vaccinations.
Croatian: Bolesnici liječeni lijekom rituksimab mogu primiti neživa cjepiva.
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.
Croatian: Malobrojni podaci iz sadašnjeg ispitivanja ne dozvoljavaju donošenje zaključaka o djelotvornosti daljnjih ciklusa rituksimaba u bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom.
English: 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated
Croatian: 6 Primijećeno najčešće u bolesnika s prethodnim srčanim poremećajima i/ili kardiotoksičnom kemoterapijom i najčešće vezano uz reakcije povezane s infuzijom.
English: Name and address of the manufacturer of the biological active substance CELLTRION Inc.,
Croatian: Naziv i adresa proizvođača biološke djelatne tvari