FrancophonIA/ELRC3.0 huggingface dataset:
English: In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
Croatian: U istraživanjima opće toksičnosti na Cynomolgus majmunima nisu primijećeni štetni učinci na reproduktivne organe mužjaka niti ženki.
English: Animal studies did not reveal deleterious effects of rituximab on reproductive organs.
Croatian: Istraživanja na životinjama nisu ukazala na štetne učinke rituksimaba na reproduktivne organe.
English: In rheumatoid arthritis most infusion-related events reported in clinical trials were mild to moderate in severity.
Croatian: Kod reumatoidnog artritisa je većina infuzijskih reakcija prijavljenih u kliničkim ispitivanjima bila blage do umjerene težine.
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: Ritemvia contains sodium
Croatian: Ritemvia sadrži natrij
English: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected.
Croatian: Ipak, primijećena je o dozi ovisna farmakološka deplecija B-stanica u limfoidnim organima fetusa, koja se nastavila postnatalno i bila popraćena smanjenjem razine IgG-a u novorođenih životinja.
English: The primary outcome measure was achievement of complete remission at 6 months defined as a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 0, and off glucocorticoid therapy.
Croatian: Primarna mjera ishoda bilo je postizanje potpune remisije nakon 6 mjeseci, definirano kao BVAS/WG indeks 0 (Birmingham Vasculitis Activity Score za Wegenerovu granulomatozu) i bez primjene glukokortikoida.
English: Therefore patients with a history of cardiac disease should be monitored closely (see Infusion-related reactions, above).
Croatian: Stoga se bolesnici s anamnezom bolesti srca moraju pažljivo nadzirati (vidjeti Reakcije povezane s infuzijom u gornjem tekstu).
English: Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Croatian: Modified Total Sharp Score, mTSS) i njegovim sastavnicama, stupnju erozije i stupnju suženja zglobnog prostora.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i vrlo rijetko (< 1/10 000).
English: Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course.
Croatian: Ozbiljne reakcije povezane s infuzijom bile su manje česte (0,5 % bolesnika) i pretežno su uočene tijekom početnog ciklusa.
English: Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Croatian: Uključeni su bolesnici bili u dobi od 21 do 75 godina i imali su novodijagnosticiranu ili relapsirajuću bolest koja je bila u potpunoj remisiji nakon liječenja glukokortikoidima u kombinaciji s pulsnom terapijom ciklofosfamidom.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ritemvia.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Ritemvia.
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Croatian: Svi bolesnici Novodijagnosticirani Relaps n = 99 n = 48 n = 51
English: Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Croatian: Teške infekcije prijavljene su u oko 4 % bolesnika liječenih monoterapijom rituksimabom.
English: The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Croatian: Analiza svih sekundarnih parametara (stope odgovora, preživljenja bez progresije bolesti, preživljenja bez bolesti, trajanja odgovora) potvrdila je pozitivan učinak liječenja R-CHOP-om u odnosu na liječenje CHOP-om.
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: The estimated median terminal elimination half-life of rituximab was 22 days (range, 6.1 to 52 days).
Croatian: Procijenjeni medijan terminalnog poluvremena eliminacije rituksimaba iznosi 22 dana (raspon od 6,1 do 52 dana).
English: Specific studies to determine the effects of rituximab on fertility have not been performed.
Croatian: Nisu provedena specifična istraživanja kojima bi se utvrdio učinak rituksimaba na plodnost.
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).
Croatian: Bolesnici koji su bili seropozitivni na RF i/ili anti-CCP na početku liječenja u 24. su tjednu imali značajno veću vjerojatnost da će postići odgovor ACR20 i ACR50 u usporedbi sa seronegativnim bolesnicima (p = 0,0312 i p = 0,0096) (Tablica 15).
English: Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Croatian: Neutropenija nije bila povezana s opaženim porastom ozbiljnih infekcija u bolesnika liječenih rituksimabom.
English: NR: not reached; a: only applicable to patients achieving a CR
Croatian: ND: nije dostignuto; a: primjenjivo samo u bolesnika koji su postigli CR
English: Occurred at various times up to several months after completion of rituximab therapy
Croatian: Pojavili su se u različito vrijeme do nekoliko mjeseci nakon završetka liječenja rituksimabom.
English: In patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.
Croatian: U bolesnika u kojih se liječenje pokaže djelotvornim, Ritemvia se može nastaviti primjenjivati tijekom2 godine nakon završetka početnog liječenja.
English: The majority of these subjects were also exposed to cytotoxic chemotherapy.
Croatian: Većina je tih osoba bila izložena i citotoksičnoj kemoterapiji.
English: This is because Ritemvia can across the placenta and may affect your baby.
Croatian: To je potrebno zato što Ritemvia može proći kroz posteljicu i naškoditi djetetu.
English: No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Croatian: Nisu zamijećene razlike između skupina koje su primale R-CHOP odnosno CHOP s obzirom na incidenciju drugih srčanih poremećaja stupnja 3 i 4, uključujući zatajenje srca, bolesti miokarda i manifestacije koronarne arterijske bolesti.
English: In the event of relapse, patients may receive 1000 mg IV.
Croatian: U slučaju relapsa bolesnici mogu primiti i.v. dozu od 1000 mg.
English: It sticks to the surface of a type of white blood cell called “B-Lymphocyte”.
Croatian: Veže se na površinu jedne vrste bijelih krvnih stanica koje se zovu „B-limfociti“.
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: Number of Subjects with Major Relapse
Croatian: Broj ispitanika s teškim relapsom
English: Rituximab in combination with methotrexate significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Croatian: Rituksimab je u kombinaciji s metotreksatom znatno povećao udio bolesnika koji su postigli najmanje 20 %-tno poboljšanje ACR rezultata u usporedbi s bolesnicima koji su liječeni samo metotreksatom (Tablica 12).
English: All IRRs were CTC Grade 1 or 2.
Croatian: Sve su infuzijske reakcije bile 1. ili 2. stupnja prema CTC kriterijima.
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Croatian: Liječnik treba pregledati bolesnika kako bi utvrdio ukazuju li simptomi na neurološki poremećaj, i ako je tako, upućuju li možda na PML.
English: In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Croatian: bolesnika liječenih zbog hematoloških zloćudnih bolesti obnova B-stanica počela je unutar 6 mjeseci od liječenja te su se vratile na normalnu razinu unutar 12 mjeseci nakon završetka liječenja, iako u nekih bolesnika to može trajati dulje (do medijana vremena obnove od 23 mjeseca nakon uvođenja liječenja).
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving rituximab in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Croatian: Radiološka analiza nakon dvije godine u Ispitivanju 1 pokazala je znatno smanjenje napredovanja strukturnog oštećenja zglobova u bolesnika koji su primali rituksimab u kombinaciji s metotreksatom u usporedbi s bolesnicima koji su primali samo metotreksat, kao i znatno veći udio bolesnika u kojih oštećenje zglobova uopće nije napredovalo tijekom te dvije godine.
English: The rate of serious infections did not show any significant increase following multiple courses of rituximab.
Croatian: Stopa ozbiljnih infekcija nije se značajno povećala nakon višestrukih ciklusa rituksimaba.
English: When Ritemvia is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Croatian: Kad se Ritemvia primjenjuje u kombinaciji s kemoterapijom, moraju se primijeniti uobičajena smanjenja doze kemoterapijskih lijekova.
English: (n=268) or R-FCM (n=44), according to the investigators' choice.
Croatian: om (n = 881), R-CVP-om (n = 268) ili R-FCM-om (n = 44) prema odabiru ispitivača.
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 10b).
Croatian: Korist u smislu PFS-a dosljedno se opažala u većini podskupina bolesnika analiziranih prema početnom riziku bolesti (Binet stadiji A-C) (Tablica 10b).
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 rituksimaba (vidjeti dio 4.8).
English: FU: follow-up; NR: not reached at time of clinical cut off, TNCT: time to next chemotherapy treatment; TNLT: time to next anti lymphoma treatment.
Croatian: ND: nije dosegnuto u trenutku prekida kliničkog promatranja; TNCT: vrijeme do sljedeće kemoterapije; TNLT: vrijeme do sljedećeg liječenja limfoma.
English: Herpes zoster Nasopharyngitis
Croatian: herpes zoster nazofaringitis
English: Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Croatian: Ispitivanja razvojne toksičnosti koja su provedena na Cynomolgus majmunima pri dozama do 100 mg/kg (primjena od 20. do 50. dana gestacije) nisu pokazala znakove toksičnosti za fetus koju bi uzrokovao rituksimab.
English: Ritemvia will be given to you once a week for 4 weeks.
Croatian: Lijek Ritemvia primat ćete jedanput na tjedan tijekom 4 tjedna.
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Croatian: 3/4) prijavljena je u 4,2 %, anemija u 1,1 %, a trombocitopenija u 1,7 % bolesnika.
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 rituksimaba.
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167).
Croatian: Ukupno je 334 bolesnika u kojih je nakon indukcijske terapije došlo do potpune ili djelomične remisije u drugom koraku randomizirano u skupinu koja je primala terapiju održavanja rituksimabom (n = 167) ili u opservacijsku skupinu (n = 167).
English: In all these studies, rituximab pharmacokinetics were dose proportional over the limited dose range studied.
Croatian: U svim su tim ispitivanjima farmakokinetička svojstva rituksimaba bila razmjerna dozi u ograničenom ispitivanom rasponu doza.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta i biljne lijekove.
English: M39021 CVP, 159 R-CVP, 162 53
Croatian: CVP: 159 R-CVP: 162
English: This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years.
Croatian: Lijek će se primijeniti u obliku 2 zasebne infuzije u razmaku od 2 tjedna, a zatim će se primjenjivati 1 infuzija svakih 6 mjeseci tijekom najmanje 2 godine.
English: Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Croatian: Znakovi i simptomi obuhvaćali su smetnje vida, glavobolju, epileptičke napadaje i promijenjeno mentalno stanje, uz pridruženu hipertenziju ili bez nje.
English: 4.04 years
Croatian: ND 4,04 godine
English: Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Croatian: Tablica 18 Postotak bolesnika s PV-om koji su u 24. mjesecu ostvarili potpunu remisiju bez primjene kortikosteroida tijekom dva ili više mjeseci (populacija s namjerom liječenja - PV)
English: The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Croatian: Medijan PFS-a iznosio je 42,2 mjeseca u skupini koja je primala terapiju održavanja rituksimabom u usporedbi s 14,3 mjeseca u opservacijskoj skupini.
English: Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether rituximab was administered as monotherapy or in combination with methotrexate.
Croatian: Broj B-stanica u perifernoj krvi počinje se povećavati od 24. tjedna, a dokaz repopulacije stanica u većine se bolesnika zamjećuje do 40. tjedna, pri monoterapiji rituksimabom i u kombinaciji s metotreksatom.
English: For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Croatian: S obzirom na sličnost među bolestima, može se pretpostaviti da bi rezultati za bolesnike s KLL-om bili slični, ali to nije ispitivano u kliničkim ispitivanjima.
English: 40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Croatian: Odgovor je bio prisutan u 40 % bolesnika sa zahvaćenošću koštane srži, u odnosu na 59 % bolesnika u kojih nije bila zahvaćena koštana srž (p = 0,0186).
English: Trial 1 evaluated 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Croatian: Ispitivanje 1 obuhvatilo je 517 bolesnika koji nisu dovoljno dobro odgovorili na jedno ili više liječenja TNF-inhibitorima ili ih nisu podnosili.
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 rituksimaba ni idućih 12 mjeseci nakon liječenja.
English: Patients were excluded from the study in relapsed/refractory CLL if they had previously been treated with monoclonal antibodies or if they were refractory (defined as failure to achieve a partial remission for at least 6 months) to fludarabine or any nucleoside analogue.
Croatian: Bolesnici su isključeni iz ispitivanja relapsirajućeg/refraktornog KLL-a ako su prethodno liječeni monoklonskim antitijelima, ili ako nisu odgovorili (nisu postigli djelomičnu remisiju tijekom najmanje šest mjeseci) na fludarabin ili bilo koji nukleozidni analog.
English: Re-treatment
Croatian: Ponovno liječenje
English: It is not known whether Ritemvia has an effect on you being able to drive or use any tools or machines.
Croatian: Nije poznato utječe li Ritemvia na sposobnost upravljanja vozilima ili rada s alatima i strojevima.
English: A total of 1078 patients responded to induction therapy, of which 1018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Croatian: Na početno liječenje odgovorilo je ukupno 1078 bolesnika, od kojih je njih 1018 randomizirano u skupinu koja je primala terapiju održavanja rituksimabom (n = 505) ili u opservacijsku skupinu (n = 513).
English: In studies of rituximab in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Croatian: U ispitivanjima primjene rituksimaba u bolesnika s Waldenstromovom makroglobulinemijom primijećena su prolazna povećanja serumske razine IgM-a nakon početka liječenja, što može biti povezano s hiperviskoznošću i srodnim simptomima.
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 rituksimaba 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: 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 rituksimaba treba odmah pregledati te odgovarajuće liječiti.
English: Nearly all infusion-related reactions were mild to moderate.
Croatian: Gotovo sve reakcije povezane s infuzijom bile su blage do umjerene težine.
English: • The need to monitor patients for infections, especially PML, during and after Ritemvia treatment
Croatian: • Bolesnike je potrebno nadzirati zbog mogućeg razvoja infekcija, osobito PML-a, tijekom i nakon liječenja lijekom Ritemvia.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Croatian: U bolesnika u kojih dođe do predoziranja treba odmah prekinuti infuziju i pomno ih nadzirati.
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).
Croatian: Informacije o sigurnosti prikupljene nakon stavljanja lijeka u promet odražavaju očekivani profil nuspojava koji je bio vidljiv u kliničkim ispitivanjima rituksimaba (vidjeti dio 4.4).
English: • Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
Croatian: • Informacije o znakovima i simptomima infekcija, osobito PML-a, i napomenu da se odmah obrate svom liječniku ako primijete neki od njih
English: There were no differences reported for the incidence of anaemia.
Croatian: Nije prijavljena različita incidencija anemije.
English: Disease activity outcomes
Croatian: Ishodi ispitivanja aktivnosti bolesti
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Croatian: Ukupno je 4% bolesnika u skupini liječenoj lijekom rituksimab imalo štetne događaje koji su doveli do prekida liječenja.
English: Rituximab was administered on the first day of each treatment cycle.
Croatian: Rituksimab je primijenjen prvog dana svakog ciklusa liječenja.
English: Very rarely, severe blistering skin conditions that can be life-threatening may occur.
Croatian: Vrlo rijetko mogu se razviti teške kožne reakcije s plikovima, koje mogu biti opasne po život.
English: Treatment of relapse
Croatian: Liječenje relapsa
English: In the post-marketing setting five cases of rituximab overdose have been reported.
Croatian: Nakon stavljanja lijeka u promet prijavljeno je pet slučajeva predoziranja rituksimabom.
English: A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with rituximab, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Croatian: Zabilježen je malen broj spontanih i u literaturi opisanih slučajeva hipogamaglobulinemije u pedijatrijskih bolesnika liječenih rituksimabom, od kojih su neki bili teški i zahtijevali dugotrajnu supstitucijsku terapiju imunoglobulinima.
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, ≥ 60 years), FLIPI score (≤1, 2 or ≥ 3), induction therapy (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Croatian: Terapija održavanja rituksimabom donijela je dosljednu korist u svim unaprijed definiranim ispitanim podskupinama: s obzirom na spol (muški, ženski), dob (< 60 godina, >= 60 godina), FLIPI indeks (≤1, 2 ili ≥3) i početnu terapiju (R-CHOP, R-CVP ili R-FCM) te bez obzira na kvalitetu odgovora na početnu terapiju (CR/CRu ili PR).
English: What Ritemvia is and what it is used for What Ritemvia is
Croatian: Što je Ritemvia i za što se koristi Što je Ritemvia
English: Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Croatian: Bolesnici s ranijom respiratornom insuficijencijom ili oni s tumorskim infiltratom na plućima imaju povećan rizik za lošiji ishod te ih treba liječiti s povećanim oprezom.
English: Sustained improvement in physical function as indicated by the HAQ-DI score and the proportion of patients achieving MCID for HAQ-DI were observed.
Croatian: Promatrano je trajno poboljšanje fizičke funkcije, na što upućuju HAQ-DI indeks i udio bolesnika koji su postigli MCID za HAQ-DI.
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and 0.27% (2/731) of placebo-treated patients developed severe neutropenia.
Croatian: U placebom kontroliranim razdobljima kliničkih ispitivanja u 0,94 % (13/1382) bolesnika liječenih rituksimabom te 0,27 % (2/731) bolesnika koji su primali placebo razvila se teška neutropenija.