FrancophonIA/ELRC3.0 huggingface dataset:
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, pyrexia.
Croatian: Sljedeće su nuspojave prijavljene tijekom kliničkih ispitivanja, no njihova je incidencija bila slična ili manja u skupinama koje su primale rituksimab u odnosu na kontrolne skupine: hematotoksičnost, neutropenijska infekcija, infekcija mokraćnih putova, poremećaj osjeta, vrućica.
English: What Rixathon is used for
Croatian: Za što se Rixathon koristi
English: Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/dL).
Croatian: Klinički i statistički značajno poboljšanje primijećeno je i u svim pojedinačnim komponentama ACR odgovora (broj bolnih i otečenih zglobova, opća ocjena bolesnika i liječnika, rezultat indeksa nesposobnosti (Upitnik za procjenu zdravlja, engl.
English: Rixathon should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Croatian: Rixathon se treba primijeniti u obliku dviju i.v. infuzija od 500 mg u razmaku od dva tjedna, nakon čega se primjenjuje doza od 500 mg i.v. infuzijom svakih 6 mjeseci.
English: 1 vial contains 10 mg/mL rituximab.
Croatian: 1 bočica sadrži 10 mg/ml rituksimaba.
English: The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Croatian: Imunizacija Sigurnost imunizacije živim virusnim cjepivima nakon liječenja rituksimabom nije ispitivana u bolesnika s NHL-om i KLL-om pa se cijepljenje živim virusnim cjepivima ne preporučuje.
English: Therefore vaccination with live virus vaccines is not recommended whilst on Rixathon or whilst peripherally B cell depleted.
Croatian: Stoga se ne preporučuje cijepljenje živim virusnim cjepivima za vrijeme primjene lijeka Rixathon odnosno dok je prisutna deplecija B-stanica u perifernoj krvi.
English: The reported cases had recognized risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Croatian: U prijavljenim slučajevima postojali su faktori rizika za PRES/RPLS, uključujući osnovnu bolest bolesnika, hipertenziju, terapiju imunosupresivima i/ili kemoterapiju.
English: If the more rapid infusion is tolerated, this infusion schedule can be used when administering subsequent infusions.
Croatian: Ako bolesnik dobro podnosi bržu infuziju, opisani se raspored može primijeniti i u daljnjim infuzijama.
English: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
Croatian: • oslabljen imunitet - posljedica niskih razina protutijela zvanih „imunoglobulini“ (IgG) u krvi;
English: p-value Risk reduction1)
Croatian: CHOP R-CHOP p-vrijednost Smanjenje rizika1)
English: The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg upon re-treatment in the second course.
Croatian: Ispitana su farmakokinetička svojstva rituksimaba nakon dvije intravenske doze od 500 mg i 1000 mg primijenjene u ponovnom liječenju u drugom ciklusu.
English: During the treatment course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Croatian: Za vrijeme liječenja u ispitivanjima rituksimaba u kombinaciji s kemoterapijom obično su s većom učestalošću u usporedbi s primjenom samo kemoterapije prijavljene: leukopenija stupnja 3/4 (R-CHOP 88 % u odnosu na CHOP 79 %, R-FC 23 % u odnosu na FC 12 %), neutropenija (R-CVP 24 % u odnosu na CVP 14 %; R-CHOP 97 % u odnosu na CHOP 88 %, R-FC 30 % u odnosu na FC 19 % u prethodno neliječenom KLL-u) i pancitopenija (R-FC 3 % u odnosu na FC 1 % u prethodno neliječenom KLL-u).
English: Rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Croatian: Terapija održavanja lijekom Rixathon indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma koji su odgovorili na uvodnu terapiju.
English: The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of > 0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Croatian: Minimal Clinically Important Difference, MCID) u HAQ-DI (definirano kao smanjenje pojedinačnog ukupnog rezultata za > 0,22) bio je veći nego udio takvih bolesnika koji su primali samo metotreksat (Tablica 14).
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 10a).
Croatian: terapije u odnosu na primjenu samo FC kemoterapije (p = 0,0319, log-rang test) (Tablica 10a).
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Croatian: Ostale nuspojave uključuju: a) Bolesnici koji se liječe od ne-Hodgkinova limfoma ili kronične limfocitne leukemije
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time)
Croatian: Tablica 8 Indukcijska faza: pregled rezultata djelotvornosti CHOP-a i R-CHOP-a (medijan vremena promatranja je 31 mjesec)
English: Patients were followed beyond week 24 for long term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Croatian: Bolesnici su praćeni dulje od 24 tjedna radi utvrđivanja dugoročnih mjera ishoda, uključivo i radiološku procjenu u
English: c) Rheumatoid arthritis
Croatian: c) reumatoidnog artritisa
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs. 0% FC.
Croatian: U bolesnika s relapsirajućim/refraktornim KLL-om incidencija hepatitis B infekcije stupnja 3/4 (reaktivacija i primarna infekcija) iznosila je 2 % kod primjene R-FC terapije u odnosu na
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Croatian: Tablica 9 Faza održavanja: pregled rezultata djelotvornosti rituksimaba u odnosu na opservacijsku skupinu (medijan vremena promatranja je 28 mjeseci)
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 Rixathon.
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 Rixathon.
English: Rixathon contains the active substance “rituximab”.
Croatian: Rixathon sadrži djelatnu tvar „rituksimab“.
English: The Patient educational leaflet about Rixathon contains the following key elements: - Detailed information on the risk of infections and PML - Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any - The importance of sharing this information with their partner or caregiver - Information on the Patient Alert Card
Croatian: Informacijski letak za bolesnike o lijeku Rixathon sadrži sljedeće ključne elemente: - Detaljne informacije o riziku od infekcija i PML-a - Informacije o znakovima i simptomima infekcija, osobito PML-a, i napomenu da se odmah obrate svom liječniku ako primijete neki od njih
English: • Anxiety, depression
Croatian: • tjeskoba, depresija
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of rituximab (containing) treatment.
Croatian: Incidencija pojave simptoma povezanih s infuzijom znatno se smanjila u narednim infuzijama te je do osmog ciklusa terapije koja je sadržavala rituksimab iznosila < 1 %.
English: • unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
Croatian: • neuobičajeni osjeti na koži, kao što su utrnulost, trnci, bockanje, žarenje, osjećaj da nešto gmiže po koži, smanjen osjet dodira.
English: Rituximab was administered as two intravenous infusions separated by an interval of 15 days.
Croatian: Rituksimab su primali u obliku dvije zasebne intravenske infuzije u razmaku od 15 dana.
English: • general discomfort or feeling uneasy or tired, shaking, signs of flu
Croatian: • opća nelagoda, uznemirenost ili umor, drhtanje, znakovi gripe
English: Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Croatian: Također se pokazalo da vezanje rituksimaba na antigen CD20 na B-limfocitima može inducirati staničnu smrt putem apoptoze.
English: Patients in both arms received 1,000 mg of pulse intravenous methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Croatian: Bolesnici u obje skupine su tijekom 1 do 3 dana primali pulsnu intravensku terapiju metilprednizolonom u dozi od 1000 mg na dan (ili drugi glukokortikoid u ekvivalentnoj dozi), a zatim peroralni prednizon (1 mg/kg na dan, ali ne više od 80 mg na dan).
English: 53-months p=0.029
Croatian: 53 mjeseca p = 0,029
English: In a non-randomised study, patients with relapsed low-grade NHL who received rituximab monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for > 2-fold increase in antibody titer).
Croatian: U nerandomiziranom ispitivanju, bolesnici u relapsu NHL-a niskog stupnja malignosti koji su primali monoterapiju rituksimabom su u usporedbi sa zdravim neliječenim kontrolnim ispitanicima imali nižu stopu odgovora na cijepljenje antigenom tetanusa (16 % u odnosu na 81 %) i Keyhole Limpet Haemocyanin (KLH) neoantigenom (4 % u odnosu na 76 % kada se mjerilo više nego dvostruko povećanje titra antitijela).
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Croatian: European League Against Rheumatism) odgovor postiglo je znatno više bolesnika liječenih rituksimabom i metotreksatom nego onih koji su liječeni samo metotreksatom (Tablica 12).
English: Following induction of remission with Rixathon, maintenance treatment should be initiated no sooner than 16 weeks after the last rituximab infusion.
Croatian: Nakon primjene lijeka Rixathon za poticanje remisije, terapiju održavanja treba započeti najmanje 16 tjedana nakon posljednje infuzije rituksimaba.
English: The overall safety profile of rituximab in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
Croatian: Sažetak sigurnosnog profila Ukupan sigurnosni profil rituksimaba u liječenju ne-Hodgkinova limfoma i KLL-a temelji se na podacima o bolesnicima koji su sudjelovali u kliničkim ispitivanjima i praćenju nakon stavljanja lijeka u promet.
English: If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: Ako se liječite od reumatoidnog artritisa, granulomatoze s poliangitisom, mikroskopskog poliangitisa ili običnog pemfigusa, ove ćete informacije naći i u Kartici za bolesnika koju Vam je dao liječnik.
English: Make sure you have a list of all your medicines when you see a health care professional.
Croatian: obavezno sa sobom ponesite popis svih lijekova koje uzimate.
English: How to store Rixathon
Croatian: Kako čuvati lijek Rixathon
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Rixathon treatment, as appropriate according to local clinical practice guidelines.
Croatian: Pneumocystic jirovecii tijekom i nakon liječenja lijekom Rixathon, prema potrebi i u skladu s lokalnim smjernicama za kliničku praksu
English: The prepared Rixathon solution should be administered as an intravenous infusion through a dedicated line.
Croatian: Pripremljenu otopinu lijeka Rixathon treba primijeniti intravenskom infuzijom kroz posebnu infuzijsku liniju.
English: Hepatitis B virus
Croatian: Infekcije virusom hepatitisa B
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Croatian: Pogoršanja već postojećih srčanih bolesti, npr. angine pektoris i kongestivnog zatajenja srca, ili teški srčani poremećaji (zatajenje srca, infarkt miokarda, fibrilacija atrija), plućni edem, višeorgansko zatajenje, sindrom lize tumora, sindrom otpuštanja citokina, zatajenje bubrega i zatajenje dišnog sustava prijavljeni su s manjom ili nepoznatom učestalošću.
English: Fourteen patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Croatian: Infekcije povezane s liječenjem zabilježene su u 14 bolesnika (37 %) u skupini liječenoj rituksimabom te 15 bolesnika (42 %) u skupini liječenoj standardnom dozom prednizona.
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Croatian: Sigurnost cijepljenja živim virusnim cjepivima nakon terapije rituksimabom nije ispitivana.
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Croatian: Trajanje odgovora* Preživljenje bez bolesti (DFS)**
English: Physicians should exercise caution when considering the use of Rixathon in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Croatian: Liječnici trebaju biti oprezni ako razmatraju primjenu lijeka Rixathon u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim stanjima koje ih mogu dodatno predisponirati za ozbiljne infekcije (vidjeti dio 4.8).
English: Infusionrelated reactions3 (generalised oedema, bronchospas m, wheezing, laryngeal oedema, angioneuroti c oedema, generalised pruritus, anaphylaxis, anaphylactoi d reaction)
Croatian: reakcije povezane s infuzijom3 (generalizirani edem, bronhospazam, piskanje, edem larinksa, angioneurotski edem, opći svrbež,
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Croatian: Nema podataka o sigurnosti rituksimaba u bolesnika s umjerenim zatajenjem srca (NYHA stupanj III)
English: Corticosteroids will usually be given by injection before the start of Rixathon treatment.
Croatian: Obično će se prije početka liječenja lijekom Rixathon primijeniti injekcije kortikosteroida.
English: Packs of 2 or 3 vials.
Croatian: Pakiranje od 2 ili 3 bočice.
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC
Croatian: ispitivanju prve linije liječenja KLL-a, bolesnici u stadiju C bolesti prema Binetovoj klasifikaciji koji su primali R-FC imali su više nuspojava u usporedbi s onima koji su primali FC (R-FC 83 % u odnosu na FC 71 %).
English: Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin's lymphoma.
Croatian: Sigurnost i djelotvornost rituksimaba u kombinaciji s drugim kemoterapijskim protokolima u liječenju difuznog ne-Hodgkinovog limfoma velikih B-stanica nisu ustanovljene.
English: The proportion of CTC Grade 3 events and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Croatian: Udio događaja 3. stupnja prema CTC kriterijima i reakcija povezanih s infuzijom koje su dovele do prekida liječenja smanjivao se nakon svakog ciklusa i takvi su događaji bili su rijetki od 3. ciklusa nadalje.
English: +Left ventricular failure, +supraventri cular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia
Croatian: +zatajenje lijeve klijetke, +supraventrikular na tahikardija, +ventrikularna tahikardija, +angina, +ishemija miokarda, bradikardija teški srčani poremećaji4 i zatajenje srca4 i
English: Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest X-ray.
Croatian: Bolesnicima s ne-Hodgkinovim limfomom tada treba procijeniti stanje zbog mogućeg sindroma lize tumora, što uključuje odgovarajuće laboratorijske pretrage te radiološko snimanje grudnog koša radi otkrivanja moguće plućne infiltracije.
English: The incidence of all grade infections was similar between the arms.
Croatian: Incidencija infekcija svih stupanja težine bila je slična u obje liječene skupine.
English: Consultation with a Neurologist should be considered as clinically indicated.
Croatian: Ako je klinički indicirano, valja razmotriti konzultaciju s neurologom.
English: Interstitial lung disease7
Croatian: hipoksija intersticijska bolest pluća7
English: Patients treated with Rixathon must be given the patient alert card with each infusion.
Croatian: Bolesnici koji se liječe lijekom Rixathon moraju kod svake infuzije dobiti karticu s upozorenjima za bolesnika.
English: • Periodic safety update reports (PSUR)
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: 7 includes fatal cases
Croatian: 7 Obuhvaća slučajeve sa smrtnim ishodom.
English: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Croatian: koje predstavlja glikozilirani imunoglobulin s konstantnim regijama ljudskog IgG1 i varijabilnim nizovima mišjih lakih i teških lanaca.
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 rituksimaba.
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Rixathon infusion.
Croatian: Budući da tijekom infuzije rituksimaba može doći do hipotenzije, treba razmotriti mogućnost izostavljanja antihipertenzivnih lijekova 12 sati prije primjene infuzije lijeka Rixathon.
English: The chemotherapy should be given after the Rixathon infusion.
Croatian: Kemoterapiju treba dati nakon infuzije lijeka Rixathon.
English: Neutropenia1
Croatian: Nuspojava1
English: For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Croatian: Za bolesnike randomizirane u fazu održavanja u ovom ispitivanju medijan vremena promatranja bio je
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 - 49 days).
Croatian: Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali rituksimab u dozi od 375 mg/m2 jedanput tjedno tijekom četiri tjedna, procijenjen medijan terminalnog poluvremena eliminacije bio je 23 dana
English: Table 2 Summary of ADRs reported in clinical trials or during postmarketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab System Organ Class
Croatian: Tablica 2 Sažetak nuspojava prijavljenih u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet u bolesnika s reumatoidnim artritisom koji su primali rituksimab
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Croatian: Nuspojave navedene u Tablici 3 su sve nuspojave koje su se pojavile s incidencijom od ≥ 5 % u skupini koja je primala rituksimab i s većom učestalošću nego u usporednoj skupini.
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)
Croatian: Pregled rezultata djelotvornosti terapije održavanja rituksimabom u odnosu na opservacijsku skupinu u primarnoj analizi prema planu ispitivanja i nakon medijana od 9 godina praćenja (završna analiza)
English: The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Croatian: Sigurnosni profil rituksimaba u kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida u liječenju bolesnika s običnim pemfigusom ispitivao se u randomiziranom, kontroliranom, multicentričnom, otvorenom ispitivanju faze 3 među bolesnicima s pemfigusom, u kojem je 38 bolesnika s običnim pemfigusom (PV) bilo randomizirano u skupinu liječenu rituksimabom.
English: • Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
Croatian: • promjene krvnog tlaka, mučnina, osip, vrućica, svrbež, curenje iz nosa ili začepljen nos te kihanje, tresavica, ubrzano kucanje srca i umor • glavobolja
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Croatian: Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije terapija održavanja rituksimabom u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 7).