FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you respond well to treatment, you may be given Rixathon as a maintenance treatment every 2 or 3 months for two years.
Croatian: • Ako dobro odgovorite na liječenje, možda ćete primati lijek Rixathon kao terapiju održavanja svaka 2 ili 3 mjeseca tijekom dvije godine.
English: This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.
Croatian: U tom slučaju lijek ćete primiti nakon 12 mjeseci i nakon 18 mjeseci od početnog liječenja, a zatim svakih 6 mjeseci prema potrebi ili Vaš liječnik može odrediti drukčije, ovisno o tome koliko dobro reagirate na liječenje
English: • taste problems - such as changes in the way things taste
Croatian: • tegobe s osjetom okusa - poput promjena u okusu
English: Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomization.
Croatian: Doza prednizona postupno se smanjivala, a potom održavala na niskoj razini (približno 5 mg na dan) tijekom najmanje 18 mjeseci nakon randomizacije.
English: • What the signs of an infection are
Croatian: • koji su znakovi infekcije
English: • loss of hair
Croatian: • opadanje kose
English: However with non-live vaccines response rates may be reduced.
Croatian: Međutim, stope odgovora na neživo cjepivo mogu biti smanjene.
English: Log-rank p value
Croatian: Log-rang p-vrijednost
English: Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well.
Croatian: Granulomatoza s poliangitisom i mikroskopski poliangitis su dva oblika upale krvnih žila koji uglavnom zahvaćaju pluća i bubrege, ali mogu zahvatiti i druge organe.
English: • hives, increased sweating, night sweats
Croatian: • koprivnjača, pojačano znojenje, noćno znojenje
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood
Croatian: • povišena razina šećera u krvi, gubitak tjelesne težine, oticanje lica i tijela, povišene razine enzima „LDH“ u krvi, niske razine kalcija u krvi
English: 10.49 years
Croatian: 10,49 godina
English: • After aseptic dilution in sodium chloride solution:
Croatian: • Nakon aseptičkog razrjeđivanja u otopini natrijeva klorida:
English: Disease-free survivala Subgroup analysis PFS
Croatian: Preživljenje bez bolestia Analiza podskupina PFS
English: Vaccination should be completed at least 4 weeks prior to first administration of Rixathon.
Croatian: Cijepljenje treba dovršiti najmanje 4 tjedna prije prve primjene lijeka Rixathon.
English: In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings.
Croatian: Niti u jednog bolesnika infuziju ne treba ponovno započinjati dok ne nestanu svi simptomi i dok ne dođe do normalizacije laboratorijskih nalaza i rendgenološkog nalaza grudnog koša.
English: • low mood and loss of interest or enjoyment in doing things, feeling nervous
Croatian: • neraspoloženost i gubitak interesa ili zadovoljstva u obavljanju aktivnosti, nervoza
English: This is because Rixathon can affect the way some other medicines work.
Croatian: To je važno jer Rixathon može utjecati na način djelovanja nekih lijekova.
English: 6.11 years
Croatian: 6,11 godina
English: ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS
Croatian: ACR20 ACR50 ACR70 EULAR odgovor (dobar/umjeren) Srednja vrijednost promjene rezultata aktivnosti bolesti (DAS)
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Croatian: S obzirom na mehanizam djelovanja rituksimaba i činjenicu da B stanice igraju važnu ulogu u održavanju normalnog imunološkog odgovora, nakon terapije rituksimabom bolesnici su izloženi povećanom riziku od infekcija (vidjeti dio 5.1).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Prednisone N=36
Croatian: Prednizon N = 36
English: The HCP educational leaflets and the Patient educational leaflet will be agreed with the National Competent Authorities prior to distribution.
Croatian: HCP informacijski letci za liječnike i Informacijski letak za bolesnike usuglasit će se s nadležnim nacionalnim tijelom prije podjele.
English: • low number of red blood cells (anaemia), low number of all blood cells
Croatian: • nizak broj crvenih krvnih stanica (anemija), nizak broj svih krvnih stanica
English: All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon
Croatian: Svi liječnici za koje se očekuje da će propisivati lijek Rixathon za NHL/KLL dobit će sljedeće materijale radi smanjenja rizika od pogrešaka puta primjene: - Informacije o lijeku - HCP karticu s upozorenjima o pravilnoj upotrebi lijeka Rixathon
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 rituksimabom (vidjeti dio 4.8).
English: • heart problems - such as heart attack, uneven or fast heart rate
Croatian: • srčane tegobe - kao što su srčani udar, nepravilni ili ubrzani otkucaji srca
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Rixathon maintenance therapy, up to 5 years.
Croatian: Za bolesnike koji bi mogli biti izloženi većem riziku od relapsa liječnici trebaju razmotriti dulje trajanje terapije održavanja lijekom Rixathon (do 5 godina).
English: Rixathon can be given alone or with other medicines called “chemotherapy”.
Croatian: Rixathon se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following rituximab (see section 4.5).
Croatian: Premalo je podataka iz kliničkih ispitivanja da bi se u potpunosti mogla procijeniti sigurnost sekvencijske primjene drugih DMARD-a (uključujući TNF-inhibitore i ostale biološke lijekove) nakon rituksimaba (vidjeti dio 4.5).
English: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted postnatally 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: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL.
Croatian: Infekcije (pretežno bakterijske i virusne) nastupile su tijekom kliničkih ispitivanja u približno 30-55 % bolesnika s NHL-om te u 30-50 % bolesnika tijekom kliničkog ispitivanja bolesnika s KLL-om.
English: Rixathon may be used for the treatment of several different conditions in adults.
Croatian: Rixathon se može primjenjivati za liječenje nekoliko različitih bolesti u odraslih bolesnika.
English: No incompatibilities between Rixathon and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Croatian: Nisu zamijećene inkompatibilnosti između lijeka Rixathon i polivinilkloridnih ili polietilenskih vrećica ili kompleta za infuziju.
English: Rixathon is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects.
Croatian: Rixathon se primjenjuje za liječenje reumatoidnog artritisa u osoba koje su već koristile neke druge lijekove, koji su prestali djelovati, nisu djelovali dovoljno dobro, ili su uzrokovali nuspojave.
English: Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Croatian: Svaki se ciklus liječenja sastoji od dviju zasebnih infuzija koje se daju u razmaku od 2 tjedna.
English: Abbreviation: NS, non-significant
Croatian: Skraćenica: NZ, nije značajno
English: If a patient develops PML, the dosing of Rixathon must be permanently discontinued.
Croatian: Ako se u bolesnika razvije PML, primjena lijeka Rixathon mora se trajno obustaviti.
English: Median TTF: 2.6 years Not reached p < 0.001
Croatian: Medijan TTF: 2,6 godina Nije dostignuto p < 0,001
English: Percent age of Patients with First Major Relapse
Croatian: Postotak bolesnika s prvim teškim relapsom
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Croatian: Broj bolesnika s odgovorom (stopa odgovora [%]) ap-vrijednost dobivena je Fisherovim egzaktnim testom uz korekciju srednje p-vrijednosti bInterval pouzdanosti od 95 % je korigirani Newcombeov interval
English: The cells that are affected by Rixathon help to fight infection and you should wait until the infection has passed before you are given Rixathon.
Croatian: Rixathon utječe na stanice koje pomažu u borbi protiv infekcija pa stoga morate pričekati dok infekcija ne prođe prije nego što primite lijek Rixathon.
English: Also some other medicines can affect the way Rixathon works.
Croatian: Isto tako neki lijekovi mogu utjecati na način djelovanja lijeka Rixathon.
English: • tremors (shakiness, often in the hands)
Croatian: • omaglica • tremor (drhtanje, često šaka)
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 - 15).
Croatian: Stopa ozbiljnih srčanih događaja iznosila je 2,1 na 100 bolesnik-godina (95 % CI 3-15).
English: This antigen does not internalise upon antibody binding and is not shed from the cell surface.
Croatian: Nakon vezanja antitijela ovaj se antigen ne internalizira i ne odvaja od stanične površine.
English: Rituximab N=505
Croatian: Rituksimab N = 505
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.
Croatian: Incidencija hematoloških i limfatičkih nuspojava stupnja 3/4 bila je veća u starijih bolesnika u usporedbi s mlađim bolesnicima (< 65 godina) s prethodno neliječenim ili relapsirajućim/refraktornim
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: - prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Croatian: - pripremljena u komori s laminarnim strujanjem zraka ili u mikrobiološkom zaštitnom kabinetu uz standardne mjere opreza za sigurno rukovanje intravenskim lijekovima.
English: The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (<4%).
Croatian: Incidencija simptoma reakcija povezanih s infuzijom bila je najveća tijekom ili nakon prve infuzije (9 %), da bi se sa sljedećim infuzijama smanjivala (< 4 %).
English: Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Croatian: Bolesnike s velikom zahvaćenošću tumorom ili visokim brojem (≥ 25 x 109/l) cirkulirajućih zloćudnih stanica, kao što su bolesnici s KLL-om, u kojih može postojati povećan rizik od osobito teškog sindroma otpuštanja citokina, treba liječiti uz izniman oprez.
English: Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood.
Croatian: Bolesnici s kroničnom limfocitnom leukemijom imaju previše abnormalnih limfocita, koji se uglavnom nakupljaju u koštanoj srži i krvi.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome have been reported.
Croatian: Prijavljeni su slučajevi intersticijske bolesti pluća, neki sa smrtnim ishodom.
English: Table 16 Percentage of patients who achieved complete remission at 6 months (intent-to-treat population*)
Croatian: Postotak bolesnika koji su postigli potpunu remisiju nakon 6 mjeseci (populacija s namjerom liječenja*)
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Croatian: • alergijske reakcije koje su najvjerojatnije tijekom infuzije, ali se mogu javiti do 24 sata nakon infuzije
English: n.a.
Croatian: n.p.
English: Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion.
Croatian: Bolesnicima koji boluju od klinički značajne kardiovaskularne bolesti, uključujući aritmije, ili su ranije imali ozbiljnu infuzijsku reakciju na bilo koju prethodnu biološku terapiju ili na rituksimab, ne smije se primijeniti brža infuzija.
English: Mean change in HAQ-DI
Croatian: Srednja vrijednost promjene HAQ-DI
English: The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Croatian: Udio bolesnika koji su imali reakciju povezanu s infuzijom iznosio je 29 % (11 bolesnika) prilikom prve infuzije, 40 % (15 bolesnika) prilikom druge, 13 % (5 bolesnika) prilikom treće i 10 % (4 bolesnika) prilikom četvrte infuzije.
English: Date of most recent infusion: __________ Date of first infusion: ________________ Patient's Name:_____________________ Doctor's Name:_____________________ Doctor's contact details:______________
Croatian: Datum prve infuzije:____________________ Ime bolesnika:_________________________
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population)
Croatian: Tablica 12 Klinički odgovor u trenutku primarne mjere ishoda ispitivanja 1 (ITT
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
English: Keep this card with you for 2 years after your last dose of Rixathon.
Croatian: Karticu nosite sa sobom još 2 godine nakon što primite posljednju dozu lijeka Rixathon.
English: Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Croatian: b) kronične limfocitne leukemije Kronična limfocitna leukemija (KLL) je najčešći oblik leukemije u odraslih.
English: Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
Croatian: Sljedeće se infuzije smiju primijeniti najranije 16 tjedana nakon prethodne infuzije.
English: Observation N=513
Croatian: Opservacijska skupina N = 513
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: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breast-feed while treated with Rixathon and for 12 months following Rixathon 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 Rixathon ni idućih 12 mjeseci nakon liječenja.
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 rituksimabu nisu ispitivane u kliničkim ispitivanjima.
English: The best responses to Rixathon are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP).
Croatian: Najbolji odgovor na lijek Rixathon uočen je u bolesnika koji imaju pozitivan nalaz testa na reumatoidni faktor (RF) i/ili protutijela na cikličke citrulinirane peptide (anti-CCP) u krvi.
English: Your doctor may need to take special care of you during your treatment with Rixathon.
Croatian: Liječnik će Vas možda morati osobito pažljivo nadzirati tijekom liječenja lijekom Rixathon.
English: How much and how often you will receive your treatment a) If you are being treated for non-Hodgkin's Lymphoma
Croatian: Koliko ćete lijeka primiti i koliko često a) Bolesnici koji se liječe od ne-Hodgkinova limfoma
English: Other rarely-reported side-effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Croatian: Ostale rijetko prijavljene nuspojave liječenja rituksimabom uključuju smanjenje broja bijelih krvnih stanica (neutrofila) koje pomažu u savladavanju infekcija.
English: Measure blood neutrophils prior to each course of Rixathon, 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 Rixathon, redovito tijekom najdulje 6 mjeseci nakon prestanka liječenja te po pojavi znakova ili simptoma infekcije (vidjeti dio 4.8).
English: Rheumatoid arthritis is a disease of the joints.
Croatian: Reumatoidni artritis je bolest zglobova.
English: The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥2 months).
Croatian: Primarni cilj ispitivanja bila je potpuna remisija (potpuna epitelizacija i odsutnost novih i/ili otprije postojećih lezija) u 24. mjesecu bez primjene prednizona tijekom dva ili više mjeseci (potpuna remisija bez primjene kortikosteroida tijekom ≥ 2 mjeseca).
English: Patients reporting signs and symptoms of infection following Rixathon therapy should be promptly evaluated and treated appropriately.
Croatian: Bolesnike u kojih se pojave znakovi i simptomi infekcije nakon terapije lijekom Rixathon treba odmah pregledati te odgovarajuće liječiti.
English: Alternative subsequent, faster, infusion schedule
Croatian: Alternativni raspored primjene daljnjih infuzija većom brzinom
English: When Rixathon is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Croatian: Kad se Rixathon primjenjuje u kombinaciji s kemoterapijom, moraju se primijeniti uobičajena smanjenja doze kemoterapijskih lijekova.
English: Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Croatian: Rixathon se ne smije primijeniti bolesnicima s aktivnom teškom infekcijom (npr. tuberkulozom, sepsom i oportunističkim infekcijama, vidjeti dio 4.3).
English: Rixathon should be used in combination with CHOP chemotherapy.
Croatian: Rixathon se treba davati u kombinaciji s CHOP kemoterapijom.
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
Croatian: • tegobe sa zgrušavanjem krvi, smanjeno stvaranje crvenih krvnih stanica i pojačano uništavanje crvenih krvnih stanica (aplastična hemolitička anemija), otečeni ili povećani limfni čvorovi
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: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).
Croatian: • Drugi sastojci su: natrijev citrat, polisorbat 80, natrijev klorid, natrijev hidroksid, kloridna kiselina i voda za injekcije (vidjeti dio 2).
English: Rixathon is used for the treatment of rheumatoid arthritis.
Croatian: Rixathon se primjenjuje za liječenje reumatoidnog artritisa.
English: This is because Rixathon can cross the placenta and may affect your baby.
Croatian: To je potrebno zato što Rixathon može proći kroz posteljicu i naškoditi djetetu.
English: Final analysis (median FU:9.0 years)
Croatian: (medijan praćenja: 9,0 godina)
English: Rixathon contains sodium
Croatian: Rixathon sadrži natrij
English: Late neutropenia2
Croatian: odgođena neutropenija2
English: Data from extended follow up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT, and TNCT (Table 7).
Croatian: Podaci prikupljeni tijekom produljenog praćenja bolesnika u ispitivanju (medijan praćenja 9 godina) potvrdili su dugoročnu korist terapije održavanja rituksimabom s obzirom na PFS, EFS, TNLT i
English: Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately (see section 4.2) and should receive aggressive symptomatic treatment.
Croatian: U bolesnika u kojih se pojavi teški oblik sindroma otpuštanja citokina mora se odmah prekinuti primjena infuzije (vidjeti dio 4.2) i primijeniti agresivno simptomatsko liječenje.
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
Croatian: U 28. mjesecu teški je relaps (definiran kao ponovna pojava kliničkih i/ili laboratorijskih znakova aktivnosti vaskulitisa [BVAS > 0] koji bi mogao dovesti do zatajenja ili oštećenja organa odnosno ugroziti život) nastupio u 3 bolesnika (5 %) u skupini liječenoj rituksimabom i 17 bolesnika (29 %) u skupini liječenoj azatioprinom (p = 0,0007).
English: Rixathon 500 mg concentrate for solution for infusion EU/1/17/1185/003
Croatian: Rixathon 500 mg koncentrat za otopinu za infuziju EU/1/17/1185/003
English: Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Croatian: Kontraindikacije za primjenu kod ne-Hodgkinovog limfoma i kronične limfocitne leukemije Preosjetljivost na djelatnu tvar, mišje proteine ili neku od ostalih pomoćnih tvari navedenih u dijelu 6.1.