FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1000 mg, IV, 2 weeks apart), were similar with a mean maximum serum concentration of 369 µg/mL and a mean terminal half-life of 19.2 days.
Croatian: inhibitorom su uz isti režim doziranja (2 x 1000 mg, intravenski, u razmaku od dva tjedna) bili slični, uz prosječnu najvišu koncentraciju u serumu od 369 µg/ml i srednji terminalni poluvijek od 19,2 dana.
English: OS rates - survival rates at the time of the analyses
Croatian: stope OS - stope preživljenja u trenutku analize (engl.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rituzena Alert Card for patients with non-oncology diseases
Croatian: Rituzena kartica s upozorenjima za bolesnike s neonkološkim bolestima
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 lijeka rituksimab u bolesnika s umjerenim zatajenjem srca (NYHA
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Croatian: Preporučuje se prije početka liječenja lijekom rituksimab odrediti razine imunoglobulina.
English: The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after
Croatian: Incidencija simptoma povezanih s infuzijom znatno se smanjuje u sljedećim infuzijama te nakon osam doza rituksimaba iznosi manje od 1 %.
English: See section 4.
Croatian: Tablica 7.
English: • The need to check, prior to Rituzena treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned,
Croatian: imunosupresiju, prethodnu/trenutačnu primjenu lijekova koji djeluju na imunološki sustav te nedavna ili planirana cijepljenja.
English: The most common IRRs included cytokine release syndrome, flushing, throat irritation, and tremor.
Croatian: Najčešće infuzijske reakcije bile su sindrom otpuštanja citokina, navale crvenila, iritacija grla i tremor.
English: Rituzena was administered on the first day of the
Croatian: Rituzena je primijenjena prvog dana ciklusa liječenja.
English: This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and
Croatian: To uključuje primjenu u reumatoidnom artritisu i neodobrenim indikacijama za liječenje autoimunih bolesti kao što su sistemski lupus eritematodes i vaskulitis.
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs.
Croatian: Najčešće nuspojave nakon primitka rituksimaba u kliničkim ispitivanjima bile su reakcije povezane s infuzijom.
English: Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic
Croatian: Kontraindikacije za primjenu kod reumatoidnog artritisa, granulomatoze s poliangiitisom i mikroskopskog poliangiitisa
English: Rituzena is used for inducing remission in granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Croatian: Rituzena se u kombinaciji s kortikosteroidima primjenjuje za poticanje remisije granulomatoze s poliangiitisom (ranije se zvala Wegenerova granulomatoza) i mikroskopskog poliangiitisa.
English: Summary of the Safety Profile (granulomatosis with polyangiitis and microscopic polyangiitis) In the clinical trial in granulomatosis with polyangiitis and microscopic polyangitis, 99 patients were treated with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Croatian: U kliničkom ispitivanju kod granulomatoze s poliangiitisom i mikroskopskog poliangiitisa 99 bolesnika je liječeno rituksimabom (375 mg/m2, jedanput tjedno tijekom 4 tjedna) i glukokortikoidima (vidjeti dio 5.1).
English: Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in
Croatian: Preosjetljivost na djelatnu tvar, mišje proteine ili neku od ostalih pomoćnih tvari navedenih u dijelu 6.1.
English: • The need to monitor patients for infections, especially PML, during and after
Croatian: • Bolesnike je potrebno nadzirati zbog mogućeg razvoja infekcija, osobito PML-a, tijekom i nakon liječenja lijekom Rituzena.
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2
Croatian: IPI), Ann Arbor stadij, ECOG (engl.
English: The effect of multiple rituximab courses on the development of neutropenia in granulomatosis with polyangiitis and microscopic polyangiitis patients has not been
Croatian: Učinak višestrukih ciklusa rituksimaba na razvoj neutropenije u bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom nije ispitivan u kliničkim ispitivanjima.
English: SUBSTANCE AND MANUFACTURERS RESPONSIBLE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OTHER CONDITIONS AND REQUIREMENTS OF THE CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Croatian: ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: Your doctor will check if you should have any vaccines
Croatian: Vaš će liječnik provjeriti morate li primiti neko cjepivo prije nego što primite lijek Rituzena.
English: dysgeusia peripheral neuropathy, facial nerve cranial neuropathy, loss of other
Croatian: kranijalna neuropatija, gubitak drugih osjeta5
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
Croatian: Sve bolesnike mora se prije početka liječenja lijekom rituksimab testirati na virus hepatitisa B (HBV).
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 x 1000 mg dose group.
Croatian: Srednje terminalno poluvrijeme eliminacije iznosilo je od 15 do 16 dana u skupini koja je primala dozu od 2 x 500 mg te 17 do 21 dan u skupini koja je primala dozu od 2 x 1000 mg.
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the2 x 500 mg dose and ranged from 355 to 404 µg/mL for the 2 x 1000 mg dose.
Croatian: Nakon druge se infuzije prosječni Cmax kretao između 183 i 198 µg/ml pri dozi od 2 x 500 mg, odnosno između 355 i 404 µg/ml pri dozi od 2 x 1000 mg.
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing
Croatian: Djelotvornost je opažena i u bolesnika s novodijagnosticiranom bolešću i u bolesnika s relapsirajućom bolešću (Tablica 8).
English: Table 8 Complete remission at 6-months by disease status Cyclophosphamide Difference (CI 95%)
Croatian: Potpuna remisija nakon 6 mjeseci prema statusu bolesti Ciklofosfamid
English: You must also do this for 12 months after your last treatment with Rituzena.
Croatian: Morate to činiti i još 12 mjeseci nakon posljednje primjene lijeka
English: microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Croatian: ekstranodalna sijela, zahvaćenost koštane srži) omjer rizika za preživljenje bez događaja (R-CHOP u odnosu na CHOP) bio je manji od 0,83, a za ukupno preživljenje manji od 0,95.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for
Croatian: Liječnik će pažljivo nadzirati bolesnike koji su imali infekciju virusom hepatitisa B kako bi uočio moguće znakove infekcije.
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p <
Croatian: Medijan odgovora iznosio je 37,7 mjeseci u skupini liječenoj R-CVP-om i 13,5 mjeseci u skupini liječenoj CVP-om (p < 0,0001, log-rang test).
English: c) Granulomatosis with polyangiitis or microscopic polyangiitis
Croatian: c) granulomatoze s poliangiitisom ili mikroskopskog poliangiitisa
English: Table 5b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Number of patients
Croatian: Omjeri hazarda za preživljenje bez progresije bolesti prema Binetovom stadiju (ITT populacija) - medijan vremena promatranja je 48,1 mjesec Preživljenje bez progresije bolesti (PFS)
English: The consequences of long term B cell depletion in paediatric
Croatian: Posljedice dugotrajne deplecije B stanica u pedijatrijskih bolesnika nisu poznate.
English: At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32 %.
Croatian: Kasnija analiza trajanja ukupnog preživljenja, provedena nakon medijana praćenja od 60 mjeseci, potvrdila je prednost liječenja R-CHOP-om u odnosu na liječenje CHOP-om (p = 0,0071), što predstavlja smanjenje rizika za 32 %.
English: Pack of 2
Croatian: 2 bočice
English: Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
Croatian: Reumatoidni artritis, granulomatoza s poliangiitisom i mikroskopski poliangiitis
English: For the 60 re-treatments on study, the ORR was 38% (CI95 % 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
Croatian: 26 % - 51 %; CR 10 %, PR 28 %), a procijenjeni medijan TTP-a u bolesnika koji su odgovorili na liječenje 17,8 mjeseci (raspon 5,4-26,6 mjeseci).
English: In most cases, the infusion can be resumed at a 50 % reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely
Croatian: 100 mg/sat na 50 mg/sat) kada se simptomi u potpunosti povuku.
English: severe bullous skin reactions, Stevens-Johns on Syndrome toxic epidermal necrolysis (Lyell's Syndrome)7,
Croatian: Poremećaji kože i potkožnog tkiva toksična epidermalna nekroliza (Lyellov sindrom), StevensJohnsonov sindrom5
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission
Croatian: Ispitivanje je pokazalo neinferiornost rituksimaba u odnosu na ciklofosfamid u postizanju potpune remisije nakon 6 mjeseci (Tablica 7).
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab
Croatian: Dostupni podaci pokazuju da je stopa klinički značajnih infekcija nepromijenjena kada se ti lijekovi primjenjuju u bolesnika koji su prethodno liječeni rituksimabom.
English: Some vaccines should not be given at the same time as Rituzena or in the months after you receive Rituzena.
Croatian: Rituzena ili nekoliko mjeseci nakon liječenja lijekom Rituzena.
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (RCVP).
Croatian: U otvorenom randomiziranom ispitivanju ukupno su 322 prethodno neliječena bolesnika s folikularnim limfomom slučajnim odabirom određena za primanje CVP kemoterapije (ciklofosfamid 750 mg/m2, vinkristin 1,4 mg/m2 do najviše 2 mg prvog dana liječenja, prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u 8 ciklusa liječenja, ili rituksimaba u dozi od 375 mg/m2 u kombinaciji s CVP kemoterapijom (R-CVP).
English: Cardiovascular adverse reactions
Croatian: Kardiovaskularne nuspojave
English: Your doctor may need to take special care during your treatment with
Croatian: Liječnik će Vas možda morati osobito pažljivo nadzirati tijekom liječenja lijekom Rituzena.
English: Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for four doses.
Croatian: Početno liječenje, prošireni tumor, jedanput tjedno tijekom 4 tjedna U objedinjenim podacima iz tri ispitivanja 39 bolesnika s relapsirajućim ili kemorezistentnim proširenim ne-Hodgkinovim limfomom (promjer jedne lezije ≥ 10 cm) niskog stupnja malignosti ili folikularnim B-staničnim ne-Hodgkinovim limfomom je primilo rituksimab u dozi od 375 mg/m2
English: Also do not breast-feed for 12 months after your last treatment with Rituzena.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Rituzena i još 12 mjeseci nakon posljednje primjene lijeka jer se Rituzena može izlučiti u majčino mlijeko.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rituzena.
Croatian: Prije svake primjene lijeka Rituzena uvijek treba primijeniti premedikaciju koja obuhvaća antipiretik i antihistaminik, npr. paracetamol i difenhidramin.
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Croatian: Bolesnici s reumatoidnim artritisom koji prethodno nisu liječeni metotreksatom Primjena lijeka rituksimab ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Croatian: infekcije krvi (sepsa), upala pluća, herpes zoster, prehlada, infekcije bronha, gljivične infekcije, infekcije nepoznata uzroka, upala sinusa, hepatitis B nizak broj crvenih krvnih stanica (anemija), nizak broj svih krvnih stanica alergijske reakcije (preosjetljivost)
English: Dyspnoea Epistaxis Nasal congestion
Croatian: Infekcije i infestacije herpes zoster nazofaringitis
English: Log-rank p value
Croatian: Log-rang pvrijednost
English: The ORR was 36 % (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Croatian: ORR je iznosio 36 % (95 % CI 21 % - 51 %; CR 3 %, PR 33 %), a medijan TTP-a u bolesnika koji su odgovorili na liječenje
English: The Physician information about Rituzena should contain the following key elements: Information that the product should be administered as IV only to avoid administration route errors.
Croatian: Informacije za liječnike o lijeku Rituzena moraju sadržavati sljedeće ključne elemente: • Neophodan je poman nadzor tijekom primjene u okruženju u kojem su izravno dostupni svi
English: In case of such an event with a suspected relationship to rituximab, treatment should be permanently discontinued.
Croatian: uz sumnju na povezanost s lijekom rituksimab, liječenje se mora trajno prekinuti.
English: Cases of posterior reversible encephalopathy syndrome (PRES) reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Croatian: Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS) u autoimunim stanjima.
English: transient increase in serum IgM levels3
Croatian: Poremećaji krvi i limfnog sustava prolazno povećanje serumske razine IgM-a3
English: Rituzena 500 mg concentrate for solution for infusion
Croatian: Rituzena 500 mg koncentrat za otopinu za infuziju
English: This is because some people have a fall in their blood pressure while they are being given Rituzena.
Croatian: 12 sati prije primjene lijeka Rituzena zato što nekim bolesnicima može pasti krvni tlak tijekom primjene lijeka Rituzena.
English: General disorders and administration site conditions pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Croatian: urtikarija, iritacija grla, navale vrućine, hipotenzija, rinitis, tresavica, tahikardija, umor, bol u ustima i ždrijelu, periferni edem, eritem)
English: Pack of 1
Croatian: 1 bočica
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (<7 g/L) after induction treatment in both the observation and the rituximab groups.
Croatian: IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti (< 7 g/l) i u opservacijskoj skupini i u skupini koja je primala rituksimab.
English: The recommended dose of Rituzena monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once
Croatian: • Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka Rituzena u monoterapiji kod uvodnog liječenja odraslih bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije iznosi 375 mg/m2 površine tijela, a primjenjuje se u obliku intravenske infuzije jedanput tjedno tijekom četiri tjedna.
English: General disorders and administratio nsite conditions fever , chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering,
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, glavobolja tumora, navale crvenila, opća slabost, sindrom prehlade, +umor, +drhtavica, +zatajenje više organa4
English: Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in
Croatian: Istodobna primjena s metrotreksatom nije imala utjecaja na farmakokinetiku rituksimaba u bolesnika s reumatoidnim artritisom.
English: angina pectoris, atrial fibrillation, heart failure, myocardial infarction atrial flutter toxic epidermal necrolysis (Lyell's
Croatian: Srčani poremećaji angina pektoris, fibrilacija atrija, zatajenje srca, infarkt undulacija atrija
English: Rituzena is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Croatian: Rituzena je u kombinaciji s kemoterapijom indicirana u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji prethodno nisu liječeni.
English: Pneumocystis jiroveci pneumonia (PCP) prophylaxis is recommended for patients with granulomatosis with polyangiitis or microscopic polyangiitis during and following Rituzena
Croatian: U bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom preporučuje se profilaksa pneumonije uzrokovane Pneumocystic jirovecii tijekom i nakon liječenja lijekom Rituzena, prema potrebi.
English: Package leaflet: Information for the patient Rituzena 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Rituzena 100 mg koncentrat za otopinu za infuziju rituksimab
English: Package leaflet: Information for the patient Rituzena 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Rituzena 500 mg koncentrat za otopinu za infuziju rituksimab
English: Rituzena 100 mg concentrate for solution for infusion
Croatian: Rituzena 100 mg koncentrat za otopinu za infuziju
English: The recommended dose of Rituzena in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Croatian: Preporučena doza lijeka Rituzena u kombinaciji s kemoterapijom za uvodno liječenje bolesnika s prethodno neliječenim ili relapsirajućim/refraktornim folikularnim limfomom iznosi 375 mg/m2
English: Malignancies
Croatian: Monoterapija
English: Tell your doctor immediately if you have 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: group (p=0.0028).
Croatian: skupini (p < 0,0001, log-rang test).
English: OS rates,
Croatian: CR,
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
English: • raised blood pressure
Croatian: povećana razina kalija u krvi
English: Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,
Croatian: prednizolon) indicirana u liječenju bolesnika s CD20 pozitivnim difuznim ne-Hodgkinovim limfomom velikih B-stanica.
English: • difficulty sleeping (insomnia)
Croatian: Psihijatrijski poremećaji nesanica
English: You might get infections more easily during your treatment with Rituzena.
Croatian: Tijekom liječenja lijekom Rituzena možda ćete biti podložniji infekcijama.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Croatian: CVP-om (80,9 %) nego u skupini liječenoj CVP-om (57,2 %).
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Croatian: om dovelo je do poboljšanja ishoda i za visokorizične i za niskorizične bolesnike prema dobno prilagođenom međunarodnom prognostičkom indeksu.
English: Your doctor may decide to stop your Rituzena treatment if these reactions are
Croatian: Liječnik može odlučiti prekinuti liječenje lijekom
English: Contraception in males and females
Croatian: Infekcije i infestacije
English: In the active-controlled, randomised, double-blind, multicentre, non-inferiority trial of rituximab in granulomatosis with polyangiitis and microscopic polyangiitis, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Croatian: u 24 % bolesnika koji su primali rituksimab (jedan ciklus) i 23 % bolesnika u skupini liječenoj ciklofosfamidom razvila se neutropenija 3. ili višeg stupnja prema CTC kriterijima.
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41 %.
Croatian: medijan preživljenja bez događaja iznosio je 35 mjeseci za R-CHOP skupinu, odnosno 13 mjeseci za
English: Rituzena 500 mg concentrate for solution for infusion Rituximab
Croatian: Rituzena 500 mg koncentrat za otopinu za infuziju rituksimab
English: Cases of posterior reversible encephalopathy syndrome (PRES) reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Croatian: Neurološki događaji Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS).