FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Croatian: Primjeri takvih ozbiljnih virusnih infekcija su infekcije izazvane herpes virusima (citomegalovirus, varičela zoster virus i herpes simpleks virus), JC virusom (progresivna multifokalna leukoencefalopatija (PML)) te virusom hepatitisa C.
English: The cells that are affected by Ritemvia help to fight infection and you should wait until the infection has passed before you are given Ritemvia.
Croatian: Ritemvia utječe na stanice koje pomažu u borbi protiv infekcija pa stoga morate pričekati dok infekcija ne prođe prije nego što primite lijek Ritemvia.
English: Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure.
Croatian: Višestruki ciklusi liječenja povezani su sa sličnim profilom nuspojava kao i nakon prve izloženosti.
English: Physical function and quality of life outcomes
Croatian: Ishodi vezani uz fizičku funkciju i kvalitetu života
English: Cumulative incidence over time of first major relapse
Croatian: Kumulativna incidencija prvog teškog relapsa kroz vrijeme
English: Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Croatian: Ritemvia rijetko može uzrokovati ozbiljnu infekciju mozga koja se naziva 'progresivna multifokalna leukoencefalopatija' ili PML.
English:  Cardiovascular events, see section 4.4.
Croatian: • kardiovaskularni događaji, vidjeti dio 4.4.
English: Ritemvia is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Croatian: Ritemvia je bistra, bezbojna otopina, dostupna u obliku koncentrata za otopinu za infuziju u staklenoj bočici.
English: • an increase in the amount of potassium in the blood
Croatian: • povećana razina kalija u krvi
English: In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Croatian: Za razliku od sindroma otpuštanja citokina, prave reakcije preosjetljivosti obično se pojavljuju nekoliko minuta nakon početka infuzije.
English: 5 Includes fatal cases
Croatian: 5 Uključuje slučajeve sa smrtnim ishodom
English: Keep this card with you for 2 years after your last dose of Ritemvia.
Croatian: Karticu nosite sa sobom još 2 godine nakon što primite posljednju dozu lijeka Ritemvia.
English: The incidence of infections that were serious or required IV antibiotics, was approximately 4 per 100 patient years.
Croatian: Incidencija infekcija koje su bile ozbiljne ili zahtijevale i.v. primjenu antibiotika iznosila je otprilike 4 na 100 bolesnik-godina.
English: A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm.
Croatian: Prijavljeno je blago, ali ne značajno poboljšanje ukupnog preživljenja u R-FC skupini u usporedbi s FC skupinom.
English: serious viral infection2 pneumocystis jirovecii
Croatian: ozbiljne virusne infekcije2, Pneumocystis jirovecii
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Croatian: Od 356 bolesnika ispitivanih na antitijela na lijek, pozitivno je bilo njih 1,1 % (četiri bolesnika).
English: Table 17 Complete remission at 6-months by disease status Rituximab
Croatian: Tablica 17 Potpuna remisija nakon 6 mjeseci prema statusu bolesti Rituksimab
English: Mean change in DAS † Outcome at 24 weeks
Croatian: † Ishod nakon 24 tjedna
English: Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Croatian: Podaci o približno 180 bolesnika prethodno liječenih rituksimabom pokazali su kliničku korist liječenja (uključujući CR) i podupiru ponovno liječenje rituksimabom.
English: Medicines given before each Ritemvia administration
Croatian: Lijekovi koji se daju prije svake primjene lijeka Ritemvia
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Croatian: S mikrobiološkog stajališta, pripremljenu otopinu za infuziju treba odmah primijeniti.
English: A statistically significant correlation was noted between response rates and bone marrow involvement.
Croatian: Statistički značajna korelacija zamijećena je između stopa odgovora i zahvaćenosti koštane srži.
English: 53%, NS
Croatian: 53 %, NZ
English: Elderly No dose adjustment is required in elderly patients (aged > 65 years).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (u dobi od > 65 godina).
English: • skin rashes, including acne or spots
Croatian: • kožni osip, uključujući akne ili mrlje
English: Neutropenic events, including severe late onset and persistent neutropenia, have been rarely reported in the post-marketing setting, some of which were associated with fatal infections.
Croatian: Neutropenija, uključujući slučajeve teške odgođene i perzistentne neutropenije, je prijavljena rijetko nakon stavljanja lijeka u promet, a neki od prijavljenih slučajeva bili su povezani sa smrtonosnim infekcijama.
English: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Croatian: Za terapiju održavanja treba primijeniti dozu od 500 mg intravenskom infuzijom u 12. i 18. mjesecu, a zatim svakih 6 mjeseci ako je potrebno, na temelju kliničke ocjene.
English: However, the higher incidence of neutropenia in patients treated with rituximab and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Croatian: Međutim, veća incidencija neutropenije u bolesnika liječenih rituksimabom i kemoterapijom nije bila povezana s većom incidencijom infekcija i infestacija u usporedbi s bolesnicima liječenima samo kemoterapijom.
English: Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Croatian: Bolesnicima u kojih se pojave znakovi teških reakcija, posebno jaka dispneja, bronhospazam ili hipoksija, odmah treba prekinuti primjenu infuzije.
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 prsnog koša.
English: The incidence of ADRs of any grade was similar in these two groups.
Croatian: Incidencija nuspojava bilo kojeg stupnja bila je slična u tim dvjema skupinama.
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: • pain in the muscles • heart beating faster than normal
Croatian: • bol u mišićima • brže kucanje srca nego obično
English: Your doctor may need to take special care of you during your treatment with Ritemvia.
Croatian: Liječnik će Vas možda morati osobito pažljivo nadzirati tijekom liječenja lijekom Ritemvia.
English: Table 13 Radiographic outcomes at 1 year (mITT population)
Croatian: Tablica 13 Radiološki ishodi nakon 1 godine (prilagođena ITT populacija)
English: No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Croatian: Nisu provedena ispitivanja o utjecaju lijeka rituksimaba na sposobnost upravljanja vozilima i rada sa strojevima, iako farmakološka aktivnost i dosad prijavljene nuspojave ukazuju na to da rituksimab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Croatian: Uključeni bolesnici su bolovali od aktivnog reumatoidnog artritisa, dijagnosticiranog prema kriterijima Američkog društva za reumatologiju (engl.
English: If you respond well to treatment, you may be given Ritemvia as a maintenance treatment.
Croatian: Ako dobro odgovorite na liječenje, možda ćete primati lijek Ritemvia kao terapiju održavanja.
English: From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Croatian: Od 12. do 18. mjeseca zabilježeno je 8 relapsa u skupini koja je primala rituksimab u usporedbi s četiri u skupini liječenoj ciklofosfamidom.
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Croatian: Od bolesnika koji su prvotno primali samo metotreksat, njih je 81 % primilo rituksimab ili kao „spasonosnu“ terapiju između 16. i 24. tjedna ili tijekom produljenja ispitivanja, prije 56. tjedna.
English: Efficacy outcomes in rituximab treated patients were analysed based on autoantibody status prior to commencing treatment.
Croatian: Ishodi djelotvornosti u bolesnika liječenih rituksimabom analizirani su na temelju statusa autoantitijela prije početka liječenja.
English: The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
Croatian: Antigen je izražen u > 95 % svih B-staničnih ne-Hodgkinovih limfoma.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Ritemvia maintenance therapy, up to 5 years.
Croatian: U bolesnika koji bi mogli biti izloženi većem riziku od relapsa liječnici trebaju razmotriti dulje trajanje terapije održavanja lijekom Ritemvia (do 5 godina).
English: The rate of serious infections was approximately 25 per 100 patient years.
Croatian: Stopa ozbiljnih infekcija iznosila je približno 25 na 100 bolesnik-godina.
English: Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Croatian: Prethodna intravenska primjena glukokortikoida značajno je smanjila incidenciju i težinu reakcija povezanih s infuzijom (vidjeti dijelove 4.2 i 4.4).
English: This antigen does not internalize 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: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Croatian: Druge prijavljene ozbiljne nuspojave uključuju reaktivaciju hepatitisa B i PML (vidjeti dio 4.4).
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 KLL-om.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To je potrebno uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: In clinical trials more than 3100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2400 patients received two or more courses of treatment with over 1000 having received 5 or more courses.
Croatian: U kliničkim je ispitivanjima više od 3100 bolesnika primilo barem jedan ciklus liječenja, a praćeni su u razdobljima od 6 mjeseci do više od 5 godina; približno 2400 bolesnika primilo je dva ili više ciklusa liječenja dok je više od 1000 bolesnika primilo pet ili više ciklusa.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of rituximab.
Croatian: Malen udio bolesnika imao je dugotrajnu depleciju perifernih B stanica u trajanju od 2 godine ili više nakon posljednje doze rituksimaba.
English: A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Croatian: Terapiju je primio ukupno 321 bolesnik (162 R-CVP, 159 CVP), koji su dalje analizirani kako bi se odredila djelotvornost.
English:  Infections, see section 4.4.
Croatian: • infekcije, vidjeti dio 4.4
English: Disease‐free survivala Subgroup analysis PFS
Croatian: Preživljenje bez bolestia Analiza podskupina PFS
English: Long-term efficacy with multiple course therapy
Croatian: Dugoročna djelotvornost višekratnih ciklusa terapije
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 populacija)
English: Late neutropenia
Croatian: Odgođena neutropenija
English: Number of responders (response rate [%]) a p-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: 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: Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Croatian: Kardiovaskularne reakcije tijekom kliničkih ispitivanja monoterapije rituksimabom prijavljene su u 18,8 % bolesnika, pri čemu su najčešće reakcije bile hipotenzija i hipertenzija.
English: Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Croatian: Rituksimab se pokazao visoko specifičnim za CD20 antigen na B-stanicama.
English: In general, the proportion of patients experiencing any infusion reaction was higher following the first infusion than following the second infusion of any treatment course.
Croatian: Općenito je udio bolesnika koji su imali neku reakciju povezanu s infuzijom bio veći nakon prve infuzije nego nakon druge infuzije u bilo kojem ciklusu liječenja.
English: The benefit in terms of PFS was observed in almost all patient subgroups analysed according to disease risk at baseline.
Croatian: Korist u smislu PFS-a bila je uočena u gotovo svim podskupinama bolesnika analiziranima prema početnom riziku bolesti.
English: No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Croatian: Nisu zamijećene inkompatibilnosti između rituksimaba i polivinilkloridnih ili polietilenskih vrećica ili kompleta za infuziju.
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 28 mjeseci od randomizacije u tu fazu.
English: Frequencies are defined as very common (≥ 1/10), common
Croatian: Kategorije učestalosti definirane su kao vrlo često (≥ 1/10), često
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Croatian: Ispitivanje je pokazalo neinferiornost rituksimaba u odnosu na ciklofosfamid u postizanju potpune remisije nakon 6 mjeseci (Tablica 16).
English: IgG immunoglobulins are known to cross the placental barrier.
Croatian: Poznato je da IgG imunoglobulini prelaze posteljičnu barijeru.
English: The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Croatian: Nuspojave koje su uočene samo tijekom praćenja nakon stavljanja lijeka u promet i za koje nije moguće procijeniti učestalost svrstane su u kategoriju „nepoznato“.
English: It should not be administered as an intravenous push or bolus.
Croatian: Ne smije se primijeniti brzom intravenskom injekcijom niti kao bolus.
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 lijeka rituksimaba (vidjeti dio 4.5).
English: These are often colds, but there have been cases of pneumonia or urinary infections.
Croatian: Često je riječ o prehladama, ali bilo je i slučajeva upale pluća ili infekcije mokraćnih putova.
English: The consequences of long term B cell depletion in paediatric patients are unknown.
Croatian: Posljedice dugotrajne deplecije B stanica u pedijatrijskih bolesnika nisu poznate.
English: The 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 odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
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 lijeka rituksimaba i činjenicu da B stanice igraju važnu ulogu u održavanju normalnog imunološkog odgovora, nakon terapije lijekom rituksimaba bolesnici su izloženi povećanom riziku od infekcija (vidjeti dio 5.1).
English: Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Croatian: Populacijskom farmakokinetičkom analizom istih podataka dobivene su slične srednje vrijednosti sistemskog klirensa i poluvijeka od 0,26 l/dan odnosno 20,4 dana.
English: This is because in a few cases, Ritemvia could cause hepatitis B to become active again, which can be fatal in very rare cases.
Croatian: Naime, u nekim slučajevima Ritemvia može ponovno aktivirati hepatitis B, što u vrlo rijetkim slučajevima može biti smrtonosno.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Croatian: Prosječni Cmax za obje je doze bio 16 % do 19 % veći nakon druge infuzije u usporedbi s prvom infuzijom.
English: Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
Croatian: Prijavljeno je nekoliko slučajeva odgođene neutropenije koja se pojavila nakon više od četiri tjedna od posljednje infuzije rituksimaba.
English: At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
Croatian: Seropozitivni bolesnici imali su 2-3 puta veću vjerojatnost postizanja ACR odgovora u 48. tjednu nego seronegativni bolesnici.
English: On the basis of standardised incidence ratios, the incidence of malignancies appears to be similar to that previously reported in patients with ANCA-associated vasculitis.
Croatian: Na temelju standardiziranih omjera incidencije, čini se da je incidencija zloćudnih bolesti podjednaka prethodno zabilježenoj incidenciji u bolesnika s ANCA vaskulitisom.
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Croatian: kožni papilom * Reakcije povezane s infuzijom uključivale su simptome prijavljene pri sljedećem planiranom posjetu nakon svake infuzije te nuspojave koje su se javile na dan primjene infuzije ili jedan dan nakon njezine primjene.
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: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Croatian: Tijekom razdoblja liječenja (razdoblje uvodnog liječenja koje se sastojalo od primjene R-CHOP tijekom najviše osam ciklusa) četvero bolesnika (2 %) iz R-CHOP skupine, svi s kardiovaskularnim faktorima rizika, doživjelo je cerebrovaskularnu tromboemboliju tijekom prvog ciklusa liječenja.
English: For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Croatian: Za svaku se nuspojavu izračun učestalosti temelji na reakcijama svih stupnjeva težine (od blagih do teških), osim za nuspojave označene znakom „+“, za koje se izračun učestalosti temelji samo na teškim reakcijama (stupanj ≥ 3 prema općim kriterijima toksičnosti Nacionalnog instituta za rak).
English: Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Croatian: Prijavljeni su i slučajevi aritmije stupnja 3 ili 4 (uključujući ventrikularnu i supraventrikularnu tahikardiju) te angine pektoris za vrijeme infuzije.
English: Event free survival Response rate (CR, nPR, or PR)
Croatian: Stopa odgovora (CR, nPR, ili PR)
English: Time to new lymphoma treatment
Croatian: Vrijeme do novog liječenja limfoma
English: In case of such an event, with a suspected relationship to rituximab, treatment should be permanently discontinued.
Croatian: U slučaju takvog događaja, uz sumnju na povezanost s lijekom rituksimaba, liječenje se mora trajno prekinuti.
English: You should also tell them about your Ritemvia treatment.
Croatian: Recite im i da se liječite lijekom Ritemvia.
English: Rituximab has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Croatian: Rituksimab je primijenjen u 21 bolesnika s autolognom transplantacijom koštane srži i drugim rizičnim skupinama bolesnika s pretpostavljenom smanjenom funkcijom koštane srži, a da nije došlo do mijelotoksičnosti.
English: • The need for patients to contact their health care professional if symptoms occur
Croatian: • Bolesnici se trebaju obratiti svom liječniku ako se pojave simptomi
English: Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Croatian: Tablica 16 Postotak bolesnika koji su postigli potpunu remisiju nakon 6 mjeseci (populacija s namjerom liječenja*)
English: Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Croatian: Bolesnici se moraju redovito nadzirati zbog moguće pojave novih ili pogoršanja već postojećih neuroloških simptoma ili znakova koji mogu upućivati na PML.
English: • Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision.
Croatian: Znakovi PML-a uključuju: smetenost, gubitak pamćenja ili poteškoće s razmišljanjem gubitak ravnoteže ili promjenu u načinu hoda ili govora gubitak snage ili slabost na jednoj strani tijela zamagljen vid ili gubitak vida