FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients received 2 x 1000 mg intravenous infusions of MabThera or placebo in combination with MTX.
Croatian: Bolesnici su intravenskom infuzijom primili 2 x 1000 mg lijeka MabThera ili placebo u kombinaciji s metotreksatom.
English: 50 mL vial - Pack of 1 vial
Croatian: Bočica od 50 ml - pakiranje od 1 bočice
English: The most commonly reported serious infection in the MabThera group was mild or moderate bronchitis.
Croatian: Najčešće prijavljena ozbiljna infekcija u skupini liječenoj lijekom MabThera bila je blagi ili umjereni bronhitis.
English: Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
Croatian: Sveukupno su rezultati potvrdili da supkutana formulacija lijeka MabThera u dozi od 1600 mg ima profil koristi/rizika usporediv s profilom intravenske formulacije lijeka MabThera u dozi od 500 mg/m2.
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: CVP, 159 R-CVP, 162
Croatian: M39021 CVP: 159 R-CVP: 162
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58 % vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Croatian: Analizom podskupina pokazalo se da je ORR bio veći u bolesnika s histološkim podtipovima IWF B, C i D u odnosu na podtip IWF A (58% u odnosu na 12%), veći u bolesnika u kojih je najdulji promjer najvećih lezija bio < 5 cm u odnosu na > 7 cm (53% u odnosu na 38%) i veći u bolesnika u relapsu koji su odgovorili na kemoterapiju u odnosu na kemorezistentne bolesnike (definirane trajanjem odgovora < 3 mjeseca) u relapsu (50% u odnosu na 22%).
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the MabThera group (12%) and eight patients in the azathioprine group (14%).
Croatian: Blagi relapsi (koji nisu bili opasni po život niti su doveli do većeg oštećenja organa) zabilježeni su u 7 bolesnika u skupini liječenoj lijekom MabThera (12%) i 8 bolesnika u skupini liječenoj azatioprinom (14%).
English: 2 Frequency category derived from post-marketing data.
Croatian: 2 Kategorija učestalosti dodijeljena na temelju podataka nakon stavljanja lijeka u promet.
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Croatian: Prijavljeni su vrlo rijetki slučajevi progresivne multifokalne leukopatije (PML) sa smrtnim ishodom nakon primjene lijeka MabThera u liječenju reumatoidnog artritisa i autoimunih bolesti uključujući sistemski lupus eritematodes (SLE) i vaskulitis.
English: MabThera + low-dose prednisone (n = 38)
Croatian: MabThera + niska doza prednizona (n = 38)
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera maintenance therapy (n=167) or observation (n=167).
Croatian: Ukupno je 334 bolesnika u kojih je nakon indukcijske terapije došlo do potpune ili djelomične remisije u drugom koraku randomizirano u skupinu koja je primala terapiju održavanja lijekom MabThera (n = 167) ili u opservacijsku skupinu (n = 167).
English: Neutropenia can occur several months after the administration of MabThera (see section 4.4).
Croatian: Neutropenija se može javiti i nekoliko mjeseci nakon primjene lijeka MabThera (vidjeti dio 4.4).
English: Geometric mean AUC values at cycle 7 µg.day/mL
Croatian: Geometrijske srednje vrijednosti AUC-a u 7. ciklusu µg.dan/ml
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001
Croatian: Značajna razlika u odnosu na placebo u primarnoj vremenskoj točki: * p < 0,05, **p < 0,001, ***p ≤ 0,0001
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to MabThera therapy.
Croatian: Liječnici trebaju provjeriti bolesnikov status cijepljenja i slijediti važeće smjernice o cijepljenju prije terapije lijekom MabThera.
English: No PK/clinical data are available in patients with a refractory or relapsing disease.
Croatian: Nema dostupnih farmakokinetičkih/kliničkih podataka o bolesnicima s refraktornom ili relapsirajućom bolešću.
English: As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Croatian: Kao i kod formulacije za intravensku primjenu, formulaciju lijeka MabThera za supkutanu primjenu treba primjenjivati u okruženju u kojem su izravno dostupni svi uređaji za oživljavanje te pod izravnim nadzorom iskusnog zdravstvenog radnika.
English: The overall safety profile was consistent with the well-established safety profile for MabThera in approved autoimmune indications, including GPA/MPA.
Croatian: Ukupan sigurnosni profil bio je u skladu s dobro poznatim sigurnosnim profilom lijeka MabThera u odobrenim indikacijama za liječenje autoimunih bolesti, uključujući GPA/MPA.
English: The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
Croatian: Usporedba predviđenog medijana vrijednosti Cmax za formulacije lijeka MabThera za supkutanu i intravensku primjenu sažeto su prikazani u tablici 7.
English: There were no missing covariate values except baseline B-cell count.
Croatian: Nije nedostajala niti jedna kovarijantna vrijednost osim broja B-stanica na početku ispitivanja.
English: Stage 1 enrolled previously untreated patients (n=127) CD20-positive, Follicular Lymphoma (FL) Grade 1, 2 or 3a.
Croatian: U 1. dio bili su uključeni prethodno neliječeni bolesnici (n=127) s CD20-pozitivnim folikularnim limfomom (FL) stupnja 1, 2 ili 3a.
English: Initiate at a rate of 250mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Croatian: Infuzija se započinje brzinom od 250 mg/sat tijekom prvih 30 minuta, a nastavlja brzinom od 600 mg/sat tijekom sljedećih 90 minuta.
English: In the post-marketing setting five cases of MabThera overdose have been reported.
Croatian: Nakon stavljanja lijeka u promet prijavljeno je pet slučajeva predoziranja lijekom MabThera.
English: If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg MabThera administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Croatian: Ako bolesnici nisu razvili ozbiljnu reakciju na infuziju tijekom prve ili neke od sljedećih infuzija doze od 1000 mg lijeka MabThera primijenjene prema standardnom rasporedu primjene, druga ili sljedeće infuzije mogu se dati većom brzinom, uz istu koncentraciju kao i u prethodnim infuzijama (4 mg/ml u volumenu od 250 ml).
English: Trials of MabThera in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
Croatian: U ispitivanjima primjene lijeka MabThera u bolesnika s ranim artritisom (bolesnika koji prethodno nisu liječeni metotreksatom i bolesnika koji nisu dovoljno dobro odgovorili na metotreksat, no još nisu liječeni inhibitorima TNF-alfa) postignute su primarne mjere ishoda.
English: MabThera subcutaneous formulation was given at a fixed dose of 1400 mg.
Croatian: MabThera u formulaciji za supkutanu primjenu davala se u fiksnoj dozi od 1400 mg.
English: An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
Croatian: Analiza ukupnog preživljenja potvrdila je značajnu korist terapije održavanja lijekom MabThera u odnosu na opservacijsku skupinu (p = 0,0039, log-rang test).
English: In the clinical trial on induction of remission, which included 99 MabThera-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Croatian: U kliničkom ispitivanju primjene lijeka za poticanje remisije, koje je obuhvatilo 99 bolesnika liječenih lijekom MabThera, ukupna stopa infekcija iznosila je približno 237 na 100 bolesnik-godina (95% CI 197 - 285) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: Anti-rituximab antibodies were detected in only 13 patients and did not result in any clinically relevant increase in steady-state clearance.
Croatian: Antitijela na rituksimab pronađena su samo u 13 bolesnika i nisu uzrokovala klinički značajna povećanja klirensa u stanju dinamičke ravnoteže.
English: In these patients the rate of clinically relevant infection while on MabThera was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Croatian: U tih je bolesnika stopa klinički značajnih infekcija za vrijeme primjene lijeka MabThera iznosila 6,01 na 100 bolesnik-godina, u usporedbi s 4,97 na 100 bolesnik-godina nakon primjene biološkog DMARD-a.
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized to receive azathioprine (59 patients) or MabThera (58 patients) in a prospective, multi-center, controlled, open-label study.
Croatian: Ukupno 117 bolesnika (88 bolesnika s GPA-om, 24 s MPA-om i 5 s ANCA vaskulitisom ograničenim na bubrege) kod kojih je bolest bila u remisiji bilo je randomizirano za primanje azatioprina (59 bolesnika) ili lijeka MabThera (58 bolesnika) u prospektivnom, multicentričnom, kontroliranom, otvorenom ispitivanju.
English: All of these arrhythmias either occurred in the context of a MabThera infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Croatian: Sve su se te aritmije pojavile vezano uz infuziju lijeka MabThera ili su bile povezane s predisponirajućim stanjima kao što su vrućica, infekcija, akutni infarkt miokarda ili postojeća bolest dišnog i kardiovaskularnog sustava.
English: • if you are taking medicines for high blood pressure.
Croatian: Osobito je važno da kažete liječniku: · ako uzimate lijekove za liječenje visokog krvnog tlaka.
English: At minimum this should include HBsAg-status and HBcAb-status.These can be complemented with other appropriate markers as per local guidelines.
Croatian: Potrebno je najmanje odrediti status HBsAg i HBcAb, a testiranje se može dopuniti i određivanjem drugih odgovarajućih biljega, sukladno lokalnim smjernicama.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and strength is being given to the patient, as prescribed.
Croatian: Važno je provjeriti tekst na pakiranju lijeka kako bi se osiguralo da bolesnik primi odgovarajuću formulaciju (formulaciju za intravensku ili supkutanu primjenu) i jačinu lijeka, u skladu s onime što je propisano.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed.
Croatian: Važno je provjeriti tekst na pakiranju lijeka kako bi se osiguralo da bolesnik primi odgovarajuću formulaciju lijeka (formulaciju za intravensku ili supkutanu primjenu), u skladu s onime što je propisano.
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: None of the patients who tested positive for anti-rHuPH20 antibodies tested positive for neutralizing antibodies.
Croatian: Nijedan od bolesnika s pozitivnim nalazom antitijela na rHuPH20 nije bio pozitivan na neutralizirajuća antitijela.
English: MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion.
Croatian: MabThera je bistra, bezbojna otopina, dostupna u obliku koncentrata za otopinu za infuziju.
English: The estimated half-life of Mabthera subcutaneous formulation of 1600 mg is 30 days, the estimated clearance is 0.22 L/day and the volume of distribution of the central compartment is 4.65 L.
Croatian: Procijenjen poluvijek supkutane formulacije lijeka MabThera od 1600 mg iznosi 30 dana, procijenjen klirens 0,22 l/dan, a volumen distribucije u središnjem odjeljku 4,65 l.
English: Your doctor may prescribe MabThera for the treatment of:
Croatian: Liječnik Vam može propisati lijek MabThera za liječenje sljedećih bolesti:
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the MabThera arm experienced at least one infusion-related reaction.
Croatian: U kliničkom ispitivanju primjene lijeka za terapiju održavanja 7/57 (12%) bolesnika u skupini liječenoj lijekom MabThera imalo je najmanje jednu reakciju povezanu s infuzijom.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek MabThera.
English: Newly diagnosed n=48
Croatian: Novodijagnosticirani n=48
English: The highest risk of experiencing an administration related reaction is generally observed at cycle one.
Croatian: Najveći rizik od pojave reakcija na primjenu općenito je primijećen u prvom ciklusu liječenja.
English: Yeonsu-gu, Incheon 21987,
Croatian: Samsung BioLogics 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987, Koreja
English: In case of such an event, with suspected relationship to MabThera, treatment should be permanently discontinued.
Croatian: U slučaju takvog događaja, uz sumnju na povezanost s lijekom MabThera, liječenje se mora trajno prekinuti.
English: B-cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Croatian: Razine B-stanica u ljudske novorođenčadi nakon izloženosti majke lijeku MabThera nisu ispitivane u kliničkim ispitivanjima.
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in two open-label trials involving patients with follicular lymphoma during induction and maintenance (SABRINA/BO22334) and during maintenance only (SparkThera/BP22333).
Croatian: Rizik od akutnih reakcija povezanih s primjenom supkutane formulacije lijeka MabThera ocijenjen je u dvama otvorenim ispitivanjima u bolesnika s folikularnim limfomom tijekom uvodne terapije i terapije održavanja (SABRINA/BO22334) i tijekom samo terapije održavanja (SparkThera/BP22333).
English: Currently, there are limited data on possible drug interactions with MabThera.
Croatian: Trenutno su dostupni ograničeni podaci o mogućim interakcijama drugih lijekova s lijekom
English: Patient subpopulations - MabThera combination therapy Elderly patients (≥ 65 years)
Croatian: Podskupine bolesnika - monoterapija lijekom MabThera Stariji bolesnici (≥ 65 godina):
English: • The need to check, prior to MabThera treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Croatian: · Prije liječenja lijekom MabThera potrebno je provjeriti status bolesnika s obzirom na infekcije, imunosupresiju, prethodnu/trenutačnu primjenu lijekova koji djeluju na imunološki sustav te nedavna ili planirana cijepljenja.
English: distribution volume, and elimination half-life were comparable for both formulations.
Croatian: Farmakokinetički parametri poput klirensa, volumena distribucije i poluvremena eliminacije bili su usporedivi za obje formulacije.
English: Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Croatian: Primjena lijeka MabThera može biti povezana s povećanim rizikom od progresivne multifokalne leukoencefalopatije (PML).
English: MabThera subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only.
Croatian: Formulacija lijeka MabThera za supkutanu primjenu nije namijenjena za intravensku primjenu i smije se primijeniti isključivo supkutanom injekcijom.
English: In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Croatian: U kliničkim ispitivanjima primjene lijeka MabThera u monoterapiji kroz 4 tjedna hematološki poremećaji su se pojavili u manjeg broja bolesnika i obično su bili blagi i reverzibilni.
English: None of the 99 MabThera-treated patients were ADA positive at screening.
Croatian: Nijedan od 99 bolesnika liječenih lijekom MabThera nije bio pozitivan na antitijela na lijek pri probiru.
English: No incompatibilities between MabThera and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Croatian: Nisu zamijećene inkompatibilnosti između lijeka MabThera i polivinilkloridnih ili polietilenskih vrećica ili kompleta za infuziju.
English: Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Croatian: Bolesnici su primali 2 x 1000 mg lijeka MabThera u razmacima od dva tjedna kao dodatak metotreksatu (10 do 25 mg na tjedan).
English: For storage conditions after first opening see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka vidjeti u dijelu 6.3.
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 MabThera.
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 MabThera.
English: The overall rate of infection was approximately 94 per 100 patient years in MabThera treated patients.
Croatian: Infekcije Ukupna stopa infekcija iznosila je približno 94 na 100 bolesnik-godina u bolesnika koji su primali lijek MabThera.
English: During the treatment course with MabThera subcutaneous formulation, other medicinal products for subcutaneous administration should preferably be given at different sites.
Croatian: Tijekom ciklusa liječenja lijekom MabThera u formulaciji za supkutanu primjenu, druge lijekove za supkutanu primjenu poželjno je davati na drugim mjestima.
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-treated group and the standard-dose prednisone group up to month 24.
Croatian: Nuspojave navedene u Tablici 5 predstavljaju štetne događaje čija je stopa među bolesnicima s PV-om liječenima lijekom MabThera iznosila ³ 5% i za koje je apsolutna razlika u incidenciji između skupine liječene lijekom MabThera i one liječene standardnom dozom prednizona iznosila ³ 2% do 24. mjeseca.
English: MabThera subcutaneous formulation should be injected subcutaneously into the abdominal wall and never into areas where the skin is red, bruised, tender, hard or areas where there are moles or scars.
Croatian: MabThera u formulaciji za supkutanu primjenu injicira se supkutano u trbušnu stijenku, ali nikada na područjima gdje je koža crvena, prekrivena modricama, bolna na dodir ili tvrda niti na područjima gdje ima madeža ili ožiljaka.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
Croatian: U bolesnika s granulomatozom s poliangitisom (Wegenerova granulomatoza) ili mikroskopskim poliangitisom se prije prve infuzije lijeka MabThera preporučuje intravenska primjena metilprednizolona u dozi od 1000 mg na dan tijekom 1 do 3 dana (posljednja doza metilprednizolona može se dati istoga dana kao i prva infuzija lijeka MabThera).
English: MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Croatian: MabThera u kombinaciji s kemoterapijom uništava te stanice, koje se postupno uklanjaju iz tijela biološkim procesima.
English: • The active ingredient in MabThera is called rituximab.
Croatian: • Djelatna tvar u lijeku MabThera zove se rituksimab.
English: In trial SparkThera, no severe administration-related reactions were reported.
Croatian: U ispitivanju SparkThera nisu prijavljene teške reakcije povezane s primjenom.
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Croatian: ORR u bolesnika prethodno liječenih autolognom transplantacijom koštane srži iznosio je 78% u odnosu na 43% u bolesnika koji nisu bili podvrgnuti tom postupku.
English: µg.day/mL
Croatian: µg.dan/ml
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and 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: Aseptically withdraw the necessary amount of MabThera, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Croatian: U aseptičkim uvjetima izvucite potrebnu količinu lijeka MabThera i razrijedite do izračunate koncentracije od 1 do 4 mg/ml rituksimaba u vrećici za infuziju koja sadrži sterilnu apirogenu otopinu natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili 5%-tnu vodenu otopinu glukoze.
English: For CLL patients similar results are assumable considering similarities between both diseases, but this has not been investigated in clinical trials.
Croatian: S obzirom na sličnost među bolestima, može se pretpostaviti da bi rezultati za bolesnike s KLL-om bili slični, ali to nije ispitivano u kliničkim ispitivanjima.
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Croatian: Mogući mehanizmi stanične lize posredovane efektorom uključuju citotoksičnost ovisnu o komplementu, nastalu kao rezultat vezanja C1q, i staničnu citotoksičnost ovisnu o antitijelima, posredovanu jednim ili više Fcg receptora na površini granulocita, makrofaga i NK-stanica.