FrancophonIA/ELRC3.0 huggingface dataset:
English: Rituximab intravenous formulation (n = 88)
Croatian: Rituksimab, intravenska formulacija (n = 88)
English: Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with MabThera (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Croatian: U kliničkom je ispitivanju 99 bolesnika liječeno lijekom MabThera (375 mg/m2, jedanput tjedno tijekom 4 tjedna) i glukokortikoidima za poticanje remisije GPA i MPA (vidjeti dio 5.1).
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS MabThera Alert Card for patients with non-oncology diseases
Croatian: MabThera kartica s upozorenjima za bolesnike s neonkološkim bolestima
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 10 mg/mL rituximab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica sadrži 10 mg/ml rituksimaba.
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 2a).
Croatian: terapije u odnosu na primjenu samo FC kemoterapije (p = 0,0319, log-rang test) (Tablica 2a).
English: Sodium MabThera 1400 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Croatian: Natrij Mabthera 1400 mg sadrži manje od 1 mmol natrija po dozi, tj. zanemarive količine natrija.
English: Very rare side effects (may affect up to 1 in 10, 000 people):
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba):
English: Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Croatian: Tablica 6 Sažetak najvažnijih rezultata četiriju randomiziranih ispitivanja faze III u kojima se procjenjivala korist liječenja folikularnog limfoma lijekom MabThera u kombinaciji s različitim režimima kemoterapije
English: MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Croatian: Granulomatoza s poliangitisom i mikroskopski poliangitis MabThera je u kombinaciji s glukokortikoidima indicirana za liječenje odraslih bolesnika s teškom aktivnom granulomatozom s poliangitisom (Wegenerova granulomatoza) (GPA) i mikroskopskim poliangitisom (MPA).
English: Table 3 Summary of key results from four phase III randomized trials evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Croatian: Tablica 3 Sažetak najvažnijih rezultata četiriju randomiziranih ispitivanja faze III u kojima se procjenjivala korist liječenja folikularnog limfoma lijekom MabThera u kombinaciji s različitim režimima kemoterapije
English: MabThera at a fixed dose of 1600 mg was administered for 5 cycles subcutaneously at 4-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated CLL patients in combination with chemotherapy (fludarabine and cyclophosphamide (FC).
Croatian: Apsorpcija MabThera u fiksnoj dozi od 1600 mg primjenjivala se supkutano tijekom 5 ciklusa u 4-tjednim intervalima, nakon prvog ciklusa liječenja formulacijom lijeka MabThera za intravensku primjenu, u kombinaciji s kemoterapijom (fludarabin i ciklofosfamid, FC) u prethodno neliječenih bolesnika s KLL-om.
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Croatian: proljev, bol u abdomenu, disfagija, stomatitis, konstipacija, dispepsija, anoreksija, iritacija grla povećanje abdomena gastrointestinalna perforacija7
English: The study showed statistically significant results of MabThera and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Croatian: U 24. mjesecu ispitivanja kombinacija lijeka MabThera i niske doze prednizona ostvarila je statistički značajne rezultate u odnosu na standardnu dozu prednizona s obzirom na postizanje potpune remisije bez primjene kortikosteroida tijekom ≥ 2 mjeseca u bolesnika s PV-om (vidjeti Tablicu 18).
English: Each 50 mL vial contains 500 mg of rituximab.
Croatian: Jedna bočica od 50 ml sadrži 500 mg rituksimaba.
English: Time to new lymphoma treatment
Croatian: Vrijeme do novog liječenja
English: Occurred at various times up to several months after completion of MabThera therapy 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 7 includes fatal cases
Croatian: 6 Primijećeno najčešće u bolesnika s prethodnim srčanim poremećajima i/ili kardiotoksičnom kemoterapijom i najčešće vezano uz reakcije povezane s infuzijom.
English: Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with MabThera compared to patients treated with methotrexate alone.
Croatian: Functional Assessment of Chronic Illness Therapy - Fatigue, FACIT-Fatigue) u odnosu na bolesnike liječene samo metotreksatom.
English: In CLL patients, co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Croatian: U bolesnika s KLL-om, čini se da istodobna primjena lijeka MabThera nije utjecala na farmakokinetiku fludarabina niti ciklofosfamida.
English: The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
Croatian: · Bolesnici se trebaju obratiti svom liječniku ako se pojave simptomi Informacije za liječnike, Informacije za bolesnike i Kartica s upozorenjima za bolesnika moraju se prije podjele usuglasiti s nadležnim nacionalnim tijelom.
English: Table 6 Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time) Efficacy Parameter
Croatian: Tablica 6 Faza održavanja: pregled rezultata djelotvornosti lijeka MabThera naspram opservacijske skupine (medijan vremena promatranja je 28 mjeseci) Parametar djelotvornosti
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
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).
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Croatian: Liječenje R-CHOP-om dovelo je do poboljšanja ishoda i za visokorizične i za niskorizične bolesnike prema dobno prilagođenom međunarodnom prognostičkom indeksu.
English: Table 2b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Progression-free survival (PFS)
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: Cases of hepatitis B reactivation have been reported in subjects receiving MabThera including fulminant hepatitis with fatal outcome.
Croatian: U osoba koje su primale lijek MabThera prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući fulminantni hepatitis sa smrtnim ishodom.
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: (citomegalovirus, varičela zoster virus i herpes simpleks virus), JC virusom (progresivna multifokalna leukoencefalopatija (PML)) te virusom hepatitisa C.
English: Patients randomised to the MabThera group received an initial intravenous infusion of 1000 mg MabThera on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Croatian: Bolesnici randomizirani u skupinu liječenu lijekom MabThera primili su početnu intravensku infuziju lijeka MabThera u dozi od 1000 mg na 1. dan ispitivanja te su primali prednizon u peroralnoj dozi od 0,5 mg/kg na dan, koja se postupno smanjivala tijekom 3 mjeseca ako su imali umjerenu bolest, odnosno u peroralnoj dozi od 1 mg/kg na dan, koja se postupno smanjivala tijekom 6 mjeseci ako su imali tešku bolest.
English: The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: first cycle with MabThera intravenous formulation 375 mg/m2
Croatian: Preporučena doza lijeka MabThera u kombinaciji s kemoterapijom za uvodno liječenje bolesnika s prethodno neliječenim ili relapsirajućim/refraktornim folikularnim limfomom je sljedeća: u prvom ciklusu primjenjuje se formulacija lijeka MabThera za intravensku primjenu u dozi od 375 mg/m2
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before administration with MabThera to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Croatian: U bolesnika s KLL-om koji imaju broj limfocita > 25 x 109/l preporučuje se primjena prednizona/prednizolona u dozi od 100 mg intravenski neposredno prije primjene lijeka MabThera kako bi se smanjila stopa i težina akutne infuzijske reakcije i/ili sindroma otpuštanja citokina.
English: A two-part phase Ib, multicenter, randomized, open-label, parallel-group trial (SAWYER BO25341) was conducted in patients with previously untreated CLL, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with chemotherapy.
Croatian: randomizirano, otvoreno ispitivanje faze Ib s paralelnim skupinama (SAWYER BO25341) radi ocjenjivanja neinferiornosti farmakokinetičkog profila te djelotvornosti i sigurnosti lijeka MabThera u formulaciji za supkutanu primjenu u kombinaciji s kemoterapijom.
English: Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Croatian: Poremećaji kože i potkožnog tkiva Vrlo su rijetko prijavljeni toksična epidermalna nekroliza (Lyellov sindrom) i Stevens-Johnsonov sindrom, ponekad sa smrtnim ishodom.
English: Geometric mean AUCτ cycle 2 (q3m)
Croatian: 2. ciklus (q3m)
English: The objective of stage 2 was to provide additional efficacy and safety data for subcutaneous rituximab compared with rituximab intravenous using the 1400 mg subcutaneous dose established in stage 1.
Croatian: Cilj 2. dijela bio je pružiti dodatne podatke o djelotvornosti i sigurnosti supkutane formulacije rituksimaba u usporedbi s intravenskom formulacijom rituksimaba, uz primjenu supkutane doze od
English: In a population pharmacokinetic analysis in 403 follicular lymphoma patients who received subcutaneous and/or intravenous MabThera, single or multiple infusions of MabThera as a single agent or in combination with chemotherapy, the population estimates of nonspecific clearance (CL1), initial specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.194 L/day, 0.535 L/day, and 4.37 L/day, respectively.
Croatian: MabThera, samostalno ili u kombinaciji s kemoterapijom, procjene za tipičnu populaciju bolesnika bile su: za nespecifični klirens (CL1) 0,194 l/dan, početni specifični klirens (CL2) kojemu su vjerojatno pridonijele B-stanice ili zahvaćenost tumorom 0,535 l/dan, a za volumen distribucije u središnjem odjeljku (V1) 4,37 l/dan.
English: Dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Croatian: Poremećaji probavnog sustava dispepsija, proljev, gastroezofagealni refluks, vrijed usta, bol u gornjem abdomenu
English: MabThera 1400 mg subcutaneous formulation should be administered as subcutaneous injection only, over approximately 5 minutes.
Croatian: Supkutane injekcije: MabThera od 1400 mg u formulaciji za supkutanu primjenu smije se primijeniti isključivo u obliku supkutane injekcije tijekom približno 5 minuta.
English: MabThera contains sodium
Croatian: Mabthera sadrži natrij
English: Clinical experience of MabThera concentrate for solution for infusion in Non-Hodgkin's lymphoma
Croatian: Klinička iskustva s primjenom MabThera koncentrata za otopinu za infuziju u liječenju ne-Hodgkinova limfoma Folikularni limfom
English: MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion
Croatian: MabThera 100 mg koncentrat za otopinu za infuziju MabThera 500 mg koncentrat za otopinu za infuziju
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with MabThera.
Croatian: Sve bolesnike mora se prije početka liječenja lijekom MabThera testirati na virus hepatitisa B (HBV).
English: Similarly, the geometric mean AUC (CV%) values at Cycle 6 were higher among the subcutaneous group than the intravenous group; 4088 µg•day/mL (34.2) versus 3630 µg•day/mL (32.8) respectively) with a resulting adjusted geometric mean ratio [90% CI] of 1.10 [0.98-1.24].
Croatian: Slično tome, geometrijska srednja vrijednost AUC-a (CV%) u 6. ciklusu bila je veća među bolesnicima liječenima supkutanom formulacijom nego onima koji su primala intravensku formulaciju: 4088 µg·dan/ml (34,2) naspram 3630 µg·dan/ml (32,8), uz prilagođen omjer geometrijskih srednjih vrijednosti [90% CI] od 1,10 [0,98
English: log-rank p value hazard ratio (95% CI) risk reduction
Croatian: log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika
English: MabThera subcutaneous formulation
Croatian: MabThera u formulaciji za supkutanu primjenu
English: • The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Croatian: · Detaljne informacije o riziku od PML-a, nužnost pravodobne dijagnoze PML-a i odgovarajuće mjere za dijagnosticiranje PML-a · Bolesnicima treba objasniti rizik od infekcija i PML-a, uključujući simptome kojih moraju biti svjesni i napomenuti im da se odmah obrate svom liječniku ako primijete neki od njih.
English: Cmax following second infusion, was 207 µg/mL for the 2 x 500 mg dose and ranged from 377 to 386 µg/mL for the 2 x 1000 mg dose.
Croatian: Nakon druge infuzije vrijednost Cmax iznosila je 207 µg/ml pri dozi od 2 x 500 mg te 377 do 386 µg/ml pri dozi od 2 x 1000 mg.
English: Tabulated list of adverse reactions Table 1 ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/maintenance or in combination with chemotherapy
Croatian: Tablični prikaz nuspojava Tablica 1 Nuspojave prijavljene u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka u promet u bolesnika s NHL-om i KLL-om koji su lijek MabThera primali kao monoterapiju/terapiju održavanja ili u kombinaciji s kemoterapijom
English: c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Croatian: c) Bolesnici koji se liječe od granulomatoze s poliangitisom ili mikroskopskog poliangitisa
English: The European Medicines Agency has waived the obligation to submit the results of studies with MabThera in all subsets of the paediatric population with autoimmune arthritis.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka MabThera u svim podskupinama pedijatrijske populacije s autoimunim artritisom.
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Croatian: Nakon stavljanja lijeka MabThera u promet prijavljeni su vrlo rijetki slučajevi progresivne multifokalne leukoencefalopatije (PML) u bolesnika s NHL-om i KLL-om (vidjeti dio 4.8).
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group.
Croatian: (p = 0,029, log-rang test stratificiran prema centru): stope preživljenja nakon 53 mjeseca bile su 80,9% za bolesnike u R-CVP skupini, u usporedbi sa 71,1% za bolesnike u CVP skupini.
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Croatian: Prosječni Cmax rituksimaba u serumu nakon prve infuzije bio je 170 do 175 µg/ml pri dozi od 2 x 500 mg, odnosno 317 do 370 µg/ml pri dozi od 2 x 1000 mg.
English: Post-authorisation efficacy study (PAES): In order to further investigate the efficacy of Mabthera in the subgroup of patients with established PV as well as to further characterise its long term efficacy and safety on disease progression, the MAH should submit the preliminary study and the final study report of the ongoing randomised phase 3 study (PEMPHIX WA29330).
Croatian: Ispitivanje djelotvornosti nakon dobivanja odobrenja za stavljanje lijeka u promet (engl. post-authorisation efficacy study, PAES): Nositelj odobrenja mora dostaviti preliminarno i završno izvješće za randomizirano ispitivanje faze III koje se trenutno provodi (PEMPHIX WA29330) kako bi se dodatno razmotrila djelotvornost lijeka Mabthera u podskupini bolesnika s utvrđenim PV-om, kao i za daljnju karakterizaciju njegove dugoročne djelotvornosti i sigurnosti u progresiji bolesti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 2 June 1998
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in -three clinical trials: SparkThera and SABRINA (the two trials in NHL) and SAWYER the CLL trial.
Croatian: Nuspojave prijavljene pri uporabi formulacije lijeka MabThera za supkutanu primjenu Rizik od akutnih reakcija povezanih s primjenom supkutane formulacije lijeka MabThera ocijenjen je u trima kliničkim ispitivanjima: SparkThera i SABRINA (dva ispitivanja provedena u bolesnika s
English: Each 10mL vial contains 100 mg of rituximab.
Croatian: Jedna bočica od 10 ml sadrži 100 mg rituksimaba.
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Croatian: Većina bolesnika primala je rituksimab u kombinaciji s kemoterapijom ili u postupku transplantacije hematopoetskih matičnih stanica.
English: Geometric mean AUCτ cycle 2 (q2m)
Croatian: 2. ciklus (q2m)
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more MabThera treated patients treated with MabThera and methotrexate compared to patients treated with methotrexate alone (Table 12).
Croatian: Against Rheumatism) odgovor postiglo je znatno više bolesnika liječenih lijekom MabThera i metotreksatom nego onih koji su liječeni samo metotreksatom (Tablica 12).
English: Cycle 5 (pre-dose Cycle 6) were higher among the MabThera subcutaneous group than the MabThera intravenous group; 97.5 µg/mL (42.6) versus 61.5 µg/mL (63.9) respectively with a resulting adjusted geometric mean ratio [90% CI] of 1.53 [1.27-1.85].
Croatian: bila je veća u skupini koja je primala supkutanu formulaciju lijeka MabThera nego u onoj koja je primala intravensku formulaciju: 97,5 mg/ml (42,6) naspram 61,5 mg/ml (63,9), uz prilagođen omjer geometrijskih srednjih vrijednosti [90% CI] od 1,53 [1,27 - 1,85].
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of MabThera treatment.
Croatian: Nakon toga treba tijekom i nakon 4-tjednog ciklusa uvodnog liječenja lijekom MabThera peroralno davati prednizon u dozi od 1 mg/kg na dan (ne više od 80 mg na dan i što brže postupno smanjivati dozu, ovisno o kliničkoj potrebi).
English: For patients randomized to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Croatian: Za bolesnike randomizirane u fazu održavanja u ovom ispitivanju medijan vremena promatranja bio je
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the 2 × 500 mg dose and ranged from 355 to 404 µg/mL for the 2 × 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
English: The most frequent adverse reactions considered due to receipt of MabThera were IRRs.
Croatian: Najčešće nuspojave koje se smatraju posljedicom primjene lijeka MabThera bile su reakcije povezane s infuzijom.
English: Mean change DAS28-ESR -1.97**
Croatian: srednja vrijednost promjene DAS28-ESR indeksa
English: Similarly, for subjects in the high BSA tritile, Ctrough values were the same for the intravenous and subcutaneous regimens.
Croatian: Slično tome, vrijednosti Ctrough u ispitanika s velikom površinom tijela (gornja trećina) bile su jednake kod intravenskog i supkutanog režima liječenja.
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Croatian: Prosječni Cmax rituksimaba u serumu nakon prve infuzije kretao se između 157 i 171 µg/ml pri dozi od 2 x 500 mg, odnosno između 298 i 341 µg/ml pri dozi od 2 x 1000 mg.
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADAin clinical studies following therapy with MabThera.
Croatian: U kliničkim ispitivanjima je nakon terapije lijekom MabThera ukupno 392/3095 (12,7%) oboljelih od reumatoidnog artritisa bilo pozitivno na antitijela na lijek.
English: Three patients in the MabThera subcutaneous NHL formulation trial SABRINA (BO22334) were inadvertently adminstered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
Croatian: U ispitivanju SABRINA (BO22334), u kojem se ispitivala formulacija lijeka MabThera za supkutanu primjenu kod NHL-a, u tri je bolesnika intravenskim putem slučajno primijenjena formulacija za supkutanu primjenu u dozi koja je sadržavala najviše 2780 mg rituksimaba, ali nisu zabilježeni štetni učinci.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Patients achieving at least PR were entered on MabThera intravenous formulation maintenance therapy once every 8 weeks for 24 months.
Croatian: MabThera u formulaciji za intravensku primjenu jedanput svakih 8 tjedana tijekom 24 mjeseca.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% in FC.
Croatian: KLL-om incidencija hepatitis B infekcije stupnja 3/4 (reaktivacija i primarna infekcija) iznosila je 2% kod primjene R-FC terapije u odnosu na 0% kod primjene FC terapije.
English: For information related to the autoimmune indications, please refer to the SmPC of MabThera intravenous formulation.
Croatian: Za informacije povezane s primjenom lijeka u indikacijama autoimunih bolesti vidjeti Sažetak opisa svojstava lijeka MabThera u formulaciji za intravensku primjenu.