FrancophonIA/ELRC3.0 huggingface dataset:
English: Bronchitis, sinusitis, gastroenteritis, tinea pedis
Croatian: Infekcije i infestacije infekcija gornjih dišnih puteva, infekcije mokraćnih puteva bronhitis, sinusitis, gastroenteritis, tinea pedis
English: M39021
Croatian: ND 0,0319
English: In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
Croatian: IgG-a potom povisio iznad donje granice normalnih vrijednosti, dok je u skupini koja je primala lijek MabThera ostao nepromijenjen.
English: What MabThera 1400 mg solution for subcutaneous injection contains
Croatian: Što MabThera 1400 mg otopina za supkutanu injekciju sadrži
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
Croatian: 552 bolesnika s relapsirajućim/refraktornim KLL-om randomizirano da primaju FC kemoterapiju (fludarabin 25 mg/m2, ciklofosfamid 250 mg/m2, prva tri dana) svaka 4 tjedna kroz 6 ciklusa, ili lijek MabThera u kombinaciji s FC kemoterapijom (R-FC).
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following MabThera therapy.
Croatian: Dostupni podaci pokazuju da je stopa klinički značajnih infekcija nepromijenjena kada se ti lijekovi primjenjuju u bolesnika koji su prethodno liječeni lijekom MabThera.
English: ORR - Overall Response Rate
Croatian: ORR - stopa ukupnog odgovora (engl.
English: MabThera maintenance treatment consisted of a single infusion of MabThera at 375 mg/m2 body surface area given every 3 months until disease progression or for a maximum period of two years.
Croatian: Terapija održavanja lijekom MabThera sastojala se od primjene jedne infuzije lijeka MabThera u dozi od 375 mg/m2 tjelesne površine svaka 3 mjeseca do progresije bolesti ili najdulje dvije godine.
English: MabThera should be administered on day 1 of each chemotherapy cycle, after administration of the glucocorticoid component of the chemotherapy if applicable.
Croatian: MabThera se treba primijeniti prvog dana svakog kemoterapijskog ciklusa, nakon primjene glukokortikoidne komponente kemoterapije, ako je liječenje obuhvaća.
English: P<0.0001
Croatian: Medijan TTP: p < 0,0001
English: MabThera maintenance treatment consisted of a single infusion of MabThera at 375 mg/m2 body surface area given every 2 months until disease progression or for a maximum period of two years.
Croatian: Terapija održavanja lijekom MabThera sastojala se od jedne infuzije lijeka MabThera u dozi od 375 mg/m2 tjelesne površine svaka 2 mjeseca do progresije bolesti ili najdulje dvije godine.
English: The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Croatian: Preporučena doza lijeka MabThera u kombinaciji s kemoterapijom za prethodno neliječene bolesnike i bolesnike koji nisu odgovorili na liječenje ili su u relapsu iznosi 375 mg/m2 tjelesne površine primijenjeno nultog dana prvog ciklusa liječenja, nakon čega slijedi 500 mg/m2 tjelesne površine primijenjeno prvog dana svakog sljedećeg ciklusa, tijekom ukupno 6 ciklusa.
English: In total: 8 cycles.
Croatian: površine tijela po ciklusu, tijekom najviše 8 ciklusa.
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving MabThera for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Croatian: Tablica 4 Nuspojave koje su nastupile u ≥ 5% bolesnika koji su primali lijek MabThera za terapiju održavanja GPA i MPA i koje su se javile s većom učestalošću nego u usporednoj skupini Organski sustav Nuspojava1
English: NR: not reached; a: only applicable to patients achieving a CR
Croatian: ND: nije dostignuto; n.p.: nije primjenjivo *: primjenjivo samo za bolesnike koji su postigli CR, nPR ili PR **: primjenjivo samo za bolesnike koji su postigli CR
English: In studies evaluating MabThera in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Croatian: U ispitivanjima primjene lijeka MabThera u kombinaciji s kemoterapijom incidencija pojave srčanih aritmija stupnja 3 i 4, uglavnom supraventrikularnih aritmija kao što su tahikardija i undulacija/fibrilacija atrija, bila je veća u skupini liječenoj kombinacijom
English: Rituximab (n=99)
Croatian: Rituksimab (n=99)
English: Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the MabThera infusion.
Croatian: S obzirom da tijekom infuzije lijeka MabThera može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije davanja infuzije.
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Croatian: 273 na 100 bolesnik-godina (95% CI 149-470) u trenutku primarne mjere ishoda nakon 6 mjeseci.
English: Three patients in the MabThera subcutaneous formulation trial SABRINA (BO22334) were inadvertently administered 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, 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: Nervous system disorders Dizziness
Croatian: Poremećaji živčanog sustava omaglica tremor
English: The incidence of infusion-related symptoms decreased substantially with subsequent intravenous infusions and is <1% of patients by the eighth cycle of MabThera (containing) treatment.
Croatian: Incidencija pojave simptoma povezanih s infuzijom znatno se smanjila u narednim intravenskim infuzijama te je do osmog ciklusa terapije koja je sadržavala lijek MabThera iznosila < 1%.
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving MabThera for induction of remission of GPA and MPA, and at a higher frequency than the comparator group.
Croatian: Tablica 3 Nuspojave koje su u 6 mjeseci nastupile u ≥ 5% bolesnika koji su primali lijek MabThera za poticanje remisije GPA i MPA i koje su se javile s većom učestalošću nego u usporednoj skupini Organski sustav Nuspojava
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at 3 month follow-up visit (Part 2) b - at time of final analysis (median follow-up 53 months)
Croatian: a - pri posjetu radi praćenja u 3. mjesecu (2. dio) b - u trenutku provođenja završne analize (medijan praćenja: 53 mjeseca)
English: Intravenous infusion administration
Croatian: Primjena intravenskom infuzijom
English: The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is: MabThera intravenous formulation 375 mg/m2 body surface area administered on day 0 of the first cycle of treatment followed by MabThera subcutaneous formulation injected at a fixed dose of 1600 mg per cycle, on day 1 of each subsequent cycle (in total: 6 cycles).
Croatian: Preporučena doza lijeka MabThera u formulaciji za intravensku primjenu u kombinaciji s kemoterapijom za prethodno neliječene bolesnike i bolesnike koji nisu odgovorili na liječenje ili su u relapsu iznosi 375 mg/m2 tjelesne površine primijenjeno nultog dana prvog ciklusa liječenja, nakon čega slijedi injekcija formulacije lijeka MabThera za supkutanu primjenu u fiksnoj dozi od 1600 mg po ciklusu primijenjena 1. dana svakog sljedećeg ciklusa (ukupno: 6 ciklusa).
English: 9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
Croatian: ND 4,04 godine 9,25 godina log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika TNLT (medijan)
English: Local cutaneous reactions were very common in patients receiving MabThera subcutaneous in clinical trials.
Croatian: Lokalne kožne reakcije bile su vrlo česte u bolesnika koji su u kliničkim ispitivanjima primali formulaciju lijeka MabThera za supkutanu primjenu.
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), grade 3/4 neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), grade 3/4 pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Croatian: Za vrijeme liječenja u ispitivanjima lijeka MabThera u kombinaciji s kemoterapijom obično su s većom učestalošću u usporedbi s primjenom samo kemoterapije prijavljene: leukopenija stupnja 3/4 (R-CHOP 88% naspram CHOP 79%; R-FC 23% naspram FC 12%), neutropenija stupnja 3/4 (R-CVP 24% naspram CVP 14%; R-CHOP 97% naspram CHOP 88%; R-FC 30% naspram FC 19% kod prethodno neliječenog KLL-a), pancitopenija stupnja 3/4
English: The geometric mean tmax in the MabThera subcutaneous group was approximately 3 days as compared to the tmax occuring at or close to the end of the infusion for the MabThera intravenous group.
Croatian: Geometrijska srednja vrijednost tmax u skupini koja je primala supkutanu formulaciju lijeka MabThera iznosila je približno 3 dana, dok je tmax u skupini koja je primala intravensku formulaciju lijeka MabThera nastupio na kraju ili pri kraju infuzije.
English: Clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma
Croatian: Klinička iskustva s primjenom lijeka MabThera u formulaciji za supkutanu primjenu u liječenju ne-Hodgkinova limfoma
English: Rate
Croatian: Prema
English: MabThera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Croatian: MabThera se treba primijeniti prvog dana svakog kemoterapijskog ciklusa, nakon intravenske primjene glukokortikoidne komponente kemoterapije, ako je liječenje obuhvaća.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (PML) and hepatitis C virus.
Croatian: (citomegalovirus, varičela zoster virus i herpes simpleks virus), JC virusom (PML) te virusom hepatitisa C.
English: The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is <1% of patients by the eighth cycle of MabThera (containing) treatment.
Croatian: Incidencija pojave simptoma povezanih s infuzijom znatno se smanjila u narednim infuzijama te je do osmog ciklusa terapije koja je sadržavala lijek MabThera iznosila < 1%.
English: Symptoms included pain, swelling, induration, haemorrhage, erythema, pruritus and rash (see section 4.8).
Croatian: krvarenje, eritem, svrbež i osip (vidjeti dio 4.8).
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Croatian: U primarnoj je analizi uočena i značajna korist od terapije održavanja lijekom MabThera u pogledu sekundarnih mjera ishoda: preživljenja bez pojave događaja (EFS), vremena do sljedećeg liječenja limfoma (engl. time to next anti-lymphoma treatment, TNLT), vremena do sljedeće kemoterapije (engl. time to next chemotherapy, TNCT) te stope ukupnog odgovora (ORR) (Tablica 7).
English: For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
Croatian: Za informacije povezane s drugim indikacijama vidjeti Sažetak opisa svojstava lijeka MabThera u formulaciji za intravensku primjenu.
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: (95% CI 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 a non-randomised study, patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Croatian: U nerandomiziranom ispitivanju, bolesnici u relapsu NHL-a niskog stupnja malignosti koji su primali monoterapiju lijekom MabThera su u usporedbi sa zdravim neliječenim kontrolnim ispitanicima imali nižu stopu odgovora na cijepljenje antigenom tetanusa (16% u odnosu na 81%) i Keyhole Limpet Haemocyanin (KLH) neoantigenom (4% u odnosu na 76% kada se mjerilo više nego dvostruko povećanje titra antitijela).
English: MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Croatian: MabThera 500 mg koncentrat za otopinu za infuziju Jedan ml sadrži 10 mg rituksimaba.
English: The recommended dose of MabThera used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Croatian: Preporučena doza lijeka MabThera u terapiji održavanja u bolesnika s prethodno neliječenim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m2 površine tijela jedanput svaka 2 mjeseca (počevši 2 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 12 infuzija).
English: What MabThera is and what it is used for What you need to know before you are given MabThera How MabThera is given
Croatian: U ovoj se kartici navodi · što morate znati prije nego primite lijek MabThera
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 4).
Croatian: U primarnoj je analizi uočena i značajna korist od terapije održavanja lijekom MabThera u pogledu sekundarnih mjera ishoda: preživljenja bez pojave događaja (EFS), vremena do sljedećeg liječenja limfoma (engl. time to next anti-lymphoma treatment, TNLT), vremena do sljedeće kemoterapije (engl. time to next chemotherapy, TNCT) te stope ukupnog odgovora (ORR) (Tablica 4).
English: MabThera 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, prednisolone) chemotherapy.
Croatian: MabThera je u kombinaciji s CHOP kemoterapijom (ciklofosfamid, doksorubicin, vinkristin, prednizolon) indicirana u liječenju bolesnika s CD20 pozitivnim difuznim ne-Hodgkinovim limfomom velikih B-stanica.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Croatian: Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali lijek MabThera u dozi od 375 mg/m2
English: Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when compared to observation.
Croatian: MabThera u trajanju do 2 godine primijećena je veća sveukupna učestalost infekcija, uključujući infekcije stupnja 3 i 4, u usporedbi s opservacijskom skupinom.
English: Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Croatian: Poremećaji krvi i limfnog sustava neutropenija, leukopenija, +febrilna neutropenija, +trombocitopenija anemija, +pancitopenija, +granulocitopenija poremećaji zgrušavanja,
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 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 eight cycles, or MabThera 375 mg/m2 plus
Croatian: U randomiziranom otvorenom ispitivanju ukupno je 399 prethodno neliječenih starijih bolesnika (u dobi od 60 do 80 godina) s difuznim limfomom velikih B-stanica primalo standardnu CHOP kemoterapiju (ciklofosfamid 750 mg/m2, doksorubicin 50 mg/m2, vinkristin 1,4 mg/m2 do najviše
English: MabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL).
Croatian: 4.1 Terapijske indikacije MabThera je u kombinaciji s kemoterapijom indicirana za liječenje odraslih bolesnika s prethodno neliječenom i relapsirajućom/refraktornom kroničnom limfocitnom leukemijom (KLL).
English: 4.06 years
Croatian: 6.3 Rok valjanosti
English: Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Croatian: Terapija održavanja lijekom MabThera dovela je do klinički relevantnih i statistički značajnih poboljšanja u primarnoj mjeri ishoda, što je bio PFS (vrijeme od randomizacije na terapiju održavanja do relapsa, progresije bolesti ili smrti), u usporedbi s opservacijskom skupinom (p < 0,0001, log-rang test).
English: How MabThera is given
Croatian: Kako se MabThera primjenjuje
English: The estimated median terminal elimination half-life of MabThera was 22 days (range, 6.1 to 52 days).
Croatian: Procijenjeni medijan vrijednosti terminalnog poluvremena eliminacije lijeka MabThera u formulaciji za supkutanu primjenu iznosio je 29,7 dana (raspon: 9,9 do 91,2 dana).
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
Croatian: Prije svake primjene lijeka MabThera uvijek treba primijeniti premedikaciju koja obuhvaća antipiretik i antihistaminik, npr. paracetamol i difenhidramin.
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
Croatian: MabThera opažena je hipogamaglobulinemija (IgA, IgG ili IgM ispod donje granice normalnih vrijednosti).
English: In a non-randomized study, patients with relapsed low-grade NHL who received the MabThera intravenous formulation as monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 69% when assessed for >2-fold increase in antibody titer).
Croatian: U nerandomiziranom ispitivanju, bolesnici u relapsu NHL-a niskog stupnja malignosti koji su primali monoterapiju lijekom MabThera u formulaciji za intravensku primjenu su u usporedbi sa zdravim neliječenim kontrolnim ispitanicima imali nižu stopu odgovora na cijepljenje antigenom tetanusa (16% u odnosu na 81%) i Keyhole Limpet Haemocyanin (KLH) neoantigenom (4% u odnosu na 69% kada se mjerilo više nego dvostruko povećanje titra antitijela).
English: Adverse reactions reported in MabThera subcutaneous formulation usage
Croatian: Nuspojave prijavljene pri uporabi formulacije lijeka MabThera za supkutanu primjenu
English: Subcutaneous injections:
Croatian: Prošireni tumori:
English: body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Croatian: do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
English: The recommended dose of MabThera 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 weekly for four weeks.
Croatian: · Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka MabThera u monoterapiji kod početnog 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: Co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Croatian: Istodobna primjena lijeka MabThera nije utjecala na farmakokinetiku fludarabina niti ciklofosfamida.
English: MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Croatian: MabThera 100 mg koncentrat za otopinu za infuziju Jedan ml sadrži 10 mg rituksimaba.
English: MabThera is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Croatian: MabThera se povezuje s reakcijama na infuziju, koje mogu biti posljedica otpuštanja citokina i/ili drugih kemijskih medijatora.
English: Clinical experience of MabThera subcutaneous formulation in chronic lymphocytic leukaemia
Croatian: Klinička iskustva s primjenom lijeka MabThera u formulaciji za supkutanu primjenu u liječenju kronične limfocitne leukemije
English: Most common local cutaneous reactions were injection site erythema (26%), injection site pain (16%), and injection site swelling (5%).Two patients in SAWYER trial who experienced Grade 3 local cutaneous reactions (injection site erythema, injection site pain and injection site swelling).
Croatian: Najčešće lokalne kožne reakcije bile su eritem na mjestu injekcije (26%), bol na mjestu injekcije (16%) i oticanje na mjestu injekcije (5%).
English: Very rare cases of fatal PML have been reported following use of MabThera.
Croatian: Nakon primjene lijeka MabThera prijavljeni su vrlo rijetki slučajevi PML-a sa smrtnim ishodom.
English: +myocardial infarction4 and 6,
Croatian: +infarkt miokarda4 i 6, aritmija, +fibrilacija atrija, tahikardija,
English: Information to appear on Peel-off sticker
Croatian: Podaci koji se moraju nalaziti na odvojivoj naljepnici Lot
English: Localized candida infections as well as Herpes zoster were reported at a higher incidence in the MabThera-containing arm of randomized studies.
Croatian: Lokalizirane infekcije kandidom te herpes zoster u randomiziranim su ispitivanjima prijavljeni s većom incidencijom u skupinama koje su primale lijek MabThera.