FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
Croatian: Na početku, 56% bolesnika imalo je barem jedan tumor ≥ 5 cm, 26% imalo je del11q.
English: In patients who develop signs and/or symptoms of ventricular tachyarrhythmia, IMBRUVICA should be temporarily discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy.
Croatian: U bolesnika kod kojih se razviju znakovi i/ili simptomi ventrikularne tahiartimije, lijek IMBRUVICA potrebno je privremeno ukinuti iz terapije te se prije mogućeg ponovnog započinjanja terapije treba napraviti temeljitu ocjenu kliničke koristi/rizika.
English: The overall response to IMBRUVICA was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognostic factors, bulky disease, gender or age.
Croatian: Ukupni odgovor na lijek IMBRUVICA bio je neovisan o prethodnom liječenju uključujući bortezomib i lenalidomid ili o postojećim čimbenicima rizika/prognostičkim čimbenicima, prisutnosti velike tumorske mase, spolu ili dobi.
English: • non-melanoma skin cancer, most frequently squamous cell and basal cell skin cancer
Croatian: • nemelanomski rak kože, najčešće rak skvamoznih stanica i bazalnih stanica kože
English: Supplements such as fish oil and vitamin E preparations should be avoided.
Croatian: Dodatke prehrani, poput pripravaka ribljeg ulja i vitamina E potrebno je izbjegavati.
English: The median age was 67 years (range, 47 to 90 years).
Croatian: Medijan dobi iznosio je 67 godina (raspon: 47 do 90 godina).
English: Treatment on both arms continued until disease progression or unacceptable toxicity.
Croatian: Liječenje se u obje skupine nastavilo do progresije bolesti ili neprihvatljive toksičnosti.
English: Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Croatian: Ibrutinib nije pokazao značajnu inhibiciju agregacije trombocita uz korištenje drugih agonista agregacije trombocita.
English: The first dose of obinutuzumab was divided between day 1 (100 mg) and day 2 (900 mg).
Croatian: Prva je doza obinutuzumaba bila podijeljena u dvije doze, od kojih je jedna primijenjena 1. dana (100 mg), a druga 2. dana (900 mg).
English: What IMBRUVICA looks like and contents of the pack IMBRUVICA are white opaque, hard capsules marked with “ibr 140 mg” in black ink on one side.
Croatian: Kako IMBRUVICA izgleda i sadržaj pakiranja IMBRUVICA su bijele neprozirne tvrde kapsule označene s „ibr 140 mg” crnom bojom na jednoj strani.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking IMBRUVICA:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek IMBRUVICA:
English: Fifty-seven patients randomised to ofatumumab crossed over following progression to receive IMBRUVICA.
Croatian: Pedeset i sedam bolesnika randomiziranih da primaju ofatumumab, nakon progresije prešlo je na lijek IMBRUVICA.
English: Do not open, break or chew them.
Croatian: Nemojte ih otvarati, lomiti ili žvakati.
English: The open-label, multi-center study (PCYC-1102-CA) included 51 patients with relapsed or refractory CLL, who received 420 mg once daily.
Croatian: Otvoreno, multicentrično ispitivanje (PCYC-1102-CA) uključivalo je 51 bolesnika s relapsnim ili refraktornim KLL-om, koji su primili 420 mg jedanput dnevno.
English: • If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.
Croatian: • Ako niste sigurni, razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom o tome kada ćete uzeti sljedeću dozu.
English: Fatigue, dizziness and asthenia have been reported in some patients taking IMBRUVICA and should be considered when assessing a patient's ability to drive or operate machines.
Croatian: Umor, omaglica i astenija bili su prijavljeni u nekih bolesnika koji su uzimali lijek IMBRUVICA i moraju se uzeti u obzir pri procjeni bolesnikove sposobnosti da upravlja vozilima ili radi sa strojevima.
English: • Swallow the capsules whole.
Croatian: • Kapsule progutajte cijele.
English: Preclinical studies have shown that ibrutinib effectively inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
Croatian: Pretklinička ispitivanja pokazala su da ibrutinib učinkovito inhibira proliferaciju i preživljenje malignih B-stanica in vivo kao i migraciju stanica i adheziju na supstrat in vitro.
English: The overall known safety profile of IMBRUVICA-exposed patients remained consistent, other than an increasing prevalence of hypertension, with no new safety concerns identified.
Croatian: Sveukupno je profil sigurnosti u tih bolesnika odgovarao poznatom sigurnosnom profilu lijeka IMBRUVICA, uz izuzetak povećane prevalencije hipertenzije, te nisu utvrđeni nikakvi novi sigurnosni problemi.
English: Women should avoid becoming pregnant while taking IMBRUVICA and for up to 3 months after ending treatment.
Croatian: Žene moraju izbjegavati trudnoću tijekom uzimanja lijeka IMBRUVICA i do 3 mjeseca nakon završetka liječenja.
English: Lowest Observed Effect Level (LOEL) (60 mg/kg/day) margins in the dog are 3.6-fold (males) and 2.3-fold (females).
Croatian: Lowest Observed Effect Level, LOEL) (60 mg/kg/dan) u pasa su 3,6 puta (mužjaci) i 2,3 puta (ženke).
English: Chlorambucil+Obinutuzumab N=116
Croatian: Klorambucil + obinutuzumab N=116
English: Use of either anticoagulants or medicinal products that inhibit platelet function (antiplatelet agents) concomitantly with IMBRUVICA increases the risk of major bleeding.
Croatian: Primjena antikoagulansa ili lijekova koji inhibiraju funkciju trombocita (antitrombocitni lijekovi) istodobno s lijekom IMBRUVICA povećava rizik od velikog krvarenja.
English: White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink.
Croatian: Bijela neprozirna, tvrda kapsula duljine 22 mm, označena s „ibr 140 mg” crnom bojom.
English: The free fraction of ibrutinib also increased with degree of impairment, with 3.0, 3.8 and 4.8% in subjects with mild, moderate and severe liver impairment, respectively, compared to 3.3% in plasma from matched healthy controls within this study.
Croatian: Slobodna frakcija ibrutiniba se također povećala sa stupnjem oštećenja, 3,0% u ispitanika s blagim, 3,8% u ispitanika s umjerenim i 4,8% u ispitanika s teškim oštećenjem jetre, u usporedbi s 3,3% u plazmi iz odgovarajuće kontrole zdravih ispitanika u ovom ispitivanju.
English: A smaller proportion of patients treated with ibrutinib experienced a clinically meaningful worsening of lymphoma symptoms versus temsirolimus (27% versus 52%) and time to worsening of symptoms occurred more slowly with ibrutinib versus temsirolimus (HR 0.27, p<0.0001).
Croatian: Manji udio bolesnika liječenih s ibrutinibom doživjelo je klinički značajno pogoršanje simptoma limfoma naspram temsirolimusa (27% naspram 52%) i vrijeme do pogoršanja simptoma pojavilo se sporije s ibrutinibom naspram temsirolimusa (HR 0,27; p < 0,0001).
English: Based on in vitro data, ibrutinib is a weak reversible inhibitor towards CYP3A4 at the intestinal level and may therefore increase the exposure to CYP3A4 substrates sensitive to gut CYP3A metabolism.
Croatian: Na temelju in vitro podataka, ibrutinib je slabi reverzibilni inhibitor CYP3A4 na crijevnoj razini i stoga može povećati izloženost supstratima CYP3A4 osjetljivim na crijevni CYP3A metabolizam.
English: If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments should be considered.
Croatian: U slučaju bilo kakve nedoumice, potrebno je uzeti u obzir upućivanje neurologu i provođenje prikladnih dijagnostičkih pretraga za PML uključujući snimanje magnetskom rezonancom (MR) po mogućnosti s kontrastom, ispitivanje cerebrospinalne tekućine na DNK JC virusa i ponovljene neurološke procjene.
English: All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%).
Croatian: Svi su bolesnici na početku ispitivanja imali ECOG funkcionalni status 0 (48%) ili 1 - 2 (52%).
English: The dihydrodiol metabolite of ibrutinib is a weak inhibitor toward CYP2B6, CYP2C8, CYP2C9, and CYP2D6.
Croatian: Dihidrodiolni metabolit ibrutiniba je slabi inhibitor CYP2B6, CYP2C8, CYP2C9, i CYP2D6.
English: Total N=111
Croatian: Ukupno N = 111
English: ORR was assessed according to the 2008 IWCLL criteria by investigators and IRC.
Croatian: Ukupnu stopu odgovora procijenili su prema kriterijima IWCLL-a iz 2008. ispitivači i IRC.
English: • fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath - these could be signs of an infection (viral, bacterial or fungal).
Croatian: • vrućica, zimica, bol u tijelu, osjećaj umora, simptomi prehlade ili gripe, nedostatak zraka - ovo mogu biti znakovi infekcije (virusne, bakterijske ili gljivične).
English: In this same study, a concentration dependent shortening in the QTc interval was observed (-5.3 ms [90% CI: -9.4, -1.1] at a Cmax of 719 ng/mL following the supratherapeutic dose of 1,680 mg).
Croatian: U tom istom ispitivanju, bilo je opaženo skraćenje QTc intervala ovisno o koncentraciji (-5,3 ms [90% CI: -9,4; -1,1] pri Cmax od 719 ng/ml nakon supraterapijske doze od 1680 mg).
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH.
Croatian: Ibrutinib ima topljivost ovisnu o pH vrijednosti, s nižom topljivosti pri višem pH.
English: Dose adjustments Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib (see sections 4.4 and 4.5).
Croatian: Prilagodbe doze Umjereni i snažni CYP3A4 inhibitori povećavaju izloženost ibrutinibu (vidjeti dijelove 4.4 i 4.5).
English: Leukostasis syndrome
Croatian: Sindrom leukostaze
English: At a median duration follow up of 16.4 months, the ORR by IRC for the 51 relapsed or refractory patients was 64.7% (95% CI: 50.1%; 77.6%), all PRs.
Croatian: Pri medijanu trajanja praćenja od 16,4 mjeseci, ukupna stopa odgovora prema IRC-u u 51 bolesnika s relapsnim ili refraktornim oblikom bolesti bila je 64,7% (95% CI: 50,1%; 77,6%), sve djelomični odgovori.
English: To minimise the potential for an interaction in the GI tract, oral narrow therapeutic range, P-gp or BCRP substrates such as digoxin or methotrexate should be taken at least 6 hours before or after IMBRUVICA.
Croatian: Kako bi se minimizirao potencijal za interakciju u probavnom sustavu, peroralni supstrati P-gp-a ili BCRP-a s uskom terapijskom širinom poput digoksina ili metotreksata moraju se uzeti barem 6 sati prije ili nakon lijeka IMBRUVICA.
English: Grapefruit and Seville oranges should be avoided during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A4 (see section 4.2).
Croatian: Grejpfrut i seviljska (gorka) naranča moraju se izbjegavati tijekom liječenja lijekom IMBRUVICA, jer oni sadrže umjerene inhibitore CYP3A4 (vidjeti dio 4.2).
English: Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4).
Croatian: Ibrutinib se primarno metabolizira putem enzima 3A4 citokroma P450 (CYP3A4).
English: Avoid concomitant use of strong or moderate CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin).
Croatian: Izbjegavajte istodobnu primjenu snažnih ili umjerenih CYP3A4 induktora (npr. karbamazepin, rifampicin, fenitoin).
English: If symptoms persist, consider the risks and benefits of IMBRUVICA treatment and follow the dose modification guidelines.
Croatian: Ukoliko su simptomi perzistirajući, u obzir uzmite rizike i koristi liječenja lijekom IMBRUVICA i slijedite smjernice za prilagodbu doze.
English: Very common Pyrexia Oedema peripheral
Croatian: Vrlo često Pireksija Periferni edem
English: Based on in vitro data, ibrutinib is a weak CYP2B6 inducer and may have the potential to affect the expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR), e.g. CYP2C9, CYP2C19, UGT1A1 and MRP2.
Croatian: Na temelju in vitro podataka, ibrutinib je slabi induktor CYP2B6 i može potencijalno utjecati na ekspresiju drugih enzima i prijenosnika reguliranih putem konstitutivnog receptora za androstan (engl. constitutive androstane receptor, CAR), npr. CYP2C9, CYP2C19, UGT1A1 i MRP2.
English: If you forget to take IMBRUVICA
Croatian: Ako ste zaboravili uzeti lijek IMBRUVICA
English: • Do not breast-feed while you are taking this medicine.
Croatian: • Nemojte dojiti tijekom uzimanja ovog lijeka.
English: In vitro studies indicated that ibrutinib is a weak reversible inhibitor toward CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and intestinal (but not hepatic) CYP3A4 and does not display clinically relevant time-dependent inhibition of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2D6.
Croatian: In vitro ispitivanja pokazala su da je ibrutinib slabi reverzibilni inhibitor CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i crijevnog (ali ne jetrenog) CYP3A4 i ne pokazuje klinički značajnu vremenski ovisnu inhibiciju CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
English: Skin infection
Croatian: Infekcija kože*
English: If the benefit outweighs the risk and a strong or moderate CYP3A4 inducer must be used, monitor patient closely for lack of efficacy (see sections 4.3 and 4.4).
Croatian: Ako korist primjene nadvladava rizik i mora se koristiti snažni ili umjereni CYP3A4 induktor, pratite bolesnika pažljivo zbog mogućeg nedostatka djelotvornosti (vidjeti dijelove 4.3 i 4.4).
English: There was a statistically significant sustained platelet or haemoglobin improvement in the ITT population in favor of ibrutinib versus chlorambucil.
Croatian: Postojalo je statistički značajno održano poboljšanje vrijednosti trombocita ili hemoglobina u populaciji predviđenoj za liječenje (engl. intent to treat, ITT) u korist ibrutiniba naspram klorambucila.
English: The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia.
Croatian: Najčešće nuspojave stupnja 3/4 (≥ 5%) bile su neutropenija, pneumonija i trombocitopenija.
English: The safety and efficacy of IMBRUVICA in patients with CLL were demonstrated in one uncontrolled study and one randomised, controlled study.
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA u bolesnika s KLL-om dokazani su u jednom nekontroliranom ispitivanju i u jednom randomiziranom, kontroliranom ispitivanju.
English: Monitor patients for the appearance of non-melanoma skin cancer.
Croatian: Potrebno je pratiti bolesnike kako bi se uočila pojava nemelanomskog raka kože.
English: Preparations containing St. John's Wort are contraindicated during treatment with IMBRUVICA, as efficacy may be reduced.
Croatian: Pripravci koji sadrže gospinu travu kontraindicirani su tijekom liječenja lijekom IMBRUVICA, jer djelotvornost može biti smanjena.
English: IMBRUVICA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: IMBRUVICA sadrži natrij IMBRUVICA sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: • Waldenström's macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes.
Croatian: • Waldenströmova makroglobulinemija, vrsta raka koji zahvaća bijele krvne stanice koje se zovu limfociti.
English: Based on mean exposure (AUC) at the 560 mg/day clinical dose, AUC ratios were 2.6 and 21 at the NOAEL in male and female rats, and 0.4 and 1.8 at the NOAEL in male and female dogs, respectively.
Croatian: Temeljeno na srednjoj vrijednosti izloženosti (AUC) pri kliničkoj dozi od 560 mg/dan, omjeri AUC bili su 2,6 i 21 pri NOAEL vrijednosti u mužjaka i u ženki štakora, odnosno 0,4 i 1,8 pri NOAEL vrijednosti u mužjaka i u ženki pasa.
English: IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Croatian: IMBRUVICA je u kombinaciji s rituksimabom indicirana za liječenje odraslih bolesnika s WM-om.
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
Croatian: IMBRUVICA je u monoterapiji indicirana za liječenje odraslih bolesnika s Waldenströmovom makroglobulinemijom (WM) koji su prethodno primili najmanje jednu terapiju, ili u prvoj liniji liječenja za bolesnike kod kojih kemoimunoterapija nije prikladno liječenje.
English: Responses to IMBRUVICA are shown in Table 2.
Croatian: Odgovori na lijek IMBRUVICA prikazani su u Tablici 2.
English: If a CYP3A4 inducer must be used, closely monitor patients for signs of IMBRUVICA lack of efficacy.
Croatian: Ako se mora uzimati CYP3A4 induktor, potrebno je pažljivo pratiti bolesnike zbog moguće pojave znakova nedostatka djelotvornosti lijeka IMBRUVICA.
English: • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.
Croatian: • limfom plaštenih stanica, vrsta raka koji zahvaća limfne čvorove, kada se bolest vratila ili nije reagirala na liječenje.
English: • Take the capsules orally (by mouth) with a glass of water.
Croatian: • Uzmite kapsule kroz usta s čašom vode.
English: Do not break or chew.
Croatian: Nemojte lomiti niti žvakati.
English: In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive.
Croatian: Kod limfoma plaštenih stanica, kronične limfocitne leukemije i Waldenströmove makroglobulinemije, IMBRUVICA djeluje tako da blokira Brutonovu tirozin kinazu, protein u tijelu koji pomaže stanicama ovih vrsta raka da žive i rastu.
English: If you stop taking IMBRUVICA
Croatian: Ako prestanete uzimati lijek IMBRUVICA
English: Efficacy results were also assessed by an IRC demonstrating an ORR of 83%, with a 11% VGPR rate and a 51% PR rate.
Croatian: Rezultati djelotvornosti bili su također ocijenjeni od strane IRC-a pokazujući ORR od 83%, sa stopom jako dobrog djelomičnog odgovora od 11% i stopom djelomičnog odgovora od 51%.
English: BTK, a member of the Tec kinase family, is an important signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways.
Croatian: BTK, koja pripada obitelji Tec kinaza, važna je molekula signalnih puteva B-staničnih receptora za antigene (engl.
English: High risk (del17p/TP53/del11q/unmutated IGHV) Yes
Croatian: Visok rizik (delecija 17p/mutacija TP53/delecija 11q/nemutiran IGHV) Da
English: In an in vitro study, ibrutinib demonstrated inhibition of collagen-induced platelet aggregation.
Croatian: U in vitro ispitivanju, ibrutinib je pokazao inhibiciju kolagenom inducirane agregacije trombocita.
English: Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity.
Croatian: Bolesnicima s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) lijek IMBRUVICA smije se primijeniti samo ako korist nadilazi rizik te je potrebno pažljivo pratiti bolesnike zbog moguće pojave znakova toksičnosti.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na boci iza oznake „EXP”.
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Croatian: Fibrilacija atrija, undulacija atrija i slučajevi ventrikularne tahiaritmije bili su prijavljeni u bolesnika koji se liječe lijekom IMBRUVICA.
English: It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.
Croatian: Koristi se u bolesnika koji prethodno nisu bili liječeni za Waldenströmovu makroglobulinemiju ili kada se bolest vratila ili nije reagirala na liječenje ili u bolesnika za koje kemoterapija koja se daje zajedno s protutijelima nije primjerena terapija.
English: Population pharmacokinetics data indicated that gender does not significantly influence ibrutinib clearance from the circulation.
Croatian: Podaci populacijske farmakokinetike ukazuju da spol ne utječe značajno na klirens ibrutiniba iz cirkulacije.
English: The median time since diagnosis was 52.6 months (treatmentnaïve patients=6.5 months and previously treated patients=94.3 months).
Croatian: Medijan vremena od dijagnoze iznosio je 52,6 mjeseci (prethodno neliječeni bolesnici = 6,5 mjeseci; prethodno liječeni bolesnici = 94,3 mjeseca).
English: Paediatric population No pharmacokinetic studies were performed with IMBRUVICA in patients under 18 years of age.
Croatian: U bolesnika mlađih od 18 godina nisu provedena farmakokinetička ispitivanja s lijekom IMBRUVICA.
English: The primary endpoint in this study was investigator-assessed overall response rate (ORR).
Croatian: Primarna mjera ishoda u ovom ispitivanju bila je ukupna stopa odgovora (engl. overall response rate, ORR) prema procjeni ispitivača.
English: Table 1: Adverse reactions reported in clinical studies or during post marketing surveillance in patients with B-cell malignancies
Croatian: Tablica 1: Nuspojave prijavljene u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka u promet u bolesnika sa zloćudnim bolestima B-stanica Klasifikacija organskih sustava
English: The long-term safety data over 5 years from 1178 patients (treatment-naïve CLL/SLL n = 162, relapsed/refractory CLL/SLL n = 646, and relapsed/refractory MCL n = 370) treated with IMBRUVICA were analysed.
Croatian: Provedena je analiza podataka o dugoročnoj sigurnosti prikupljenih tijekom 5 godina u 1178 bolesnika (prethodno neliječeni bolesnici s KLL-om/limfomom malih stanica (LMS-om): n=162; bolesnici s relapsnim/refraktornim KLL-om/limfomom malih stanica (LMS-om) n=646, i bolesnici s relapsnim/refraktornim MCL-om: n=370) liječenih lijekom IMBRUVICA.
English: The BCR pathway is implicated in the pathogenesis of several B-cell malignancies, including MCL, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and CLL.
Croatian: Put BCR uključen je u patogenezu nekoliko zloćudnih bolesti B-stanica, uključujući MCL, difuzni limfom velikih B-stanica, folikularni limfom i KLL.
English: The median OS was 67.7 months [95% CI (61.0, not estimable)] in the IMBRUVICA arm.
Croatian: Medijan OS-a iznosio je 67,7 mjeseci [95% CI (61,0; nije procjenjivo)] u skupini liječenoj lijekom IMBRUVICA.
English: Hepatitis B virus (HBV) status should be established before initiating treatment with IMBRUVICA.
Croatian: Prije početka liječenja s lijekom IMBRUVICA, mora se ustanoviti status virusa hepatitisa B (HBV).
English: Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed below by system organ class and frequency grouping.
Croatian: Nuspojave u bolesnika koji su se liječili ibrutinibom zbog B-staničnih malignih bolesti i nuspojave prijavljene nakon stavljanja lijeka u promet poredane su niže prema klasifikaciji organskih sustava i kategoriji učestalosti.
English: • if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs
Croatian: • ako imate nepravilne otkucaje srca ili ste u prošlosti imali nepravilne otkucaje srca ili teško zatajenje srca ili ako osjećate bilo što od sljedećeg: nedostatak zraka, slabost, omaglicu, ošamućenost, nesvjesticu ili skoro da ćete se onesvijestiti, bol u prsnom košu ili oticanje nogu
English: Rituximab was administered weekly at a dose of 375 mg/m2 for 4 consecutive weeks (weeks 1-4) followed by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20).
Croatian: Rituksimab se primjenjivao jednom tjedno u dozi od 375 mg/m2 tijekom 4 uzastopna tjedna (1. - 4. tjedan), nakon čega je uslijedio drugi ciklus tjedne primjene rituksimaba tijekom 4 uzastopna tjedna (17. - 20. tjedan).