FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop from an injury
Croatian: • krv u želucu, crijevima, stolici ili mokraći, jača menstrualna krvarenja ili nezaustavljivo krvarenje iz ozljede
English: Efficacy results for Study MCL3001 are shown in Table 3 and the Kaplan-Meier curve for PFS in Figure 1.
Croatian: Rezultati djelotvornosti iz Ispitivanja MCL3001 prikazani su u Tablici 3 i Kaplan-Meierovoj krivulji za PFS na Slici 1.
English: In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered.
Croatian: U bolesnika s postojećom atrijskom fibrilacijom, kojima je potrebna terapija antikoagulansima, mora se u obzir uzeti alternativna opcija liječenja od liječenja lijekom IMBRUVICA.
English: The efficacy data was further evaluated by an Independent Review Committee (IRC) demonstrating an ORR of 69%, with a 21% complete response (CR) rate and a 48% partial response (PR) rate.
Croatian: Independent Review Committee, IRC), te je pokazalo ukupnu stopu odgovora od 69%, sa stopom kompletnog odgovora od 21% i sa stopom djelomičnog odgovora od 48%.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Croatian: Prije započinjanja liječenja, bolesnike će pažljivo kontrolirati njihov liječnik na znakove ove infekcije.
English: The ORR including PR with lymphocytosis was 70.6%.
Croatian: Ukupna stopa odgovora uključujući djelomični odgovor s limfocitozom bila je 70,6%.
English: What IMBRUVICA contains
Croatian: Što IMBRUVICA sadrži
English: Median duration of overall response, months (range)
Croatian: Medijan trajanja ukupnog odgovora, mjeseci (raspon)
English: On the contrary, co-administration of CYP3A4 inducers may lead to decreased IMBRUVICA exposure and consequently a risk for lack of efficacy.
Croatian: Suprotno tome, istodobna primjena induktora CYP3A4 može dovesti do smanjene izloženosti lijeku IMBRUVICA i posljedično do rizika od nedostatka djelotvornosti.
English: 8.1 months HR=0.215 [95% CI: 0.146; 0.317]
Croatian: 8,1 mjeseci HR = 0,215 [95% CI: 0,146; 0,317]
English: Patients treated for MCL in clinical studies received IMBRUVICA at 560 mg once daily and patients treated for CLL or WM in clinical studies received IMBRUVICA at 420 mg once daily.
Croatian: Bolesnici kojima je liječen MCL u kliničkim ispitivanjima primali su 560 mg lijeka IMBRUVICA jedanput dnevno, a bolesnici kojima je liječena KLL ili WM u kliničkim ispitivanjima primali su 420 mg lijeka IMBRUVICA jedanput dnevno.
English: • medicines for fungal infections - posaconazole, ketoconazole, itraconazole, fluconazole or voriconazole
Croatian: • lijekove za gljivične infekcije - posakonazol, ketokonazol, itrakonazol, flukonazol ili vorikonazol
English: • medicines for HIV infection - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
Croatian: • lijekove za HIV infekciju - ritonavir, kobicistat, indinavir, nelfinavir, sakvinavir, amprenavir,
English: Co-administration with CYP substrates
Croatian: Istodobna primjena sa supstratima CYP-a
English: No specific clinical studies have been conducted in patients with renal impairment.
Croatian: Nisu provedena specifična klinička ispitivanja u bolesnika s oštećenjem bubrega.
English: Cases of atrial fibrillation and atrial flutter have been reported particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation.
Croatian: Slučajevi fibrilacije atrija i undulacije atrija bili su prijavljeni naročito u bolesnika s čimbenicima rizika za bolesti srca, hipertenzijom, akutnim infekcijama i s prethodnom atrijskom fibrilacijom u anamnezi.
English: Table 2: ORR and DOR in patients with relapsed or refractory MCL (Study PCYC-1104-CA)
Croatian: Tablica 2: ORR i DOR u bolesnika s relapsnim ili refraktornim MCL-om (Ispitivanje PCYC-1104-CA)
English: Includes 1 patient in the IMBRUVICA+obinutuzumab arm with a complete response with incomplete marrow recovery (CRi).
Croatian: Uključuje 1 bolesnika u skupini liječenoj lijekom IMBRUVICA u kombinaciji s obinutuzumabom koji je postigao potpun odgovor uz nepotpun oporavak koštane srži (CRi).
English: In fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days, compared to ibrutinib alone, geometric mean ratios (90% CI) were 83% (68-102%), 92% (78-110%), and 38% (26-53%) for AUC0-24, AUClast, and Cmax, respectively.
Croatian: U zdravih ispitanika kojima je primijenjena jedna doza ibrutiniba od 560 mg natašte nakon uzimanja 40 mg omeprazola jedanput na dan tijekom 5 dana u usporedbi sa samim ibrutinibom, omjeri geometrijskih srednjih vrijednosti (90% CI) bili su 83% (68-102%), 92% (78-110%) i 38% (26-53%) za AUC0-24, AUCposljednji, odnosno Cmax.
English: Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each.
Croatian: Jedna kutija za 30 dana sadrži 30 filmom obloženih tableta u 3 kartonska omota, svaki s 10 filmom obloženih tableta.
English: In patients at high risk and where alternatives to IMBRUVICA are non-suitable, tightly controlled treatment with anticoagulants should be considered.
Croatian: U bolesnika s visokim rizikom u kojih primjena alternativne terapije od liječenja lijekom IMBRUVICA nije prikladna, mora se razmotriti dobro kontrolirano liječenje s antikoagulansima.
English: The dihydrodiol metabolite is at most a weak inducer of CYP450 isoenzymes in vitro.
Croatian: Dihidrodiolni metabolit je, u najgorem slučaju slabi induktor CYP450 izoenzima in vitro.
English: Lymphocytosis was not observed in patients with WM treated with IMBRUVICA.
Croatian: Limfocitoza nije zabilježena u bolesnika s WM-om liječenih lijekom IMBRUVICA.
English: Bendamustine was dosed at 70 mg/m2 infused IV over 30 minutes on Cycle 1, Days 2 and 3, and on Cycles 2-6, Days 1 and 2 for up to 6 cycles.
Croatian: Bendamustin je u dozi 70 mg/m2 primijenjen kao i.v. infuzija tijekom 30 minuta u 1. ciklusu na 1. i 3. dan, a u 2.-6. ciklusu,na 1. i 2. dan, do 6 ciklusa.
English: Cryptococcal infections Pneumocystis infections Aspergillus infections Hepatitis B reactivation
Croatian: Infekcije gljivicom Aspergillus* Reaktivacija hepatitisa B
English: Patients with congenital bleeding diathesis have not been studied.
Croatian: Bolesnici s kongenitalnom hemoragijskom dijatezom nisu ispitivani.
English: Transient ischaemic attack Ischaemic stroke a, #
Croatian: Prolazni ishemijski napadaj Ishemijski moždani udar a, #
English: The steady state AUC observed in patients at 560 mg is (mean ± standard deviation) 953 ± 705 ng h/mL.
Croatian: AUC u stanju dinamičke ravnoteže uočen u bolesnika pri 560 mg je 953 ± 705 ng h/ml (srednja vrijednost ± standardna devijacija).
English: Median PFS
Croatian: Medijan PFS-a
English: IMBRUVICA is used in patients who have not previously been treated for CLL or when the disease has come back or has not responded to treatment.
Croatian: IMBRUVICA se koristi u bolesnika koji prethodno nisu bili liječeni za kroničnu limfocitnu leukemiju ili kada se bolest vratila ili nije reagirala na liječenje.
English: No human data on the effects of ibrutinib on fertility are available.
Croatian: Nisu dostupni podaci o učincima ibrutiniba na plodnost kod ljudi.
English: Sensitivity analysis in which crossover patients from the ofatumumab arm were not censored at the date of first dose of IMBRUVICA.
Croatian: Analiza osjetljivosti u kojoj su se bolesnici koji su prešli iz skupine s ofatumumabom uzeli u obzir, u vrijeme prve doze lijeka IMBRUVICA.
English: The median DOR was not reached.
Croatian: Medijan trajanja odgovora nije dostignut.
English: Chlorambucil N=133
Croatian: Klorambucil N = 133
English: Patients should be monitored for fever, neutropenia and infections and appropriate anti-infective therapy should be instituted as indicated.
Croatian: Bolesnike se mora pratiti zbog moguće pojave znakova vrućice, neutropenije i infekcije, a prema potrebi mora se započeti prikladno liječenje infekcije.
English: These included pneumonia, atrial fibrillation, haemorrhage, and thrombocytopenia.
Croatian: One su uključivale pneumoniju, atrijsku fibrilaciju, krvarenje i trombocitopeniju.
English: The median age was 68 years (range: 37 to 82 years), median time since diagnosis was 80 months, and median number of prior treatments was 4 (range: 1 to 12 treatments), including 92.2% with a prior nucleoside analog, 98.0% with prior rituximab, 86.3% with a prior alkylator, 39.2% with prior bendamustine and 19.6% with prior ofatumumab.
Croatian: Medijan dobi bio je 68 godina (raspon: 37 do 82 godine), medijan vremena od dijagnoze bio je 80 mjeseci, a medijan broja prethodnih liječenja bio je 4 (raspon: 1 do 12 liječenja), uključujući 92,2% s prethodnim nukleozidnim analogom, 98,0% s prethodnim rituksimabom, 86,3% s prethodnim alkilirajućim lijekom, 39,2% s prethodnim bendamustinom i 19,6% s prethodnim ofatumumabom.
English: What IMBRUVICA looks like and contents of the pack IMBRUVICA 140 mg film-coated tablets
Croatian: Kako IMBRUVICA izgleda i sadržaj pakiranja IMBRUVICA 140 mg filmom obložene tablete
English: At baseline, the median serum IgM value was 3.5 g/dL, and 60% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L).
Croatian: Na početku, medijan vrijednosti serumskog IgM bio je 3,5 g/dl i 60% bolesnika imalo je anemiju (hemoglobin ≤ 11 g/dl ili 6,8 mmol/l).
English: Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 10 film-coated tablets in a cardboard wallet.
Croatian: Blister od polivinilklorida (PVC) laminiran s poliklorotrifluoroetilenom (PCTFE)/aluminijem s 10 filmom obloženih tableta u kartonskom omotu.
English: 14.6 (10.4, NE) HR=0.43 [95% CI: 0.32, 0.58]
Croatian: 14,6 (10,4; NP) HR = 0,43 [95% CI: 0,32; 0,58]
English: 120 capsules
Croatian: 90 kapsula 120 kapsula
English: Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA.
Croatian: Potrebno je razmotriti rizike i koristi antikoagulantne ili antitrombocitne terapije kada se primjenjuju istodobno s lijekom IMBRUVICA.
English: Patients should be closely monitored for signs of IMBRUVICA toxicity if a CYP3A4 inhibitor must be used (see sections 4.2 and 4.5).
Croatian: Bolesnike je potrebno pažljivo pratiti zbog moguće pojave znakova toksičnosti lijeka IMBRUVICA ako se mora uzimati CYP3A4 inhibitor (vidjeti dijelove 4.2 i 4.5).
English: Discontinuation and dose reduction due to adverse reactions Of the 1200 patients treated with IMBRUVICA for B-cell malignancies, 5% discontinued treatment primarily due to adverse reactions.
Croatian: Od 1200 bolesnika liječenih lijekom IMBRUVICA zbog B-staničnih malignih bolesti, 5% je prekinulo liječenje prvenstveno radi nuspojava.
English: Therefore, women of child-bearing potential must use highly effective contraceptive measures while taking IMBRUVICA and for three months after stopping treatment.
Croatian: Stoga, žene reproduktivne dobi moraju koristiti visoko učinkovite mjere kontracepcije tijekom uzimanja lijeka IMBRUVICA i do tri mjeseca nakon prestanka liječenja.
English: Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Croatian: Bolesnici s blagim ili umjerenim oštećenjem bubrega bili su liječeni u kliničkim ispitivanjima lijeka IMBRUVICA.
English: The response rate per IRC observed in the monotherapy arm was 71% (0% CR, 29% VGPR, 42% PR).
Croatian: Stopa odgovora prema ocjeni IRC-a u skupini liječenoj monoterapijom iznosila je 71% (CR: 0%; VGPR: 29%; PR: 42%).
English: Do not take IMBRUVICA
Croatian: Nemojte uzimati lijek IMBRUVICA
English: Film-coat
Croatian: Film ovojnica
English: A hepatic impairment trial was performed in non-cancer subjects administered a single dose of 140 mg of medicinal product under fasting conditions.
Croatian: Ispitivanje kod oštećenja jetre provedeno je u ispitanika koji nemaju rak, pri čemu je lijek primijenjen u jednokratnoj dozi od 140 mg natašte.
English: The overall response rate per IRC observed in the monotherapy arm was 87% (0% CR, 29% VGPR, 42% PR, 16% MR).
Croatian: Ukupna stopa odgovora prema ocjeni IRC-a u skupini liječenoj monoterapijom iznosila je 87% (CR: 0%; VGPR: 29%; PR: 42%; MR: 16%).
English: Caution should be exercised if co-administering ibrutinib with CYP3A4 substrates administered orally with narrow therapeutic range (such as dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus).
Croatian: Treba biti na oprezu ako se ibrutinib primjenjuje istodobno s peroralno primijenjenim supstratima CYP3A4 uske terapijske širine (poput dihidroergotamina, ergotamina, fentanila, ciklosporina, sirolimusa i takrolimusa).
English: There is no information about the safety of IMBRUVICA in pregnant women.
Croatian: Ne postoje podaci o sigurnosti lijeka IMBRUVICA u trudnica.
English: Ibrutinib was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse at oral doses up to 2000 mg/kg/day with an exposure margin of approximately 23 (males) to 37 (females) times the human AUC of ibrutinib at a dose of 560 mg daily.
Croatian: Ibrutinib nije bio kancerogen u 6-mjesečnom ispitivanju u transgeničnih (Tg. rasH2) miševa uz peroralne doze do 2000 mg/kg/dan s marginom izloženosti od približno 23 (kod mužjaka) do 37 (kod ženki) puta vrijednosti AUC-a ibrutiniba u ljudi pri dozi od 560 mg na dan.
English: Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 14 film-coated tablets in a cardboard wallet.
Croatian: Blister od polivinilklorida (PVC) laminiran s poliklorotrifluoroetilenom (PCTFE)/aluminijem s 14 filmom obloženih tableta u kartonskom omotu.
English: Dizziness Uncommon Cerebrovascular accident a, #
Croatian: Omaglica Manje često Cerebrovaskularni inzult a, #
English: The following side effects may happen with this medicine:
Croatian: Uz ovaj lijek mogu se javiti sljedeće nuspojave:
English: Population pharmacokinetics indicated that age does not significantly influence ibrutinib clearance from the circulation.
Croatian: Starije osobe Populacijska farmakokinetika ukazuje da dob ne utječe značajno na klirens ibrutiniba iz cirkulacije.
English: The IRC estimated median DOR was 19.6 months.
Croatian: Nezavisno povjerenstvo za procjenu procijenilo je medijan trajanja odgovora na 19,6 mjeseci.
English: The patient should not take extra capsules to make up the missed dose.
Croatian: Bolesnici ne smiju uzeti dodatne kapsule kako bi nadoknadili propuštenu dozu.
English: Median DOR (CR+PR) (months)
Croatian: Medijan trajanja odgovora (CR+PR) (mjeseci)
English: The study enrolled patients who were 65 years of age or older or <65 years of age with coexisting medical conditions, reduced renal function as measured by creatinine clearance <70 mL/min, or presence of del17p/TP53 mutation.
Croatian: U ispitivanje su bili uključeni bolesnici u dobi od 65 i više godina ili oni mlađi od 65 godina koji su imali popratne bolesti, smanjenu bubrežnu funkciju (klirens kreatinina < 70 ml/min) ili prisutnost delecije 17p/mutacije TP53.
English: • allergic reaction, sometimes severe, that may include a swollen face, lip, mouth, tongue or throat, difficulty swallowing or breathing, itchy rash (hives)
Croatian: • alergijska reakcija, ponekad teška, koja može uključivati otečeno lice, usnu, usta, jezik ili grlo,
English: Co-administration of strong or moderate CYP3A4 inhibitors with IMBRUVICA may lead to increased ibrutinib exposure and consequently a higher risk for toxicity.
Croatian: Istodobna primjena snažnih ili umjerenih CYP3A4 inhibitora s lijekom IMBRUVICA može dovesti do povećane izloženosti ibrutinibu i posljedično većeg rizika za toksičnost.
English: Drug-drug interactions
Croatian: Interakcije lijekova
English: In both arms, patients received 1000 mg of obinutuzumab on Days 1, 8 and 15 of the first cycle, followed by treatment on the first day of 5 subsequent cycles (total of 6 cycles, 28 days each).
Croatian: Bolesnici iz obje skupine primili su 1000 mg obinutuzumaba 1., 8. i 15. dana prvog ciklusa liječenja, a zatim su ga primali prvoga dana svakog od sljedećih 5 ciklusa (ukupno šest 28-dnevnih ciklusa).
English: The median duration of treatment for CLL/SLL was 51 months (range, 0.2 to 98 months) with 70% and 52% of patients receiving treatment for more than 2 years and 4 years, respectively.
Croatian: Medijan trajanja liječenja za KLL/LMS iznosio je 51 mjesec (raspon, 0,2 do 98 mjeseci), pri čemu je 70% bolesnika liječenje primalo dulje od 2 godine, a njih 52% dulje od 4 godine.
English: Agents that may increase ibrutinib plasma concentrations Concomitant use of IMBRUVICA and medicinal products that strongly or moderately inhibit CYP3A4 can increase ibrutinib exposure and strong CYP3A4 inhibitors should be avoided.
Croatian: Lijekovi koji mogu povećati koncentraciju ibrutiniba u plazmi Istodobna primjena lijeka IMBRUVICA i lijekova koji snažno ili umjereno inhibiraju CYP3A4 može povećati izloženost ibrutinibu i snažni CYP3A4 inhibitori moraju se izbjegavati.
English: The most commonly occurring adverse reactions (≥20%) were diarrhoea, rash, haemorrhage (e.g., bruising), neutropenia, musculoskeletal pain, nausea, and thrombocytopenia.
Croatian: Nuspojave koje su se najčešće javljale (≥ 20%) bile su proljev, osip, krvarenje (npr. modrice), neutropenija, mišićno-koštana bol, mučnina i trombocitopenija.
English: Do not break or chew them.
Croatian: Nemojte ih lomiti ili žvakati.
English: There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).
Croatian: Ne postoje podaci za bolesnike s teškim oštećenjem bubrega ili za bolesnike na dijalizi (vidjeti dio 5.2).
English: ORR including PR with lymphocytosis d (%)
Croatian: ORR uključujući djelomični odgovor s limfocitozom (%)
English: Periodically monitor all patients clinically for cardiac arrhythmia.
Croatian: Sve bolesnike potrebno je periodički klinički pratiti zbog moguće pojave aritmije srca.
English: Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension.
Croatian: Prilikom primjene ibrutiniba prijavljeni su slučajevi cerebrovaskularnog inzulta, prolaznog ishemijskog napadaja i ishemijskog moždanog udara, uključujući smrtne slučajeve, sa i bez istodobne fibrilacije atrija i/ili hipertenzije.
English: sinus or throat (upper respiratory tract infection), or lung, or skin.
Croatian: Ovo može uključiti infekcije nosa, sinusa ili grla (infekcija gornjeg dišnog sustava), ili pluća, ili kože.
English: The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively.
Croatian: Medijan trajanja liječenja za MCL iznosio je 11 mjeseci (raspon, 0 do 87 mjeseci), pri čemu je 31% bolesnika liječenje primalo dulje od 2 godine, a njih 17% dulje od 4 godine.
English: Agents that may decrease ibrutinib plasma concentrations Administration of IMBRUVICA with inducers of CYP3A4 can decrease ibrutinib plasma concentrations.
Croatian: Lijekovi koji mogu smanjiti koncentraciju ibrutiniba u plazmi Primjena lijeka IMBRUVICA s induktorima CYP3A4 može smanjiti koncentracije ibrutiniba u plazmi.
English: All patients had a baseline ECOG performance status of 0 or 1.
Croatian: Svi bolesnici imali su ECOG funkcionalni status na početku 0 ili 1.
English: p<0.005 for OS.
Croatian: p < 0,005 za ukupno preživljenje.
English: IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).
Croatian: IMBRUVICA je u monoterapiji ili u kombinaciji s obinutuzumabom indicirana za liječenje odraslih bolesnika s prethodno neliječenom kroničnom limfocitnom leukemijom (KLL) (vidjeti dio 5.1).
English: In patients with baseline cytopenias, sustained hematologic improvement was: platelets 77.1% versus 42.9%; haemoglobin 84.3% versus 45.5% for ibrutinib and chlorambucil respectively.
Croatian: U bolesnika koji su na početku imali citopeniju, održano hematološko poboljšanje bilo je: trombociti 77,1% naspram 42,9%; hemoglobin 84,3% naspram 45,5% za ibrutinib odnosno klorambucil.
English: Table 9: Efficacy Results in patients with CLL (Study CLL3001)
Croatian: Tablica 9: Rezultati djelotvornosti u bolesnika s KLL-om (Ispitivanje CLL3001)
English: There are limited data on the effects of IMBRUVICA overdose.
Croatian: Podaci o učinku predoziranja lijekom IMBRUVICA su ograničeni.
English: Women of childbearing potential must use a highly effective method of contraception while taking IMBRUVICA (see section 4.6).
Croatian: Za vrijeme uzimanja lijeka IMBRUVICA, žene reproduktivne dobi moraju koristiti visoko učinkovitu metodu kontracepcije (vidjeti dio 4.6).
English: • Take the tablets orally (by mouth) with a glass of water.
Croatian: • Uzmite tablete kroz usta s čašom vode.
English: Each carton contains (30 film-coated tablets) 3 wallets.
Croatian: Svaka kutija sadrži (30 filmom obloženih tableta) 3 omota.
English: The 4-year PFS estimate was 73.9% in the IMBRUVICA arm and 15.5% in the chlorambucil arm, respectively.
Croatian: Procijenjeni 4-godišnji PFS iznosio je 73,9% u skupini liječenoj lijekom IMBRUVICA te 15,5% u onoj liječenoj klorambucilom.
English: Interstitial Lung Disease (ILD)
Croatian: Intersticijska bolest pluća (IBP)
English: Consider temporarily withholding IMBRUVICA.
Croatian: Razmotrite privremeni prekid primjene lijeka IMBRUVICA.
English: Febrile neutropenia Leukocytosis Lymphocytosis
Croatian: Febrilna neutropenija Leukocitoza
English: IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Croatian: IMBRUVICA je u monoterapiji ili u kombinaciji s bendamustinom i rituksimabom (BR) indicirana za liječenje odraslih bolesnika s KLL koji su prethodno primili najmanje jednu terapiju.
English: At baseline, 39.2% of patients had Rai Stage IV, 45.1% had bulky disease (≥5 cm), 35.3% had deletion 17p and 31.4% had deletion 11q.
Croatian: Na početku je 39,2% bolesnika imalo Rai stadij IV, 45,1% imalo je veliku tumorsku masu (≥ 5 cm), 35,3% imalo je deleciju 17p i 31,4% imalo je deleciju 11q.
English: Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each.
Croatian: Jedna kutija za 28 dana sadrži 28 filmom obloženih tableta u 2 kartonska omota, svaki s 14 filmom obloženih tableta.
English: Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA.
Croatian: Žene reproduktivne dobi moraju koristiti visoko učinkovitu metodu kontracepcije tijekom uzimanja lijeka IMBRUVICA i do tri mjeseca nakon završetka liječenja, kako bi izbjegle trudnoću tijekom liječenja lijekom IMBRUVICA.
English: IMBRUVICA was administered until disease progression or unacceptable toxicity.
Croatian: Lijek IMBRUVICA bio je primjenjivan do progresije bolesti ili do neprihvatljive toksičnosti.
English: In rats, moderate pancreatic acinar cell atrophy (considered adverse) was observed at doses of ≥100 mg/kg in male rats (AUC exposure margin of 2.6-fold) and not observed in females at doses up to 300 mg/kg/day (AUC exposure margin of 21.3-fold).
Croatian: U štakora je bila uočena umjerena atrofija acinusnih stanica gušterače (za koju se smatralo da je štetna) pri dozama od ≥ 100 mg/kg, u mužjaka štakora (granica AUC izloženosti od 2,6 puta), a nije uočena u ženki pri dozama do 300 mg/kg/dan (granica AUC izloženosti od 21,3 puta).