FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time since diagnosis was 42 months, and median number of prior treatments was 3 (range: 1 to 5 treatments), including 35% with prior high-dose chemotherapy, 43% with prior bortezomib, 24% with prior lenalidomide, and 11% with prior autologous or allogeneic stem cell transplant.
Croatian: Medijan vremena od dijagnoze bio je 42 mjeseca, a medijan broja prethodnih liječenja bio je 3 (raspon: 1 do 5 liječenja), uključujući 35% s prethodnim liječenjem kemoterapijom visoke doze, 43% s prethodnim bortezomibom, 24% s prethodnim lenalidomidom, i 11% s prethodnom autolognom ili alogenom transplantacijom matičnih stanica.
English: At baseline, 65% of patients presented with CLL/SLL with high risk factors (del17p/TP53 mutation [18%], del11q [15%], or unmutated IGHV [54%]).
Croatian: Na početku ispitivanja 65% bolesnika imalo je KLL/LMS s faktorima visokog rizika (delecijom 17p/mutacijom TP53 [18%], delecijom 11q [15%] ili nemutiranim IGHV-om [54%]).
English: Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Croatian: U bolesnika koji imaju povećani rizik za oportunističke infekcije u obzir uzmite profilaksu sukladno standardnoj skrbi.
English: Second restart at 420 mg daily restart at 280 mg daily
Croatian: Druga započnite ponovno s 420 mg na dan započnite ponovno s 280 mg na dan
English: PFS Median (95% CI), months
Croatian: PFS Medijan (95% CI), mjeseci
English: 120 hard capsules
Croatian: 90 tvrdih kapsula 120 tvrdih kapsula
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Croatian: Janssen Pharmaceutica NV Turnhoutseweg 30
English: Simulations using fasted conditions suggested that the strong CYP3A4 inhibitor clarithromycin may increase the AUC of ibrutinib by a factor of 14.
Croatian: Simulacije u stanju natašte pokazale su da snažni CYP3A4 inhibitor klaritromicin može povećati AUC ibrutiniba 14 puta.
English: Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
Croatian: Po uvođenju liječenja kod otprilike tri četvrtine bolesnika s KLL-om liječenih lijekom IMBRUVICA bio je uočen reverzibilan porast broja limfocita (tj. ≥ 50% porast u odnosu na početnu vrijednost i apsolutni broj > 5000/μl), često udružen sa smanjenjem limfadenopatije.
English: Black iron oxide (E172) Propylene glycol (E1520)
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol (E1520)
English: Consequently the foetal NOAEL was 10 mg/kg/day (approximately 1.3 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6).
Croatian: Posljedično NOAEL za fetus bio je 10 mg/kg/dan (otprilike 1,3 puta AUC ibrutiniba pri dozi od 560 mg na dan) (vidjeti dio 4.6).
English: ORR OS
Croatian: OOR OS
English: A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
Croatian: U nekih bolesnika je uočen veliki porast broja limfocita u cirkulaciji (tj. > 400 000/μl).
English: Leukostasis
Croatian: Leukostaza
English: Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Croatian: Istodobna primjena rifampicina, snažnog induktora CYP3A4, u 18 zdravih ispitanika natašte, smanjila je izloženost ibrutinibu (Cmax za 92% i AUC za 90%).
English: No maximum tolerated dose was reached in the phase 1 study in which patients received up to 12.5 mg/kg/day (1,400 mg/day).
Croatian: U ispitivanju faze 1 u kojem su bolesnici primili do 12,5 mg/kg/dan (1400 mg/dan) nije postignuta maksimalna podnošljiva doza.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
Croatian: CI = interval pouzdanosti; HR = omjer hazarda; CR = potpuni odgovor; PR = djelomični odgovor.
English: CI=confidence interval; HR=hazard ratio; CR=complete response; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response IRC evaluated, median follow-up 18.4 months.
Croatian: CI = interval pouzdanosti; HR = omjer hazarda; CR = potpuni odgovor; ORR = ukupna stopa odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije; PR = djelomični odgovor procijenjeno prema IRC-u, medijan praćenja 18,4 mjeseci.
English: IMBRUVICA was administered orally at 420 mg once daily until disease progression or unacceptable toxicity.
Croatian: Lijek IMBRUVICA je bio primjenjivan peroralno u dozi od 420 mg jedanput dnevno do progresije bolesti ili neprihvatljive toksičnosti.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg (one capsule) for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Croatian: Ako korist nadvladava rizik, a snažni CYP3A4 inhibitor se mora uzimati, smanjite dozu lijeka IMBRUVICA na 140 mg (jedna kapsula) dok traje primjena inhibitora ili privremeno prekinite lijek IMBRUVICA (na 7 dana ili manje).
English: The median time since diagnosis was 43 months, and median number of prior treatments was 2 (range: 1 to 9 treatments), including 51% with prior high-dose chemotherapy, 18% with prior bortezomib, 5% with prior lenalidomide, and 24% with prior stem cell transplant.
Croatian: Medijan vremena od dijagnoze bio je 43 mjeseca i medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 9 liječenja), uključujući 51% s prethodnom kemoterapijom u visokoj dozi, 18% s prethodnim liječenjem bortezomibom, 5% s prethodnim liječenjem lenalidomidom i 24% s prethodnom transplantacijom matičnih stanica.
English: The recommended dose of IMBRUVICA is 560 mg once a day.
Croatian: Preporučena doza lijeka IMBRUVICA je 560 mg jedanput na dan.
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Croatian: Ako korist nadvladava rizik, a snažni CYP3A4 inhibitor se mora uzimati, smanjite dozu lijeka IMBRUVICA na 140 mg dok traje primjena inhibitora ili privremeno prekinite lijek IMBRUVICA (na 7 dana ili manje).
English: HR (95% CI) ORR
Croatian: HR (95% CI) OOR
English: The investigator-assessed ORR was 91.2% in the IMBRUVICA arm versus 36.8% in the chlorambucil arm.
Croatian: Ukupna stopa odgovora prema ocjeni ispitivača iznosila je 91,2% u skupini koja je primala lijek IMBRUVICA te 36,8% u onoj liječenoj klorambucilom.
English: The recommended dose of IMBRUVICA is four capsules (560 mg) once a day.
Croatian: Preporučena doza lijeka IMBRUVICA je četiri kapsule (560 mg) jedanput na dan.
English: Among previously treated patients, the median number of prior treatments was 2 (range, 1 to 6 treatments).
Croatian: Među prethodno liječenim bolesnicima medijan broja prethodnih terapija iznosio je 2 (raspon: 1 do 6 terapija).
English: Tumor flare in the form of IgM increase occurred in 8.0% of subjects in the IMBRUVICA+rituximab arm and 46.7% of subjects in the placebo+rituximab arm.
Croatian: IgM javilo se u 8,0% ispitanika koji su primali lijek IMBRUVICA plus rituksimab te u 46,7% onih koji su primali placebo plus rituksimab.
English: IMBRUVICA should not be used in children and adolescents.
Croatian: Djeca i adolescenti ne smiju uzimati lijek IMBRUVICA.
English: Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. A lower Cmax was observed in fasted healthy subjects administered a single 560 mg dose of ibrutinib after taking omeprazole at 40 mg once daily for 5 days (see section 5.2).
Croatian: Niži Cmax bio je zabilježen u zdravih ispitanika kojima je primijenjena jedna doza ibrutiniba od 560 mg natašte nakon uzimanja 40 mg omeprazola jedanput na dan tijekom 5 dana (vidjeti dio 5.2).
English: Toxicity occurrence
Croatian: Pojava toksičnosti
English: These may be signs and symptoms of stroke.
Croatian: To mogu biti znaci i simptomi moždanog udara.
English: • Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes.
Croatian: • kronična lifmocitna leukemija, vrsta raka koja zahvaća bijele krvne stanice koje se zovu limfociti, a zahvaća i limfne čvorove.
English: If a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg for the duration of the inhibitor use.
Croatian: Ako je indiciran umjereni CYP3A4 inhibitor (npr. flukonazol, eritromicin, amprenavir, aprepitant, atazanavir, ciprofloksacin, krizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron i dronedaron), smanjite dozu lijeka IMBRUVICA na 280 mg dok traje primjena inhibitora.
English: In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
Croatian: U bolesnika s malignim bolestima B-stanica koji uzimaju lijek IMBRUVICA s hranom, istodobna primjena CYP3A4 inhibitora eritromicina povisila je Cmax za 3,4 puta i AUC za 3,0 puta.
English: Very common Pneumonia Upper respiratory tract infection
Croatian: Vrlo često Pneumonija* Infekcija gornjeg dišnog sustava
English: Co-administration of grapefruit juice, containing CYP3A4 inhibitors, in eight healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by approximately 4- and 2-fold, respectively.
Croatian: Istodobna primjena soka od grejpfruta, koji sadrži CYP3A4 inhibitore, u osam zdravih ispitanika povisila je izloženost ibrutinibu (Cmax za oko 4 i AUC za oko 2 puta).
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek.
English: The treatment effect of ibrutinib in Study PCYC-1112-CA was consistent across high-risk patients with deletion 17p/TP53 mutation, deletion 11q, and/or unmutated IGHV.
Croatian: Učinak liječenja ibrutinibom u ispitivanju PCYC-1112-CA bio je dosljedan u svih visokorizičnih bolesnika s delecijom 17p/mutacijom TP53, delecijom 11q i/ili nemutiranim IGHV-om.
English: Co-administration of ketoconazole, a very strong CYP3A4 inhibitor, in 18 fasted healthy subjects, increased exposure (Cmax and AUC) of ibrutinib by 29- and 24-fold, respectively.
Croatian: Istodobna primjena ketokonazola, vrlo snažnog CYP3A4 inhibitora, u 18 zdravih ispitanika natašte, povećala je izloženost ibrutinibu (Cmax 29 puta i AUC 24 puta).
English: Very common Haemorrhage Bruising Hypertension
Croatian: Vrlo često Krvarenje* Modrice* Hipertenzija*
English: 30 film-coated tablets
Croatian: 10 filmom obloženih tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules)
Croatian: EU/1/14/945/001 (90 tvrdih kapsula) EU/1/14/945/002 (120 tvrdih kapsula)
English: Agents that may have their plasma concentrations altered by ibrutinib Ibrutinib is a P-gp and breast cancer resistance protein (BCRP) inhibitor in vitro.
Croatian: Ibrutinib je inhibitor P-gp-a i proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP) in vitro.
English: Cerebrovascular accidents
Croatian: Cerebrovaskularni inzult
English: Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Croatian: Tablica 7: Rezultati djelotvornosti u bolesnika s KLL-om (Ispitivanje PCYC-1112-CA) Ishod
English: Patients (n=578) were randomised 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with BR until disease progression, or unacceptable toxicity.
Croatian: Bolesnici (n = 578) su bili randomizirani 1:1 kako bi primili ili lijek IMBRUVICA 420 mg dnevno ili placebo u kombinaciji s BR do progresije bolesti ili neprihvatljive toksičnosti.
English: Monitor patients for pulmonary symptoms indicative of ILD.
Croatian: Pratite bolesnike zbog moguće pojave plućnih simptoma koji upućuju na intersticijsku bolest pluća.
English: Median time to initial response, months (range) Median time to CR, months (range)
Croatian: Medijan vremena do inicijalnog odgovora, mjeseci (raspon)
English: The treatment effect of ibrutinib in Study PCYC-1115-CA was consistent across high-risk patients with del17p/TP53 mutation, del11q, and/or unmutated IGHV.
Croatian: Učinak liječenja ibrutinibom u ispitivanju PCYC-1115-CA bio je dosljedan u svih visokorizičnih bolesnika s delecijom 17p/mutacijom TP53, delecijom 11q i/ili nemutiranim IGHV-om.
English: Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Croatian: Rituksimab je bio primijenjen u dozi od 375 mg/m dana u prvom ciklusu i 500 mg/m2 1. dana u 2.-6. ciklusu.
English: The effect of impaired liver function varied substantially between individuals, but on average a 2.7-, 8.2-, and 9.8-fold increase in ibrutinib exposure (AUClast) was observed in subjects with mild (n=6, Child-Pugh class A), moderate (n=10, Child-Pugh class B) and severe (n=8, Child-Pugh class C) hepatic impairment, respectively.
Croatian: (AUClast) od 2,7 puta u ispitanika s blagim (n = 6, Child-Pugh stadij A), 8,2 puta u ispitanika s umjerenim (n = 10, Child-Pugh stadij B) odnosno 9,8 puta u ispitanika s teškim (n = 8, Child-Pugh stadij C) oštećenjem jetre.
English: The Kaplan-Meier curve for PFS is shown in Figure 6.
Croatian: Kaplan-Meierova krivulja za preživljenje bez progresije bolesti (PFS) prikazana je na Slici 6.
English: CLL
Croatian: KLL
English: Monitor patients for signs of IMBRUVICA toxicity and follow dose modification guidance as needed.
Croatian: Potrebno je pratiti bolesnike zbog moguće pojave znakova toksičnosti lijeka IMBRUVICA i prema potrebi slijediti smjernice za prilagodbu doze.
English: IMBRUVICA contains sodium
Croatian: IMBRUVICA sadrži laktozu
English: CYP3A4 inhibitor (e.g., fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone and dronedarone) is indicated, reduce IMBRUVICA dose to 280 mg (two capsules) for the duration of the inhibitor use.
Croatian: Ako je indiciran umjereni CYP3A4 inhibitor (npr. flukonazol, eritromicin, amprenavir, aprepitant, atazanavir, ciprofloksacin, krizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodaron i dronedaron), smanjite dozu lijeka IMBRUVICA na 280 mg (dvije kapsule) dok traje primjena inhibitora.
English: Each hard capsule contains 140 mg of ibrutinib.
Croatian: Jedna tvrda kapsula sadrži 140 mg ibrutiniba.
English: The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Croatian: Medijan vremena od dijagnoze bio je 74 mjeseca, i medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 11 liječenja).
English: Moderate CYP3A4 inhibitors
Croatian: Umjereni CYP3A4 inhibitori
English: Neoplasms benign and malignant (incl cysts and polyps)
Croatian: Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe)
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Croatian: Preživljenje bez progresije bolesti (engl. progression free survival, PFS) prema procjeni IRC-a prema kriterijima IWCLL-a ukazalo je na 78% statistički značajno smanjenje rizika od smrti ili progresije bolesti za bolesnike u skupini liječenoj lijekom IMBRUVICA.
English: Includes multiple adverse reaction terms.
Croatian: * Uključuje više termina za nuspojavu.
English: INFORMATION IN BRAILLE Imbruvica 560 mg
Croatian: imbruvica 560 mg
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek IMBRUVICA.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Croatian: NALJEPNICA NA BOCI 140 MG KAPSULE
English: The median investigator-assessed PFS was not reached in the IMBRUVICA arm and was 15 months [95% CI (10.22, 19.35)] in the chlorambucil arm; (HR=0.14 [95% CI (0.09, 0.21)]).
Croatian: Medijan PFS-a prema ocjeni ispitivača nije dostignut u skupini liječenoj lijekom IMBRUVICA, dok je u onoj koja je primala klorambucil iznosio 15 mjeseci [95% CI (10,22; 19,35)]; (HR=0,14 [95% CI (0,09; 0,21)]).
English: Patients randomised to ofatumumab were censored when starting IMBRUVICA if applicable.
Croatian: Bolesnici randomizirani na ofatumumab nisu se uzeli u obzir ako su započinjali liječenje lijekom IMBRUVICA.
English: Patients (n=391) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or ofatumumab for up to 12 doses (300/2,000 mg).
Croatian: Bolesnici (n = 391) su bili randomizirani u omjeru 1:1 kako bi primili ili lijek IMBRUVICA u dozi od 420 mg dnevno do progresije bolesti ili neprihvatljive toksičnosti, ili ofatumumab do najviše 12 doza (300/2000 mg).
English: Mild CYP3A4 inhibitors
Croatian: Slabi CYP3A4 inhibitori
English: INFORMATION IN BRAILLE Imbruvica 280 mg
Croatian: imbruvica 280 mg
English: Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Croatian: Žutozelene do zelene okrugle (9 mm) tablete, s „ibr” ispisanim na jednoj strani i „140” na drugoj strani.
English: Tumour lysis syndrome Hyperuricaemia
Croatian: Sindrom lize tumora Hiperuricemija
English: The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Croatian: Medijan dobi bio je 73 godine (raspon 65 do 90 godina), 63% su bili muškarci, i 91% su bili bijele rase.
English: The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Croatian: Medijan vremena od dijagnoze bio je 91 mjesec, a medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 13 liječenja).
English: If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Croatian: Ako se toksičnost ponovno pojavi, dnevna doza se mora smanjiti za 140 mg.
English: Table 5: Efficacy results in Study PCYC-1130-CA
Croatian: Tablica 5: Rezultati djelotvornosti u ispitivanju PCYC-1130-CA
English: Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Croatian: Slika 1: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju MCL3001
English: The 2-year PFS rate estimates for the high-risk CLL/SLL population were 78.8% [95% CI (67.3, 86.7)] and 15.5% [95% CI (8.1, 25.2)] in the IMBRUVICA+obinutuzumab and chlorambucil+obinutuzumab arms, respectively.
Croatian: Procijenjena stopa 2-godišnjeg PFS-a za populaciju visokorizičnih bolesnika s KLL-om/LMS-om iznosila je 78,8% [95% CI (67,3; 86,7)] u skupini liječenoj lijekom IMBRUVICA u kombinaciji s obinutuzumabom te 15,5% [95% CI (8,1; 25,2)] u skupini koja je primala klorambucil plus obinutuzumab.
English: IMBRUVICA 140 mg hard capsules ibrutinib
Croatian: IMBRUVICA 140 mg tvrde kapsule ibrutinib
English: In pregnant rats, ibrutinib at a dose of 80 mg/kg/day was associated with increased post-implantation loss and increased visceral (heart and major vessels) malformations and skeletal variations with an exposure margin 14 times the AUC found in patients at a daily dose of 560 mg. At a dose of ≥40 mg/kg/day, ibrutinib was associated with decreased foetal weights (AUC ratio of ≥5.6 as compared to daily dose of 560 mg in patients).
Croatian: U skotnih štakora, ibrutinib pri dozi od 80 mg/kg/dan je bio povezan s povećanim postimplantacijskim gubitkom i povećanim visceralnim (srce i velike žile) malformacijama i promjenama kostura s granicom izloženosti 14 puta većom od AUC pronađenog u bolesnika pri dnevnoj dozi od 560 mg.
English: At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL <60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
Croatian: Na početku, 45% bolesnika imalo je uznapredovali klinički stadij (Rai stadij III ili IV), 35% bolesnika imalo je najmanje jedan tumor ≥ 5 cm, 39% imalo je anemiju na početku, 23% imalo je tromboctopeniju na početku, 65% imalo je povišen β2 mikroglobulin > 3500 µg/l, 47% imalo je CrCL < 60 ml/min, 20% bolesnika imalo je del11q, njih 6% imalo je deleciju 17p/mutaciju gena za tumorski protein 53 (TP53), dok je 44% bolesnika imalo nemutiran varijabilni dio teškog lanca imunoglobulina (engl. immunoglobulin heavy chain variable region, IGHV).
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Croatian: Medijan dobi bio je 64 godine (raspon, 31 do 86 godina), 66% bili su muškarci i 91% bili su bijele rase.
English: MCL dose modification after recovery CLL/WM dose modification after recovery
Croatian: Prilagodba doze nakon oporavka za limfom plaštenih stanica
English: Patients (n=269) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or chlorambucil at a starting dose of 0.5 mg/kg on days 1 and 15 of each 28-day cycle for a maximum of 12 cycles, with an allowance for intrapatient dose increases up to 0.8 mg/kg based on tolerability.
Croatian: Bolesnici (n = 269) su bili randomizirani u omjeru 1:1 u skupinu koja je primila ili lijek IMBRUVICA 420 mg dnevno do progresije bolesti ili neprihvatljive toksičnosti, ili klorambucil u početnoj dozi od 0,5 mg/kg, 1. i 15. dana svakog 28-dnevnog ciklusa do maksimalno 12 ciklusa, uz dopuštenje za porast doze u bolesnika do 0,8 mg/kg ovisno o podnošljivosti.
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Croatian: OS analiza pokazala je 57% statistički značajno smanjenje rizika od smrti za bolesnike u skupini liječenoj lijekom IMBRUVICA.
English: INFORMATION IN BRAILLE Imbruvica 420 mg
Croatian: imbruvica 420 mg
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
Croatian: IMBRUVICA 140 mg filmom obložene tablete IMBRUVICA 280 mg filmom obložene tablete IMBRUVICA 420 mg filmom obložene tablete IMBRUVICA 560 mg filmom obložene tablete
English: Sepsis
Croatian: Sepsa*
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 months Follow-up
Croatian: Slika 7: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1112-CA u završnoj analizi s 65-mjesečnim praćenjem
English: The median investigator-assessed PFS according to IWCLL criteria was 44.1 months [95% CI (38.47, 56.18)] in the IMBRUVICA arm and 8.1 months [95% CI (7.79, 8.25)] in the ofatumumab arm, respectively; HR=0.15 [95% CI (0.11, 0.20)].
Croatian: Medijan PFS-a prema ocjeni ispitivača na temelju kriterija IWCLL-a iznosio je 44,1 mjesec [95% CI (38,47; 56,18)] u skupini liječenoj lijekom IMBRUVICA te 8,1 mjesec [95% CI (7,79; 8,25)] u onoj liječenoj ofatumumabom; HR=0,15 [95% CI (0,11; 0,20)].
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Croatian: HR = omjer hazarda; CI = interval pouzdanosti; ORR = ukupna stopa odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije; PR = djelomični odgovor