natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
Istodobna primjena ketokonazola, vrlo snažnog CYP3A4 inhibitora, u 18 zdravih ispitanika natašte, povećala je izloženost ibrutinibu (Cmax 29 puta i AUC 24 puta).
Very common Haemorrhage Bruising Hypertension 
Vrlo često Krvarenje* Modrice* Hipertenzija*
30 film-coated tablets 
10 filmom obloženih tableta
MARKETING AUTHORISATION NUMBER(S) EU/1/14/945/001 (90 hard capsules) EU/1/14/945/002 (120 hard capsules) 
EU/1/14/945/001 (90 tvrdih kapsula) EU/1/14/945/002 (120 tvrdih kapsula)
Agents that may have their plasma concentrations altered by ibrutinib Ibrutinib is a P-gp and breast cancer resistance protein (BCRP) inhibitor in vitro. 
Ibrutinib je inhibitor P-gp-a i proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP) in vitro.
Cerebrovascular accidents 
Cerebrovaskularni inzult
Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint 
Tablica 7: Rezultati djelotvornosti u bolesnika s KLL-om (Ispitivanje PCYC-1112-CA) Ishod
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. 
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.
Monitor patients for pulmonary symptoms indicative of ILD. 
Pratite bolesnike zbog moguće pojave plućnih simptoma koji upućuju na intersticijsku bolest pluća.
Median time to initial response, months (range) Median time to CR, months (range) 
Medijan vremena do inicijalnog odgovora, mjeseci (raspon)
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. 
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.
Rituximab was administered at a dose of 375 mg/m2 in the first cycle, 
Rituksimab je bio primijenjen u dozi od 375 mg/m dana u prvom ciklusu i 500 mg/m2 1. dana u 2.-6. ciklusu.
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. 
(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.
The Kaplan-Meier curve for PFS is shown in Figure 6. 
Kaplan-Meierova krivulja za preživljenje bez progresije bolesti (PFS) prikazana je na Slici 6.
Monitor patients for signs of IMBRUVICA toxicity and follow dose modification guidance as needed. 
Potrebno je pratiti bolesnike zbog moguće pojave znakova toksičnosti lijeka IMBRUVICA i prema potrebi slijediti smjernice za prilagodbu doze.
IMBRUVICA contains sodium 
IMBRUVICA sadrži laktozu
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. 
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.
Each hard capsule contains 140 mg of ibrutinib. 
Jedna tvrda kapsula sadrži 140 mg ibrutiniba.
The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments). 
Medijan vremena od dijagnoze bio je 74 mjeseca, i medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 11 liječenja).
Moderate CYP3A4 inhibitors 
Umjereni CYP3A4 inhibitori
Neoplasms benign and malignant (incl cysts and polyps) 
Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe)
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. 
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.
Includes multiple adverse reaction terms. 
* Uključuje više termina za nuspojavu.
INFORMATION IN BRAILLE Imbruvica 560 mg 
imbruvica 560 mg
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA. 
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.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE 
NALJEPNICA NA BOCI 140 MG KAPSULE
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)]). 
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)]).
Patients randomised to ofatumumab were censored when starting IMBRUVICA if applicable. 
Bolesnici randomizirani na ofatumumab nisu se uzeli u obzir ako su započinjali liječenje lijekom IMBRUVICA.
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). 
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).
Mild CYP3A4 inhibitors 
Slabi CYP3A4 inhibitori
INFORMATION IN BRAILLE Imbruvica 280 mg 
imbruvica 280 mg
Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side. 
Žutozelene do zelene okrugle (9 mm) tablete, s „ibr” ispisanim na jednoj strani i „140” na drugoj strani.
Tumour lysis syndrome Hyperuricaemia 
Sindrom lize tumora Hiperuricemija
The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian. 
Medijan dobi bio je 73 godine (raspon 65 do 90 godina), 63% su bili muškarci, i 91% su bili bijele rase.
The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments). 
Medijan vremena od dijagnoze bio je 91 mjesec, a medijan broja prethodnih liječenja bio je 2 (raspon: 1 do 13 liječenja).
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. 
Ako se toksičnost ponovno pojavi, dnevna doza se mora smanjiti za 140 mg.
Table 5: Efficacy results in Study PCYC-1130-CA 
Tablica 5: Rezultati djelotvornosti u ispitivanju PCYC-1130-CA
Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001 
Slika 1: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju MCL3001
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. 
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.
IMBRUVICA 140 mg hard capsules ibrutinib 
IMBRUVICA 140 mg tvrde kapsule ibrutinib
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). 
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.
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). 
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).
The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian. 
Medijan dobi bio je 64 godine (raspon, 31 do 86 godina), 66% bili su muškarci i 91% bili su bijele rase.
MCL dose modification after recovery CLL/WM dose modification after recovery 
Prilagodba doze nakon oporavka za limfom plaštenih stanica
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. 
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.
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. 
OS analiza pokazala je 57% statistički značajno smanjenje rizika od smrti za bolesnike u skupini liječenoj lijekom IMBRUVICA.
INFORMATION IN BRAILLE Imbruvica 420 mg 
imbruvica 420 mg
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets 
IMBRUVICA 140 mg filmom obložene tablete IMBRUVICA 280 mg filmom obložene tablete IMBRUVICA 420 mg filmom obložene tablete IMBRUVICA 560 mg filmom obložene tablete
Sepsis 
Sepsa*
Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 months Follow-up 
Slika 7: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1112-CA u završnoj analizi s 65-mjesečnim praćenjem
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)]. 
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)].
HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response 
HR = omjer hazarda; CI = interval pouzdanosti; ORR = ukupna stopa odgovora; OS = ukupno preživljenje; PFS = preživljenje bez progresije; PR = djelomični odgovor
The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian. 
Medijan dobi bio je 68 godina (raspon, 34; 88 godina), 74% bili su muškarci, a 87% bilo je bijele rase.
There have been reports of bleeding events in patients treated with IMBRUVICA, both with and without thrombocytopenia. 
U bolesnika koji su liječeni lijekom IMBRUVICA prijavljeni su događaji krvarenja, povezani s trombocitopenijom i bez nje.
The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment. 
U vrijeme završne analize, 133 (67,9%) od 196 ispitanika koji su prvobitno bili randomizirani za liječenje ofatumumabom prešlo je na liječenje ibrutinibom.
Tumour lysis syndrome has been reported with IMBRUVICA therapy. 
Uz terapiju s lijekom IMBRUVICA bio je prijavljen sindrom lize tumora.
Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. 
Bolesnici s velikom tumorskom masom prije liječenja imaju rizik za nastanak sindroma lize tumora.
Yellow-green to green round tablets (9 mm), debossed with “ibr” on one side and “140” on the other side. 
Žutozelene do zelene okrugle tablete (9 mm), s utisnutim „ibr” na jednoj strani i „140” na drugoj strani.
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib 
IMBRUVICA 140 mg filmom obložene tablete IMBRUVICA 280 mg filmom obložene tablete IMBRUVICA 420 mg filmom obložene tablete IMBRUVICA 560 mg filmom obložene tablete ibrutinib
The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments). 
Medijan vremena od dijagnoze bio je 6 godina, a medijan broja prethodnih liječenja bio je 2 (raspon, 1 do 11 liječenja).
Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up 
Slika 4: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1115-CA uz 48-mjesečno praćenje
Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles. 
Bolesnici (n=229) su bili randomizirani u omjeru 1:1 za primanje lijeka IMBRUVICA u dozi od 420 mg na dan do progresije bolesti ili pojave neprihvatljive toksičnosti ili klorambucila u dozi od 0,5 mg/kg 1. i 15. dana svakog 28-dnevnog ciklusa tijekom 6 ciklusa.
Table 11: Efficacy results in Study PCYC-1127-CA Endpoint 
Tablica 11: Rezultati djelotvornosti u ispitivanju PCYC-1127-CA
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib. 
IMBRUVICA 140 mg filmom obložene tablete: jedna tableta sadrži 140 mg ibrutiniba.
Cardiac arrhythmia 
Aritmija srca
The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian. 
Medijan dobi iznosio je 71 godinu (raspon: 40 do 87 godina), 64% ispitanika bili su muškarci, a 96% bijelci.
The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian. 
Medijan dobi bio je 68 godina (raspon: 40 do 84 godina), 77% bili su muškarci, a 92% bijele rase.
For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule). 
Za bolesnike s umjerenim oštećenjem jetre (Child-Pugh stadij B), preporučena doza je 140 mg na dan (jedna kapsula).
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules). 
Za bolesnike s blagim oštećenjem jetre (Child-Pugh stadij A), preporučena doza je 280 mg na dan (dvije kapsule).
Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria. 
International Working Group, IWG) za ne-Hodgkinov limfom (NHL).
For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily. 
Za bolesnike s umjerenim oštećenjem jetre (Child-Pugh stadij B), preporučena doza je 140 mg na dan.
Cases of hepatitis B reactivation have been reported in patients receiving IMBRUVICA. 
U ispitanika koji su uzimali lijek IMBRUVICA, zabilježeni su slučajevi reaktivacije hepatitisa B.
The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001). 
Sigurnost i djelotvornost lijeka IMBRUVICA u bolesnika u kojih je kronična limfocitna leukemija prethodno liječena bile su dalje procijenjene u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju faze 3 lijeka IMBRUVICA u kombinaciji s bendamustinom i rituksimabom (BR) naspram placeba + BR (Ispitivanje CLL3001).
CI=confidence interval; CR=complete response; HR=hazard ratio; MR=minor response; NE=not estimable; PR=partial response; R=Rituximab; TTnT=time to next treatment; VGPR=very good partial response IRC evaluated. 
CI = interval pouzdanosti; CR = potpuni odgovor; HR = omjer hazarda; MR = slabi odgovor; NP = ne može se procijeniti; PR = djelomični odgovor; R = rituksimab; VGPR = jako dobar djelomični odgovor Prema ocjeni IRC-a. p-vrijednost povezana sa stopom odgovora iznosila je < 0,0001.
The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian. 
Medijan dobi bio je 63 godine (raspon: 44 do 86 godina), 76% bili su muškarci, i 95% su bili bijele rase.
• infections of the urinary tract 
• infekcije mokraćnog sustava
Very common Arthralgia Muscle spasms Musculoskeletal pain 
Mišićni spazmi Mišićno-koštana bol*
At baseline, 58% of patients had at least one tumour ≥5 cm. Thirty-two percent of patients had deletion 17p (with 50% of patients having deletion 17p/TP53 mutation), 24% had 11q deletion, and 47% of patients had unmutated IGHV. 
Trideset i dva posto bolesnika imalo je deleciju 17p (50% njih imalo je deleciju 17p/mutaciju TP53), 24% imalo je deleciju 11q, dok je 47% bolesnika imalo nemutiran IGHV.
Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA) 
Tablica 8: PFS analiza bolesti u podskupinama (Ispitivanje PCYC-1112-CA) Omjer hazarda
The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian. 
Medijan dobi bio je 67 godina (raspon: 30 do 88 godina), 68% ih je bilo muškog spola i 90% ih je bilo bijele rase.
INFORMATION IN BRAILLE Imbruvica 140 mg 
imbruvica 140 mg
PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets 
28 filmom obloženih tableta 30 filmom obloženih tableta
• breaking of the nails 
• pucanje noktiju
Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate. 
Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 560 mg sadrži 112 mg laktoze hidrata.
IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib. 
IMBRUVICA 560 mg filmom obložene tablete: jedna tableta sadrži 560 mg ibrutiniba.
Table 4: Efficacy results in Study PCYC-1115-CA Endpoint 
Tablica 4: Rezultati djelotvornosti u ispitivanju PCYC-1115-CA Ishod
At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening. 
Na početku, 39% bolesnika imalo je veliku tumorsku masu (engl. bulky disease) (≥ 5 cm), 49% imalo je skor visokog rizika prema Pojednostavljenom internacionalnom prognostičkom indeksu za MCL (engl.
Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy 
Borgo S. Michele, 04100 Latina, Italija
IMBRUVICA 140 mg film-coated tablets 
IMBRUVICA 140 mg filmom obložene tablete
The recommended dose for the treatment of WM is 420 mg (three capsules) once daily. 
Preporučena doza lijeka IMBRUVICA je tri kapsule (420 mg) jedanput na dan.
Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side. 
Žute do narančaste duguljaste tablete (19 mm dužine i 8,1 mm širine), s „ibr” ispisanim na jednoj strani i „560” na drugoj strani.
IMBRUVICA 420 mg film-coated tablets 
IMBRUVICA 420 mg filmom obložene tablete
IMBRUVICA 560 mg film-coated tablets 
IMBRUVICA 560 mg filmom obložene tablete
Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2. 
Devedest i jedan posto bolesnika imalo je na početku ECOG funkcionalni status 0 ili 1, a 9% bolesnika imalo je ECOG funkcionalni status 2. Ispitivanje je uključivalo 269 bolesnika s KLL.
Uncommon Angioedema Panniculitis 
Manje često Angioedem Panikulitis*
IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib. 
IMBRUVICA 560 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 560 mg ibrutiniba.
Interstitial lung disease 
Intersticijska bolest pluća*
Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity. 
Bolesnici (n=150) su bili randomizirani u omjeru 1:1 za primanje lijeka IMBRUVICA u dozi od 420 mg na dan ili placeba u kombinaciji s rituksimabom, a liječenje se primjenjivalo do progresije bolesti ili pojave neprihvatljive toksičnosti.
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily. 
Za bolesnike s blagim oštećenjem jetre (Child-Pugh stadij A), preporučena doza je 280 mg na dan.
Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com 
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio 
Tablica 6: Analiza PFS-a u podskupinama (ispitivanje PCYC-1130-CA) N Omjer hazarda 95% CI
The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatment-naïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA). 
Sigurnost i djelotvornost lijeka IMBRUVICA kod WM-a dodatno su se ocjenjivale u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju faze 3 u kojem su prethodno neliječeni ili prethodno liječeni bolesnici s WM-om primali lijek IMBRUVICA u kombinaciji s rituksimabom ili placebo u kombinaciji s rituksimabom (PCYC-1127-CA).
NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated. 
NP = nije procjenjivo; HR = omjer hazarda; CI = interval pouzdanosti; ORR = ukupna stopa odgovora; PFS = preživljenje bez progresije procijenjeno prema IRC-u.
IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib. 
IMBRUVICA 420 mg filmom obložene tablete: jedna tableta sadrži 420 mg ibrutiniba.
PFS Median PFS (95% CI), (months) 
Medijan PFS-a (95% CI), (mjeseci)
Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA 
Slika 8: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1127-CA