natgillin/translations-raw huggingface dataset:
Median time to initial response, months (range) Median time to CR, months (range) 
mediana časa do začetnega odgovora, meseci (razpon) mediana časa do popolnega odgovora, meseci (razpon)
The dihydrodiol metabolite and other metabolites are P-gp substrates. 
Dihidrodiolni presnovek in drugi presnovki so substrati P-glikoproteina.
Ibrutinib may also inhibit BCRP in the liver and increase the exposure of medicinal products that undergo BCRP-mediated hepatic efflux, such as rosuvastatin. 
Ibrutinib lahko zavira tudi BCRP v jetrih in zveča izpostavljenost zdravilom, katerih izločanje skozi jetra je povezano z BCRP, kot je rosuvastatin.
The dihydrodiol metabolite of ibrutinib is a weak inhibitor toward CYP2B6, CYP2C8, CYP2C9, and CYP2D6. 
Dihidrodiolni presnovek ibrutiniba je šibek zaviralec encimov CYP2B6, CYP2C8, CYP2C9 in CYP2D6.
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. 
Da bi zmanjšali možnost medsebojnega delovanja v prebavilih, je treba substrate P-glikoproteina ali BCRP, ki imajo ozko peroralno terapevtsko okno, kot sta digoksin ali metotreksat, jemati najmanj 6 ur pred odmerjanjem zdravila IMBRUVICA oziroma najmanj 6 ur po njem.
Film-coat 
Filmska obloga
Patients with congenital bleeding diathesis have not been studied. 
Bolnikov s prirojeno hemoragično diatezo niso preučevali.
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. 
Izgled zdravila IMBRUVICA in vsebina pakiranja Zdravilo IMBRUVICA so bele, neprozorne trde kapsule s črno oznako "ibr 140 mg" na eni strani.
IMBRUVICA therapy should be withheld for any new onset or worsening grade ≥3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities. 
Zdravljenje z zdravilom IMBRUVICA je treba prekiniti pri pojavu nehematološke toksičnosti stopnje 3 ali več ali pri poslabšanju že prej prisotnih znakov hematološke toksičnosti na stopnjo 3 ali več, pri nevtropeniji stopnje 3 s pridruženo okužbo ali zvišanjem telesne temperature ali pri znakih hematološke toksičnosti stopnje 4.
PFS Median PFS (95% CI), (months) 
PFS mediana PFS (95% IZ), (meseci)
Ibrutinib forms a covalent bond with a cysteine residue (Cys-481) in the BTK active site, leading to sustained inhibition of BTK enzymatic activity. 
Ibrutinib tvori kovalentno vez s cisteinskim ostankom (Cys-481) na aktivnem mestu BTK, kar povzroči dolgotrajno zaviranje aktivnosti tega encima.
In both disease types, lymphocytosis typically occurs during the first month of IMBRUVICA therapy and typically resolves within a median of 8.0 weeks in patients with MCL and 14 weeks in patients with CLL. 
Pri obeh vrstah bolezni se limfocitoza običajno pojavi v prvem mesecu zdravljenja z zdravilom IMBRUVICA in praviloma izzveni v mediano 8,0 tedna pri bolnikih z limfomom plaščnih celic in v 14 tednih pri bolnikih s kronično limfocitno levkemijo.
IMBRUVICA should not be used during pregnancy. 
Zdravila IMBRUVICA se ne sme jemati med nosečnostjo.
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4 (CYP3A4). 
Ibrutinib primarno presnavlja encim 3A4 (CYP3A4) citokromoma P450.
ORR including PR with lymphocytosis d (%) 
ORR, ki vključuje delni odgovor z limfocitozo d (%)
Ibrutinib has a pH dependent solubility, with lower solubility at higher pH. 
Topnost ibrutiniba je odvisna od pH in je pri višjem pH manjša.
IMBRUVICA with food 
Zdravilo IMBRUVICA skupaj s hrano
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. 
O primerih atrijske fibrilacije in atrijske undulacije so poročali zlasti pri bolnikih z dejavniki tveganja za bolezni srca, hipertenzijo, z akutnimi okužbami in z atrijsko fibrilacijo v anamnezi.
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. 
Rezultati študij in vitro kažejo, da je ibrutinib šibek reverzibilni zaviralec encimov CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4 v črevesju (v jetrih pa ne) ter ne kaže klinično pomembnega, od časa odvisnega zaviranja CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
Once the symptoms of the toxicity have resolved to grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose. 
Ko se simptomi toksičnega delovanja zmanjšajo na stopnjo 1 ali povsem izzvenijo (ko bolnik okreva), se lahko zdravilo IMBRUVICA ponovno uvede (v začetnem odmerku).
14.6 (10.4, NE) HR=0.43 [95% CI: 0.32, 0.58] 
14,6 (10,4; NE) HR = 0,43 [95% IZ: 0,32; 0,58]
Table 9: Efficacy Results in patients with CLL (Study CLL3001) 
Preglednica 9: Rezultati učinkovitosti pri bolnikih s KLL (študija CLL3001)
Ibrutinib is rapidly absorbed after oral administration with a median Tmax of 1 to 2 hours. 
Ibrutinib se po peroralnem odmerjanju hitro absorbira, pri čemer je mediana časa do najvišje koncentracije (Tmax) 1 do 2 uri.
The investigator-assessed ORR was 91.2% in the IMBRUVICA arm versus 36.8% in the chlorambucil arm. 
ORR po oceni raziskovalca je bil v skupini z zdravilom IMBRUVICA 91,2% v primerjavi s 36,8% v skupini s klorambucilom.
As no clinical data are available on this interaction, it cannot be excluded that ibrutinib could inhibit intestinal P-gp and BCRP after a therapeutic dose. 
Kliničnih podatkov o tem medsebojnem delovanju ni, zato ni mogoče izključiti možnosti, da bi ibrutinib pri terapevtskih odmerkih zaviral P-glikoprotein in BCRP v črevesju.
All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated. 
Vsi bolniki so v kliničnih študijah prejemali zdravilo IMBRUVICA, dokler so ga dobro prenašali ali do napredovanja bolezni.
Population pharmacokinetics indicated that age does not significantly influence ibrutinib clearance from the circulation. 
Populacijska farmakokinetika kaže, da starost ne vpliva bistveno na izločanje ibrutiniba iz krvnega obtoka.
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. 
V primeru dvoma je treba bolnika napotiti k nevrologu in razmisliti o nadaljnih ustreznih diagnostičnih metodah za ugotavljanje PML, vključno s slikanjem z magnetno resonanco (MRI), po možnosti s kontrastom, določanjem prisotnosti DNK virusa JC v cerebrospinalni tekočini in ponovno nevrološko oceno.
Ibrutinib is a potent, small-molecule inhibitor of Bruton's tyrosine kinase (BTK). 
Ibrutinib je majhna molekula z močnim zaviralnim delovanjem na Brutonovo tirozinsko kinazo (BTK).
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). 
Na začetku zdravljenja so bile mediane serumske koncentracije IgM 3,5 g/dl, 60% bolnikov je bilo anemičnih (hemoglobin ≤ 11 g/dl ali 6,8 mmol/l).
These include minor bleeding events such as contusion, epistaxis, and petechiae; and major bleeding events, some fatal, including gastrointestinal bleeding, intracranial haemorrhage, and haematuria. 
To vključuje manjše hemoragične dogodke, kot so podplutbe, krvavitev iz nosu in petehije, ter večje krvavitve (nekatere so bile smrtne), vključno z gastrointestinalno in intrakranialno krvavitvijo ter hematurijo.
Paediatric population No pharmacokinetic studies were performed with IMBRUVICA in patients under 18 years of age. 
Pri bolnikih, ki so stari manj kot 18 let, niso izvedli nobene farmakokinetične študije z zdravilom IMBRUVICA.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake "Uporabno do" oziroma "EXP".
Cryptococcal infections Pneumocystis infections Aspergillus infections Hepatitis B reactivation 
občasni kriptokokna okužba* pnevmocistična okužba* okužba z aspergilusom* reaktivacija hepatitisa B
In a hepatic impairment study, data showed an increase in ibrutinib exposure (see section 5.2). 
Podatki iz študij uporabe zdravila pri bolnikih z okvaro jeter kažejo povečano izpostavljenost ibrutinibu (glejte poglavje 5.2).
No specific dose adjustment is required for elderly patients (aged ≥65 years). 
Starejši Pri starejših bolnikih (starih 65 let ali več) posebno prilagajanje odmerjanja ni potrebno.
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. 
Pri zdravih teščih osebah, ki so prejele enkratni 560 mg odmerek ibrutiniba po jemanju 40 mg omeprazola enkrat na dan, 5 dni, v primerjavi s tistimi, ki so prejeli samo ibrutinib, je bilo razmerje geometrijskih sredin (90% IZ) 83% (68-102%), 92% (78-110%), in 38% (26-53%) za AUC0-24, AUCzadnja, oziroma Cmax.
Intolerance to excipients 
Intoleranca na pomožne snovi
Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid depletion in rats and dogs with a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day in both species. 
Ugotovili so, da ibrutinib pri podganah in psih povzroča gastrointestinalne učinke (mehko blato/drisko in/ali vnetje) in pomanjkanje limfocitov (limfocitno deplecijo); koncentracija brez opaznega škodljivega učinka (NOAEL - No Observed Adverse Effect Level) je bila 30 mg/kg/dan pri obeh vrstah živali.
• Waldenström's macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes. 
- Waldenstromova makroglobulinemija (WM), to je vrsta raka, ki prizadene bele krvne celice (limfocite).
IMBRUVICA may make you bleed more easily. 
Zdravilo IMBRUVICA lahko poveča možnost krvavitve.
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). 
Rituksimab so jim odmerjali enkrat na teden v odmerku 375 mg/m2 4 zaporedne tedne (v tednih 1 do 4) in nato v drugem krogu odmerjanja rituksimaba enkrat na teden 4 zaporedne tedne (v tednih 17 do 20).
Each 28 day carton contains 28 film-coated tablets in 2 cardboard wallets of 14 film-coated tablets each. 
Ena škatla z 28-dnevnim pakiranjem vsebuje 28 filmsko obloženih tablet v 2 kartonskih zgibankah, v katerih je v vsaki po 14 filmsko obloženih tablet.
The patient should not take extra tablets to make up the missed dose. 
Bolnik naj ne jemlje dodatnih tablet, da bi nadomestil pozabljeni odmerek.
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. 
Glede na povprečno izpostavljenost (AUC) pri kliničnem odmerku 560 mg/dan je bilo razmerje AUC pri NOAEL 2,6 oziroma 21 pri podganjih samcih oziroma samicah in 0,4 oziroma 1,8 pri pasjih samcih oziroma samicah.
Patients should be monitored for fever, neutropenia and infections and appropriate anti-infective therapy should be instituted as indicated. 
Bolnike je treba spremljati glede morebitnega pojava zvišane telesne temperature, nevtropenije in okužbe ter po potrebi uvesti ustrezno antimikrobno zdravljenje.
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. 
Zdravilo IMBRUVICA je namenjeno bolnikom s še nezdravljeno KLL oziroma bolnikom, pri katerih se je bolezen ponovila ali niso odgovorili na zdravljenje.
Do not get pregnant while you are taking this medicine. 
Nosečnost in dojenje Pazite, da ne boste zanosili v času jemanja tega zdravila.
Avoid concomitant use of strong or moderate CYP3A4 inducers (e.g., carbamazepine, rifampicin, phenytoin). 
Izogibati se je treba sočasni uporabi močnih ali zmernih induktorjev CYP3A (na primer karbamazepina, rifampicina, fenitoina).
High risk (del17p/TP53/del11q/unmutated IGHV) Yes 
Povečano tveganje (delecija 17p/mutacija TP53/delecija 11q/nemutiran gen za IGHV) Da ne
The patient should not take extra capsules to make up the missed dose. 
Bolnik naj ne jemlje dodatnih kapsul, da bi nadomestil pozabljeni odmerek.
Chlorambucil N=133 
klorambucil N = 133
If a CYP3A4 inducer must be used, closely monitor patients for signs of IMBRUVICA lack of efficacy. 
Če je potrebna sočasna uporaba z induktorji CYP3A4, je treba bolnike skrbno spremljati glede znakov pomanjkanja učinkovitosti.
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. 
Pri nekaterih bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o utrujenosti, omotičnosti in asteniji, kar je treba upoštevati pri presoji bolnikove sposobnosti za vožnjo in upravljanje strojev.
HR (95% CI) 
HR (95% IZ)
Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria. 
Tumorski odgovor so ocenjevali po popravljenih kriterijih mednarodne delovne skupine (IWG - International Working Group) za ne-Hodgkinove limfome.
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. 
Na osnovi podatkov in vitro je ibrutinib šibek reverzibilni zaviralec CYP3A4 v prebavilih in lahko zveča izpostavljenost substratom CYP3A4, občutljivim na metabolizem CYP3A v črevesju.
Race There are insufficient data to evaluate the potential effect of race on ibrutinib pharmacokinetics. 
Rasa Za oceno morebitnega vpliva rase na farmakokinetiko ibrutiniba ni dovolj podatkov.
The capsules should be swallowed whole with water and should not be opened, broken, or chewed. 
- Kapsule pogoltnite cele, ne smete jih odpirati, drobiti ali žvečiti.
Patients with CLL who received at least one prior therapy Single agent 
Bolniki s KLL, ki so prej prejeli vsaj eno vrsto zdravljenja Samostojno zdravilo
Median follow-up time on study=9 months 
Mediano trajanje spremljanja bolnikov v študiji je bilo 9 mesecev.
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. 
Ob izhodišču je imelo 39,2% bolnikov stadij IV po Rai-u, 45,1% jih je imelo bolezen z veliko tumorsko maso (≥ 5 cm), 35,3% jih je imelo delecijo 17p in 31,4% jih je imelo delecijo 11q.
White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink. 
Bela neprosojna 22 mm dolga trda kapsula s črno oznako "ibr 140 mg".
Ibrutinib has minimal renal clearance; urinary excretion of metabolites is <10% of the dose. 
Ibrutinib se le v majhni meri izloča skozi ledvice; izločanje presnovkov z urinom predstavlja manj kot 10% danega odmerka.
If a dose is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. 
Če bolnik izpusti odmerek, ga lahko vzame čimprej istega dne, naslednjega dne pa spet začne z odmerjanjem po običajnem razporedu.
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. 
Podatke o učinkovitosti je dodatno ovrednotila neodvisna komisija za pregled podatkov (IRCIndependent Review Committee) in ugotovila, da je ORR znašal 69%, pri čemer je bilo bolnikov s popolnim odgovorom 21%, bolnikov z delnim odgovorom pa 48%.
A second reduction of dose by 140 mg may be considered as needed. 
Po potrebi se lahko odmerek ponovno zmanjša za 140 mg.
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. 
Zdravilo IMBRUVICA je kot samostojno zdravilo ali v kombinaciji z bendamustinom in rituksimabom (BR) indicirano za zdravljenje odraslih bolnikov s KLL, ki so predhodno prejeli vsaj eno vrsto zdravljenja.
At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q. 
Ob izhodišču je imelo 56% bolnikov najmanj en tumor velikosti ≥ 5 cm, 26% bolnikov je imelo prisotno delecijo 11q.
With a median follow-up time on study of 65 months in Study PCYC-1112-CA, an 85% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm. 
Z medianim trajanjem spremljanja bolnikov v študiji 65 mesecev so v študiji PCYC-1112-CA ugotavljali 85-odstotno zmanjšanje tveganja za smrt ali napredovanje bolezni po oceni raziskovalca pri bolnikih v skupini z zdravilom IMBRUVICA.
Severe cardiac disease Patients with severe cardiovascular disease were excluded from IMBRUVICA clinical studies. 
Bolniki s hudimi kardiovaskularnimi boleznimi niso bili vključeni v klinične študije zdravila IMBRUVICA.
Population pharmacokinetics data indicated that body weight (range: 41-146 kg; mean [SD]: 83 [19 kg]) had a negligible effect on ibrutinib clearance. 
Podatki populacijske farmakokinetike so pokazali, da je vpliv telesne mase (v razponu od 41 do 146 kg s povprečjem 83 kg in standardno deviacijo 19 kg) na očistek ibrutiniba zanemarljiv.
Repeat CT scans required to confirm response. 
Po podatkih IRC; za potrditev odgovora je bilo potrebno ponovno CT slikanje.
The median time since diagnosis was 52.6 months (treatmentnaïve patients=6.5 months and previously treated patients=94.3 months). 
Mediana časa od postavitve diagnoze je bila 52,6 meseca (pri predhodno nezdravljenih bolnikih 6,5 meseca in pri predhodno zdravljenih bolnikih 94,3 meseca).
If patients have positive hepatitis B serology, a liver disease expert should be consulted before the start of treatment and the patient should be monitored and managed following local medical standards to prevent hepatitis B reactivation. 
Pri bolnikih s pozitivnim izvidom presejalnega testa za okužbo s HBV se priporoča posvet s specialistom za zdravljenje hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B se je treba pred uvedbo zdravljenja posvetovati s strokovnjakom za obolenja jeter, bolnika pa spremljati in zdraviti skladno z lokalnimi smernicami za preprečevanje reaktivacije hepatitisa B.
There are limited data on the effects of IMBRUVICA overdose. 
O učinkih prevelikega odmerjanja zdravila IMBRUVICA je zelo malo podatkov.
Table 2: ORR and DOR in patients with relapsed or refractory MCL (Study PCYC-1104-CA) 
Preglednica 2: ORR in DOR pri bolnikih s ponovitvijo oziroma neodzivno obliko MCL (študija PCYC-1104-CA)
Toxicity occurrence 
Pojav toksičnega delovanja
Study PCYC-1127-CA had a separate monotherapy arm of 31 patients with previously treated WM who failed prior rituximab-containing therapy and received single agent IMBRUVICA. 
V študiji PCYC-1127-CA so oblikovali tudi posebno skupino z monoterapijo, v kateri je bilo 31 bolnikov, ki so imeli WM in so bili predhodno zdravljeni, pri čemer predhodno zdravljenje, ki je vključevalo rituksimab, ni bilo uspešno, zato so ti bolniki prejemali zdravilo IMBRUVICA samostojno.
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. 
Biokemična pot B-celičnega antigenskega receptorja je vpletena v patogenezo številnih malignih bolezni celic B, vključno z limfomom plaščnih celic, difuznim velikoceličnim limfomom B (DLBCL - diffuse large B-cell lymphoma), folikularnim limfomom in kronično limfocitno levkemijo.
No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance). 
Pri bolnikih z blago oziroma zmerno okvaro ledvic (z očistkom kreatinina več kot 30 ml/min) prilagajanje odmerjanja ni potrebno.
The most commonly occurring adverse reactions (≥20%) were diarrhoea, rash, haemorrhage (e.g., bruising), neutropenia, musculoskeletal pain, nausea, and thrombocytopenia. 
Najpogostejši (≥ 20%) neželeni učinki so bili diareja, izpuščaj, krvavitve (podplutbe), nevtropenija, mišičnoskeletna bolečina, navzea in trombocitopenija.
Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio 
Preglednica 6: Analiza podatkov PFS po podskupinah (študija PCYC-1130-CA) N Hazard Ratio
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). 
Pri podganah so opažali zmerno atrofijo acinarnih celic trebušne slinavke (kot neželeni učinek) pri odmerkih ≥ 100 mg/kg pri samcih (pri meji izpostavljenosti, ki je bila 2,6-kratnik AUC), niso pa je opazili pri podganjih samicah pri odmerkih do 300 mg/kg/dan (pri meji izpostavljenosti, ki je bila 21,3-kratnik AUC).
This is because IMBRUVICA may affect the way some other medicines work. 
Zdravilo IMBRUVICA namreč lahko vpliva na delovanje nekaterih drugih zdravil, pa tudi druga zdravila lahko vplivajo na delovanje zdravila IMBRUVICA.
Population pharmacokinetics data indicated that gender does not significantly influence ibrutinib clearance from the circulation. 
Populacijska farmakokinetika kaže, da spol ne vpliva bistveno na izločanje ibrutiniba iz krvnega obtoka.
CI=confidence interval; DOR=duration of response; NR=not reached; MR=minor response; PR=partial response; VGPR=very good partial response; ORR=MR+PR+VGPR Median follow-up time on study=14.8 months 
IZ = interval zaupanja, ND = ni dosežen; DOR (duration of response) = trajanje odgovora, MR = minimalni odgovor; PR = delni odgovor; VGPR = zelo dober delni odgovor; ORR = MR+PR+VGPR Mediano trajanje spremljanja bolnikov v študiji je bilo 14,8 meseca.
This effect has also been observed in about one third of patients with relapsed or refractory MCL treated with IMBRUVICA. 
Ta učinek so opazili tudi pri približno eni tretjini bolnikov s ponovitvijo oziroma z neodzivno obliko limfoma plaščnih celic, ki so prejemali zdravilo IMBRUVICA.
Progression-free survival (PFS) was assessed by IRC according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria. 
Podatke o preživetju brez napredovanja bolezni (PFS -.Progression Free Survival) je ocenjevala IRC po popravljenih kriterijih mednarodne delovne skupine (IWG) za ne-Hodgkinove limfome (NHLnon-Hodgkin's lymphoma).
Dose adjustments Moderate and strong CYP3A4 inhibitors increase the exposure of ibrutinib (see sections 4.4 and 4.5). 
Pri sočasni uporabi zmerni in močni zaviralci CYP3A4 povečajo izpostavljenost ibrutinibu (glejte poglavji 4.4 in 4.5).
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. 
Po mediani trajanja spremljanja 16,4 meseca je bil ORR (ki ga je ocenjevala neodvisna komisija za pregled podatkov) pri 51 bolnikih s ponovitvijo ali neodzivno obliko bolezni 64,7% (95% IZ: 50,1%; 77,6%).
Agents that may decrease ibrutinib plasma concentrations Administration of IMBRUVICA with inducers of CYP3A4 can decrease ibrutinib plasma concentrations. 
Zdravila, ki lahko zmanjšajo koncentracijo ibrutiniba v plazmi Sočasna uporaba zdravila IMBRUVICA z induktorji CYP3A4 lahko zmanjša koncentracijo ibrutiniba v plazmi.
Monitor complete blood counts monthly. 
Celotno krvno sliko je treba določati enkrat mesečno.
Responses to IMBRUVICA are shown in Table 2. 
Odgovori na zdravilo IMBRUVICA so prikazani v Preglednici 2.
Efficacy results for Study MCL3001 are shown in Table 3 and the Kaplan-Meier curve for PFS in Figure 1. 
Rezultati učinkovitosti za študijo MCL3001 so prikazani v Preglednici 3, Slika 1 pa prikazuje Kaplan-Meierjevo krivuljo za PFS.