natgillin/translations-raw huggingface dataset:
Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint 
Preglednica 7: Rezultati učinkovitosti pri bolnikih s KLL (študija PCYC-1112-CA) Cilj opazovanja
IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 
Zdravilo IMBRUVICA je kot samostojno zdravilo indicirano za zdravljenje odraslih bolnikov s ponovitvijo limfoma plaščnih celic (MCL - mantle cell lymphoma) ali z na zdravljenje neodzivno obliko te bolezni.
The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments). 
Mediana časa od postavitve diagnoze je bila 91 mesecev, mediano število predhodnih terapij je bilo 2 (od 1 do 13 terapij).
Not known Not known 
,a neznana pogostnost
The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments). 
Mediana časa od postavitve diagnoze je bila 74 mesecev, mediano število predhodnih terapij pa je bilo 2 (od 1 do 11 terapij).
There was a statistically significant sustained platelet or haemoglobin improvement in the ITT population in favor of ibrutinib versus chlorambucil. 
Pri ITT populaciji bolnikov je v prid ibrutinibu v primerjavi s klorambicilom prišlo do statistično značilnega dolgotrajnega izboljšanja v številu trombocitov ali koncentraciji hemoglobina.
At baseline, 53% of patients had bulky disease (≥5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening. 
Ob izhodišču na izbirnem (angl. screening) obisku je imelo 53% bolnikov bolezen z veliko tumorsko maso (≥ 5 cm), 21% jih je imelo ocenjeno visoko tveganje s poenostavljenim mednarodnim prognostičnim indeksom MIPI, pri 60% bolnikov se je bolezen razširila izven bezgavk in 54% bolnikov je zajela kostni mozeg.
Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side. 
Vijolične, podolgovate tablete (15 mm dolge in 7 mm široke) z vtisnjeno oznako “ibr” na eni in "280" na drugi strani.
p<0.005 for OS 
ofatumumab p<0,0001
Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women. 
Glede na ugotovitve pri živalih bi zdravilo IMBRUVICA pri uporabi med nosečnostjo lahko imelo škodljiv učinek na plod.
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. 
Bolniki (n=229) so bili v razmerju 1:1 randomizirani na prejemanje bodisi zdravila IMBRUVICA 420 mg na dan do napredovanja bolezni ali do nesprejemljive toksičnosti ali na prejemanje klorambucila v odmerku 0,5 mg/kg na 1. in 15. dan 28-dnevnega kroga zdravljenja, 6 krogov zdravljenja.
In patients who develop signs and/or symptoms of ventricular tachyarrhythmia, IMBRUVICA should be temporarily discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy. 
Pri bolnikih, pri katerih so se pojavili simptomi in/ali znaki ventrikularne tahiaritmije je treba zdravljenje z zdravilom IMBRUVICA začasno prekiniti.
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). 
V obeh skupinah so bolniki prejeli 1000 mg obinutuzumaba na 1., 8. in 15. dan prvega kroga zdravljenja in nato prvi dan v
HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response 
HR (hazard ratio) = razmerje ogroženosti, IZ = interval zaupanja, ORR (Overall Response Rate) = celokupni delež odgovora, OS (overall survival) = celokupno preživetje, PFS (Progression Free Survival) = preživetje brez napredovanja bolezni, PR (partial response) = delni odgovor
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 filmsko obložene tablete IMBRUVICA 280 mg filmsko obložene tablete IMBRUVICA 420 mg filmsko obložene tablete IMBRUVICA 560 mg filmsko obložene tablete
The updated Kaplan-Meier curve for PFS is shown in Figure 4. 
Dopolnjena Kaplan-Meierjeva krivulja PFS je prikazana na Sliki 4.
Number of deaths (%) HR (95% CI) 
HR (95% IZ) ORR (CR +PR) vrednost-p OS število smrti (%) HR (95% IZ)
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. 
Bolnike (n = 578) so randomizirali 1:1 na prejemanje 420 mg zdravila IMBRUVICA na dan ali placeba v kombinaciji z BR do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravila.
Consider alternative agents with less CYP3A4 induction. 
Razmisliti velja o uporabi drugih učinkovin, ki v manjši meri inducirajo CYP3A4.
Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone 
Jedro tablete brezvodni koloidni silicijev dioksid premrežen natrijev karmelozat laktoza monohidrat magnezijev stearat mikrokristalna celuloza povidon natrijev lavrilsulfat (E487)
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). 
Bolnike (n = 391) so randomizirali v razmerju 1:1 tako, da so prejemali bodisi 420 mg zdravila IMBRUVICA dnevno do napredovanja bolezni ali nesprejemljivega toksičnega delovanja zdravila, ali ofatumumab do največ 12 odmerkov (300/2000 mg).
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. 
Pri osmih zdravih prostovoljcih je sočasno uživanje soka grenivke, ki vsebuje zaviralce CYP3A4, povečalo izpostavljenost (Cmax in AUC) ibrutinibu za približno 4-krat oziroma 2-krat.
- Keep this leaflet. 
Razprite zgibanko.
Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up 
Slika 4: Kaplan-Meierjeva krivulja PFS (ITT populacija) v študiji PCYC-1115-CA z 48-mesečnim spremljanjem
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). 
Če mora bolnik jemati katerega od močnih zaviralcev CYP3A4, in koristi sočasne uporabe presegajo tveganja, je treba odmerek zdravila IMBRUVICA med sočasno uporabo zaviralcev zmanjšati na 140 mg (na eno kapsulo) ali pa začasno (za 7 dni ali manj) prekiniti zdravljenje z zdravilom IMBRUVICA.
The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian. 
Mediana starost bolnikov je bila 71 let (od 40 do 87 let), 64% jih je bilo moškega spola in 96% je bilo belcev.
The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian. 
Mediana starost bolnikov je bila 73 let (od 65 do 90 let), 63% jih je bilo moškega spola, 91% je bilo belcev.
The overall response rate per IRC observed in the monotherapy arm was 87% (0% CR, 29% VGPR, 42% PR, 16% MR). 
Celokupni delež odgovora po oceni komisije IRC je bil v skupini z monoterapijo 87% (0% s popolnim odgovorom, 29% z zelo dobrim delnim odgovorom, 42% z delnim odgovorom in 16% z minimalnim odgovorom).
Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side. 
Rumeno-zelene do zelene, podolgovate tablete (17,5 mm dolge in 7,4 mm široke) z vtisnjeno oznako “ibr” na eni in "420" na drugi 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 filmsko obložene tablete IMBRUVICA 280 mg filmsko obložene tablete IMBRUVICA 420 mg filmsko obložene tablete IMBRUVICA 560 mg filmsko obložene tablete ibrutinib
The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian. 
Mediana starost bolnikov je bila 68 let (razpon, 34; 88 let), 74% jih je bilo moškega spola in 87% je bilo belcev.
Administer supportive care including hydration and/or cytoreduction as indicated. 
Bolnike je treba skrbno spremljati in po potrebi uvesti podporne ukrepe vključno s hidracijo in/ali citoredukcijo.
Ninety patients randomised to placebo+BR crossed over to receive IMBRUVICA following IRC confirmed progression. 
Ko je IRC potrdila napredovanje bolezni, je 90 bolnikov, ki so bili randomizirani na placebo + BR prešlo na zdravljenje z zdravilom IMBRUVICA.
Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side. 
Rumene do oranžne, podolgovate tablete (19 mm dolge in 8,1 mm široke) z vtisnjeno oznako “ibr” na eni in "560" na drugi strani.
Lymphocytosis was not observed in patients with WM treated with IMBRUVICA. 
Pri bolnikih z WM, zdravljenih z zdravilom IMBRUVICA, limfocitoze niso opazili.
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. 
V 6-tedenski študiji pri transgenih miših (Tg.rasH2), ki so peroralno prejemale ibrutinib v odmerku do 2000 mg/kg/dan in meji izpostavljenosti, ki je bila 23-kratnik (samci) do 27-kratnik (samice) vrednosti AUC ibrutiniba pri ljudeh, ki so prejemali dnevni odmerek 560 mg, ibrutinib ni bil karcinogen.
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. 
Če se znaki toksičnega učinkovanja ponovijo, je treba dnevni odmerek zmanjšati za 140 mg.
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). 
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih, predhodno zdravljenih za KLL so ocenjevali tudi v randomizirani, multicentrični, dvojno slepi študiji faze 3, kjer so primerjali zdravilo IMBRUVICA v kombinaciji z BR in kombinacijo placebo + BR (študija CLL3001).
In vitro platelet aggregation 
Agregacija trombocitov in vitro
HDPE bottles with a child-resistant polypropylene closure. 
Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko.
Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2. 
Triindevetdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 7% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian. 
Njihova mediana starost je bila 68 let (od 40 do 84 let), 77% jih je bilo moškega spola in 92% je bilo belcev.
Number of events (%) Median (95% CI), months 
PFS število dogodkov (%) mediana (95% IZ), meseci ni dosežena
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily. 
Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg na dan.
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules). 
Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg (dve kapsuli) na dan.
Table 11: Efficacy results in Study PCYC-1127-CA Endpoint 
Preglednica 11: Rezultati učinkovitosti v študiji PCYC-1127-CA
At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status. 
(hemoglobin ≤11 g/dl ali 6,8 mmol/l), mutacije MYD88 L265P pa so bile prisotne pri 77% bolnikov in odsotne pri 13% bolnikov, medtem ko pri 9% bolnikih mutacijskega statusa ni bila mogoče oceniti.
IMBRUVICA contains sodium 
Zdravilo IMBRUVICA vsebuje natrij
CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached 
IZ = interval zaupanja, CR (complete response) = popolni odgovor, DOR (duration of response) = trajanje odgovora, ND = ni dosežen
Not reached HR=0.203 [95% CI: 0.150, 0.276] 
PFS mediana (95% IZ), meseci ni dosežena HR = 0,203 [95% IZ: 0,150; 0,276]
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). 
Če mora bolnik jemati katerega od močnih zaviralcev CYP3A4, in koristi sočasne uporabe presegajo tveganja, je treba odmerek zdravila IMBRUVICA med sočasno uporabo zaviralcev zmanjšati na 140 mg ali pa začasno (za 7 dni ali manj) prekiniti zdravljenje z zdravilom IMBRUVICA.
• Do not breast-feed while you are taking this medicine. 
- V času jemanja tega zdravila ne smete dojiti.
Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001 
Slika 1: Kaplan-Meierjeva krivulja PFS (populacija z namenom zdravljenja; (ITT-Intention To Treat Population) v študiji MCL3001
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib. 
IMBRUVICA 140 mg filmsko obložene tablete: Ena tableta vsebuje 140 mg ibrutiniba.
• If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. 
Če ste pozabili vzeti zdravilo IMBRUVICA - Če ste pozabili vzeti odmerek, ga lahko vzamete čimprej istega dne, naslednjega dne pa spet začnete z odmerjanjem po običajnem razporedu.
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. 
Bolniki (n=150) so bili v razmerju 1:1 randomizirani na prejemanje bodisi zdravila IMBRUVICA 420 mg na dan ali placeba v kombinaciji z rituksimabom do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravil.
VGPR (%) 
PFS (%)
• Tell your doctor immediately if you become pregnant. 
- Če zanosite, takoj obvestite zdravnika.
The response rate per IRC observed in the monotherapy arm was 71% (0% CR, 29% VGPR, 42% PR). 
Po oceni komisije IRC je bil delež odgovora v skupini z monoterapijo 71% (0% s popolnim odgovorom, 29% z zelo dobrim delnim odgovorom in 42% z delnim odgovorom).
The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian. 
Mediana starost bolnikov je bila 64 let (od 31 do 86 let), 66% jih je bilo moškega spola in 91% je bilo belcev.
The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments). 
Mediana časa od postavitve diagnoze je bila 6 let, mediano število predhodnih terapij je bilo 2 (od 1 do 11 terapij).
Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies. 
Pri bolnikih z okvaro ledvic niso izvajali posebnih študij, so pa bolnike z blago oziroma zmerno okvaro ledvic zdravili v okviru kliničnih študij zdravila IMBRUVICA.
• Take the tablets orally (by mouth) with a glass of water. 
Jemanje tega zdravila - Tablete zaužijte peroralno s kozarcem vode.
HOW TO TAKE IMBRUVICA 
Kako jemati zdravilo IMBRUVICA
How to take IMBRUVICA 
KAKO JEMATI ZDRAVILO IMBRUVICA
All subjects 
vsi preiskovanci
Do not open, break or chew them. 
Kapsul se ne sme odpirati, drobiti ali žvečiti.
The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab. 
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih s KLL/SLL brez predhodnega zdravljenja so ocenjevali tudi v randomizirani, multicentrični, odprti študiji faze 3 (študiji PCYC-1130-CA) z zdravilom IMBRUVICA v kombinaciji z obinutuzumabom v primerjavi s klorambucilom v kombinaciji z obinutuzumabom.
IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib. 
IMBRUVICA 560 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 560 mg ibrutiniba.
Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation. 
Pri sočasni uporabi ibrutiniba z drugimi agonisti agregacije trombocitov ibrutinib ni pomembno zaviral agregacije trombocitov.
Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2. 
Enainosemdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 19% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine. 
Zdravnik bo pregledoval vašo krvno sliko pred zdravljenjem ali med njim.
Strong CYP3A4 inhibitors 
Močni zaviralci CYP3A4
Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate. 
Pomožne snovi z znanim učinkom Ena 560 mg filmsko obložena tableta vsebuje 112 mg laktoze (v obliki monohidrata)
Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate. 
Pomožne snovi z znanim učinkom Ena 420 mg filmsko obložena tableta vsebuje 84 mg laktoze (v obliki monohidrata)
Moderate CYP3A4 inhibitors 
Zmerni zaviralci CYP3A4
IMBRUVICA 420 mg film-coated tablets 
IMBRUVICA 420 mg filmsko obložene tablete
CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response. 
IZ = interval zaupanja, HR (hazard ratio) = razmerje ogroženosti, CR (complete response) = popolni odgovor, ORR
Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2. 
Enaindevetdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 9% pa ECOG 2.
What IMBRUVICA is 
Kaj je zdravilo IMBRUVICA
NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated. 
NE (not estimable) = ocena ni mogoča, HR (hazard ratio) = razmerje ogroženosti, IZ = interval zaupanja, ORR (Overall Response Rate) = celokupni delež odgovora, PFS (Progression Free Survival) = preživetje brez napredovanja bolezni ocenjeno s strani IRC
The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily. 
MCL Priporočeni odmerek za zdravljenje MCL je 560 mg (štiri kapsule) enkrat na dan.
Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections. 
Pri bolnikih s povečanim tveganjem za oportunistične okužbe razmislite o standardnih ukrepih za njihovo preprečevanje.
Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy. 
Pri uporabi ibrutiniba ob predhodni ali sočasni uporabi imunosupresivnega zdravljenja so poročali o progresivni multifokalni levkoencefalopatiji (PML), vključno s smrtnimi primeri.
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). 
Varnost in učinkovitost zdravila IMBRUVICA pri WM so ocenjevali tudi pri bolnikih, ki predhodno še niso bili oziroma so že bili predhodno zdravljeni za WM, in sicer v randomizirani, multicentrični, dvojno slepi študiji faze 3 z zdravilom IMBRUVICA v kombinaciji z rituksimabom v primerjavi z uporabo placeba v kombinaciji z rituksimabom (študija PCYC-1127-CA).
IMBRUVICA 560 mg film-coated tablets 
IMBRUVICA 560 mg filmsko obložene tablete
Therefore, no precautions are necessary in patients with different CYP2D6 genotypes. 
Kaže, da je encim CYP2D6 v zelo majhni meri vpleten v presnovo ibrutiniba, zato pri bolnikih z različnimi genotipi encima CYP2D6 ni potrebna posebna previdnost pri odmerjanju zdravila.
Hazard Ratio 
Stadij Rai
IMBRUVICA 140 mg hard capsules ibrutinib 
IMBRUVICA 140 mg kapsule ibrutinib
The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian. 
Mediana starost bolnikov je bila 67 let (od 30 do 88 let), 68% jih je bilo moškega spola, 90% je bilo belcev.
No specific studies have been conducted to date in subjects with impaired renal function. 
Pri bolnikih z zmanjšanim delovanjem ledvic do zdaj niso izvajali nobenih specifičnih študij.
The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian. 
Njihova mediana starost je bila 63 let (od 44 do 86 let), 76% jih je bilo moškega spola in 95% je bilo belcev.
A hepatic impairment trial was performed in non-cancer subjects administered a single dose of 140 mg of medicinal product under fasting conditions. 
V študiji uporabe zdravila pri neonkoloških bolnikih z okvaro jeter, so bolniki na tešče prejeli enkratni, 140 mg odmerek zdravila.
PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets 
28 filmsko obloženih tablet 30 filmsko obloženih tablet
Table 4: Efficacy results in Study PCYC-1115-CA Endpoint 
Preglednica 4: Rezultati učinkovitosti v študiji PCYC-1115-CA Cilji opazovanja
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. 
V času pregleda končne analize je skupno 133 preiskovancev (67,9%) od 196 tistih, ki so bili sprva randomizirani v skupino z ofatumumabom, kasneje prejemalo ibrutinib v okviru navzkrižnega zdravljenja.
IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib. 
IMBRUVICA 560 mg filmsko obložene tablete: Ena tableta vsebuje 560 mg ibrutiniba
Very common Arthralgia Muscle spasms Musculoskeletal pain 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti artralgija mišični krči mišičnoskeletne bolečine*
IMBRUVICA 280 mg film-coated tablets 
IMBRUVICA 280 mg filmsko obložene tablete
Transient ischaemic attack Ischaemic stroke a, # 
prehodni ishemični napad ishemična možganska kap a, #
Cases of leukostasis have been reported in patients treated with IMBRUVICA. 
Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o primerih levkostaze.
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. 
IZ = interval zaupanja; CR (complete response) = popolni odgovor; HR (hazard ratio) = razmerje ogroženosti; MR (minor response) = minimalni odgovor; NE (not estimable) = ocena ni mogoča; PR (partial response) = delni odgovor; R =rituksimab; TTnT (time to next treatment) = čas do naslednjega zdravljenja; VGPR (very good partial response) = zelo dober delni odgovor ocenjeno s strani IRC vrednost p v povezavi z deležem odgovora je bila <0,0001 opredeljeno kot zvišanje za ≥2 g/dl nad izhodiščno koncentracijo ne glede na vrednost izhodiščne koncentracije ali kot zvišanje na >11 g/dl z izboljšanjem za ≥0,5 g/dl, če je bila izhodiščna koncentracija ≤11 g/dl.
IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib. 
IMBRUVICA 280 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 280 mg ibrutiniba.
IMBRUVICA 140 mg film-coated tablets 
IMBRUVICA 140 mg filmsko obložene tablete