natgillin/translations-raw huggingface dataset:
In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken. 
Če se atrijska fibrilacija pojavi med zdravljenjem z zdravilom IMBRUVICA, je potrebno temeljito oceniti tveganje za trombembolične bolezni.
If the benefit outweighs the risk and a strong or moderate CYP3A4 inducer must be used, monitor patient closely for lack of efficacy (see sections 4.3 and 4.4). 
Če je potrebna uporaba močnega ali zmernega induktorja CYP3A4 in pričakovana korist presega morebitno tveganje, je treba bolnika skrbno spremljati glede znakov pomanjkanja učinkovitosti (glejte poglavji 4.3 in 4.4).
Simulations using fasted conditions suggested that the mild CYP3A4 inhibitors azithromycin and fluvoxamine may increase the AUC of ibrutinib by <2-fold. 
Simulacije v stanju na tešče kažejo, da šibka zaviralca CYP3A4 azitromicin in fluvoksamin lahko povečata AUC ibrutiniba za < 2-krat.
The long-term safety data over 5 years from 1178 patients (treatment-naïve CLL/SLL n = 162, relapsed/refractory CLL/SLL n = 646, and relapsed/refractory MCL n = 370) treated with IMBRUVICA were analysed. 
Podatke o varnosti pri dolgotrajni uporabi v obdobju 5 let so analizirali pri 1178 bolnikih (še nezdravljenih za kronično limfocitno levkemijo (KLL)/drobnoceličnim limfocitnim limfomom (SLLsmall lymphocytic lymphoma), n=162, bolnikih s ponovitvijo/na zdravljenje neodzivno KLL/SLL n=646 oziroma bolnikih s ponovitvijo/na zdravljenje neodzivnim MCL, n=370), ki so prejemali zdravilo IMBRUVICA.
A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients. 
Pri nekaterih bolnikih so opazili velik porast števila cirkulirajočih limfocitov (na primer na > 400.000/mikroliter).
The 4-year PFS estimate was 73.9% in the IMBRUVICA arm and 15.5% in the chlorambucil arm, respectively. 
Ocenjena stopnja 4-letnega preživetja brez napredovanja bolezni je bila 73,9% v skupini z zdravilom IMBRUVICA in 15,5% v skupini s klorambucilom.
Ibrutinib is metabolised primarily by CYP3A4 to produce a dihydrodiol metabolite with an inhibitory activity towards BTK approximately 15 times lower than that of ibrutinib. 
Ibrutinib se presnavlja predvsem z encimom CYP3A4/5, pri čemer nastane dihidrodiolni presnovek, ki ima v primerjavi z ibrutinibom približno 15-krat šibkejši zaviralni učinek na Brutonovo tirozinsko kinazo.
IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). 
Zdravilo IMBRUVICA je kot samostojno zdravilo ali v kombinaciji z obinutuzumabom indicirano za zdravljenje odraslih bolnikov s predhodno nezdravljeno kronično limfocitno levkemijo (KLL) (glejte poglavje 5.1).
Agents that may have their plasma concentrations altered by ibrutinib Ibrutinib is a P-gp and breast cancer resistance protein (BCRP) inhibitor in vitro. 
Zdravila, pri katerih ibrutinib lahko vpliva na plazemsko koncentracijo In vitro ibrutinib zavira P-glikoprotein in protein pri odpornosti za raka dojke (BCRP-breast cancer resistance protein).
Patients randomised to ofatumumab were censored when starting IMBRUVICA if applicable. 
Podatki bolnikov, ki so bili randomizirani v skupino z ofatumumabom, so bili cenzurirani, ko so bolniki začeli jemati zdravilo IMBRUVICA, če so ga začeli jemati.
Grade 3 or 4 infusion-related reactions were observed in 1% of patients treated with IMBRUVICA+rituximab and 16% of patients treated with placebo+rituximab. 
Infuzijske reakcije stopnje 3 ali 4 so opazili pri 1% bolnikov, ki so prejemali zdravilo IMBRUVICA in rituksimab, in pri 16% bolnikov, ki so prejemali placebo in rituksimab.
HR=0.434 [95% CI: 0.238; 0.789] HR=0.387 [95% CI: 0.216; 0.695] 
HR = 0,434 [95% IZ: 0,238; 0,789] HR = 0,387 [95% IZ: 0,216 0,695]
Monitor patients for the appearance of non-melanoma skin cancer. 
Med zdravljenjem je treba bolnike spremljati glede morebitnega pojava nemelanomskega kožnega raka.
There is no information about the safety of IMBRUVICA in pregnant women. 
O varnosti pri uporabi zdravila IMBRUVICA pri nosečnicah nimamo na voljo nobenih podatkov.
Each 30 day carton contains 30 film-coated tablets in 3 cardboard wallets of 10 film-coated tablets each. 
Ena škatla s 30-dnevnim pakiranjem vsebuje 30 filmsko obloženih tablet v 3 kartonskih zgibankah, v katerih je v vsaki po 10 filmsko obloženih tablet.
With a median follow-up time on study of 48 months in Study PCYC-1115-CA and its extension study, an 86% 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 48 mesecev so v študiji PCYC-1115-CA in podaljšanju te študije po oceni raziskovalca ugotovili 86-odstotno zmanjšanje tveganja za smrt ali napredovanje bolezni pri bolnikih v skupini z zdravilom IMBRUVICA.
The safety and efficacy of IMBRUVICA were demonstrated in a randomised phase 3, open-label, multicenter study including 280 patients with MCL who received at least one prior therapy (Study MCL3001). 
Varnost in učinkovitost zdravila IMBRUVICA so dokazali v multicentrični, randomizirani, odprti, klinični študiji faze 3, v katero je bilo vključenih 280 bolnikov z MCL, ki so predhodno prejeli vsaj eno vrsto zdravljenja (študija MCL3001).
Infections and infestations Very common Pneumonia Upper respiratory tract infection Skin infection 
Infekcijske in parazitske bolezni zelo pogosti pljučnica* okužba zgornjih dihal okužba kože*
Agents that may increase ibrutinib plasma concentrations Concomitant use of IMBRUVICA and medicinal products that strongly or moderately inhibit CYP3A4 can increase ibrutinib exposure and strong CYP3A4 inhibitors should be avoided. 
Učinkovine, ki lahko zvečajo koncentracijo ibrutiniba v plazmi Sočasna uporaba zdravila IMBRUVICA in zdravil, ki močno ali zmerno zavirajo CYP3A4, lahko poveča izpostavljenost ibrutinibu, zato se je treba uporabi močnih zaviralcev CYP3A4 izogibati.
Unchanged ibrutinib accounted for approximately 1% of the radiolabeled excretion product in faeces and none in urine. 
Količina nespremenjenega ibrutiniba je znašala približno 1% radioaktivno označene učinkovine, ki se je izločila z blatom, medtem ko v urinu nespremenjenega ibrutiniba niso prestregli.
The recommended dose for the treatment of WM is 420 mg once daily. 
Priporočeni odmerek za zdravljenje WM je 420 mg enkrat na dan.
Ibrutinib caused malformations in rabbits at a dose of 15 mg/kg/day (approximately 2.0 times the exposure (AUC) in patients with MCL administered ibrutinib 560 mg daily and 2.8 times the exposure in patients with CLL or WM receiving ibrutinib dose 420 mg per day). 
Ibrutinib je povzročil malformacije pri kuncih v odmerku 15 mg/kg/dan (približno 2,0-kratna izpostavljenost (AUC) pri bolnikih z MCL, ki so prejemali 560 mg ibrutiniba na dan in 2,8-kratna izpostavljenost pri bolnikih s KLL ali WM, ki so prejemali 420 mg ibrutiniba na dan).
Breast-feeding should be discontinued during treatment with IMBRUVICA. 
Med zdravljenjem z zdravilom IMBRUVICA je treba prenehati z dojenjem.
The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia. 
Najpogostejši (≥ 5%,) neželeni učinki stopnje 3/4 so bili nevtropenija, pljučnica in trombocitopenija.
Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 10 film-coated tablets in a cardboard wallet. 
Polivinilklorid (PVC), laminiran s polikloro- trifluoroetilenom (PCTFE) in aluminijasto pretisno plastjo z 10 filmsko obloženimi tabletami v kartonski zgibanki.
It is not recommended to administer IMBRUVICA to patients with severe hepatic impairment (Child-Pugh class C). 
Uporaba zdravila IMBRUVICA pri bolnikih s hudo okvaro jeter (razreda C po Child-Pughu) ni priporočljiva.
On the contrary, co-administration of CYP3A4 inducers may lead to decreased IMBRUVICA exposure and consequently a risk for lack of efficacy. 
Pri sočasni uporabi z induktorji CYP3A4 lahko pride do zmanjšane izpostavljenosti zdravilu IMBRUVICA in do tveganja za pomanjkanje učinkovitosti.
Del17p 
Vsi preiskovanci Del17P
No dose adjustment is required in combination with mild inhibitors. 
V kombinaciji s šibkimi zaviralci prilagajanje odmerjanja ni potrebno.
See package leaflet for further information. 
Za dodatne informacije glejte priloženo navodilo.
The median duration of treatment for CLL/SLL was 51 months (range, 0.2 to 98 months) with 70% and 52% of patients receiving treatment for more than 2 years and 4 years, respectively. 
Mediano trajanje zdravljenja pri KLL/SLL je bilo 51 mesecev (od 0,2 meseca do 98 mesecev), pri tem je 70% bolnikov prejemalo zdravljenje več kot 2 leti, 52% pa več kot 4 leta.
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). 
Pri brejih podganah je ibrutinib v odmerku 80 mg/kg/dan povečal število smrti zarodka po vgnezditvi in število visceralnih malformacij (na srcu in velikih žilah) ter skeletnih variacij pri meji izpostavljenosti, ki je bila 14-kratnik vrednosti AUC pri bolnikih, ki so prejemali dnevni odmerek 560 mg. Ibrutinib je povzročal zmanjšano telesno maso ploda pri odmerkih ≥ 40 mg/kg/dan (kar pomeni ≥ 5,6-kratno AUC v primerjavi z odmerjanjem 560 mg dnevno pri bolnikih).
8.1 months HR=0.215 [95% CI: 0.146; 0.317] 
8,1 meseca HR = 0,215 [95% IZ: 0,146; 0,317]
Polyvinyl chloride (PVC) laminated with polychlorotrifluoroethylene (PCTFE)/aluminium blister of 14 film-coated tablets in a cardboard wallet. 
Polivinilklorid (PVC), laminiran s polikloro- trifluoroetilenom (PCTFE) in aluminijasto pretisno plastjo s 14 filmsko obloženimi tabletami v kartonski zgibanki.
The treatment effect of ibrutinib was consistent across the high-risk CLL/SLL population (del17p/TP53 mutation, del11q, or unmutated IGHV), with a PFS HR of 0.15 [95% CI (0.09, 0.27)], as shown in Table 6. 
Učinek zdravljenja z ibrutinibom je bil enoten v vseh skupinah bolnikov s KLL/SLL s povečanim tveganjem (z delecijo 17p/mutacijo TP53, delecijo 11q ali z nemutiranim genom za IGHV), in sicer je bilo razmerje ogroženosti za PFS 0,15 [95-odstotni IZ (0,09; 0,27)], kot je prikazano v Preglednici 6.
Any grade infusion-related reactions were observed in 25% of patients treated with IMBRUVICA+obinutuzumab and 58% of patients treated with chlorambucil+obinutuzumab. 
Infuzijske reakcije katere koli stopnje so opazili pri 25% bolnikov, ki so prejemali zdravilo IMBRUVICA in obinutuzumab, ter pri 58% bolnikov, ki so prejemali klorambucil in obinutuzumab.
Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. 
Tveganje za pojav sindroma razpada tumorja je večje pri bolnikih z večjo maso tumorja pred začetkom zdravljenja.
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. 
Do prehodnega zagona rakave bolezni v obliki zvišanja IgM je prišlo pri 8,0% preiskovancev v skupini z zdravilom IMBRUVICA in rituksimabom ter pri 46,7% preiskovancev v skupini s placebom in rituksimabom.
• Chronic lymphocytic leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes. 
- Kronična limfocitna levkemija (KLL), to je vrsta raka, ki prizadene bele krvne celice (limfocite), prizadene pa tudi bezgavke.
The median age was 68 years (range: 37 to 82 years), median time since diagnosis was 80 months, and median number of prior treatments was 4 (range: 1 to 12 treatments), including 92.2% with a prior nucleoside analog, 98.0% with prior rituximab, 86.3% with a prior alkylator, 39.2% with prior bendamustine and 19.6% with prior ofatumumab. 
Mediana starost bolnikov je bila 68 let (od 37 do 82 let), mediana časa od postavitve diagnoze je bila 80 mesecev, mediano število predhodnih terapij pa je bilo 4 (od 1 do 12 terapij), kar vključuje 92,2% bolnikov s predhodno uporabo nukleozidnih analogov, 98,0% bolnikov s predhodno uporabo rituksimaba, 86,3% bolnikov s predhodno uporabo alkilirajočih citostatikov, 39,2% bolnikov s predhodno uporabo bendamustina in 19,6% bolnikov s predhodno upotrabo ofatumumaba.
Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is 420 mg once a day. 
Kronična limfocitna levkemija (KLL)/Waldenstromova makroglobulinemija (WM) Priporočeni odmerek zdravila IMBRUVICA je (420 mg enkrat na dan.
Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving IMBRUVICA, to avoid becoming pregnant while being treated with IMBRUVICA. 
Ženske v rodni dobi morajo uporabljati zelo učinkovito metodo kontracepcije v času jemanja zdravila IMBRUVICA in še tri mesece po zaključku zdravljenja z njim, da ne bi prišlo do zanositve v času uporabe zdravila IMBRUVICA.
Efficacy results were also assessed by an IRC demonstrating an ORR of 83%, with a 11% VGPR rate and a 51% PR rate. 
Podatke o učinkovitosti je ovrednotila (IRC in ugotovila, da je ORR znašal 83%, pri čemer je bilo bolnikov z VGPR 11%, bolnikov z delnim odgovorom pa 51%.
Hazard ratio based on non-stratified analysis 
Razmerje ogroženosti temelji na nestratificirani analizi.
Monitor patient closely for toxicity and follow dose modification guidance as needed. 
Bolnike je treba skrbno spremljati glede toksičnega delovanja zdravila in po potrebi upoštevati smernice za prilagajanje odmerka.
Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is three capsules (420 mg) once a day. 
Kronična limfocitna levkemija (KLL)/Waldenstromova makroglobulinemija (WM) Priporočeni odmerek zdravila IMBRUVICA je tri kapsule (420 mg) enkrat na dan.
In pregnant rabbits, ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss. 
Pri brejih kunčjih samicah so ibrutinib v odmerku 15 mg/kg/dan ali več povezovali z malformacijami skeleta (fuzija prsnice), v odmerku 45 mg/kg/dan pa s povečano izgubo zarodkov po ugnezdenju.
Regularly monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust antihypertensive medication throughout treatment with IMBRUVICA as appropriate. 
Bolnikom, ki prejemajo zdravilo IMBRUVICA, je treba med celotnim potekom zdravljenja redno meriti krvni tlak in jim po potrebi uvesti ali prilagoditi odmerjanje antihipertenzivnih zdravil.
Cases of invasive fungal infections, including cases of Aspergillosis, Cryptococcosis and Pneumocystis jiroveci infections have been reported following the use of ibrutinib. 
Po uporabi ibrutiniba so poročali so o primerih invazivnih glivičnih okužb, vključno s primeri aspergiloze, kriptokokoze in okužbe s Pneumocystis jiroveci.
Preparations containing St. John's Wort are contraindicated during treatment with IMBRUVICA, as efficacy may be reduced. 
Med zdravljenjem z zdravilom IMBRUVICA je uporaba rastlinskih pripravkov s šentjanževko kontraindicirana, ker se lahko zmanjša učinkovitost zdravila.
No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (Human Equivalent Dose [HED] 16 mg/kg/day) (see section 5.3). 
Niso opazili učinkov na plodnost ali sposobnost razmnoževanja pri podganjih samcih ali samicah, ki so prejemali odmerke do največ 100 mg/kg/dan (odmerek, ekvivalenten odmerku 16 mg/kg/dan pri ljudeh) (glejte poglavje 5.3).
IMBRUVICA should not be used in children and adolescents. 
Zdravila IMBRUVICA se ne sme uporabljati pri otrocih in mladostnikih, ker v teh starostnih skupinah njegova uporaba ni raziskana.
Patients were randomised 1:1 to receive either IMBRUVICA orally at 560 mg once daily for 21 days or temsirolimus intravenously at 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21-day cycle. 
Bolnike so randomizirali 1:1 na prejemanje 560 mg zdravila IMBRUVICA enkrat na dan, 21 dni oziroma 175 mg temsirolimusa intravensko na 1., 8. 15. dan v prvem krogu zdravljenja, nato pa 75 mg na 1., 8. 15. dan v vsakem naslednjem 21-dnevnem krogu zdravljenja.
IMBRUVICA was administered until disease progression or unacceptable toxicity. 
Zdravilo IMBRUVICA so prejemali do napredovanja bolezni oziroma do nesprejemljivega toksičnega delovanja zdravila.
The steady state AUC observed in patients at 560 mg is (mean ± standard deviation) 953 ± 705 ng h/mL. 
Pri bolnikih, ki so prejemali odmerke 560 mg, so v stanju dinamičnega ravnovesja izmerili AUC 953 ± 705 ng h/ml (povprečje ± standardna deviacija).
Capsule content Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487) 
Vsebina kapsule premrežen natrijev karmelozat magnezijev stearat mikrokristalna celuloza natrijev lavrilsulfat (E487)
Stop taking IMBRUVICA and tell a doctor straight away if you notice any of the following side effects: itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat - you may be having an allergic reaction to the medicine. 
Če opazite katerega od naslednjih neželenih učinkov, prenehajte jemati zdravilo IMBRUVICA in takoj obvestite zdravnika: srbeč izpuščaj z bulicami na koži, oteženo dihanje, otekanje v obraz, ustnice ali grlo oziroma žrelomorda imate alergijsko reakcijo na zdravilo.
(Stevens-Johnson syndrome). 
Johnsonov sindrom)
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg once daily (for details of the combination regimen, see section 5.1). 
Priporočeni odmerek za zdravljenje KLL, samostojno ali v kombinaciji, je 420 mg enkrat na dan (za podrobne informacije o odmerjanju v kombinaciji glejte poglavje 5.1).
Lowest Observed Effect Level (LOEL) (60 mg/kg/day) margins in the dog are 3.6-fold (males) and 2.3-fold (females). 
Pri psih je najnižja koncentracija z opaznim učinkom (LOEL - Lowest Observed Effect Level) (60 mg/kg/dan) 3,6-kratna (pri samcih) in 2,3-kratna (pri samicah).
Grade 3 or higher or serious infusion-related reactions were observed in 3% of patients treated with IMBRUVICA+obinutuzumab and 9% of patients treated with chlorambucil+obinutuzumab. 
Infuzijske reakcije stopnje 3 ali več oziroma resne infuzijske reakcije so opazili pri 3% bolnikov, ki so prejemali zdravilo IMBRUVICA in obinutuzumab, ter pri 9% bolnikov, ki so prejemali klorambucil in obinutuzumab.
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. 
Ob izhodišču je imelo 58% bolnikov najmanj en tumor velikosti ≥5 cm. Dvaintrideset odstotkov bolnikov je imelo prisotno delecijo 17p (pri čemer je imelo 50% bolnikov delecijo 17p/mutacijo TP53), 24% jih je imelo delecijo 11q in 47% bolnikov je imelo nemutiran gen za IGHV.
In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the strong CYP3A4 inhibitor voriconazole increased Cmax by 6.7-fold and AUC by 5.7-fold. 
Pri bolnikih z malignomi celic B, ki jemljejo zdravilo IMBRUVICA s hrano, je sočasno jemanje vorikonazola, močnega zaviralca CYP3A4, povečalo Cmax za 6,7-krat in AUC za 5,7-krat.
Adverse reactions in patients treated with ibrutinib for B-cell malignancies and post-marketing adverse reactions are listed below by system organ class and frequency grouping. 
Neželeni učinki pri bolnikih z malignomi celic B in neželeni učinki, poročani po začetku trženja zdravila, so navedeni po organskih sistemih in kategorijah pogostnosti.
A randomised, multicenter, open-label phase 3 study (PCYC-1115-CA) of IMBRUVICA versus chlorambucil was conducted in patients with treatment-naïve CLL who were 65 years of age or older. 
Randomizirano, multicentrično, odprto študijo faze 3 zdravila IMBRUVICA v primerjavi s klorambucilom (študija PCYC-1115-CA) so izvedli pri bolnikih s še nezdravljeno KLL, starih 65 let ali več.
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. 
Vpliv okvarjenega delovanja jeter se je med posamezniki sicer precej razlikoval, v povprečju pa so pri bolnikih z blago (n = 6; razred A po Child-Pughu), zmerno (n = 10; razred B po Child-Pughu ) oziroma hudo okvaro jeter (n = 8; razred C po Child-Pughu) opazili 2,7-kratno, 8,2-kratno oziroma 9,8-kratno povečanje izpostavljenosti ibrutinibu (AUCzadnja).
Strong inhibitors of CYP3A4 (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodon, cobicistat, voriconazole and posaconazole) should be avoided. 
Močnim zaviralcem CYP3A4 (na primer ketokonazolu, indinavirju, nelfinavirju, ritonavirju, sakvinavirju, klaritromicinu, telitromicinu, itrakonazolu, nefazodonu, kobicistatu, vorikonazolu in posakonazolu) se je treba izogibati.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine. 
Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom jemanja tega zdravila posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In an in vitro study, ibrutinib demonstrated inhibition of collagen-induced platelet aggregation. 
V in vitro študiji je ibrutinib zaviral s kolagenom povzročeno agregacijo trombocitov.
Consequently the foetal NOAEL was 5 mg/kg/day (approximately 0.7 times the AUC of ibrutinib at a dose of 560 mg daily) (see section 4.6). 
Koncentracija NOAEL pri plodu je bila posledično 5 mg/kg/dan, kar pomeni približno 0,7-kratnik AUC ibrutiniba pri odmerjanju 560 mg/dan (glejte poglavje 4.6).
Cases of cerebrovascular accident, transient ischaemic attack and ischaemic stroke including fatalities have been reported with the use of ibrutinib, with and without concomitant atrial fibrillation and/or hypertension. 
Ob uporabi ibrutiniba so poročali o primerih cerebrovaskularnega insulta, prehodnega ishemičnega napada in ishemične možganske kapi s sočasno atrijsko fibrilacijo in/ali hipertenzijo ali brez njiju.
120 capsules 
90 kapsul 120 kapsul
The recommended dose for the treatment of CLL, either as a single agent or in combination, is 420 mg (three capsules) once daily (for details of the combination regimen, see section 5.1). 
Priporočeni odmerek za zdravljenje KLL, samostojno ali v kombinaciji, je 420 mg (tri kapsule) enkrat na dan (za podrobne informacije o odmerjanju v kombinaciji glejte poglavje 5.1).
All patients had a baseline ECOG performance status of 0 or 1. 
Vsi bolniki so imeli oceno splošne zmogljivosti po lestvici ECOG 0 ali 1.
The ORR including PR with lymphocytosis was 70.6%. 
Pri limfocitozi je bil ORR (vključno z delnim odgovorom) 70,6%.
The recommended dose of IMBRUVICA is four capsules (560 mg) once a day. 
Priporočeni odmerek zdravila IMBRUVICA je štiri kapsule (560 mg) enkrat na dan.
What IMBRUVICA looks like and contents of the pack IMBRUVICA 140 mg film-coated tablets 
Izgled zdravila IMBRUVICA in vsebina pakiranja IMBRUVICA 140 mg filmsko obložene tablete
There are no data from the use of IMBRUVICA in pregnant women. 
Podatkov o uporabi zdravila IMBRUVICA pri nosečnicah ni.
IMBRUVICA Film-Coated Tablets Janssen-Cilag SpA Via C. Janssen, 
IMBRUVICA filmsko obložene tablete Janssen-Cilag SpA
Not known Stevens-Johnson syndrome 
Stevens-Johnsonov sindrom neznana pogostnost neznana pogostnost