natgillin/translations-raw huggingface dataset:
A higher risk for major bleeding was observed with anticoagulant than with antiplatelet agents. 
Večje tveganje za večjo krvavitev so opazili pri antikoagulantih kot pri protitrombocitnih zdravilih.
This may lead to changes in kidney function, abnormal heartbeat, or seizures. 
To lahko vodi do sprememb v delovanju ledvic, nenormalnega bitja srca ali epileptičnih krčev.
Although ibrutinib is a sensitive CYP3A4 substrate, it does not have a clinically relevant effect on its own exposure. 
Čeprav je ibrutinib občutljiv substrat CYP3A4, na svojo izpostavljenost ne vpliva klinično pomembno.
There is no specific antidote for IMBRUVICA. 
Za zdravilo IMBRUVICA ni specifičnega antidota.
These may be signs and symptoms of stroke. 
To so lahko znaki in simptomi možganske kapi.
IMBRUVICA contains lactose (a type of sugar). 
Zdravilo IMBRUVICA vsebuje laktozo (vrsto sladkorja).
Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity. 
Zdravilo IMBRUVICA se sme dati bolnikom s hudo okvaro ledvic (z očistkom kreatinina < 30 ml/min) samo v primeru, da koristi presegajo tveganja, bolnike pa je treba skrbno spremljati glede znakov toksičnega delovanja.
Co-administration with transport substrates/inhibitors In vitro studies indicated that ibrutinib is not a substrate of P-gp, nor other major transporters, except OCT2. 
Sočasna uporaba s substrati/zaviralci prenašalcev In vitro študije kažejo, da ibrutinib ni substrat P-glikoproteina, niti drugih pomembnih prenašalcev, razen OCT2.
The following side effects may happen with this medicine: 
Pri tem zdravilu lahko pride do naslednjih neželenih učinkov:
Do not use this medicine after the expiry date which is stated on the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake "EXP".
• Take the capsules about the same time each day. 
- Kapsule vzemite vsak dan ob približno istem času.
Monitor patients for pulmonary symptoms indicative of ILD. 
Bolnike spremljajte glede pljučnih simptomov ILD.
Latency from the initiation of treatment with ibrutinib to the onset of ischaemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasising the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8). 
Latenca od začetka zdravljenja z ibrutinibom do pojava ishemičnih žilnih bolezni osrednjega živčevja je večinoma znašala nekaj mesecev (več kot 1 mesec v 78 % in več kot 6 mesecev v 44 % primerov), kar poudarja potrebo po rednem spremljanju bolnikov (glejte poglavje 4.4, Srčne aritmije in Hipertenzija, ter poglavje 4.8).
This is because it can increase the amount of IMBRUVICA in your blood. 
To je pomembno zato, ker se ob sočasnem uživanju lahko poveča količina zdravila IMBRUVICA v krvi.
• if you are allergic to ibrutinib or any of the other ingredients of this medicine (listed in section 6) 
Ne jemljite zdravila IMBRUVICA - če ste alergični na ibrutinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The safety profile is based on pooled data from 1200 patients treated with IMBRUVICA in three phase 2 clinical studies and six randomised phase 3 studies and from post-marketing experience. 
Podatki o varnosti zdravila temeljijo na združenih podatkih 1.200 bolnikov, ki so jih zdravili z zdravilom IMBRUVICA v treh kliničnih študijah faze 2, šestih randomiziranih študijah faze 3 in podatkih po začetku trženja zdravila.
Some of these infections have been associated with hospitalisation and death. 
V nekaj primerih teh okužb je bila potrebna hospitalizacija, nekateri pa so se končali s smrtjo.
Administration of ibrutinib in fasted condition resulted in approximately 60% of exposure (AUClast) as compared to either 30 minutes before, 30 minutes after (fed condition) or 2 hours after a high fat breakfast. 
Odmerjanje ibrutiniba v teščem stanju je povzročilo približno 60-odstotno raven izpostavljenosti (AUCzadnja) v primerjavi z AUCzadnja pri odmerjanju bodisi 30 minut pred obrokom ali 30 minut po njem (v stanju sitosti) oziroma 2 uri po zajtrku z veliko vsebnostjo maščob.
MCL dose modification after recovery CLL/WM dose modification after recovery 
Prilagoditev odmerjanja po okrevanju pri KLL/WM
The Kaplan-Meier landmark estimate for OS at 48-months was 85.5% in the IMBRUVICA arm. 
KaplanMeierjeva ocena s postavljenim mejnikom (landmark estimate) za OS po 48 mesecih je bila v skupini z zdravilom IMBRUVICA 85,5%.
There is no evidence that the lower Cmax would have clinical significance, and medicinal products that increase stomach pH (e.g., proton pump inhibitors) have been used without restrictions in the pivotal clinical studies. 
Ni dokazov, da bila nižja vrednost Cmax klinično pomembna in v ključnih kliničnih študijah so zdravila, ki zvišajo pH želodca (npr. zaviralci protonske črpalke) uporabljali brez omejitev.
IMBRUVICA should be administered orally once daily with a glass of water approximately at the same time each day. 
Zdravilo IMBRUVICA je treba jemati peroralno enkrat na dan s kozarcem vode, in sicer vsak dan ob približno istem času.
In MCL, CLL and WM, IMBRUVICA works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. 
Pri MCL, KLL in WM deluje zdravilo IMBRUVICA tako, da zavira “Brutonovo tirozinsko kinazo”, beljakovino v telesu, ki pomaga rakastim celicam, da preživijo in se razmnožujejo.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE27. 
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE27.
Effect on QT/QTc interval and cardiac electrophysiology The effect of ibrutinib on the QTc interval was evaluated in 20 healthy male and female subjects in a randomised, double-blind thorough QT study with placebo and positive controls. 
Vpliv na QT/QTc interval in elektrofiziologijo srca Vpliv ibrutiniba na QTc interval so ocenjevali pri 20 zdravih moških in ženskah v randomizirani, dvojno slepi s placebom in učinkovino nadzorovani temeljiti študiji QTc.
The overall response to IMBRUVICA was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognostic factors, bulky disease, gender or age. 
Celokupni odgovor na zdravilo IMBRUVICA ni bil odvisen od predhodnega zdravljenja, vključno z uporabo bortezomiba in lenalidomida, oziroma od osnovnega tveganja/prognostičnih dejavnikov, prisotnosti velike tumorske mase ter spola ali starosti bolnika.
How to store IMBRUVICA Contents of the pack and other information 
Shranjevanje zdravila IMBRUVICA Vsebina pakiranja in dodatne informacije
Bulky disease <5 cm 
Obsežna bolezen < 5 cm
If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other cancers and to reduce the activity of the immune system (e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours before or after IMBRUVICA. 
Če jemljete digoksin, zdravilo za težave s srcem, ali metotreksat, zdravilo za zdravljenje drugih vrst raka ter za zmanjšanje delovanja imunskega sistema (npr. za zdravljenje revmatoidnega artritisa ali luskavice), ju morate vzeti najmanj 6 ur pred ali 6 ur po jemanju zdravila IMBRUVICA.
Warfarin or other vitamin K antagonists should not be administered concomitantly with IMBRUVICA. 
Varfarina in drugih antagonistov vitamina K se ne sme jemati sočasno z zdravilom IMBRUVICA.
What you need to know before you take IMBRUVICA 
Kaj morate vedeti, preden boste vzeli zdravilo IMBRUVICA
Median OS not reached for both arms. 
Mediana celokupnega preživetja ni bila dosežena pri nobeni od obeh skupin.
The free fraction of ibrutinib also increased with degree of impairment, with 3.0, 3.8 and 4.8% in subjects with mild, moderate and severe liver impairment, respectively, compared to 3.3% in plasma from matched healthy controls within this study. 
S stopnjo okvare se je povečevala tudi prosta frakcija ibrutiniba, in sicer je znašala 3,0%, 3,8% oziroma 4,8% pri bolnikih z blago, zmerno oziroma hudo okvaro jeter v primerjavi s 3,3% v plazmi ustreznih zdravih kontrolnih oseb v tej študiji.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Posodobljen RMP je treba predložiti: - na zahtevo Evropske agencije za zdravila; - ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
In this same study, a concentration dependent shortening in the QTc interval was observed (-5.3 ms [90% CI: -9.4, -1.1] at a Cmax of 719 ng/mL following the supratherapeutic dose of 1,680 mg). 
V isti študiji so opazili od koncentracije odvisno skrajšanje intervala QTc (-5,3 ms [90% IZ: -9,4; -1,1] pri Cmax 719 ng/ml po supraterapevtskem odmerku 1.680 mg).
IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib. 
IMBRUVICA je zdravilo proti raku, ki vsebuje učinkovino ibrutinib.
Efficacy results for Study CLL3001 are shown in Table 9. 
Rezultati učinkovitosti za študijo CCL3001 so prikazani v Preglednici 9.
The safety and efficacy of IMBRUVICA in patients with CLL were demonstrated in one uncontrolled study and one randomised, controlled study. 
Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih s KLL so dokazali v eni nenadzorovani in v eni randomizirani nadzorovani študiji.
BTK, a member of the Tec kinase family, is an important signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. 
BTK, ki sodi v družino kinaz Tec, je pomembna signalna molekula za biokemične poti B-celičnega antigenskega receptorja (BCR) in citokinskih receptorjev.
Women of childbearing potential must use a highly effective method of contraception while taking IMBRUVICA (see section 4.6). 
Ženske v rodni dobi morajo v času jemanja zdravila IMBRUVICA uporabljati zelo učinkovito metodo kontracepcije (glejte poglavje 4.6).
Mantle cell lymphoma (MCL) 
Limfom plaščnih celic (MCL)
What IMBRUVICA is and what it is used for What you need to know before you take IMBRUVICA How to take IMBRUVICA 
Kaj je zdravilo IMBRUVICA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo IMBRUVICA Kako jemati zdravilo IMBRUVICA Možni neželeni učinki
ORR was assessed according to the 2008 IWCLL criteria by investigators and IRC. 
ORR so ocenjevali raziskovalci in IRC po kriterijih IWCLL, določenih leta 2008.
All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%). 
Vsi bolniki so imeli izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 (48%) ali 1-2 (52%).
When administering IMBRUVICA in combination with anti-CD20 therapies, it is recommended to administer IMBRUVICA prior to rituximab or obinutuzumab when given on the same day. 
Pri odmerjanju zdravila IMBRUVICA v kombinaciji z zdravili, ki so usmerjena proti CD20, je priporočljivo vzeti zdravilo IMBRUVICA pred rituksimabom ali obinutuzumabom, kadar ju je treba vzeti na isti dan.
Patients between 65 and 70 years of age were required to have at least one comorbidity that precluded the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide, and rituximab. 
Bolniki, stari od 65 do 70 let, so morali imeti najmanj eno pridruženo bolezen, zaradi katere uporaba kemoimunoterapija z fludarabinom, ciklofosfamidom in rituksimabom v prvi liniji zdravljenja ni bila mogoča.
The clinical relevance is not known, but the exposure to substrates of CYP2B6 (such as efavirenz and bupropion) and of co-regulated enzymes may be reduced upon co-administration with ibrutinib. 
Klinična pomembnost sicer ni znana, a izpostavljenost substratom CYP2B6 (kot sta efavirenz in bupropion) in substratom encimov, na katere vpliva CYP2B6, je lahko po sočasnem jemanju z ibrutinibom zmanjšana.
Treatment on both arms continued until disease progression or unacceptable toxicity. 
Zdravljenje v obeh skupinah je potekalo do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravila.
IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. 
Zdravilo IMBRUVICA je v kombinaciji z rituksimabom indicirano za zdravljenje odraslih bolnikov z WM.
Pancreatic findings partially recovered during comparable reversal periods. 
Izvidi preiskav trebušne slinavke so se deloma popravili v približno enako dolgem obdobju okrevanja.
Patients who develop arrhythmic symptoms or new onset of dyspnoea, dizziness or fainting should be evaluated clinically and if indicated have an electrocardiogram (ECG) performed. 
Bolnike, pri katerih se pojavijo simptomi aritmije ali se na novo pojavi zadihanost, omotica ali omedlevica, je treba klinično pregledati in jim po potrebi posneti elektrokardiogram (EKG).
You may feel tired or dizzy after taking IMBRUVICA, which may affect your ability to drive or use any tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Po odmerjanju zdravila IMBRUVICA lahko postanete utrujeni ali omotični, kar lahko vpliva na vašo sposobnost vožnje ali uporabe orodja in strojev.
When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML). 
Če med jemanjem zdravila IMBRUVICA opazite ali pa pri vas opazi kdo drug, da izgubljate spomin, imate težave pri mišljenju, težko hodite ali izgubljate vid, o tem takoj obvestite zdravnika, ker se to lahko pojavi zaradi redke resne okužbe možganov, ki je lahko smrtna (progresivna multifokalna levkoencefalopatija ali PML).
Fifty-seven patients randomised to ofatumumab crossed over following progression to receive IMBRUVICA. 
Sedeminpetdeset bolnikov, randomiziranih v skupino z ofatumumabom, je po napredovanju bolezni navzkrižno prešlo na jemanje zdravila IMBRUVICA.
Do not take IMBRUVICA with grapefruit or Seville oranges (bitter oranges) - this includes eating them, drinking the juice or taking a supplement that might contain them. 
V času jemanja zdravila IMBRUVICA ne uživajte grenivk ali seviljskih (grenkih) pomarančkar vključuje uživanje sadeža, pitje soka ali jemanje prehranskega nadomestka, ki bi lahko vseboval grenivko ali seviljsko pomarančo.
If you miss a dose of IMBRUVICA, take it as soon as you remember on the same day. 
Če pozabite vzeti odmerek zdravila IMBRUVICA, ga vzemite čimprej istega dne.
Based on in vitro data, ibrutinib is a weak CYP2B6 inducer and may have the potential to affect the expression of other enzymes and transporters regulated via the constitutive androstane receptor (CAR), e.g. CYP2C9, CYP2C19, UGT1A1 and MRP2. 
Na osnovi podatkov in vitro je ibrutinib šibek induktor CYP2B6 in lahko vpliva na izraženost drugih encimov in prenašalcev, uravnavanih z konstitutivnimi androstanskimi receptorji (CAR-constitutive androstane receptors), kot so CYP2C9, CYP2C19, UGT1A1 in MRP2.
Patients previously untreated for CLL 
Bolniki s predhodno nezdravljeno KLL
Do not stop taking this medicine unless your doctor tells you. 
Če ste prenehali jemati zdravilo IMBRUVICA Ne prenehajte jemati tega zdravila, razen če vam tako naroči zdravnik.
In patients with preexisting atrial fibrillation requiring anticoagulant therapy, alternative treatment options to IMBRUVICA should be considered. 
Pri bolnikih z obstoječo atrijsko fibrilacijo, ki potrebujejo zdravljenje z antikoagulanti, je treba razmisliti o drugih možnostih zdravljenja.
A smaller proportion of patients treated with ibrutinib experienced a clinically meaningful worsening of lymphoma symptoms versus temsirolimus (27% versus 52%) and time to worsening of symptoms occurred more slowly with ibrutinib versus temsirolimus (HR 0.27, p<0.0001). 
Pri manjšem deležu bolnikov, zdravljenih z ibrutinibom je prišlo do klinično pomembnega poslabšanja simptomov limfoma v primerjavi s temsirolimusom (27% proti 52%), čas do poslabšanja simptomov pa je bil počasnejši pri ibrutinibu v primerjavi s temsirolimusom (HR 0,27, p < 0,0001).
Total N=111 
skupaj N = 111
Ibrutinib is metabolised in the liver. 
Ibrutinib se presnavlja v jetrih.
Take IMBRUVICA tablet by mouth, at about the same time each day, with a glass of water. 
Tablete zdravila IMBRUVICA zaužijte, vsak dan ob približno istem času, s kozarcem vode.
Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5). 
Ibrutinib je in vitro zaviralec P-glikoproteina in BCRP (glejte poglavje 4.5).
The capsules are provided in a plastic bottle with a child resistant polypropylene closure. 
Kapsule so na voljo v plastenkah z za otroke varno polipropilensko zaporko.
Hypertension has occurred in patients treated with IMBRUVICA (see section 4.8). 
Pri bolnikih, zdravljenih z zdravilom IMBRUVICA, se je pojavljala hipertenzija (glejte poglavje 4.8).
It is used in patients who have not previously been treated for WM or when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy. 
Zdravilo je namenjeno bolnikom s še ne zdravljeno WM ali bolnikom, pri katerih se je bolezen ponovila ali niso odgovorili na zdravljenje oziroma bolnikom, ki niso primerni za kemoterapijo v kombinaciji s protitelesi.
By blocking this protein, IMBRUVICA helps kill and reduce the number of cancer cells. 
Z zaviranjem te beljakovine pomaga zdravilo IMBRUVICA uničevati rakaste celice in zmanjševati njihovo število, hkrati pa tudi upočasni poslabšanje rakave bolezni.
Each bottle contains either 90 or 120 capsules. 
Ena plastenka vsebuje bodisi 90 ali 120 kapsul.
Chlorambucil+Obinutuzumab N=116 
klorambucil+obinutuzumab N=116
The study enrolled patients who were 65 years of age or older or <65 years of age with coexisting medical conditions, reduced renal function as measured by creatinine clearance <70 mL/min, or presence of del17p/TP53 mutation. 
V študijo so bili vključeni bolniki, ki so bili stari 65 let ali več ali bolniki, mlajši od 65 let s sočasnimi boleznimi, zmanjšano ledvično funkcijo, opredeljeno z očistkom kreatinina <70 ml/min, ali prisotno delecijo 17p oziroma mutacijo TP53.
PFS hazard ratios for treatment-naïve patients, previously treated patients, and patients with or without MYD88 L265P mutations were consistent with the PFS hazard ratio for the ITT population. 
Razmerja ogroženosti za PFS pri bolnikih brez predhodnega zdravljenja, pri bolnikih s predhodnim zdravljenjem in pri bolnikih z mutacijo MYD88 L265P oziroma brez nje so se ujemala z razmerjem ogroženosti za PFS pri populaciji ITT.
The open-label, multi-center study (PCYC-1102-CA) included 51 patients with relapsed or refractory CLL, who received 420 mg once daily. 
Odprta multicentrična študija (PCYC-1102-CA) je vključevala 51 bolnikov s ponovitvijo ali z neodzivno obliko KLL, ki so prejemali odmerek 420 mg enkrat na dan.
Use of either anticoagulants or medicinal products that inhibit platelet function (antiplatelet agents) concomitantly with IMBRUVICA increases the risk of major bleeding. 
Sočasna uporaba zdravila IMBRUVICA z antikoagulanti ali z zdravili, ki zavirajo delovanje trombocitov (protitrombocitna zdravila) poveča tveganje za večjo krvavitev.
Reversible binding of ibrutinib to human plasma protein in vitro was 97.3% with no concentration dependence in the range of 50 to 1,000 ng/mL. 
In vitro je reverzibilna vezava ibrutiniba na humane plazemske beljakovine znašala 97,3% in v območju od 50 do 1.000 ng/ml ni bila odvisna od koncentracije.
The median age was 67 years (range, 47 to 90 years). 
Mediana starost bolnikov je bila 67 let (od 47 do 90 let).
Bulky disease <5 cm ≥5 cm 
Velika tumorska masa <5 cm ≥5 cm
Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment. 
Limfocitoza: V prvih nekaj tednih zdravljenja lahko izvidi laboratorijskih preiskav pokažejo zvečano število belih krvnih celic (imenovanih "limfociti") v vaši krvi.
Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (12% of patients age ≥65 versus 7% of patients <65 years of age). 
Pri starejših bolnikih, ki so prejemali zdravilo IMBRUVICA, se je pogosteje pojavila pljučnica stopnje 3 ali več (12% bolnikov, starih ≥ 65 v primerjavi s 7% bolnikov < 65 let).
The first dose of obinutuzumab was divided between day 1 (100 mg) and day 2 (900 mg). 
Prvi odmerek obinutuzumaba so prejeli deljeno: 100 mg 1. dan in 900 mg 2. dan.
Each carton contains one bottle of either 90 or 120 hard capsules. 
Ena škatla vsebuje eno plastenko z 90 ali 120 trdimi kapsulami.
Treatment should continue until disease progression or no longer tolerated by the patient. 
Z zdravljenjem je treba nadaljevati do napredovanja bolezni oziroma dokler bolnik prenaša zdravilo.
Responses to IMBRUVICA are shown in Table 10. 
Odgovori na zdravilo IMBRUVICA so prikazani v Preglednici 10.
No human data on the effects of ibrutinib on fertility are available. 
Podatkov o vplivu ibrutiniba na plodnost pri ljudeh ni na voljo.
Sensitivity analysis in which crossover patients from the ofatumumab arm were not censored at the date of first dose of IMBRUVICA. 
Analiza občutljivosti, za katero pri bolnikih iz skupine z ofatumumabom, ki so zamenjali zdravilo, podatki niso bili cenzurirani z dnem prvega odmerka zdravila IMBRUVICA.
If symptoms develop, interrupt IMBRUVICA and manage ILD appropriately. 
Če se simptomi pojavijo, je treba zdravljenje z zdravilom IMBRUVICA prekiniti in ILD ustrezno zdraviti.
IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. 
Zdravilo IMBRUVICA je kot samostojno zdravilo indicirano za zdravljenje odraslih bolnikov z Waldenstromovo makroglobulinemijo (WM - Waldenström's macroglobulinaemia), ki so predhodno prejeli vsaj eno vrsto zdravljenja oziroma v prvi liniji pri bolnikih, ki niso primerni za kemoimunoterapijo.
Unmutated IGHV Yes 
Nemutiran gen za IGHV da ne
In patients at high risk and where alternatives to IMBRUVICA are non-suitable, tightly controlled treatment with anticoagulants should be considered. 
Pri bolnikih z velikim tveganjem in kadar druge možnosti zdravljenja niso primerne, je treba razmisliti o zdravljenju z antikoagulanti, ki pa mora biti skrbno nadzorovano.
Progression free survival (PFS) was assessed by IRC according to IWCLL criteria. 
Podatke o preživetju brez napredovanja bolezni (PFS) je ocenjevala IRC po kriterijih IWCL.
Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4). 
Bolnike je treba skrbno spremljati glede toksičnega delovanja zdravila in po potrebi upoštevati smernice za prilagajanje odmerka (glejte poglavji 4.2 in 4.4).
If the toxicity reoccurs, the once daily dose should be reduced by one capsule (140 mg). 
Če se znaki toksičnega učinkovanja ponovijo, je treba dnevni odmerek zmanjšati za eno kapsulo (za 140 mg).
Mild inducers may be used concomitantly with IMBRUVICA, however, patients should be monitored for potential lack of efficacy. 
Zdravilo IMBRUVICA se sočasno lahko uporablja z blagimi induktorji, vendar je treba bolnike skrbno spremljati glede znakov pomanjkanja učinkovitosti.
• Take the tablets about the same time each day. 
- Tablete vzemite vsak dan ob približno istem času.
Grapefruit and Seville oranges should be avoided during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A4 (see section 4.2). 
Med zdravljenjem z zdravilom IMBRUVICA se je treba izogibati uživanju grenivk in seviljskih pomaranč, ker vsebujejo zmerne zaviralce CYP3A4 (glejte poglavje 4.2).