FrancophonIA/ELRC3.0 huggingface dataset:
English: • unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)
Croatian: • neuobičajene razine kemijskih tvari u krvi uzrokovane brzim raspadom stanica raka koje su se pojavile tijekom liječenja raka, a ponekad čak i bez liječenja (sindrom lize tumora)
English: • 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.
Croatian: • Ako propustite dozu, možete je uzeti što je prije moguće isti dan, s povratkom na uobičajeni raspored uzimanja sljedeći dan.
English: Mild inducers may be used concomitantly with IMBRUVICA, however, patients should be monitored for potential lack of efficacy.
Croatian: Slabi induktori mogu se koristiti istodobno s lijekom IMBRUVICA, međutim, bolesnike se mora pratiti radi potencijalnog nedostatka djelotvornosti.
English: What IMBRUVICA is used for It is used to treat the following blood cancers in adults:
Croatian: Koristi se za liječenje sljedećih vrsta raka krvi u odraslih:
English: IMBRUVICA with food
Croatian: IMBRUVICA s hranom
English: A high number of circulating lymphocytes (>400,000/mcL) may confer increased risk.
Croatian: Visok broj limfocita (> 400 000/μl) u cirkulaciji može doprinijeti povećanom riziku.
English: Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje ovim lijekom mora započeti, te nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: • painful arms or legs
Croatian: • bolne ruke ili noge
English: 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.
Croatian: Ako uzimate digoksin, lijek za probleme sa srcem, ili metotreksat, lijek koji se primjenjuje za liječenje drugih vrsta raka i za smanjenje aktivnosti imunološkog sustava (npr. za reumatoidni artritis ili psorijazu), potrebno ga je uzeti najmanje 6 sati prije ili nakon uzimanja lijeka IMBRUVICA.
English: IMBRUVICA must not be taken with grapefruit juice or Seville oranges (see section 4.5).
Croatian: IMBRUVICA se ne smije uzimati sa sokom od grejpfruta ili seviljske (gorke) naranče (vidjeti dio 4.5).
English: Not known Stevens-Johnson syndrome
Croatian: Nepoznato Stevens-Johnsonov sindrom
English: ciprofloxacin, erythromycin or rifampicin
Croatian: telitromicin, ciprofloksacin, eritromicin ili rifampicin
English: 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.
Croatian: Ako bolesnici imaju pozitivan serološki nalaz na hepatitis B, prije početka liječenja potrebno je savjetovati se sa stručnjakom za bolesti jetre, a bolesnik se mora pratiti i liječiti sukladno lokalnim medicinskim standardima, radi sprječavanja reaktivacije hepatitisa B.
English: A risk to breast-fed children cannot be excluded.
Croatian: Rizik za djecu na majčinom mlijeku ne može se isključiti.
English: A higher risk for major bleeding was observed with anticoagulant than with antiplatelet agents.
Croatian: Veći rizik od velikog krvarenja uočen je s antikoagulansom nego s antitrombocitnim lijekovima.
English: The largest upper bound of the 2-sided 90% CI for the baseline adjusted mean differences between ibrutinib and placebo was below 10 ms.
Croatian: Najveća gornja granica dvostranog 90%-tnog CI za početne prilagođene srednje vrijednosti razlika između ibrutiniba i placeba bila je ispod 10 ms.
English: • medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia - carbamazepine or phenytoin.
Croatian: • lijekove za sprječavanje napadaja ili za liječenje epilepsije, ili lijekove za liječenje bolnog stanja lica koje se zove trigeminalna neuralgija - karbamazepin ili fenitoin.
English: No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance).
Croatian: Nije potrebna prilagodba doze za bolesnike s blagim ili umjerenim oštećenjem bubrega (klirens kreatinina veći od 30 ml/min).
English: Population pharmacokinetics data indicated that body weight (range: 41-146 kg; mean [SD]: 83 [19 kg]) had a negligible effect on ibrutinib clearance.
Croatian: Podaci populacijske farmakokinetike ukazuju da je tjelesna težina (raspon: 41-146 kg; srednja vrijednost [SD]: 83 [19 kg]) imala zanemariv utjecaj na klirens ibrutiniba.
English: Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater were excluded from the study.
Croatian: Eastern Cooperative Oncology Group, ECOG) jednakim 3 ili većim nisu bili uključeni u ispitivanje.
English: • bruising or increased tendency of bruising.
Croatian: • nastanak modrica ili povećana sklonost stvaranju modrica.
English: Treatment should continue until disease progression or no longer tolerated by the patient.
Croatian: Liječenje se mora nastaviti do progresije bolesti ili dok bolesnik više ne podnosi liječenje.
English: Hazard ratio based on non-stratified analysis
Croatian: Omjer hazarda na temelju nestratificirane analize
English: Tell your doctor immediately if you notice or someone notices in you: sudden numbness or weakness in the limbs (especially on one side of the body), sudden confusion, trouble speaking or understanding speech, sight loss, difficulty walking, loss of balance or lack of coordination, sudden severe headache with no known cause.
Croatian: Odmah obavijestite svog liječnika ako Vi ili netko kod Vas primijeti: iznenadnu utrnulost ili slabost u udovima (posebno jedne strane tijela), iznenadnu smetenost, poteškoće u govoru ili razumijevanju govora, gubitak vida, poteškoće s hodanjem, gubitak ravnoteže ili nedostatak koordinacije, iznenadnu jaku glavobolju bez poznatog uzroka.
English: Although ibrutinib is a sensitive CYP3A4 substrate, it does not have a clinically relevant effect on its own exposure.
Croatian: Iako je ibrutinib osjetljiv supstrat CYP3A4, nema klinički značajan učinak na vlastitu izloženost.
English: Median OS not reached for both arms.
Croatian: Medijan OS nije dostignut za obje skupine.
English: In a separate study, one healthy subject who received a dose of 1,680 mg experienced reversible grade 4 hepatic enzyme increases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)].
Croatian: U drugom ispitivanju, jedan zdravi ispitanik koji je primio dozu od 1680 mg doživio je reverzibilno povećanje jetrenih enzima 4. stupnja [aspartat aminotransferaze (AST) i alanin aminotransferaze (ALT)].
English: Frequencies are rounded to the nearest integer.
Croatian: Učestalosti su zaokružene na vrijednost najbližeg cijelog broja.
English: If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
Croatian: U slučaju sumnje na PML potrebno je poduzeti prikladne dijagnostičke procjene, te prekinuti liječenje dok se ne isključi PML.
English: At a supratherapeutic dose of 1,680 mg, ibrutinib did not prolong the QTc interval to any clinically relevant extent.
Croatian: Pri supraterapijskoj dozi od 1680 mg, ibrutinib nije produljio QTc interval u bilo kojoj klinički značajnoj mjeri.
English: • Take the tablets about the same time each day.
Croatian: • Uzmite tablete svaki dan, otprilike u isto vrijeme.
English: Del17p/TP53
Croatian: Delecija 17p/mutacija TP53
English: IRC evaluated.
Croatian: Prema ocjeni IRC-a.
English: • medicines to prevent nausea and vomiting associated with chemotherapy - aprepitant
Croatian: • lijekove koji sprječavaju mučninu i povraćanje koje su povezane s kemoterapijom - aprepitant
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane prema padajućoj ozbiljnosti.
English: Peripheral neuropathy
Croatian: Periferna neuropatija*
English: 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.
Croatian: Sigurnosni profil temelji se na objedinjenim podacima 1200 bolesnika liječenih lijekom IMBRUVICA u tri klinička ispitivanja faze 2 i šest randomiziranih ispitivanja faze 3 te iz razdoblja nakon stavljanja lijeka u promet.
English: Bleeding-related events
Croatian: Događaji povezani s krvarenjem
English: 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.
Croatian: Učinak na QT/QTc interval i elektrofiziologija srca Učinak ibrutiniba na QTc interval bio je procijenjen u 20 zdravih muških i ženskih ispitanika u randomiziranom, dvostruko slijepom temeljitom ispitivanju QT-intervala s placebom i pozitivnim kontrolama.
English: Unchanged ibrutinib accounted for approximately 1% of the radiolabeled excretion product in faeces and none in urine.
Croatian: Nepromijenjeni ibrutinib činio je oko 1% radioaktivno označenog lijeka u fecesu i ništa u mokraći.
English: In vitro platelet aggregation
Croatian: In vitro agregacija trombocita
English: Each carton contains one bottle of either 90 or 120 hard capsules.
Croatian: Jedna kartonska kutija sadrži bocu s 90 ili 120 tvrdih kapsula.
English: Also some other medicines can affect the way IMBRUVICA works.
Croatian: Osim toga, neki drugi lijekovi mogu utjecati na djelovanje lijeka IMBRUVICA.
English: • heart medicines/anti-arrhythmics - amiodarone or dronedarone
Croatian: • lijekove za srce/antiaritmike - amiodaron ili dronedaron
English: Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5).
Croatian: Ibrutinib je in vitro inhibitor Pgp-a i BCRP-a (vidjeti dio 4.5).
English: Viral reactivation
Croatian: Virusna reaktivacija
English: All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated.
Croatian: Svi bolesnici u kliničkim ispitivanjima primali su lijek IMBRUVICA do progresije bolesti ili dok ga više nisu podnosili.
English: 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.
Croatian: Istodobna primjena sa supstratima/inhibitorima prijenosnika In vitro ispitivanja su pokazala da ibrutinib nije supstrat P-gp-a, niti drugih glavnih prijenosnika, osim OCT2.
English: Bulky disease <5 cm ≥5 cm
Croatian: Velika tumorska masa < 5 cm ≥ 5 cm
English: 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.
Croatian: U obje vrste bolesti, limfocitoza se tipično pojavljuje tijekom prvog mjeseca liječenja lijekom IMBRUVICA i isto tako se obično povlači tijekom medijana od 8,0 tjedana u bolesnika s MCL-om te 14 tjedana u bolesnika s KLL-om.
English: Ibrutinib forms a covalent bond with a cysteine residue (Cys-481) in the BTK active site, leading to sustained inhibition of BTK enzymatic activity.
Croatian: Ibrutinib stvara kovalentnu vezu s cisteinskim ostatkom (Cys-481) na aktivnom mjestu BTK-a, dovodeći do neprekidne inhibicije enzimatske aktivnosti BTK-a.
English: These include minor bleeding events such as contusion, epistaxis, and petechiae; and major bleeding events, some fatal, including gastrointestinal bleeding, intracranial haemorrhage, and haematuria.
Croatian: To uključuje manje događaje krvarenja poput kontuzija, epistakse i petehija, te velike događaje krvarenja, neke sa smrtnim ishodom, uključujući gastrointestinalno krvarenje, intrakranijalno krvarenje i hematuriju.
English: The capsules are provided in a plastic bottle with a child resistant polypropylene closure.
Croatian: Kapsule dolaze u plastičnoj boci sa sigurnosnim čepom za djecu od polipropilena.
English: Ibrutinib may also inhibit BCRP in the liver and increase the exposure of medicinal products that undergo BCRP-mediated hepatic efflux, such as rosuvastatin.
Croatian: Ibrutinib također može inhibirati BCRP u jetri i povećati izloženost lijekovima koji prolaze kroz BCRP-om posredovani hepatički efluks, poput rosuvastatina.
English: 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).
Croatian: Latencija od početka liječenja ibrutinibom do nastupa ishemijskih vaskularnih stanja središnjeg živčanog sustava bila je u većini slučajeva više od nekoliko mjeseci (više od jednog mjeseca u 78 % slučajeva i više od šest mjeseci u 44 % slučajeva), zbog čega je naglašena potreba redovitog praćenja bolesnika (vidjeti dio 4.4 Aritmija srca i hipertenzija i dio 4.8).
English: • if you are taking a herbal medicine called St. John's Wort, used for depression.
Croatian: • ako uzimate biljni lijek na bazi gospine trave, koji se koristi za depresiju.
English: 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.
Croatian: Kada se IMBRUVICA primjenjuje u kombinaciji s protutijelima na CD20, preporučuje se lijek IMBRUVICA primijeniti prije rituksimaba ili obinutuzumaba ako se daju istoga dana.
English: IMBRUVICA should not be used during pregnancy.
Croatian: IMBRUVICA se ne smije uzimati za vrijeme trudnoće.
English: • if you have liver or kidney problems
Croatian: • ako imate tegobe s jetrom ili bubrezima
English: No specific studies have been conducted to date in subjects with impaired renal function.
Croatian: Do danas nisu provedena specifična ispitivanja na ispitanicima s oštećenom funkcijom bubrega.
English: It is not known whether ibrutinib or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se ibrutinib ili njegovi metaboliti u majčino mlijeko.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: In a hepatic impairment study, data showed an increase in ibrutinib exposure (see section 5.2).
Croatian: U ispitivanju oštećenja jetre, podaci su pokazali povećanje izloženosti ibrutinibu (vidjeti dio 5.2).
English: Breast-feeding should be discontinued during treatment with IMBRUVICA.
Croatian: Dojenje se mora prekinuti tijekom liječenja lijekom IMBRUVICA.
English: It is not recommended to administer IMBRUVICA to patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Ne preporučuje se primjena lijeka IMBRUVICA bolesnicima s teškim oštećenjem jetre (Child-Pugh stadij C).
English: Responses to IMBRUVICA are shown in Table 10.
Croatian: Odgovori na lijek IMBRUVICA prikazani su u tablici 10.
English: This is because IMBRUVICA could cause hepatitis B to become active again.
Croatian: To je zbog toga što lijek IMBRUVICA može uzrokovati ponovnu aktivaciju hepatitisa B.
English: 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.
Croatian: Klinički značaj nije poznat, ali izloženost supstratima CYP2B6 (poput efavirenza i bupropiona), te koreguliranih enzima može biti smanjena nakon istodobne primjene s ibrutinibom.
English: Therefore, concomitant use of IMBRUVICA with strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers should be avoided whenever possible and co-administration should only be considered when the potential benefits clearly outweigh the potential risks.
Croatian: Stoga se istodobna primjena lijeka IMBRUVICA sa snažnim CYP3A4 inhibitorima i snažnim ili umjerenim CYP3A4 induktorima mora izbjegavati kada god je moguće, a istodobna primjena može se uzeti u obzir samo kada potencijalna korist jasno nadvladava potencijalne rizike.
English: • medicines called statins to treat high cholesterol - rosuvastatin
Croatian: • lijekove koji se nazivaju statini za liječenje povišenog kolesterola - rosuvastatin
English: Infections (including sepsis, neutropenic sepsis, bacterial, viral, or fungal infections) were observed in patients treated with IMBRUVICA.
Croatian: Infekcije (uključujući sepsu, neutropenijsku sepsu, bakterijske, virusne ili gljivične infekcije) zabilježene su u bolesnika liječenih lijekom IMBRUVICA.
English: • an increase in the number or proportion of white blood cells shown in blood tests
Croatian: • povećanje broja ili udjela bijelih krvnih stanica što se vidi u krvnim pretragama
English: 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).
Croatian: Pneumonija stupnja 3 ili višeg, češće se javila u starijih bolesnika liječenih lijekom IMBRUVICA (12% bolesnika u dobi od ≥ 65 godina u odnosu na 7% bolesnika < 65 godina starosti).
English: Pharmacokinetics of ibrutinib does not significantly differ in patients with different B-cell malignancies.
Croatian: Farmakokinetika ibrutiniba ne razlikuje se značajno u bolesnika s različitim zloćudnim bolestima B-stanica.
English: The European Medicines Agency has waived the obligation to submit the results of studies with IMBRUVICA in all subsets of the paediatric population in MCL, CLL and lymphoplasmacytic lymphoma (LPL) (for information on paediatric use, see section 4.2).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka IMBRUVICA u svim podskupinama pedijatrijske populacije za MCL, KLL i limfoplazmocitoidni limfom (LPL) (za informacije o pedijatrijskoj primjeni, vidjeti dio 4.2).
English: • blood thinners such as warfarin, heparin or other medicines for blood clots
Croatian: • lijekove koji razrjeđuju krv, poput varfarina, heparina ili drugih lijekova za krvne ugruške
English: 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.
Croatian: Ibrutinib se metabolizira prvenstveno putem CYP3A4 te nastaje dihidrodiolni metabolit s inhibitornom aktivnošću prema BTK otprilike 15 puta nižom od one ibrutiniba.
English: The prevalence for Grade 3 or greater hypertension was 4% (year 0-1), 6% (year 1-2), 8% (year 2-3), 9% (year 3-4), and 9% (year 4-5).
Croatian: Prevalencija hipertenzije 3. ili višeg stupnja težine iznosila je 4% (0. - 1. godina), 6% (1. - 2. godina), 8% (2. - 3. godina), 9% (3. - 4. godina) i 9% (4. - 5. godina).
English: Defined as increase of ≥2 g/dL over baseline regardless of baseline value, or an increase to >11 g/dL with a ≥0.5 g/dL improvement if baseline was ≤11 g/dL.
Croatian: Definiralo se kao povećanje za ≥ 2 g/dl u odnosu na početnu vrijednost, neovisno o tome koliko je ona iznosila, ili povećanje do > 11 g/dl, uz poboljšanje od ≥ 0,5 g/dl ako je početna vrijednost bila ≤ 11 g/dl.
English: Lower level term (LLT) used for selection.
Croatian: Lower level term, LLT).
English: What you need to know before you take IMBRUVICA
Croatian: Što morate znati prije nego počnete uzimati lijek IMBRUVICA
English: Ibrutinib is a potent, small-molecule inhibitor of Bruton's tyrosine kinase (BTK).
Croatian: Ibrutinib je potentna, mala molekula, inhibitor Brutonove tirozin kinaze (BTK).
English: Your doctor or another healthcare provider may do blood tests to check for TLS.
Croatian: Vaš liječnik ili drugi zdravstveni radnik može zatražiti pretrage krvi kako bi provjerio je li došlo do sindroma lize tumora.
English: Ninety patients randomised to placebo+BR crossed over to receive IMBRUVICA following IRC confirmed progression.
Croatian: Devedeset bolesnika randomiziranih na placebo + BR prešlo je na uzimanje lijeka IMBRUVICA nakon što je nezavisno IRC potvrdio progresiju.
English: Efficacy results for Study CLL3001 are shown in Table 9.
Croatian: Rezultati djelotvornosti za ispitivanje CLL3001 prikazani su u Tablici 9.
English: 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.
Croatian: Bolesnike u kojih se razviju simptomi aritmije ili nova pojava dispneje, omaglice ili nesvjestice mora se klinički procijeniti i ako je indicirano mora im se napraviti elektrokardiogram (EKG).
English: • severe fungal infections
Croatian: • teške gljivične infekcije
English: IMBRUVICA is an anticancer medicine that contains the active substance ibrutinib.
Croatian: IMBRUVICA je lijek protiv raka koji sadrži djelatnu tvar ibrutinib.
English: Number of deaths (%) HR (95% CI)
Croatian: Broj smrti (%) HR (95% CI)
English: BTK's pivotal role in signalling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis and adhesion.
Croatian: Ključna uloga BTK u signaliziranju putem površinskih receptora B-stanica rezultira aktivacijom puteva neophodnih za migraciju, kemotaksiju i adheziju B-stanica.
English: IMBRUVICA may make you bleed more easily.
Croatian: Radi lijeka IMBRUVICA može lakše doći do krvarenja.
English: • confusion, headache with slurred speech or feeling faint - these could be signs of serious internal bleeding in your brain
Croatian: • smetenost, glavobolja praćena nerazgovijetnim govorom ili osjećaj kao da ćete se onesvijestiti to mogu biti znakovi ozbiljnog unutarnjeg krvarenja u mozgu
English: 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.
Croatian: Zahtjev za bolesnike u dobi između 65 i 70 godina bio je prisutnost barem jednog komorbiditeta koji je onemogućavao primjenu prve linije kemoimunoterapije s fludarabinom, ciklofosfamidom i rituksimabom.
English: This may lead to changes in kidney function, abnormal heartbeat, or seizures.
Croatian: To može dovesti do promjena u radu bubrega, poremećaja otkucaja srca ili napadaja.
English: Juvenile toxicity studies have not been conducted.
Croatian: Nisu provedena ispitivanja toksičnosti u mladunčadi.
English: 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.
Croatian: Prestanite uzimati lijek IMBRUVICA i odmah recite liječniku, ako primijetite bilo koju od sljedećih nuspojava: osip s izbočinama koji svrbi, poteškoće s disanjem, oticanje lica, usnica, jezika ili grla - možda imate alergijsku reakciju na lijek.
English: If the toxicity reoccurs, the once daily dose should be reduced by one capsule (140 mg).
Croatian: Ako se toksičnost ponovno pojavi, dnevna doza se mora smanjiti za jednu kapsulu (140 mg).
English: Ibrutinib has no genotoxic properties when tested in bacteria, mammalian cells or in mice.
Croatian: Ibrutinib nije pokazao genotoksična svojstva kada se ispitivao na bakterijama, stanicama sisavaca ili miševima.
English: Patients with CLL who received at least one prior therapy Single agent
Croatian: Bolesnici s KLL koji su prethodno primili najmanje jednu terapiju Monoterapija