FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Učinak liječenja ibrutinibom bio je dosljedan u cijeloj populaciji visokorizičnih bolesnika s KLL-om/LMS-om (delecija 17p/mutacija TP53, delecija 11q ili nemutirani IGHV), pri čemu je HR za PFS iznosio 0,15 [95% CI (0,09; 0,27)], kao što je prikazano u Tablici
English: IMBRUVICA Hard Capsules Janssen Pharmaceutica NV Turnhoutseweg 30
Croatian: IMBRUVICA tvrde kapsule Janssen Pharmaceutica NV Turnhoutseweg 30
English: Severe cardiac disease Patients with severe cardiovascular disease were excluded from IMBRUVICA clinical studies.
Croatian: Bolesnici s teškom kardiovaskularnom bolesti nisu bili uključeni u klinička ispitivanja lijeka IMBRUVICA.
English: CI=confidence interval; DOR=duration of response; NR=not reached; MR=minor response; PR=partial response; VGPR=very good partial response; ORR=MR+PR+VGPR Median follow-up time on study=14.8 months
Croatian: CI = interval pouzdanosti; DOR = trajanje odgovora; ND = nije dostignuto; MR = slab odgovor; PR = djelomičan odgovor; VGPR = jako dobar djelomičan odgovor; ORR = MR+PR+VGPR Medijan trajanja praćenja u sklopu ispitivanja = 14,8 mjeseci
English: Fourth discontinue IMBRUVICA
Croatian: Četvrta prekinite primjenu lijeka IMBRUVICA
English: Third restart at 280 mg daily restart at 140 mg daily
Croatian: Treća započnite ponovno s 280 mg na dan započnite ponovno sa 140 mg na dan
English: Simulations using fasted conditions suggested that the mild CYP3A4 inhibitors azithromycin and fluvoxamine may increase the AUC of ibrutinib by <2-fold.
Croatian: Simulacije u stanju natašte ukazale su da slabi CYP3A4 inhibitori azitromicin i fluvoksamin mogu povećati AUC ibrutiniba za < 2 puta.
English: 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).
Croatian: Ibrutinib je uzrokovao malformacije u kunića u dozi od 15 mg/kg/dan (otprilike 2,0 puta izloženost (AUC) u bolesnika s MCL-om kojima je primijenjen ibrutinib 560 mg na dan i 2,8 puta izloženost u bolesnika s KLL-om ili WM-om koji su primali ibrutinib u dozi od 420 mg na dan).
English: All PRs achieved; p<0.0001 for ORR.
Croatian: Svi postignuti djelomični odgovori; p < 0,0001 za ukupnu stopu odgovora.
English: • medicines called antibiotics to treat bacterial infections - clarithromycin, telithromycin,
Croatian: • lijekove koji se nazivaju antibiotici za liječenje bakterijskih infekcija- klaritromicin,
English: Administer supportive care including hydration and/or cytoreduction as indicated.
Croatian: Prema potrebi, primijenite potporne mjere uključujući hidrataciju i/ili citoredukciju.
English: 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).
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA bile su dokazane u randomiziranom, otvorenom, multicentričnom ispitivanju faze 3 koje je uključilo 280 bolesnika s MCL-om koji su prethodno primili barem jednu terapiju (Ispitivanje MCL3001).
English: IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Croatian: IMBRUVICA je u monoterapiji indicirana za liječenje odraslih bolesnika s relapsnim ili refraktornim limfomom plaštenih stanica (engl. mantle cell lymphoma, MCL).
English: Do not take extra doses to make up the missed dose.
Croatian: Nemojte uzimati dodatne doze kako biste nadoknadili propuštenu dozu.
English: There are no data in patients with severe renal impairment or patients on dialysis (see section 4.2).
Croatian: Nema podataka u bolesnika s teškim oštećenjem bubrega ili u bolesnika na dijalizi (vidjeti dio 4.2).
English: The patient should not take extra tablets to make up the missed dose.
Croatian: Bolesnici ne smiju uzeti dodatne tablete kako bi nadoknadili propuštenu dozu.
English: IMBRUVICA therapy should be withheld for any new onset or worsening grade ≥3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities.
Croatian: Liječenje lijekom IMBRUVICA mora se prekinuti za svaku novu pojavu ili pogoršanje ne-hematološke toksičnosti stupnja ≥ 3, neutropenije s infekcijom ili vrućicom stupnja 3 ili višeg, ili hematološke toksičnosti stupnja 4. Jednom kada se simptomi toksičnosti povuku na stupanj 1 ili vrate na početno stanje (oporavak), liječenje lijekom IMBRUVICA se može ponovno započeti s početnom dozom.
English: Urinary tract infection Sinusitis
Croatian: Infekcija mokraćnog sustava Sinusitis*
English: A randomised, multi-center, open-label phase 3 study of IMBRUVICA versus ofatumumab (PCYC-1112-CA) was conducted in patients with relapsed or refractory CLL.
Croatian: Randomizirano, multicentrično, otvoreno ispitivanje faze 3 lijeka IMBRUVICA naspram ofatumumaba (PCYC-1112-CA) bilo je provedeno u bolesnika s relapsnim ili refraktornim KLL-om.
English: Regularly monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust antihypertensive medication throughout treatment with IMBRUVICA as appropriate.
Croatian: Bolesnicima koji uzimaju lijek IMBRUVICA treba redovito kontrolirati krvni tlak te po potrebi uvesti ili prilagoditi terapiju antihipertenzivima tijekom liječenja lijekom IMBRUVICA.
English: With a median follow-up time on study of 65 months in Study PCYC-1112-CA, an 85% reduction in the risk of death or progression by investigator assessment was observed for patients in the IMBRUVICA arm.
Croatian: Uz medijan od 65 mjeseci praćenja u sklopu ispitivanja PCYC-1112-CA, u skupini koja je primala lijek IMBRUVICA opaženo je smanjenje rizika od smrti ili progresije bolesti za 85% prema ocjeni ispitivača.
English: 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.
Croatian: Uz medijan od 48 mjeseci praćenja u sklopu ispitivanja PCYC-1115-CA i njegova produžetka, u skupini liječenoj lijekom IMBRUVICA opaženo je smanjenje rizika od smrti ili progresije bolesti za 86% prema ocjeni ispitivača.
English: The safety and efficacy of IMBRUVICA in patients with relapsed or refractory MCL were evaluated in a single open-label, multi-center phase 2 study (PCYC-1104-CA) of 111 patients.
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA u bolesnika s relapsnim ili refraktornim MCL-om bile su procijenjene u jednom otvorenom, multicentričnom ispitivanju faze 2 (PCYC-1104-CA) na 111 bolesnika.
English: Monitor for signs and symptoms of bleeding.
Croatian: Bolesnike je potrebno pratiti zbog moguće pojave znakova i simptoma krvarenja.
English: The corresponding increase in unbound ibrutinib exposure (AUCunbound, last) is estimated to be 4.1-, 9.8-, and 13-fold in subjects with mild, moderate, and severe hepatic impairment, respectively (see section 4.2).
Croatian: Odgovarajuće povećanje izloženosti nevezanom ibrutinibu (AUCnevezani, last) procijenjeno je na 4,1 puta u ispitanika s blagim, 9,8 puta u ispitanika s umjerenim i 13 puta u ispitanika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: Mildly decreased trabecular and cortical bone was seen in female rats administered ≥100 mg/kg/day (AUC exposure margin of 20.3-fold).
Croatian: Blago smanjena trabekularna i kortikalna kost uočena je kod ženki štakora kod primjene ≥ 100 mg/kg/dan (granica AUC izloženosti od 20,3 puta).
English: • fast heart rate, missed heart beats, weak or uneven pulse, lightheadedness, shortness of breath,
Croatian: • ubrzani puls, propušteni otkucaji srca, slab ili neravnomjeran puls, ošamućenost, nedostatak zraka, nelagoda u prsnom košu (simptomi problema sa srčanim ritmom)
English: Median DOR months (range)
Croatian: Medijan DOR mjeseci (raspon)
English: Use of preparations containing St. John's Wort is contraindicated in patients treated with IMBRUVICA.
Croatian: Uzimanje pripravaka koji sadrže gospinu travu je kontraindicirano u bolesnika koji uzimaju lijek IMBRUVICA.
English: • acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen
Croatian: • acetilsalicilatnu kiselinu i nesteroidne protuupalne lijekove poput ibuprofena ili naproksena
English: Strong inhibitors of CYP3A4 (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazodon, cobicistat, voriconazole and posaconazole) should be avoided.
Croatian: Snažni inhibitori CYP3A4 (npr. ketokonazol, indinavir, nelfinavir, ritonavir, sakvinavir, klaritromicin, telitromicin, itrakonazol, nefazodon, kobicistat, vorikonazol i posakonazol) moraju se izbjegavati.
English: Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid depletion in rats and dogs with a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day in both species.
Croatian: Otkriveno je da ibrutinib inducira gastrointestinalne učinke (mekana stolica/proljev i/ili upala) i limfoidnu depleciju u štakora i u pasa, s razinom bez opaženih štetnih učinaka (engl.
English: In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken.
Croatian: Kod bolesnika koji tijekom uzimanja lijeka IMBRUVICA razviju fibrilaciju atrija, potrebno je detaljno procijeniti rizik od tromboembolijske bolesti.
English: Progression free survival (PFS) was assessed by IRC according to IWCLL criteria.
Croatian: Preživljenje bez progresije (PFS) procijenjeno je prema IRC-u prema IWCLL kriterijima.
English: IMBRUVICA+Obinutuzumab N=113
Croatian: + obinutuzumab N=113
English: The safety and efficacy of IMBRUVICA in WM (IgM-excreting lymphoplasmacytic lymphoma) were evaluated in an open-label, multi-center, single-arm trial of 63 previously treated patients.
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA u WM-u (limfoplazmocitoidni limfom s IgM ekskrecijom ) su procijenjene u otvorenom, multicentričnom ispitivanju s jednom skupinom od 63 prethodno liječenih bolesnika.
English: Consider alternative agents with less CYP3A4 induction.
Croatian: Razmotrite alternativne lijekove koji su slabiji CYP3A4 induktori.
English: 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.
Croatian: Na početku, 53% bolesnika imalo je veliku tumorsku masu (≥ 5 cm), 21% imalo je skor visokog rizika prema Pojednostavljenom MIPI indeksu, 60% imalo je ekstranodalnu bolest i 54% imalo je zahvaćenost koštane srži pri probiru.
English: • weakness, numbness, tingling or pain in your hands or feet or other parts of the body (peripheral neuropathy).
Croatian: • slabost, utrnulost, trnci ili bol u Vašim šakama ili stopalima ili drugim dijelovima tijela
English: HDPE bottles with a child-resistant polypropylene closure.
Croatian: HDPE boce sa sigurnosnim čepom za djecu od polipropilena.
English: IMBRUVICA was administered orally at 560 mg once daily until disease progression or unacceptable toxicity.
Croatian: IMBRUVICA je bila primijenjena peroralno, u dozi od 560 mg jedanput dnevno do progresije bolesti ili neprihvatljive toksičnosti.
English: Each carton contains (28 film-coated tablets) 2 wallets.
Croatian: Svaka kutija sadrži (28 filmom obloženih tableta) 2 omota.
English: • medicines called calcium channel blockers for high blood pressure or chest pain - diltiazem or verapamil
Croatian: • lijekove za visoki krvni tlak ili bol u prsnom košu, koji se zovu blokatori kalcijevih kanala diltiazem ili verapamil
English: If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek.
English: Hypertension has occurred in patients treated with IMBRUVICA (see section 4.8).
Croatian: U bolesnika liječenih lijekom IMBRUVICA zabilježena je hipertenzija (vidjeti dio 4.8).
English: 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.
Croatian: Ibrutinib u dozi od 15 mg/kg/dan ili višoj bio je povezan s koštanim malformacijama (fuzija sternebri), a ibrutinib u dozi od 45 mg/kg/dan bio je povezan s povećanim postimplantacijskim gubitkom u skotnih kunića.
English: 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.
Croatian: Bolesnici su bili randomizirani 1:1 kako bi primili ili 560 mg lijeka IMBRUVICA peroralno jedanput dnevno tijekom perioda od 21 dana ili 175 mg temsirolimusa intravenski 1., 8., 15. dan u prvom ciklusu nakon čega je slijedilo 75 mg 1., 8., 15. dan svakog sljedećeg 21-dnevnog ciklusa.
English: • The other ingredients are: capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauril sulfate (E487) capsule shell: gelatin and titanium dioxide (E171) printing ink: shellac, black iron oxide (E172), and propylene glycol (E1520).
Croatian: • Drugi sastojci su: sadržaj kapsule: umrežena karmelozanatrij, magnezijev stearat, mikrokristalična celuloza i natrijev laurilsulfat (E487) ovojnica kapsule: želatina i titanijev dioksid (E171) tinta za označavanje: šelak, crni željezov oksid (E172) i propilenglikol (E1520).
English: How IMBRUVICA works
Croatian: Kako IMBRUVICA djeluje
English: Not reached (1.9+, 36.4+)
Croatian: Nije dostignut (1,9+; 36,4+) 24,8 (1,9; 30,3+)
English: Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4).
Croatian: Pažljivo pratite bolesnika na toksičnost i prema potrebi slijedite smjernice za prilagodbu doze (vidjeti dijelove 4.2 i 4.4).
English: HR (95% CI) Overall Response Rate CR
Croatian: HR (95% CI) Ukupna stopa odgovora
English: Monitor patient closely for toxicity and follow dose modification guidance as needed.
Croatian: Pratite bolesnika pažljivo na toksičnost i prema potrebi slijedite smjernice za prilagodbu doze.
English: Progression Free Survival Number of events (%) Median (95% CI), months
Croatian: Preživljenje bez progresije bolesti Broj događaja (%) Medijan (95% CI), mjeseci
English: First restart at 560 mg daily restart at 420 mg daily
Croatian: Prva započnite ponovno s 560 mg na dan započnite ponovno s 420 mg na dan
English: 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).
Croatian: Zbog toga je fetalni NOAEL bio 5 mg/kg/dan (otprilike 0,7 puta AUC ibrutiniba u dozi od 560 mg na dan) (vidjeti dio 4.6).
English: Cases of invasive fungal infections, including cases of Aspergillosis, Cryptococcosis and Pneumocystis jiroveci infections have been reported following the use of ibrutinib.
Croatian: Nakon primjene ibrutiniba prijavljeni su slučajevi invazivnih gljivičnih infekcija, uključujući slučajeve aspergiloze, kriptokokoze i infekcija gljivicom Pneumocystis jiroveci.
English: 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.
Croatian: Omjeri hazarda za PFS u prethodno neliječenih i prethodno liječenih bolesnika te u bolesnika s mutacijama L265P u genu MYD88 i bolesnika bez navedenih mutacija odgovarali su omjeru hazarda za PFS u ITT populaciji.
English: Not reached HR=0.203 [95% CI: 0.150, 0.276]
Croatian: Nije dostignuto HR = 0,203 [95% CI: 0,150; 0,276]
English: Women of child-bearing potential/Contraception in females Based on findings in animals, IMBRUVICA may cause foetal harm when administered to pregnant women.
Croatian: Na temelju nalaza u životinja, IMBRUVICA može izazvati oštećenja fetusa ako se primjenjuje trudnicama.
English: The median investigator-assessed PFS2 (time from randomisation until PFS event after first subsequent anti-neoplastic therapy) according to IWCLL criteria was 65.4 months [95% CI (51.61, not estimable)] in the IMBRUVICA arm and 38.5 months [95% CI (19.98, 47.24)] in the ofatumumab arm, respectively; HR=0.54 [95% CI (0.41, 0.71)].
Croatian: Medijan PFS2 prema ocjeni ispitivača (vrijeme od randomizacije do PFS događaja nakon prve sljedeće terapije antineoplasticima) na temelju kriterija IWCLL-a iznosio je 65,4 mjeseca [95% CI (51,61; nije procjenjivo)] u skupini liječenoj lijekom IMBRUVICA i 38,5 mjeseci [95% CI (19,98; 47,24)] u onoj liječenoj ofatumumabom; HR=0,54 [95% CI (0,41; 0,71)].
English: What IMBRUVICA is
Croatian: Što je IMBRUVICA
English: Table 3: Efficacy Results in patients with relapsed or refractory MCL (Study MCL3001) Endpoint
Croatian: Tablica 3: Rezultati djelotvornosti u bolesnika s relapsnim ili refraktornim MCL-om (Ispitivanje MCL3001)
English: Any grade infusion-related reactions were observed in 25% of patients treated with IMBRUVICA+obinutuzumab and 58% of patients treated with chlorambucil+obinutuzumab.
Croatian: Reakcije na infuziju bilo kojeg stupnja težine opažene su u 25% bolesnika liječenih lijekom IMBRUVICA u kombinaciji s obinutuzumabom te u 58% onih koji su primali klorambucil plus obinutuzumab.
English: IMBRUVICA Film-Coated Tablets Janssen-Cilag SpA Via C. Janssen,
Croatian: IMBRUVICA filmom obložene tablete Janssen-Cilag SpA
English: If symptoms develop, interrupt IMBRUVICA and manage ILD appropriately.
Croatian: Ukoliko se razviju simptomi, privremeno ukinite lijek IMBRUVICA iz terapije i prikladno liječite intersticijsku bolest pluća.
English: Progression-free survival (PFS) was assessed by IRC according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Croatian: Preživljenje bez progresije (engl. progression free survival, PFS) bilo je procijenjeno od strane IRC-a prema revidiranim kriterijima Međunarodne radne skupine za non-Hodgkinov limfom (NHL).
English: There are no data from the use of IMBRUVICA in pregnant women.
Croatian: Nema podataka o primjeni lijeka IMBRUVICA u trudnica.
English: CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
Croatian: CI = interval pouzdanosti; CR = kompletni odgovor; DOR = trajanje odgovora; ORR = ukupna stopa odgovora; PR = djelomični odgovor; ND = nije dostignuto
English: 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.
Croatian: U bolesnika s malignim bolestima B-stanica koji uzimaju lijek IMBRUVICA s hranom, istodobna primjena snažnog CYP3A4 inhibitora vorikonazola povisila je Cmax za 6,7 puta i AUC za 5,7 puta.
English: The Kaplan-Meier landmark estimate for OS at 48-months was 85.5% in the IMBRUVICA arm.
Croatian: U skupini koja je primala lijek IMBRUVICA procijenjeni OS prema Kaplan-Meieru u 48. mjesecu kao ključnoj vremenskoj točki iznosio je 85,5%.
English: 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.
Croatian: Randomizirano, multicentrično, otvoreno ispitivanje faze 3 (PCYC-1115-CA) s lijekom IMBRUVICA naspram klorambucila provedeno je u bolesnika u dobi od 65 godina ili starijih koji prehodno nisu bili liječeni za KLL.
English: The ORR and DOR were assessed using criteria adopted from the Third International Workshop of WM.
Croatian: ORR i DOR (engl. duration of response, trajanje odgovora) bili su procijenjeni uz korištenje kriterija usvojenih na trećoj internacionalnoj radionici o WM (engl. the Third International Workshop of Waldenström's macroglobulinaemia).
English: 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.
Croatian: Reakcije na infuziju 3. ili 4. stupnja težine opažene su u 1% bolesnika koji su primali lijek IMBRUVICA plus rituksimab te u 16% onih koji su primali placebo plus rituksimab.
English: • medicines called kinase inhibitors for treatment of other cancers - crizotinib or imatinib
Croatian: • lijekove za liječenje drugih vrsta raka, koji se zovu inhibitori kinaza - krizotinib, imatinib
English: Tests and check-ups before and during treatment Tumour lysis syndrome (TLS): 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.
Croatian: Sindrom lize tumora: tijekom liječenja raka, a ponekad čak i bez liječenja pojavile su se neuobičajene razine kemijskih tvari u krvi uzrokovane brzim raspadom stanica raka.
English: Capsule content Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium lauril sulfate (E487)
Croatian: Sadržaj kapsule karmelozanatrij, umrežena magnezijev stearat celuloza, mikrokristalična natrijev laurilsulfat (E487)
English: Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Croatian: Citopenije stupnja 3 ili 4 nastale tijekom liječenja (neutropenija, trombocitopenija i anemija) bile su prijavljene u bolesnika liječenih lijekom IMBRUVICA.
English: Number of events (%) Median (95% CI), months
Croatian: Broj događaja (%) Medijan (95% CI), mjeseci
English: 90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
Croatian: C]-ibrutiniba u zdravih ispitanika, otprilike 90% radioaktivnosti izlučilo se unutar 168 sati, većim dijelom (80%) izlučilo se fecesom, a < 10% mokraćom.
English: 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).
Croatian: Preporučena doza za liječenje kronične limfocitne leukemije, bilo u monoterapiji ili u kombinaciji, je 420 mg jedanput na dan (za detalje kombiniranog režima liječenja, vidjeti dio 5.1).
English: 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).
Croatian: Preporučena doza za liječenje kronične limfocitne leukemije, bilo u monoterapiji ili u kombinaciji, je 420 mg (tri kapsule) jedanput na dan (za detalje kombiniranog režima liječenja, vidjeti dio 5.1).
English: No effects on fertility or reproductive capacities were observed in male or female rats up to the maximum dose tested, 100 mg/kg/day (HED 16 mg/kg/day).
Croatian: Nisu zabilježeni učinci na plodnost ili reproduktivne kapacitete u mužjaka ili ženki štakora do maksimalne ispitane doze, 100 mg/kg/dan (HED 16 mg/kg/dan).
English: Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma
Croatian: Nemelanomski rak kože* Karcinom bazalnih stanica Karcinom skvamoznih stanica
English: 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.
Croatian: Reakcije na infuziju 3. i višeg stupnja težine ili ozbiljne reakcije na infuziju opažene su u 3% bolesnika liječenih lijekom IMBRUVICA u kombinaciji s obinutuzumabom te u 9% onih koji su primali klorambucil plus obinutuzumab.
English: Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Croatian: Atrijska fibrilacija Manje često Ventrikularna tahiaritmija*