FrancophonIA/ELRC3.0 huggingface dataset:
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Croatian: Medijan dobi bio je 68 godina (raspon, 34; 88 godina), 74% bili su muškarci, a 87% bilo je bijele rase.
English: There have been reports of bleeding events in patients treated with IMBRUVICA, both with and without thrombocytopenia.
Croatian: U bolesnika koji su liječeni lijekom IMBRUVICA prijavljeni su događaji krvarenja, povezani s trombocitopenijom i bez nje.
English: The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Croatian: U vrijeme završne analize, 133 (67,9%) od 196 ispitanika koji su prvobitno bili randomizirani za liječenje ofatumumabom prešlo je na liječenje ibrutinibom.
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Croatian: Uz terapiju s lijekom IMBRUVICA bio je prijavljen sindrom lize tumora.
English: Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Croatian: Bolesnici s velikom tumorskom masom prije liječenja imaju rizik za nastanak sindroma lize tumora.
English: Yellow-green to green round tablets (9 mm), debossed with “ibr” on one side and “140” on the other side.
Croatian: Žutozelene do zelene okrugle tablete (9 mm), s utisnutim „ibr” na jednoj strani i „140” na drugoj strani.
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
Croatian: IMBRUVICA 140 mg filmom obložene tablete IMBRUVICA 280 mg filmom obložene tablete IMBRUVICA 420 mg filmom obložene tablete IMBRUVICA 560 mg filmom obložene tablete ibrutinib
English: The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Croatian: Medijan vremena od dijagnoze bio je 6 godina, a medijan broja prethodnih liječenja bio je 2 (raspon, 1 do 11 liječenja).
English: Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Croatian: Slika 4: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1115-CA uz 48-mjesečno praćenje
English: Patients (n=229) were randomized 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity or chlorambucil at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.
Croatian: Bolesnici (n=229) su bili randomizirani u omjeru 1:1 za primanje lijeka IMBRUVICA u dozi od 420 mg na dan do progresije bolesti ili pojave neprihvatljive toksičnosti ili klorambucila u dozi od 0,5 mg/kg 1. i 15. dana svakog 28-dnevnog ciklusa tijekom 6 ciklusa.
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Croatian: Tablica 11: Rezultati djelotvornosti u ispitivanju PCYC-1127-CA
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Croatian: IMBRUVICA 140 mg filmom obložene tablete: jedna tableta sadrži 140 mg ibrutiniba.
English: Cardiac arrhythmia
Croatian: Aritmija srca
English: The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Croatian: Medijan dobi iznosio je 71 godinu (raspon: 40 do 87 godina), 64% ispitanika bili su muškarci, a 96% bijelci.
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Croatian: Medijan dobi bio je 68 godina (raspon: 40 do 84 godina), 77% bili su muškarci, a 92% bijele rase.
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Croatian: Za bolesnike s umjerenim oštećenjem jetre (Child-Pugh stadij B), preporučena doza je 140 mg na dan (jedna kapsula).
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Croatian: Za bolesnike s blagim oštećenjem jetre (Child-Pugh stadij A), preporučena doza je 280 mg na dan (dvije kapsule).
English: Tumour response was assessed according to the revised International Working Group (IWG) for non-Hodgkin's lymphoma (NHL) criteria.
Croatian: International Working Group, IWG) za ne-Hodgkinov limfom (NHL).
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
Croatian: Za bolesnike s umjerenim oštećenjem jetre (Child-Pugh stadij B), preporučena doza je 140 mg na dan.
English: Cases of hepatitis B reactivation have been reported in patients receiving IMBRUVICA.
Croatian: U ispitanika koji su uzimali lijek IMBRUVICA, zabilježeni su slučajevi reaktivacije hepatitisa B.
English: The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA u bolesnika u kojih je kronična limfocitna leukemija prethodno liječena bile su dalje procijenjene u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju faze 3 lijeka IMBRUVICA u kombinaciji s bendamustinom i rituksimabom (BR) naspram placeba + BR (Ispitivanje CLL3001).
English: CI=confidence interval; CR=complete response; HR=hazard ratio; MR=minor response; NE=not estimable; PR=partial response; R=Rituximab; TTnT=time to next treatment; VGPR=very good partial response IRC evaluated.
Croatian: CI = interval pouzdanosti; CR = potpuni odgovor; HR = omjer hazarda; MR = slabi odgovor; NP = ne može se procijeniti; PR = djelomični odgovor; R = rituksimab; VGPR = jako dobar djelomični odgovor Prema ocjeni IRC-a. p-vrijednost povezana sa stopom odgovora iznosila je < 0,0001.
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Croatian: Medijan dobi bio je 63 godine (raspon: 44 do 86 godina), 76% bili su muškarci, i 95% su bili bijele rase.
English: • infections of the urinary tract
Croatian: • infekcije mokraćnog sustava
English: Very common Arthralgia Muscle spasms Musculoskeletal pain
Croatian: Mišićni spazmi Mišićno-koštana bol*
English: 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.
Croatian: Trideset i dva posto bolesnika imalo je deleciju 17p (50% njih imalo je deleciju 17p/mutaciju TP53), 24% imalo je deleciju 11q, dok je 47% bolesnika imalo nemutiran IGHV.
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Croatian: Tablica 8: PFS analiza bolesti u podskupinama (Ispitivanje PCYC-1112-CA) Omjer hazarda
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Croatian: Medijan dobi bio je 67 godina (raspon: 30 do 88 godina), 68% ih je bilo muškog spola i 90% ih je bilo bijele rase.
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Croatian: imbruvica 140 mg
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Croatian: 28 filmom obloženih tableta 30 filmom obloženih tableta
English: • breaking of the nails
Croatian: • pucanje noktiju
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 560 mg sadrži 112 mg laktoze hidrata.
English: IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.
Croatian: IMBRUVICA 560 mg filmom obložene tablete: jedna tableta sadrži 560 mg ibrutiniba.
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Croatian: Tablica 4: Rezultati djelotvornosti u ispitivanju PCYC-1115-CA Ishod
English: At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening.
Croatian: Na početku, 39% bolesnika imalo je veliku tumorsku masu (engl. bulky disease) (≥ 5 cm), 49% imalo je skor visokog rizika prema Pojednostavljenom internacionalnom prognostičkom indeksu za MCL (engl.
English: Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Croatian: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy
Croatian: Borgo S. Michele, 04100 Latina, Italija
English: IMBRUVICA 140 mg film-coated tablets
Croatian: IMBRUVICA 140 mg filmom obložene tablete
English: The recommended dose for the treatment of WM is 420 mg (three capsules) once daily.
Croatian: Preporučena doza lijeka IMBRUVICA je tri kapsule (420 mg) jedanput na dan.
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side.
Croatian: Žute do narančaste duguljaste tablete (19 mm dužine i 8,1 mm širine), s „ibr” ispisanim na jednoj strani i „560” na drugoj strani.
English: IMBRUVICA 420 mg film-coated tablets
Croatian: IMBRUVICA 420 mg filmom obložene tablete
English: IMBRUVICA 560 mg film-coated tablets
Croatian: IMBRUVICA 560 mg filmom obložene tablete
English: Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2.
Croatian: Devedest i jedan posto bolesnika imalo je na početku ECOG funkcionalni status 0 ili 1, a 9% bolesnika imalo je ECOG funkcionalni status 2. Ispitivanje je uključivalo 269 bolesnika s KLL.
English: Uncommon Angioedema Panniculitis
Croatian: Manje često Angioedem Panikulitis*
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Croatian: IMBRUVICA 560 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 560 mg ibrutiniba.
English: Interstitial lung disease
Croatian: Intersticijska bolest pluća*
English: Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Croatian: Bolesnici (n=150) su bili randomizirani u omjeru 1:1 za primanje lijeka IMBRUVICA u dozi od 420 mg na dan ili placeba u kombinaciji s rituksimabom, a liječenje se primjenjivalo do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Croatian: Za bolesnike s blagim oštećenjem jetre (Child-Pugh stadij A), preporučena doza je 280 mg na dan.
English: Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
Croatian: Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700 jjsafety@JNJCR.JNJ.com
English: Table 6: Subgroup Analysis of PFS (Study PCYC-1130-CA) N Hazard Ratio
Croatian: Tablica 6: Analiza PFS-a u podskupinama (ispitivanje PCYC-1130-CA) N Omjer hazarda 95% CI
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatment-naïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA kod WM-a dodatno su se ocjenjivale u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju faze 3 u kojem su prethodno neliječeni ili prethodno liječeni bolesnici s WM-om primali lijek IMBRUVICA u kombinaciji s rituksimabom ili placebo u kombinaciji s rituksimabom (PCYC-1127-CA).
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Croatian: NP = nije procjenjivo; HR = omjer hazarda; CI = interval pouzdanosti; ORR = ukupna stopa odgovora; PFS = preživljenje bez progresije procijenjeno prema IRC-u.
English: IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
Croatian: IMBRUVICA 420 mg filmom obložene tablete: jedna tableta sadrži 420 mg ibrutiniba.
English: PFS Median PFS (95% CI), (months)
Croatian: Medijan PFS-a (95% CI), (mjeseci)
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Croatian: Slika 8: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1127-CA
English: • feeling or being sick (nausea or vomiting)
Croatian: • mučnina ili povraćanje
English: At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Croatian: Na početku ispitivanja 52% bolesnika imalo je uznapredovali klinički stadij bolesti (Rai stadij III ili IV), 32% bolesnika imalo je veliku tumorsku masu (≥ 5 cm), njih 44% je na početku ispitivanja imalo anemiju, a 22% trombocitopeniju, 28% bolesnika imalo je CrCL < 60 ml/min, a medijan rezultata na ljestvici za kumulativnu ocjenu bolesti u starijih bolesnika (engl.
English: Lymphocytosis
Croatian: Limfocitoza
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 140 mg sadrži 28 mg laktoze hidrata.
English: • blurred vision
Croatian: • zamagljen vid
English: IMBRUVICA 280 mg film-coated tablets
Croatian: IMBRUVICA 280 mg filmom obložene tablete
English: IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
Croatian: IMBRUVICA 280 mg filmom obložene tablete: jedna tableta sadrži 280 mg ibrutiniba.
English: The recommended dose for the treatment of MCL is 560 mg once daily.
Croatian: MCL Preporučena doza za liječenje limfoma plaštenih stanica je 560 mg jedanput na dan.
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 420 mg sadrži 84 mg laktoze hidrata.
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), written with “ibr” on one side and “420” on the other side.
Croatian: Žutozelene do zelene duguljaste tablete (17,5 mm dužine i 7,4 mm širine), s „ibr” ispisanim na jednoj strani i „420” na drugoj strani.
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Croatian: IMBRUVICA 420 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 420 mg ibrutiniba.
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Croatian: Žutozelene do zelene duguljaste tablete (dužine 17,5 mm i širine 7,4 mm), s utisnutim „ibr” na jednoj strani i „420” na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Croatian: IMBRUVICA 140 mg tvrde kapsule
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Croatian: IMBRUVICA 280 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 280 mg ibrutiniba.
English: Urticaria Erythema Onychoclasis
Croatian: Prijavljivanje nuspojava
English: Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Croatian: Ljubičaste duguljaste tablete (dužine 15 mm i širine 7 mm), s utisnutim „ibr” na jednoj strani i „280” na drugoj strani.
English: Subdural haematoma
Croatian: Manje često Subduralni hematom
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side.
Croatian: Žute do narančaste duguljaste tablete (dužine 19 mm i širine 8,1 mm), s utisnutim „ibr” na jednoj strani i „560” na drugoj strani.
English: Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy.
Croatian: Nakon primjene ibrutiniba uz prethodno ili konkomitantno imunosupresivno liječenje, prijavljeni su slučajevi progresivne multifokalne leukoencefalopatije (PML), uključujući i one sa smrtnim ishodom.
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Croatian: Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 280 mg sadrži 56 mg laktoze hidrata.
English: • Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171); IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172); IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172); IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
Croatian: Jezgra tablete: koloidni, bezvodni silicijev dioksid, umrežena karmelozanatrij, laktoza hidrat (vidjeti dio 2 „IMBRUVICA sadrži laktozu“), magnezijev stearat, mikrokristalična celuloza, povidon, natrijev laurilsulfat (E487) Film ovojnica tablete: poli(vinilni alkohol), makrogol, talk, titanijev dioksid (E171) IMBRUVICA 140 mg i IMBRUVICA 420 mg filmom obložene tablete također sadrže crni željezov oksid (E172) i žuti željezov oksid (E172);
English: Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
Croatian: U objedinjenim komparativnim, randomiziranim ispitivanjima faze 3, prijavljen je nemelanomski rak kože s većom učestalošću u bolesnika liječenih lijekom IMBRUVICA nego u bolesnika liječenih poredbenim lijekovima.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Croatian: OMOT 420 MG TABLETE (30 dana)
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Croatian: MCL Preporučena doza za liječenje limfoma plaštenih stanica je 560 mg (četiri kapsule) jedanput na dan.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Croatian: OMOT 560 MG TABLETE (30 dana)
English: Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Croatian: Na početku ispitivanja 81% bolesnika imalo je ECOG funkcionalni status 0 ili 1, dok je njih 19% imalo ECOG funkcionalni status 2. Medijan broja prethodnih terapija iznosio je 4 (raspon: 1 do 7 terapija).
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Croatian: Medijan dobi iznosio je 69 godina (raspon: 36 do 89 godina), 66% ispitanika bili su muškarci, a 79% bijelci.
English: • Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see section 2 “IMBRUVICA contains lactose”), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).
Croatian: Jezgra tablete silicijev dioksid, koloidni, bezvodni karmelozanatrij, umrežena laktoza hidrat magnezijev stearat celuloza, mikrokristalična povidon natrijev laurilsulfat (E487)
English: The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Croatian: Sigurnost i djelotvornost lijeka IMBRUVICA dodatno su se ocjenjivale u randomiziranom, multicentričnom, otvorenom ispitivanju faze 3 (PCYC-1130-CA) provedenom u prethodno neliječenih bolesnika s KLL-om/LMS-om koji su primali lijek IMBRUVICA u kombinaciji s obinutuzumabom ili klorambucil u kombinaciji s obinutuzumabom.
English: Study PCYC-1127-CA had a separate monotherapy arm of 31 patients with previously treated WM who failed prior rituximab-containing therapy and received single agent IMBRUVICA.
Croatian: Obuhvaćala je 31 bolesnika s prethodno liječenim WM-om koji nisu odgovorili na prethodnu terapiju koja je sadržavala rituksimab i koji su primali lijek IMBRUVICA u monoterapiji.
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Croatian: Slika 5: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1130-CA
English: How to take IMBRUVICA
Croatian: KAKO UZIMATI LIJEK IMBRUVICA
English: HOW TO TAKE IMBRUVICA
Croatian: Kako uzimati lijek IMBRUVICA
English: • liver failure
Croatian: • zatajenje jetre
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Croatian: OMOT 560 MG TABLETE (28 dana)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Croatian: OMOT 280 MG TABLETE (30 dana)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Croatian: IMBRUVICA 560 mg tablete ibrutinib
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Croatian: OMOT 420 MG TABLETE (28 dana)
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Croatian: 14 filmom obloženih tableta
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Croatian: Slika 6: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1112- CA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Croatian: OMOT 280 MG TABLETE (28 dana)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Croatian: IMBRUVICA 420 mg tablete ibrutinib
English: • back pain or joint pain
Croatian: • bol u leđima ili zglobovima
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Croatian: Stopa potpunog odgovora prema kriterijima IWCLL-a iznosila je 16,2% u skupini liječenoj lijekom IMBRUVICA te 3,0% u onoj koja je primala klorambucil.
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Croatian: Stopa odgovora (CR, VGPR, PR)
English: Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Croatian: U bolesnika liječenih lijekom IMBRUVICA prijavljeni su slučajevi leukostaze.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Croatian: IMBRUVICA 280 mg tablete ibrutinib
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Croatian: Kada se uzima istodobno s umjerenim CYP3A4 inhibitorima, doza ibrutiniba mora se sniziti na 280 mg jedanput na dan (dvije kapsule).
English: Purple oblong (15 mm in length and 7 mm in width), written with “ibr” on one side and “280” on the other side.
Croatian: Ljubičaste duguljaste tablete (15 mm dužine i 7 mm širine), s „ibr” ispisanim na jednoj strani i „280” na drugoj strani.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Croatian: OMOT 140 MG TABLETE (30 dana)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Croatian: IMBRUVICA 140 mg tablete ibrutinib
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Croatian: OMOT 140 MG TABLETE (28 dana)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Croatian: IMBRUVICA 140 mg filmom obložene tablete ibrutinib
English: Warfarin or other vitamin K antagonists should not be administered concomitantly with IMBRUVICA.
Croatian: Varfarin ili drugi antagonisti vitamina
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Croatian: IMBRUVICA 420 mg filmom obložene tablete ibrutinib
English: Per IRC.
Croatian: Via C.
English: Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.
Croatian: Preporučena doza za liječenje Waldenströmove makroglobulinemije je 420 mg (tri kapsule) jedanput na dan.
English: The recommended dose for the treatment of WM is 420 mg once daily.
Croatian: Preporučena doza za liječenje Waldenströmove makroglobulinemije je 420 mg jedanput na dan.
English: Others
Croatian: DRUGO