FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovak: U samcov a samíc potkanov sa pri maximálnych skúšaných dávkach až do 100 mg/kg/deň (HED 16 mg/kg/deň) nepozorovali žiadne vplyvy na fertilitu ani na reprodukčné schopnosti.
English: Do not break or chew.
Slovak: Nelámte ju ani nežujte.
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Slovak: Odporúčaná dávka pre liečbu MCL je 560 mg (štyri kapsuly) jedenkrát denne.
English: IMBRUVICA contains lactose
Slovak: IMBRUVICA obsahuje laktózu
English: If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Slovak: Ak sa opäť vyskytne toxicita, dávka jedenkrát denne sa má znížiť o 140 mg.
English: Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Slovak: Atriálna fibrilácia Menej časté Ventrikulárna tachyarytmia*
English: HR=0.434 [95% CI: 0.238; 0.789] HR=0.387 [95% CI: 0.216; 0.695]
Slovak: 0,387 [95 % IS: 0,216; 0,695]
English: The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Slovak: Medián veku bol 73 rokov (rozpätie 65 až 90 rokov), 63 % bolo mužov a 91 % bolo belochov.
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.
Slovak: Purpurovočervené podlhovasté tablety (15 mm dlhé a 7 mm široké), označené „ibr“ na jednej strane a „280“ na druhej strane.
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.
Slovak: 150) boli randomizovaní v pomere 1:1 buď na IMBRUVICA 420 mg denne, alebo na placebo v kombinácii s rituximabom až do progresie ochorenia alebo neprijateľnej toxicity.
English: All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%).
Slovak: Všetci pacienti mali východiskový výkonnostný stav podľa ECOG 0 (48
English: Rituximab was administered weekly at a dose of 375 mg/m2 for 4 consecutive weeks (weeks 1-4) followed by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20).
Slovak: Rituximab sa podával týždenne v dávke 375 mg/m2 počas 4 po sebe nasledujúcich týždňov (1.
English: The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia.
Slovak: 5 %) boli neutropénia, pneumónia a trombocytopénia.
English: Lower level term (LLT) used for selection.
Slovak: Názov nižšej úrovne (LLT, z angl.
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).
Slovak: Bezpečnosť a účinnosť IMBRUVICA u pacientov s predchádzajúcou liečbou CLL boli ďalej hodnotené v randomizovanej, multicentrickej, dvojito zaslepenej štúdii fázy 3 s IMBRUVICA v kombinácii s BR v porovnaní s placebom + BR (štúdia CLL3001).
English: IMBRUVICA 140 mg hard capsules ibrutinib
Slovak: IMBRUVICA 140 mg tvrdé kapsuly ibrutinib
English: Table 5: Efficacy results in Study PCYC-1130-CA
Slovak: Tabuľka 5: Výsledky účinnosti v štúdii PCYC-1130-CA
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Slovak: U pacientov s ľahkou poruchou funkcie pečene (Childova-Pughova trieda A) je odporúčaná dávka 280 mg denne (dve kapsuly).
English: Sepsis
Slovak: Sepsa*
English: Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Slovak: Obrázok 4: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii PCYC-1115-CA s followup 48 mesiacov
English: 30 film-coated tablets
Slovak: 10 filmom obalených tabliet
English: The median investigator-assessed PFS according to IWCLL criteria was 44.1 months [95% CI (38.47, 56.18)] in the IMBRUVICA arm and 8.1 months [95% CI (7.79, 8.25)] in the ofatumumab arm, respectively; HR=0.15 [95% CI (0.11, 0.20)].
Slovak: Medián PFS hodnotený skúšajúcim podľa kritérií IWCLL bol 44,1 mesiaca [95 % IS (38,47; 56,18)] v skupine s IMBRUVICA a 8,1 mesiaca [95
English: 120 hard capsules
Slovak: 90 tvrdých kapsúl 120 tvrdých kapsúl
English: Transient ischaemic attack Ischaemic stroke a, #
Slovak: Prechodný ischemický záchvat Ischemická cievna mozgová príhoda a, #
English: The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Slovak: Medián veku bol 71 rokov (rozpätie: 40 až 87 rokov), 64 % boli muži a 96 % boli belosi.
English: Very common Neutropenia Thrombocytopenia
Slovak: Veľmi časté Neutropénia Trombocytopénia
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Slovak: Pri liečbe s IMBRUVICA bol hlásený syndróm lýzy tumoru.
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.
Slovak: Žlté až oranžové podlhovasté tablety (19 mm dlhé a 8,1 mm široké), označené „ibr“ na jednej strane a „560“ na druhej strane.
English: Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Slovak: Obrázok 1: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii MCL3001
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
Slovak: IMBRUVICA 140 mg filmom obalené tablety IMBRUVICA 280 mg filmom obalené tablety IMBRUVICA 420 mg filmom obalené tablety IMBRUVICA 560 mg filmom obalené tablety
English: Very common Arthralgia Muscle spasms Musculoskeletal pain
Slovak: Veľmi časté Artralgia Svalové kŕče Bolesť svalov a kostí*
English: A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
Slovak: U niektorých pacientov bol pozorovaný vysoký nárast počtu cirkulujúcich lymfocytov (napr.
English: IMBRUVICA+Obinutuzumab N=113
Slovak: IMBRUVICA + Obinutuzumab
English: Yellow-green to green round tablets (9 mm), debossed with “ibr” on one side and “140” on the other side.
Slovak: Žltozelené až zelené okrúhle tablety (9 mm), označené „ibr“ na jednej strane a „140“ na druhej strane.
English: INFORMATION IN BRAILLE Imbruvica 280 mg
Slovak: imbruvica 280 mg
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).
Slovak: 9 % (3. - 4. rok) a 9 % (4. - 5. rok).
English: How IMBRUVICA works
Slovak: Ako IMBRUVICA účinkuje
English: At a median duration follow up of 16.4 months, the ORR by IRC for the 51 relapsed or refractory patients was 64.7% (95% CI: 50.1%; 77.6%), all PRs.
Slovak: Podľa IRC bola ORR pri následnom sledovaní s mediánom 16,4 mesiacov u 51 pacientov s relabujúcim alebo refraktérnym ochorením 64,7
English: The median time since diagnosis was 74 months, and the median number of prior treatments was 2 (range: 1 to 11 treatments).
Slovak: Medián času od stanovenia diagnózy bol 74 mesiacov a medián počtu predchádzajúcich terapií bol 2 (rozpätie: 1 až 11 terapií).
English: Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5).
Slovak: Dihydrodiolový metabolit a iné metabolity sú substrátmi P-gp. Ibrutinib je in vitro inhibítorom P-gp a BCRP (pozri časť 4.5).
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
Slovak: IMBRUVICA 140 mg filmom obalené tablety IMBRUVICA 280 mg filmom obalené tablety IMBRUVICA 420 mg filmom obalené tablety IMBRUVICA 560 mg filmom obalené tablety ibrutinib
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Slovak: NÁLEPKA NA FĽAŠI 140 MG KAPSULA
English: Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Slovak: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: Absolute bioavailability in fasted condition (n=8) was 2.9% (90% CI=2.1 - 3.9) and doubled when combined with a meal.
Slovak: 2,1 - 3,9) a bola dvojnásobná, keď sa liek skombinoval s jedlom.
English: INFORMATION IN BRAILLE Imbruvica 560 mg
Slovak: imbruvica 560 mg
English: Janssen-Cilag, S.A. Tel: +34 91 722 81 00 contacto@its.jnj.com
Slovak: Tel: +34 91 722 81 00 contacto@its.jnj.com
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Slovak: Medián veku bol 68 rokov (rozpätie 34; 88 rokov), 74 % boli muži a 87 % boli belosi.
English: Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
Slovak: U pacientov liečených s IMBRUVICA bola hlásená atriálna fibrilácia, atriálny flutter a prípady ventrikulárnej tachyarytmie.
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatmentnaïve 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).
Slovak: Bezpečnosť a účinnosť IMBRUVICA pri WM bola ďalej hodnotená u pacientov bez predchádzajúcej liečby alebo s predchádzajúcou liečbou WM v randomizovanej, multicentrickej, dvojito zaslepenej štúdii fázy 3 s IMBRUVICA v kombinácii s rituximabom v porovnaní s placebom v kombinácii s rituximabom (PCYC-1127-CA).
English: Cases of ILD have been reported in patients treated with IMBRUVICA.
Slovak: U pacientov liečených s IMBRUVICA boli hlásené prípady ILD.
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Slovak: V úvode bol medián hladiny IgM v sére 3,2 g/dl (rozpätie: 0,6 až 8,3 g/dl), 63 % pacientov bolo anemických (hemoglobín ≤ 11 g/dl alebo 6,8 mmol/l) a mutácie MYD88 L265P
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Slovak: Medián veku bol 67 rokov (rozpätie: 30 až 88 rokov), 68 % bolo mužov a 90 % bolo belochov.
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.
Slovak: Žltozelené až zelené podlhovasté tablety (17,5 mm dlhé a 7,4 mm široké), označené „ibr“ na jednej strane a „420“ na druhej strane.
English: The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Slovak: Medián času od diagnózy bol 91 mesiacov a medián počtu predchádzajúcich terapií bol 2 (rozpätie: 1 až 13 terapií).
English: INFORMATION IN BRAILLE Imbruvica 420 mg
Slovak: imbruvica 420 mg
English: At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
Slovak: 5 cm, 26 % malo del11q.
English: • back pain or joint pain
Slovak: • bolesť chrbta alebo kĺbov
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Slovak: Medián veku bol 64 rokov (rozpätie od 31 až 86 rokov), 66 % boli muži a 91 % boli belosi.
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Slovak: Tabuľka 11: Výsledky účinnosti v štúdii PCYC-1127-CA
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Slovak: Prežívanie bez progresie (PFS) hodnotené IRC podľa kritérií IWCLL naznačovalo 78 %, štatisticky významné zníženie rizika úmrtia alebo progresie u pacientov v skupine s IMBRUVICA.
English: • The active substance is ibrutinib.
Slovak: Liečivo je ibrutinib.
English: UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88 lt@its.jnj.com
Slovak: Tel: +370 5 278 68 88 lt@its.jnj.com
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule).
Slovak: U pacientov so stredne ťažkou poruchou funkcie pečene (Childova-Pughova trieda B) je odporúčaná dávka 140 mg denne (jedna kapsula).
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Slovak: Medián veku bol 68 rokov (rozpätie: 40 až 84 rokov), 77 % bolo mužov a 92 % bolo belochov.
English: The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Slovak: Dávka ibrutinibu sa má znížiť na 140 mg jedenkrát denne (jedna kapsula) alebo vynechať 7 dní, keď sa užíva súčasne so silnými inhibítormi CYP3A4.
English: ORR (%) p-value p<0.0001
Slovak: (%) p-hodnota p <
English: atazanavir, or fosamprenavir
Slovak: atazanavir alebo fosamprenavir
English: Median time to initial response, months (range) Median time to CR, months (range)
Slovak: Medián času do CR, mesiace (rozpätie)
English: Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Slovak: U pacientov liečených s IMBRUVICA boli hlásené prípady leukostázy.
English: Day 1, and 500 mg/m2 Cycles 2 through 6, Day 1.
Slovak: prvého cyklu a v 1. a 2. deň druhého až šiesteho cyklu po dobu šiestich cyklov.
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.
Slovak: Môžu sa vyskytnúť nezvyčajné hladiny chemických látok v krvi zapríčinené rýchlym rozpadom rakovinových buniek počas liečby rakoviny a niekedy aj bez liečby.
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.
Slovak: Bezpečnosť a účinnosť IMBRUVICA u pacientov s CLL/SLL bez predchádzajúcej liečby bola ďalej hodnotená v randomizovanej, multicentrickej, otvorenej štúdii fázy 3 (PCYC-1130-CA) zameranej na IMBRUVICA v kombinácii s obinutuzumabom v porovnaní s chlorambucilom v kombinácii s obinutuzumabom.
English: 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).
Slovak: SI: -9,4, -1,1] u Cmax 719 ng/ml pri uvedenej supraterapeutickej dávke 1680 mg).
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.
Slovak: Reakcie 3. alebo vyššieho stupňa alebo závažné reakcie súvisiace s infúziou boli pozorované u 3 % pacientov liečených s IMBRUVICA
English: Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Slovak: Rituximab bol podávaný v dávke 375 mg/m2 v 1. deň prvého cyklu a 500 mg/m2 v 1. deň druhého až šiesteho cyklu.
English: Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
Slovak: Tlf: +45 4594 8282 jacdk@its.jnj.com
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Slovak: Pomocné látky so známym účinkom Jedna 560 mg filmom obalená tableta obsahuje 112 mg monohydrátu laktózy.
English: The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Slovak: Medián času od stanovenia diagnózy bol 6 rokov a medián počtu predchádzajúcich terapií bol 2 (rozpätie: 1 až 11 terapií).
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 Months Follow-up
Slovak: Obrázok 7: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii PCYC-1112-CA pri finálnej analýze s follow-up 65 mesiacov
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.
Slovak: % malo vysoké rizikové skóre podľa zjednodušeného medzinárodného prognostického indexu (MIPI), 60 % malo extranodálne ochorenie a 54 % malo postihnutie kostnej drene pri skríningu.
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Slovak: Pomocné látky so známym účinkom Jedna 420 mg filmom obalená tableta obsahuje 84 mg monohydrátu laktózy.
English: Tumor flare in the form of IgM increase occurred in 8.0% of subjects in the IMBRUVICA+rituximab arm and 46.7% of subjects in the placebo+rituximab arm.
Slovak: + rituximab, a u 46,7 % pacientov, ktorí dostávali placebo + rituximab.
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Slovak: Tabuľka 4: Výsledky účinnosti v štúdii PCYC-1115-CA
English: The median duration of treatment for MCL was 11 months (range, 0 to 87 months) with 31% and 17% of patients receiving treatment for more than 2 years and 4 years, respectively.
Slovak: Medián trvania liečby MCL bol 11 mesiacov (rozpätie 0 až 87 mesiacov), pričom sa 31
English: HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Slovak: HR = pomer rizík; IS = interval spoľahlivosti; ORR = miera celkovej odpovede; OS = celkové prežívanie; PFS = prežívanie bez progresie; PR = čiastočná odpoveď
English: Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
Slovak: +33 1 55 00 40 03 medisource@its.jnj.com
English: Mild CYP3A4 inhibitors
Slovak: Slabé inhibítory CYP3A4
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Slovak: Medián veku bol 63 rokov (rozpätie: 44 až 86 rokov), 76 % bolo mužov a 95 % bolo belochov.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy
Slovak: Borgo S. Michele, 04100 Latina, Taliansko
English: The dose of ibrutinib should be reduced to 140 mg once daily or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors.
Slovak: Dávka ibrutinibu sa má znížiť na 140 mg jedenkrát denne alebo vynechať 7 dní, keď sa užíva súčasne so silnými inhibítormi CYP3A4.
English: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Slovak: Jadro tablety koloidný oxid kremičitý bezvodý sodná soľ kroskarmelózy monohydrát laktózy stearan horečnatý mikrokryštalická celulóza povidón nátriumlaurylsulfát (E487)
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Slovak: imbruvica 140 mg
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Slovak: U pacientov s ľahkou poruchou funkcie pečene (Childova-Pughova trieda A) je odporúčaná dávka 280 mg denne.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Slovak: IMBRUVICA 140 mg tvrdé kapsuly
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Slovak: Medián veku bol 69 rokov (rozpätie: 36 až 89 rokov), 66 % boli muži a 79 % boli belosi.
English: The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Slovak: Dávka ibrutinibu sa má znížiť na 280 mg jedenkrát denne (dve kapsuly), keď sa užíva súčasne so stredne silnými inhibítormi CYP3A4.
English: 90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
Slovak: C]-ibrutinibu zdravým osobám sa približne 90 % izotopom značenej látky vylúčilo do 168 hodín, pričom väčšina (80
English: For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
Slovak: U pacientov so stredne ťažkou poruchou funkcie pečene (Childova-Pughova trieda B) je odporúčaná dávka 140 mg denne.
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Slovak: Pomocné látky so známym účinkom Jedna 140 mg filmom obalená tableta obsahuje 28 mg monohydrátu laktózy.
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.
Slovak: 2 g/dl oproti východiskovej hodnote bez ohľadu na východiskovú hodnotu, alebo zvýšenie na >
English: IMBRUVICA 140 mg film-coated tablets
Slovak: IMBRUVICA 140 mg filmom obalené tablety
English: Very common Headache Common
Slovak: Veľmi časté Vyrážka* Časté
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Slovak: Dávka ibrutinibu sa má znížiť na 280 mg jedenkrát denne, keď sa užíva súčasne so stredne silnými inhibítormi CYP3A4.
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Slovak: Analýza OS preukázala 57 %, štatisticky významné zníženie rizika úmrtia u pacientov v skupine s IMBRUVICA.
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).
Slovak: Pneumónia 3. alebo vyššieho stupňa sa častejšie vyskytovala u starších pacientov liečených s IMBRUVICA (12
English: IMBRUVICA 420 mg film-coated tablets
Slovak: IMBRUVICA 420 mg filmom obalené tablety
English: Urticaria Erythema Onychoclasis
Slovak: • lámanie nechtov
English: How to store IMBRUVICA
Slovak: Ako uchovávať IMBRUVICA
English: IMBRUVICA 560 mg film-coated tablets
Slovak: IMBRUVICA 560 mg filmom obalené tablety
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Slovak: Miera odpovede (CR, VGPR, PR)
English: HR=0.628 [95% CI: 0.385, 1.024]
Slovak: [95 % IS: 0,385; 1,024]
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.
Slovak: Deväťdesiatjeden percent pacientov malo v úvode liečby hodnotu výkonnostného stavu ECOG 0 alebo 1 a 9 % malo hodnotu výkonnostného stavu ECOG 2.Do štúdie bolo zaradených 269 pacientov s CLL.
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Slovak: Pomocné látky so známym účinkom Jedna 280 mg filmom obalená tableta obsahuje 56 mg monohydrátu laktózy.
English: Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Slovak: U pacientov so zvýšeným rizikom oportúnnych infekcií je potrebné zvážiť profylaxiu podľa liečebných štandardov.
English: The 2-year PFS rate estimates for the high-risk CLL/SLL population were 78.8% [95% CI (67.3, 86.7)] and 15.5% [95% CI (8.1, 25.2)] in the IMBRUVICA+obinutuzumab and chlorambucil+obinutuzumab arms, respectively.
Slovak: % [95 % IS (8,1; 25,2)] v skupine chlorambucil + obinutuzumab.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Slovak: PUZDRO 420 MG TABLETA (30 dní)
English: IMBRUVICA 280 mg film-coated tablets
Slovak: IMBRUVICA 280 mg filmom obalené tablety
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Slovak: PUZDRO 560 MG TABLETA (28 dní)
English: Metabolism
Slovak: Monoterapia
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Slovak: PUZDRO 420 MG TABLETA (28 dní)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Slovak: IMBRUVICA 420 mg tablety ibrutinib
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.
Slovak: U pacientov s relabujúcim alebo refraktérnym CLL sa uskutočnila randomizovaná multicentrická otvorená štúdia fázy 3 s IMBRUVICA v porovnaní s ofatumumabom (PCYC-1112-CA).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Slovak: PUZDRO 560 MG TABLETA (30 dní)
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Slovak: 14 filmom obalených tabliet