natgillin/translations-raw huggingface dataset:
At baseline, 45% had advanced clinical stage (Rai Stage III or IV), 35% of patients had at least one tumor ≥5 cm, 39% with baseline anemia, 23% with baseline thrombocytopenia, 65% had elevated β2 microglobulin >3500 mcg/L, 47% had a CrCL<60 mL/min, 20% of patients presented with del11q, 6% of patients presented with del17p/tumor protein 53 (TP53) mutation, and 44% of patients presented with unmutated immunoglobulin heavy chain variable region (IGHV).
5 cm, 39 % východiskovú anémiu, 23 % východiskovú trombocytopéniu, 65 % malo zvýšenú hladinu β2-mikroglobulínu > 3500 μg/l, 47 % malo CrCl < 60 ml/min, 20 % pacientov malo del11q, 6 % pacientov malo del17p/mutáciu nádorového proteínu 53 (TP53) a 44 % pacientov malo nemutovanú variabilnú oblasť ťažkého reťazca imunoglobulínu (IGHV).
Table 7: Efficacy results in patients with CLL (Study PCYC-1112-CA) Endpoint
Tabuľka 7: Výsledky účinnosti u pacientov s CLL (Štúdia PCYC-1112-CA)
Yellow-green to green round (9 mm) tablets, written with “ibr” on one side and “140” on the other side.
Žltozelené až zelené okrúhle (9 mm) tablety, označené „ibr“ na jednej strane a „140“ na druhej strane.
In patients with B-cell malignancies taking IMBRUVICA with food, co-administration of the CYP3A4 inhibitor erythromycin increased Cmax by 3.4-fold and AUC by 3.0-fold.
B buniek, ktorí užívajú IMBRUVICA s jedlom, súčasné užívanie inhibítora CYP3A4 erytromycínu zvýšilo Cmax 3,4-násobne a AUC 3-násobne.
Co-administration of rifampicin, a strong CYP3A4 inducer, in 18 fasted healthy subjects, decreased exposure (Cmax and AUC) of ibrutinib by 92 and 90%, respectively.
Súčasné užívanie rifampicínu, silného induktora CYP3A4, nalačno u 18 zdravých osôb znížilo expozíciu (Cmax a AUC) ibrutinibu o 92 resp.
The steady state AUC observed in patients at 560 mg is (mean ± standard deviation) 953 ± 705 ng h/mL.
Expozícia ibrutinimu sa zvyšuje s dávkami až do výšky 840 mg. AUC v rovnovážnom stave pozorovaná u pacientov pri dávke 560 mg predstavuje 953 ± 705 ng.h/ml (priemer ± štandardná odchýlka).
The median investigator-assessed PFS was not reached in the IMBRUVICA arm and was 15 months [95% CI (10.22, 19.35)] in the chlorambucil arm; (HR=0.14 [95% CI (0.09, 0.21)]).
Medián PFS hodnotený skúšajúcim nebol dosiahnutý v skupine s IMBRUVICA a v skupine s chlorambucilom bol 15 mesiacov [95 % IS (10,22; 19,35)];
Upon initiation of treatment, a reversible increase in lymphocyte counts (i.e., ≥50% increase from baseline and an absolute count >5,000/mcL), often associated with reduction of lymphadenopathy, has been observed in about three fourths of patients with CLL treated with IMBRUVICA.
5 000/μl), často súvisiace s redukciou lymfadenopatie, u približne troch štvrtín pacientov s CLL liečených s IMBRUVICA.
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).
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.
Do not break or chew.
Nelámte ju ani nežujte.
IMBRUVICA contains lactose
IMBRUVICA obsahuje laktózu
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.
Ak sa opäť vyskytne toxicita, dávka jedenkrát denne sa má znížiť o 140 mg.
Atrial fibrillation Uncommon Ventricular tachyarrhythmia
Atriálna fibrilácia Menej časté Ventrikulárna tachyarytmia*
HR=0.434 [95% CI: 0.238; 0.789] HR=0.387 [95% CI: 0.216; 0.695]
0,387 [95 % IS: 0,216; 0,695]
The median age was 73 years (range, 65 to 90 years), 63% were male, and 91% were Caucasian.
Medián veku bol 73 rokov (rozpätie 65 až 90 rokov), 63 % bolo mužov a 91 % bolo belochov.
Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Purpurovočervené podlhovasté tablety (15 mm dlhé a 7 mm široké), označené „ibr“ na jednej strane a „280“ na druhej strane.
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.
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.
All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%).
Všetci pacienti mali východiskový výkonnostný stav podľa ECOG 0 (48
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).
Rituximab sa podával týždenne v dávke 375 mg/m2 počas 4 po sebe nasledujúcich týždňov (1.
The most common grade 3/4 adverse reactions (≥5%) were neutropenia, pneumonia, and thrombocytopenia.
5 %) boli neutropénia, pneumónia a trombocytopénia.
Lower level term (LLT) used for selection.
Názov nižšej úrovne (LLT, z angl.
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).
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).
Table 5: Efficacy results in Study PCYC-1130-CA
Tabuľka 5: Výsledky účinnosti v štúdii PCYC-1130-CA
Figure 4: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1115-CA with 48 Months Follow-up
Obrázok 4: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii PCYC-1115-CA s followup 48 mesiacov
30 film-coated tablets
10 filmom obalených tabliet
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)].
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
120 hard capsules
90 tvrdých kapsúl 120 tvrdých kapsúl
Transient ischaemic attack Ischaemic stroke a, #
Prechodný ischemický záchvat Ischemická cievna mozgová príhoda a, #
The median age was 71 years (range, 40 to 87 years), 64% were male, and 96% were Caucasian.
Medián veku bol 71 rokov (rozpätie: 40 až 87 rokov), 64 % boli muži a 96 % boli belosi.
Very common Neutropenia Thrombocytopenia
Veľmi časté Neutropénia Trombocytopénia
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.
Žlté až oranžové podlhovasté tablety (19 mm dlhé a 8,1 mm široké), označené „ibr“ na jednej strane a „560“ na druhej strane.
Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Obrázok 1: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii MCL3001
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
IMBRUVICA 140 mg filmom obalené tablety IMBRUVICA 280 mg filmom obalené tablety IMBRUVICA 420 mg filmom obalené tablety IMBRUVICA 560 mg filmom obalené tablety
Very common Arthralgia Muscle spasms Musculoskeletal pain
Veľmi časté Artralgia Svalové kŕče Bolesť svalov a kostí*
A large increase in the number of circulating lymphocytes (e.g., >400,000/mcL) has been observed in some patients.
U niektorých pacientov bol pozorovaný vysoký nárast počtu cirkulujúcich lymfocytov (napr.
IMBRUVICA+Obinutuzumab N=113
IMBRUVICA + Obinutuzumab
Yellow-green to green round tablets (9 mm), debossed with “ibr” on one side and “140” on the other side.
Žltozelené až zelené okrúhle tablety (9 mm), označené „ibr“ na jednej strane a „140“ na druhej strane.
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).
9 % (3. - 4. rok) a 9 % (4. - 5. rok).
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.
Podľa IRC bola ORR pri následnom sledovaní s mediánom 16,4 mesiacov u 51 pacientov s relabujúcim alebo refraktérnym ochorením 64,7
Ibrutinib is an in vitro inhibitor of P-gp and BCRP (see section 4.5).
Dihydrodiolový metabolit a iné metabolity sú substrátmi P-gp. Ibrutinib je in vitro inhibítorom P-gp a BCRP (pozri časť 4.5).
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
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
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
NÁLEPKA NA FĽAŠI 140 MG KAPSULA
Absolute bioavailability in fasted condition (n=8) was 2.9% (90% CI=2.1 - 3.9) and doubled when combined with a meal.
2,1 - 3,9) a bola dvojnásobná, keď sa liek skombinoval s jedlom.
The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Medián veku bol 68 rokov (rozpätie 34; 88 rokov), 74 % boli muži a 87 % boli belosi.
Atrial fibrillation, atrial flutter and cases of ventricular tachyarrhythmia have been reported in patients treated with IMBRUVICA.
U pacientov liečených s IMBRUVICA bola hlásená atriálna fibrilácia, atriálny flutter a prípady ventrikulárnej tachyarytmie.
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).
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).
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.
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
The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Medián veku bol 67 rokov (rozpätie: 30 až 88 rokov), 68 % bolo mužov a 90 % bolo belochov.
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.
Žltozelené až zelené podlhovasté tablety (17,5 mm dlhé a 7,4 mm široké), označené „ibr“ na jednej strane a „420“ na druhej strane.
The median time since diagnosis was 91 months and the median number of prior treatments was 2 (range: 1 to 13 treatments).
Medián času od diagnózy bol 91 mesiacov a medián počtu predchádzajúcich terapií bol 2 (rozpätie: 1 až 13 terapií).
At baseline, 56% of patients had at least one tumour ≥5 cm, 26% had del11q.
5 cm, 26 % malo del11q.
• back pain or joint pain
• bolesť chrbta alebo kĺbov
The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Medián veku bol 64 rokov (rozpätie od 31 až 86 rokov), 66 % boli muži a 91 % boli belosi.
Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Tabuľka 11: Výsledky účinnosti v štúdii PCYC-1127-CA
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.
Prežívanie bez progresie (PFS) hodnotené IRC podľa kritérií IWCLL naznačovalo 78 %, štatisticky významné zníženie rizika úmrtia alebo progresie u pacientov v skupine s IMBRUVICA.
• The active substance is ibrutinib.
Liečivo je ibrutinib.
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88 lt@its.jnj.com
Tel: +370 5 278 68 88 lt@its.jnj.com
The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Medián veku bol 68 rokov (rozpätie: 40 až 84 rokov), 77 % bolo mužov a 92 % bolo belochov.
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.
Dávka ibrutinibu sa má znížiť na 140 mg jedenkrát denne (jedna kapsula) alebo vynechať 7 dní, keď sa užíva súčasne so silnými inhibítormi CYP3A4.
ORR (%) p-value p<0.0001
(%) p-hodnota p <
atazanavir, or fosamprenavir
atazanavir alebo fosamprenavir
Median time to initial response, months (range) Median time to CR, months (range)
Medián času do CR, mesiace (rozpätie)
Day 1, and 500 mg/m2 Cycles 2 through 6, Day 1.
prvého cyklu a v 1. a 2. deň druhého až šiesteho cyklu po dobu šiestich cyklov.
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.
Môžu sa vyskytnúť nezvyčajné hladiny chemických látok v krvi zapríčinené rýchlym rozpadom rakovinových buniek počas liečby rakoviny a niekedy aj bez liečby.
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.
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.
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).
SI: -9,4, -1,1] u Cmax 719 ng/ml pri uvedenej supraterapeutickej dávke 1680 mg).
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.
Reakcie 3. alebo vyššieho stupňa alebo závažné reakcie súvisiace s infúziou boli pozorované u 3 % pacientov liečených s IMBRUVICA
Rituximab was administered at a dose of 375 mg/m2 in the first cycle,
Rituximab bol podávaný v dávke 375 mg/m2 v 1. deň prvého cyklu a 500 mg/m2 v 1. deň druhého až šiesteho cyklu.
Danmark Janssen-Cilag A/S Tlf: +45 4594 8282 jacdk@its.jnj.com
Tlf: +45 4594 8282 jacdk@its.jnj.com
Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Pomocné látky so známym účinkom Jedna 560 mg filmom obalená tableta obsahuje 112 mg monohydrátu laktózy.
Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 Months Follow-up
Obrázok 7: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii PCYC-1112-CA pri finálnej analýze s follow-up 65 mesiacov
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.
% malo vysoké rizikové skóre podľa zjednodušeného medzinárodného prognostického indexu (MIPI), 60 % malo extranodálne ochorenie a 54 % malo postihnutie kostnej drene pri skríningu.
Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Pomocné látky so známym účinkom Jedna 420 mg filmom obalená tableta obsahuje 84 mg monohydrátu laktózy.
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.
+ rituximab, a u 46,7 % pacientov, ktorí dostávali placebo + rituximab.
Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Tabuľka 4: Výsledky účinnosti v štúdii PCYC-1115-CA
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.
Medián trvania liečby MCL bol 11 mesiacov (rozpätie 0 až 87 mesiacov), pričom sa 31
HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
HR = pomer rizík; IS = interval spoľahlivosti; ORR = miera celkovej odpovede; OS = celkové prežívanie; PFS = prežívanie bez progresie; PR = čiastočná odpoveď
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 medisource@its.jnj.com
+33 1 55 00 40 03 medisource@its.jnj.com
Manufacturer Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina, Italy
Borgo S. Michele, 04100 Latina, Taliansko
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.
Dávka ibrutinibu sa má znížiť na 140 mg jedenkrát denne alebo vynechať 7 dní, keď sa užíva súčasne so silnými inhibítormi CYP3A4.
Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Jadro tablety koloidný oxid kremičitý bezvodý sodná soľ kroskarmelózy monohydrát laktózy stearan horečnatý mikrokryštalická celulóza povidón nátriumlaurylsulfát (E487)
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
U pacientov s ľahkou poruchou funkcie pečene (Childova-Pughova trieda A) je odporúčaná dávka 280 mg denne.
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
IMBRUVICA 140 mg tvrdé kapsuly
The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Medián veku bol 69 rokov (rozpätie: 36 až 89 rokov), 66 % boli muži a 79 % boli belosi.
The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Dávka ibrutinibu sa má znížiť na 280 mg jedenkrát denne (dve kapsuly), keď sa užíva súčasne so stredne silnými inhibítormi CYP3A4.
90% of radioactivity was excreted within 168 hours, with the majority (80%) excreted in the faeces and <10% accounted for in urine.
C]-ibrutinibu zdravým osobám sa približne 90 % izotopom značenej látky vylúčilo do 168 hodín, pričom väčšina (80
For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.
U pacientov so stredne ťažkou poruchou funkcie pečene (Childova-Pughova trieda B) je odporúčaná dávka 140 mg denne.
Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Pomocné látky so známym účinkom Jedna 140 mg filmom obalená tableta obsahuje 28 mg monohydrátu laktózy.
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.
2 g/dl oproti východiskovej hodnote bez ohľadu na východiskovú hodnotu, alebo zvýšenie na >
IMBRUVICA 140 mg film-coated tablets
IMBRUVICA 140 mg filmom obalené tablety
Very common Headache Common
Veľmi časté Vyrážka* Časté
The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Dávka ibrutinibu sa má znížiť na 280 mg jedenkrát denne, keď sa užíva súčasne so stredne silnými inhibítormi CYP3A4.
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.
Analýza OS preukázala 57 %, štatisticky významné zníženie rizika úmrtia u pacientov v skupine s IMBRUVICA.
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).
Pneumónia 3. alebo vyššieho stupňa sa častejšie vyskytovala u starších pacientov liečených s IMBRUVICA (12
IMBRUVICA 420 mg film-coated tablets
IMBRUVICA 420 mg filmom obalené tablety
Urticaria Erythema Onychoclasis
• lámanie nechtov
IMBRUVICA 560 mg film-coated tablets
IMBRUVICA 560 mg filmom obalené tablety
Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Miera odpovede (CR, VGPR, PR)
HR=0.628 [95% CI: 0.385, 1.024]
[95 % IS: 0,385; 1,024]
Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2.
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.
Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Pomocné látky so známym účinkom Jedna 280 mg filmom obalená tableta obsahuje 56 mg monohydrátu laktózy.
Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
U pacientov so zvýšeným rizikom oportúnnych infekcií je potrebné zvážiť profylaxiu podľa liečebných štandardov.
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.
% [95 % IS (8,1; 25,2)] v skupine chlorambucil + obinutuzumab.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
PUZDRO 420 MG TABLETA (30 dní)
IMBRUVICA 280 mg film-coated tablets
IMBRUVICA 280 mg filmom obalené tablety
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
PUZDRO 560 MG TABLETA (28 dní)
Metabolism
Monoterapia
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
PUZDRO 420 MG TABLETA (28 dní)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
IMBRUVICA 420 mg tablety ibrutinib
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.
U pacientov s relabujúcim alebo refraktérnym CLL sa uskutočnila randomizovaná multicentrická otvorená štúdia fázy 3 s IMBRUVICA v porovnaní s ofatumumabom (PCYC-1112-CA).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
PUZDRO 560 MG TABLETA (30 dní)
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
14 filmom obalených tabliet
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
IMBRUVICA 560 mg tablety ibrutinib
Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Obrázok 5: Kaplanova-Meierova krivka PFS (populácia ITT) v štúdii PCYC-1130-CA
Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Obrázok 6: Kaplanova-Meierova krivka PFS (ITT populácia) v štúdii PCYC-1112- CA
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).
5 cm), 44 % malo východiskovú anémiu, 22 % malo východiskovú trombocytopéniu, 28 % malo CrCl < 60 ml/min a medián skóre škály súhrnného hodnotenia ochorení u geriatrických pacientov (CIRS-G, z angl.
• 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).
IMBRUVICA 140 mg a IMBRUVICA 420 mg filmom obalené tablety tiež obsahujú čierny oxid železitý (E172) a žltý oxid železitý (E172);
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Jedna filmom obalená tableta obsahuje 140 mg ibrutinibu.
EU/1/14/945/010 (30 tablets)
EU/1/14/945/010 (30 tabliet)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
PUZDRO 280 MG TABLETA (28 dní)
• infections of the urinary tract
• infekcie močových ciest