FrancophonIA/ELRC3.0 huggingface dataset:
English: In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Croatian: U bolesnika visoke starosti (≥ 75 godina) koji su primali Abraxane u kombinaciji s gemcitabinom, bila je veća incidencija ozbiljnih nuspojava i nuspojava koje su dovele do prekida liječenja uključujući hematološke toksičnosti, perifernu neuropatiju, smanjeni apetit i dehidraciju.
English: If the suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako suspenzija dođe u dodir s kožom, kožu je potrebno odmah temeljito oprati vodom i sapunom.
English: First Second Third
Croatian: Prvi put Drugi put
English: • Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
Croatian: • Abraxane se koristi za liječenje metastatskog raka dojke kada se pokušalo s najmanje jednim od drugih oblika liječenja ali nije bio djelotvoran, i kada niste podobni za liječenja koja sadrže skupinu lijekova pod nazivom antraciklini.
English: • Loss of hair (the majority of cases of hair loss happened less than one month after starting
Croatian: • gubitak kose (u većini slučajeva gubitak kose pojavio se za manje od mjesec dana od početka uzimanja lijeka Abraxane, a kada se dogodi, gubitak kose je izrazit (više od 50%) u većine bolesnika)
English: CI = confidence interval, HRA+G/G = hazard ratio of Abraxane+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of Abraxane+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Croatian: = omjer stope odgovora za Abraxane+gemcitabin/gemcitabin a stratificirani Coxov model proporcionalnog hazarda b stratificirani log-rang test, stratificiran prema zemljopisnoj regiji (Sjeverna Amerika nasuprot ostalih regija), KPS (70 do 80 nasuprot 90 do 100), i prisutnost metastaza jetre (‘da' nasuprot ‘ne').
English: Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator Efficacy variable
Croatian: Tablica 10: Rezultati ukupne stope odgovora, medijana vremena do progresije bolesti te preživljenja bez progresije bolesti prema procjeni ispitivača Varijabla djelotvornosti
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
Croatian: Periferna neuropatija (uglavnom senzorna neuropatija 1. ili 2. stupnja) opažena je u 68% bolesnika koji su primali Abraxane, u 10% bolesnika bila je 3. stupnja, a nije bilo slučajeva neuropatije 4. stupnja.
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6-hydroxypaclitaxel; and to two minor metabolites, 3'-p-hydroxypaclitaxel and 6-3'-p-dihydroxypaclitaxel.
Croatian: Na temelju objavljene literature, in vitro ispitivanja s mikrosomomima iz ljudske jetre i rezovima tkiva pokazala su da se paklitaksel primarno metabolizira u 6α-hidroksipaklitaksel te u dva manja metabolita, 3'-p-hidroksipaklitaksel i 6α-3'-p-dihidroksipaklitaksel.
English: Abraxane induced infertility in male rats (see section 5.3).
Croatian: Abraxane potiče neplodnost u mužjaka štakora (vidjeti dio 5.3).
English: • Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst,
Croatian: • snižena razina fosfora u krvi, zadržavanje tekućine, niska razina albumina u krvi, pojačana žeđ,
English: Abraxane (100 mg/m2/week) + carboplatin (N=521)
Croatian: Abraxane (100 mg/m2 tjedno) + karboplatin (N = 521)
English: Of the 17 cases of pneumonitis reported in patients treated with Abraxane in combination with gemcitabine, 2 had a fatal outcome.
Croatian: Od 17 slučajeva pneumonitisa zabilježenih u bolesnika liječenih Abraxaneom u kombinaciji s gemcitabinom, u 2 je slučaja ishod bila smrt.
English: Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea
Croatian: Gastrointestinalna toksičnost: mukozitis ili proljev 3. stupnja
English: The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Croatian: Simptomi su obično bili prolazni, i obično su se pojavljivali tri dana nakon primjene lijeka te bi se povukli unutar tjedan dana.
English: Upon intravenous administration, the nanoparticles dissociate rapidly into soluble, albumin bound paclitaxel complexes of approximately 10 nm in size.
Croatian: Prilikom intravenske primjene nanočestice se brzo raspadnu u topive komplekse paklitaksela vezanog na albumin, veličine približno 10 nm.
English: Taking into account the seriousness of the event, as well as the fact that scleroderma is included in the SmPC of several solvent-based paclitaxel products, the MAH is requested to add scleroderma to section 4.8 of the SmPC with frequency not known.
Croatian: Uzimajući u obzir ozbiljnost događaja, kao i činjenicu da je skleroderma uključena u sažetak opisa svojstava lijeka za nekoliko lijekova paklitaksela koji se temelje na otapalu, od nositelja odobrenja za stavljanje lijeka u promet zahtijeva se da doda sklerodermu u dio 4.8 sažetka opisa svojstava lijeka s nepoznatom učestalošću.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Abraxane in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Abraxane u svim podskupinama pedijatrijske populacije za liječenje metastatskog karcinoma dojke, adenokarcinoma pankreasa i karcinoma nemalih stanica pluća (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients who experience severe neutropenia (neutrophil count < 500 cells/mm3 for a week or longer) or severe sensory neuropathy during Abraxane therapy should have the dose reduced to 220 mg/m2 for subsequent courses.
Croatian: Bolesnicima koji su razvili tešku neutropeniju (broj neutrofila < 500 stanica/mm3 tijekom tjedan dana ili dulje) ili tešku senzornu neuropatiju tijekom liječenja lijekom Abraxane treba smanjiti dozu na 220 mg/m2 u narednim ciklusima liječenja.
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Croatian: Nisu dostupni farmakokinetički podaci za bolesnike s ukupnim bilirubinom > 5 x GGN niti za one s metastatskim adenokarcinomom pankreasa (vidjeti dio 4.2).
English: Anemia and thrombocytopenia were more commonly reported in the Abraxane arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Croatian: Anemija i trombocitopenija bile su češće zabilježene u skupini koja je primala Abraxane nego u onoj koja je primala Taxol (54% naspram 28% odnosno 45% naspram 27%).
English: If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.
Croatian: Ako se pojavi pjena ili nakupine, suspenzija mora odstajati najmanje 15 minuta dok se pjena ne slegne.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored Abraxane and carboplatin (p ≤ 0.002).
Croatian: Prema analizi ponovljenog mjerenja, 3 od 4 podljestvice (periferna neuropatija, bol u šakama/stopalima te sluh) bile su u korist lijeka Abraxane i karboplatina (p ≤ 0,002).
English: Population pharmacokinetic analyses for Abraxane indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
Croatian: Analize populacijske farmakokinetike za Abraxane pokazuju da spol, rasa (azijati nasuprot bijelaca) te vrsta solidnih tumora nemaju klinički važan učinak na sistemsku izloženost paklitakselu (AUC i Cmax).
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome,
Croatian: • teška upala/erupcija na koži i sluznicama (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza).
English: However, a subsequent analysis in 981 patients receiving Abraxane monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Croatian: Međutim, kasnija analiza provedena u 981 bolesnika koji su primali Abraxane kao monoterapiju za metastatski karcinom dojke, od kojih je 15% bilo u dobi od ≥ 65 godina te 2% u dobi od ≥ 75 godina, pokazala je veću incidenciju epistakse, proljeva, dehidracije, umora i perifernog edema u bolesnika u dobi od ≥ 65 godina.
English: There is no relevant use of Abraxane in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Croatian: Nema relevantne primjene lijeka Abraxane u pedijatrijskoj populaciji za indikaciju metastatskog karcinoma dojke ili adenokarcinoma pankreasa ili karcinoma nemalih stanica pluća.
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Croatian: > 1. linije terapije 26,5 [18,98; 34,05] (n = 132) 13,2 [7,54; 18,93] (n = 136)
English: Abraxane 5 mg/ml powder for suspension for infusion paclitaxel
Croatian: Abraxane 5 mg/ml prašak za suspenziju za infuziju paklitaksel
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Croatian: U bolesnika s adenokarcinomom pankreasa u dobi od 75 i više godina, treba pažljivo procijeniti njihovu sposobnost podnošenja Abraxanea u kombinaciji s gemcitabinom, a osobito valja obratiti pozornost na opći status, komorbiditete i povećani rizik od infekcija (vidjeti dio 4.2 i 4.8).
English: In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Croatian: U jednom ispitivanju Abraxane je primijenjen kao 30-minutna infuzija u dozi od 175 mg/m2 u 43 bolesnika s metastatskim karcinomom dojke.
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Croatian: Podaci od 106 bolesnika uključenih u dva otvorena ispitivanja s jednom skupinom i od 454 bolesnika liječena u fazi III komparativnog, randomiziranog ispitivanja, dostupni su kako bi poduprli uporabu lijeka Abraxane za liječenje metastatskog karcinoma dojke.
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Croatian: Za bolesnika s normalnim razinama CA19-9 na početku, omjer hazarda preživljenja bio je 1,07 (95% CI 0,692; 1,661).
English: Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Croatian: Abraxane je indiciran u kombinaciji s karboplatinom kao prva linija liječenja karcinoma nemalih stanica pluća u odraslih bolesnika koji nisu kandidati za potencijalno kurativni kirurški zahvat i/ili terapiju zračenjem.
English: Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Croatian: Erlotinib se ne smije primjenjivati zajedno s Abraxaneom u kombinaciji s gemcitabinom (vidjeti dio 4.5).
English: Asthenia/Fatigue was reported in 40% of the patients.
Croatian: Astenija/umor prijavljeni su u 40% bolesnika.
English: Rare: Pancytopenia
Croatian: Rijetko: pancitopenija
English: Abraxane should not be used in combination with other anticancer agents.
Croatian: Abraxane se ne smije primjenjivati u kombinaciji s drugim antitumorskim lijekovima.
English: After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Croatian: Nakon rekonstitucije, svaki ml suspenzije sadrži 5 mg paklitaksela.
English: For patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Croatian: Za bolesnike s metastatskim adenokarcinomom pankreasa koji imaju umjereno do teško oštećenje jetrene funkcije, nema dovoljno podataka koji bi omogućili preporuke doza (vidjeti dijelove 4.4 i 5.2).
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving Abraxane.
Croatian: Zabilježeni su rijetki slučajevi kongestivnog zatajenja srca i disfunkcije lijeve klijetke u osoba koje primaju Abraxane.
English: Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.
Croatian: Nakon primjene preporučuje se intravensku liniju isprati otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju kako bi se osigurala primjena cijele doze.
English: There was no statistically significant difference in progression-free survival (by blinded radiologist assessment) and overall survival between the two treatment arms.
Croatian: Između dviju terapijskih skupina nije bilo statistički značajne razlike u preživljenju bez progresije bolesti (prema maskiranoj radiološkoj procjeni) i sveukupnog preživljenja.
English: • Pain at site of tumour, death of the tumour
Croatian: • bol na mjestu tumora, odumiranje tumora
English: Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Croatian: Paklitaksel je citotoksični antitumorski lijek i, kao i s drugim potencijalno toksičnim tvarima, treba biti oprezan prilikom rukovanja lijekom Abraxane.
English: For non-small cell lung cancer patients treated with Abraxane and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Croatian: Za bolesnike s karcinomom nemalih stanica pluća liječenih Abraxaneom u kombinaciji s karboplatinom, medijan vremena do prve pojave periferne neuropatije 3. stupnja povezane s liječenjem iznosio je 121 dan, a medijan vremena do poboljšanja periferne neuropatije s 3. stupnja na 1. stupanj bio je 38 dana.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: 16,1 [15,0; 18,3] (n = 135)
English: In patients with metastatic breast cancer, after a 30-minute infusion of Abraxane at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Croatian: U bolesnika s metastatskim karcinomom dojke, nakon 30-minutne infuzije lijeka Abraxane u dozi od 260 mg/m2, srednja vrijednost kumulativne urinarne ekskrecije nepromijenjene djelatne tvari iznosi 4% ukupne primijenjene doze s manje od 1% u obliku metabolita, 6α-hidroksipaklitaksela i 3'-p-hidroksipaklitaksela, što upućuje na znatan klirens koji zaobilazi bubreg.
English: A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare Abraxane/gemcitabine versus gemcitabine monotherapy as first-line treatment in patients with metastatic adenocarcinoma of the pancreas.
Croatian: Provedeno je multicentrično, multinacionalno, randomizirano, otvoreno ispitivanje u 861 bolesnika kako bi se usporedila primjena kombinacije Abraxane/gemcitabin nasuprot monoterapiji gemcitabina kao prve linije liječenja u bolesnika s metastatskim adenokarcinomom pankreasa.
English: The frequencies of adverse reactions associated with the administration of Abraxane are listed in Table 6 (Abraxane as monotherapy) and Table 7 (Abraxane in combination with gemcitabine), and Table 9 (Abraxane in combination with carboplatin).
Croatian: Učestalosti nuspojava povezanih s primjenom lijeka Abraxane navedene su u tablici 6 (Abraxane kao monoterapija), u tablici 7 (Abraxane u kombinaciji s gemcitabinom) i u tablici 9 (Abraxane u kombinaciji s karboplatinom).
English: What Abraxane is
Croatian: Što je Abraxane
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Croatian: Muški bolesnici trebaju zatražiti savjet o pohrani sperme prije početka liječenja zbog mogućnosti ireverzibilne neplodnosti koja može nastati kao posljedica liječenja lijekom Abraxane.
English: Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Croatian: Tablica 13: Analize neinferiornosti za preživljenje bez progresije bolesti i sveukupno preživljenje u randomiziranom ispitivanju bolesnika s karcinomom nemalih stanica pluća (populacija s namjerom liječenja)
English: • People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Croatian: • U bolesnika s metastatskim rakom dojke koji su primali Abraxane kada se druga terapija pokazala neuspješnom, opažena je veća vjerojatnost smanjenja veličine tumora, a bolesnici su živjeli dulje od onih koji su se liječili nekom drugom terapijom.
English: skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face
Croatian: promjena boje kože, pojačano znojenje, noćna znojenja, bijela područja kože, rane, otečeno lice
English: Abraxane is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Croatian: Abraxane se ne preporučuje u bolesnika u kojih je ukupni bilirubin > 5 x GGN ili AST > 10 x GGN.
English: Do not use Abraxane
Croatian: Nemojte primjenjivati Abraxane
English: On Days 8 or 15 of the 21-day cycle reduce the dose of Abraxane; reduce the dose of carboplatin in the subsequent cycle.
Croatian: Dozu lijeka Abraxane smanjite 8. ili 15. dana 21dnevnog ciklusa; dozu karboplatina smanjite u sljedećem ciklusu.
English: Male patients are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Croatian: Muškim se bolesnicima savjetuje da koriste učinkovitu kontracepciju i da izbjegavaju začeće djeteta tijekom liječenja, i do šest mjeseci nakon završetka liječenja, te bi trebali potražiti savjet o pohrani sjemena prije početka liječenja jer postoji mogućnost trajne neplodnosti zbog liječenja lijekom Abraxane.
English: For treatment of advanced pancreatic cancer, Abraxane is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Abraxane.
Croatian: Za liječenje uznapredovalog raka gušterače, Abraxane se daje 1., 8. i 15. dana svakog 28-dnevnog ciklusa, s tim da se gemcitabin daje odmah nakon primjene lijeka Abraxane.
English: 1 Peripheral neuropathy evaluated using the SMQ (broad scope).
Croatian: 1 Periferna neuropatija procijenjena na temelju SMQ-a (široki raspon).
English: There was a statistically significant improvement in OS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Croatian: U bolesnika koji su primali Abraxane/gemcitabin postojalo je statistički značajno poboljšanje u sveukupnom preživljenju u odnosu na bolesnike liječene samo gemcitabinom, s povećanjem medijana sveukupnog preživljenja od 1,8 mjeseci, sveukupnim smanjenjem rizika od smrti od 28%, poboljšanjem stope preživljenja u 1 godini od 59% i poboljšanjem stope preživljenja u 2 godine od
English: Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Croatian: Svaki ml koncentrata sadrži 0,183 mmol natrija što odgovara 4,2 mg natrija.
English: Abraxane contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state.
Croatian: Abraxane sadrži nanočestice paklitaksela, veličine približno 130 nm, vezane za ljudski serumski albumin gdje je paklitaksel zastupljen u nekristaliničnom, amorfnom stanju.
English: Some people may feel tired or dizzy after being given Abraxane.
Croatian: Neke osobe mogu osjećati umor ili omaglicu nakon primjene lijeka Abraxane.
English: Abraxane is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).
Croatian: Abraxane je indiciran kao monoterapija za karcinom dojke, u kombinaciji s gemcitabinom za adenokarcinom pankreasa ili u kombinaciji s karboplatinom za karcinom nemalih stanica pluća (vidjeti dio 4.1).
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Croatian: U bolesnika s umjerenim (ukupni bilirubin od > 1,5 do ≤ 3 x GGN) ili teškim (ukupni bilirubin od > 3 do ≤ 5 x GGN) oštećenjem jetrene funkcije, smanjenje maksimalne brzine eliminacije paklitaksela iznosi 22% do 26%, a povećanje srednje vrijednosti AUC-a paklitaksela iznosi približno 20% u usporedbi s bolesnicima s normalnom jetrenom funkcijom.
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Croatian: Uporaba posebnih spremnika ili kompleta za primjenu otopine bez di(2-etilheksil)ftalata (DEHP) nije nužna za pripremu ili primjenu infuzije lijeka Abraxane.
English: For the treated population, the median relative dose intensity for gemcitabine was 75% in the Abraxane/gemcitabine arm and 85% in the gemcitabine arm.
Croatian: Za liječenu populaciju, medijan relativnog intenziteta doze za gemcitabin bio je 75% u skupini koja je primala Abraxane/gemcitabin i 85% u skupini koja je primala gemcitabin.
English: Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Croatian: Abraxane je indiciran u odraslih kao monoterapija za liječenje metastatskog karcinoma dojke kod bolesnika koji nisu reagirali na prvu liniju liječenja za metastatsku bolest, i za koje nije indicirana standardna terapija antraciklinima (vidjeti dio 4.4).