FrancophonIA/ELRC3.0 huggingface dataset:
English: In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
Croatian: U ispitivanju sarkoma faze III (Ispitivanje 309), G-CSF je primilo 26% bolesnika liječenih eribulinom.
English: To ensure that the whole dose of HALAVEN is given it is recommended that a saline solution is flushed into the vein after HALAVEN is given.
Croatian: Kako bi se osigurala primjena cijele doze lijeka HALAVEN, preporučuje se ispiranje intravenske linije fiziološkom otopinom nakon primjene lijeka HALAVEN.
English: Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Croatian: Liječenje eribulinom smije se započeti samo u bolesnika s vrijednostima ABN ≥ 1,5 x 109/l i brojem trombocita > 100 x 109/l.
English: No carcinogenicity studies have been conducted with eribulin.
Croatian: Nisu provedena ispitivanja kancerogenosti eribulina.
English: Platelets < 25 x 109/l thrombocytopenia Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion Non-haematological:
Croatian: Broj trombocita < 25 x 109/l trombocitopenija Broj trombocita < 50 x 109/l trombocitopenija komplicirana krvarenjem ili zahtijeva transfuziju krvi ili trombocita Nehematološka:
English: In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1.
Croatian: U nekontroliranom elektrokardiografskom (EKG) ispitivanju otvorenog tipa u 26 bolesnika, produljenje QT intervala primijećeno je 8. dana i nije ovisilo o koncentraciji eribulina, s time da 1. dana produljenje QT intervala nije bilo primijećeno.
English: In vitro studies have also indicated that eribulin is not a substrate for OCT1.
Croatian: Ispitivanja in vitro pokazala su također da eribulin nije supstrat za OCT1.
English: Hyperglycaemia Hypophosphataemia Hypocalcaemia
Croatian: Hiperglikemija Hipofosfatemija Hipokalcijemija
English: Treatment effects of eribulin were limited to patients with liposarcoma (45% dedifferentiated, 37% myxoid/round cell and 18% pleomorphic in Study 309) based on pre-planned subgroup analyses of OS and PFS.
Croatian: Učinci liječenja eribulinom bili su ograničeni na bolesnike s liposarkomom (45% dediferenciranih, 37% miksoidnih/okruglih stanica i 18% pleomorfnih u Ispitivanju 309) na temelju prethodno planiranih analiza podskupina u pogledu ukupnog preživljenja i preživljenja bez progresije bolesti.
English: It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.
Croatian: Također se koristi u odraslih kod uznapredovalog ili metastatskog liposarkoma (vrste raka koji nastaje iz masnog tkiva) kad je prethodno iskušana terapija izgubila učinak.
English: 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively).
Croatian: G-CSF je primilo 18% odnosno 13% bolesnika liječenih eribulinom u dva ispitivanja raka dojke faze III (Ispitivanja 305 odnosno 301).
English: Pregnant rats were treated with eribulin mesilate equivalent to 0.009, 0.027, 0.088 and 0.133 mg/kg eribulin at gestation days 8, 10 and 12.
Croatian: Skotne ženke štakora primile su eribulinmesilat u dozama koje su odgovarale 0,009, 0,027, 0,088 i 0,133 mg/kg eribulina 8., 10. i 12. dana gestacije.
English: Patients had previously received up to three prior chemotherapy regimens, including both an anthracycline and a taxane and a maximum of two for advanced disease, with the percentage who had received 0, 1 or 2 prior chemotherapy treatments for metastatic breast cancer being 20.0%, 52.0% or 27.2% respectively.
Croatian: Bolesnici su prethodno primili do tri kemoterapijska režima, uključujući i antraciklin i taksan, a najviše dva za uznapredovalu bolest, s tim da je 0, 1 ili 2 prethodne kemoterapije primilo 20,0%, odnosno 52,0% ili 27,2% bolesnika.
English: Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Croatian: Kod bolesnika s vrijednostima alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) > 3 x iznad gornje granice normale (GGN) zabilježena je veća incidencija neutropenije i febrilne neutropenije 4. stupnja.
English: Consider discontinuation
Croatian: Razmotriti prekid primjene
English: The patients in this study (n=452) had locally recurrent, inoperable and/or metastatic soft tissue sarcoma of one of two subtypes - leiomyosarcoma or liposarcoma.
Croatian: Bolesnici u tom ispitivanju (n = 452) imali su jedan od dva podtipa lokalno rekurentnog, inoperabilnog i/ili metastatskog sarkoma mekog tkiva - leiomiosarkom ili liposarkom.
English: Neutropenia was reported as a Treatment Emergent Adverse Event (TEAE) in 151/404 (37.4% for all grades) in the sarcoma population, compared with 902/1559 (57.9% for all grades) in the breast cancer population.
Croatian: Treatment Emergent Adverse Event - TEAE) u 151/404 (37,4% za sve stupnjeve) u populaciji bolesnika sa sarkomom u odnosu na 902/1559 (57,9% za sve stupnjeve) u populaciji bolesnika s rakom dojke.
English: The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
Croatian: Gore navedene doze mogu se koristiti u bolesnika s blagim i umjerenim oštećenjem funkcije jetre, ali savjetuje se pomno praćenje bolesnika jer se može pokazati potreba za prilagodbom doze.
English: Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents.
Croatian: Eribulinmesilat je inhibitor mikrotubularne dinamike koji pripada halikondrinskoj klasi antineoplastičnih lijekova.
English: HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
Croatian: HALAVEN se smije primjenjivati samo pod nadzorom kvalificiranog liječnika s odgovarajućim iskustvom u primjeni citotoksičnih lijekova.
English: How to store HALAVEN
Croatian: Kako čuvati HALAVEN
English: Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines.
Croatian: Teška neutropenija može se liječiti primjenom G-CSF ili ekvivalentnim lijekom, prema procjeni liječnika i u skladu s važećim smjernicama.
English: In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
Croatian: U bolesnika s rakom dojke i postojećom perifernom neuropatijom 1. ili 2. stupnja, učestalost periferne neuropatije 3. stupnja koja se javila za vrijeme liječenja iznosila je 14%.
English: Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic anion (OAT1, OAT3, OATP1B1, OATP1B3), multi-drug resistance-associated protein (MRP2, MRP4) and bile salt export pump (BSEP) transporters.
Croatian: Eribulin nije supstrat sljedećih prijenosnih proteina: proteina rezistencije raka dojke (BCRP), transportera organskih aniona (OAT1, OAT3, OATP1B1, OATP1B3), proteina multirezistencije na lijekove (MRP2, MRP4) i pumpe za izbacivanje žučnih soli (BSEP).
English: *Disseminated intravascular coagulation b
Croatian: *Diseminirana intravaskularna koagulacijab
English: They were randomized 2:1 to receive either HALAVEN, or treatment of physician's choice (TPC), which consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxane, 9% anthracycline, 10% other chemotherapy), or 3% hormonal therapy.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 u skupinu koja je primala HALAVEN ili u skupinu koja je primala terapiju po izboru liječnika, i u kojoj je 97% primalo kemoterapiju (26% vinorelbin, 18% gemcitabin, 18% kapecitabin, 16% taksan, 9% antraciklin, 10% drugu kemoterapiju) ili 3% hormonalnu terapiju.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake “Rok valjanosti“/EXP.
English: Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see section 5.1).
Croatian: Tešku neutropeniju može se kontrolirati primjenom čimbenika stimulacije rasta granulocita (G-CSF) ili ekvivalentnog lijeka, ovisno o procjeni liječnika i u skladu s važećim smjernicama (vidjeti dio 5.1).
English: Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m2.
Croatian: Izračunavanje pojedinačne doze za primjenu bolesniku mora se temeljiti na jačini gotove otopine koja sadrži 0,44 mg/ml eribulina i preporučenoj dozi od 1,23 mg/m2.
English: The transport protein involved in the excretion is presently unknown.
Croatian: Trenutno nije poznato koji je prijenosni protein uključen u izlučivanje.
English: Objective response rate as assessed by independent review was also similar between eribulin and capecitabine; 11.0% (95% CI: 8.5, 13.9) in the eribulin group and 11.5% (95% CI: 8.9, 14.5) in the capecitabine group.
Croatian: Objektivna stopa odgovora prema neovisnoj procjeni bila je također slična između eribulina i kapecitabina; 11,0% (95% CI: 8,5, 13,9) u skupini koja primala eribulin i 11,5% (95% CI: 8,9,14,5) u skupini koja je primala kapecitabin.
English: HER2 Negative
Croatian: HER2-negativan
English: Although data are limited, patients with bilirubin > 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia (see also sections 4.2 and 5.2).
Croatian: Premda su podaci ograničeni, bolesnici s vrijednošću bilirubina > 1,5 x GGN također imaju veću incidenciju neutropenije i febrilne neutropenije 4. stupnja (vidjeti također dio 4.2 i dio 5.2).
English: Common (Frequency %)
Croatian: Često (učestalost %)
English: Study 309 ITT Population
Croatian: Ispitivanje 309
English: Eribulin is eliminated primarily by biliary excretion.
Croatian: Eribulin se primarno eliminira izlučivanjem u žuč.
English: Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
Croatian: Eribulin ima embriotoksično, fetotoksično i teratogeno djelovanje u štakora.
English: At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
Croatian: U klinički značajnim koncentracijama, eribulin nije inhibirao aktivnost posredovanu prijenosnicima BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 i OATP1B3.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HALAVEN in one or more subsets of the paediatric population for the treatment of rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka HALAVEN u jednoj ili više podskupina pedijatrijske populacije u liječenju rabdomiosarkomskog i nerabdomiosarkomskog sarkoma mekog tkiva.
English: In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4.
Croatian: Podaci in vitro pokazuju da je eribulin blagi inhibitor enzima CYP3A4 koji je važan za metaboliziranje lijekova.
English: The HER2 status of the patients was: 16.1% positive, 74.2% negative and 9.7% unknown, whilst 18.9% of patients were triple negative.
Croatian: Status HER2 bio je u tih bolesnika sljedeći: pozitivan u 16,1% bolesnika, negativan u 74,2%, nepoznat u 9,7%, dok je u 18,9% bolesnika bio trostruko negativan.
English: HALAVEN should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents.
Croatian: HALAVEN smiju pripremati i primjenjivati samo zdravstveni djelatnici odgovarajuće osposobljeni za rukovanje citotoksičnim lijekovima.
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with HALAVEN.
Croatian: Bolesnici muškog spola moraju potražiti savjet o pohrani sperme prije liječenja, jer HALAVEN može izazvati ireverzibilnu neplodnost.
English: A study evaluated the pharmacokinetics of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=4) hepatic impairment due to liver metastases.
Croatian: Farmakokinetika eribulina ispitala se u bolesnika s blagim (Child-Pugh A; n = 7) i umjerenim (ChildPugh B; n = 4) oštećenjem funkcije jetre zbog jetrenih metastaza.
English: Frequency not known
Croatian: ** Učestalost nepoznata.
English: Nominal P value (log rank)
Croatian: Nominalna P-vrijednost (log-rang)
English: ANC < 0.5 x 109/l lasting more than 7 days ANC < 1 x 109/l neutropenia complicated by fever or infection
Croatian: ABN < 0,5 x 109/l traje dulje od 7 dana ABN < 1 x 109/l neutropenija komplicirana vrućicom ili infekcijom
English: Median months
Croatian: Medijan (mjeseci)
English: Dose reduction recommendations Adverse reaction after previous HALAVEN administration Recommended dose of eribulin
Croatian: Preporučeno smanjenje doze Nuspojava nakon prethodne primjene lijeka HALAVEN Preporučena doza eribulina
English: It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.
Croatian: Koristi se u odraslih kod lokalno uznapredovalog ili metastatskog raka dojke (rak dojke koji se proširio izvan primarnog tumora) nakon što je prethodno primijenjena najmanje jedna druga terapija, ali je prestala djelovati.
English: In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Croatian: Najčešća nuspojava u 1559 bolesnika s rakom dojke, zbog koje je bilo potrebno prekinuti liječenje eribulinom, bila je periferna neuropatija (3,4%).
English: The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Croatian: Najčešće prijavljene nuspojave povezane s lijekom HALAVEN jesu supresija koštane srži koja se očituje kao neutropenija, leukopenija, anemija, trombocitopenija s pridruženim infekcijama.
English: Overall Survival Number of Events Median (months)
Croatian: Ukupno preživljenje Broj događaja Medijan (mjeseci) Omjer hazarda
English: The 762 patients in the pivotal Phase 3 EMBRACE study (Study 305) had locally recurrent or metastatic breast cancer, and had previously received at least two and a maximum of five chemotherapy regimens, including an anthracycline and a taxane (unless contraindicated).
Croatian: U ključnom ispitivanju faze III, ispitivanju EMBRACE (Ispitivanje 305), 762 bolesnika s rakom dojke imala su lokalni povrat bolesti ili metastaze, i prethodno su primila najmanje dva a najviše pet kemoterapijskih režima koji su uključivali primjenu antraciklina i taksana (osim u slučaju kontraindikacije).
English: The pack sizes are cartons of 1 or 6 vials.
Croatian: Veličine pakiranja: 1 ili 6 bočica u kartonskoj kutiji.
English: Dose delays during therapy
Croatian: Odgoda primjene doze za vrijeme liječenja
English: No drug-drug interactions are expected with CYP3A4 inhibitors and inducers.
Croatian: Ne očekuju se interakcije s lijekovima koji inhibiraju ili induciraju enzim CYP3A4.
English: Despite reduction to 0.62 mg/m2
Croatian: Usprkos smanjenju na 0,62 mg/m2
English: Haematological:
Croatian: Hematološka:
English: aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
Croatian: aCoxov model proporcionalnog hazarda bStratificirano prema geografskim regijama, statusu HER2/neu i prethodnoj terapiji kapecitabinom
English: See section 4.2 for dosage recommendation.
Croatian: Vidjeti dio 4.2 za preporuke o dozama.
English: The second Phase 3 study in earlier line metastatic breast cancer, Study 301, was an open-label, randomized, study in patients (n=1102) with locally advanced or metastatic breast cancer to investigate the efficacy of HALAVEN monotherapy compared to capecitabine monotherapy in terms of OS and PFS as co-primary endpoint.
Croatian: Drugo ispitivanje faze III u prethodno liječenih bolesnika s metastatskim rakom dojke, Ispitivanje 301, bilo je randomizirano ispitivanje otvorenog tipa u kojem se u bolesnika s lokalno uznapredovalim ili metastatskim rakom dojke (n = 1102) ispitivala djelotvornost monoterapije lijekom HALAVEN u usporedbi s monoterapijom kapecitabinom, s obzirom na ukupno preživljenje i preživljenje bez progresije bolesti kao koprimarnim ishodom.
English: Despite reduction to 0.97 mg/m2
Croatian: Usprkos smanjenju na 0,97 mg/m2
English: P value (log rank)
Croatian: P-vrijednost (log-rang)
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Croatian: U slučaju dodira otopine sa sluznicama, sluznice treba temeljito isprati vodom.
English: In clinical trials, patients with pre-existing neuropathy were as likely to develop new or worsening symptoms as those who entered the study without the condition.
Croatian: U kliničkim ispitivanjima bolesnici koji su već imali neuropatiju bili su jednako skloni razvoju novih ili pogoršanju postojećih simptoma kao i oni koji nisu imali neuropatiju u vrijeme uključivanja u ispitivanje.
English: The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively.
Croatian: Učestalost kombiniranih grupiranih štetnih događaja nastalih tijekom liječenja bila je 307/404 (76,0%), a abnormalnih laboratorijskih nalaza neutrofila bila je 1314/1559 (84,3%).
English: Progression free survival assessed by independent review was similar between eribulin and capecitabine with medians of 4.1 months vs 4.2 months (HR 1.08; [95% CI: 0.932, 1.250]) respectively.
Croatian: Preživljenje bez progresije bolesti na temelju neovisne procjene bilo je slično između eribulina i kapecitabina s medijanima od 4,1 mjeseca, odnosno 4,2 mjeseca (HR 1,08; [95% CI: 0,932, 1,250]).
English: Administration of HALAVEN at a dose of 0.97 mg/m2 to patients with mild hepatic impairment and 0.62 mg/m2 to patients with moderate hepatic impairment resulted in a somewhat higher exposure than after a dose of 1.23 mg/m2 to patients with normal hepatic function.
Croatian: HALAVEN u dozi od 0,97 mg/m2 u bolesnika s blagim oštećenjem funkcije jetre i u dozi od 0,62 mg/m2 u onih s umjerenim oštećenjem funkcije jetre izazvala je nešto veću izloženost nego primjena doze od 1,23 mg/m2 u bolesnika s normalnom funkcijom jetre.
English: Good peripheral venous access, or a patent central line, should be ensured prior to administration.
Croatian: Prije primjene potrebno je osigurati dobar pristup perifernoj veni ili centralnoj liniji kod bolesnika.
English: No Grade 4 events Rare
Croatian: Nema događaja 4. stupnja.
English: Neutrophil counts of < 0.5 x 109/l that lasted for more than 7 days occurred in 13% of breast cancer patients treated with eribulin in the EMBRACE study.
Croatian: U ispitivanju EMBRACE, broj neutrofila < 0,5 x 109/l trajao je dulje od 7 dana u 13% bolesnika s rakom dojke liječenih eribulinom.
English: The administration of HALAVEN should be delayed on Day 1 or Day 8 for any of the following: - Absolute neutrophil count (ANC) < 1 x 109/l - Platelets < 75 x 109/l - Grade 3 or 4 non-hematological toxicities.
Croatian: Primjenu lijeka HALAVEN 1. i 8. dana treba odgoditi u sljedećim slučajevima: - ako je apsolutni broj neutrofila (ABN) < 1 x 109/l - ako je broj trombocita < 75 x 109/l - ako postoji nehematološka toksičnost 3. ili 4. stupnja.
English: Urinary tract infection (8.5%) (G3/4: 0.7%) Pneumonia (1.6%) (G3/4: 1.0%) Oral candidiasis Oral herpes Upper respiratory tract infection Nasopharyngitis Rhinitis
Croatian: Infekcija mokraćnih puteva (8,5%) (G3/4: 0,7%) Pneumonija (1,6%) (G3/4: 1,0%) Oralna kandidijaza Oralni herpes Infekcija gornjih dišnih puteva Nazofaringitis Rinitis
English: Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
Croatian: Neutropenija je bila razlog prekida primjene eribulina u < 1% bolesnika.
English: - Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion.
Croatian: - vrućica uz ubrzane otkucaje srca, brzo i plitko disanje, hladna, blijeda, vlažna koža ili koža s mrljama promijenjene boje, i/ili smetenost.
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 isprati intravensku liniju otopinom za injekciju natrijevog klorida 9 mg/ml (0,9%) kako bi se osigurala primjena cijela doze.
English: How to use HALAVEN
Croatian: Kako primjenjivati HALAVEN
English: However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
Croatian: Međutim, vjerojatnost da će se u bolesnika s postojećom neuropatijom 1. ili 2. stupnja razviti novi simptomi ili pogoršati postojeći, nije bila veća nego u onih koji nisu imali neuropatiju u trenutku uključivanja u ispitivanje.
English: Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 3-fold in patients with mild and moderate hepatic impairment, respectively.
Croatian: U usporedbi s bolesnicima s normalnom funkcijom jetre (n = 6), izloženost eribulinu povećala se 1,8 puta u onih s blagim oštećenjem funkcije jetre i 3 puta u onih s umjerenim oštećenjem funkcije jetre.
English: Number of Events Median months Hazard Ratio (95% CI) p-value (log rank)
Croatian: Broj događaja Medijan (mjeseci) Omjer hazarda (95% CI) P-vrijednost (log-rang)
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Musculoskeletal pain Musculoskeletal chest pain
Croatian: Mišićno-koštani bol Mišićno-koštani bol prsišta
English: Neutropenia (53.6%) (G3/4: 46.0%) Leukopenia (27.9%) (G3/4: 17.0%) Anaemia (21.8%) (G3/4: 3.0%)
Croatian: Neutropenija (53,6%) (G3/4: 46,0%) Leukopenija (27,9%) (G3/4: 17,0%) Anemija (21,8%) (G3/4: 3,0%)
English: Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Croatian: Angioedem **Stevens-Johns onov sindrom/toksičn a epidermalna nekrolizab
English: magnesium or calcium in the blood - Inability to sleep, depression, changed sense of taste - Rash, itching, nail problems, dry or red skin - Excessive sweating (including night sweats) - Ringing in the ears - Blood clots in the lungs - Shingles - Swelling of the skin and numbness of the hands and feet
Croatian: magnezija ili kalcija u krvi - nesanica, depresija, promjena osjeta okusa - osip, svrbež, problemi s noktima, suha ili crvena koža - pretjerano znojenje (uključujući noćno znojenje) - zvonjava u ušima - krvni ugrušci u plućima - herpes zoster - oticanje kože i utrnulost šaka i stopala
English: Peripheral neuropathyc (35.9%) (G3/4: 7.3%) Headache (17.5%) (G3/4: 0.7%)
Croatian: Periferna neuropatijac (35,9%) (G3/4: 7,3%) Glavobolja (17,5%) (G3/4: 0,7%)
English: Ethanol anhydrous,Water for injections, Hydrochloric acid, Sodium hydroxide See leaflet for further information
Croatian: POPIS POMOĆNIH TVARI etanol bezvodni, voda za injekcije, kloridna kiselina, natrijev hidroksid Za dodatne informacije vidjeti uputu o lijeku.
English: Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus assay.
Croatian: Eribulin je bio pozitivan na testu mutageneze na mišjem limfomu i pokazao je klastogeno djelovanje u mikronukleusnom testu in vivo u štakora.