natgillin/translations-raw huggingface dataset:
ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias or concomittant treatment with medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities.
EKG praćenje preporučuje se ako se terapijom započinje u bolesnika s kongestivnim zatajenjem srca, bradiaritmijama ili u onih koji istodobno uzimaju lijekove za koje se zna da produljuju QT interval, uključujući antiaritmike klase Ia i III i u onih s poremećajem elektrolita.
In some patients with normal/abnormal liver enzymes prior treatment with eribulin, increased levels of liver enzymes have been reported with initiation of eribulin treatment.
U nekih bolesnika s normalnim/poremećenim jetrenim enzimima prije liječenja eribulinom, povišene razine jetrenih enzima zabilježene su pri započinjanju liječenja eribulinom.
Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy.
Od 404 bolesnika sa sarkomom, 2 bolesnika prekinula su liječenje eribulinom zbog periferne neuropatije.
Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Eribulin inhibira mikrotubule u fazi rasta i pritom ne utječe na fazu skraćivanja te cijepa tubulin u neproduktivne agregate.
The plasma protein binding of eribulin (100-1000 ng/ml) ranged from 49% to 65% in human plasma.
Vezanje eribulina za proteine plazme (100 - 1000 ng/ml) u ljudi kretalo se u rasponu od 49% do 65%.
Dose related increased number of resorptions and decreased foetal weight were observed at doses ≥ 0.088 mg/kg and increased incidence of malformations (absence of lower jaw, tongue, stomach and spleen) was recorded at 0.133 mg/kg.
Povećana resorpcija fetusa i smanjena tjelesna težina fetusa ovisne o dozi primijećene su pri dozama ≥ 0,088 mg/kg, a povećana incidencija malformacija (nedostatak donje čeljusti, jezika, želuca i slezene) bila je zabilježena pri dozi od 0,133 mg/kg.
Eribulin has a low clearance (range of means 1.16 to 2.42 l/h/m2).
Eribulin ima mali klirens (raspon prosječnih vrijednosti od 1,16 do 2,42 l/h/m2).
Febrile neutropenia occurred in < 5% of patients treated with eribulin.
Febrilna neutropenija razvila se u < 5% bolesnika liječenih eribulinom.
HALAVEN is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
HALAVEN je indiciran u liječenju odraslih bolesnika s neresektabilnim liposarkomom koji su prethodno primili terapiju koja sadrži antraciklin (osim ako nije bilo prikladno) zbog uznapredovale ili metastatske bolesti (vidjeti dio 5.1).
There are no data from the use of eribulin in pregnant women.
Nema podataka o primjeni eribulina u trudnica.
Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.
Ostale nuspojave uključuju umor, alopeciju, povišene jetrene enzime, sepsu i sindrom mišićno-koštanog bola.
However it has been shown that at clinically relevant concentrations eribulin is not a Pgp inhibitor in vitro.
Međutim, pokazalo se da u klinički značajnim koncentracijama eribulin nije inhibitor Pgp-a in vitro.
Talk to your doctor or nurse before using HALAVEN: - if you have liver problems - if you have a fever or an infection - if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness - if you have heart problems
Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite HALAVEN: - ako imate tegobe s jetrom - ako imate vrućicu ili infekciju - ako osjetite utrnulost, trnce, žmarce, razvijete osjetljivost na dodir ili mišićnu slabost - ako imate srčane tegobe
Severe hepatic impairment (Child-Pugh C) has not been studied but it is expected that a more marked dose reduction is needed if eribulin is used in these patients.
Primjena u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) nije se ispitivala, ali smatra se da je dozu potrebno još više smanjiti ako se eribulin primjenjuje u ovih bolesnika.
See section 4.2 for treatment recommendations.
Vidjeti dio 4.2 za preporuke za liječenje.
HALAVEN may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby.
HALAVEN može prouzročiti ozbiljne urođene mane i ne smijete ga primati za vrijeme trudnoće, osim ako se nakon pažljivog razmatranja svih rizika za Vas i Vaše dijete nije jasno pokazalo da je liječenje neophodno.
It should not be diluted in glucose 5% infusion solution.
Ne smije se razrjeđivati pomoću 5%-tne otopine glukoze za infuziju.
In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age.
U populaciji od 404 bolesnika sa sarkomom, 90 bolesnika (22,3%) liječenih eribulinom bilo je u dobi od ≥ 65 godina.
HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml or 3ml of solution.
HALAVEN je bistra, bezbojna vodena otopina za injekciju u staklenoj bočici koja sadrži 2 ml ili 3 ml otopine.
No significant accumulation of eribulin is observed on weekly administration.
Nije bilo primijećeno značajno nakupljanje eribulina kod tjedne primjene.
Eribulin should be avoided in patients with congenital long QT syndrome.
Primjenu eribulina treba izbjegavati u bolesnika s urođenim sindromom produljenog QT intervala.
PROPORTION OF PATIENTS ALIVE
UDIO ŽIVIH BOLESNIKA
Unchanged eribulin represented most of the total radioactivity in faeces and urine.
Eribulin u neizmijenjenom obliku bio je odgovoran za veći dio ukupne radioaktivnosti u stolici i mokraći.
Diluted solutions of HALAVEN (0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride 9 mg/ml (0.9%)) solution for injection should not be stored longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Razrijeđena otopina lijeka HALAVEN (0,018 mg/ml do 0,18 mg/ml eribulina u otopini za injekciju natrijevog klorida 9 mg/ml (0,9%)) ne smije se čuvati dulje od 24 sata na temperaturi od 2°C - 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
There is no known antidote for eribulin overdose.
Nije poznat antidot kod predoziranja eribulinom.
There is no evidence that eribulin mesilate is a vesicant or an irritant.
Nema dokaza da eribulinmesilat izaziva plikove ili nadraženost.
HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1).
HALAVEN je indiciran u liječenju odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom dojke u kojih je bolest napredovala nakon najmanje jednog kemoterapijskog režima za uznapredovalu bolest (vidjeti dio 5.1).
Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged and irreversible mitotic blockage.
Antimitotički mehanizam djelovanja eribulina zbog njegovih učinaka na tubulin dovodi do blokade staničnog ciklusa u G2/M fazi, cijepanja diobenog vretena i, na kraju, do apoptotičke smrti stanice nakon produljene i ireverzibilne blokade mitoze.
Out of 1963 breast cancer and soft tissue sarcoma patients who received eribulin at the recommended dose in clinical trials there was one fatal event each of neutropenic sepsis (0.1%) and febrile neutropenia (0.1%).
U 1963 bolesnika s rakom dojke ili sarkomom mekog tkiva koji su u kliničkim ispitivanjima primali preporučenu dozu eribulina, bio je jedan slučaj sa smrtnim ishodom zbog neutropenične sepse (0,1%) i jedan zbog febrilne neutropenije (0,1%).
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Uvjete čuvanja lijeka nakon prvog otvaranja i razrjeđivanja lijeka vidjeti u dijelu 6.3.
They were randomized 1:1 to receive either eribulin 1.23 mg/m2 on days 1 and 8 of a 21 day cycle or dacarbazine 850 mg/m2, 1000 mg/m2 or 1200 mg/m2 (dose determined by the investigator prior to randomization),
Bili su randomizirani u omjeru 1:1 u skupinu koja je primala eribulin u dozi od 1,23 mg/m2 1. i 8. dana 21-dnevnog ciklusa ili skupinu koja je primala dakarbazin u dozi od 850 mg/m2, 1000 mg/m2 ili 1200 mg/m2 (dozu je određivao ispitivač prije randomizacije), svakih 21 dan.
Hypoaesthesia Lethargy Neurotoxicity
Hipoestezija Letargija Neurotoksičnost
The HER2 status of the patients was: 15.3% positive, 68.5% negative and 16.2% unknown, whilst 25.8% of patients were triple negative.
15,3% bolesnika pozitivan, u 68,5% negativan i 16,2% nepoznat, dok je u 25,8% bolesnika bio trostruko negativan.
The dose reduction recommendations shown below are also shown as the dose of eribulin to be administered based on the strength of the ready to use solution.
Niže navedene preporuke za sniženje doze, prikazane su i u obliku doze eribulina koja će biti primijenjena na temelju jačine gotove otopine.
In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
U ispitivanju sarkoma faze III (Ispitivanje 309), G-CSF je primilo 26% bolesnika liječenih eribulinom.
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.
Kako bi se osigurala primjena cijele doze lijeka HALAVEN, preporučuje se ispiranje intravenske linije fiziološkom otopinom nakon primjene lijeka HALAVEN.
Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Liječenje eribulinom smije se započeti samo u bolesnika s vrijednostima ABN ≥ 1,5 x 109/l i brojem trombocita > 100 x 109/l.
No carcinogenicity studies have been conducted with eribulin.
Nisu provedena ispitivanja kancerogenosti eribulina.
Platelets < 25 x 109/l thrombocytopenia Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion Non-haematological:
Broj trombocita < 25 x 109/l trombocitopenija Broj trombocita < 50 x 109/l trombocitopenija komplicirana krvarenjem ili zahtijeva transfuziju krvi ili trombocita Nehematološka:
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.
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.
In vitro studies have also indicated that eribulin is not a substrate for OCT1.
Ispitivanja in vitro pokazala su također da eribulin nije supstrat za OCT1.
Hyperglycaemia Hypophosphataemia Hypocalcaemia
Hiperglikemija Hipofosfatemija Hipokalcijemija
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.
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.
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.
Također se koristi u odraslih kod uznapredovalog ili metastatskog liposarkoma (vrste raka koji nastaje iz masnog tkiva) kad je prethodno iskušana terapija izgubila učinak.
18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively).
G-CSF je primilo 18% odnosno 13% bolesnika liječenih eribulinom u dva ispitivanja raka dojke faze III (Ispitivanja 305 odnosno 301).
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.
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.
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.
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.
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.
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.
Consider discontinuation
Razmotriti prekid primjene
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.
Bolesnici u tom ispitivanju (n = 452) imali su jedan od dva podtipa lokalno rekurentnog, inoperabilnog i/ili metastatskog sarkoma mekog tkiva - leiomiosarkom ili liposarkom.
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.
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.
The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
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.
Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents.
Eribulinmesilat je inhibitor mikrotubularne dinamike koji pripada halikondrinskoj klasi antineoplastičnih lijekova.
HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
HALAVEN se smije primjenjivati samo pod nadzorom kvalificiranog liječnika s odgovarajućim iskustvom u primjeni citotoksičnih lijekova.
How to store HALAVEN
Kako čuvati HALAVEN
Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines.
Teška neutropenija može se liječiti primjenom G-CSF ili ekvivalentnim lijekom, prema procjeni liječnika i u skladu s važećim smjernicama.
In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
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%.
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.
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).
*Disseminated intravascular coagulation b
*Diseminirana intravaskularna koagulacijab
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.
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.
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake “Rok valjanosti“/EXP.
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).
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).
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.
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.
The transport protein involved in the excretion is presently unknown.
Trenutno nije poznato koji je prijenosni protein uključen u izlučivanje.
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.
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.
HER2 Negative
HER2-negativan
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).
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).
Common (Frequency %)
Često (učestalost %)
Study 309 ITT Population
Ispitivanje 309
Eribulin is eliminated primarily by biliary excretion.
Eribulin se primarno eliminira izlučivanjem u žuč.
Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
Eribulin ima embriotoksično, fetotoksično i teratogeno djelovanje u štakora.
At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
U klinički značajnim koncentracijama, eribulin nije inhibirao aktivnost posredovanu prijenosnicima BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 i OATP1B3.
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.
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.
In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4.
Podaci in vitro pokazuju da je eribulin blagi inhibitor enzima CYP3A4 koji je važan za metaboliziranje lijekova.
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.
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.
HALAVEN should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents.
HALAVEN smiju pripremati i primjenjivati samo zdravstveni djelatnici odgovarajuće osposobljeni za rukovanje citotoksičnim lijekovima.
Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with HALAVEN.
Bolesnici muškog spola moraju potražiti savjet o pohrani sperme prije liječenja, jer HALAVEN može izazvati ireverzibilnu neplodnost.
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.
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.
Frequency not known
** Učestalost nepoznata.
Nominal P value (log rank)
Nominalna P-vrijednost (log-rang)
ANC < 0.5 x 109/l lasting more than 7 days ANC < 1 x 109/l neutropenia complicated by fever or infection
ABN < 0,5 x 109/l traje dulje od 7 dana ABN < 1 x 109/l neutropenija komplicirana vrućicom ili infekcijom
Median months
Medijan (mjeseci)
Dose reduction recommendations Adverse reaction after previous HALAVEN administration Recommended dose of eribulin
Preporučeno smanjenje doze Nuspojava nakon prethodne primjene lijeka HALAVEN Preporučena doza eribulina
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.
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.
In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Najčešća nuspojava u 1559 bolesnika s rakom dojke, zbog koje je bilo potrebno prekinuti liječenje eribulinom, bila je periferna neuropatija (3,4%).
The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Najčešće prijavljene nuspojave povezane s lijekom HALAVEN jesu supresija koštane srži koja se očituje kao neutropenija, leukopenija, anemija, trombocitopenija s pridruženim infekcijama.
Overall Survival Number of Events Median (months)
Ukupno preživljenje Broj događaja Medijan (mjeseci) Omjer hazarda
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).
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).
The pack sizes are cartons of 1 or 6 vials.
Veličine pakiranja: 1 ili 6 bočica u kartonskoj kutiji.
Dose delays during therapy
Odgoda primjene doze za vrijeme liječenja
No drug-drug interactions are expected with CYP3A4 inhibitors and inducers.
Ne očekuju se interakcije s lijekovima koji inhibiraju ili induciraju enzim CYP3A4.
Despite reduction to 0.62 mg/m2
Usprkos smanjenju na 0,62 mg/m2
Haematological:
Hematološka:
aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
aCoxov model proporcionalnog hazarda bStratificirano prema geografskim regijama, statusu HER2/neu i prethodnoj terapiji kapecitabinom
See section 4.2 for dosage recommendation.
Vidjeti dio 4.2 za preporuke o dozama.