natgillin/translations-raw huggingface dataset:
HALAVEN will be given to you by a doctor or nurse as an injection into a vein, over a period of 2 to 5 minutes.
HALAVEN će Vam dati liječnik ili medicinska sestra injekcijom u venu tijekom 2 do 5 minuta.
Halaven is not recommended for children aged under 18 with paediatric sarcomas as it is not yet known how well it works in this age group.
Halaven se ne preporučuje za djecu mlađu od 18 godina sa sarkomima dječje dobi jer još nije poznato koliko dobro djeluje u ovoj dobnoj skupini.
HALAVEN is for intravenous use.
HALAVEN je za intravensku primjenu.
Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.
Liječenje predoziranja mora uključivati potporne medikamentozne mjere, kako bi se liječile prisutne kliničke manifestacije.
The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height.
Doza koju ćete dobiti ovisit će o veličini površine Vašeg tijela (izraženo u kvadratnim metrima ili m2) koja se izračunava na temelju
Insomnia Depression
Nesanica Depresija
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX41
Farmakoterapijska skupina: drugi antineoplastični lijekovi, ATK oznaka: L01XX41
HER2 Positive
HER2-pozitivan
No in vivo data are available.
Podaci in vivo nisu dostupni.
Nail disorder Night sweats Dry skin
Poremećaji noktiju Noćno znojenje Suha koža Eritem
Dose reduction recommendations for retreatment are shown in the following table.
Preporučena smanjenja doze kod ponovnog liječenja prikazana su u sljedećoj tablici.
Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Kategorije po učestalosti definirane su na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
New onset or worsening of pre-existing peripheral neuropathy has also been reported.
Također je zabilježen nastanak ili pogoršanje postojeće periferne neuropatije.
Note: Concomitant anti-HER2 therapy was not included in Study 305 and Study 301.
Napomena: Istodobna anti-HER2 terapija nije bila uključena u Ispitivanje 305 i Ispitivanje 301.
Treatment of Physician's Choice
Terapija po izboru liječnika
A risk to newborns/infants cannot be excluded and therefore HALAVEN must not be used during breast-feeding (see section 4.3).
Ne može se isključiti rizik za novorođenče i dojenče pa se stoga HALAVEN ne smije primjenjivati tijekom dojenja (vidjeti dio 4.3).
Eribulin is weakly bound to plasma proteins.
Eribulin se slabo veže za proteine plazme.
These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
To mogu biti znakovi manje česte alergijske reakcije (može se javiti u manje od 1 na 100 osoba).
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
- A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.
- ozbiljan poremećaj zgrušavanja krvi koji dovodi do opsežnog stvaranja krvnih ugrušaka i unutarnjeg krvarenja
What you need to know before you use HALAVEN
Što morate znati prije nego počnete primjenjivati HALAVEN
In the event of extravasation, treatment should be symptomatic.
U slučaju ekstravazacije lijeka, liječenje je simptomatsko.
There is no relevant use of HALAVEN in children and adolescents for the indication of breast cancer.
Nema relevantne primjene lijeka HALAVEN u djece i adolescenata za indikaciju raka dojke.
Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Sveukupno, profili sigurnosti u populacije bolesnika s rakom dojke i populacije bolesnika sa sarkomom mekog tkiva su bili slični.
Eribulin is mainly (up to 70%) eliminated through biliary excretion.
Eribulin se uglavnom (do 70%) eliminira izlučivanjem u žuč.
Patients must have progressed within 6 months of their last chemotherapeutic regimen.
Bolesnici su morali imati progresiju bolesti unutar 6 mjeseci od zadnjeg kemoterapijskog režima.
Patients may experience nausea or vomiting.
Bolesnici mogu osjećati mučninu ili povraćati.
In the event of an overdose, the patient should be closely monitored.
U slučaju predoziranja bolesnika valja pomno nadzirati.
It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
On je strukturalno pojednostavljen sintetički analog halikondrina B, prirodne tvari izolirane iz morske spužve Halichondria okadai.
If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water.
Ako otopina dođe u dodir s kožom, kožu treba odmah temeljito isprati vodom i sapunom.
Patients should be advised not to drive or use machines if they feel tired or dizzy.
Bolesnicima valja savjetovati da ne voze i da ne upravljaju strojevima ako osjete umor ili omaglicu.
The development of severe peripheral neurotoxicity requires a delay or reduction of dose (see section 4.2)
U slučaju razvoja teške periferne neurotoksičnosti potrebno je odgoditi primjenu ili smanjiti dozu (vidjeti dio 4.2).
Dose reduction during therapy
Smanjenje doze za vrijeme liječenja
Adverse Reactions - all Grades Very Common (Frequency %)
Nuspojave - svi stupnjevi Vrlo često (učestalost %)
What HALAVEN is and what it is used for What you need to know before you use HALAVEN How to use HALAVEN
Što je HALAVEN i za što se koristi Što morate znati prije nego počnete primjenjivati HALAVEN
No dose adjustments are recommended for the elderly population.
Nema preporuka za prilagodbu doze u starije populacije.
Pregnant staff should not handle HALAVEN.
Zdravstvene djelatnice koje su trudne ne smiju rukovati lijekom HALAVEN.
These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis.
To mogu biti znakovi stanja koje se zove Stevens-Johnsonov sindrom/toksična epidermalna nekroliza.
Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in section 4.2.
Bolesnike s febrilnom neutropenijom, teškom neutropenijom ili trombocitopenijom treba liječiti u skladu s preporukama u dijelu 4.2.
Each carton contains either 1 or 6 vials.
Jedna kutija sadrži 1 ili 6 bočica.
The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Profil sigurnosti primjene eribulina u starijih bolesnika (u dobi od ≥ 65 godina) bio je sličan onom u bolesnika u dobi od < 65 godina, osim za asteniju/umor gdje se pokazao trend porasta s dobi.
Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Koncentracije metabolita činile su < 0,6% ishodišnog spoja, čime se potvrdilo da u ljudi ne nastaju neki važni metaboliti eribulina.
- The active substance is eribulin.
- Djelatna tvar je eribulin.
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo.
Do not use HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati HALAVEN - ako ste alergični na eribulinmesilat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako dojite
The transport protein involved in this process is unknown.
Nije poznato koji prijenosni protein sudjeluje u tom procesu.
No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
Ne postoje posebne preporuke za prilagodbu doze na temelju dobi bolesnika (vidjeti dio 4.8).
There was no difference in efficacy between eribulin and dacarbazine in patients with advanced or metastatic leiomyosarcoma.
Nije bilo razlike u djelotvornosti između eribulina i dakarbazina u bolesnika s uznapredovalim ili metastatskim leiomiosarkomom.
Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected prior to initiating HALAVEN and these electrolytes should be monitored periodically during therapy.
Hipokalijemiju, hipokalcijemiju ili hipomagnezijemiju treba korigirati prije početka liječenja lijekom HALAVEN i te elektrolite povremeno određivati tijekom liječenja.
- Serious skin rashes with blistering of the skin, mouth, eyes and genitals.
- ozbiljni kožni osipi s mjehurima po koži, u ustima, na očima i spolnim organima.
HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
HALAVEN sadrži etanol (alkohol) Ovaj lijek sadrži male količine etanola (alkohol), manje od 100 mg u bočici.
Patients had received at least two prior chemotherapy regimens, one of which must have been an anthracycline (unless contraindicated).
Bolesnici su prethodno primili najmanje dva kemoterapijska režima, od kojih je jedan morao sadržavati antraciklin (osim ako je bio kontraindiciran).
The dose of eribulin should not be re-escalated after it has been reduced.
Nakon što je doza eribulina bila smanjena, ne smije se ponovno povećavati.
Patients should be closely monitored for signs of peripheral motor and sensory neuropathy.
Bolesnike valja pomno pratiti zbog moguće pojave znakova periferne motoričke i senzoričke neuropatije.
It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
Ne smije se miješati s drugim lijekovima i ne smije se razrjeđivati u 5%-tnoj otopini glukoze za infuziju.
Women of childbearing potential must be advised to avoid becoming pregnant whilst they or their male partner are receiving HALAVEN and have to use effective contraception during and up to 3 months after treatment.
Ženama reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću dok one ili njihovi partneri primaju HALAVEN i napomenuti da moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon liječenja.
Testicular toxicity has been observed in rats and dogs (see section 5.3).
U štakora i pasa primijećena je testikularna toksičnost (vidjeti dio 5.3).
If not used immediately HALAVEN as the undiluted solution in a syringe should not normally be stored longer than 4 hours at 25°C and ambient lighting, or 24 hours at 2°C - 8°C.
Ako se ne primijeni odmah, HALAVEN u obliku nerazrijeđene otopine u štrcaljki ne smije se u normalnim okolnostima čuvati dulje od 4 sata na temperaturi od 25°C i pri sobnom osvjetljenju ili dulje od 24 sata na temperaturi od 2°C - 8°C.
The usual dose of HALAVEN is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors.
Uobičajena je doza lijeka HALAVEN 1,23 mg/m2, ali liječnik je može prilagoditi ovisno o Vašim krvnim nalazima ili drugim čimbenicima.
In the EU the recommended dose refers to the base of the active substance (eribulin).
U Europskoj uniji preporučena doza odnosi se na djelatnu tvar u obliku baze (eribulin).
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Ovaj lijek sadrži male količine etanola (alkohola), manje od 100 mg po dozi.
If you have any further questions about the use of this medicine, ask your doctor.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
The European Medicines Agency has waived the obligation to submit the results of studies with eribulin in all subsets of the paediatric population in the indication of breast cancer (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka HALAVEN u svim podskupinama pedijatrijske populacije za indikaciju raka dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment.
HALAVEN može prouzročiti i kasnije trajne probleme s plodnošću u muškaraca koji ga primaju, te bi oni morali razgovarati sa svojim liječnikom prije početka liječenja.
An embryofoetal development study in rat confirmed the developmental toxicity and teratogenic potential of eribulin.
Ispitivanja utjecaja na embriofetalni razvoj u štakora potvrdila su razvojnu toksičnost i teratogeni potencijal eribulina.
HALAVEN contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.
HALAVEN sadrži djelatnu tvar eribulin i antitumorski je lijek koji djeluje tako da zaustavlja rast i širenje stanica raka.
Some patients with moderately or severely impaired renal function (creatinine clearance <50 ml/min) may have increased eribulin exposure and may need a reduction of the dose.
Neki bolesnici s umjereno ili teško oštećenom funkcijom bubrega (klirens kreatinina < 50 ml/min) mogu imati povećanu izloženost eribulinu te im može biti potrebno smanjiti dozu.
In addition there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%).
Osim toga, smrtni ishod imala su 3 slučaja sepse (0,2%) i jedan septičnog šoka (0,1%).
The median time to Grade 2 peripheral neuropathy was 18.4 weeks.
Medijan vremena do periferne neuropatije 2. stupnja iznosio je 18,4 tjedana.
aCox proportional hazard bStratified by geographic region, HER2/neu status
aCoxov model proporcionalnog hazarda bStratificirano prema geografskim regijama, statusu HER2/neu
This patient group has not been studied.
Primjena nije ispitivana u ovoj skupini bolesnika.
Cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.
Zabilježeni su slučajevi diseminirane intravaskularne koagulacije, obično povezani s neutropenijom i/ili sepsom.
HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).
HALAVEN nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh C).
Myelosuppression is dose dependent and primarily manifested as neutropenia (section 4.8).
Mijelosupresija ovisi o dozi i primarno se očituje kao neutropenija (vidjeti dio 4.8).
This translated into a 2 month improvement in median OS (13.5 months for eribulin treated patients vs. 11.5 months for dacarbazine treated patients).
To se očitovalo u poboljšanju medijana ukupnog preživljenja za 2 mjeseca (13,5 mjeseci za bolesnike liječene eribulinom naspram 11,5 mjeseci za bolesnike liječene dakarbazinom).
HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling.
HALAVEN je citotoksični antitumorski lijek i njime se, kao i s drugim toksičnim spojevima, mora rukovati s oprezom.
Additionally, in vivo, concomitant administration of ketoconazole, a Pgp inhibitor, has no effect on eribulin exposure (AUC and Cmax).
Osim toga, in vivo, istodobna primjena ketokonazola, inhibitora Pgp-a, nema utjecaja na izloženost eribulinu (AUC i Cmax).
Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
Prethodna terapija morala je uključivati antraciklin i taksan kao adjuvantnu ili metastatsku terapiju, osim ako ti bolesnici nisu bili pogodni za ta liječenja.
Such elevations appeared to have occurred early with eribulin treatment in cycle 1 - 2 for the majority of these patients and whilst thought likely to be a phenomenon of adaptation to eribulin treatment by the liver and not a sign of significant liver toxicity in most patients, hepatotoxicity has also been reported.
Čini se da su ta povišenja kod većine takvih bolesnika nastupila rano u terapiji eribulinom u 1. do 2. ciklusu, pa iako se smatralo da je to u većine bolesnika vjerojatno fenomen prilagodbe jetre na liječenje eribulinom, a ne znak značajne toksičnosti za jetru, zabilježena je i hepatotoksičnost.
The median duration of treatment was 12.0 weeks for sarcoma patients and 15.9 weeks for breast cancer patients.
Medijan trajanja liječenja iznosio je 12,0 tjedana u bolesnika sa sarkomom, a 15,9 tjedana u bolesnika s rakom dojke.
The efficacy of HALAVEN in breast cancer is primarily supported by two randomized Phase 3 comparative studies.
Djelotvornost lijeka HALAVEN u liječenju raka dojke prvenstveno je dokazana u dva randomizirana komparativna ispitivanja faze III.
It is unknown whether eribulin/metabolites are excreted in human or animal breast milk.
Nije poznato izlučuju li se eribulin/metaboliti eribulina u majčino mlijeko u ljudi i mlijeko životinja.
Development of Grade 3 or 4 peripheral neuropathy occurred in 7.4% of breast cancer patients and 3.5% of sarcoma patients.
Periferna neuropatija 3. ili 4. stupnja razvila se u 7,4% bolesnika s rakom dojke i 3,5% bolesnika sa sarkomom.
HALAVEN may cause adverse reactions such as tiredness and dizziness which may lead to minor or moderate influence on the ability to drive or use machines.
HALAVEN može prouzročiti nuspojave kao što su umor i omaglica, zbog čega može imati mali do umjereni utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
- The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.
- Drugi sastojci su etanol i voda za injekcije, s kloridnom kiselinom i natrijevim hidroksidom koji mogu biti prisutni u vrlo malim količinama.
The pharmacokinetic properties are not dose or time dependent in the range of eribulin doses of 0.22 to 3.53 mg/m2.
Farmakokinetička svojstva ne ovise o dozi niti o vremenu primjene u rasponu doza eribulina od 0,22 do 3,53 mg/m2.
Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy d
Uključuje preporučene izraze za perifernu neuropatiju, perifernu motoričku neuropatiju, polineuropatiju, paresteziju, perifernu senzoričku neuropatiju, perifernu senzomotoričku neuropatiju i demijelinizirajuću polineuropatiju.
Women of childbearing age should use effective contraception during and up to 3 months after treatment with HALAVEN.
Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju za vrijeme liječenja i do 3 mjeseca nakon završetka liječenja lijekom HALAVEN.
Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concentrations.
Eribulin ne inhibira CYP enzime CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ili 2E1 u klinički značajnim koncentracijama.
From a microbiological point of view unless the method of opening precludes the risk of microbial contamination the product should be used immediately.
S mikrobiološkog stajališta, lijek se mora odmah primijeniti osim kad način otvaranja bočice sprječava rizik od mikrobiološke kontaminacije.
In liposarcoma the efficacy of eribulin is supported by the pivotal Phase 3 sarcoma study (Study 309).
Djelotvornost eribulina kod liposarkoma potkrijepljena je ključnim ispitivanjem sarkoma faze III (Ispitivanje 309).
The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles).
Medijan vremena do nastanka periferne neuropatije 2. stupnja iznosio je 12,6 tjedana (nakon 4 ciklusa).
HALAVEN should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
HALAVEN se ne smije primjenjivati tijekom trudnoće, osim ako je to neophodno i tek nakon pažljivog razmatranja potrebe liječenja majke i rizika za fetus.
Eribulin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test).
Eribulin nije izazvao mutacije in vitro na testu povratnih mutacija u bakterija (Amesov test).
Where Grade 3 or 4 reactions occurred, the actual total frequency and the frequency of Grade 3 or 4 reactions are given.
Ako su se pojavile nuspojave 3. ili 4. stupnja, prikazana je njihova stvarna ukupna učestalost i učestalost nuspojava 3. ili 4. stupnja.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Ako se lijek ne primijeni odmah, trajanje i uvjeti čuvanja bočice nakon otvaranja odgovornost su korisnika.
The overall survival in patients in HER2 negative and HER2 positive patients in the eribulin and control groups in Study 305 and Study 301 is shown below:
Ukupno preživljenje u bolesnika s HER2-negativnim i HER2-pozitivnim statusom u skupini koja je primala eribulin i kontrolnoj skupini u Ispitivanju 305 i Ispitivanju 301 prikazano je ispod:
Mouth ulceration Pancreatitis
Ulceracije u ustima Pankreatitis
A fertility study was not conducted with eribulin, but based on non-clinical findings in repeated-dose studies where testicular toxicity was observed in both rats (hypocellularity of seminiferous epithelium with hypospermia/aspermia) and dogs, male fertility may be compromised by treatment with eribulin.
Nisu provedena ispitivanja utjecaja eribulina na plodnost, ali na temelju nekliničkih nalaza u ispitivanjima ponovljene doze u kojima je bila primijećena testikularna toksičnost u štakora (hipocelularnost epitela sjemenih kanalića s hipospermijom/aspermijom) i pasa, liječenje eribulinom može oštetiti plodnost muškaraca.
Chest pain Influenza like illness
Bol u prsištu Bolest nalik gripi
The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (< 0.5 x 109/l) was 8 days.
Primijećena neutropenija bila je reverzibilna i nije bila kumulativna; prosječno vrijeme smanjenja broja neutrofila na najniže vrijednosti iznosilo je 13 dana, a prosječno vrijeme do oporavka od teške neutropenije (< 0,5 x 109/l) iznosilo je 8 dana.
HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.
HALAVEN ne smijete primati za vrijeme dojenja zbog mogućeg rizika za dijete.
Both adverse reactions resolved with supportive care.
Obje nuspojave riješene su s pomoću potpornih mjera.
Other medicines and HALAVEN Tell your doctor if you are using, have recently used or might use any other medicines.
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Caution and monitoring for adverse events is recommended with concomitant use of substances that have a narrow therapeutic window and that are eliminated mainly via CYP3A4-mediated metabolism (eg alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
Oprez i praćenje zbog mogućih štetnih događaja preporučuju se pri istodobnoj primjeni tvari uske terapijske širine te koje se eliminiraju uglavnom putem metabolizma posredovanog enzimom CYP3A4 (npr. alfentanil, ciklosporin, ergotamin, fentanil, pimozid, kinidin, sirolimus, takrolimus).
From spontaneous reporting c
Iz spontanih prijava.
Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age.
Od 1559 bolesnika s rakom dojke liječenih preporučenom dozom eribulina, 283 bolesnika (18,2%) bilo je u dobi od ≥ 65 godina.
Unless otherwise noted, the table shows the incidence rates of adverse reactions observed in breast cancer and soft tissue sarcoma patients who received the recommended dose in Phase 2 and Phase 3 studies.
Ako nije navedeno drugačije, u sljedećoj su tablici prikazane stope incidencije nuspojava primijećenih u bolesnika s rakom dojke i sarkomom mekog tkiva koji su primili preporučenu dozu u ispitivanjima faze II i faze III.