FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of HALAVEN in breast cancer is primarily supported by two randomized Phase 3 comparative studies.
Slovenian: Učinkovitost zdravila HALAVEN pri raku dojke podpirata predvsem dve randomizirani primerjalni študiji 3. faze.
English: The median duration of treatment was 12.0 weeks for sarcoma patients and 15.9 weeks for breast cancer patients.
Slovenian: Mediana trajanja zdravljenja je bila 12,0 tedna za bolnike s sarkomom in 15,9 tedna za bolnike z rakom dojke.
English: What HALAVEN is and what it is used for
Slovenian: Kaj je zdravilo HALAVEN in za kaj ga uporabljamo
English: The transport protein involved in the excretion is presently unknown.
Slovenian: Transportna beljakovina, ki sodeluje v procesu izločanja, trenutno ni znana.
English: - A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.
Slovenian: - resna motnja strjevanja krvi, ki povzroči obsežno nastajanje krvnih strdkov in notranje krvavitve.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če zdravila ne porabite takoj, je za čase shranjevanja med uporabo in za pogoje odgovoren uporabnik.
English: What you need to know before you use HALAVEN
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo HALAVEN
English: TIME (months) NUMBER OF PATIENTS AT RISK HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
Slovenian: ČAS (meseci) ŠTEVILO BOLNIKOV S TVEGANJEM HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 kapecitabin 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
English: Sepsis is uncommon (may affect up to 1 in 100 people) and can be lifethreatening and may result in death.
Slovenian: Sepsa je občasna (lahko se pojavi pri največ 1 od 100 bolnikov) in je lahko smrtno nevarna in se lahko konča s smrtjo.
English: No dose adjustments are recommended for the elderly population.
Slovenian: Prilagajanje odmerkov za starejše bolnike se ne priporoča.
English: Myelosuppression is dose dependent and primarily manifested as neutropenia (section 4.8).
Slovenian: Mielosupresija je odvisna od odmerka in se primarno kaže kot nevtropenija (poglavje 4.8).
English: Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in section 4.2.
Slovenian: Bolnike, pri katerih se pojavijo febrilna nevtropenija, huda nevtropenija ali trombocitopenija, je treba zdraviti v skladu s priporočili v poglavju 4.2.
English: Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.
Slovenian: Zdravljenje prevelikega odmerka naj vključuje podporno zdravljenje nastalih kliničnih manifestacij.
English: In the EU the recommended dose refers to the base of the active substance (eribulin).
Slovenian: Priporočeni odmerek v EU velja za bazo zdravilne učinkovine (eribulin).
English: Study 309 ITT Population
Slovenian: Študija 309 populacija ITT
English: No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
Slovenian: Specifičnih priporočil za prilagoditev odmerka zaradi starosti bolnika ni (glejte poglavje 4.8).
English: It is unknown whether eribulin/metabolites are excreted in human or animal breast milk.
Slovenian: Ni znano, ali se eribulin/presnovki izločajo v materino mleko pri človeku ali živalih.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX41
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX41
English: In liposarcoma the efficacy of eribulin is supported by the pivotal Phase 3 sarcoma study (Study 309).
Slovenian: Učinkovitost eribulina pri liposarkomu podpira ključna študija sarkoma 3. faze (študija 309).
English: There was no difference in efficacy between eribulin and dacarbazine in patients with advanced or metastatic leiomyosarcoma.
Slovenian: Razlike v učinkovitosti med eribulinom in dakarbazinom pri bolnikih z napredovalim ali metastatskim leiomiosarkomom ni bilo.
English: These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
Slovenian: To bi lahko bili znaki občasne alergijske reakcije (lahko se pojavi pri največ 1 od 100 bolnikov).
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Slovenian: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Velika Britanija.
English: HALAVEN is usually given on Days 1 and 8 of every 21-day cycle.
Slovenian: Zdravilo HALAVEN se običajno daje 1. in 8. dan vsakega 21-dnevnega cikla.
English: These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis.
Slovenian: To utegnejo biti znaki bolezni, ki se imenuje Stevens-Johnsonov sindrom/toksična epidermalna nekroliza.
English: 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.
Slovenian: Nekateri bolniki z zmerno ali hudo okvarjenim delovanjem ledvic (očistek kreatinina <50 ml/min) utegnejo imeti zvečano izpostavljenost eribulinu in bodo morda potrebovali nižji odmerek.
English: 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.
Slovenian: Če zdravila HALAVEN ne porabite takoj, nerazredčene raztopine v brizgi običajno ne smete shranjevati dlje kot 4 ure pri 25 °C in na sobni svetlobi ali 24 ur pri 2 °C - 8 °C.
English: It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Slovenian: Po zgradbi je poenostavljen sintetični analog halihondrina B, naravnega produkta, izoliranega iz morske spužve Halichondria okadai.
English: 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.
Slovenian: Spodaj navedena priporočila za zmanjšanje odmerka so prikazana tudi kot odmerek eribulina, ki se uporabi na podlagi jakosti raztopine, pripravljene za uporabo.
English: There is no relevant use of HALAVEN in children and adolescents for the indication of breast cancer.
Slovenian: Zdravilo HALAVEN ni namenjeno uporabi pri otrocih in mladostnikih za indikacijo rak dojke.
English: A risk to newborns/infants cannot be excluded and therefore HALAVEN must not be used during breast-feeding (see section 4.3).
Slovenian: Ker tveganja za dojenega novorojenca/otroka ne moremo izključiti, se zdravilo HALAVEN med dojenjem ne sme uporabljati (glejte poglavje 4.3).
English: Women of childbearing age should use effective contraception during and up to 3 months after treatment with HALAVEN.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še do 3 mesece po zdravljenju z zdravilom HALAVEN.
English: Note: Concomitant anti-HER2 therapy was not included in Study 305 and Study 301.
Slovenian: Opozorilo: sočasno anti-HER2 zdravljenje v študijo 305 in študijo 301 ni bilo vključeno.
English: HER2 Positive
Slovenian: pozitivni glede na HER2
English: Overall Survival Number of Events Median (months)
Slovenian: Število dogodkov Mediana (meseci)
English: From a microbiological point of view unless the method of opening precludes the risk of microbial contamination the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba zdravilo porabiti takoj, razen če metoda odprtja izključuje tveganje mikrobne kontaminacije.
English: It should not be diluted in glucose 5% infusion solution.
Slovenian: Ne sme se ga redčiti v 5-odstotni infuzijski raztopini glukoze.
English: Patients had received at least two prior chemotherapy regimens, one of which must have been an anthracycline (unless contraindicated).
Slovenian: Bolniki so predhodno prejeli vsaj dve kemoterapevtski shemi, ena od katerih je morala biti antraciklin (če ni bil kontraindiciran).
English: After administration of 14C-eribulin to patients, approximately 82% of the dose was eliminated in faeces and 9% in urine indicating that renal clearance is not a significant route of eribulin elimination.
Slovenian: Po dajanju 14C-eribulina bolnikom se je približno 82 % odmerka izločilo v blatu in 9 % v urinu, kar kaže, da ledvični očistek ni pomembna pot izločanja eribulina.
English: Cases of disseminated intravascular coagulation have been reported, typically in association with neutropenia and/or sepsis.
Slovenian: Poročali so o primerih diseminirane intravaskularne koagulacije, običajno v povezavi z nevtropenijo in/ali sepso.
English: The study met its primary endpoint with an overall survival (OS) result that was statistically significantly better in the eribulin group compared to TPC at 55% of events.
Slovenian: Študija je primarni končni opazovan dogodek dosegla z rezultatom celokupnega preživetja (overall survival, OS), ki je bil statistično značilno boljši v skupini z eribulinom v primerjavi s skupino PIZ v 55 % dogodkov.
English: The development of severe peripheral neurotoxicity requires a delay or reduction of dose (see section 4.2)
Slovenian: Pri razvoju hude periferne nevrotoksičnosti je treba odmerek prestaviti ali zmanjšati (glejte poglavje 4.2).
English: The safety and efficacy of HALAVEN in children from birth to 18 years of age have not yet been established in soft tissue sarcoma.
Slovenian: Varnost in učinkovitost zdravila HALAVEN pri otrocih od rojstva do 18. leta starosti pri sarkomu mehkih tkiv še nista bili dokazani.
English: The doses above may be used in mild and moderate impairment but close monitoring is advised as the doses may need readjustment.
Slovenian: Zgornje odmerke se lahko uporabi za blago do zmerno okvaro, vendar se priporoča skrbno nadziranje, saj bo odmerke morda treba ponovno prilagoditi.
English: Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Slovenian: Eribulin zavira fazo rasti mikrotubulov, ne da bi vplival na fazo krajšanja in sekvestrira tubulin v neproduktivne agregate.
English: 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.
Slovenian: Zdravilo HALAVEN lahko povzroči neželene učinke, kot sta utrujenost in omotičnost, ki lahko povzročita blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: HALAVEN contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells.
Slovenian: HALAVEN vsebuje zdravilno učinkovino eribulin in je zdravilo proti raku, ki učinkuje tako, da ustavi rast in širjenje rakavih celic.
English: 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:
Slovenian: Celokupno preživetje bolnikov, negativnih oziroma pozitivnih glede na HER2 v skupini z eribulinom in kontrolni skupini v študiji 305 in študiji 301 je prikazano spodaj:
English: 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.
Slovenian: Če ni zabeleženo drugače, prikazuje tabela stopnjo incidence neželenih učinkov, ki so jih opazili pri bolnikih z rakom dojke in sarkomom mehkih tkiv, ki so prejemali priporočeni odmerek v študijah 2. faze in študijah 3. faze.
English: Time (months) NUMBER OF PATIENTS AT RISK: HALAVEN 71 63 51 43 39 34 30 20 15 12 Dacarbazine 72 59 42 33 22 17 12 11 6
Slovenian: ČAS (meseci) ŠTEVILO BOLNIKOV S TVEGANJEM: HALAVEN 71 63 51 43 39 34 30 20 15 12 dakarbazin 72 59 42 33 22 17 12 11 6
English: Development of Grade 3 or 4 peripheral neuropathy occurred in 7.4% of breast cancer patients and 3.5% of sarcoma patients.
Slovenian: Razvoj periferne nevropatije 3. ali 4. stopnje se je pojavil pri 7,4 % bolnikov z rakom dojke in pri 3,5 % bolnikov s sarkomom.
English: 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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z eribulinom za vse podskupine pediatrične populacije za indikacijo raka na dojki (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia (Grade 3) on Day 7.
Slovenian: V enem primeru prevelikega odmerjanja je bolnik nenamerno prejel 7,6 mg eribulina (približno 4-kratni načrtovani odmerek), posledično sta se razvili preobčutljivostna reakcija (3. stopnje) 3. dne in nevtropenija (3. stopnje) 7. dne.
English: - The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.
Slovenian: - Drugi sestavini zdravila sta etanol in voda za injekcije; obstaja možnost, da sta klorovodikova kislina in natrijev hidroksid prisotna v zelo majhnih količinah.
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Slovenian: To zdravilo vsebuje majhne količine etanola (alkohola), manj kot 100 mg na odmerek.
English: In the phase 3 sarcoma study (Study 309), 26% of the eribulin treated patients received G-CSF.
Slovenian: V študiji sarkoma 3. faze (študija 309) je 26 % bolnikov, zdravljenih z eribulinom, prejemalo G-CSF.
English: 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).
Slovenian: To je pomenilo 2-mesečno izboljšanje medianega OS (13,5 meseca pri bolnikih, zdravljenih z eribulinom, proti 11,5 meseca pri bolnikih, zdravljenih z dakarbazinom).
English: Monitoring of complete blood counts should be performed on all patients prior to each dose of eribulin.
Slovenian: Pri vseh bolnikih je treba pred vsakim odmerkom eribulina opraviti pregled celotne krvne slike.
English: 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.
Slovenian: Eribulin izraža svoje učinke prek antimitotskega mehanizma na osnovi tubulina, kar povzroči blokado celičnega cikla G2/M, prekinitev mitotskega vretena, in v končni fazi apoptotsko smrt celic po podaljšani in ireverzibilni mitotski blokadi.
English: 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.
Slovenian: Nevtropenija, ki so jo opazili, je bila reverzibilna in ni bila kumulativna; povprečni čas do najvišje točke je bil 13 dni in povprečni čas do okrevanja od hude nevtropenije (<0,5 x 109/l) je bil 8 dni.
English: In addition there were 3 fatal events of sepsis (0.2%) and one of septic shock (0.1%).
Slovenian: Poleg tega so bili 3 smrtni primeri sepse (0,2 %) in en smrtni primer septičnega šoka (0,1 %).
English: - Serious skin rashes with blistering of the skin, mouth, eyes and genitals.
Slovenian: - resni kožni izpuščaji z mehurjenjem kože, ust, oči in spolovil.
English: 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.
Slovenian: Zdravilo HALAVEN vam bo dal zdravnik ali medicinska sestra v obliki 2- do 5-minutne injekcije v veno.
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.
Slovenian: Moški bolniki naj se pred zdravljenjem posvetujejo o shranjevanju sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom HALAVEN.
English: HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C).
Slovenian: HALAVEN niso preučili pri bolnikih s hudo okvaro jeter (stopnje C po Child-Pughu).
English: 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.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj ne zanosijo v času, ko same ali njihov moški partner dobivajo zdravilo HALAVEN, in da morajo uporabljati učinkovit način kontracepcije med zdravljenjem in še do 3 mesece po njem.
English: 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),
Slovenian: Randomizirali so jih v razmerju 1:1 na prejemanje bodisi eribulina 1,23 mg/m2 na 1. in 8. dan 21-dnevnega cikla bodisi dakarbazina 850 mg/m2, 1000 mg/m2 ali 1200 mg/m2 (odmerek je določil raziskovalec pred randomizacijo), vsakih 21 dni.
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.
Slovenian: Število nevtrofilcev <0,5 x 109/l s trajanjem več kot 7 dni se je pojavilo pri 13 % bolnikov z rakom dojke, zdravljenih z eribulinom v študiji EMBRACE.
English: 18% and 13% of eribulin treated patients received G-CSF in the two phase 3 breast cancer studies (Studies 305 and 301, respectively).
Slovenian: 18 % oziroma 13 % bolnikov, zdravljenih z eribulinom, je prejemalo G-CSF v dveh študijah raka dojke 3. faze (študiji 305 oziroma 301).
English: In clinical trials, patients with pre-existing neuropathy greater than Grade 2 were excluded.
Slovenian: V kliničnih preskušanjih so bili bolniki z obstoječo nevropatijo več kot 2. stopnje izključeni.
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.
Slovenian: V nekontrolirani, odprti študiji z EKG so pri 26 bolnikih 8. dan opažali podaljšanje QT intervala, neodvisno od odmerka eribulina, pri čemer 1. dan niso opažali nikakršnega podaljšanja QT intervala.
English: No drug-drug interactions are expected with CYP3A4 inhibitors and inducers.
Slovenian: Medsebojno delovanje zdravil se z zaviralci in induktorji CYP3A4 ne pričakuje.
English: If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water.
Slovenian: Po stiku kože z raztopino moramo kožo takoj in temeljito sprati z milom in vodo.
English: - Any difficulty breathing, or swelling of your face, mouth, tongue or throat.
Slovenian: - oteženo dihanje ali otekline obraza, ust, jezika ali žrela.
English: No carcinogenicity studies have been conducted with eribulin.
Slovenian: Z eribulinom niso izvajali študij kancerogenosti.
English: P value (log rank)
Slovenian: Vrednost p (test log rank)
English: HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
Slovenian: Zdravilo HALAVEN vsebuje etanol (alkohol) Zdravilo vsebuje majhne količine etanola (alkohola), manj kot 100 mg na vialo.
English: Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concentrations.
Slovenian: Eribulin ne zavira CYP encimov CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ali 2E1 v pomembnih kliničnih koncentracijah.
English: Febrile neutropenia occurred in < 5% of patients treated with eribulin.
Slovenian: Febrilna nevtropenija se je pojavila pri < 5 % bolnikov, zdravljenih z eribulinom.
English: 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.
Slovenian: Pri večini teh bolnikov se je takšno zvišanje pojavilo zgodaj med zdravljenjem z eribulinom, v 1. ali 2. ciklu zdravljenja, in čeprav gre verjetno za fenomen prilagajanja jeter na zdravljenje z eribulinom, ne pa znak pomembne toksičnosti za jetra, so poročali tudi o hepatotoksičnosti.
English: Common (Frequency %)
Slovenian: Pogosti (pogostnost %)
English: 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%).
Slovenian: Od 1963 bolnikov z rakom dojke in sarkomi mehkih tkiv, ki so v kliničnih preskušanjih prejeli eribulin v priporočenem odmerku, je bil po en smrtni dogodek zaradi nevtropenične sepse (0,1 %) in febrilne nevtropenije (0,1 %).
English: Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age.
Slovenian: Od 1559 bolnikov z rakom dojke, zdravljenih s priporočenim odmerkom eribulina, je bilo 283 bolnikov (18,2 %) starih ≥65 let.
English: Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Slovenian: Koncentracije presnovka so predstavljale <0,6 % izvorne spojine, kar potrjuje, da ni glavnih človeških presnovkov eribulina.
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.
Slovenian: Učinki zdravljenja z eribulinom so bili omejeni na bolnike z liposarkomom (45 % dediferenciranih, 37 % miksoidnih/okrogloceličnih in 18 % pleomorfnih v študiji 309) na podlagi vnaprej načrtovanih analiz OS in PFS v podskupinah.
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.
Slovenian: Bolniki v tej študiji (n=452) so imeli lokalno recidiven, inoperabilen in/ali metastatski sarkom mehkih tkiv ene od dveh podvrst - leiomiosarkom ali liposarkom.
English: The plasma protein binding of eribulin (100-1000 ng/ml) ranged from 49% to 65% in human plasma.
Slovenian: Razpon vezave eribulina na beljakovine v plazmi (100-1.000 ng/ml) je bil od 49 % do 65 % v človeški plazmi.
English: The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles).
Slovenian: Mediani čas do periferne nevropatije 2. stopnje je bil 12,6 tedna (po 4 ciklih).
English: HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.
Slovenian: Zdravilo HALAVEN se med dojenjem ne sme uporabljati zaradi možnega tveganja za otroka.
English: 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.
Slovenian: Zdravilo HALAVEN lahko povzroči hude prirojene okvare, zato ga nosečnice ne smejo uporabljati, razen kadar je to nujno potrebno in po skrbnem pretehtanju vseh tveganj za vas in za otroka.
English: Patients must have progressed within 6 months of their last chemotherapeutic regimen.
Slovenian: V roku 6 mesecev od zadnjega režima kemoterapije je morala bolezen pri bolnikih napredovati.
English: Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Slovenian: Zdravljenje z eribulinom se lahko uvede le pri bolnikih z vrednostmi ANC ≥ 1,5 x 109/l in s trombociti > 100 x 109/l.