natgillin/translations-raw huggingface dataset:
Of the 1559 breast cancer patients treated with the recommended dose of eribulin, 283 patients (18.2%) were ≥ 65 years of age.
Od 1559 bolnikov z rakom dojke, zdravljenih s priporočenim odmerkom eribulina, je bilo 283 bolnikov (18,2 %) starih ≥65 let.
Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Koncentracije presnovka so predstavljale <0,6 % izvorne spojine, kar potrjuje, da ni glavnih človeških presnovkov eribulina.
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.
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.
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.
Bolniki v tej študiji (n=452) so imeli lokalno recidiven, inoperabilen in/ali metastatski sarkom mehkih tkiv ene od dveh podvrst - leiomiosarkom ali liposarkom.
The plasma protein binding of eribulin (100-1000 ng/ml) ranged from 49% to 65% in human plasma.
Razpon vezave eribulina na beljakovine v plazmi (100-1.000 ng/ml) je bil od 49 % do 65 % v človeški plazmi.
The median time to Grade 2 peripheral neuropathy was 12.6 weeks (post 4 cycles).
Mediani čas do periferne nevropatije 2. stopnje je bil 12,6 tedna (po 4 ciklih).
HALAVEN must not be used during breast-feeding because of the possibility of risk to the child.
Zdravilo HALAVEN se med dojenjem ne sme uporabljati zaradi možnega tveganja za otroka.
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.
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.
Patients must have progressed within 6 months of their last chemotherapeutic regimen.
V roku 6 mesecev od zadnjega režima kemoterapije je morala bolezen pri bolnikih napredovati.
Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Zdravljenje z eribulinom se lahko uvede le pri bolnikih z vrednostmi ANC ≥ 1,5 x 109/l in s trombociti > 100 x 109/l.
In vitro studies have also indicated that eribulin is not a substrate for OCT1.
Študije in vitro so pokazale, da eribulin ni substrat za OCT1.
Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Johnsonov sindrom/ toksična epidermalna nekrolizab
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).
Priporočljiva je previdnost in spremljanje glede neželenih učinkov, kadar sočasno uporabljamo snovi, ki imajo ozko terapevtsko okno in se odstranjujejo iz telesa predvsem s presnovo preko CYP3A4 (npr. alfentanil, ciklosporin, ergotamin, fentanil, pimozid, kinidin, sirolimus, takrolimus).
Other undesirable effects include fatigue, alopecia, increased liver enzymes, sepsis and musculoskeletal pain syndrome.
Med drugimi neželenimi učinki so utrujenost, alopecija, zvečani jetrni encimi, sepsa in mišičnoskeletni bolečinski sindrom.
The median time to Grade 2 peripheral neuropathy was 18.4 weeks.
Mediani čas do periferne nevropatije 2. stopnje je bil 18,4 tedna.
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.
Od odmerka odvisno zvišano število resorpcij in znižano telesno maso zarodka so opazili pri odmerkih ≥0,088 mg/kg, zvišano incidenco deformacij (odsotnost spodnje čeljusti, jezika, želodca in vranice) pa so opazili pri 0,133 mg/kg.
Patients may experience nausea or vomiting.
Bolnikom je lahko slabo ali bruhajo.
The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively.
Pogostnosti združenega razvrščenega TEAE in laboratorijske nenormalnosti nevtrofilcev sta bili 307/404 (76,0 %) oziroma 1314/1559 (84,3 %).
In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age.
V populaciji 404 bolnikov s sarkomom je bilo 90 bolnikov (22,3 %), zdravljenih z eribulinom, starih ≥65 let.
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.
Bolniki so predhodno prejeli največ po tri predhodne režime kemoterapije, vključno tako z antraciklinom kot s taksanom, in največ dva za napredovalo bolezen, odstotni delež tistih, ki so prejeli 0, 1 ali 2 predhodni kemoterapevtski zdravljenji za metastatičnega raka dojke, pa je bil 20,0 %, 52,0 % oziroma 27,2 %.
HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling.
Zdravilo HALAVEN je citotoksično zdravilo proti raku, zato je treba z njim, kot z drugimi strupenimi snovmi, ravnati previdno.
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).
762 bolnikov v osrednji študiji 3. faze EMBRACE (študija 305) je imelo lokalni recidiv ali metastatskega raka dojke in je pred tem prejelo vsaj dva in največ pet režimov kemoterapije, vključno z antraciklinom in taksanom (razen, kadar sta bila kontraindicirana).
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po prvem odprtju in redčenju zdravila glejte poglavje 6.3.
Increased eribulin exposure was seen in some patients with moderately or severely impaired renal function, with high between-subject variability.
Zvečano izpostavljenost eribulinu so ugotovili pri nekaterih bolnikih z zmerno ali hudo okvaro delovanja ledvic, z veliko variabilnostjo med preiskovanci.
However it has been shown that at clinically relevant concentrations eribulin is not a Pgp inhibitor in vitro.
Vendar pa se je pokazalo, da eribulin v klinično pomembnih koncentracijah in vitro ni zaviralec Pgp.
Eribulin should be avoided in patients with congenital long QT syndrome.
Eribulina ne smemo dajati bolnikom s prirojenim sindromom dolgega intervala QT.
Eribulin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test).
Eribulin in vitro v preskusu bakterijske reverzne mutacije (Amesov preskus) ni bil mutagen.
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.
Razredčene raztopine zdravila HALAVEN (0,018 mg/ml do 0,18 mg/ml eribulina v 0,9-odstotni raztopini natrijevega klorida (9 mg/ml)) za injiciranje ne smete shranjevati dlje kot 24 ur pri 2 °C - 8 °C, razen kadar je redčenje potekalo pod kontroliranimi in validiranimi aseptičnimi pogoji.
Where Grade 3 or 4 reactions occurred, the actual total frequency and the frequency of Grade 3 or 4 reactions are given.
Kjer so se učinki 3. ali 4. stopnje pojavili s pogostnostjo ≥ 1 %, je navedena dejanska skupna pogostnost in pogostnost neželenih učinkov 3. ali 4. stopnje.
HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml or 3ml of solution.
Zdravilo HALAVEN je bistra, brezbarvna vodna raztopina za injekcije v steklenih vialah, ki vsebujejo 2 ml ali 3 ml raztopine.
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.
Pri nekaterih bolnikih z normalnimi/nenormalnimi jetrnimi encimi pred zdravljenjem z eribulinom so ob uvedbi zdravljenja poročali o zvišanju ravni jetrnih encimov .
In Study 309, a statistically significant improvement in OS was observed in patients randomized to the eribulin arm compared to the control arm.
V študiji 309 so ugotovili statistično signifikantno izboljšanje celotnega preživetja pri bolnikih, randomiziranih na krak z eribulinom v primerjavi s kontrolnim krakom.
Additionally, in vivo, concomitant administration of ketoconazole, a Pgp inhibitor, has no effect on eribulin exposure (AUC and Cmax).
Dodatno sočasna uporaba ketokonazola, zaviralca Pgp, in vivo ni imela vpliva na izpostavljenost eribulinu (AUC in Cmax).
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.
Izračun posamičnega odmerka za bolnika mora temeljiti na jakosti raztopine, pripravljene za uporabo, ki vsebuje 0,44 mg/ml eribulina, in priporočenem odmerku 1,23 mg/m2.
HALAVEN should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
Zdravilo HALAVEN se daje samo pod nadzorom usposobljenega zdravnika z izkušnjami v uporabi citotoksičnih zdravil.
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.
Študije plodnosti z eribulinom niso izvajali, toda na podlagi predkliničnih podatkov študij ponavljajočih odmerkov, kjer so opazovali testikularno toksičnost tako pri podganah (hipocelularnost seminifernega epitelija s hipospermijo/aspermijo) kot pri psih, je možno, da zdravljenje z eribulinom vpliva na plodnost pri moških.
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.
Pri bolnikih z alanin-aminotransferazo (ALT) ali aspartat-aminotransferazo (AST) >3 x zgornja meja normale (ULN-upper limit of normal) je bila incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja.
Hazard Ratio (95% CI)
Razmerje tveganja (95-% CI)
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.
O nevtropeniji so poročali kot o neželenem učinku, ki se je pojavil med zdravljenjem (TEAEtreatment emergent adverse event) pri 151/404 (37,4 % za vse stopnje) v populaciji s sarkomom, v primerjavi z 902/1559 (57,9 % za vse stopnje) v populaciji z rakom dojke.
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.
Status bolnikov glede na HER2 je bil: 15,3 % pozitivnih, 68,5 % negativnih, 16,2 % neznano, 25,8 % bolnikov pa je bilo trojno negativnih.
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.
Bolniki so bili randomizirani 2:1 v skupino, ki je prejemala zdravilo HALAVEN, ali v skupino, ki se je zdravila po izbiri zdravnika (PIZ), kar je sestavljala v 97 % kemoterapija (26 % vinorelbin, 18 % gemcitabin, 18 % kapecitabin, 16 % taksan, 9 % antraciklin, 10 % druga kemoterapija) ali v 3 % hormonsko zdravljenje.
What HALAVEN is and what it is used for What you need to know before you use HALAVEN How to use HALAVEN
Kaj je zdravilo HALAVEN in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo HALAVEN Kako uporabljati zdravilo HALAVEN Možni neželeni učinki
Preclinical in vitro studies indicate that eribulin is transported by Pgp.
Predklinične študije in vitro kažejo, da eribulin prenaša Pgp.
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.
Brejim podganjim samicam so dajali eribulinijev mesilat, ki ustreza 0,009; 0,027; 0,088 in 0,133 mg/kg eribulina, na 8., 10. in 12. dan brejosti.
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 ni substrat proteina odpornosti proti raku dojke (BCRP - breast cancer resistant protein), prenašalcev organskih anionov (OAT - organic anion transporter) (OAT1, OAT3, OATP1B1, OATP1B3), prenašalcev proteinov, povezanih z odpornostjo proti številnim zdravilom (MRP - multidrug resistance-associated protein) (MRP2, MRP4) in prenašalcev eksportne črpalke žolčnih soli (BSEP - bile salt export pump).
No in vivo data are available.
Podatki in vivo niso na voljo.
In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Pri 1559 bolnikih z rakom dojke je bil najpogostejši neželeni učinek, ki je imel za posledico prekinitev zdravljenja z eribulinom, periferna nevropatija (3,4 %).
Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy.
Od 404 bolnikov s sarkomom je pri dveh bolnikih prišlo do prekinitve zdravljenja z eribulinom zaradi periferne nevropatije.
Includes preferred terms of peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, paraesthesia, peripheral sensory neuropathy, peripheral sensorimotor neuropathy and demyelinating polyneuropathy d
Vključuje dogovorjene izraze za periferno nevropatijo, periferno motorično nevropatijo, polinevropatijo, parestezijo, periferno senzorično nevropatijo, periferno senzorimotorično nevropatijo in demielinizacijsko polinevropatijo.
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).
Zdravilo HALAVEN je indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim rakom dojke, ki je napredoval po vsaj enem režimu kemoterapije za napredovalo bolezen (glejte poglavje 5.1).
Overall survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue Progression-free survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue
Celotno preživetje Število dogodkov Mediana (meseci) Razmerje tveganja (95-% CI) Nominalna vrednost p Preživetje brez napredovanja bolezni Število dogodkov Mediana (meseci) Razmerje tveganja (95-% CI) Nominalna vrednost p
Dose reduction during therapy
Zmanjšanje odmerka med zdravljenjem
Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected prior to initiating HALAVEN and these electrolytes should be monitored periodically during therapy.
Pred začetkom zdravljenja z zdravilom HALAVEN je treba popraviti hipokaliemijo, hipokalciemijo in hipomagneziemijo in te elektrolite je treba občasno kontrolirati med zdravljenjem.
There was no significant difference in progression-free survival or overall response rate between the treatment arms in the overall population.
Med obema krakoma zdravljenja v celotni populaciji ni bilo signifikantne razlike v preživetju brez napredovanja bolezni ali celotni odzivnosti.
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).
Zdravilo HALAVEN je indicirano za zdravljenje odraslih bolnikov z neresektabilnim liposarkomom, ki so predhodno prejeli zdravljenje, ki vsebuje antraciklin (razen če ni bilo primerno) za napredovalo ali metastatsko bolezen (glejte poglavje 5.1).
How to use HALAVEN
Kako uporabljati zdravilo HALAVEN
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 bolnikov glede na HER2 je bilo: 16,1 % pozitivnih, 74,2 % negativnih, za 9,7 % je bilo stanje neznano, 18,9 % bolnikov pa je bilo trojno negativnih.
No Grade 4 events Rare
d brez dogodkov 4. stopnje * redki ** pogostnost ni znana
It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
Zdravila ne smemo mešati z drugimi zdravili ali redčiti s 5-odstotno raztopino glukoze za infundiranje.
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.
Študij za hudo okvaro delovanja jeter (stopnje C po Child-Pughu) niso izvedli, toda pričakuje se, da je treba tem bolnikom dati še manjši odmerek eribulina.
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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.
Predhodna zdravljenja morajo vključevati antraciklin in taksan, bodisi kot adjuvantno zdravljenje ali za zdravljenje metastatskega raka dojke, razen če to zdravljenje za bolnika ni bilo primerno.
Eribulin has a low clearance (range of means 1.16 to 2.42 l/h/m2).
Izločanje eribulina je majhno (razpon sredin 1,16 do 2,42 l/h/m2).
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.
Druga študija 3. faze, v zgodnejši fazi zdravljenja metastatičnega raka dojke, študija 301, je bila odprta randomizirana študija pri bolnikih (n=1102) z lokalno napredovalim ali metastatskim rakom dojke, v kateri so raziskovali učinkovitost monoterapije z zdravilom HALAVEN v primerjavi z monoterapijo s kapecitabinom glede OS in preživetja brez napredovanja bolezni kot primarnega opazovanega dogodka.
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.
Uporablja se tudi pri odraslih za zdravljenje napredovalega ali metastatskega liposarkoma (vrsta raka, ki vznikne iz maščobnega tkiva), kadar se je poskusilo s predhodnim zdravljenjem, a je postalo neučinkovito.
In breast cancer patients with pre-existing Grade 1 or 2 peripheral neuropathy the frequency of treatment-emergent Grade 3 peripheral neuropathy was 14%.
Pri bolnikih z rakom dojke z obstoječo periferno nevropatijo 1. ali 2. stopnje je bila pogostnost periferne nevtropatije 3. stopnje, ki je bila posledica zdravljenja, 14 %.
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).
Hudo nevtropenijo lahko zdravnik zdravi z uporabo granulocitne kolonije stimulirajočega faktorja (GCSF-granulocyte colony-stimulating factor,) ali enakovrednim zdravilom po presoji zdravnika v skladu z ustreznimi smernicami (glejte poglavje 5.1).
Severe neutropenia may be managed by the use of G-CSF or equivalent at the physician's discretion in accordance with relevant guidelines.
Hudo nevtropenijo lahko zdravnik zdravi z uporabo G-CSF ali enakovrednim zdravilom po presoji zdravnika v skladu z ustreznimi smernicami.
Dacarbazine
dakarbazine
- The active substance is eribulin.
- Zdravilna učinkovina je eribulin.
*Disseminated intravascular coagulation b
*diseminirana intravaskularna koagulacijab
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO
No significant accumulation of eribulin is observed on weekly administration.
Značilnega kopičenja eribulina ob tedenskem dajanju niso opazili.
Eribulin is eliminated primarily by biliary excretion.
Eribulin se izloča predvsem z žolčem.
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.
Zdravila HALAVEN ne smete uporabljati med nosečnostjo, razen kadar je to nujno potrebno in po skrbnem pretehtanju koristi za mater in tveganj za zarodek.
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
Pred začetkom uporabe zdravila HALAVEN se posvetujte z zdravnikom ali medicinsko sestro: - če imate težave z jetri, - če imate zvišano telesno temperaturo ali okužbo, - če občutite otrplost, ščemenje, zbadanje, občutljivost na dotik ali mišično oslabelost, - če imate težave s srcem.
- Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion.
- zvišana telesna temperatura z močno pospešenim srčnim utripom, hitro plitvo dihanje, hladna, bleda, znojna ali pisana koža in/ali zmedenost.
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.
Dajanje zdravila HALAVEN na 1. ali 8. dan je treba preložiti, če se pojavi kaj od naslednjega: - absolutno število nevtrofilcev (ANC - absolute neutrophil count) < 1 x 109/l, - trombociti < 75 x 109/l, - nehematološke toksičnosti 3. ali 4. stopnje.
Haematological:
Hematološki:
In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4.
Podatki in vitro kažejo, da je eribulin blag inhibitor pomembnega encima CYP3A4, ki presnavlja zdravila.
What HALAVEN looks like and contents of the pack
Izgled zdravila HALAVEN in vsebina pakiranja
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).
Čeprav je podatkov malo, je tudi pri bolnikih z bilirubinom >1,5 x zgornja meja normale incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja (glejte tudi poglavji 4.2 in 5.2).
Treatment of Physician's Choice
Zdravljenje po izbiri zdravnika (PIZ)
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.
Tudi objektivna odzivnost, ocenjena z neodvisnim pregledom, je bila pri eribulinu in kapecitabinu podobna; 11,0 % (95-% CI: 8,5, 13,9) v skupini z eribulinom in 11,5 % (95-% CI: 8,9, 14,5) v skupini s kapecitabinom.
Dacarbazine (n=72)
dakarbazin (n=72)
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.
Dajanje zdravila HALAVEN v odmerku 0,97 mg/m2 bolnikom z blago okvarjenim delovanjem jeter in 0,62 mg/m2 bolnikom z zmerno okvarjenim delovanjem jeter je povzročilo nekoliko višjo izpostavljenost kot po odmerku 1,23 mg/m2 pri bolnikih z normalnim delovanjem jeter.