natgillin/translations-raw huggingface dataset:
Secondary endpoints included Progression Free Survival [PFS (defined as time from randomization to tumour progression, Prostatic Specific Antigen (PSA) progression, pain progression, or death due to any cause, whichever occurred first], Tumour Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST), PSA Progression (defined as a ≥25% increase or >50% in PSA non-responders or responders respectively), PSA response (declines in serum PSA levels of at least 50%), pain progression [assessed using the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire and an Analgesic Score (AS)] and pain response (defined as 2-point greater reduction from baseline median PPI with no concomitant increase in AS, or reduction of ≥50% in analgesic use from baseline mean AS with no concomitant increase in pain).
Sekundarni opazovani dogodki so vključevali preživetje brez napredovanja [PBN (opredeljeno kot čas od randomizacije do napredovanja tumorja, napredovanja prostatično specifičnega antigena (PSA), napredovanja bolečin ali smrti zaradi kateregakoli razloga, kar od tega se je zgodilo najprej], delež odziva tumorja na podlagi meril RECIST (Response Evaluation Criteria in Solid Tumours), napredovanje PSA (opredeljeno kot ≥ 25 % porast PSA pri neodzivnih oz. > 50 % porast PSA pri odzivnih), odziv PSA (zmanjšanje koncentracije PSA v serumu za vsaj 50 %), napredovanje bolečin [ocenjeno z lestvico PPI (Present Pain Intensity) iz McGill-Melzackovega vprašalnika in s točkovno oceno AS (Analgesic Score) in odziv bolečin (opredeljen kot 2-točki večje zmanjšanje izhodiščnega medianega PPI brez sočasnega povečanja AS ali kot ≥ 50 % zmanjšanje uporabe analgetika od izhodiščne povprečne AS brez hkratnega povečanja bolečin).
Colitis, enterocolitis, gastritis, neutropenic enterocolitis have been observed.
Opažali so kolitis, enterokolitis, gastritis in nevtropenični enterokolitis.
Cabazitaxel demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice.
Kabazitaksel je pokazal širok spekter protitumorskega delovanja proti napredovalim človeškim tumorjem, presajenim mišim.
Harmful for those suffering from alcoholism.
To je škodljivo za osebe, ki imajo težave s prekomernim uživanjem alkohola.
Number of deaths, n (%) Median survival (95% CI) (months)
Celokupno preživetje Število smrti, n (%) Mediano preživetje (95 % IZ) (meseci)
Its common name is cabazitaxel.
Njegovo splošno ime je kabazitaksel.
• you have any bleeding problems from the gut or have changes in the colour of your stool or stomach pain.
• imate krvavitev iz črevesa ali spremenjeno barvo blata ali bolečine v želodcu.
The incidence of grade ≥3 anaemia, increased AST, ALT, and bilirubin based on laboratory abnormalities were 10.5%, 0.7%, 0.9%, and 0.6%, respectively.
Incidence anemije, zvišanja AST, ALT in bilirubina ≥ 3. stopnje je bila na podlagi laboratorijskih nepravilnosti so bile 10,5 %, 0,7 %, 0,9 % in 0,6 %.
Patients received a median duration of 6 cycles of cabazitaxel.
Bolniki so mediano prejeli 6 ciklusov kabazitaksela.
This study included patients over 18 years of age with metastatic castration resistant prostate cancer either measurable by RECIST criteria or non-measurable disease with rising PSA levels or appearance of new lesions, and Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Ta študija je vključila bolnike, starejše od 18 let z metastatskim, na kastracijo odpornim rakom prostate, z merljivo boleznijo po merilih RECIST ali z nemerljivo boleznijo, z naraščanjem koncentracije PSA ali pojavom novih lezij in s stanjem zmogljivosti od 0 do 2 po ECOG (Eastern Cooperative Oncology Group).
Serious allergic reactions can occur during treatment with JEVTANA.
Med zdravljenjem z zdravilom JEVTANA se lahko pojavijo resne alergijske reakcije.
Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Premedikacija Priporočeno shemo premedikacije naj bi se začelo izvajati vsaj 30 minut pred vsako uporabo zdravila JEVTANA, in sicer z naslednjimi intravenskimi zdravili, da bi zmanjšali tveganje in izrazitost preobčutljivosti:
Safety and effectiveness of JEVTANA have not been established in children and adolescents below 18 years of age.
Pediatrični bolniki Varnost in učinkovitost zdravila JEVTANA pri otrocih in mladostnikih do 18 let nista ugotovljeni.
People with low blood counts can develop life-threatening infections.
Osebam z majhnim številom krvnih celic se lahko pojavijo smrtno nevarne okužbe.
Results of environmental risk assessment studies indicated that use of JEVTANA will not cause significant risk to the aquatic environment (see section 6.6 for disposal of unused product).
Ocena okoljskega tveganja (ERA - Environmental Risk Assessment) Rezultati študij ocene okoljskega tveganja kažejo, da uporaba zdravila JEVTANA ne povzroča pomembnega tveganja za vodno okolje (glejte poglavje 6.6 za odlaganje neporabljenega zdravila).
Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features (age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia.
O primarni profilaksi z G-CSF je treba razmisliti pri bolnikih z velikim kliničnim tveganjem (starost > 65 let, slabo stanje zmogljivosti, predhodna obdobja febrilne nevtropenije, obsežna predhodna obsevanja, slabo prehransko stanje ali druga resna komorbidna stanja), ki imajo večje nagnjenje k zapletom dolgotrajne nevtropenije.
A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced solid tumours (n=69), metastatic breast cancer (n=34) and metastatic prostate cancer (n=67).
Analiza populacijske farmakokinetike je bila opravljena pri 170 bolnikih, vključno z bolniki z napredovalimi parenhimskimi tumorji (n = 69), metastatskim rakom dojke (n = 34) in metastatskim rakom prostate (n = 67).
There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
V omenjeni skupini ni bilo značilne razlike v celotnem preživetju (ROg (95% IZ) 0,96 (0,49-1,86))
Severe hypersensitivity reactions require immediate discontinuation of cabazitaxel and appropriate therapy.
Hude preobčutljivostne reakcije zahtevajo takojšnjo prekinitev dajanja kabazitaksela in ustrezno zdravljenje.
There was no statistical difference between both treatment arms in pain progression and pain response.
Terapevtska kraka se nista statistično značilno razlikovala glede napredovanja bolečin in odziva bolečin.
After final dilution in the infusion bag/bottle
Po končnem redčenju v vrečki/steklenici za infundiranje:
Elderly people (≥65 years of age) may be more likely to experience certain adverse reactions including neutropenia and febrile neutropenia (see section 4.8).
Pri starejših bolnikih (starih ≥ 65 let) lahko obstaja večja verjetnost določenih neželenih učinkov, vključno z nevtropenijo in febrilno nevtropenijo (glejte poglavje 4.8).
As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
Kot del zdravljenja boste vsak dan zaužili tudi kortikosteroidno zdravilo (prednizon ali prednizolon).
To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
To je treba upoštevati v skupinah z velikim tveganjem, npr. pri bolnikih z boleznijo jeter ali z epilepsijo.
Facilities and equipment for the treatment of serious hypersensitivity reactions like hypotension and bronchospasm must be available (see section 4.4).
Na voljo morajo biti prostor in oprema za zdravljenje resnih preobčutljivostnih reakcij, npr. hipotenzije in bronhospazma (glejte poglavje 4.4).
Interruption of cabazitaxel therapy is recommended until diagnosis is available.
Priporočljiva je prekinitev zdravljenja s kabazitakselom, dokler ni postavljena diagnoza.
For instructions on preparation and administration of the product, see section 6.6.
Za navodila za pripravo in dajanje zdravila glejte poglavje 6.6.
In rats, cabazitaxel and its metabolites are excreted in maternal milk at a quantity up to 1.5% of administered dose over 24 hours.
Pri podganah se kabazitaksel in njegovi presnovki izločijo v materinem mleku v količini do 1,5 % uporabljenega odmerka v 24 urah.
However a clinical study has shown that cabazitaxel (25 mg/m2 administered as a single 1-hour infusion) did not modify the plasma levels of midazolam, a probe substrate of CYP3A.
Vendar je klinična študija pokazala, da kabazitaksel (25 mg/m2 v eni sami 1-urni infuziji) ni spremenil plazemske koncentracije midazolama, ki je testni substrat CYP3A.
Neutropenic complications included neutropenic infections (0.5%), neutropenic sepsis (0.8%), and septic shock (1.1%), which in some cases resulted in a fatal outcome.
Med nevtropeničnimi zapleti so bile nevtropenične okužbe (0,5 %), nevtropenična sepsa (0,8 %) in septični šok (1,1 %), v nekaterih primerih s smrtnim izidom.
Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly.
Kabazitaksel se veže na tubulin in pospešuje združevanje tubulina v mikrotubule, hkrati pa zavre njihovo razgrajevanje.
You may feel tired or dizzy when having this medicine.
Med zdravljenjem s tem zdravilom se vam lahko pojavi utrujenost ali omotica.
OTHER This vial contains an overfill.
DRUGI PODATKI Viala vsebuje prepolnitev.
• sore in the mouth or on lips
• razjeda v ustih ali na ustnicah
Cabazitaxel is minimally excreted via the kidney (2.3% of the dose).
Kabazitaksel se le minimalno izloča skozi ledvice (2,3 % odmerka).
As with all parenteral products, the resulting infusion solution should be visually inspected prior to use.
Tako kot vsa zdravila za parenteralno uporabo je treba nastalo raztopino za infundiranje pred uporabo pregledati.
Decreased appetite Vomiting
Zmanjšan apetit
Remove the syringe and needle and mix manually and gently by repeated inversions until obtaining a clear and homogeneous solution.
Odstranite brizgo in iglo in previdno ročno premešajte tako, da vialo večkrat obrnete, dokler ne dobite bistre in homogene raztopine.
The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders.
Predvideni zapleti prevelikega odmerjanja bi obsegali poslabšanje neželenih učinkov, npr. supresije kostnega mozga in gastrointestinalnih težav.
In vitro cabazitaxel did not inhibit Multidrug-Resistant Proteins (MRP): MRP1 and MRP2 or Organic Cation Transporter (OCT1).
In vitro kabazitaksel ni zavrl proti več zdravilom odpornih beljakovin (MRP) MRP1 in MRP2 ali prenašalcev organskih kationov (OCT1).
• rapid or irregular heartbeat
• hitro ali neredno bitje srca
Excipient with known effect Each vial of solvent contains 573.3 mg of ethanol 96%.
Pomožna snov z znanim učinkom Ena viala vehikla vsebuje 573,3 mg 96 % etanola.
The risk of interaction with OATP1B1 substrates (e.g. statins, valsartan, repaglinide) is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion.
Tveganje medsebojnega delovanja s substrati OATP1B1 (npr. statini, valsartan, repaglinid) je možno predvsem v času trajanja infuzije (1 uro) in do 20 minut po koncu infuzije.
• JEVTANA must be prepared (diluted) before it is given.
• Zdravilo JEVTANA je treba pred dajanjem pripraviti (redčiti).
Incidence of grade ≥3 neutropenia based on laboratory data was 81.7%.
Na podlagi laboratorijskih podatkov je bila incidenca nevtropenije ≥ 3. stopnje 81,7 %.
Step 1: Initial dilution of the concentrate for solution for infusion with the supplied solvent.
1. korak: Začetno redčenje koncentrata za raztopino za infundiranje s priloženim vehiklom.
1 vial of 1.5 ml concentrate and 1 vial of 4.5 ml solvent.
1 viala z 1,5 ml koncentrata in 1 viala s 4,5 ml vehikla.
From 20 to 15 mg/m2: 58 (10.0%) From 15 to 12 mg/m2: 9 (1.6%)
Z 20 na 15 mg/m2: 58 (10,0 %) S 15 na 12 mg/m2: 9 (1,6 %)
Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment.
Zaradi možne izpostavljenosti preko semenske tekočine morajo moški, zdravljeni s kabazitakselom, med celotnim zdravljenjem poskrbeti, da ejakulat ne pride v stik z drugo osebo.
This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine.
Zdravilo vsebuje 15% v/v etanola; to ustreza 14 ml piva ali 6 ml vina.
Data in patients below the 20 mg/m2 dose are limited.
Podatkov o bolnikih z odmerkom pod 20 mg/m2 je malo.
Exposures in animals were similar or lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Izpostavljenosti pri živalih so bile podobne ali manjše kot pri ljudeh, ki prejemajo klinično pomembne odmerke kabazitaksela.
Based on in vitro studies, the potential risk of inhibition by cabazitaxel at clinically relevant concentrations is possible towards medicinal products that are mainly substrate of CYP3A.
Na podlagi študij in vitro je mogoče, da pri klinično pomembnih koncentracijah kabazitaksela obstaja tveganje zavrtja zdravil, ki so predvsem substrati CYP3A.
In the population pharmacokinetic analysis in 70 patients of 65 years and older (57 from 65 to 75 and 13 patients above 75), no age effect on the pharmacokinetics of cabazitaxel was observed.
V populacijski farmakokinetični analizi 70 bolnikov, starih 65 let in več (57 od 65 do 75 let in 13 starejših od 75 let), niso opazili vpliva starosti na farmakokinetiko kabazitaksela.
Patients presenting end stage renal disease (creatinine clearance (CLCR< 15 mL/min/1.73 m2), by their condition and the limited amount of data available should be treated with caution and monitored carefully during treatment (see sections 4.4 and
Bolnike s končno fazo ledvične bolezni (očistek kreatinina je manjši od 15 ml/min/1.73 m2 ) je treba glede na njihovo stanje in zaradi maloštevilnih dostopnih podatkov zdraviti previdno in jih med zdravljenjem natančno kontrolirati (glejte poglavji 4.4 in 5.2).
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vials after EXP.
Tega zdravila JEVTANA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na nalepki vial poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
The safety profile of cabazitaxel 25 mg/m2 observed in study EFC11785 was qualitatively and quantitatively similar to that observed in the study EFC6193.
Varnostne značilnosti 25 mg/m2 kabazitaksela so bile v študiji EFC11785 kakovostno in količinsko podobne kot v študiji EFC6193.
Animal studies showed that cabazitaxel affected reproductive system in male rats and dogs without any functional effect on fertility (see section 5.3).
Študije na živalih so pokazale, da kabazitaksel vpliva na reproduktivni sistem pri podganjih in pasjih samcih, ne da bi funkcijsko vplival na plodnost (glejte poglavje 5.3).
The phase 2 part did not demonstrate efficacy of cabazitaxel as single agent in paediatric population with recurrent or refractory diffuse intrinsic pontine glioma (DIPG) and high grade glioma (HGG) treated at 30 mg/m².
Druga faza ni pokazala učinkovitosti kabazitaksela v monoterapiji pri pediatrični populaciji s ponovnim ali refraktarnim difuznim intrinzičnim pontinim gliomom (DIPG) ali visokostopenjskim gliomom (HGG - high grade glioma), zdravljeni s 30 mg/m2.
Therefore, no pharmacokinetic interaction of cabazitaxel on warfarin is expected in vivo.
Zato in vivo ni pričakovati farmakokinetičnega medsebojnega delovanja kabazitaksela na varfarin.
The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent (see section 2 “JEVTANA contains alcohol”).
Pomožne snovi so polisorbat 80 in citronska kislina v koncentratu ter 96 % etanol in voda za injekcije v vehiklu (glejte poglavje 2 »Zdravilo JEVTANA vsebuje alkohol«).
This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick
Pojavi se lahko, če imate hudo ali dolgotrajno drisko, zvišano telesno temperaturo ali če bruhate.
• you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6),
• če ste alergični na kabazitaksel, druge taksane, ali polisorbat 80 ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
• antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),
• antihistaminik (5 mg deksklorfeniramina ali 25 mg difenhidramina ali enakovredni zdravili),
Cabazitaxel inhibited the transport of P-glycoprotein (PgP) (digoxin, vinblastin), Breast-Cancer-Resistant-Proteins (BCRP) (methotrexate) and Organic Anion Transporting Polypeptide OATP1B3 (CCK8) at concentrations at least 15 fold what is observed in clinical setting while it inhibited the transport of OATP1B1 (estradiol-17β-glucuronide) at concentrations only 5 fold what is observed in clinical setting.
Kabazitaksel je zavrl transport s P-glikoproteinom (PgP) (digoksin, vinblastin), z rezistenčnimi beljakovinami raka dojke (BCRP; Breast Cancer Resistance Proteins) (metotreksat) in z organskim anionskim prenašalnim polipepetidom 1B3 OATP1B3 (CCK8) v koncentracijah, ki so bile vsaj 15-krat tolikšne, kot so jih zabeležili v kliničnih okoliščinah; hkrati pa je kabazitaksel zavrl transport OATP1B1 (estradiol-17β-glukuronid) v koncentracijah, ki so bile le 5-krat tolikšne, kot so jih zabeležili v kliničnih okoliščinah.
Your doctor may reduce the dose of JEVTANA or stop the treatment.
Zdravnik vam lahko zmanjša odmerek zdravila JEVTANA ali konča zdravljenje.
The number of patients who completed the study treatment (10 cycles) was respectively 29.4% and 13.5% in the JEVTANA group and in the comparator group.
Delež bolnikov, ki so dokončali raziskovano zdravljenje (10 ciklusov), je bil v skupini z zdravilom JEVTANA 29,4 % in v primerjalni skupini 13,5 %.
These medicines include the following: - ketoconazole, rifampicin (for infections); - carbamazepine, phenobarbital or phenytoin (for seizures); - St John's Wort (Hypericum perforatum) (herbal remedy for depression and other conditions); - statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing the cholesterol in your blood); - valsartan (for hypertension); - repaglinide (for diabetes).
Med takšnimi zdravili so: - ketokonazol, rifampicin (za okužbe), - karbamazepin, fenobarbital ali fenitoin (za napade krčev), - šentjanževka (Hypericum perforatum) (zeliščno zdravilo proti depresiji in drugim stanjem), - statini (kot so simvastatin, lovastatin, atorvastatin, rosuvastatin ali pravastatin) (za zniževanje ravni holesterola v vaši krvi), - valsartan (za povišan krvni tlak), - repaglinid (za sladkorno bolezen).
The concentrate is a clear yellow to brownish-yellow oily solution.
Koncentrat je bistra, rumena do rjavkastorumena oljnata raztopina.
This was confirmed by a dedicated comparative pharmacokinetic study in solid cancer patients with normal renal function (8 patients), moderate (8 patients) and severe (9 patients) renal impairment, who received several cycles of cabazitaxel in single IV infusion up to 25 mg/m2.
To je bilo potrjeno z namensko primerjalno farmakokinetično študijo bolnikov s parenhimskimi tumorji in normalnim delovanjem ledvic (8 bolnikov) ali z zmerno (8 bolnikov) ali hudo (9 bolnikov) okvaro ledvic, ki so prejeli več ciklusov kabazitaksela v enkratni intravenski infuziji do 25 mg/m2.
Patients with a history of congestive heart failure, or myocardial infarction within last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study.
V študijo niso bili vključeni bolniki s kongestivnim srčnim popuščanjem, bolniki z miokardnim infarktom v zadnjih 6 mesecih in bolniki z neobvladanimi motnjami srčnega ritma, angino pektoris in/ali hipertenzijo.
Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine).
Kabazitaksel se v glavnem izloči v blatu v obliki številnih presnovkov (76 % odmerka), na račun ledvičnega izločanja kabazitaksela in presnovkov pa gre manj kot 4 % odmerka (2,3 % kot nespremenjeno zdravilo v urinu).
The study met its primary objective of demonstrating the non-inferiority of cabazitaxel 20 mg/m2 in comparison with 25 mg/m2 (see table 4).
Študija je dosegla svoj primarni cilj in je dokazala neinferiornost 20 mg/m2 kabazitaksela v primerjavi s 25 mg/m2 (glejte preglednico 4).
PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENO OSEBJE O PRIPRAVI, UPORABI IN RAVNANJU Z ZDRAVILOM JEVTANA 60 MG KONCENTRAT IN VEHIKEL ZA RAZTOPINO ZA INFUNDIRANJE
Patients under treatment with cabazitaxel should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
Bolnikom, ki prejemajo kabazitaksel, je treba naročiti, naj pred nadaljevanjem zdravljenja obvestijo svojega zdravnika, če se jim pojavijo simptomi nevropatije, npr. bolečine, pekoč občutek, mravljinčenje, omrtvičenost ali šibkost.
• liver problems occur during the treatment.
• če se vam med zdravljenjem pojavijo težave z jetri.
Study EFC11785 demonstrated a better safety profile for the cabazitaxel 20 mg/m2 dose.
Študija EFC11785 je dokazala boljše varnostne značilnosti odmerka 20 mg/m2 kabazitaksela.
This is because JEVTANA may increase the risk of bleeding or developing holes in the gut wall.
Zdravilo JEVTANA namreč lahko poveča tveganje za krvavitve ali za nastanek predrtja (luknje) v steni črevesa.
The concentrate and solvent vials must be used immediately.
Viali koncentrata in vehikla je treba uporabiti nemudoma.
There is no known antidote to cabazitaxel.
Za kabazitaksel ni znanega antidota.
• inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).
• vnetje sečnega mehurja, ki se lahko pojavi, če je bil mehur kdaj izpostavljen obsevalnemu zdravljenju (cistitis zaradi pojava pomnjenja obsevanja).
• pain in mouth or throat
• bolečine v ustih ali žrelu
Concentrate vial: polysorbate 80 and citric acid; Solvent vial: ethanol 96% and water for injections.
Viala s koncentratom: polisorbat 80 in citronska kislina; Viala z vehiklom: 96 % etanola in voda za injekcije.
Overall survival was significant longer with JEVTANA compared to mitoxantrone (15.1 months versus 12.7 respectively), with a 30% reduction in the risk of death compared to mitoxantrone (see table 3 and figure 1).
Celokupno preživetje je bilo značilno daljše z zdravilom JEVTANA kot z mitoksantronom (15,1 mesece v primerjavi z 12,7 meseca), s 30 % zmanjšanjem tveganja smrti v primerjavi z mitoksantronom (glejte preglednico 3 in sliko 1).
In 3 patients with severe hepatic impairment (total bilirubin >3 ULN), a 39% decrease in clearance was observed when compared to patients with mild hepatic impairment, indicating some effect of severe hepatic impairment on cabazitaxel pharmacokinetics.
Pri 3 bolnikih s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZNM) so v primerjavi z bolniki z blago okvaro jeter opažali 39 % zmanjšanje očistka; to kaže na določen vpliv hude okvare jeter na farmakokinetiko kabazitaksela.
• skin feeling hot or flushed
• občutek vroče kože ali zardevanje
Repeated administration of rifampin (600 mg once daily), a strong CYP3A inducer, resulted in an increase in cabazitaxel clearance of 21% corresponding to a decrease in AUC of 17%.
Ponavljajoče se uporaba rifampina (600 mg enkrat na dan), ki je močan induktor CYP3A, je povečala očistek kabazitaksela za 21 %; to ustreza zmanjšanju AUC za 17 %.