FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal disorders, have been reported in association with sepsis, severe dehydration due to diarrhoea, vomiting and obstructive uropathy.
Slovenian: Ledvične motnje so bile opisane v povezavi s sepso, hudo dehidracijo zaradi driske, bruhanjem in obstruktivno uropatijo.
English: From a microbiological point of view, the concentrate-solvent mixture should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba mešanico koncentrata z vehiklom uporabiti nemudoma.
English: Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with prednisone or prednisolone in the TROPIC study (n=371)
Slovenian: Preglednica 2: Opisani neželeni učinki in hematološke nepravilnosti med zdravljenjem z kabazitakselom skupaj s prednizonom ali prednizolonom v študiji TROPIC (n=371)
English: There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P).
Slovenian: Glede drugih sekundarnih opazovanih dogodkov (PFS, odziv tumorja in bolečin, napredovanje tumorja in bolečin in štirih podkategorij FACT-P) ni bilo statistično značilnih razlik.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial.
Slovenian: Uporabite brizgo z nameščeno iglo in aseptično izvlecite celotno količino priloženega vehikla iz viale tako, da vialo delno obrnete.
English: Overall survival (OS) was the primary efficacy end-point.
Slovenian: Primarni opazovani dogodek učinkovitosti je bilo celokupno preživetje (OS).
English: Hazard Ratioa versus CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=confidence interval, LCI=lower bound of the confidence interval, UCI=upper bound of the confidence interval a Hazard ratio is estimated using a Cox Proportional Hazards regression model.
Slovenian: s CBZ25 + PRED 1-stranski 98,89 % ZIZ 1-stranski 98,89 % SIZ CBZ20 = kabazitaksel 20 mg/m2, CBZ25 = kabazitaksel 25 mg/m2, PRED = prednizon/prednizolon IZ = interval zaupanja, SIZ = spodnja meja intervala zaupanja, ZIZ = zgornja meja intervala zaupanja a Razmerje ogroženosti je ocenjeno s Coxovim regresijskim modelom sorazmernih ogroženosti.
English: However, in repeated-dose toxicity studies, degeneration of seminal vesicle and seminiferous tubule atrophy in the testis were observed in rats, and testicular degeneration (minimal epithelial single cell necrosis in epididymis), was observed in dogs.
Slovenian: Toda v študijah toksičnosti ponavljajočih se odmerkov so pri podganah opazili degeneracijo seminalnih vezikul in atrofijo semenskih tubulov v modih, pri psih pa degeneracijo testisov (minimalno nekrozo posameznih epitelijskih celic v epididimisu).
English: Cabazitaxel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Kabazitaksela ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: After initial dilution of JEVTANA 60 mg concentrate with the entire contents of the solvent vial chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature.
Slovenian: Po začetnem redčenju koncentrata JEVTANA 60 mg z celotno vsebino viale z vehiklom: Kemična in fizikalna stabilnost med uporabo sta dokazani za 1 uro na okoljski temperaturi.
English: • abnormal feeling or loss of sensation or pain in hands and feet
Slovenian: • nenormalni občutki ali izguba zaznavanja ali bolečine v dlaneh in stopalih
English: Concomitant administration of aprepitant, a moderate CYP3A inhibitor, had no effect on cabazitaxel clearance.
Slovenian: Sočasna uporaba zmernega zaviralca CYP3A aprepitanta ni vplivala na očistek kabazitaksela.
English: Required amount of concentrate-solvent mixture
Slovenian: Zahtevana količina mešanice koncentata in vehikla
English: From 25 to 20 mg/m2: 128 (21.5%) From 20 to 15 mg/m2: 19 (3.2%) From 15 to 12 mg/m2: 1 (0.2%)
Slovenian: S 25 na 20 mg/m2: 128 (21,5 %) Z 20 na 15 mg/m2: 19 (3,2 %) S 15 na 12 mg/m2: 1 (0,2 %)
English: The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine.
Slovenian: Viala z vehiklom vsebuje 573,3 mg 96 % (15% v/v) etanola; to ustreza 14 ml piva ali 6 ml vina.
English: This medicine must not be mixed with other medicines except those used for the dilutions.
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki se uporabljajo za redčenje.
English: Confounding causes such as disease progression, instrumentation, infection or anticoagulation/NSAID/aspirin therapy were identified in nearly two thirds of the cases.
Slovenian: V skoraj dveh tretjinah primerov so bili ugotovljeni moteči vzroki, npr. napredovanje bolezni, instrumentacija, okužba ali zdravljenje z antikoagulansi/NSAID/acetilsalicilno kislino.
English: In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.
Slovenian: Poleg tega se je izkazal za aktivnega v tumorskih modelih, neobčutljivih za kemoterapijo, vključno z docetakselom.
English: A population pharmacokinetic analysis carried out in 170 patients that included 14 patients with moderate renal impairment (creatinine clearance in the range of 30 to 50 ml/min) and 59 patients with mild renal impairment (creatinine clearance in the range of 50 to 80 ml/min) showed that mild to moderate renal impairment did not have meaningful effects on the pharmacokinetics of cabazitaxel.
Slovenian: Populacijska farmakokinetična analiza 170 bolnikov, med katerimi je bilo 14 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do 50 ml/min) in 59 bolnikov z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min), je pokazala, da blaga do zmerna okvara ledvic nima pomembnega vpliva na farmakokinetiko kabazitaksela.
English: Transaminases increased a based on laboratory values
Slovenian: Preiskave zmanjšanje telesne mase zvišanje aspartataminotransferaze zvišanje transaminaz a na podlagi laboratorijskih vrednosti
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4,5 ml (96 % etanol in voda za injekcije)
English: Neutropenia is the most common adverse reaction of cabazitaxel (see section 4.8).
Slovenian: Nevtropenija je najpogostejši neželeni učinek kabazitaksela (glejte poglavje 4.8).
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
English: From a microbiological point of view, the infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba raztopino za infundiranje uporabiti takoj.
English: Administration of cabazitaxel to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety.
Slovenian: Pri bolnikih z blago okvaro jeter je treba kabazitaksel uporabljati previdno in ob skrbnem spremljanju varnosti.
English: Adequate hydration should be ensured throughout treatment with cabazitaxel.
Slovenian: Med celotnim zdravljenjem s kabazitakselom je treba zagotoviti zadostno hidracijo.
English: JEVTANA is administered as a 1 hour infusion.
Slovenian: Zdravilo JEVTANA se daje v 1-urni infuziji.
English: A sub-group of 59 patients received prior cumulative dose of docetaxel <225 mg/m² (29 patients in JEVTANA arm, 30 patients in mitoxantrone arm).
Slovenian: Podskupina z 59 bolniki, ki so predhodno prejeli kumulativni odmerek docetaksela <225 mg/m² (29 bolnikov v kraku z zdravilom JEVTANA, 30 bolnikov v kraku z mitoksantronom).
English: This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix.
Slovenian: Ta polnilni volumen so ugotovili med razvojem zdravila JEVTANA in sicer za nadomestitev izgube tekočine med pripravo mešanice.
English: The efficacy and safety of JEVTANA in combination with prednisone or prednisolone were evaluated in a randomised, open-label, international, multi-center, phase III study (EFC6193 study), in patients with metastatic castration resistant prostate cancer previsouly treated with a docetaxel containing regimen.
Slovenian: Učinkovitost in varnost zdravila JEVTANA v kombinaciji s prednizonom ali prednizolonom so ocenili v randomizirani, odprti mednarodni multicentrični študiji III. faze (študija EFC6193) pri bolnikih z metastatskim, na kastracijo odpornim rakom prostate, predhodno zdravljenih s shemo, ki je obsegala docetaksel.
English: Haematological abnormalitiesc (%)
Slovenian: Hematološke nepravilnostic (%)
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Slovenian: Izpostavljenosti pri živalih so bile manjše kot pri ljudeh, ki prejemajo klinično pomembne odmerke kabazitaksela.
English: Do not use JEVTANA if:
Slovenian: Ne uporabljajte zdravila JEVTANA:
English: The incidence of tachycardia on cabazitaxel was 1.6%, none of which were Grade ≥3.
Slovenian: Incidenca tahikardije je bila med prejemniki kabazitaksela 1,6 %; noben primer ni bil ≥ 3. stopnje.
English: Clinical neutropenia
Slovenian: Klinična nevtropenija
English: METHOD OF ADMINISTRATION Use the ENTIRE content for dilution (see package leaflet).
Slovenian: POSTOPEK UPORABE Za redčenje uporabite CELOTNO vsebino (glejte navodilo za uporabo).
English: Nevertheless, considering the pharmacological activity of taxanes, their genotoxic potential and effect of several compounds of this class on fertility in animal studies, effect on male fertility could not be excluded in human.
Slovenian: Pri človeku ni mogoče izključiti vpliva na plodnost moških glede na farmakološko delovanje taksanov, njihov genotoksični potencial in vpliv več spojin iz te skupine na plodnost v študijah na živalih.
English: Therefore, at therapeutic doses, co-administration of CYP3A substrates with cabazitaxel to patients is not expected to have any clinical impact.
Slovenian: Zato ni pričakovati, da bi sočasna uporaba substratov CYP3A in kabazitaksela pri bolnikih imela kakšen kliničen vpliv.
English: Other medicines and JEVTANA
Slovenian: Druga zdravila in zdravilo JEVTANA
English: Patients should be re-treated only when neutrophils recover to a level ≥1,500/mm3 (see section 4.3).
Slovenian: Zdravljenje bolnikov znova začnite, šele ko se število nevtrofilcev poveča na ≥ 1500/mm3 (glejte poglavje 4.3).
English: Patients had to have neutrophils >1,500/mm3, platelets >100,000/mm3, haemoglobin >10 g/dl, creatinine <1.5 x ULN, total bilirubin <1 x ULN, AST and ALT <1.5 x ULN.
Slovenian: Bolniki so morali imeti število nevtrofilcev > 1.500/mm3 in trombocitov > 100.000/mm3, hemoglobin > 10 g/dl, kreatinin < 1,5-kratno ZNM, celotni bilirubin < 1-kratno ZNM ter AST in ALT < 1,5-kratno ZNM.
English: As an example, a dose of 45 mg JEVTANA would require 4.5 ml of the concentrate-solvent mixture prepared following Step 1.
Slovenian: Primer: odmerek 45 mg zdravila JEVTANA bi zahteval 4,5 ml mešanice koncentrata in vehikla, pripravljene v koraku 1.
English: Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy or gastrointestinal disease, such as ulceration and GI bleeding.
Slovenian: Previdnost je potrebna pri zdravljenju bolnikov, ki jih najbolj ogrožajo zapleti na prebavilih: pri bolnikih z nevtropenijo, starejših, med sočasno uporabo NSAID, antiagregacijskih zdravil ali antikoagulantov ter pri bolnikih z anamnezo obsevanja v predelu medenice ali anamnezo bolezni prebavil, npr. razjed in krvavitev v prebavilih.
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (including the 1-hour infusion time) and for 48 hours at refrigerated conditions (including the 1-hour infusion time).
Slovenian: Kemična in fizikalna stabilnost raztopine za infundiranje je dokazana za 8 ur na okoljski temperaturi (vključno z 1-urnim časom infundiranja) in za 48 ur v hladilniku (vključno z 1-urnim časom infundiranja).
English: Repeated administration of ketoconazole (400 mg once daily), a strong CYP3A inhibitor, resulted in a 20% decrease in cabazitaxel clearance corresponding to a 25% increase in AUC.
Slovenian: Ponavljajoča se uporaba ketokonazola (400 mg enkrat na dan), ki je močan zaviralec CYP3A, je povzročila 20 % zmanjšanje očistka kabazitaksela; to ustreza 25 % povečanju AUC.
English: Ask your doctor to give you information about this other medicine.
Slovenian: Za informacije o tem drugem zdravilu se obrnite na svojega zdravnika.
English: p-value 1HR estimated using Cox model; a hazard ratio of less than 1 favours JEVTANA
Slovenian: 1Razmerje ogroženosti je ocenjeno s Coxovim modelom; razmerje ogroženosti, manjše od 1, je v korist zdravila JEVTANA.
English: Cardiac arrhythmias have been reported, most commonly tachycardia and atrial fibrillation (see section 4.8).
Slovenian: Tveganje srčnih aritnij Poročali so o srčnih aritmijah, najpogosteje o tahikardiji in atrijski fibrilaciji (glejte poglavje 4.8).
English: Risk of neutropenia
Slovenian: Tveganje nevtropenije
English: Use a condom during sex if your partner is or could become pregnant.
Slovenian: Če je vaša partnerka noseča ali bi lahko zanosila, med spolnimi odnosi uporabljajte kondom.
English: Around 20 metabolites of cabazitaxel are excreted into human urine and faeces.
Slovenian: Pri človeku se v urinu in blatu izloči okrog 20 presnovkov kabazitaksela.
English: Patients treated with cabazitaxel may receive prophylactic G-CSF, as per American Society of Clinical Oncology (ASCO) guidelines and/or current institutional guidelines, to reduce the risk or manage neutropenia complications (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Bolniki, zdravljeni s kabazitakselom, lahko za zmanjšanje tveganja ali obvladovanje zapletov nevtropenije (febrilne nevtropenije, dolgotrajne nevtropenije ali nevtropenične okužbe) profilaktično prejemajo G-CSF po smernicah ASCO (American Society of Clinical Oncology) in/ali veljavnih smernicah ustanove.
English: The dose should be reduced in case of febrile neutropenia, or prolonged neutropenia despite appropriate treatment (see section 4.2).
Slovenian: V primeru febrilne nevtropenije ali dolgotrajne nevtropenije kljub ustreznemu zdravljenju je treba odmerek zmanjšati (glejte poglavje 4.2).
English: • you have severe abnormal liver function,
Slovenian: • če imate hude motnje delovanja jeter,
English: In a non-inferiority, multicenter, multinational, randomized, open label phase III study (EFC11785 study), 1200 patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing regimen, were randomized to receive either cabazitaxel 25 mg/m2 (n=602) or 20 mg/m2 (n=598) dose.
Slovenian: V multicentrični mednarodni randomizirani, odprti študiji neinferiornosti III. faze (študija EFC11785) so 1200 bolnikov z metastatskim, na kastracijo odpornim rakom prostate, predhodno zdravljenih s shemo, ki je vključevala docetaksel, randomizirali na prejemanje ali 25 mg/m2 (n = 602) ali 20 mg/m2 (n = 598) kabazitaksela.
English: If patients continue to experience any of these reactions at 20 mg/m2, further dose reduction to 15 mg/m2 or discontinuation of JEVTANA may be considered.
Slovenian: Če se bolniku tudi ob odmerku 20 mg/m2 še pojavlja kateri od teh učinkov, pride v poštev dodatno zmanjšanje odmerka na 15 mg/m2 ali prenehanje zdravljenja z zdravilom JEVTANA.
English: Grade ≥ 3 anaemia
Slovenian: Anemija ≥ 3. stopnje
English: A statistically significantly higher percentage (p<0.001) of patients showed a PSA response in the 25 mg/m2 group (42.9%) compared to the 20 mg/m2 group (29.5%).
Slovenian: Odziv PSA se je pojavil pri statistično značilno večjem deležu (p < 0,001) bolnikov v skupini s 25 mg/m2 (42,9 %) kot v skupini z 20 mg/m2 (29,5 %).
English: A total of 755 patients were randomised to receive either JEVTANA 25 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=378), or to receive mitoxantrone 12 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=377).
Slovenian: Skupaj 755 bolnikov je bilo randomiziranih bodisi na prejemanje zdravila JEVTANA 25 mg/m2 intravensko na 3 tedne za največ 10 ciklusov skupaj s prednizonom ali prednizolonom 10 mg peroralno na dan (n = 378) bodisi na prejemanje mitoksantrona 12 mg/m2 intravensko na 3 tedne za največ 10 ciklusov s prednizonom ali prednizolonom 10 mg peroralno na dan (n = 377).
English: Vaccination with a live attenuated vaccine should be avoided in patients receiving cabazitaxel.
Slovenian: Pri bolnikih, ki prejemajo kabazitaksel, se je treba izogibati cepljenju z živimi cepivi.
English: • Severe hepatic impairment (total bilirubin >3 x ULN).
Slovenian: • Huda okvara jeter (celokupni bilirubin > 3-kratna ZNM).
English: This is because some medicines can affect the way JEVTANA works or JEVTANA can affect how other medicines work.
Slovenian: Nekatera zdravila namreč lahko vplivajo na delovanje zdravila JEVTANA in zdravilo JEVTANA lahko vpliva na delovanje drugih zdravil.
English: Of the 595 patients treated with cabazitaxel 25 mg/m2 in the prostate cancer EFC 11785 study, 420 patients were 65 years or over.
Slovenian: Od 595 bolnikov, v študiji raka prostate EFC11785 zdravljenih z odmerkom 25 mg/m2 kabazitaksela, je bilo 420 bolnikov, starih 65 let ali več.
English: Cabazitaxel did not affect mating performances or fertility of treated male rats.
Slovenian: Kabazitaksel ni vplival na zmožnost parjenja ali plodnost zdravljenih podganjih samcev.
English: Other laboratory abnormalities
Slovenian: Druge laboratorijske nepravilnosti
English: Risk of serious gastrointestinal reactions
Slovenian: Tveganje za resne učinke na prebavilih
English: CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone a All grade adverse reactions with an incidence higher than 10% b Grade ≥ 3 adverse reactions with an incidence higher than 5% c Based on laboratory values
Slovenian: CBZ20 = kabazitaksel 20 mg/m2, CBZ25 = kabazitaksel 25 mg/m2, PRED = prednizon/prednizolon a Neželeni učinki vseh stopenj z incidenco nad 10 % b Neželeni učinki ≥ 3. stopnje z incidenco nad 5 % c Na podlagi laboratorijskih vrednosti
English: The infusion solution should be used immediately.
Slovenian: Raztopino za infundiranje je treba uporabiti takoj.
English: Concentrate and solvent for solution for infusion (sterile concentrate).
Slovenian: Koncentrat in vehikel za raztopino za infundiranje (sterilen koncentrat).
English: JEVTANA could be present in your semen and may affect the foetus.
Slovenian: Zdravilo JEVTANA se namreč lahko pojavi v semenu in lahko vpliva na plod.
English: Interactions
Slovenian: Medsebojna delovanja
English: Haematuria all grades frequency was 20.8% at 25 mg/m2 in EFC11785 study (see section 5.1).
Slovenian: Hematurijo vseh stopenj so v študiji EFC11785 pri odmerku 25 mg/m2 opažali v 20,8 % (glejte poglavje 5.1).
English: Available pharmacokinetics data in animals have shown excretion of cabazitaxel and its metabolites in milk (see section 5.3).
Slovenian: Razpoložljivi podatki o farmakokinetiki pri živalih kažejo, da se kabazitaksel in njegovi presnovki izločajo v mleku (glejte poglavje 5.3).
English: Cabazitaxel induced embryofoetal toxicity in female rats treated intravenously once daily from gestational days 6 through 17 linked with maternal toxicity and consisted of foetal deaths and decreased mean foetal weight associated with delay in skeletal ossification.
Slovenian: Kabazitaksel je bil embriofetotoksičen pri podganjih samicah, ki so ga prejemale intravensko enkrat na dan od 6. do 17. dneva gestacije, v povezavi s toksičnostjo za samice-matere; embriofetotoksični učinki so obsegali smrt plodov in zmanjšanje povprečne plodove telesne mase, povezano z zapoznelo osifikacijo okostja.
English: All grade adverse reactionsa (%) Diarrhoea
Slovenian: Neželenih učinkov vseh stopenja (%) Diareja
English: Practical information for handling and administration of JEVTANA for doctors, nurses and pharmacists is provided with this leaflet.
Slovenian: To navodilo vključuje praktične informacije za ravnanje z zdravilom JEVTANA in za njegovo dajanje, namenjene zdravnikom, medicinskim sestram in farmacevtom.
English: An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.
Slovenian: Infuzijo je priporočljivo dati po infuzijski liniji, ki ima filter z nominalno velikostjo por 0,22 mikrometrov (nanaša se tudi na 0,2 mikrometrov).
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Slovenian: Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Francija
English: Cabazitaxel should not be used during breast-feeding.
Slovenian: Kabazitaksela se ne sme uporabljati med obdobjem dojenja.
English: As for any other antineoplastic agent, caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Slovenian: Tako kot velja za druga zdravila proti raku, je tudi pri pripravi raztopin zdravila JEVTANA in ravnanju z njimi potrebna previdnost; uporabiti je treba pripomočke za zadrževanje, osebno zaščitno opremo (npr. rokavice) in upoštevati je treba postopke priprave.
English: Cabazitaxel is minimally excreted through the kidney.
Slovenian: Kabazitaksel se le minimalno izloča skozi ledvice.
English: Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion.
Slovenian: Odstranite brizgo in vsebino vrečke ali steklenice za infundiranje ročno premešajte z obračanjem sem in tja.
English: Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly administation at exposure levels lower than clinical exposure levels and with possible relevance to clinical use were arteriolar/periarterolar necrosis in the liver, bile ductule hyperplasia and/or hepatocellular necrosis (see section 4.2).
Slovenian: Neželeni učinki, ki jih niso zabeležili v kliničnih študijah, ugotovili pa so jih pri psih po enkratnem odmerku, 5-dnevni in tedenski uporabi ob izpostavljenostih, ki so bile manjše od klinične izpostavljenosti, in bi lahko bile pomembne za klinično uporabo, so arteriolna/periarteriolna nekroza v jetrih, hiperplazija žolčnih izvodilc in/ali nekroza jetrnih celic (glejte poglavje 4.2).
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia (see sections 4.2 and 4.4).
Slovenian: Ugotovljeno je, da uporaba G-CSF zmanjša incidenco in izrazitost nevtropenije (glejte poglavji 4.2 in
English: JEVTANA + prednisone n=378
Slovenian: JEVTANA + prednizon n = 378
English: In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2).
Slovenian: Študije in vitro so pokazale, da se kabazitaksel v glavnem presnovi s CYP3A4 (80 % do 90 %) (glejte poglavje 5.2)
English: Cabazitaxel had a high plasma clearance of 48.5 l/h (26.4 l/h/m² for a patient with a median BSA of 1.84 m²) and a long terminal half-life of 95 hours.
Slovenian: Kabazitaksel ima velik plazemski očistek 48,5 l/h (26,4 l/h/m2 za bolnika z mediano telesno površino 1,84 m2) in dolg terminalni razpolovni čas 95 ur.
English: In the JEVTANA group, the mean age was 68 years, range (46-92) and the racial distribution was 83.9% Caucasian, 6.9% Asian/Oriental, 5.3% Black and 4% Others.
Slovenian: V skupini, ki je prejemala zdravilo JEVTANA, je bila povprečna starost 68 let (razpon: od 46 do 92) in porazdelitev po rasah 83,9 % belcev, 6,9 % azijskega/orientalskega porekla, 5,3 % črncev in 4 % drugih.