FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SOLVENT for JEVTANA
Slovenian: IME ZDRAVILA IN POT(I) UPORABE VEHIKEL za zdravilo JEVTANA
English: The following two-step dilution process must be carried out in an aseptic manner for preparing the solution for infusion.
Slovenian: Za pripravo raztopine za infundiranje je treba naslednji dvostopenjski postopek redčenja opraviti aseptično.
English: All Grade events among cardiac disorders were more common on cabazitaxel of which 6 patients (1.6%) had Grade ≥3 cardiac arrhythmias.
Slovenian: Učinki vseh stopenj med srčnimi boleznimi so bili s kabazitakselom pogostejši; 6 od teh bolnikov (1,6 %) je imelo motnje srčnega ritma ≥ 3. stopnje.
English: Adverse reactions not observed in clinical studies, but seen in rats during repeat-dose toxicity studies at exposure levels higher than clinical exposure levels and with possible relevance to clinical use were eye disorders characterized by subcapsular lens fiber swelling/degeneration.
Slovenian: Neželeni učinki, ki jih niso zabeležili v kliničnih študijah, ugotovili pa so jih pri podganah med študijami ponavljajočih se odmerkov ob izpostavljenostih, večjih od klinične izpostavljenosti, in bi lahko bile pomembne za klinično uporabo, so očesne bolezni, katerih značilnost je otekanje/degeneracija subkapsularnih vlaken leče.
English: Cabazitaxel is active in docetaxel-sensitive tumours.
Slovenian: Kabazitaksel je aktiven v tumorjih, občutljivih za docetaksel.
English: Cabazitaxel is eliminated primarily via liver metabolism.
Slovenian: Kabazitaksel se odstranjuje predvsem z jetrno presnovo.
English: This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml deliverable volume).
Slovenian: Nastala mešanica koncentrata in vehikla vsebuje 10 mg/ml kabazitaksela (vsaj 6 ml uporabne količine).
English: JEVTANA was evaluated in an open label, multi-center Phase 1/2 study conducted in a total of 39 paediatric patients (aged between 4 to18 years for the phase 1 part of the study and between 3 to 16 years for the phase 2 part of the study).
Slovenian: faze, ki so jo izvedli pri skupno 39 pediatričnih bolnikih (starih od 4 do 18 let v tistem delu študije, ki je bil 1. faze, in od 3 do 16 let v tistem delu študije, ki je bil 2. faze).
English: Therefore concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) should be avoided as an increase of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina, vorikonazola) se je treba izogibati, ker lahko pride do povečanja koncentracije kabazitaksela v plazmi (glejte poglavji 4.2 in
English: mitoxantrone + prednisone n=377
Slovenian: mitoksantron + prednizon n = 377
English: If JEVTANA, at any step of its handling, should come into contact with the skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride zdravilo JEVTANA v katerikoli fazi ravnanja z njim v stik s kožo, je treba kožo takoj in temeljito umiti z milom in vodo.
English: Cystitis due to radiation recall phenomenon, including haemorrhagic cystitis, were reported uncommonly.
Slovenian: Občasno so poročali o cistitisu zaradi pojava pomnjenja obsevanja ("radiation recall"), vključno s hemoragičnim cistitisom.
English: Bone marrow suppression manifested as neutropenia, anaemia, thrombocytopenia, or pancytopenia may occur (see “Risk of neutropenia” and “Anaemia” in section 4.4 below).
Slovenian: Lahko pride do supresije kostnega mozga, ki se kaže kot nevtropenija, anemija, trombocitopenija ali pancitopenija (glejte "Tveganje nevtropenije" in "Anemija" v poglavju 4.4 spodaj).
English: In vitro, cabazitaxel has also been shown to inhibit the transport proteins of the Organic Anion Transport Polypeptides OATP1B1.
Slovenian: S študijami in vitro so dokazali tudi, da kabazitaksel zavira transportne beljakovine, t.i. organske anionske prenašalne polipepetide (OATP1B1).
English: JEVTANA must not be mixed with any other medicinal products than those mentioned.
Slovenian: Zdravilo JEVTANA se ne sme mešati z nobenimi drugimi zdravili razen z omenjenimi.
English: A hazard ratio < 1 indicates a lower risk of cabazitaxel 20 mg/m2 with respect to 25 mg/m2.
Slovenian: Razmerje ogroženosti < 1 pomeni manjše tveganje z odmerkom kabazitaksela 20 mg/m2 kot s 25 mg/m2.
English: The volume of distribution (Vss) was 4870 l (2640 l/m² for a patient with a median BSA of 1.84 m²) at steady state.
Slovenian: Porazdelitev Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je bil 4870 l (2640 l/m2 za bolnika z mediano telesno površino 1,84 m2).
English: JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1).
Slovenian: Zdravilo JEVTANA je v kombinaciji s prednizonom ali prednizolonom indicirano za zdravljenje odraslih bolnikov z metastatskim, na kastracijo odpornim rakom prostate, predhodno zdravljenim s shemo, ki je obsegala docetaksel (glejte poglavje 5.1).
English: Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Injicirajte v sterilen vsebnik brez PVC, v katerem je 5 % raztopina glukoze ali 0,9 % raztopina natrijevega klorida za infundiranje.
English: JEVTANA must not be mixed with any other medicinal products than those mentioned in section 6.6.
Slovenian: Zdravilo JEVTANA se ne sme mešati z nobenimi drugimi zdravili razen z tistimi, ki so omenjena v poglavju 6.6.
English: Diarrhoea can occur more frequently in patients that have received prior abdomino-pelvic radiation.
Slovenian: Driska se lahko pojavi pogosteje pri bolnikih, ki so bili predhodno obsevani v predelu trebuha oz. medenice.
English: The recommended dose of JEVTANA is 25 mg/m2 administered as a 1 hour intravenous infusion every 3 weeks in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.
Slovenian: Priporočeni odmerek zdravila JEVTANA je 25 mg/m2 v 1-urni intravenski infuziji na 3 tedne v kombinaciji s peroralnim prednizonom ali prednizolonom v odmerku 10 mg vsak dan ves čas zdravljenja.
English: Shelf life and special precautions for storage
Slovenian: Rok uporabnosti in posebna navodila za shranjevanje
English: In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m2.
Slovenian: Pri bolnikih z zmerno okvaro jeter (celokupni bilirubin > 1,5- do ≤ 3,0-kratna ZNM) je bil največji tolerirani odmerek (MTD - maximum tolerated dose) 15 mg/m2.
English: • the number of your white blood cells is too low (neutrophil counts less than or equal to
Slovenian: • če imate premalo belih krvnih celic (število nevtrofilcev manj kot ali enako 1.500/mm3),
English: There is no relevant use of JEVTANA in the paediatric population.
Slovenian: Zdravilo Jevtana ni namenjeno za uporabo pri pediatrični populaciji.
English: The most commonly (≥10%) occurring adverse reactions in all grades were anaemia (97.3%), leukopenia (95.7%), neutropenia (93.5%), thrombocytopenia (47.4%), and diarrhoea (46.6%).
Slovenian: Najpogostejši (≥10%) neželeni učinki, ki so zajemali vse stopnje, so bili anemija (97,3%), levkopenija (95,7%), nevtropenija (93,5%), trombocitopenija (47,4%) in diareja (46,6%).
English: Hypotension Deep vein thrombosis Hypertension Orthostatic hypotension Hot flush Flushing
Slovenian: Žilne bolezni hipotenzija globoka venska tromboza hipertenzija ortostatska hipertenzija valovi vročine zardevanje
English: All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see section 4.2).
Slovenian: Vsi bolniki morajo pred začetkom infundiranja kabazitaksela dobiti premedikacijo (glejte poglavje 4.2).
English: How to use JEVTANA
Slovenian: Kako uporabljati zdravilo JEVTANA
English: • Hypersensitivity to cabazitaxel, to other taxanes, or polysorbate 80 or any excipients listed in section 6.1.
Slovenian: • Preobčutljivost na kabazitaksel, druge taksane, ali polisorbat 80 ali katero koli pomožno snov,
English: The MTD of cabazitaxel in patients with severe hepatic impairment was not established.
Slovenian: Minimalni tolerirani odmerek kabazitaksela pri bolnikih s hudo okvaro jeter ni ugotovljen.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate and solvent for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat in vehikel za raztopino za infundiranje.
English: The incidence of grade ≥3 clinical neutropenia and febrile neutropenia adverse reactions were 21.3% and 7.5% respectively.
Slovenian: Incidenca klinične nevtropenije ≥ 3. stopnje je bila 21,3 % in febrilne nevtropenije ≥ 3. stopnje 7,5 %.
English: • kidney disease or problems
Slovenian: • bolezen ledvic ali težave z ledvicami
English: No dose adjustment is necessary in patients with renal impairment, not requiring hemodialysis.
Slovenian: Bolnikom z okvaro ledvic, ki ne potrebujejo hemodialize, odmerka ni treba prilagoditi.
English: No specific dose adjustment for the use of cabazitaxel in elderly patients is recommended (see also sections 4.4, 4.8 and 5.2).
Slovenian: Starejši bolniki Starejšim bolnikom odmerka kabazitaksela ni treba posebej prilagoditi (glejte tudi poglavja 4.4, 4.8 in
English: Haemoglobin and haematocrit should be checked before treatment with cabazitaxel and if patients exhibit signs or symptoms of anaemia or blood loss.
Slovenian: Pred zdravljenjem s kabazitakselom in v primeru, da se bolniku pojavijo znaki ali simptomi anemije ali izgube krvi, je treba kontrolirati hemoglobin in hematokrit.
English: A dedicated study in 43 cancer patients with hepatic impairment showed no influence of mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) or moderate (total bilirubin >1.5 to ≤3.0 x ULN) hepatic impairment on cabazitaxel pharmacokinetics.
Slovenian: Namenska študija pri 43 bolnikih z rakom in okvaro jeter ni pokazala, da bi blaga (celokupni bilirubin > 1- do ≤ 1,5-kratna ZNM ali AST > 1,5-kratna ZNM) ali zmerna (celokupni bilirubin > 1,5- do ≤ 3,0-kratna ZNM) okvara jeter vplivali na farmakokinetiko kabazitaksela.
English: Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Slovenian: Preglednica 5 - Povzetek podatkov o varnosti za skupino z odmerkom kabazitaksela 25 mg/m2 v primerjavi s skupino z odmerkom kabazitaksela 20 mg/m2 v študiji EFC11785
English: Studies in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3) and that cabazitaxel crosses the placenta barrier (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja pri odmerkih, toksičnih za samice matere (glejte poglavje 5.3); pokazale so tudi, da kabazitaksel prehaja skozi placentno pregrado (glejte poglavje 5.3).
English: A statistically significantly higher risk of PSA progression in patients with the 20 mg/m2 dose with respect to the 25 mg/m2 dose was observed (HR 1.195 ; 95%CI: 1.025 to 1.393).
Slovenian: Pri bolnikih, ki so prejemali odmerek 20 mg/m2, je bilo tveganje za napredovanje PSA statistično značilno večje kot pri tistih, ki so prejemali odmerek 25 mg/m2 (razmerje ogroženosti 1,195, 95 % IZ: 1,025 do 1,393).
English: This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.
Slovenian: Ta polnilni volumen so določili med razvojem zdravila JEVTANA; To večje polnjenje raztopine zagotavlja, da je po dodatku celotne vsebine viale z vehiklom k viali s 60 mg koncentrata zdravila JEVTANA, koncentracija mešanice 10 mg/ml zdravila JEVTANA.
English: Inspect the concentrate vial and the supplied solvent.
Slovenian: Preglejte vialo koncentrata in priloženi vehikel.
English: Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Slovenian: Psihiatrične motnje anksioznost stanje zmedenosti
English: 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion
Slovenian: 5 % raztopina glukoze ali 0,9 % raztopina natrijevega klorida za infundiranje
English: However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections 4.4 and 4.5).
Slovenian: Toda, če bolniki sočasno potrebujejo močan zaviralec CYP3A, je treba razmisliti o 25 % znižanju odmerka kabazitaksela (glejte poglavji 4.4. in 4.5).
English: Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections 4.3, 4.4 and 5.2).
Slovenian: Kabazitaksela se ne sme dajati bolnikom s hudo okvaro jeter (celokupni bilirubin >3-kratna ZNM (glejte poglavja 4.3, 4.4 in 5.2).
English: Therefore concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) should be avoided as a decrease of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Slovenian: Sočasni uporabi močnih induktorjev CYP3A (npr. fenitoina, karbamazepina, rifampina, rifabutina, rifapentina, fenobarbitala) se je treba izogibati, ker lahko pride do zmanjšanja koncentracije kabazitaksela v plazmi (glejte poglavji 4.2 in 4.4).
English: Anaemia has been observed in patients receiving cabazitaxel (see section 4.8).
Slovenian: Pri bolnikih, ki so dobivali kabazitaksel, so opažali anemijo (glejte poglavje 4.8).
English: The concentrate vial (fill: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Slovenian: Viala s koncentratom (polnilni volumen: 73,2 mg kabazitaksela/1,83 ml) in viala z vehiklom (polnilni volumen: 5,67 ml), vsebujeta prepolnitev za nadomestitev izgube tekočine med pripravo.
English: The incidence of the following grade ≥3 adverse reactions were higher in patients 65 years of age compared to younger patients; neutropenia based on laboratory abnormalities (86.3% versus 73.3%), clinical neutropenia (23.8% versus 16.8%) and febrile neutropenia (8.3% versus 6.1%) (see sections 4.2 and 4.4).
Slovenian: Incidenca naslednjih neželenih učinkov ≥ 3. stopnje je bila večja med bolniki, starimi  65 let, kot med mlajšimi bolniki: nevtropenija na podlagi laboratorijskih nepravilnosti (86,3 % v primerjavi s 73,3 %), klinična nevtropenija (23,8 % v primerjavi s 16,8 %) in febrilna nevtropenija (8,3 % v primerjavi s 6,1 %) (glejte poglavji 4.2 in 4.4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION JEVTANA 60 mg sterile concentrate cabazitaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE JEVTANA 60 mg sterilen koncentrat kabazitaksel
English: PVC infusion containers and polyurethane infusion sets should not be used.
Slovenian: Infuzijskih vsebnikov iz PVC ali kompletov za infundiranje iz poliuretana se ne sme uporabljati.
English: Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Slovenian: Opomba: Obe viali, viala s koncentratom JEVTANA 60 mg/1,5 ml (polnilni volumen: 73,2 mg kabazitaksela/1,83 ml) in viala z vehiklom (polnilni volumen: 5,67 ml), vsebujeta prepolnitev za nadomestitev izgube tekočine med pripravo.
English: More than one vial of the concentrate-solvent mixture may be necessary to administer the prescribed dose.
Slovenian: Za dajanje predpisanega odmerka je lahko potrebna več kot ena viala mešanice koncentrata in vehikla.
English: Based on safety and tolerability data, cabazitaxel dose should be reduced in patients with mild hepatic impairment (see sections 4.2, 4.4).
Slovenian: Glede na podatke o varnosti in prenašanju je treba bolnikom z blago okvaro jeter odmerek zmanjšati (glejte poglavji 4.2 in 4.4).
English: For the pack of JEVTANA 60 mg concentrate and solvent Do not store above 30°C.
Slovenian: Pakiranje koncentrata in vehikla zdravila JEVTANA 60 mg: Ne shranjujte pri temperaturi nad 30°C.
English: Interstitial pneumonia/pneumonitis and interstitial lung disease have been reported and may be associated with fatal outcome (see section 4.8).
Slovenian: Poročali so o intersticijski pljučnici/pnevmonitisu in intersticijski pljučni bolezni, včasih s smrtnim izidom (glejte poglavje 4.8).
English: Treatment delay or dose reduction may be necessary for grade ≥3 diarrhoea (see section 4.2).
Slovenian: V primeru driske ≥ 3. stopnje je lahko potrebna odložitev odmerka ali njegovo zmanjšanje (glejte poglavje 4.2).
English: • you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.
Slovenian: • če imate občutek omrtvičenosti, mravljinčenja, pekoč občutek ali zmanjšan občutek v vaših rokah in nogah.
English: Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Slovenian: Ena viala z 1,5 ml (nominalni volumen) koncentrata vsebuje 60 mg kabazitaksela.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD04
Slovenian: Oznaka ATC: L01CD04
English: Men being treated with cabazitaxel are advised to seek advice on conservation of sperm prior to treatment.
Slovenian: Priporočljivo je, da se s kabazitakselom zdravljeni moški pred zdravljenjem posvetujejo o shranitvi semena.
English: Table 4 - Overall survival in EFC11785 study in cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm (Intent-to-treat analysis) - Efficacy primary endpoint
Slovenian: Preglednica 4 - Celokupno preživetje v študiji EFC11785 v skupini s 25 mg/m2 kabazitaksela in skupini z 20 mg/m2 kabazitaksela (analiza z-namenom-zdravljenja) - primarni opazovani dogodek učinkovitosti CBZ20 + PRED n = 598
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Number of patients with deaths (%) Median survival (months) (95% CI) Hazard Ratio (HR)1 (95% CI)
Slovenian: Celotno preživetje Število umrlih bolnikov (%) Mediano preživetje (meseci) (95 % IZ)
English: Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Odmerek je treba zmanjšati pri bolnikih z blago okvaro jeter (celokupni bilirubin > 1- do ≤ 1,5-kratna ZNM ali AST > 1,5-kratna ZNM) (glejte poglavji 4.2 in 5.2).
English: The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Slovenian: Najpogostejši (≥5%) neželeni učinki ≥ 3. stopnje v skupini, ki je prejemala kabazitaksel, so bili nevtropenija (81,7%), levkopenija (68,2%), anemija (10,5%), febrilna nevtropenija (7,5%), driska (6,2).
English: Grade>3 n (%)
Slovenian: stopnje n (%)
English: In addition, patients should also refrain from taking St. John's Wort.
Slovenian: Poleg tega naj bolniki ne uporabljajo šentjanževke.
English: Read this ENTIRE section carefully before mixing and diluting.
Slovenian: Pred mešanjem in redčenjem zdravila skrbno in V CELOTI preberite to poglavje.
English: After 1-hour intravenous administration at 25 mg/m2 cabazitaxel in patients with metastatic prostate cancer (n=67), the Cmax was 226 ng/ml (Coefficient of Variation (CV): 107%) and was reached at the end of the 1-hour infusion (Tmax).
Slovenian: (n = 67) je bila Cmax 226 ng/ml (koeficient variacije (KV): 107 %) in je bila dosežena na koncu 1-urnega infundiranja (tmax).
English: Step 2.1
Slovenian: Korak 2.1
English: Solvent vial
Slovenian: Viala z vehiklom
English: What JEVTANA contains
Slovenian: Kaj vsebuje zdravilo JEVTANA
English: A time interval of 12 hours is recommended before the infusion and at least 3 hours after the end of infusion before administering the OATP1B1 substrates.
Slovenian: Pred jemanjem substratov OATP1B1 se priporoča časovni interval 12 ur pred infuzijo in vsaj 3 ure po koncu infuzije.
English: JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.
Slovenian: Nosečnice in ženske v rodni dobi, ki ne uporabljajo kontracepcije, ne smejo prejemati zdravila JEVTANA.
English: Cardiac failure events were more common on cabazitaxel, the event term being reported for 2 patients (0.5%).
Slovenian: Dogodki s srčnim popuščanjem so bili med prejemniki kabazitaksela pogostejši; dogodek je bil opisan pri 2 bolnikih (0,5 %).
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15°C - 30°C) including the 1-hour infusion time and for 48 hours at refrigerated conditions including the 1-hour infusion time.
Slovenian: Po končnem redčenju v vrečki/steklenici za infundiranje Kemična in fizikalna stabilnost raztopine za infundiranje je dokazana za 8 ur na temperaturi okolice (15°C - 30°C), vključno z 1-urnim časom infundiranja, in za 48 ur v hladilniku, vključno z 1-urnim časom infundiranja.
English: Alopecia Dry skin Erythema
Slovenian: Bolezni kože in podkožja alopecija suha koža eritem
English: The following adverse reactions reported at rates 5% higher in patients 65 years of age or greater compared to younger patients were fatigue (40.4% versus 29.8%), clinical neutropenia (24.2% versus 17.6%), asthenia (23.8% versus 14.5%), pyrexia (14.6% versus 7.6%), dizziness (10.0% versus 4.6%), urinary tract infection (9.6% versus 3.1%) and dehydration (6.7% versus 1.5%), respectively.
Slovenian: Naslednji neželeni učinki so bili pri bolnikih, starih 65 let ali več, opisani z več kot  5 % večjim deležem kot pri mlajših bolnikih: utrujenost (40,4 % v primerjavi z 29,8 %), medicinska nevtropenija (24,2 % v primerjavi s 17,6 %), astenija (23,8 % v primerjavi s 14,5 %), pireksija (14,6 % v primerjavi s 7,6 %), omotica (10,0 % v primerjavi s 4,6 %), okužba sečil (9,6 % v primerjavi s 3,1 %) in dehidracija (6,7 % v primerjavi z 1,5 %).
English: What JEVTANA looks like and contents of the pack JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).
Slovenian: Izgled zdravila JEVTANA in vsebina pakiranja Zdravilo JEVTANA sestavljata koncentrat in vehikel za raztopino za infundiranje (sterilen koncentrat).
English: Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Slovenian: Odložite zdravljenje do izboljšanja ali izginotja, potem odmerek kabazitaksela zmanjšajte s 25 mg/m2 na 20 mg/m2.
English: Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Slovenian: Bolnikom z blago okvaro jeter (celokupni bilirubin > 1 do ≤ 1,5-kratna zgornja normalna meja (ZNM) ali AST > 1,5-kratna ZNM) je treba odmerek kabazitaksela zmanjšati na 20 mg/m2.
English: After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Slovenian: Po začetnem redčenju s celotno količino vehikla, vsak ml raztopine vsebuje 10 mg kabazitaksela.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: EXP Read the leaflet for the shelf life of the diluted solution.
Slovenian: EXP Glede roka uporabnosti redčene raztopine preberite navodilo za uporabo.
English: Treatment with JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) (See sections 4.3 and 5.2).
Slovenian: Zdravljenje z zdravilom JEVTANA je kontraindicirano pri bolnikih s hudo okvaro jeter (celokupni bilirubin > 3-kratna ZNM) (glejte poglavji 4.3 in 5.2).