FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of overdose, the patient should be kept in a specialised unit and closely monitored.
Croatian: U slučaju predoziranja bolesnika je potrebno zadržati na specijaliziranom odjelu i pomno nadzirati.
English: Overall survival (OS) was the primary efficacy end-point.
Croatian: Ukupno preživljenje bilo je primarni ishod djelotvornosti.
English: JEVTANA is used to treat prostate cancer that has progressed after having had other chemotherapy.
Croatian: JEVTANA se koristi za liječenje raka prostate koji je napredovao nakon što ste već primali neku drugu kemoterapiju.
English: • decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection)
Croatian: • smanjen broj crvenih krvnih stanica (anemija) ili bijelih krvnih stanica (koje su važne za borbu protiv infekcija)
English: This leaflet was last revised in MMM/YYYY.
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG.
English: • rapid or irregular heartbeat
Croatian: • brzo ili nepravilno kucanje srca
English: Appropriate measures should be taken to re-hydrate patients.
Croatian: Potrebno je poduzeti odgovarajuće mjere za rehidraciju bolesnika.
English: Around 20 metabolites of cabazitaxel are excreted into human urine and faeces.
Croatian: Približno 20 metabolita kabazitaksela izlučuje se u ljudskom urinu i fecesu.
English: • inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).
Croatian: • upala mokraćnog mjehura koja se može pojaviti kada je Vaš mjehur prethodno bio izložen terapiji zračenjem (cistitis zbog fenomena upalne reakcije ozračenog područja)
English: The risk of interaction with OATP1B1 transporter is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion (see section 4.5).
Croatian: Moguć je rizik od interakcije s prijenosnikom OATP1B1, naročito za vrijeme trajanja infuzije (1 sat) i do 20 minuta nakon završetka infuzije (vidjeti dio 4.5).
English: Cabazitaxel did not induce mutations in the bacterial reverse mutation (Ames) test.
Croatian: Kabazitaksel nije potaknuo mutacije u testu bakterijske reverzne mutacije (Amesov test).
English: Confounding causes such as disease progression, instrumentation, infection or anticoagulation/NSAID/aspirin therapy were identified in nearly two thirds of the cases.
Croatian: Ometajući uzroci kao što su progresija bolesti, instrumentarij, infekcija ili terapija antikoagulansima/NSAIL lijekovima/aspirinom utvrđeni su u gotovo dvije trećine slučajeva.
English: JEVTANA is administered as a 1 hour infusion.
Croatian: JEVTANA se primjenjuje u obliku infuzije u trajanju od 1 sata.
English: As with all parenteral products, the resulting infusion solution should be visually inspected prior to use.
Croatian: Kao što je slučaj sa svim parenteralnim pripravcima, pripremljena otopina za infuziju mora se vizualno provjeriti prije primjene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 March 2011
Croatian: Datum prvog odobrenja: 17. ožujka 2011.
English: Fatal ventricular fibrillation was reported in 1 patient (0.3%), and cardiac arrest in 2 patients (0.5%).
Croatian: Smrtonosna ventrikularna fibrilacija prijavljena je u 1 bolesnika (0,3%), a srčani zastoj u 2 bolesnika
English: The safety and the efficacy of JEVTANA in children and adolescents below 18 years of age have not been established (see section 5.1).
Croatian: Sigurnost i djelotvornost lijeka JEVTANA u djece i adolescenata mlađih od 18 godina nisu još ustanovljene (vidjeti dio 5.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/676/001
Croatian: EU/1/11/676/001
English: However these genotoxicity findings are inherent to the pharmacological activity of the compound (inhibition of tubulin depolymerization) and have been observed with medicinal products exhibiting the same pharmacological activity.
Croatian: Međutim, ti nalazi genotoksičnosti inherentni su farmakološkoj aktivnosti tvari (inhibicija depolimerizacije tubulina) i opaženi su kod lijekova koji imaju istu farmakološku aktivnost.
English: Respiratory disorders
Croatian: Respiratorni poremećaji
English: Number of deaths, n (%) Median survival (95% CI) (months)
Croatian: Broj smrti, n (%) Medijan preživljenja (95% CI) (mjeseci)
English: The benefit of resuming cabazitaxel treatment must be carefully evaluated.
Croatian: Korist nastavka liječenja kabazitakselom mora se pažljivo procijeniti.
English: Haemoglobin and haematocrit should be checked before treatment with cabazitaxel and if patients exhibit signs or symptoms of anaemia or blood loss.
Croatian: Potrebno je provjeriti hemoglobin i hematokrit prije početka liječenja kabazitakselom i ako bolesnici pokazuju znakove ili simptome anemije ili gubitka krvi.
English: • JEVTANA will be given by a drip (infusion) into one of your veins (intravenous use) in hospital for about an hour.
Croatian: • Lijek JEVTANA ćete dobivati u bolnici, infuzijom (drip) u jednu od vena (intravenska primjena) koja će trajati oko sat vremena.
English: Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of cabazitaxel, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available.
Croatian: Reakcije preosjetljivosti mogu se pojaviti u roku od nekoliko minuta nakon početka primjene infuzije kabazitaksela te stoga treba imati dostupan prostor i opremu za liječenje hipotenzije i bronhospazma.
English: Patients should be advised not to drive or use machines if they experience these adverse reactions during treatment.
Croatian: Bolesnicima je potrebno savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako tijekom liječenja iskuse te nuspojave.
English: • alteration in sense of taste
Croatian: • promjena osjeta okusa
English: No major deviation to the dose proportionality was observed from 10 to 30 mg/m² in patients with advanced solid tumours (n=126).
Croatian: Nije uočeno veliko odstupanje od proporcionalnosti doze u rasponu doza od 10 do 30 mg/m2 u bolesnika s uznapredovalim solidnim tumorima (n=126).
English: Number of patients with dose reduction n (%)
Croatian: Broj bolesnika sa smanjenjem doze n (%)
English: 1.5 ml 10 mg/ml after first dilution.
Croatian: 10 mg/ml nakon prvog razrjeđenja.
English: Colitis, enterocolitis, gastritis, neutropenic enterocolitis have been observed.
Croatian: Primijećeni su kolitis, enterokolitis, gastritis i neutropenijski enterokolitis.
English: People with low blood counts can develop life-threatening infections.
Croatian: U osoba s malim brojem krvnih stanica mogu se razviti po život opasne infekcije.
English: The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.
Croatian: Koncentracija otopine za infuziju treba biti između 0,10 mg/ml i 0,26 mg/ml.
English: In rats, cabazitaxel and its metabolites are excreted in maternal milk at a quantity up to 1.5% of administered dose over 24 hours.
Croatian: U štakora se kabazitaksel i njegovi metaboliti izlučuju u mlijeko u količini do 1,5% primijenjene doze tijekom 24 sata.
English: Since foam may persist on the wall of the vial of this solution, following its preparation described in Step 1, it is preferable to place the needle of the syringe in the middle when extracting.
Croatian: Budući da na stijenkama bočice s ovom otopinom nakon pripreme opisane u koraku 1 može zaostati pjena, poželjno je prilikom izvlačenja iglu štrcaljke staviti u sredinu otopine.
English: The name of your medicine is JEVTANA.
Croatian: Ovaj se lijek zove JEVTANA.
English: Inject the entire contents into the corresponding concentrate vial.
Croatian: Ubrizgajte cjelokupan sadržaj u odgovarajuću bočicu s koncentratom.
English: Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion.
Croatian: Uklonite štrcaljku i promiješajte sadržaj infuzijske vrećice ili boce ručno, ljuljajućim pokretima.
English: These patients received cabazitaxel at doses of 10 to 30 mg/m2 weekly or every 3 weeks.
Croatian: Ti su bolesnici primali kabazitaksel u dozi od 10 do 30 mg/m2 tjedno ili svaka 3 tjedna.
English: • corticosteroid (dexamethasone 8 mg or equivalent), and
Croatian: • kortikosteroida (deksametazon 8 mg ili ekvivalent) i
English: The European Medicines Agency has waived the obligation to submit the results of studies with JEVTANA in all subsets of the paediatric population in the indication of prostate cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka JEVTANA u svim podskupinama pedijatrijske populacije u indikaciji karcinoma prostate (vidjeti dio 4.2. za informacije o pedijatrijskoj upotrebi).
English: This medicine must not be mixed with other medicines except those used for the dilutions.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih koji se koriste za razrjeđivanje.
English: There are no data from the use of cabazitaxel in pregnant women.
Croatian: Nema podataka o primjeni kabazitaksela u trudnica.
English: There is no potential risk of inhibition of medicinal products that are substrates of other CYP enzymes (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6) as well as no potential risk of induction by cabazitaxel on medicinal products that are substrates of CYP1A, CYP2C9, and CYP3A.
Croatian: Nema rizika od inhibicije lijekova koji su supstrati ostalih CYP enzima (1A2, 2B6, 2C9, 2C8, 2C19, 2E1 i 2D6) kao ni rizika da kabazitaksel inducira djelovanje lijekova koji su supstrati CYP1A, CYP2C9 i CYP3A.
English: During treatment with JEVTANA, it is more likely that your white blood cell count may be reduced.
Croatian: Tijekom liječenja lijekom JEVTANA veća je vjerojatnost da će Vam se smanjiti broj bijelih krvnih stanica.
English: In vitro, the binding of cabazitaxel to human serum proteins was 89-92% and was not saturable up to 50,000 ng/ml, which covers the maximum concentration observed in clinical studies.
Croatian: Vezivanje kabazitaksela za proteine u ljudskom serumu u ljudi in vitro iznosilo je 89-92% i nije bilo zasićeno do razine od 50 000 ng/ml, što pokriva maksimalne koncentracije zabilježene u kliničkim ispitivanjima.
English: Concentrate Polysorbate 80 Citric acid
Croatian: Koncentrat polisorbat 80 citratna kiselina
English: Discontinuation of treatment due to adverse reactions occurred in 68 patients (18.3%) receiving cabazitaxel.
Croatian: Liječenje je prekinuto zbog razvoja nuspojava u 68 bolesnika (18,3%) koji su primali kabazitaksel.
English: Appropriate measures should be taken to rehydrate patients and to monitor and correct serum electrolyte levels, particularly potassium.
Croatian: Potrebno je poduzeti odgovarajuće mjere za rehidraciju bolesnika te pratiti i korigirati razine elektrolita u serumu, osobito kalija.
English: Cabazitaxel crossed the placenta barrier in rats.
Croatian: Pokazalo se da kabazitaksel prelazi placentarnu barijeru u štakora.
English: The incidence of atrial fibrillation was 1.1% in the cabazitaxel group.
Croatian: Incidencija fibrilacije atrija iznosila je 1,1% za skupinu koja je primala kabazitaksel.
English: More than one vial of the concentrate-solvent mixture may be necessary to administer the prescribed dose.
Croatian: Ponekad će možda biti potrebno više od jedne bočice mješavine koncentrata i otapala kako bi se primijenila propisana doza.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne upotrijebe odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika.
English: This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine.
Croatian: Ovaj lijek sadrži 15% v/v etanola (alkohola), što odgovara količini od 14 ml piva ili 6 ml vina.
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia.
Croatian: Dokazano je da primjena G-CSF-a smanjuje incidenciju i težinu neutropenije.
English: Your doctor may reduce the dose of JEVTANA or stop the treatment.
Croatian: Liječnik će Vam možda smanjiti dozu lijeka JEVTANA ili prekinuti liječenje.
English: This is because some medicines can affect the way JEVTANA works or JEVTANA can affect how other medicines work.
Croatian: To je zato što neki lijekovi mogu utjecati na djelovanje lijeka JEVTANA ili JEVTANA može utjecati na djelovanje drugih lijekova.
English: 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
Croatian: Bolesnike koji su u terminalnoj fazi bubrežne bolesti (klirens kreatinina (CLCR< 15 mL/min/1,73 m2), prema njihovom stanju i ograničenoj dostupnosti podataka treba liječiti uz oprez i pomno ih nadzirati tijekom liječenja (vidjeti dijelove 4.4 i
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
Croatian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main
English: • pain in mouth or throat
Croatian: • bol u ustima ili grlu
English: • sore in the mouth or on lips
Croatian: • ranice u ustima ili na usnama
English: Facilities and equipment for the treatment of serious hypersensitivity reactions like hypotension and bronchospasm must be available (see section 4.4).
Croatian: Prostorije i oprema za liječenje ozbiljnih reakcija preosjetljivosti, kao što je hipotenzija i bronhospazam moraju biti dostupni (vidjeti dio 4.4).
English: Other appropriate symptomatic measures should be taken.
Croatian: Potrebno je poduzeti i drugo simptomatsko liječenje.
English: Due to potential effects on male gametes and to potential exposure via seminal liquid, men treated with cabazitaxel should use effective contraception throughout treatment and are recommended to continue this for up to 6 months after the last dose of cabazitaxel.
Croatian: Zbog mogućeg učinka na muške gamete i moguću izloženost putem sjemene tekućine, muškarci koji se liječe kabazitakselom moraju koristiti učinkovitu metodu kontracepcije cijelo vrijeme trajanja liječenja, a preporučuje se da nastave s korištenjem kontracepcije do 6 mjeseci nakon posljednje doze kabazitaksela.
English: Information about storage and the time to use JEVTANA, once it has been diluted and is ready to use, are described in the section “PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA“.
Croatian: Podaci o uvjetima čuvanja i roku valjanosti lijeka JEVTANA nakon što je razrijeđen i spreman za uporabu navedeni su u dijelu "PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENE RADNIKE O PRIPREMI, PRIMJENI I RUKOVANJU LIJEKOM JEVTANA".
English: The in vitro blood-to-plasma concentration ratios in human blood ranged from 0.90 to 0.99 indicating that cabazitaxel was equally distributed between blood and plasma.
Croatian: In vitro omjer koncentracije lijeka u krvi u odnosu na plazmu u ljudskoj krvi kretao se u rasponu od 0,90 do 0,99, što ukazuje na to da se kabazitaksel ravnomjerno raspoređuje između krvi i plazme.
English: • As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
Croatian: • Kao dio terapije, svakoga dana ćete kroz usta uzimati i kortikosteroidni lijek (prednizon ili prednizolon).
English: • you have any bleeding problems from the gut or have changes in the colour of your stool or stomach pain.
Croatian: • ako imate bilo kakvih problema s krvarenjem u crijevima, ako Vam je stolica promijenila boju ili osjećate bolove u trbuhu.
English: Therefore the risk of interaction with substrates of MRP, OCT1, PgP, BCRP and OATP1B3 is unlikely in vivo at the dose of 25 mg/m2.
Croatian: Stoga nije vjerojatan rizik od interakcije sa supstratima za MRP, OCT1, PgP, BCRP i OATP1B3 in vivo pri dozama od 25 mg/m2.
English: Any of these events could cause severe dehydration.
Croatian: Svaki od tih događaja može izazvati ozbiljnu dehidraciju i možda će Vas trebati liječiti.
English: Incidence of grade ≥3 neutropenia based on laboratory data was 81.7%.
Croatian: Incidencija neutropenije stupnja ≥ 3 prema laboratorijskim nalazima iznosila je 81,7%.
English: Concomitant medicinal products that are strong inducers or strong inhibitors of CYP3A should be avoided.
Croatian: Istodobnu primjenu drugih lijekova koji su snažni induktori ili snažni inhibitori CYP3A treba izbjegavati.
English: Cabazitaxel is mainly bound to human serum albumin (82.0%) and lipoproteins (87.9% for HDL, 69.8% for LDL, and 55.8% for VLDL).
Croatian: Kabazitaksel se uglavnom veže za humani serumski albumin (82,0%) i lipoproteine (87,9% za HDL, 69,8% za LDL i 55,8% za VLDL).
English: Before each treatment with JEVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive JEVTANA.
Croatian: Prije svake primjene lijeka JEVTANA obavit ćete krvne pretrage kako bi se utvrdilo imate li dovoljno krvnih stanica te odgovarajuću funkciju jetre i bubrega kako biste mogli primiti lijek JEVTANA.
English: Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.
Croatian: Tijekom cjelokupnog liječenja mora se osigurati primjerena hidracija bolesnika, kako bi se spriječile komplikacije poput zatajenja bubrega.
English: It was not clastogenic in an in vitro test in human lymphocytes (no induction of structural chromosomal aberration but it increased number of polyploid cells) and induced an increase of micronuclei in the in vivo test in rats.
Croatian: Nije se pokazao klastogenim u in vitro ispitivanjima na ljudskim limfocitima (nije inducirao strukturne kromosomske aberacije, ali je povećao broj poliploidnih stanica), a inducirao je povećanje mikronukleusa u ispitivanju na štakorima in vivo.
English: Elderly people (≥65 years of age) may be more likely to experience certain adverse reactions including neutropenia and febrile neutropenia (see section 4.8).
Croatian: U starijih je osoba (≥ 65 godina) veća vjerojatnost razvoja određenih nuspojava, uključujući neutropeniju i febrilnu neutropeniju (vidjeti dio 4.8).
English: 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.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnicama na bočicama iza oznake "EXP".
English: As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
Croatian: Kao dio terapije, svakoga dana ćete kroz usta uzimati i kortikosteroidni lijek (prednizon ili prednizolon).
English: Among the 371 patients treated with cabazitaxel in the prostate cancer study, 240 patients were 65 years or over including 70 patients older than 75 years.
Croatian: Od 371 bolesnika liječenih kabazitakselom u ispitivanju karcinoma prostate, 240 bolesnika je bilo u dobi od 65 ili više godina, uključujući 70 bolesnika starijih od 75 godina.
English: For intravenous use (infusion) AFTER final dilution.
Croatian: Za primjenu u venu (infuzija) NAKON konačnog razrjeđivanja.
English: Severe hypersensitivity reactions require immediate discontinuation of cabazitaxel and appropriate therapy.
Croatian: Teške reakcije preosjetljivosti zahtijevaju trenutni prekid infuzije kabazitaksela i odgovarajuće liječenje.
English: • Hypersensitivity to cabazitaxel, to other taxanes, or polysorbate 80 or any excipients listed in section 6.1.
Croatian: • Preosjetljivost na kabazitaksel, druge taksane ili polisorbat 80 ili na bilo koju pomoćnu tvar navedenu u dijelu 6.1.
English: Ethanol 96% Water for injections
Croatian: Otapalo etanol (96%) voda za injekcije
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).
Croatian: Ne preporučuje se posebno prilagođavanje doze pri primjeni kabazitaksela u starijih bolesnika (vidjeti također dijelove 4.4, 4.8 i 5.2).
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).
Croatian: JEVTANA je procijenjena u otvorenom, multicentričnom kliničkom ispitivanju faze 1/2 provedenom na ukupno 39 pedijatrijskih bolesnika (u dobi od 4 do 18 godina u fazi 1 ispitivanja te u dobi od 3 do 16 godina u fazi 2 ispitivanja).
English: You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility.
Croatian: Savjetuje se da ne začinjete dijete tijekom trajanja liječenja i u periodu od 6 mjeseci nakon prestanka liječenja te da prije liječenja potražite savjet o pohrani sperme jer JEVTANA može utjecati na plodnost muškarca.
English: Physicians should assess for the presence or worsening of neuropathy before each treatment.
Croatian: Prije svake terapije liječnici trebaju procijeniti postojanje ili pogoršanje neuropatije.
English: Grade ≥3 diarrhoea or persisting diarrhoea despite appropriate treatment, including fluid and electrolytes replacement
Croatian: Proljev stupnja ≥ 3 ili kontinuirani proljev unatoč odgovarajućoj terapiji koja uključuje nadoknadu tekućine i elektrolita
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections.
Croatian: Primjena živih ili živih atenuiranih cjepiva u bolesnika čiji je imunološki sustav kompromitiran primjenom kemoterapeutika može rezultirati teškim ili smrtonosnim infekcijama.
English: To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Croatian: Navedeno treba uzeti u obzir u visoko rizičnim skupinama bolesnika, kao što su bolesnici s bolešću jetre ili epilepsijom.
English: Severe reactions can occur and may include generalised rash/erythema, hypotension and bronchospasm.
Croatian: Mogu nastupiti teške reakcije preosjetljivosti, koje uključuju generalizirani osip/eritem, hipotenziju i bronhospazam.
English: Cabazitaxel is the main circulating compound in human plasma.
Croatian: Kabazitaksel je glavni cirkulirajući metabolit u ljudskoj plazmi.
English: Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with prednisone or prednisolone in the TROPIC study (n=371)
Croatian: Tablica 2: Nuspojave i hematološka odstupanja prijavljeni za kabazitaksel u kombinaciji s prednizonom ili prednizolonom u ispitivanju TROPIC (n=371)
English: Men being treated with cabazitaxel are advised to seek advice on conservation of sperm prior to treatment.
Croatian: Muškarcima koji se liječe kabazitakselom preporučuje se da prije liječenja potraže savjet o pohrani sperme.
English: Interruption of cabazitaxel therapy is recommended until diagnosis is available.
Croatian: Preporuča se prekid terapije kabazitakselom dok dijagnoza nije postavljena.
English: Median number of cycles/ median duration of treatment
Croatian: Medijan broja ciklusa/
English: 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”).
Croatian: Drugi sastojci su polisorbat 80 i citratna kiselina u koncentratu te 96%-tni etanol i voda za injekcije u otapalu (vidjeti dio 2 „JEVTANA sadrži alkohol“).
English: From a microbiological point of view, the two-step dilution process must take place in controlled and aseptic conditions (see below “Preparation and administration precautions”).
Croatian: S mikrobiološkog stajališta, postupak razrjeđivanja u dva koraka mora se provesti u kontroliranim i validiranim aseptičkim uvjetima (vidjeti
English: Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly.
Croatian: Kabazitaksel se veže na tubulin i potiče spajanje tubulina u mikrotubule, uz istodobno inhibiranje njihova razdvajanja.