FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustments during treatment
Slovenian: Prilagoditev odmerka med zdravljenjem
English: Following intravenous administration, trabectedin demonstrates a high apparent volume of distribution, consistent with extensive tissue and plasma protein binding (94 to 98% of trabectedin in plasma is protein bound).
Slovenian: Po intravenskem dajanju kaže trabektedin velik navidezni volumen porazdelitve, v skladu z obsežno vezavo v tkiva in na beljakovine plazme (94 do 98 % trabektedina v plazmi je vezanega na beljakovine).
English: Colony stimulating factors can be administered for haematologic toxicity according to local standard practice.
Slovenian: Za hematološko toksičnost se lahko v skladu z lokalno standardno prakso uporabijo kolonije stimulirajoči faktorji.
English: Patients may develop a potentially severe injection site reaction when trabectedin is administered through a peripheral venous line.
Slovenian: Bolniki lahko razvijejo potencialno resne reakcije na mestu injiciranja, ko se trabektedin daje skozi periferno vensko linijo.
English: On the basis of the scientific conclusions for trabectedin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trabectedin is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za trabektedin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) trabektedin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: All patients must receive corticosteroids e.g. 20 mg of dexamethasone intravenously 30 minutes prior to PLD (in combination therapy) or Yondelis (in monotherapy); not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Slovenian: Vsi bolniki morajo prejeti kortikosteroid, tj. 20 mg deksametazona intravensko 30 minut pred dajanjem PLD (pri kombiniranem zdravljenju) ali zdravila Yondelis (kot monoterapija); ne le kot antiemetično profilakso, temveč tudi zaradi hepatoprotektivnih učinkov.
English: It is not known whether trabectedin is excreted in human milk.
Slovenian: Ni znano, ali se trabektedin izloča v materino mleko.
English: The distribution volume at steady state of trabectedin in human subjects exceeds 5,000 l.
Slovenian: Porazdelitveni volumen trabektedina v stanju dinamičnega ravnovesja pri ljudeh presega 5.000 l.
English: An infection could also give you a raised temperature
Slovenian: Okužba je lahko tudi vzrok zvišane telesne temperature
English: There could also be damage to your nerves which may result in muscle pain, weakness and numbness.
Slovenian: Možne so tudi poškodbe živcev, ki povzročijo mišično bolečino, oslabelost in otrplost.
English: Overall Response Rate (ORR)
Slovenian: Splošna stopnja odziva (SSO)
English: If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted product are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se rekonstituirana raztopina ne razredči in porabi takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
English: Trabectedin should not be used during pregnancy.
Slovenian: Trabektedin se med nosečnostjo ne sme uporabljati.
English: Their finding of possible or probable trabectedin causality in 5 of 6 fatal cases among 14 probable CLS cases warrants an update of the SmPC within this procedure to reflect there are cases with a fatal outcome.
Slovenian: Njihova ugotovitev, da je trabektedin možen ali verjeten vzrok za 5 od 6 smrtnih primerov od 14 verjetnih primerov CLS zagotavlja posodobitev povzetka glavnih značilnosti zdravila v okviru tega postopka in kaže, da so prisotni primeri s smrtnim izidom.
English: One partial response (PR) centrally confirmed was observed: overall RR: 2.5% CI95% (0.1%-13.2%).
Slovenian: Zaslediti je bilo en centralno potrjen delni odziv (PR): splošni RR: 2,5 % pri IZ 95 % (0,1 %-13,2 %).
English: Trabectedin does not induce or inhibit major cytochrome P450 enzymes.
Slovenian: Trabektedin ne inducira in ne zavira glavnih encimov citokroma P450.
English: Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regimen.
Slovenian: Dodatni podatki o učinkovitosti so na voljo v obliki 3 preskušanj faze II z enim krakom, v katerih je bila zdravljena podobna populacija bolnikov z istim režimom.
English: The effect of medicines containing phenytoin (for epilepsy) may be decreased if given together with Yondelis and this is therefore not recommended.
Slovenian: Učinek zdravil, ki vsebujejo fenitoin (za epilepsijo) se lahko ob sočasni uporabi zdravila Yondelis zmanjša, zato to ni priporočljivo.
English: Shake the vial until complete dissolution.
Slovenian: Vialo stresajte, dokler raztapljanje ni končano.
English: In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike skrbno nadzirati in po potrebi nuditi simptomatično podporno nego.
English: Secondary CLSs are mostly due to malignant hematological diseases, viral infections, and treatments such as chemotherapies and therapeutic growth factors.
Slovenian: Sekundarni CLS se najpogosteje pojavi zaradi hematoloških malignih bolezni, virusnih okužb in zdravljenja, kot so kemoterapije in terapevtski rastni faktorji.
English: Yondelis should not be used in children below 18 years with paediatric sarcomas because of efficacy concerns (see 5.1 for results of paediatric sarcoma study).
Slovenian: Zdravila Yondelis zaradi pomislekov glede učinkovitosti ne smemo uporabljati pri otrocih pod 18 let s pediatričnimi sarkomi (glejte poglavje 5.1 za rezultate študije pediatričnih sarkomov).
English: • If you experience severe muscle pain or weakness as it could be a sign of damage to your muscles (rhabdomyolysis; see section 4).
Slovenian: • Če izkusite resne bolečine mišic ali oslabelost mišic, saj bi lahko to bil znak poškodbe mišic (rabdomioliza, glejte poglavje 4).
English: No statistically significant differences were found between treatment arms in global measures of Quality of Life.
Slovenian: Med krakoma ni bilo statistično značilnih razlik v globalnem merjenju kakovosti življenja.
English: Neutrophil nadirs occurred at a median of 15 days and recovered within a week.
Slovenian: Najnižja raven nevtrofilcev se je pojavila z mediano 15 dni, do okrevanja pa je prišlo v enem tednu.
English: Do not drive or use any tools or machines if you are experiencing any of these side effects.
Slovenian: Ne vozite avtomobila in ne upravljajte orodij ali strojev, če se pojavijo ti neželeni učinki.
English: Thus the trabectedin extraction ratio can be considered moderate.
Slovenian: Zato je možno hitrost izločanja trabektedina oceniti kot zmerno.
English: The powder has a white to off-white colour and comes in a glass vial.
Slovenian: Prašek je bele do belkaste barve in je pakiran v viale.
English: Preparation for intravenous infusion
Slovenian: Priprava intravenske infuzije
English: The use of central venous access is strongly recommended (see section 4.2).
Slovenian: Močno se priporoča uporaba centralnega venskega dostopa (glejte poglavje 4.2).
English: No sufficient clinical data on exposed pregnancies are available.
Slovenian: Za trabektedin ni na voljo kliničnih podatkov o nosečnicah, ki so bile izpostavljene zdravilu.
English: PFS (months; 95% CI) ORR, n (%); Odds ratio (95% CI) DOR (months; 95% CI) CBR, n (%); Odds ratio (95% CI)
Slovenian: PFS (meseci; 95-% IZ) ORR, n (%); razmerje obetov (95-% IZ) DOR (meseci; 95-% IZ) CBR, n (%); razmerje obetov (95-% IZ)
English: Pregnant staff must be excluded from working with this medicinal product.
Slovenian: Nosečnice ne smejo delati s tem zdravilom.
English: • Your doctor may require blood tests in certain situations in order to avoid that you develop muscle damage (rhabdomyolysis).
Slovenian: • Zdravnik lahko v nekaterih okoliščinah zahteva izvedbo krvnih testov, da prepreči nastanek poškodb mišic (rabdomioliza).
English: Cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for the oxidative metabolism of trabectedin at clinically relevant concentrations.
Slovenian: Citokrom P450 3A4 je glavni izoencim citokroma P450, odgovoren za oksidacijsko presnovo trabektedina pri klinično pomembnih koncentracijah.
English: What Yondelis is and what it is used for What you need to know before you are given Yondelis How to use Yondelis
Slovenian: Kaj je zdravilo Yondelis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Yondelis Kako uporabljati zdravilo Yondelis
English: If pregnancy occurs during treatment, the patient must be informed of the potential risk to the foetus (see section 5.3) and be monitored carefully.
Slovenian: Če bolnica med zdravljenjem zanosi, jo je treba obvestiti o potencialnem tveganju za plod (glejte poglavje 5.3) in jo skrbno nadzirati.
English: If you experience severe muscle pain or weakness, you should seek medical attention immediately.
Slovenian: Če izkusite resne bolečine ali oslabelost v mišicah, morate nemudoma poiskati zdravniško pomoč.
English: What Yondelis is and what it is used for
Slovenian: Kaj je zdravilo Yondelis in za kaj ga uporabljamo
English: Renal toxicological findings were detected in multi-cycle toxicity studies conducted in monkeys.
Slovenian: Izsledki ledvične toksičnosti so bili odkriti v študijah toksičnosti v več ciklih, ki so jih izvajali pri opicah.
English: If you use any of the following medicines during your treatment with Yondelis, you need to be closely monitored as the effects of Yondelis are:
Slovenian: Če med zdravljenjem z zdravilom Yondelis uporabljate katero koli od naslednjih zdravil, vas bo treba bolj skrbno spremljati, saj se učinki zdravila Yondelis v tem primeru:
English: Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic medicines.
Slovenian: Uporabo je treba omejiti na usposobljene onkologe ali druge zdravstvene delavce, ki so specializirani za dajanje citotoksičnih zdravil.
English: Patients with increases in AST, ALT and alkaline phosphatase between cycles may necessitate dose adjustments (see section 4.2).
Slovenian: Pri bolnikih s povečanjem AST, ALT in alkalne fosfataze med cikli je morda potrebno prilagoditi odmerek (glejte poglavje 4.2).
English: The low recovery (< 9% in all studied patients) of total radioactivity in the urine after a single dose of 14C-labelled trabectedin indicates that renal impairment has little influence on the elimination of trabectedin or its metabolites.
Slovenian: Nizka stopnja skupne rekuperacije radioaktivnosti (< 9 % pri vseh preiskanih bolnikih) v urinu po enkratnem odmerku trabektedina z radioaktivno oznako 14C kaže, da je vpliv ledvične okvare na izločanje trabektedina ali njegovih presnovkov majhen.
English: Based on an ad-hoc review of CLS cases performed by an External Independent Adjudication Committee (IAC), it was determined possible or probable trabectedin causality in 5 out of 6 fatal cases among 14 probable CLS cases.
Slovenian: Na podlagi celovitega pregleda primerov CLS, ki ga je opravil Zunanji neodvisni presojevalni odbor (IAC), je bilo ugotovljeno, da je trabektedin možen ali verjeten vzrok v 5 od 6 smrtnih primerov od
English: The differences were mainly observed in relation with neutropenia (93% versus 66%), anaemia (37% versus 14%) and thrombocytopenia (41% versus 19%).
Slovenian: Razliko so opazili zlasti v zvezi z nevtropenijo (93 % v primerjavi s 66 %), anemijo (37 % v primerjavi s 14 %) in trombocitopenijo (41 % v primerjavi s 19 %).
English: Preclinical data indicate that trabectedin has limited effect on the cardiovascular, respiratory and central nervous system at exposures below the therapeutic clinical range, in terms of AUC.
Slovenian: Predklinični podatki o varnosti kažejo, da ima trabektedin omejen vpliv na kardiovaskularen, dihalni in osrednji živčni sistem pri izpostavljenosti pod terapevtskim kliničnim obsegom, izraženo z AUC.
English: If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medicine, you should immediately seek medical help.
Slovenian: Če vam je slabo, bruhate ali ne morete piti tekočine in zato izločate manj urina, kljub temu, da ste prejeli zdravilo proti slabosti, morate nemudoma poiskati zdravniško pomoč.
English: Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
Slovenian: Pri večini bolnikov poročajo o reverzibilnem akutnem povečanju aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT).
English: All randomised n=337
Slovenian: Vse randomizirano n = 337
English: You must not use Yondelis if you will receive yellow fever vaccine and it is not recommended that you use Yondelis if you will receive a vaccine containing live virus particles.
Slovenian: Zdravila Yondelis ne smete uporabiti, če boste cepljeni proti rumeni mrzlici in ni priporočljivo, da dobite cepivo, ki vsebuje žive delce virusov.
English: The median patient age was 56 years (range 17 to 81), 30% were male, 77% Caucasian, 12% African American and 4% Asian.
Slovenian: Mediana starost bolnikov je bila 56 let (v razponu od 17 do 81 let), 30 % je bilo moških, 77 % bele rase, 12 % Afroameričanov in 4 % Azijcev.
English: The inter-patient variability of the population estimate for plasma clearance of trabectedin was 49% and intra-patient variability was 28%.
Slovenian: Variabilnost ocene očistka trabektedina v plazmi med bolniki v isti populaciji je bila 49 % in variabilnost pri bolniku 28 %.
English: No cumulative toxicities have been observed in patients treated with multiple cycles.
Slovenian: Kumulativne toksičnosti pri bolnikih, zdravljenih z več cikli, niso opazili.
English: Two in vivo drug-drug interaction phase 1 studies have confirmed trends toward increased and decreased trabectedin exposures when administered with ketoconazole and rifampicin, respectively.
Slovenian: Dve študiji medsebojnega delovanja zdravil in vivo faze 1 sta potrdili trend v smeri povečanih oziroma zmanjšanih izpostavljenosti trabektedinu pri dajanju skupaj s ketokonazolom oziroma rifampicinom.
English: In order to avoid irritation at the site of injection it is recommended that Yondelis is given to you through a central venous line.
Slovenian: Da preprečite draženje mesta injiciranja se priporoča dajanje zdravila Yondelis skozi centralno vensko linijo.
English: Neutropenia:
Slovenian: Nevtropenija:
English: In clinical trials, there were no pre-defined limits to the number of cycles administered.
Slovenian: V kliničnih preskušanjih ni bilo predhodno opredeljenih omejitev števila apliciranih odmerkov.
English: • When Yondelis is used in combination with PLD, you may have syncope also called fainting.
Slovenian: • Če se zdravilo Yondelis uporablja v kombinaciji s PLD, se lahko pojavi sinkopa, ki se imenuje tudi omedlevica.
English: Most patients treated with Yondelis can be expected to have adverse reactions of any grade (91% in monotherapy and 99% in combination therapy) and less than one third serious adverse reactions of grade 3 or 4 severity (10% in monotherapy and 25% in combination therapy).
Slovenian: Pri večini bolnikov, zdravljenih z zdravilom Yondelis, se lahko pričakuje, da bodo imeli neželene učinke katere koli stopnje (91 % bolnikov pri monoterapiji in 99 % pri kombinirani terapiji), manj kot ena tretjina bo imela neželene učinke resnosti stopnje 3 ali 4 (10 % pri monoterapiji in 25 % pri kombiniranem zdravljenju).
English: In SAR-2005 phase I-II study, a total of 50 paediatric patients with rhabdomyosarcoma, Ewing sarcoma or non rhabdomyosarcoma soft tissue sarcoma were enrolled.
Slovenian: V študijo faze I-II SAR-2005 je bilo vključenih skupno 50 pediatričnih bolnikov z rabdomiosarkomom, sarkomom Ewing ali sarkomom mehkega tkiva, ki ni rabdomiosarkom.
English: • You could have increased levels of the yellow pigment bilirubin in the blood which might cause jaundice (a yellowing of the skin, mucous membranes and eyes).
Slovenian: • Možno je, da se vam zviša raven rumenega pigmenta bilirubina v krvi, kar lahko povzroči zlatenico (rumenost kože, sluznic in oči).
English: A population pharmacokinetic analysis showed that plasma trabectedin concentrations observed in the Japanese population at dose level 1.2 mg/m2 were equivalent to those obtained in the non-Japanese western population at 1.5 mg/m².
Slovenian: Populacijska farmakokinetična analiza je pokazala, da so bile koncentracije trabektedina v plazmi, izmerjene pri japonskih bolnikih ob velikosti odmerka 1,2 mg/m2, enakovredne tistim, ki so jih izmerili pri zahodnih populacijah nejaponskega porekla ob odmerku 1,5 mg/m
English: Every time you are given Yondelis for the treatment of soft tissue sarcoma, it will take about 24 hours for all of the solution to enter your blood.
Slovenian: Vsakič, ko prejmete zdravilo Yondelis za zdravljenje sarkoma mehkega tkiva, bo trajalo okoli 24 ur,
English: Yondelis must be reconstituted and further diluted prior to infusion (see also section 3).
Slovenian: Zdravilo Yondelis je treba rekonstituirati in nadalje razredčiti pred infundiranjem (glejte tudi poglavje 3).
English: Median TTP values were 3.7 months (CI: 2.1-5.4 m) in the 24-h q3wk group and 2.3 months (CI: 2.0-3.5 m) in the 3-h qwk group (p=0.0302).
Slovenian: Mediane vrednosti TTP so bile 3,7 meseca (IZ: 2,1-5,4 m) v skupini 24-h q3wk in 2,3 meseca (IZ: 2,0-3,5 m) v skupini 3-h qwk (p=0,0302).
English: A population pharmacokinetic analysis indicated that the plasma clearance of trabectedin is not influenced by age (range 19-83 years), gender, total body weight (range: 36 to 148 kg) or body surface area (range: 0.9 to 2.8 m2).
Slovenian: Populacijsk farmakokinetična analiza populacije je pokazala, da na očistek trabektedina v plazmi ne vplivata niti starost (od 19-83 let), niti spol, skupna telesna masa (razpon: 36 do 148 kg) ali površina telesa (razpon: 0,9 do 2,8 m2).
English: No studies on the effects of the ability to drive and to use machines have been performed.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
English: • If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine despite being given anti-sickness medicines.
Slovenian: • Če vam je slabo, bruhate ali ne morete piti tekočine in zato izločate manj urina, kljub temu, da ste prejeli zdravilo proti slabosti.
English: The vial must be shaken until complete dissolution.
Slovenian: Vialo je treba stresati, dokler raztapljanje ni končano.
English: Instructions for use - preparation, handling and disposal
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo - priprava, ravnanje in odstranjevanje
English: Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent.
Slovenian: Zdravila Yondelis ni dovoljeno dajati kot mešanice z drugimi zdravili v isti infuziji, razen s topilom.
English: The patients received the trabectedin dose of 1.2 mg/m2 recommended for Japanese patients [1.2 mg/m2 once every 3 weeks (q3wk 24-h)].
Slovenian: Bolniki so prejemali odmerek trabektedina 1,2 mg/m2, ki je priporočen za japonske bolnike [1,2 mg/m2 enkrat na 3 tedne (q3wk 24-h)].
English: Adverse reactions are listed by System Organ Class and frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnostih.
English: Before Yondelis is given to you, it is reconstituted and diluted for intravenous use.
Slovenian: Preden boste zdravilo Yondelis prejeli, bo rekonstituirano in razredčeno za intravensko uporabo.
English: The study assessed the efficacy and safety of trabectedin vs. best supportive care (BSC) as second-line or later therapy for patients with advanced TRS unresponsive or intolerant to standard chemotherapy regimen.
Slovenian: V študiji so ocenili učinkovitost in varnost trabektedina v primerjavi z najboljšo podporno oskrbo (BSC- best supportive care) kot terapijo drugega izbora ali poznejšega pri bolnikih z napredovalim TRS, ki se niso odzivali na standardni režim kemoterapije ali ga niso prenašali.
English: You will be given a medicine before and as needed during the treatment with Yondelis in order to protect your liver and to reduce the risk of side effects such as feeling sick (nausea) and vomiting.
Slovenian: Pred in po zdravljenju z zdravilom Yondelis boste prejeli zdravilo, ki bo ščitilo vaša jetra in zmanjšalo tveganje neželenih učinkov, kot je slabost (navzea) in bruhanje.
English: Fertility studies with trabectedin were not performed but limited histopathological changes were observed in the gonads in the repeat dose toxicity studies.
Slovenian: Študij plodnosti s trabektedinom niso izvajali, vendar pa so pri spolnih žlezah opazili omejene histopatološke spremembe v študijah toksičnosti pri ponavljajočih se odmerkih.
English: No significant differences were detected in overall survival (OS).
Slovenian: V splošni stopnji preživetja ni bilo pomembnih razlik.
English: It is also recommended to monitor LVEF at baseline and periodically during the treatment; particularly in patients at risk of cardiomyopathy from previous anthracycline exposure or in patients with symptoms of decreasing cardiac function.
Slovenian: Priporoča se tudi spremljanje iztisnega deleža levega prekata (LVEF) ob izhodišču in nato redno med zdravljenjem, še posebej pri bolnikih s tveganjem za kardiomiopatijo zaradi predhodne izpostavljenosti antraciklinu in pri bolnikih s simptomi slabšanja delovanja srca.
English: Yondelis has been administered for 6 or more cycles in 29.5% and 52% of patients treated with the monotherapy and combination dose and schedule respectively.
Slovenian: Zdravilo Yondelis je bilo aplicirano 6 ali več ciklov pri 29,5 % in 52 % bolnikov, zdravljenih z monoterapijo ali s kombiniranim odmerkom in režimom.
English: However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy.
Slovenian: Na podlagi znanih mehanizmov delovanja povzroča trabektedin resne okvare ploda, če ga prejemajo nosečnice.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično: pri uporabi bodite previdni.
English: - Hypersensitivity to trabectedin or to any of the excipients listed in section 6.1 - Concurrent serious or uncontrolled infection - Breast-feeding (see section 4.6) - Combination with yellow fever vaccine (see section 4.4)
Slovenian: - preobčutljivost na trabektedin ali katero koli pomožno snov, navedeno v poglavju 6.1 - hkratna resna ali nenadzirana okužba - dojenje (glejte poglavje 4.6) - kombinacija z zdravili proti rumeni mrzlici (glejte poglavje 4.4)
English: It could be a sign of a condition (capillary leak syndrome) that can cause excessive accumulation of fluid in your tissues, and requires urgent medical evaluation by your doctor.
Slovenian: To je lahko znak obolenja (sindrom povečane propustnosti kapilar), ki lahko v vaših tkivih povzroči prekomerno zadrževanje tekočine, kar od vašega zdravnika zahteva nujno zdravstveno oceno.
English: Studies including patients with renal insufficiency (creatinine clearance < 30 ml/min for the monotherapy, and < 60 ml/min for the combination regimen) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
Slovenian: Ledvična okvara Študije, ki so vključevale bolnike z motnjami delovanja ledvic (očistek kreatinina < 30 ml/min pri monoterapiji in < 60 ml/min pri kombiniranem režimu) niso bile izvedene, zato zdravila Yondelis ni dovoljeno uporabiti za to populacijo bolnikov (glejte poglavje 4.4).