natgillin/translations-raw huggingface dataset:
Cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for the oxidative metabolism of trabectedin at clinically relevant concentrations. 
Citokrom P450 3A4 je glavni izoencim citokroma P450, odgovoren za oksidacijsko presnovo trabektedina pri klinično pomembnih koncentracijah.
What Yondelis is and what it is used for What you need to know before you are given Yondelis How to use Yondelis 
Kaj je zdravilo Yondelis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Yondelis Kako uporabljati zdravilo Yondelis
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. 
Če bolnica med zdravljenjem zanosi, jo je treba obvestiti o potencialnem tveganju za plod (glejte poglavje 5.3) in jo skrbno nadzirati.
If you experience severe muscle pain or weakness, you should seek medical attention immediately. 
Če izkusite resne bolečine ali oslabelost v mišicah, morate nemudoma poiskati zdravniško pomoč.
What Yondelis is and what it is used for 
Kaj je zdravilo Yondelis in za kaj ga uporabljamo
Renal toxicological findings were detected in multi-cycle toxicity studies conducted in monkeys. 
Izsledki ledvične toksičnosti so bili odkriti v študijah toksičnosti v več ciklih, ki so jih izvajali pri opicah.
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: 
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:
Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic medicines. 
Uporabo je treba omejiti na usposobljene onkologe ali druge zdravstvene delavce, ki so specializirani za dajanje citotoksičnih zdravil.
Patients with increases in AST, ALT and alkaline phosphatase between cycles may necessitate dose adjustments (see section 4.2). 
Pri bolnikih s povečanjem AST, ALT in alkalne fosfataze med cikli je morda potrebno prilagoditi odmerek (glejte poglavje 4.2).
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. 
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.
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. 
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
The differences were mainly observed in relation with neutropenia (93% versus 66%), anaemia (37% versus 14%) and thrombocytopenia (41% versus 19%). 
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 %).
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. 
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.
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. 
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.
Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients. 
Pri večini bolnikov poročajo o reverzibilnem akutnem povečanju aspartat-aminotransferaze (AST) in alanin-aminotransferaze (ALT).
All randomised n=337 
Vse randomizirano n = 337
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. 
Zdravila Yondelis ne smete uporabiti, če boste cepljeni proti rumeni mrzlici in ni priporočljivo, da dobite cepivo, ki vsebuje žive delce virusov.
The median patient age was 56 years (range 17 to 81), 30% were male, 77% Caucasian, 12% African American and 4% Asian. 
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.
The inter-patient variability of the population estimate for plasma clearance of trabectedin was 49% and intra-patient variability was 28%. 
Variabilnost ocene očistka trabektedina v plazmi med bolniki v isti populaciji je bila 49 % in variabilnost pri bolniku 28 %.
No cumulative toxicities have been observed in patients treated with multiple cycles. 
Kumulativne toksičnosti pri bolnikih, zdravljenih z več cikli, niso opazili.
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. 
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.
In order to avoid irritation at the site of injection it is recommended that Yondelis is given to you through a central venous line. 
Da preprečite draženje mesta injiciranja se priporoča dajanje zdravila Yondelis skozi centralno vensko linijo.
Neutropenia: 
Nevtropenija:
In clinical trials, there were no pre-defined limits to the number of cycles administered. 
V kliničnih preskušanjih ni bilo predhodno opredeljenih omejitev števila apliciranih odmerkov.
• When Yondelis is used in combination with PLD, you may have syncope also called fainting. 
• Če se zdravilo Yondelis uporablja v kombinaciji s PLD, se lahko pojavi sinkopa, ki se imenuje tudi omedlevica.
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). 
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).
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. 
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.
• 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). 
• Možno je, da se vam zviša raven rumenega pigmenta bilirubina v krvi, kar lahko povzroči zlatenico (rumenost kože, sluznic in oči).
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. 
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
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. 
Vsakič, ko prejmete zdravilo Yondelis za zdravljenje sarkoma mehkega tkiva, bo trajalo okoli 24 ur,
Yondelis must be reconstituted and further diluted prior to infusion (see also section 3). 
Zdravilo Yondelis je treba rekonstituirati in nadalje razredčiti pred infundiranjem (glejte tudi poglavje 3).
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). 
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).
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). 
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).
No studies on the effects of the ability to drive and to use machines have been performed. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
• If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine despite being given anti-sickness medicines. 
• Če vam je slabo, bruhate ali ne morete piti tekočine in zato izločate manj urina, kljub temu, da ste prejeli zdravilo proti slabosti.
The vial must be shaken until complete dissolution. 
Vialo je treba stresati, dokler raztapljanje ni končano.
Instructions for use - preparation, handling and disposal 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo - priprava, ravnanje in odstranjevanje
Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent. 
Zdravila Yondelis ni dovoljeno dajati kot mešanice z drugimi zdravili v isti infuziji, razen s topilom.
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)]. 
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)].
Adverse reactions are listed by System Organ Class and frequency. 
Neželeni učinki so navedeni po organskih sistemih in pogostnostih.
Before Yondelis is given to you, it is reconstituted and diluted for intravenous use. 
Preden boste zdravilo Yondelis prejeli, bo rekonstituirano in razredčeno za intravensko uporabo.
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. 
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.
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. 
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.
Fertility studies with trabectedin were not performed but limited histopathological changes were observed in the gonads in the repeat dose toxicity studies. 
Študij plodnosti s trabektedinom niso izvajali, vendar pa so pri spolnih žlezah opazili omejene histopatološke spremembe v študijah toksičnosti pri ponavljajočih se odmerkih.
No significant differences were detected in overall survival (OS). 
V splošni stopnji preživetja ni bilo pomembnih razlik.
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. 
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.
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. 
Zdravilo Yondelis je bilo aplicirano 6 ali več ciklov pri 29,5 % in 52 % bolnikov, zdravljenih z monoterapijo ali s kombiniranim odmerkom in režimom.
However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy. 
Na podlagi znanih mehanizmov delovanja povzroča trabektedin resne okvare ploda, če ga prejemajo nosečnice.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično: pri uporabi bodite previdni.
- 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) 
- 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)
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. 
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.
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). 
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).
Three patients achieved stable disease (one with rhabdomyosarcoma after 15 cycles, one with spindle cell sarcoma after 2 cycles, and one with Ewing sarcoma after 4 cycles. 
Pri treh bolnikih je prišlo do stabilizacije bolezni (en bolnik z rabdomiosarkomom po 15 ciklih, en bolnik z vretenastoceličnim sarkomom po 2 ciklih in en bolnik s sarkomom Ewing po 4 ciklih).
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and further dilution. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji in nadaljnjem razredčenju.
The monotherapy and combination regimens have been used for up to 38 and 21 cycles respectively. 
Monoterapijo in kombinirani režim se je uporabljal za do 38 oziroma 21
When rifampicin was co-administered with trabectedin, it resulted in reduced plasma exposure of trabectedin by approximately 22% for Cmax and 31% for AUC. 
Pri hkratnem dajanju rifampicina in trabektedina je nastopilo zmanjšanje plazemske izpostavljenosti trabektedinu za približno 22 % za Cmax in 31 % za AUC.
Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water. 
Ob nezgodnem stiku s kožo, očmi ali sluznicami je treba prizadeto mesto nemudoma splahniti z obilico vode.
There is no relevant influence of renal function measured by creatinine clearance on trabectedin pharmacokinetics within the range of values (≥ 30.3 ml/min) present in the patients included in the clinical studies. 
Ledvična funkcija, merjena kot očistek kreatinina, nima pomembnega vpliva na farmakokinetiko trabektedina znotraj obsega vrednosti (≥ 30,3 ml/min) pri bolnikih, vključenih v klinične študije.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Liver function tests predicting severe toxicity (meeting Hy´s law) and clinical manifestations of severe hepatic injury were uncommon with a lower than 1% incidence of individual signs and symptoms including jaundice, hepatomegaly or liver pain. 
Testi delovanja jeter, ki napovedujejo hudo toksičnost (po Hy-jevem zakonu) in klinične manifestacije resnih poškodb jeter so bile občasne z incidenco individualnih znakov pod 1 % in simptomi, ki so vključevali zlatenico, hepatomegalijo ali bolečine jeter.
Soft tissue sarcoma is a malignant disease that starts somewhere in the soft tissues, such as the muscles, fat or other tissues (for example cartilages or vessels). 
Sarkom mehkega tkiva je maligno obolenje, ki se začne v mehkem tkivu, kot so mišice, maščoba ali drugo tkivo (na primer hrustanec ali žile).
Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively. 
Povečanje AST in ALT stopnje 4 se je pojavilo pri 1 % oz. 2 % ciklov.
Systemic exposure after intravenous administration as a constant rate infusion is dose proportional at doses up to and including 1.8 mg/m2. 
Porazdelitev Sistemska izpostavljenost po intravenskem odmerjanju infuzije stalne hitrosti je odmerek, sorazmeren z odmerki do vključno 1,8 mg/m2.
When ketoconazole was co-administered with trabectedin, the plasma exposure of trabectedin was increased by approximately 21% for Cmax and 66% for AUC, but no new safety concerns were identified. 
Pri hkratnem dajanju ketokonazola in trabektedina se je plazemska izpostavljenost trabektedinu povečala približno za 21 % za Cmax, za območje pod krivuljo (AUC) pa za 66 %, vendar niso ugotovili novih pomislekov glede varnosti.
The plasma trabectedin levels attained were 10.6 ± 5.4 (Cmax), higher than those reached in patients after infusion of 1,500 µg/m2 for 24 (Cmax of 1.8 ± 1.1 ng/ml) and similar to those reached after administration of the same dose by 3 hour infusion (Cmax of 10.8 ± 3.7 ng/ml). 
Dobljene ravni trabektedina v plazmi so bile 10,6 ± 5,4 (Cmax), višje, kot so jih dosegli pri bolnikih po infuziji 1.500 µg/m2 za 24 (Cmax 1,8 ± 1,1 ng/ml), in podobni tistim, doseženim po apliciranju istega odmerka v 3-urni infuziji (Cmax 10,8 ± 3,7 ng/ml).
Other medicines and Yondelis 
Druga zdravila in zdravilo Yondelis
Table 1 Dose modification table for Yondelis (as single agent for soft tissue sarcoma (STS) or in combination for ovarian cancer) and PLD 
Tabela 1 Tabela prilagoditve odmerka za zdravilo Yondelis (kot samostojno zdravilo za sarkom mehkega tkiva (STS) ali v kombinaciji za karcinom jajčnikov) in PLD
Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. 
Trabektedin se veže na manjše žlebe deoksiribonukleinske kisline (DNK), ob čemer spiralo zavije k velikemu žlebu.
Bleeding events associated to thrombocytopenia occurred in < 1% of patients treated with the monotherapy regimen. 
Krvavitev, povezana s trombocitopenijo, se je pojavila pri < 1 % bolnikov, zdravljenih z monoterapijo.
The protocol specified final time to progression (TTP) analysis showed a 26.6% reduction in the relative risk of progression for patients treated in the 24-h q3wk group [Hazard Ratio (HR)=0.734, Confidence Interval (CI): 0.554-0.974]. 
Po protokolu določen končni čas do napredovanja (TTP - „time to progression“) je pokazal 26,6 % zmanjšanje relativnega tveganja napredovanja za bolnike, zdravljene v skupini 24-h q3wk [razmerje tveganja (RT) = 0,734, interval zaupanja (IZ) 0,554-0,974].
The recommended dose in Japanese patients is lower than the usual dose for all other races, and is 1.2 mg/m2 of body surface area. 
Za bolnike japonskega porekla je priporočeni odmerek manjši od običajnega odmerka za vse ostale rase, in sicer je 1,2 mg na m2 površine telesa.
Capillary leak syndrome (CLS) is a rare entity characterized by recurrent and unpredictable attacks of capillary leakage of plasma fluid and proteins throughout the endothelium. 
Sindrom povečane propustnosti kapilar (CLS) se pojavi redko, zanj pa so značilni ponavljajoči se in nepredvideni napadi kapilarnega uhajanja plazemske tekočine in beljakovin prek endotelija.
Alcohol consumption must be avoided during treatment with Yondelis as this may harm the liver. 
Med zdravljenjem z zdravilom Yondelis ne smete uživati alkohola, saj lahko to poškoduje jetra.
Therefore, the concomitant use of trabectedin with strong CYP3A4 inducers (e.g., rifampicin, phenobarbital, Saint John's Wort) should be avoided if possible (see section 4.4). 
Torej se je treba hkratni uporabi trabektedina z močnimi spodbujevalci CYP3A4 (npr. rifampicin, fenobarbital, šentjanževka) izogniti, če je to mogoče (glejte poglavje 4.4).
Independent radiology review, all randomised n=337 
Neodvisna radiološka ocena, vse randomizirano n = 337
In the Yondelis+PLD arm, non-white (mainly Asian) patients had a higher incidence than white patients in grade 3 or 4 adverse reactions (96% versus 87%), and serious adverse reactions (44% versus 23% all grades). 
V kraku z zdravilom Yondelis+PLD je bila pri ne-belih (pretežno azijski) bolnikih višja incidenca neželenih učinkov 3. ali stopnje 4 kot pri belih bolnikih (96 % v primerjavi s 87 %) in hudih neželenih učinkov (44 % v primerjavi s 23 % vse stopnje).
No data are available comparing Yondelis+PLD to a platinum-based regimen in platinum-sensitive patients. 
Podatki o primerjavi zdravila Yondelis+PLD z režimom na podlagi platine pri bolnikih, občutljivih na platino, niso na voljo.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. 
Podatki o učinkovitosti temeljijo pretežno na bolnikih z liposarkomom in leiomiosarkomom.
The most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increase in AST/ALT, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea. 
Najpogostejši neželeni učinki katere koli stopnje resnosti so bili nevtropenija, navzea, bruhanje, povišanje AST/ALT, anemija, utrujenost, trombocitopenija, anoreksija in diareja.
Additional efficacy data are available from a randomized active-controlled phase III study of trabectedin vs. dacarbazine (Study ET743-SAR-3007), in patients treated for unresectable or metastatic lipo- or leiomyosarcoma who have been previously treated with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and one additional cytotoxic chemotherapy regimen. 
Dodatni podatki o učinkovitosti so na voljo iz randomizirane, z aktivnim zdravilom kontrolirane študije faze III, v kateri so primerjali trabektedin in dakarbazin (študija ET743-SAR-3007) pri bolnikih, zdravljenih zaradi neoperabilnega ali metastatskega liposarkoma ali leiomiosarkoma, ki so bili predhodno zdravljeni vsaj z režimom, ki je vključeval antraciklin in ifosfamid, ali z režimom, ki je vključeval antraciklin, in enim dodatnim režimom citotoksične kemoterapije.
Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4). 
Med zdravljenjem s trabektedinom se je treba izogniti uživanju alkohola zaradi hepatotoksičnosti zdravila (glejte poglavje 4.4).
Chemical and physical stability has been demonstrated for 30 hours up to 25ºC. 
Kemijska in fizikalna stabilnost je bila dokazana za 30 ur pri temperaturi do 25 ºC.