FrancophonIA/ELRC3.0 huggingface dataset:
English: Trabectedin has been shown to exert antiproliferative in vitro and in vivo activity against a range of human tumour cell lines and experimental tumours, including malignancies such as sarcoma, breast, non-small cell lung, ovarian and melanoma.
Croatian: Trabektedin je pokazao da potiče antiproliferativnu in vitro i in vivo aktivnost protiv niza staničnih linija tumorskih stanica u ljudi i pokusnih tumora, uključujući zloćudne bolesti poput sarkoma, raka dojke, raka nemalih stanica pluća, raka jajnika i melanoma.
English: Neutrophil nadirs occurred at a median of 15 days and recovered within a week.
Croatian: Najniže vrijednosti neutrofila pojavljuju se s medijanom od 15 dana, i oporavljaju unutar tjedan dana.
English: 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).
Croatian: Postignute razine trabektedina u plazmi bile su 10,6 ± 5,4 (Cmax), više od onih koje su dosegli bolesnici nakon infuzije od 1500 µg/m2 tijekom 24 sata (Cmax od 1,8 ± 1,1 ng/ml) te slične onima koje su postignute nakon primjene iste doze tijekom trosatne infuzije (Cmax od 10,8 ± 3,7 ng/ml).
English: Efficacy analyses from ET743-OVA-301 Yondelis+PLD
Croatian: Analize djelotvornosti iz ispitivanja ET743-OVA-301 Yondelis + PLD PLD Omjer hazarda / izgleda pvrijednost
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)].
Croatian: Bolesnici su primili trabektedin u dozi od 1,2 mg/m2 koja se preporučuje za japanske bolesnike [1,2 mg/m2 jednom svaka 3 tjedna (q3wk 24-h)].
English: However, based on its known mechanism of action, trabectedin may cause serious birth defects when administered during pregnancy.
Croatian: Međutim, zbog svog poznatog mehanizma djelovanja trabektedin može, ako se primjenjuje tijekom trudnoće, prouzročiti ozbiljne urođene mane.
English: Chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Croatian: Kemijska i fizikalna stabilnost dokazane su tijekom 30 sati na temperaturi do 25°C.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici iza oznake “Rok valjanosti” ili EXP.
English: Table 1 Dose modification table for Yondelis (as single agent for soft tissue sarcoma (STS) or in combination for ovarian cancer) and PLD
Croatian: Tablica 1. Tablica modifikacije doze za Yondelis (kao pojedinačni lijek za sarkom mekih tkiva ili u kombinaciji za liječenje raka jajnika) i PLD
English: During postmarketing experience, hypersensitivity reactions with very rare occurrence of fatal outcome, have been reported in association with trabectedin administration either alone or in combination with PLD (see sections 4.3 and 4.8).
Croatian: Nakon stavljanja lijeka u promet reakcije preosjetljivosti s vrlo rijetkim slučajevima smrtnog ishoda prijavljivane su uz primjenu trabektedina bilo samog bilo u kombinaciji s PLD-om (vidjeti dijelove 4.3 i 4.8).
English: No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Croatian: Nisu primijećene inkompatibilnosti između Yondelisa i bočica od stakla tipa I, vrećica i cijevi od polivinilklorida (PVC) i polietilena (PE), spremnika od poliizoprena i titanijskih ugradbenih sustava za pristup krvnim žilama.
English: Anti-emetic prophylaxis with corticosteroids such as dexamethasone must be administered to all patients (see section 4.2).
Croatian: Mučnina i povraćanje Antiemetička profilaksa kortikosteroidima kao što je deksametazon mora se primijeniti kod svih bolesnika (vidjeti dio 4.2).
English: Hepatic failure: Rare cases of hepatic failure (including cases with fatal outcomes) have been reported in patients with serious underlying medical conditions treated with trabectedin, both in clinical trials and in post marketing setting.
Croatian: Zatajenje jetre: rijetki slučajevi zatajenja jetre (uključujući slučajeve sa smrtnim ishodom) prijavljeni su kod bolesnika s prisutnim teškim osnovnim medicinskim stanjima liječenima trabektedinom, kako u kliničkim ispitivanjima tako i nakon stavljanja lijeka u promet.
English: The PR corresponded to a patient with an alveolar rhabdomyosarcoma.
Croatian: PR odgovara bolesniku s alveolarnim rabdomiosarkomom.
English: • You may notice unexplained partial or general swelling (oedema), with possible lightheadedness, dizziness or thirst (low blood pressure).
Croatian: • Mogli biste primijetiti neobjašnjivo djelomično ili opće oticanje (edem), s mogućom ošamućenosti, omaglicom ili žeđi (nizak krvni tlak).
English: In this case you may experience one or more of the following signs: fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting; see section 4).
Croatian: U tom slučaju mogli biste osjetiti jedan ili više sljedećih znakova: vrućicu, otežano disanje, crvenilo ili navale crvenila kože ili osip, mučninu ili povraćanje (povraćanje; pogledajte dio 4).
English: 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).
Croatian: Stoga, istodobnu primjenu trabektedina sa snažnim CYP3A4 induktorima (npr. rifampicin, fenobarbital, gospina trava) treba izbjegavati ako je to moguće (vidjeti dio 4.4).
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.
Croatian: Dva in vivo faze I ispitivanja interakcija među lijekovima, potvrdila su trend prema povećanju, odnosno smanjenju izloženosti trabektedinu kada je primijenjen s ketokonazolom, odnosno rifampicinom.
English: Blood creatinine increased Blood albumin decreased
Croatian: Povišen kreatinin u krvi Snižen albumin u krvi
English: The effect of medicines containing phenytoin (for epilepsy) may be decreased if given together with Yondelis and this is therefore not recommended.
Croatian: (za epilepsiju) može biti smanjen ako se ti lijekovi primjenjuju zajedno s Yondelisom te se to stoga ne preporučuje.
English: Yondelis is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised during handling.
Croatian: Yondelis je citotoksični lijek protiv raka te se njime, kao i svim drugim potencijalno toksičnim tvarima, mora rukovati oprezno.
English: Median PFS (95% CI) (months)
Croatian: Medijan PFS-a (95 % CI) (mjeseci)
English: It seems that plasma clearance and distribution volume of trabectedin are not influenced by age.
Croatian: Čini se da dob ne utječe na plazmatski klirens i volumen distribucije trabektedina.
English: Furthermore, you could feel like your heart is beating too hard or too fast in your chest (palpitations), have a weakness in the ventricles, the heart's major pumping chambers (left ventricular dysfunction), or a sudden blockage in a lung artery (pulmonary embolism).
Croatian: Nadalje, mogli biste osjetiti da vam srce prejako ili prebrzo lupa u grudima (palpitacije), imati slabost u klijetkama, glavnim srčanim komorama za pumpanje krvi
English: They were often the result of a combination of events including pancytopenia, febrile neutropenia, some of them with sepsis, hepatic involvement, renal or multiorgan failure and rhabdomyolysis.
Croatian: Često su bile rezultat kombinacije događaja uključujući pancitopeniju, febrilnu neutropeniju, ponekad udruženu sa sepsom, oštećenje jetre, zatajenje bubrega ili više organa te rabdomiolizu.
English: Trabectedin pharmacokinetic profile is consistent with a multiple-compartment disposition model.
Croatian: Farmakokinetički profil trabektedina sukladan je s modelom raspoloživosti s više odjeljaka.
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.
Croatian: Na temelju ad hoc pregleda slučajeva CLS-a koje je provelo Vanjsko neovisno povjerenstvo za procjenu utvrđena je moguća ili vjerojatna uzročna povezanost trabektedina u 5 od 6 smrtnih slučajeva od sveukupno 14 slučajeva u kojima je prisutnost CLS-a ocijenjena kao vjerojatna.
English: • You could also experience dizziness, low blood pressure and flushing or skin rash.
Croatian: • Također biste mogli osjetiti omaglicu, nizak krvni tlak i navale crvenila ili osip na koži.
English: Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic medicines.
Croatian: Njegovo korištenje moraju nadzirati kvalificirani onkolozi ili drugi zdravstveni radnici specijalizirani za primjenu citotoksičnih lijekova.
English: The percentages of patients anaemic at baseline were 46% and 35% respectively.
Croatian: Postotci anemičnih bolesnika na početku iznosili su 46 % odnosno 35 %.
English: • feel difficulty breathing and coughing
Croatian: • biti umorni • imati otežano disanje i kašljati
English: Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Croatian: Drugo Mora se izbjegavati istodobna primjena Yondelisa s potentnim inhibitorima enzima CYP3A4 (vidjeti dio 4.5).
English: Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively.
Croatian: Povišenja 4. stupnja AST-a i ALT-a pojavila su se u 1 %, odnosno 2 % ciklusa.
English: It requires further dilution and is for single-use only.
Croatian: Otopinu je potrebno dalje razrijediti te je namijenjena samo za jednokratnu uporabu.
English: Intravenous administration through a central venous line is strongly recommended (see sections 4.4 and 6.6).
Croatian: Način primjene Strogo se preporučuje intravenska primjena kroz središnji venski kateter (vidjeti dijelove 4.4 i 6.6).
English: • You may feel severe muscle aches and pain, stiffness and muscle weakness.
Croatian: • Mogli biste osjetiti jaku bol u mišićima, ukočenost i slabost mišića.
English: 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.
Croatian: Dodatni podaci o djelotvornosti dostupni su iz randomiziranog ispitivanja faze III trabektedina naspram dakarbazina kao kontrolnog aktivnog lijeka (Ispitivanje ET743-SAR-3007), u bolesnika u kojih je liječen neresektabilni ili metastatski lipo- ili leiomiosarkom, a koji su ranije bili liječeni barem režimom koji sadrži antraciklin i ifosfamid, ili režimom koji sadrži antraciklin te jedan dodatni režim citotoksične kemoterapije.
English: The table below displays the adverse reactions reported in patients with soft tissue sarcoma and ovarian cancer that were treated with Yondelis recommended regimen in each indication..
Croatian: Tablica koja slijedi prikazuje nuspojave prijavljene u bolesnika sa sarkomom mekih tkiva i rakom jajnika liječenih preporučenim režimima lijeka Yondelis za svaku indikaciju
English: Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying.
Croatian: Yondelis je lijek protiv raka koji djeluje tako da sprječava umnažanje tumorskih stanica.
English: Accidental contact with the skin, eyes or mucous membranes must be treated immediately with copious amounts of water.
Croatian: Ako dođe do slučajnoga kontakta s kožom, očima ili sluznicama, morate ih odmah isprati obilnim količinama vode.
English: Yondelis should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3.
Croatian: Yondelis se ne smije primjenjivati kod bolesnika s početnom vrijednošću neutrofila manjom od 1500 stanica/mm3 i brojem trombocita manjim od 100 000 stanica/mm3.
English: Yondelis monotherapy and combination regimens must not be used in patients with creatinine clearance < 30 ml/min and < 60 ml/min respectively (see section 4.2).
Croatian: Monoterapija Yondelisom i kombinirani režimi ne smiju se koristiti kod bolesnika koji imaju klirens kreatinina < 30 ml/min, odnosno < 60 ml/min (vidjeti dio 4.2).
English: Yondelis must be reconstituted and further diluted prior to intravenous infusion.
Croatian: Yondelis se mora rekonstituirati i potom dodatno razrijediti prije intravenske infuzije.
English: For the treatment of soft tissue sarcoma, the recommended dose is 1.5 mg/m2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles.
Croatian: Za liječenje sarkoma mekog tkiva preporučena doza je 1,5 mg/m2 površine tijela koja se primjenjuje kao intravenska infuzija tijekom 24 sata s tri tjedna pauze između ciklusa.
English: Instructions for handling and disposal
Croatian: Upute za rukovanje i odlaganje
English: • If you experience severe muscle pain or weakness as it could be a sign of damage to your muscles (rhabdomyolysis; see section 4).
Croatian: • ako osjetite jaku bol u mišićima ili slabost jer to može biti znak oštećenja mišića (rabdomioliza;
English: Trabectedin extravasation may cause tissue necrosis requiring debridement.
Croatian: Ekstravazacija trabektedina može prouzročiti nekrozu tkiva koja zahtijeva čišćenje rubova nekroze.
English: 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).
Croatian: U skupini koja je primala Yondelis + PLD, bolesnici rase koja nije bijela (uglavnom Azijci) imali su veću učestalost nuspojava 3. ili 4. stupnja (96 % prema 87 %) i ozbiljnih nuspojava (44 % prema 23 % nuspojava svih stupnjeva) nego bolesnici bijele rase.
English: • decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John's Wort (Hypericum perforatum, an herbal medicine for depression)) or
Croatian: • smanjeni (primjer su lijekovi koji sadržavaju rifampicin (za bakterijske infekcije), fenobarbital (za epilepsiju) ili gospinu travu (Hypericum perforatum, biljni lijek za depresiju) ili
English: Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/or renal or multiorgan failure.
Croatian: Rabdomioliza je prijavljivana manje često, obično udružena s mijelotoksičnošću, teškim abnormalnostima testova jetrene funkcije i/ili zatajenjem bubrega ili većeg broja organa.
English: Yondelis is used for the treatment of patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful or the patients are unsuited to receive them.
Croatian: Yondelis se koristi za liječenje bolesnika s uznapredovalim sarkomom mekog tkiva kada se prethodni lijekovi nisu pokazali uspješnima ili ako bolesnik nije podoban za liječenje tim lijekovima.
English: Similarly, the co-administration of trabectedin with potent inducers of CPY3A4 may increase the metabolic clearance of trabectedin.
Croatian: Slično tome, istodobna primjena trabektedina sa potentnim induktorima CYP3A4 može povećati metabolički klirens trabektedina.
English: It could be a sign of a condition (capillary leak syndrome) that can cause excessive accumulation of fluid in your tissues.
Croatian: To može biti znak poremećaja (sindrom kapilarnog curenja) koji uzrokuje pojačano nakupljanje tekućine u tkivima.
English: • You may experience yellowing of your skin and eyeballs (jaundice), pain in the upper right area of your abdomen, nausea, vomiting, a general sense of not feeling well, difficulty in concentrating, disorientation or confusion, sleepiness.
Croatian: • Mogli biste imati žutilo kože i bjeloočnica (žutica), bol u gornjem dijelu trbuha, mučninu, povraćanje, opće loše osjećanje, poteškoće s koncentracijom, gubitak orijentacije ili smetenost,
English: Concomitant use of trabectedin with phenytoin may reduce phenytoin absorption leading to an exacerbation of convulsions.
Croatian: Istodobna uporaba trabektedina s fenitoinom može smanjiti apsorpciju fenitoina, što uzrokuje egzacerbaciju konvulzija.
English: Blood creatine phosphokinase increased
Croatian: Povišena kreatin fosfokinaza u krvi
English: Adequate contraceptive precautions must be used by women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment.
Croatian: Žene reproduktivne dobi moraju primjenjivati odgovarajuće kontracepcijske mjere dok primaju Yondelis i 3 mjeseca nakon završetka liječenja.
English: Capillary leak syndrome (CLS) is usually characterized by peripheral oedema, hypotension which is relatively well tolerated, oliguria with acute pre-renal failure.
Croatian: Sindrom kapilarnog curenja obično karakteriziraju periferni edem, hipotenzija koja se relativno dobro podnosi te oligurija s akutnim prerenalnim zatajenjem bubrega.
English: Yondelis is given to you under the supervision of a physician experienced in the use of chemotherapy.
Croatian: Yondelis ćete primiti pod nadzorom liječnika koji ima iskustva u primjeni kemoterapije.
English: It could lead to damage and death of your tissue cells around the injection site (tissue necrosis, see also section 4) which may require surgery.
Croatian: To može dovesti do oštećenja i smrti tkivnih stanica oko mjesta injiciranja (nekroza tkiva, pogledajte također dio 4) što može zahtijevati kirurški zahvat.
English: Capillary Leak Syndrome (CLS): Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes) (see section 4.4).
Croatian: Sindrom kapilarnog curenja: Nakon primjene trabektedina prijavljeni su slučajevi sindroma kapilarnog curenja (uključujući slučajeve sa smrtnim ishodom) (vidjeti dio 4.4).
English: Palmar-plantar erythrodysaesthesia syndrome*
Croatian: Sindrom palmarnoplantarne eritrodizestezije*
English: In this trial trabectedin was administered either at 1.5 mg/m2 as a 24-hour intravenous infusion every 3 weeks or at 0.58 mg/m2 weekly as a 3-hour intravenous infusion for 3-weeks of a 4-week cycle.
Croatian: U ovom ispitivanju trabektedin se primjenjivao ili pri dozi od 1,5 mg/m2 kao 24-satna intravenska infuzija svaka 3 tjedna ili pri dozi od 0,58 mg/m2 tjedno kao trosatna intravenska infuzija tijekom 3 tjedna u ciklusu od 4 tjedna.
English: If you are given Yondelis or the combination Yondelis+PLD together with a medicine that might cause damage to the liver or to the muscles (rhabdomyolysis), you may need to be closely monitored,
Croatian: Ako primate Yondelis ili kombinaciju Yondelis + PLD istodobno s lijekom koji može oštetiti jetru ili mišiće (rabdomioliza), možda će Vas se morati pomno nadzirati jer se rizik od oštećenja mišića ili jetre može povećati.
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.
Croatian: LVEF) na početku te periodički tijekom liječenja; osobito kod bolesnika kod kojih postoji rizik od kardiomiopatije uslijed prethodnog izlaganja antraciklinima ili kod bolesnika sa simptomima smanjenja srčane funkcije.
English: You should have received training on the correct techniques to reconstitute and dilute Yondelis or its combination with PLD and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Croatian: Nužno je da prođete obuku o ispravnim tehnikama rekonstitucije i razrjeđivanja Yondelisa ili njegove kombinacije s pegiliranim liposomalnim doksorubicinom (PLD-om) te tijekom rekonstitucije i razrjeđivanja morate nositi zaštitnu odjeću, uključujući masku, zaštitne naočale i rukavice.
English: Findings observed included haematopoietic toxicity (severe leukopenia, anaemia, and lymphoid and bone marrow depletion) as well as increases in liver function tests, hepatocellular degeneration, intestinal epithelial necrosis, and severe local reactions at the injection site.
Croatian: Dobiveni nalazi obuhvaćali su hematopoetsku toksičnost (tešku leukopeniju, anemiju te depleciju limfoida i koštane srži) te porast vrijednosti testova jetrene funkcije, hepatocelularnu degeneraciju, crijevnu epitelnu nekrozu te teške lokalne reakcije na mjestu injiciranja.
English: All randomised n=337
Croatian: svi nasumično izabrani n = 337
English: Yondelis contains the active substance trabectedin.
Croatian: Yondelis sadrži djelatnu tvar trabektedin.
English: It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery.
Croatian: To može dovesti do oštećenja i smrti tkivnih stanica oko mjesta injiciranja (nekroza tkiva) što može zahtijevati kirurški zahvat.
English: If you develop any of these symptoms you should seek medical attention immediately.
Croatian: Ako razvijete bilo koji od tih simptoma, morate odmah potražiti liječničku pomoć.
English: Patients with elevated serum bilirubin levels at baseline must not be treated with Yondelis.
Croatian: Bolesnici čiji je početni serumski bilirubin povišen ne smiju se liječiti Yondelisom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and further dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon pripreme i dodatnog razrjeđivanja.
English: Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Croatian: Pretklinički podaci su pokazali da je trabektedin supstrat enzima P-gp.
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.
Croatian: Neklinički podaci upućuju da trabektedin, kad je riječ o AUC-u, ima ograničeni učinak na kardiovaskularni, dišni i središnji živčani sustav pri izlaganjima nižima od terapijskog kliničkog raspona.
English: For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m2 of body surface area.
Croatian: Za liječenje sarkoma mekog tkiva uobičajena doza iznosi 1,5 mg/m2 površine tijela.
English: These trials evaluated a total of 100 patients with lipo- and leiomyosarcoma and 83 patients with other types of sarcoma.
Croatian: bolesnika s liposarkomom i leiomiosarkomom te 83 bolesnika s drugim tipovima sarkoma.
English: Results from an expanded access program for patients with STS (study ET743-SAR- 3002) show that among the 903 subjects assessed for OS, the median survival time was 11.9 months (95% CI: 11.2, 13.8).
Croatian: Soft tissue sarcoma) (ispitivanje ET743-SAR-3002) pokazuju da je među 903 ispitanika procijenjenih za OS medijan vremena preživljenja iznosio 11,9 mjeseci (95 % CI: 11,2, 13,8).
English: The effects of trabectedin on cardiovascular and respiratory function have been investigated in vivo (anesthetised Cynomolgus monkeys).
Croatian: Učinci trabektedina na kardiovaskularnu i dišnu funkciju proučavani su in vivo (na anesteziranim
English: The vial must be shaken until complete dissolution.
Croatian: Bočicu se mora protresti dok se sadržaj potpuno ne otopi.
English: Caution should be taken if medicinal products associated with hepatotoxicity are administered concomitantly with trabectedin, since the risk of hepatotoxicity may be increased.
Croatian: Lijekovi povezani s hepatotoksičnošću se moraju primjenjivati s oprezom ako se primjenjuju istodobno s trabektedinom jer se rizik od hepatotoksičnosti može povećati.