FrancophonIA/ELRC3.0 huggingface dataset:
English: Close monitoring of toxicities is required in patients receiving trabectedin in combination with potent CYP3A4 inhibitors (e.g. oral ketoconazole, fluconazole, ritonavir, clarithromycin or aprepitant) and such combinations should be avoided if possible.
Croatian: Potrebno je pažljivo pratiti toksičnosti kod bolesnika koji primaju trabektedin u kombinaciji sa potentnim CYP3A4 inhibitorima (npr. peroralni ketokonazol, flukonazol, ritonavir, klaritromicin ili aprepitant) i ako je moguće takve kombinacije trebale bi se izbjegavati.
English: A full blood cell count including differential and platelet count must be performed at baseline, weekly for the first two cycles and then once between cycles (see section 4.2).
Croatian: Kompletnu krvnu sliku, uključujući diferencijalnu krvnu sliku i broj trombocita, mora se ispitati na početku, jednom tjedno u prva dva ciklusa i potom jednom između ciklusa (vidjeti dio 4.2).
English: Talk to your doctor before using Yondelis
Croatian: Obratite se svom liječniku prije nego primijenite Yondelis.
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
Croatian: Na temelju znanstvenih zaključaka za trabektedin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) trabektedin nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If such combinations are needed, appropriate dose adjustments should be applied in the event of toxicities (see sections 4.2 and 4.4).
Croatian: Ako su takve kombinacije lijekova nužne, u slučaju pojave toksičnosti potrebne su odgovarajuće prilagodbe doze (vidjeti dijelove 4.2 i 4.4).
English: This value is approximately one-half the rate of human hepatic blood flow.
Croatian: Ta je vrijednost približno jednaka polovini brzine protoka krvi kroz jetru u ljudi.
English: Patients with elevated serum bilirubin levels must not be treated with trabectedin (see section 4.2).
Croatian: Bolesnici s povišenim serumskim bilirubinom ne smiju se liječiti trabektedinom (vidjeti dio 4.2).
English: From a microbiological point of view, the reconstituted solution should be diluted and used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituiranu otopinu treba odmah razrijediti i upotrijebiti.
English: Yondelis must not be used in patients with elevated bilirubin.
Croatian: Yondelis se ne smije primjenjivati kod bolesnika s povišenim bilirubinom.
English: 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.
Croatian: Testovi jetrene funkcije koji predviđaju tešku toksičnost (a sukladni su Hyjevu zakonu) i kliničke manifestacije teškog oštećenja jetre bile su rijetke s manje od 1 % incidencije pojedinačnih znakova i simptoma koji uključuju žuticu, hepatomegaliju ili bol u jetri.
English: Trabectedin crossed the placenta when administered to pregnant rats.
Croatian: Trabektedin prelazi placentu kada se primjenjuje u skotnih štakora.
English: The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity.
Croatian: Glavne očekivane toksičnosti su gastrointestinalna, supresija koštane srži i jetrena toksičnost.
English: In the event of an overdose, patients should be closely monitored and symptomatic supportive care measures instituted as required.
Croatian: U slučaju predoziranja bolesnike treba pomno pratiti i prema potrebi provesti simptomatske potporne mjere.
English: 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.
Croatian: Nema bitnoga utjecaja bubrežne funkcije izmjerene klirensom kreatinina na farmakokinetiku trabektedina unutar raspona vrijednosti (≥ 30,3 ml/min) prisutnih kod bolesnika uključenih u ova klinička ispitivanja.
English: • When Yondelis is used in combination with PLD, you may have syncope also called fainting.
Croatian: • Kada se Yondelis primjenjuje u kombinaciji s PLD-om, možete imati sinkopu, još zvanu nesvjestica.
English: The inter-patient variability of the population estimate for plasma clearance of trabectedin was 49% and intra-patient variability was 28%.
Croatian: Varijabilnost između bolesnika za procjenu unutar populacije za plazmatski klirens trabektedina iznosila je 49 %, a varijabilnost za bolesnika iznosila je
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.
Croatian: Da biste izbjegli iritaciju na mjestu injiciranja, preporučuje se primanje Yondelisa kroz središnji venski kateter.
English: Based on the population estimate for plasma clearance of trabectedin (30.9 l/h) and blood/plasma ratio (0.89), the clearance of trabectedin in whole blood is approximately 35 l/h.
Croatian: Na temelju procjena unutar populacije za plazmatski klirens trabektedina (30,9 l/h) i omjera krv/plazma (0,89) klirens trabektedina u punoj krvi iznosi otprilike 35 l/h.
English: Anaemia:
Croatian: Anemija:
English: Cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for the oxidative metabolism of trabectedin at clinically relevant concentrations.
Croatian: Citokrom P450 3A4 glavni je izoenzim citokroma P450 odgovoran za oksidativni metabolizam trabektedina pri klinički značajnim koncentracijama.
English: • Your doctor may require blood tests in certain situations in order to avoid that you develop muscle damage (rhabdomyolysis).
Croatian: • Vaš liječnik će vas uputiti na krvne pretrage u nekim situacijama kako bi se izbjeglo oštećenje mišića (rabdomioliza).
English: During your treatment with Yondelis you may feel tired and experience a loss of strength.
Croatian: Tijekom liječenja Yondelisom možda ćete osjećati umor i gubitak snage.
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.
Croatian: U fazi I-II ispitivanja SAR-2005 ukupno je bilo uključeno 50 pedijatrijskih bolesnika s rabdomiosarkomom, Ewingovim sarkomom ili nerabdomiosarkomom mekog tkiva.
English: The lesions may either dry out and desquamate, or blister with ulceration.
Croatian: Lezije se mogu isušiti i oljuštiti, ili mogu nastati mjehurići s ulceracijama.
English: 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.
Croatian: Preporučena doza kod japanskih bolesnika je niža od uobičajene doze za pripadnike drugih rasa, te iznosi 1,2 mg/m2 tjelesne površine.
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.
Croatian: Analiza populacijske farmakokinetike pokazala je da su koncentracije trabektedina u plazmi kod japanske populacije pri dozi od 1,2 mg/m2 ekvivalentne onima kod ne-japanske zapadnjačke populacije pri dozi od 1,5 mg/m2.
English: After a dose of radiolabelled trabectedin administered to cancer patients, faecal mean (SD) recovery of total radioactivity is 58% (17%), and urinary mean (SD) recovery is 5.8% (1.73%).
Croatian: Nakon primjene doze trabektedina obilježenog radioaktivnim biljegom kod bolesnika s rakom aritmetička sredina (SD) prikupljene totalne radioaktivnosti u fecesu iznosila je 58 % (17 %), a aritmetička sredina (SD) prikupljena u mokraći 5,8 % (1,73 %).
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).
Croatian: Ispitivanja koja obuhvaćaju bolesnike s bubrežnom insuficijencijom (klirens kreatinina < 30 ml/min za monoterapiju i < 60 ml/min za kombinirani režim) nisu provedena i stoga se Yondelis ne smije primjenjivati u toj populaciji bolesnika (vidjeti dio 4.4).
English: Personnel should be trained in the correct techniques to reconstitute and dilute the medicinal product and should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Croatian: Osoblje treba biti obučeno u ispravnim tehnikama rekonstitucije i razrjeđivanja lijeka te treba nositi zaštitnu odjeću koja uključuje masku, zaštitne naočale i rukavice tijekom rekonstitucije i razrjeđivanja.
English: There is no specific antidote for trabectedin currently available.
Croatian: Trenutačno ne postoji specifični antidot za trabektedin.
English: Hyperbilirubinemia: Bilirubin peaks approximately a week after onset and resolves approximately two weeks after onset.
Croatian: Hiperbilirubinemija: Vršne vrijednosti bilirubina postižu se tjedan dana nakon nastupa i normaliziraju se približno dva tjedna nakon nastupa poremećaja.
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.
Croatian: Yondelis se primjenjivao tijekom 6 ili više ciklusa u 29,5 % i 52 % bolesnika liječenih monoterapijom i kombinacijom doze, odnosno rasporeda primjene.
English: Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see section 4.3).
Croatian: Kombinacija trabektedina s fenitoinom ili živim oslabljenim cjepivima nije preporučljiva, a posebno je kontraindicirana primjena cjepiva protiv žute groznice (vidjeti dio 4.3).
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.
Croatian: Ako se lijek ne razrijedi i ne upotrijebi odmah, vrijeme čuvanja i uvjeti čuvanja rekonstituiranog lijeka prije uporabe odgovornost su korisnika, te normalno ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako je rekonstitucija provedena u kontroliranim i validiranim aseptičkim uvjetima.
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.
Croatian: Ispitivanje je ocjenjivalo djelotvornost i sigurnost trabektedina u odnosu na najbolju suportivnu terapiju (engl. best supportive care, BSC) kao terapiju druge ili kasnije linije liječenja za bolesnike s uznapredovalim TRS-om koji ne odgovaraju ili ne podnose standardni režim kemoterapije.
English: Preparation for intravenous infusion
Croatian: Priprema za intravensku infuziju
English: Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove.
Croatian: Trabektedin se veže na manji utor deoksiribonukleinske kiseline (DNK-a), svijajući uzvojnicu do velikog utora.
English: The following criteria are required to allow treatment with Yondelis:
Croatian: Sljedeći su uvjeti nužni da bi se odobrilo liječenje Yondelisom:
English: Overall survival in platinum-sensitive population (Final analysis n=316 events) n=218
Croatian: Ukupno preživljenje populacije osjetljive na platinu (konačna analiza n = 316 događaja)
English: Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Croatian: Konzumacija alkohola mora se izbjegavati tijekom liječenja trabektedinom zbog hepatotoksičnosti lijeka (vidjeti dio 4.4).
English: When rifampicin was co-administered with trabectedin, it resulted in reduced plasma exposure of trabectedin by approximately 22% for Cmax and 31% for AUC.
Croatian: Kada se rifampicin primjenjivao istodobno sa trabektedinom, izloženost trabektedinu u plazmi bila je smanjena za otprilike 22 % za Cmax i 31 % za AUC.
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).
Croatian: Analiza populacijske farmakokinetike pokazala je da na plazmatski klirens trabektedina ne utječu dob (raspon od 19 do 83 godine), spol, ukupna tjelesna težina (raspon: od 36 do 148 kg) ni površina tijela (raspon: 0,9 do 2,8 m2).
English: 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.
Croatian: Sindrom kapilarnog curenja (engl. capillary leak syndrome, CLS) je rijeko stanje koje karakteriziraju ponavljajući i nepredvidljivi napadaji propuštanja plazmatske tekućine i proteina kroz endotel kapilara.
English: Grades 3 or 4 neutropenia and thrombocytopenia associated with Yondelis therapy have been very commonly reported.
Croatian: Neutropenija i tromocitopenija 3. ili 4. stupnja povezane s terapijom Yondelisom, zabilježene su vrlo često.
English: No data are available comparing Yondelis+PLD to a platinum-based regimen in platinum-sensitive patients.
Croatian: Nema raspoloživih podataka koji bi usporedili kombinaciju Yondelis + PLD s liječenjem temeljenim na platini kod bolesnika koji su osjetljivi na platinu.
English: (See also PLD Summary of Product Characteristics for specific handling instructions).
Croatian: (Vidjeti također sažetak opisa svojstava lijeka za PLD za specifične informacije o rukovanju).
English: Special caution is advised and dose adjustments may be necessary in patients with hepatic impairment since systemic exposure to trabectedin is increased and the risk of hepatotoxicity might be increased.
Croatian: Savjetuje se poseban oprez i mogu biti potrebne prilagodbe doze u bolesnika s oštećenjem jetre jer je sistemska izloženost trabektedinu povećana te može biti povećan i rizik od hepatotoksičnosti.
English: Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent.
Croatian: Yondelis se ne smije upotrebljavati u mješavini s drugim lijekovima u istoj infuziji, osim s otopinom za razrjeđivanje.
English: If you have fever you should seek medical attention immediately.
Croatian: Ako imate vrućicu, morate odmah potražiti liječničku pomoć.
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.
Croatian: Ako osjećate mučninu, povraćate ili ne možete piti tekućinu te stoga mokrite manje, unatoč tome što primate lijekove protiv mučnine, morate odmah potražiti liječničku pomoć.
English: Pulmonary embolism*
Croatian: Plućna embolija*
English: What you need to know before you are given Yondelis
Croatian: Što morate znati prije nego počnete primjenjivati Yondelis
English: Liver function tests should be monitored during treatment with Yondelis as dose adjustments may be indicated (see Table 1 and section 4.4).
Croatian: Testove jetrene funkcije treba pratiti tijekom terapije lijekom Yondelis jer mogu biti indicirane prilagodbe doze (vidjeti Tablicu 1 i dio 4.4).
English: Trabectedin must not be used in patients with CPK > 2.5 x ULN (see section 4.2).
Croatian: Trabektedin se ne smije koristiti kod bolesnika s CPK-om > 2,5 x GGN (vidjeti dio 4.2).
English: • If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine despite being given anti-sickness medicines.
Croatian: • ako još uvijek osjećate mučninu, povraćate ili ne možete piti tekućinu te stoga mokrite manje unatoč uzimanju lijekova protiv mučnine.
English: - Neutropenia < 500/mm3 lasting for more than 5 days or associated with fever or infection - Thrombocytopenia < 25,000/mm3 - Increase of bilirubin > ULN and/or alkaline phosphatase > 2.5 x ULN
Croatian: neutropenija < 500/mm3 koja traje više od 5 dana ili je povezana s vrućicom ili infekcijom trombocitopenija < 25 000/mm3 porast bilirubina > GGN i/ili alkalne fosfataze > 2,5 x GGN
English: Overall survival, n (%) Secondary endpoints n=345
Croatian: Ukupno preživljenje, n ( %) Sekundarni ishodi n=345 n=173
English: 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).
Croatian: Sarkom mekog tkiva je zloćudna bolest koja se razvija u mekom tkivu kao što su mišići, masno tkivo ili druga tkiva (primjerice hrskavice ili krvne žile).
English: • You may experience difficulty in breathing, irregular heartbeat, decreased urine output, abrupt change in mental status, areas of mottled skin, extremely low blood pressure associated with abnormal laboratory test results (decrease in platelet count).
Croatian: • Mogli biste osjetiti otežano disanje, nepravilne otkucaje srca, smanjenu količinu izlučenog urina, nagle promjene psihičkog stanja, područja pjegave kože, izuzetno niski krvni tlak udružen s odstupanjima od normalnih vrijednosti laboratorijskih pretraga (smanjeni broj trombocita u krvi).
English: If you experience severe muscle pain or weakness, you should seek medical attention immediately.
Croatian: Ako osjetite jaku bol ili slabost u mišićima, odmah zatražite medicinsku pomoć.
English: If no infusion reaction is observed, subsequent PLD infusions may be administered over a 1-hour period (see also PLD Summary of Product Characteristics [SmPC] for specific administration advice).
Croatian: Ako nije uočena infuzijska reakcija, sljedeće infuzije PLD-a mogu se primijeniti tijekom jednog sata (vidjeti također sažetak opisa svojstava lijeka za PLD za specifične informacije o primjeni).
English: Rhabdomyolysis and severe CPK elevations (> 5 x ULN)
Croatian: Rabdomioliza i jako povišen CPK (> 5 x GGN)
English: • have nose bleeds
Croatian: • krvariti iz nosa
English: 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.
Croatian: Kod istodobne primjene ketonazola sa trabektedinom, izloženost trabektedinu u plazmi bila je povećana za 21 % za Cmax i 66 % za AUC, ali bez identificiranih novih sigurnosnih pitanja.
English: Concomitant administration of inhibitors of P-gp, e.g. cyclosporine and verapamil, may alter trabectedin distribution and/or elimination.
Croatian: Istodobna primjena inhibitora P-gp, npr. ciklosporina i verapamila, može izmijeniti raspodjelu i/ili eliminaciju trabektedina.
English: Since trabectedin is metabolised mainly by CYP3A4, the concentrations of trabectedin in plasma are likely to be increased in patients who are co-administered drugs that potently inhibit the activity of this isoenzyme.
Croatian: Budući da se trabektedin metabolizira uglavnom putem CYP3A4, koncentracije trabektedina u plazmi vjerojatno će se povećati kod bolesnika koji istodobno primjenjuju lijekove koji mogu inhibirati aktivnost tog izoenzima.
English: • You may experience an abnormal build-up of fluid in the lungs, which leads to swelling (pulmonary oedema).
Croatian: • Mogli biste osjetiti abnormalno nakupljanje tekućine u plućima, što uzrokuje oticanje (plućni edem).
English: The use of central venous access is strongly recommended (see section 4.2).
Croatian: Strogo se preporučuje primjena središnjega venskog pristupa (vidjeti dio 4.2).
English: If rhabdomyolysis occurs, supportive measures such as parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
Croatian: U slučaju rabdomiolize moraju se odmah uspostaviti potporne mjere kao što su parenteralna hidracija, alkalizacija mokraće i dijaliza, kako je indicirano.
English: There is no specific antidote for extravasation of trabectedin.
Croatian: Ne postoji specifični antidot u slučaju ekstravazacije trabektedina.
English: A population pharmacokinetic analysis showed that when administered in combination with PLD, the plasma clearance of trabectedin was decreased by 31%; the plasma pharmacokinetics of PLD were not influenced by the concomitant administration of trabectedin.
Croatian: Analiza populacijske farmakokinetike pokazala je da se, kad se primijenio u kombinaciji s PLD-om, plazmatski klirens trabektedina smanjio za 31 %, a istodobna primjena trabektedina nije utjecala na plazmatsku farmakokinetiku PLD-a.
English: The solution obtained has a concentration of 0.05 mg/ml and is for single-use only.
Croatian: Dobivena otopina ima koncentraciju 0,05 mg/ml te je namijenjena samo za jednokratnu uporabu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Yondelis 0.25 mg
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Yondelis 0,25 mg
English: Patients who develop fever should promptly seek medical attention.
Croatian: Bolesnici koji dobiju vrućicu moraju odmah potražiti liječničku pomoć.
English: • You could have mucosal inflammation as a swelling redness of the inside of the mouth leading to painful ulcers and mouth sores inflammation of the mouth (stomatitis), or as an inflammation of the gastrointestinal tract when Yondelis is used with PLD.
Croatian: • Možete dobiti upalu sluznice koja se očituje kao oticanje s crvenilom na unutarnjoj strani usta koje vodi do bolnih ulceracija i mjehurića u ustima (stomatitis), ili kao upala probavnog sustava, kada se Yondelis koristi sa PLD-om.
English: The efficacy of Yondelis/PLD combination in relapsed ovarian cancer is based on ET743-OVA-301, a randomized phase 3 study of 672 patients who received either trabectedin (1.1 mg/m2) and PLD (30 mg/m2) every 3 weeks or PLD (50 mg/m2) every 4 weeks.
Croatian: Djelotvornost kombinacije Yondelis/PLD u relapsu raka jajnika temelji se na ET743-OVA-301, fazi 3 randomiziranog ispitivanja sa 672 bolesnika koji su primali ili trabektedin (1,1 mg/m2) i PLD (30 mg/m2) svaka 3 tjedna ili PLD (50 mg/m2) svaka 4 tjedna.
English: The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
Croatian: Mora se izbjegavati istodobna uporaba trabektedina s alkoholom (vidjeti dio 4.5).
English: Patients in the trabectedin arm were required to receive dexamethasone 20 mg intravenous injection prior to each trabectedin infusion.
Croatian: Bolesnici u skupini s trabektedinom morali su primati 20 mg deksametazona putem intravenske injekcije prije svake infuzije trabektedina.
English: * Adverse drug reaction only for Ovarian cancer
Croatian: * Nuspojave se odnose samo na rak jajnika.
English: Bleeding events associated to thrombocytopenia occurred in < 1% of patients treated with the monotherapy regimen.
Croatian: Krvarenja povezana s trombocitopenijom pojavila su se u < 1 % bolesnika liječenih režimom monoterapije.
English: The differences were mainly observed in relation with neutropenia (93% versus 66%), anaemia (37% versus 14%) and thrombocytopenia (41% versus 19%).
Croatian: Razlike su uglavnom primijećene u vezi s neutropenijom (93 % prema 66 %), anemijom (37 % prema 14 %) i trombocitopenijom
English: The efficacy and safety of trabectedin in soft tissue sarcoma is based in a randomised trial in patients with locally advanced or metastatic lipo- or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.
Croatian: Djelotvornost i sigurnost primjene trabektedina u sarkomu mekih tkiva temelje se na randomiziranom ispitivanju kod bolesnika s lokalno uznapredovalim ili metastatskim liposarkomom ili leiomiosarkomom, čija je bolest napredovala ili se ponovno pojavila nakon liječenja barem s anatraciklinima i ifosfamidom.
English: • bruise more easily
Croatian: • lakše dobivati modrice