FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional efficacy data are available from a randomized, open-label, multicenter phase II study [JapicCTI-121850] conducted in Japanese patients with translocation-related sarcoma (TRS), most common being myxoid round-cell liposarcoma (n=24), synovial sarcoma (n=18), mesenchymal chondrosarcoma (n=6), and extraskeletal Ewing sarcoma/PNET, alveolar soft part sarcoma, alveolar rhabdomyosarcoma and clear cell sarcoma (n=5 each).
Slovenian: Iz randomizirane, odprte multicentrične študije 2. faze [JapicCTI-121850], izvedene pri japonskih bolnikih s sarkomom, povezanim s translokacijo (TRS- translocation-related sarcoma), kjer so bili najpogostejši miksoidni okroglocelični sarkom (n = 24), sinovialni sarkom (n = 18) in mezenhimski hondrosarkom (n = 6) ter zunajskeletni Ewingov sarkom/PNET, alveolarni sarkom mehkih tkiv,
English: Yondelis 1 mg: Inject 20 ml of sterile water for injections into the vial.
Slovenian: Yondelis 1 mg: Injicirajte 20 ml sterilne vode za injekcije v viale.
English: • If you notice that Yondelis infusion leaks out of your vein while you are being given it.
Slovenian: • Če opazite, da infuzija z zdravilom Yondelis med dajanjem izteka iz vaše vene.
English: In patients with PFI ≥ 6 months (65% in Yondelis+PLD and 63% in PLD arm), median PFS was 9.7 months in the Yondelis+PLD arm compared with 7.2 months in the PLD monotherapy arm (HR=0.66, CI: 0.52-0.85).
Slovenian: Pri bolnikih s PFI ≥ 6 mesecev (65 % pri zdravilu Yondelis+PLD in 63 % v kraku s PLD) je bilo mediano PBN 9,7 mesecev v kraku z zdravilom Yondelis+PLD v primerjavi s 7,2 meseci v kraku z monoterapijo s PLD (RT = 0,66, IZ: 0,52-0,85).
English: Yondelis is given to you under the supervision of a physician experienced in the use of chemotherapy.
Slovenian: Zdravilo Yondelis se daje pod nadzorom zdravnika, ki ima izkušnje s kemoterapijo.
English: Yondelis 0.25 mg: Each vial of powder contains 0.25 mg of trabectedin.
Slovenian: Yondelis 0,25 mg: Vsaka viala s praškom vsebuje 0,25 mg trabektedina.
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin.
Slovenian: Viala iz brezbarvnega stekla tipa I z zamaškom iz butilne gume, pokritim z aluminijastim tesnilom tipa „flip-off“, ki vsebuje 0,25 mg trabektedina.
English: Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
Slovenian: Ena viala praška vsebuje 8 mg kalija in 0,4 g saharoze.
English: Using the RECIST criteria the ORR among patients treated with trabectedin was 3 (8.1%; 95% CI: 1.7.21.9%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 24 (64.9%, 95% CI: 47.5-79.9%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Slovenian: Po merilih RECIST je bila pri bolnikih, zdravljenih s trabektedinom, splošna stopnja odziva (ORR) 3 (8,1 %; 95-odstotni IZ: 1,7-21,9 %), pri bolnikih, zdravljenih z najboljšo podporno oskrbo, pa 0 (0 %, 95-odstotni IZ: 0,0-9,7 %), medtem ko je bila stopnja klinično koristnega odziva 24 (64,9 %, 95-odstotni IZ: 47,5-79,9 %) oziroma 0 (0 %, 95-odstotni IZ: 0,0-9,7 %).
English: Palmar-plantar erythrodysaesthesia syndrome*
Slovenian: Bolezni kože in podkožja sindrom palmarnoplantarne eritrodisestez ije*
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).
Slovenian: • Morda boste imeli težave z dihanjem, nepravilen srčni utrip, zmanjšano količino urina, nenadno spremembo duševnega stanja, pojav lis na nekaterih območjih kože ali izjemno nizek krvni tlak,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/417/002
English: Fatal adverse reactions have occurred in 1.9% and 0.9% of patients treated with the monotherapy and combination regimens respectively.
Slovenian: Neželeni učinki so bili smrtni pri 1,9 % bolnikov, zdravljenih z monoterapijo, in 0,9 % bolnikov, zdravljenih s kombinirano terapijo.
English: Appropriate aseptic techniques must be used to prepare the infusion solution (see Instructions for reconstitution and for dilution).
Slovenian: Pri pripravi raztopine za infundiranje (glejte Navodila za rekonstitucijo in redčenje zdravila) uporabljajte ustrezne aseptične tehnike.
English: If you have fever you should seek medical attention immediately.
Slovenian: Če imate zvišano telesno temperaturo, morate nemudoma poiskati zdravniško pomoč
English: Yondelis 1 mg: Each vial of powder contains 1 mg of trabectedin.
Slovenian: Yondelis 1 mg: Vsaka viala s praškom vsebuje 1 mg trabektedina.
English: Inspect the parenteral solution visually for particles prior to intravenous administration.
Slovenian: Parenteralne raztopine je treba pred intravenskim dajanjem vizualno pregledati za delce.
English: (combination therapy), which has not recovered by day 21 - Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
Slovenian: - Kakršni koli drugi neželeni učinki stopnje 3 ali 4 (kot je navzea, bruhanje, utrujenost)
English: Tell your doctor if you know or suspect that you have any liver, kidney or cardiac problems before starting the treatment with Yondelis.
Slovenian: Pred začetkom zdravljenja z zdravilom Yondelis zdravnika obvestite, če veste ali sumite, da imate težave z jetri, ledvicami ali srcem.
English: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Slovenian: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
English: Yondelis or its combination with PLD must not be used if you have severe liver, kidney or cardiac damage.
Slovenian: Zdravila Yondelis ali njegove kombinacije s PLD ne smete uporabljati, če imate resne okvare jeter,
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.
Slovenian: Na podlagi populacijske ocene plazemskega očistka trabektedina (30,9 l/h) in razmerje kri/plazma
English: Anaemia occurred in 93% and 94% of patients treated with the monotherapy and combination regimens respectively.
Slovenian: Anemija: Anemija se je pojavila pri 93 % bolnikov, zdravljenih z monoterapijo in pri 94 % bolnikov,
English: Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Slovenian: Ena škatla vsebuje 1 vialo s po 0,25 mg ali 1 mg trabektedina.
English: Neutropenic infection Sepsis
Slovenian: Infekcijske in parazitske bolezni nevtropenična okužba sepsa septični šok
English: The study primary endpoint was PFS, that showed a statistically significant improvement in favour of trabectedin over BSC [HR=0.07; 95% CI: 0.03-0.16; p<0.0001], with a median PFS in the trabectedin group of 5.6 months [95% CI: 4.1-7.5] and in the BSC group of 0.9 months [95% CI: 0.7-1.0].
Slovenian: Primarni opazovani dogodek študije je bilo preživetje brez napredovanja bolezni (PFS), ki je pokazalo statistično značilno izboljšanje v korist trabektedina v primerjavi z BSC [razmerje tveganj = 0,07; 95-odstotni IZ: 0,03-0,16; p < 0,0001] z medianim PFS 5,6 meseca [95-odstotni IZ: 4,1-7,5] v skupini s trabektedinom in 0,9 meseca v skupini z BSC [95-odstotni IZ: 0,7-1,0].
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.
Slovenian: Ob rekonstituciji in redčenju morajo vedno nositi zaščitna oblačila, vključno z masko, očali in rokavicami.
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.
Slovenian: 1.500 celic/mm3 in številom trombocitov manj kot 100.000 celic/mm3.
English: Based on independent oncology review, patients with platinum-free interval (PFI) < 6 months (35% in Yondelis+PLD and 37% in PLD arm) had similar PFS in the two arms with both showing median PFS of 3.7 months (HR=0.89, CI: 0.67-1.20).
Slovenian: Na podlagi neodvisne onkološke ocene so imeli bolniki s intervalom preživetja brez platine (platinumfree interval - PFI) < 6 mesecev (35 % pri zdravilu Yondelis+PLD in 37 % v kraku s PLD) podobno PBN v obeh krakih z medianim PBN 3,7 mesecev (RT = 0,89, IZ: 0,67-1,20).
English: Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes).
Slovenian: Pri uporabi trabektedina so poročali o primerih sindroma povečane prepustnosti kapilar (CLS) (vključno s primeri smrtnih izidov).
English: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Slovenian: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
English: For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.
Slovenian: Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte navodila za uporabo.
English: For the treatment of ovarian cancer, the usual dose is 1.1 mg/m2 body surface area after the administration of 30 mg/m2 body surface area of PLD.
Slovenian: Za zdravljenje karcinoma jajčnikov je običajni odmerek 1,1 mg/m2 površine telesa po apliciranju 30 mg/m2 PLD na površino telesa.
English: Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
Slovenian: Ena viala praška vsebuje 2 mg kalija in 0,1 g saharoze.
English: Trabectedin must not be used in patients with CPK > 2.5 x ULN (see section 4.2).
Slovenian: Rabdomioliza in resno povišanje ravni CPK (> 5 x ULN) Trabektedina ni dovoljeno uporabljati pri bolnikih s CPK > 2,5 ULN (glejte poglavje 4.2).
English: Patients who develop fever should promptly seek medical attention.
Slovenian: Pri bolnikih, pri katerih se razvije zvišana telesna temperature, je treba hitro ukrepati z ustreznimi zdravili.
English: Volume (ml) = BSA (m2) x individual dose (mg/m2)
Slovenian: Potreben volumen izračunajte kot sledi: Volumen (ml) = PT (m2) x individualni odmerek (mg/m2)
English: When Yondelis is used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Slovenian: Ko se zdravilo Yondelis uporablja v kombinaciji s PLD, je treba intravensko linijo dobro sprati s 50 mg/ml (5-odstotno) raztopino glukoze po infundiranju PLD in pred apliciranjem zdravila Yondelis.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mg trabectedin
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 mg trabektedina
English: The analysis per cycle performed in these patients showed thrombocytopenia of grade 3 and 4 in approximately 3% and < 1% of cycles respectively.
Slovenian: Analiza na cikel, opravljena pri teh bolnikih, je pokazala, da se je trombocitopenija stopnje 3 in 4 pojavila pri približno 3 % oz. < 1 % ciklov.
English: In the final analysis, the effect of the Yondelis+PLD combination vs. PLD alone on overall survival was more pronounced in patients with PFI ≥ 6 months (platinum-sensitive population: 27.0 vs. 24.1 months, HR=0.83, CI: 0.67-1.04) than in those with PFI < 6 months (platinum-resistant population: 14.2 vs. 12.4 months, HR=0.92, CI: 0.
Slovenian: na splošno preživetje bolj izrazit pri bolnikih s PFI ≥ 6 mesecev (populacija, občutljiva na platino: 27,0 v primerjavi s 24,1 mesecem, RT = 0,83, IZ: 0,67-1,04) kot pri PFI < 6 mesecev (populacija, rezistentna na platino: 14,2 v primerjavi z 12,4 meseci, RT = 0,92, IZ: 0,70-1,21).
English: When used in combination with PLD the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Slovenian: Ko se uporablja v kombinaciji s PLD, je treba intravensko linijo dobro sprati s 50 mg/ml (5-odstotno) raztopino glukoze po infundiranju PLD in pred apliciranjem zdravila Yondelis.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala z 1 mg trabektedina
English: To minimize the risk of PLD infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
Slovenian: hitrost začetnega odmerka ne sme biti višja kot 1 mg/minuto.
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed neutropenia of grade 3 and 4 in approximately 19% and 8% of cycles respectively.
Slovenian: Analiza na cikel, opravljena pri bolniki, zdravljenih z monoterapijo, je pokazala, da se je nevtropenija stopnje 3 in 4 pojavila pri približno 19 % oz. 8 % ciklov.
English: There may be blistering, peeling and darkening of the skin over the site.
Slovenian: Lahko pride do nastanka mehurjev, luščenja ali potemnitve kože na mestu injiciranja.
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).
Slovenian: 1-urnem obdobju infuzija PLD nadaljuje (glejte tudi povzetek glavnih značilnosti zdravila [SmPC] za PLD za posebne nasvete glede dajanja).
English: Concomitant administration of inhibitors of P-gp, e.g. cyclosporine and verapamil, may alter trabectedin distribution and/or elimination.
Slovenian: npr. ciklosporina in verapamila lahko spremenijo porazdelitev in/ali izločanje trabektedina.
English: Hyperbilirubinemia: Bilirubin peaks approximately a week after onset and resolves approximately two weeks after onset.
Slovenian: Bilirubin dosega najvišje vrednosti približno en teden po začetku in se vrne na izhodiščne vrednosti približno dva tedna po začetku.
English: It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery.
Slovenian: Lahko namreč pride do poškodb in odmiranja tkivnih celic okoli mesta injiciranja (nekroza tkiva), zaradi česar je lahko potreben kirurški poseg.
English: Reconstituted solution After reconstitution, chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Slovenian: Po rekonstituciji je kemična in fizikalna stabilnost dokazana za 30 ur pri temperaturi do 25 ºC.
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed anaemia of grade 3 and 4 in approximately 3% and 1% of cycles respectively.
Slovenian: Analiza na cikel, opravljena pri bolnikih, zdravljenih z režimom monoterapije, je pokazala anemijo stopnje 3 in 4 pri približno 3 % oz. 1 % ciklov.
English: Yondelis is a powder for concentrate for solution for infusion.
Slovenian: Zdravilo Yondelis je prašek za koncentrat za raztopino za infundiranje.
English: Patients must meet specific criteria on hepatic function parameters to start treatment with Yondelis.
Slovenian: Za začetek zdravljenja z zdravilom Yondelis morajo bolniki izpolniti določene pogoje v zvezi s parametri jetrnega delovanja.
English: The solution obtained has a concentration of 0.05 mg/ml and is for single-use only.
Slovenian: Koncentracija dobljene raztopine za enkratno uporabo je 0,05 mg/ml.
English: Adequate contraceptive precautions must be used by men in fertile age when receiving Yondelis and for 5 months following the end of treatment.
Slovenian: Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Yondelis in še 5 mesecev po njem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala z 0,25 mg trabektedina
English: Median PFS (95% CI) (months)
Slovenian: Mediano PBN (95 % IZ) (mesecev)
English: PLD Hazard/Odds ratio p-value Progression Free Survival
Slovenian: Trabektedin Dakarbazin Razmerje tveganj/razmerje obetov
English: If you get any of the previous described symptoms or signs, seek medical care immediately.
Slovenian: Če opazite katerega koli od opisanih simptomov ali znakov, nemudoma poiščite zdravniško pomoč.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 1 mg vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - 1 mg viala
English: - Platelet count ≥ 100,000/mm - Bilirubin ≤ upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 x ULN (consider hepatic isoenzymes 5-nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin).
Slovenian: - Absolutno število nevtrofilcev (ANC) ≥ 1.500/mm3 - Število trombocitov ≥ 100.000/mm - Bilirubin ≤ zgornja meja normale (ULN - „upper limit of normal“) - Alkalna fosfataza ≤ 2,5 x ULN (preučite jetrne izoencime 5-nukleotidazo ali gama-glutamil transpeptidazo (GGT), če je kost izvor povišanja).
English: - Increase of aminotransferases (AST or ALT) > 2.5 x ULN (monotherapy) or > 5 x ULN
Slovenian: - Zvišanje aminotransferaz (AST ali ALT) > 2,5 x ULN (monoterapija) ali > 5 x ULN (kombinirano zdravljenje), ki se ne vrnejo na izhodiščno vrednost do 21. dne
English: Adequate contraceptive precautions must be used by women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Yondelis in še 3 mesece po njem.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priprava intravenske infuzije
English: • bruise more easily
Slovenian: • hitro dobite modrice
English: Each vial of powder contains 1 mg of trabectedin.
Slovenian: Ena viala praška vsebuje 1 mg trabektedina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 0.25 mg vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla - 0,25 mg viala
English: Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.6).
Slovenian: Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 5 mesecev po njem (glejte poglavje 4.6).
English: In-use stability of the solutions
Slovenian: Stabilnost raztopine med uporabo
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.
Slovenian: Odpoved jeter: Pri bolnikih z resnimi osnovnimi boleznimi, ki so bili zdravljeni s trabektedinom, so tako v okviru kliničnih preizkušanj kot tudi v okviru izkušenj v obdobju trženja poročali o redkih primerih odpovedi jeter (vključno s primeri smrtnih izidov).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg trabectedin
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,25 mg trabektedina
English: Caution should be taken if medicinal products associated with hepatotoxicity are administered concomitantly with trabectedin, since the risk of hepatotoxicity may be increased.
Slovenian: Previdnost je potrebna, če se zdravila, povezana s hepatotoksičnostjo, dajejo hkrati s trabektedinom,
English: Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.4).
Slovenian: Moški v plodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 5 mesecev po njem (glejte poglavje 4.4).
English: How to store Yondelis
Slovenian: Shranjevanje zdravila Yondelis
English: This reconstituted solution contains 0.05 mg/ml of trabectedin.
Slovenian: Rekonstituirana raztopina vsebuje 0,05 mg/ml trabektedina.
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).
Slovenian: V okviru izkušenj v obdobju trženja je prišlo do preobčutljivostnih reakcij z zelo redkim nastopom smrtnega izida, o katerih so poročali v povezavi z dajanjem trabektedina samega ali v kombinaciji s
English: During your treatment with Yondelis you may feel tired and experience a loss of strength.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom Yondelis boste morda utrujeni in se počutili šibke.
English: • feel an excess of fluid in the body (oedema)
Slovenian: • imate bolečine v hrbtu in sklepih • imate preveč tekočine v telesu (edem)
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija trombocitopenija anemija levkopenija febrilna nevtropenija
English: Liver Function Test (LFT) abnormalities
Slovenian: Nenormalnosti testov delovanja jeter
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri do 1 od 100 bolnikov
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.
Slovenian: Skrbno spremljanje toksičnosti je potrebno pri bolnikih, ki prejemajo trabektedin v kombinaciji z močnimi zaviralci CYP3A4 (npr. peroralni ketokonazol,
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).
Slovenian: Sindrom povečane propustnosti kapilar (Capillary Leak Syndrome - CLS): Pri uporabi trabektedina so poročali o primerih sindroma povečane prepustnosti kapilar (CLS) (vključno s primeri smrtnih izidov)
English: Overall, 384 patients were randomized to the trabectedin group [1.5 mg/m once every 3 weeks (q3wk 24-h)] and
Slovenian: Skupno je bilo v skupino s trabektedinom randomiziranih 384 bolnikov [1,5 mg/m2 enkrat na 3 tedne (q3wk 24-h)], v skupino z dakarbazinom pa 193 bolnikov (1 g/m2 enkrat na 3 tedne).
English: Extravasation Soft tissue necrosis
Slovenian: reakcije na mestu injiciranja ekstravazacija nekroza mehkega tkiva
English: Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Slovenian: Yondelis 0,25 mg prašek za koncentrat za raztopino za infundiranje Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje
English: Pol. Ind. La Mina 28770 Colmenar Viejo (Madrid) Spain
Slovenian: La Mina 28770 Colmenar Viejo (Madrid) Španija
English: Vomiting Constipation Diarrhoea Stomatitis
Slovenian: Bolezni prebavil bolečine v trebuhu navzea bruhanje zaprtost driska stomatitis dispepsija
English: It followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Slovenian: Redko jo je spremljala zvišana telesna temperatura ali okužba.
English: 1 ml of reconstituted solution contains 0.05 mg of trabectedin.
Slovenian: 1 ml rekonstituirane raztopine vsebuje 0,05 mg trabektedina.
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).
Slovenian: Kombinacija s cepivom proti rumeni mrzlici pa je kontraindicirana (glejte poglavje 4.3).
English: If you get any of the above symptoms or signs, seek medical care immediately.
Slovenian: Če opazite katerega koli od navedenih simptomov ali znakov, nemudoma poiščite zdravniško pomoč.
English: However, fatigue and/or asthenia have been reported in patients receiving trabectedin.
Slovenian: Pri bolnikih, ki prejemajo trabektedin so poročali o utrujenosti in/ali splošni oslabelosti.
English: Each vial of powder contains 0.25 mg of trabectedin.
Slovenian: Ena viala praška vsebuje 0,25 mg trabektedina.