natgillin/translations-raw huggingface dataset:
Treatment with the combination arm resulted in a 21% risk reduction for disease progression compared to PLD alone (HR=0.79, CI: 0.65-0.96, p=0.0190).
Zdravljenje v kombiniranem kraku je pokazalo 21 % zmanjšanje tveganja za napredovanje bolezni v primerjavi s samo PLD (RT = 0,79, IZ: 0,65-0,96, p = 0,0190).
What Yondelis looks like and contents of the pack
Izgled zdravila Yondelis in vsebina pakiranja
The lesions may either dry out and desquamate, or blister with ulceration.
Lezije se lahko bodisi posušijo ali odluščijo, ali pa nastanejo mehurji z razjedami.
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.
V tem preskušanju so trabektedin odmerjali bodisi 1,5 mg/m2 kot 24-urno intravensko infuzijo vsake 3 tedne, bodisi po 0,58 mg/m2 tedensko kot 3-urno intravensko infuzijo v 3-tedenskih ali 4-tedenskih ciklih.
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.
Pokazalo se je, da deluje trabektedin antiproliferativno in vitro in in vivo pri številnih vrstah človeških tumornih celic in eksperimentalnih tumorjev, vključno z malignostmi, kot je sarkom, karcinom dojk, pljučni karcinom malih celic, karcinom na jajčnikih in melanom.
Skin hyperpigmentation*
izpuščaj alopecija hiperpigmentacija kože*
The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
Preprečite hkratno uporabo trabektedina z alkoholom (glejte poglavje 4.5).
• If you notice unexplained partial or general swelling (oedema), with possible lightheadedness, dizziness or thirst (low blood pressure).
• Če opazite delno ali splošno oteklino (edem) hkrati z morebitno omotičnostjo, vrtoglavico ali žejo (nizek krvni tlak).
Median OS (95% CI) (months)
Mediani OS (95 % IZ) (mesecev)
Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Preprečiti je treba sočasno dajanje zdravila Yondelis z močnimi inhibitorji encima CYP3A4 (glejte poglavje 4.5).
• You may experience, loss of water from the body, weight loss, digestive discomfort and a change in your sense of taste.
• Morda boste izgubljali vodo iz telesa, telesno maso, imeli težave s prebavo in spremenjen občutek za okus.
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.
Za zdravljenje sarkoma mehkega tkiva je priporočeni odmerek 1,5 mg/m2 površine telesa, apliciran kot intravenska infuzija v roku 24 ur s tritedenskimi presledki med cikli.
Trabectedin extravasation may cause tissue necrosis requiring debridement.
Ekstravazacija trabektedina lahko povzroči nekrozo tkiva, zaradi katere je potrebna njegova odstranitev.
Yondelis must not be used in patients with elevated bilirubin.
Zdravila Yondelis ni dovoljeno uporabljati pri bolnikih s povišano ravnjo bilirubina.
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,
Če prejemate zdravilo Yondelis ali kombinacijo zdravila Yondelis+PLD skupaj z zdravilom, ki lahko povzroči poškodbe jeter ali mišic (rabdomioliza), vas bo morda treba skrbno nadzirati, saj je tveganje poškodb jeter ali mišic večje.
- The active substance is trabectedin.
- Učinkovina je trabektedin.
Patients in the trabectedin arm were required to receive dexamethasone 20 mg intravenous injection prior to each trabectedin infusion.
Bolniki v kraku s trabektedinom so morali pred vsako infuzijo trabektedina prejeti intravensko injekcijo 20 mg deksametazona.
For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m2 of body surface area.
Za zdravljenje sarkoma mehkega tkiva je običajni odmerek 1,5 mg/m2 površine telesa.
Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy.
Zdravilo Yondelis se mora dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
It seems that plasma clearance and distribution volume of trabectedin are not influenced by age.
Kaže, da starost ne vpliva na plazemski očistek in porazdelitveni volumen trabektedina.
In the multivariate analyses including PFI, treatment effect on overall survival was statistically significant favouring the Yondelis+PLD combination over PLD alone (all randomised: p=0.0285; platinum-sensitive population: p=0.0319).
V multivariacijski analizi, ki je vključevala PFI, je bila učinkovitost zdravljenja na splošno preživetje značilno v prid kombinacije zdravila Yondelis+PLD v primerjavi s samostojno PLD (vse randomizirano: p = 0,0285; populacija, občutljiva na platino: p = 0,0319).
• Patients receiving Yondelis plus PLD for ovarian cancer may also have the hand and foot syndrome.
• Pri bolnicah, ki prejemajo zdravilo Yondelis in PLD za raka na jajčnikih, se lahko pojavi sindrom roke in noge.
Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Ugotovili so, da sta mielosupresija in hepatotoksičnost glavna toksična učinka trabektedina.
The following criteria are required to allow treatment with Yondelis:
Za odobritev zdravljenja z zdravilom Yondelis je treba izpolniti naslednje pogoje:
Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Zdravilo Yondelis v kombinaciji s pegiliranim liposomalnim doksorubicinom (PLD) je indicirano za zdravljenje bolnic, občutljivih na platino, s ponovljenim karcinomom jajčnikov.
Yondelis should not be used in children below 18 years of age with paediatric sarcomas.
Pri otrocih pod 18 let s pediatričnimi sarkomi zdravila Yondelis ne smemo uporabljati.
This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially “potassium-free”.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na vialo, kar v bistvu pomeni 'brez kalija'.
No data are available in patients with a creatinine clearance of less than 30.3 ml/min.
Pri bolnikih z očistkom kreatinina manj kot 30,3 ml/min, ni podatkov.
If you develop any of these symptoms you should seek medical attention immediately.
Če razvijete katerekoli od teh simptomov, morate nemudoma poiskati zdravniško pomoč.
Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of water for injections.
Vsaka viala, ki vsebuje 1 mg trabektedina, se rekonstituira z 20 ml vode za injekcije.
• You may experience an abnormal build-up of fluid in the lungs, which leads to swelling (pulmonary oedema).
• Pojavi se lahko kopičenje tekočine v pljučih, kar povzroči oteklost (pljučni edem).
Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Vsa neporabljena zdravila ali odpadni material je treba odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
If you get any of these symptoms or signs, tell your nurse or doctor immediately.
Če opazite katerega koli od teh simptomov ali znakov, o tem nemudoma obvestite medicinsko sestro ali zdravnika.
The reconstituted solution results in a clear, colourless or slightly yellowish solution, essentially free of visible particles.
Rekonstituirana raztopina postane bistra, brezbarvna in nekoliko rumenkasta, praviloma brez vidnih delcev.
Palpitations* Left ventricular dysfunction*
Srčne bolezni palpitacije* disfunkcija levega prekata*
Log rank test b Fisher's test
Test log rank b
• You may feel severe muscle aches and pain, stiffness and muscle weakness.
• Morda boste občutili resne bolečine v mišicah (mialgija), otrdelost in slabotnost mišic.
Advice on conservation of ovules or sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Yondelis.
Pred zdravljenjem se je treba posvetovati o konzervaciji jajčec ali sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
Anti-emetic prophylaxis with corticosteroids such as dexamethasone must be administered to all patients (see section 4.2).
Vsi bolniki morajo prejemati antiemetično profilakso s kortikosteroidi, kot je na primer deksametazon (glejte poglavje 4.2).
Similarly, the co-administration of trabectedin with potent inducers of CPY3A4 may increase the metabolic clearance of trabectedin.
Podobno lahko hkratno dajanje trabektedina in močnih spodbujevalcev CYP3A4 poveča presnovni očistek trabektedina.
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.
ET743-OVA-301, randomizirani študiji 3. faze 3 s 672 bolniki, ki so prejemali bodisi trabektedin (1,1 mg/m2) in PLD (30 mg/m2) vsake 3 tedne ali PLD (50 mg/m2) vsake 4 tedne.
Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za trabektedin je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Discard any unused product or waste material in accordance with local requirements.
Neuporabljen ali odpadni material odstranite v skladu z lokalnimi predpisi.
Secondary analyses of PFS and response rate also favoured the combination arm.
Tudi sekundarne analize PBN in stopnje odzivnosti so v prid kraku s kombinirano terapijo.
How to use Yondelis
Kako uporabljati zdravilo Yondelis
• You may also have blood infections (sepsis) if your immune system is greatly compromised.
• Če je vaš imunski sistem močno ogrožen, imate morda okužbo krvi (sepso).
Yondelis must be reconstituted and further diluted prior to intravenous infusion.
Zdravilo Yondelis je treba rekonstituirati in nato še razredčiti pred intravensko infuzijo.
The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion may cause precipitation of PLD.
Uporaba drugih redčil kot 50 mg/ml (5-odstotna) raztopina glukoze za infundiranje lahko povzroči obarjanje PLD.
Yondelis contains the active substance trabectedin.
Zdravilo Yondelis vsebuje učinkovino trabektedin.
Each vial containing 0.25 mg of trabectedin is reconstituted with 5 ml of water for injections.
Vsaka viala, ki vsebuje 0,25 mg trabektedina, se rekonstituira s 5 ml vode za injekcije.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
Patients should seek advice on ovules or sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Bolniki se naj pred zdravljenjem posvetujejo o konzervaciji jajčec ali sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
- The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for pH-adjustment) and potassium hydroxide (for pH-adjustment).
- Pomožne snovi so saharoza, kalijev dihidrogenfosfat, fosforna kislina (za prilagoditev pH) in kalijev hidroksid (za prilagoditev pH).
Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.
Zdravilo Yondelis je indicirano za zdravljenje odraslih bolnikov z napredovalim sarkomom mehkega tkiva, po neuspešnem zdravljenju z antraciklini in ifosfamidom, ali pri bolnikih, pri katerih uporaba teh zdravil ni primerna.
The percentages of patients anaemic at baseline were 46% and 35% respectively.
Odstotek slabokrvnih bolnikov ob izhodišču je bil 46 % oziroma
The median survival by histology tumour type was 16.2 months [95% CI: 14.1, 19.5] for subjects with leiomyosarcomas and liposarcomas and 8.4 months [95% CI: 7.1, 10.7] for subjects with other types of sarcomas.
Mediana preživetja glede na histološko vrsto tumorja je bila 16,2 meseca [95-odstotni IZ: 14,1; 19,5] za osebe z leiomiosarkomi in liposarkomi ter 8,4 meseca [95-odstotni IZ: 7,1; 10,7] za osebe z drugimi vrstami sarkomov.
Dizziness Dysgeusia Peripheral sensory neuropathy Syncope*
Psihiatrične motnje nespečnost Bolezni živčevja glavobol vrtoglavica disgevzija periferna senzorična nevropatija sinkopa*
• You could also experience dizziness, low blood pressure and flushing or skin rash.
• Lahko se pojavi vrtoglavica, nizek krvni tlak in oblivanje ali kožni izpuščaj.
• increased (examples are medicines containing ketoconazole or fluconazole (for fungal infections), ritonavir (for human immunodeficiency virus [HIV] infection), clarithromycin (for bacterial infections), aprepitant (to prevent nausea and vomiting), ciclosporin (inhibit the defensive system of the body) or verapamil (for high blood pressure and heart conditions)).
ritonavir (za okužbe z virusom humane imunske pomanjkljivosti [HIV]), klaritromicin (za bakterijske okužbe), aprepitant (za preprečevanje slabosti in bruhanja), ciklosporin (zavira obrambni sistem telesa) ali verapamil (za visok pritisk in bolezni srca)).
The final analysis showed no significant difference with a median survival follow-up of 21.2 months resulted in a median of 13.7 months (95% CI: 12.2, 16.0) for the trabectedin arm and 13.1 months [95% CI: 9.1, 16.2] for the dacarbazine arm.
Končna analiza ni pokazala značilne razlike, pri čemer je spremljanje medianega preživetja v obdobju 21,2 meseca pokazalo mediano preživetje 13,7 meseca (95-odstotni IZ: 12,2, 16,0) za krak s trabektedinom in 13,1 meseca [95-odstotni IZ: 9,1, 16,2] za krak z dakarbazinom.
Instructions for reconstitution
Navodila za rekonstituiranje
Women of childbearing potential must use effective contraception during treatment and 3 months thereafter, and immediately inform the treating physician if a pregnancy occurs (see section 5.3).
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 3 mesece po njem ter nemudoma obvestiti zdravnika, če nastopi nosečnost (glejte poglavje 5.3).
• You may present some digestive symptoms such as loss of appetite, sick (nausea) or vomit, pain in the abdomen, diarrhoea or constipation.
• Pojavijo se lahko prebavni simptomi, kot so izguba teka, slabost (navzea) ali bruhanje, bolečina v trebuhu, driska ali zaprtost.
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.
Pogosto so nastali kot posledica kombinacije dogodkov, ki so vključevali pancitopenijo, febrilno nevtropenijo, nekateri med njimi so dobili sepso, jetrne zaplete,
Intravenous administration through a central venous line is strongly recommended (see sections 4.4 and 6.6).
Močno se priporoča intravensko dajanje zdravila skozi centralno vensko linijo (glejte poglavji 4.4 in
The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion for this line flushing may cause precipitation of PLD (see also PLD Summary of Product Characteristics for specific handling instructions).
Uporaba drugih redčil za omenjeno spiranje intravenske linije razen 50 mg/ml (5-odstotne) raztopine glukoze za infundiranje lahko povzroči obarjanje PLD (glejte tudi povzetek glavnih značilnosti zdravila PLD za posebna navodila za ravnanje z zdravilom).
These findings were secondary to severe local reaction at the administration site, and therefore uncertainly attributable to trabectedin; however, caution must be guaranteed in the interpretation of these renal findings, and treatment-related toxicity cannot be excluded.
Ti izsledki so bili sekundarni po resnih lokalnih reakcijah na mestu odmerjanja, zato jih ni možno z gotovostjo pripisati trabektedinu.
Yondelis 0.25 mg: Inject 5 ml of sterile water for injections into the vial.
Yondelis 0,25 mg: Injicirajte 5 ml sterilne vode za injekcije v viale.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/417/001
Grades 3 or 4 neutropenia and thrombocytopenia associated with Yondelis therapy have been very commonly reported.
Zelo pogosto so poročali o nevtropeniji in trombocitopeniji stopnje 3 ali 4, povezani s terapijo z zdravilom Yondelis.
Both adverse reactions and laboratory values have been used to provide frequencies.
Za navedbo pogostosti so uporabljeni neželeni učinki in laboratorijske vrednosti.
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.
To bi lahko povzročilo poškodovanje in smrt tkivnih celic okoli mesta injiciranja (nekroza tkiva, glejte tudi poglavje 4), zaradi katere bo morda potrebna operacija.
Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 1mg of trabectedin.
Viala iz brezbarvnega stekla tipa I z zamaškom iz butilne gume, pokritim z aluminijastim tesnilom tipa „flip-off“, ki vsebuje 1 mg trabektedina.
The infusion is given to you every 3 weeks, although occasionally your doctor may recommend dose delays to ensure that you receive the most appropriate dose of Yondelis.
Infuzijo boste prejeli vsake 3 tedne, vendar pa lahko vaš zdravnik včasih odmerek prestavi in zagotovi,
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).
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,
Yondelis 1 mg: Inject 20 ml of sterile water for injections into the vial.
Yondelis 1 mg: Injicirajte 20 ml sterilne vode za injekcije v viale.
• If you notice that Yondelis infusion leaks out of your vein while you are being given it.
• Če opazite, da infuzija z zdravilom Yondelis med dajanjem izteka iz vaše vene.
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).
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).
Yondelis is given to you under the supervision of a physician experienced in the use of chemotherapy.
Zdravilo Yondelis se daje pod nadzorom zdravnika, ki ima izkušnje s kemoterapijo.
Yondelis 0.25 mg: Each vial of powder contains 0.25 mg of trabectedin.
Yondelis 0,25 mg: Vsaka viala s praškom vsebuje 0,25 mg trabektedina.
Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin.
Viala iz brezbarvnega stekla tipa I z zamaškom iz butilne gume, pokritim z aluminijastim tesnilom tipa „flip-off“, ki vsebuje 0,25 mg trabektedina.
Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
Ena viala praška vsebuje 8 mg kalija in 0,4 g saharoze.
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.
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 %).
Palmar-plantar erythrodysaesthesia syndrome*
Bolezni kože in podkožja sindrom palmarnoplantarne eritrodisestez ije*
• 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).
• 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,
MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/417/002
Fatal adverse reactions have occurred in 1.9% and 0.9% of patients treated with the monotherapy and combination regimens respectively.
Neželeni učinki so bili smrtni pri 1,9 % bolnikov, zdravljenih z monoterapijo, in 0,9 % bolnikov, zdravljenih s kombinirano terapijo.
Appropriate aseptic techniques must be used to prepare the infusion solution (see Instructions for reconstitution and for dilution).
Pri pripravi raztopine za infundiranje (glejte Navodila za rekonstitucijo in redčenje zdravila) uporabljajte ustrezne aseptične tehnike.
If you have fever you should seek medical attention immediately.
Če imate zvišano telesno temperaturo, morate nemudoma poiskati zdravniško pomoč
Yondelis 1 mg: Each vial of powder contains 1 mg of trabectedin.
Yondelis 1 mg: Vsaka viala s praškom vsebuje 1 mg trabektedina.
Inspect the parenteral solution visually for particles prior to intravenous administration.
Parenteralne raztopine je treba pred intravenskim dajanjem vizualno pregledati za delce.
(combination therapy), which has not recovered by day 21 - Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
- Kakršni koli drugi neželeni učinki stopnje 3 ali 4 (kot je navzea, bruhanje, utrujenost)
Tell your doctor if you know or suspect that you have any liver, kidney or cardiac problems before starting the treatment with Yondelis.
Pred začetkom zdravljenja z zdravilom Yondelis zdravnika obvestite, če veste ali sumite, da imate težave z jetri, ledvicami ali srcem.
de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
Yondelis or its combination with PLD must not be used if you have severe liver, kidney or cardiac damage.
Zdravila Yondelis ali njegove kombinacije s PLD ne smete uporabljati, če imate resne okvare jeter,
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.
Na podlagi populacijske ocene plazemskega očistka trabektedina (30,9 l/h) in razmerje kri/plazma
Anaemia occurred in 93% and 94% of patients treated with the monotherapy and combination regimens respectively.
Anemija: Anemija se je pojavila pri 93 % bolnikov, zdravljenih z monoterapijo in pri 94 % bolnikov,
Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Ena škatla vsebuje 1 vialo s po 0,25 mg ali 1 mg trabektedina.
Neutropenic infection Sepsis
Infekcijske in parazitske bolezni nevtropenična okužba sepsa septični šok