natgillin/translations-raw huggingface dataset:
Considering the pharmacokinetic characteristics of trabectedin (see section 5.2), no dose adjustments are warranted in patients with mild or moderate renal impairment.
Ob upoštevanju farmakokinetičnih lastnosti trabektedina (glejte poglavje 5. 2) prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro delovanja ledvic ni utemeljena.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila pred apliciranjem glejte poglavje 6. 6.
- Hypersensitivity to trabectedin or to any of the excipients
- Preobčutljivost na trabektedin ali katerokoli pomožno snov
- Concurrent serious or uncontrolled infection
- Hkratna resna ali nenadzirana okužba
- Breast-feeding (see section 4.6)
- Dojenje (glejte poglavje 4. 6)
- Combination with yellow fever vaccine (see section 4.4)
- Kombinacija z zdravili proti rumeni mrzlici (glejte poglavje 4. 4)
Patients with elevated bilirubin must not be treated with trabectedin (see section 4.2).
Bolnikov s povišano ravnjo bilirubina ni dovoljeno zdraviti s trabektedinom (glejte poglavje 4. 2).
Trabectedin must not be used in patients with creatinine clearance < 30 ml/ min (see section 4.2).
Uporaba trabektedina pri bolnikih z očistkom kreatinina < 30 ml/ min ni dovoljena (glejte poglavje 4. 2).
Grades 3 or 4 neutropenia and thrombocytopenia associated with trabectedin therapy have been very commonly reported.
Zelo pogosto so poročali o nevtropeniji in trombocitopeniji stopnje 3 ali 4, povezani s terapijo s trabektedinom.
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).
Število celic v polni krvi, vključno z dieferencialno krvno sliko in številom trombocitov, je treba izvesti pred začetkom zdravljenja, vsak teden prva dva cikla in nato enkrat med cikli (glejte poglavje 4. 2).
Anti-emetic prophylaxis with dexamethasone must be administered to all patients (see section 4.2).
Vsi bolniki morajo prejemati antiemetično profilakso z deksametazonom (glejte poglavje 4. 2).
Rhabdomyolysis and severe CPK elevations (> 10 x ULN)
Rabdomioliza in resno povišanje ravni CPK (> 10 x ULN)
Trabectedin must not be used in patients with CPK > 2.5 ULN (see section 4.2).
Trabektedina ni dovoljeno uporabljati pri bolnikih s CPK > 2, 5 ULN (glejte poglavje 4. 2).
Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/ or renal failure.
O rabdomiolizi poročajo redko, običajno v povezavi z mielotoksičnostjo, resnimi nenormalnostmi testov
4 parenteral hydration, urine alkalinisation and dialysis should be promptly established, as indicated.
Zato je treba CPK skrbno nadzirati vedno, ko se pri bolniku pojavi kateri koli od teh toksičnih učinkov.
Caution should be taken if medicinal products associated with rhabdomyolysis (e. g. statins), are administered concomitantly with trabectedin, since the risk of rhabdomyolysis may be increased
Previdnost je potrebna pri dajanju zdravil, povezanimi z rabdomiolizo (npr. statini), hkrati s trabektedinom, saj se lahko poveča tveganje za rabdomiolizo.
Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
Pri večini bolnikov poročajo o reverzibilnem akutnem povečanju aspartat- aminotransferaze (AST) in alanin- aminotransferaze (ALT).
Patients with increases in AST, ALT and alkaline phosphatase between cycles may necessitate dose reduction (see section 4.2).
Pri bolnikih s povečanjem AST, ALT in alkalne fosfataze med cikli je morda potrebno zmanjšati odmerek (glejte poglavje 4. 2).
The use of central venous access is strongly recommended (see section 4.2).
Močno se priporoča uporaba centralnega venskega dostopa (glejte poglavje 4. 2).
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).
Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see sections 4.3 and 4.5).
Kombinacija s cepivom proti rumeni mrzlici pa je kontraindicirana (glejte poglavji 4. 3 in 4. 5).
The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
Preprečite hkratno uporabo trabektedina z alkoholom (glejte poglavje 4. 5).
Men in fertile age and women of childbearing potential must use effective contraception during treatment and 3 months thereafter for women and immediately inform the treating physician if a pregnancy occurs, and 5 months after treatment for men (see section 4.6).
Moški naj zaščito uporabljajo še 5 mesecev po zdravljenju (glejte poglavje 4. 6).
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 “.
In vivo interaction studies have not been performed.
Študij medsebojnega delovanja in vivo niso izvajali.
Since trabectedin is metabolised mainly by CYP3A4, co-administration of substances that inhibit this isoenzyme e. g. ketoconazole, fluconazole ritonavir or clarithromycin could decrease metabolism and increase trabectedin concentrations.
Ker trabektedin presnavlja predvsem z CYP3A4, lahko hkratno dajanje učinkovin, ki zavirajo ta izoencim, npr. ketokonazol, flukonazol, ritonavir ali klaritromicin zmanjša presnovo in poveča koncentracijo trabektedina.
If such combinations are needed, close monitoring of toxicities is required (see section 4.4).
Če je taka kombinacija potrebna, je treba uvesti skrbno nadziranje toksičnosti (glejte poglavje 4. 4).
Likewise co-administration with potent inducers of this enzyme (e. g. rifampicin, phenorbarbital, Saint John’ s Wort) may decrease the systemic exposure to trabectedin.
Tudi hkratno dajanje močnih induktorjev tega encima (npr. rifampicin, fenorbarbital, šentjanževka) lahko zmanjša sistemsko izpostavljenost trabektedinu.
Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Med zdravljenje s trabektedinom se je treba izogniti uživanju alkohola zaradi hepatotoksičnosti zdravila (glejte poglavje 4. 4).
Concomitant administration of inhibitors of Pgp, e. g. cyclosporine and verapamil, may alter trabectedin distribution and/ or 5 elimination.
5 Predklinični podatki so pokazali, da je trabektedin substrat za P- gp.
The relevance of this interaction e. g.
Hkratno dajanje zaviralcev Pgp, npr. ciklosporina in verapamila lahko spremenijo porazdelitev in/ ali izločanje trabektedina.
CNS toxicity has not been established.
Pomembnosti tega medsebojnega delovanja, npr. toksičnosti za CNS, niso ugotavljali.
Trabectedin should not be used during pregnancy unless clearly necessary.
Trabektedina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus (see section 5.3) and be monitored carefully.
Nosečnice, ki uporabljajo trabektedin, je treba obvestiti o potencialnem tveganju za plod (glejte poglavje 5. 3) in jih skrbno nadzirati.
Men in fertile age and women of childbearing potential must use effective contraception during treatment and 3 months thereafter for women and immediately inform the treating physician if a pregnancy occurs (see section 5.3) and 5 months after treatment for men (see section 4.4).
Moški naj zaščito uporabljajo še 5 mesecev po zdravljenju (glejte poglavje 4. 4).
Advice on conservation of 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 sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
If pregnancy occurs during treatment the possibility of genetic counselling should be considered.
Če se nosečnost pojavi med zdravljenje, je treba razmisliti o možnosti genskega svetovanja.
It is not known whether trabectedin is excreted in human milk.
Ni znano, ali se trabektedin izloča v materino mleko pri človeku.
Breast-feeding is contraindicated during treatment and 3 months thereafter (see section 4.3).
Med zdravljenjem in 3 mesece po njem je dojenje kontraindicirano (glejte poglavje 4. 3).
However, fatigue and/ or asthenia have been reported in patients receiving trabectedin.
Pri bolnikih, ki prejemajo trabektedin so poročali o utrujenosti in/ ali splošni oslabelosti.
Patients who experience any of these events during therapy must not drive or operate machines.
Bolniki, ki izkusijo katere koli od teh neželenih učinkov med terapijo, naj ne vozijo in ne upravljajo strojev.
Unless otherwise specified, the following safety profile of Yondelis is based on the evaluation in clinical trials of 569 patients treated up to April 2007 with the recommended treatment regime in several cancer types including soft tissue sarcoma, breast cancer, osteosarcoma, ovarian cancer, GIST, melanoma and renal carcinoma.
Razen če je drugače navedeno, temelji profil varnosti za zdravilo Yondelis v nadaljevanju na ocenitvi kliničnih preskušanj na 569 bolnikih, zdravljenih do aprila 2007 s priporočenim režimom zdravljenja pri različnih vrstah raka vključno s sarkomom mehkega tkiva, karcinomom dojk, osteosarkomom, karcinomom jajčnikov, GIST, melanomom in karcinomom ledvic.
Approximately 91% of patients can be expected to have adverse reactions of any grade.
Pričakuje se, da bo neželene učinke katere koli stopnje imelo približno 91% bolnikov.
Around 40% of patients are expected to have adverse reactions of grade 3 or 4 severity.
Pričakuje se, da bo imelo okoli 40% bolnikov neželene učinke resnosti stopnje 3 ali 4.
The most common adverse reactions of any severity grade were nausea, fatigue, vomiting, anorexia, neutropenia, and increases in AST/ ALT.
Najpogostejši neželeni učinki katere koli stopnje resnosti so bili navzea, utrujenost, bruhanje, anoreksija, nevtropenija in povišanje AST/ ALT.
Fatal adverse reactions have occurred in 1.9% of patients.
Pri 1, 9% bolnikov so bili neželeni učinki smrtni.
They were often the result of a combination of events including pancytopenia, febrile neutropenia, some of them with sepsis, hepatic involvement, renal failure and rhabdomyolysis.
Pogosto so nastali kot posledica kombinacije dogodkov, ki so vključevali pancitopenijo, febrilno nevtropenijo, nekateri med njimi so dobili sepso, jetrne zaplete, odpoved ledvic in rabdomiolizo.
The frequencies of the adverse reactions reported below are classified as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1000 to < 1/ 100).
6 V nadaljevanju navedeni neželeni učinki so razvrščeni kot zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 to < 1/ 10) in občasni (≥ 1/ 1. 000 to < 1/ 100).
6 The table below displays the adverse reactions reported in ≥ 1% of patients according to the standard MedDRA system organ class.
Preglednica v nadaljevanju prikazuje neželene učinke, o katerih so poročali pri ≥ 1% bolnikov, v skladu z organskimi sistemi po MedDRA.
Both adverse events and laboratory values have been used to provide frequencies.
Za navedbo pogostosti so uporabljeni neželeni učinki in laboratorijske vrednosti.
7 System Organ Class Investigations
7 Organski sistem
Adverse reactions reported in ≥ 1% of patients in clinical trials at the recommended regime [1.5 mg/ m2, 24 hour infusion every 3 weeks (24-h q3wk)] Very Common Blood creatine phosphokinase increased, Blood creatinine increased, Blood albumin decreased Common Weight decreased
Neželeni učinki, poročani pri ≥ 1% bolnikov v kliničnih preskušanjih po priporočenem režimu [1, 5 mg/ m2, 24- urna infuzija vsake 3 tedne (24- h q3wk)]
Very Common Neutropenia, Thrombocytopenia, Anaemia, Leukopenia Common Febrile neutropenia
Zelo pogosti Nevtropenija, trombocitopenija, anemija, levkopenija Pogosti Febrilna nevtropenija
Very Common Headache Common Peripheral sensory neuropathy, Dysgeusia, Dizziness, Paraesthesia
Zelo pogosti Glavobol Pogosti Periferna senzorična nevropatija, disgevzija, vrtoglavica, parestezija
Common Dyspnoea, Cough
Pogosti Dispneja, kašelj
Very Common Vomiting, Nausea, Constipation Common Diarrhoea, Stomatitis, Abdominal pain, Dyspepsia, Upper abdominal pain
Zelo pogosti Bruhanje, navzea, zaprtost Pogosti Diareja, stomatitis, bolečine v trebuhu, dispepsija, bolečine v zgornjem delu trebuha
Common Alopecia
Pogosti Alopecija
Common Myalgia, Arthralgia, Back pain
Pogosti Mialgija, artralgija, bolečine v hrbtu
Metabolism and
Infekcijske in
Nutrition DisordersAnorexia Common Dehydration, Decreased appetite, Hypokalaemia Infections and Infestations Vascular Disorders
parazitske bolezni Okužba Žilne bolezni
Common Infection Common Hypotension, Flushing
Pogosti Hipotenzija, oblivanje
General Disorders Very Common and Administration Fatigue, Asthenia Site Conditions
Splošne težave in spremembe na mestu aplikacije
Common Pyrexia, Oedema, Oedema peripheral, Injection site reaction
Zelo pogosti Utrujenost, astenija Pogosti Pireksija, edem, periferni edem, reakcije na mestu injiciranja
Very Common Hyperbilirubinemia, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Gamma-glutamyltransferase increased
Zelo pogosti Hiperbilirubinemija, povečanje alanin aminotransferaze, povečanje aspartat aminotransferaze, povečanje alkalne fosfataze v krvi, povečanje gama - glutamiltransferaze
Common Insomnia
Pogosti Nespečnost
8 Most frequent adverse reactions
8 Najpogostejši neželeni učinki
Blood and Lymphatic system disorders
Bolezni krvi in limfatičnega sistema
Neutropenia occurred in 77% of patients.
Nevtropenija se je pojavila pri 77% bolnikov.
Grade 3 and 4 neutropenia occurred in 26% and 24% of patients respectively).
24% bolnikov.
The analysis per cycle showed that neutropenia of grade 3 and 4 occurred in approximately 19% and 8% of cycles respectively Febrile neutropenia occurred in 2% of patients and in < 1% of cycles.
8% ciklov, febrilna nevtropenija se je pojavila pri 2% bolnikov in < 1% ciklov.
Neutropenia followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Redko jo je spremljala zvišana telesna temperatura ali okužba.
Grade 3 and 4 thrombocytopenia occurred in 11% and 2% of patients respectively.
2% bolnikov.
The analysis per cycle showed that thrombocytopenia of grade 3 and 4 occurred in approximately 3% and < 1% of cycles respectively.
Analiza na cikel je pokazala, da se je trombocitopenija stopnje 3 in 4 pojavila pri približno 3% oz. < 1% ciklov.
Bleeding events associated to thrombocytopenia occurred in < 1% of patients.
Krvavitev, povezana s trombocitopenijo, se je pojavila pri < 1% bolnikov.
Anaemia occurred in 93% of patients although 46% of patients were anaemic at baseline.
Anemija se je pojavila pri 93% bolnikov, vendar je bilo 46% bolnikov slabokrvnih že pred začetkom zdravljenja.
Grade 3 and 4 anaemia occurred in 10% and 3% of patients respectively.
3% bolnikov.
The analysis per cycle showed that anaemia of grade 3 and 4 occurred in approximately 3% and 1% of cycles respectively.
1% ciklov.
AST/ ALT increases:
Povišan AST/ ALT:
Transient grade 3 increases of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were observed in 38% and 44% of the patients and grade 4 elevations in 3% and 7% of the patients, respectively.
7% bolnikov.
Most of the values had decreased to grade 1 or resolved by day 14-15 (see section 4.4).
Večina vrednosti je padla na stopnjo 1 ali se je 14- 15 dan vrnila na izhodiščno vrednost (glejte poglavje 4. 4).
Grade 3 elevations of AST and ALT occurred in 12% and 20% of cycles respectively.
20% ciklov.
Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively.
2% ciklov.
Most transaminase elevations improved to grade 1 or to pre-retreatment levels within 15 days, and less than 2% of cycles had recovering times longer than 25 days.
Večina povečanj transaminaze se je popravila na raven stopnje 1 ali tisto pred ponovnim apliciranjem v roku 15 dni in manj kot 2% ciklov je imela čase do vrnitve na izhodiščne vrednosti daljše od 25 dni.
Grades 1 to 2 bilirubin increases were observed in 23% of the patients.
Pri 23% bolnikov so opazili porast bilirubina stopnje 1 do 2.
Grade 3 hyperbilirubinemia occurred in 1% of patients.
Pri 1% bolnikov se je pojavila hiperbilirubinemija stopnje 3.
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.
Klinične manifestacije resnih poškodb jeter so bile občasne z incidenco individualnih znakov pod 1% in simptomi, ki so vključevali zlatenico, hepatomegalijo ali bolečine jeter.
Mortality in the presence of hepatic injury occurred in less than 1% of patients.
Smrtnost v prisotnosti poškodb jeter se je pojavila pri manj kot 1% bolnikov.
Nausea, vomiting, diarrhoea and constipation:
Navzea, bruhanje, diareja in zaprtost:
Nausea and vomiting were reported in 63 and 38.5% of patients respectively.
O navzei in bruhanju so poročali pri 63 oz.
Grade 3-4 nausea and vomiting were reported in 6% and 6.5% of patients, respectively.
6, 5% bolnikov.
Grade 3-4 diarrhoea and constipation were reported in less than 1% of patients.
O diareji in zaprtosti stopnje 3- 4 so poročali pri manj kot 1% bolnikov.
Grade 3-4 mucositis was reported in less than 1% of the patients.
O mukozitisu stopnje 3- 4 so poročali pri manj kot 1% bolnikov.
Fatigue/ Asthenia:
Utrujenost/ astenija:
Grade 3-4 fatigue/ asthenia occurred in 9 and 1% of patients respectively.
Utrujenost/ astenija stopnje 3- 4 se je pojavila pri 9 oz.
Grade 3-4 anorexia occurred in less than 1% of the patients.
1% bolnikov.
CPK elevations and rhabdomyolysis:
Zvišanje CPK in rabdomioliza:
CPK elevations of any grade were observed in 26% of patients.
Pri 26% bolnikov so opazili zvišanje CPK katerekoli stopnje.
Grade 3 or 4 increases of CPK were observed in 4% of patients.
Pri 4% bolnikov so opazili zvišanje CPK stopnje 3 ali 4.
CPK increases in association with rhabdomyolysis were reported in less than 1% of patients.
O zvišanju CPK v povezavi z rabdomiolizo so poročali pri manj kot 1% bolnikov.
9 Dyspnoea:
9 Alopecija:
Alopecia was reported in approximately 3% of all patients, of which the majority was grade 1 alopecia.
O alopeciji so poročali pri približno 3% vseh bolnikov, pri čemer je pri večini šlo za alopecijo stopnje 1.
Antineoplastic agent, ATC code:
Antineoplastična učinkovina, koda ATC:
Trabectedin binds to the minor groove of DNA, bending the helix to the major groove.
Trabektedin se veže na manjše žlebe DNK, ob čemer spiralo zavije k velikemu žlebu.
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.
The efficacy and safety of trabectedin is based in a randomised trial in patients with locally advanced or metastatic liposarcoma or leiomyosarcoma, whose disease had progressed or relapsed after treatment with at least anthracyclines and ifosfamide.
Učinkovitost in varnost trabektedina temelji na randomiziranem preskušanju pri bolnikih z lokalno napredovalim ali ponovljenim liposarkomom ali leiomiosarkomom, pri katerih je bolezen napredovala ali se ponovila po zdravljenju z vsaj antraciklini in ifosfamidi.
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.
The protocol specified final time to progression (TTP) analysis showed a 26.6% reduction in the relative risk of progression for patients treated in the 24-h q3wk group (Hazard Ratio = 0.734 CI 0.554-0.974).
Po protokolu določen končni čas do napredovanja (TTP - "time to progression") je pokazal 26, 6% zmanjšanje relativnega tveganja napredovanja za bolnike, zdravljene v skupini 24- h q3wk (razmerje tveganja = 0, 734 CI 0, 554- 0, 974).
Median TTP values were 3.7 months (CI:
Mediane vrednosti TTP so bile 3, 7 meseca (CI:
2.1-5.4 m) in the 24-h q3wk group and 2.3 months (CI:
2, 1- 5, 4 m) v skupini 24- h q3wk in 2, 3 meseca (CI:
2.0-3.5 m) in the 3-h qwk group (p=0.0302).
2, 0- 3, 5 m) v skupini 3- h qwk (p=0. 0302).
Median OS with the 24-h q3wk regime was 13.9 months (CI:
Mediana stopnja preživetja v režimu 24- h q3wk je bila 13, 9 mesecev (CI:
12.5-18.6) and 60.2% of patients were alive at 1 year (CI:
12, 5- 18, 6) in 60, 2% bolnikov je preživelo 1 leto (CI:
Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regime.
Dodatni podatki o učinkovitosti so na voljo v obliki 3 preskušanj faze II z enim krakom, v katerih je bila zdravljena podobna populacija bolnikov z istim režimom.
These trials evaluated a total of 100 patients with lipo and leiomyosarcoma and 83 patients with other types of sarcoma.
V teh preskušanjih je bilo ocenjenih skupaj 100 bolnikov z liposarkomom in leiomiosarkomom in 83 bolnikov z drugimi vrstami sarkoma.
10 Systemic exposure after administration as a 24 hour constant rate intravenous infusion is dose proportional at doses up to and including 1.8 mg/ m2.
Sistemska izpostavljenost po odmerjanju v obliki 24- urne intravenske infuzije stalne hitrosti je odmerek, sorazmeren z odmerki do vključno 1, 8 mg/ m2.
Following intravenous administration, trabectedin demonstrates a high apparent volume of distribution, consistent with extensive tissue and plasma protein binding (94 to 98% of trabectedin in plasma is protein bound).
10 Po intravneskem dajanju kaže trabektedin velik navidezni volumen porazdelitve, v skladu z obsežno vezavo v tkiva in na beljakovine plazme (94 do 98% trabektedina v plazmi je vezanega na beljakovine).
The distribution volume at steady state of trabectedin in human subjects exceeds 5000 l.
Porazdelitveni volumen trabektedina v stanju dinamičnega ravnovesja pri ljudeh presega 5. 000 l.
Renal elimination of unchanged trabectedin in humans is low (less than 1%).
Izločanje nespremenjenega trabektedina skozi ledvice je pri ljudeh nizko (manj kot 1%).
The terminal half-life is long (population value of the terminal elimination phase:
Končna razpolovna doba je dolga (populacijska vrednost končne faze izločanja je:
180-hr).
180 ur).
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%).
Po odmerku radioaktivno označenega trabektedina, apliciranega rakavim bolnikom, je srednja vrednost skupne radioaktivnosti v blatu 58% (17%) in srednja vrednost skupne radioaktivnosti v urinu 5, 8% (1, 73%).
Based on the population estimate for plasma clearance of trabectedin (31.5 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 (31, 5 l/ h) in razmerje kri/ plazma (0, 89) je očistek trabektedina v polni krvi približno 35 l/ h.
The inter-patient variability of the population estimate for plasma clearance of trabectedin was 51% and intra-patient variability was 28%.
Variabilnost ocene očistka trabektedina v plazmi med bolniki v isti populaciji je bila 51% in variabilnost pri bolniku 28%.