natgillin/translations-raw huggingface dataset:
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.
Pri hkratnem dajanju ketokonazola in trabektedina se je plazemska izpostavljenost trabektedinu povečala približno za 21 % za Cmax, za območje pod krivuljo (AUC) pa za 66 %, vendar niso ugotovili novih pomislekov glede varnosti.
The plasma trabectedin levels attained were 10.6 ± 5.4 (Cmax), higher than those reached in patients after infusion of 1,500 µg/m2 for 24 (Cmax of 1.8 ± 1.1 ng/ml) and similar to those reached after administration of the same dose by 3 hour infusion (Cmax of 10.8 ± 3.7 ng/ml).
Dobljene ravni trabektedina v plazmi so bile 10,6 ± 5,4 (Cmax), višje, kot so jih dosegli pri bolnikih po infuziji 1.500 µg/m2 za 24 (Cmax 1,8 ± 1,1 ng/ml), in podobni tistim, doseženim po apliciranju istega odmerka v 3-urni infuziji (Cmax 10,8 ± 3,7 ng/ml).
Other medicines and Yondelis
Druga zdravila in zdravilo Yondelis
Table 1 Dose modification table for Yondelis (as single agent for soft tissue sarcoma (STS) or in combination for ovarian cancer) and PLD
Tabela 1 Tabela prilagoditve odmerka za zdravilo Yondelis (kot samostojno zdravilo za sarkom mehkega tkiva (STS) ali v kombinaciji za karcinom jajčnikov) in PLD
Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove.
Trabektedin se veže na manjše žlebe deoksiribonukleinske kisline (DNK), ob čemer spiralo zavije k velikemu žlebu.
Bleeding events associated to thrombocytopenia occurred in < 1% of patients treated with the monotherapy regimen.
Krvavitev, povezana s trombocitopenijo, se je pojavila pri < 1 % bolnikov, zdravljenih z monoterapijo.
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 (HR)=0.734, Confidence Interval (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 (RT) = 0,734, interval zaupanja (IZ) 0,554-0,974].
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.
Za bolnike japonskega porekla je priporočeni odmerek manjši od običajnega odmerka za vse ostale rase, in sicer je 1,2 mg na m2 površine telesa.
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.
Sindrom povečane propustnosti kapilar (CLS) se pojavi redko, zanj pa so značilni ponavljajoči se in nepredvideni napadi kapilarnega uhajanja plazemske tekočine in beljakovin prek endotelija.
Alcohol consumption must be avoided during treatment with Yondelis as this may harm the liver.
Med zdravljenjem z zdravilom Yondelis ne smete uživati alkohola, saj lahko to poškoduje jetra.
Therefore, the concomitant use of trabectedin with strong CYP3A4 inducers (e.g., rifampicin, phenobarbital, Saint John's Wort) should be avoided if possible (see section 4.4).
Torej se je treba hkratni uporabi trabektedina z močnimi spodbujevalci CYP3A4 (npr. rifampicin, fenobarbital, šentjanževka) izogniti, če je to mogoče (glejte poglavje 4.4).
Independent radiology review, all randomised n=337
Neodvisna radiološka ocena, vse randomizirano n = 337
In the Yondelis+PLD arm, non-white (mainly Asian) patients had a higher incidence than white patients in grade 3 or 4 adverse reactions (96% versus 87%), and serious adverse reactions (44% versus 23% all grades).
V kraku z zdravilom Yondelis+PLD je bila pri ne-belih (pretežno azijski) bolnikih višja incidenca neželenih učinkov 3. ali stopnje 4 kot pri belih bolnikih (96 % v primerjavi s 87 %) in hudih neželenih učinkov (44 % v primerjavi s 23 % vse stopnje).
No data are available comparing Yondelis+PLD to a platinum-based regimen in platinum-sensitive patients.
Podatki o primerjavi zdravila Yondelis+PLD z režimom na podlagi platine pri bolnikih, občutljivih na platino, niso na voljo.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Podatki o učinkovitosti temeljijo pretežno na bolnikih z liposarkomom in leiomiosarkomom.
The most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increase in AST/ALT, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea.
Najpogostejši neželeni učinki katere koli stopnje resnosti so bili nevtropenija, navzea, bruhanje, povišanje AST/ALT, anemija, utrujenost, trombocitopenija, anoreksija in diareja.
Additional efficacy data are available from a randomized active-controlled phase III study of trabectedin vs. dacarbazine (Study ET743-SAR-3007), in patients treated for unresectable or metastatic lipo- or leiomyosarcoma who have been previously treated with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and one additional cytotoxic chemotherapy regimen.
Dodatni podatki o učinkovitosti so na voljo iz randomizirane, z aktivnim zdravilom kontrolirane študije faze III, v kateri so primerjali trabektedin in dakarbazin (študija ET743-SAR-3007) pri bolnikih, zdravljenih zaradi neoperabilnega ali metastatskega liposarkoma ali leiomiosarkoma, ki so bili predhodno zdravljeni vsaj z režimom, ki je vključeval antraciklin in ifosfamid, ali z režimom, ki je vključeval antraciklin, in enim dodatnim režimom citotoksične kemoterapije.
Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Med zdravljenjem s trabektedinom se je treba izogniti uživanju alkohola zaradi hepatotoksičnosti zdravila (glejte poglavje 4.4).
Chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Kemijska in fizikalna stabilnost je bila dokazana za 30 ur pri temperaturi do 25 ºC.
During the treatment period, your doctor will carefully monitor you and decide the most appropriate dosage of
V času zdravljenja vas bo zdravnik skrbno nadziral in določil najbolj ustrezni odmerek zdravila Yondelis za vas.
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.
Priporoča se posebna previdnost in morda bo pri bolnikih z motenim delovanjem jeter potrebna prilagoditev odmerka, saj se sistemska izpostavljenost trabektedinu poveča, s čimer verjetno naraste tudi tveganje hepatotoksičnosti.
If severe neutropenia (ANC < 500 cells/mm3) lasting more than 5 days or associated with fever or infection occurs, dose reduction is recommended (see section 4.2).
(ANC < 500 celic/mm3), kit raja več kot 5 dni ali je povezana z zvišano telesno temperature ali okužbo, se priporoča zmanjšanje odmerka (glejte poglavje 4.2).
Blood creatinine increased Blood albumin decreased
Preiskave zvišan kreatin v krvi znižan albumin v krvi zmanjšanje telesne mase
Capillary Leak Syndrome (CLS)
Sindrom povečane propustnosti kapilar (Capillary Leak Syndrome - CLS)
Findings observed included haematopoietic toxicity (severe leukopenia, anaemia, and lymphoid and bone marrow depletion) as well as increases in liver function tests, hepatocellular degeneration, intestinal epithelial necrosis, and severe local reactions at the injection site.
Opaženi izsledki vključujejo hematopoetsko toksičnost (resna levkopenija, anemija in izginjanje limfnega ter kostnega mozga), kot tudi povišane vrednosti jetrnih testov, hepatocelularno degeneracijo, nekrozo črevesnega epitelija ter številne lokalne reakcije na mestu injiciranja.
Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying.
Zdravilo Yondelis je zdravilo proti raku, ki deluje tako, da preprečuje razmnoževanje celic tumorja.
A 1 hour infusion schedule was selected to attain maximum plasma levels (Cmax values) in the range of those observed in the clinic.
Za določitev najvišjih plazemskih koncentracij Cmax) je bil izbran 1-uren infuzijski režim, med tistimi, ki so bili opazovani v kliniki.
The following safety profile of Yondelis is based on adverse reactions reported in clinical trials, postauthorisation safety studies and spontaneous reporting.
Tabelarični povzetek neželenih učinkov Profil varnosti zdravila Yondelis temelji na neželenih učinkih, o katerih so poročali v kliničnih preskušanjih, študijah varnosti v obdobju trženja in iz spontanega poročanja.
ORR (95% CI) (%)
ORR (95 % IZ) (%)
The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity.
Glavni pričakovani toksični učinki so gastrointestinalni, supresija kostnega mozga in toksičnost za jetra.
Yondelis in combination with pegylated liposomal doxorubicin (PLD: another anti-cancer medicine) is used for the treatment of patients with ovarian cancer that has come back after at least 1 previous therapy and are not resistant to anti-cancer medicines containing platinum compounds.
Zdravilo Yondelis v kombinaciji s pegiliranim liposomalnim doksorubicinom (PLD: drugo zdravilo proti raku) se uporablja za zdravljenje bolnic s karcinomom jajčnika, ki se je po vsaj 1 predhodnem zdravljenju ponovil, in ki niso občutljive na zdravila proti raku, ki vsebujejo spojine platine.
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.
Liver function tests should be monitored during treatment with Yondelis as dose adjustments may be indicated (see Table 1 and section 4.4).
Med zdravljenjem z zdravilom Yondelis je treba izvajati teste delovanja jeter, saj bo morda treba odmerek prilagoditi(glejte tabelo 1 in poglavje 4.4).
• decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John's Wort (Hypericum perforatum, an herbal medicine for depression)) or
• zmanjšajo (primeri so zdravila, ki vsebujejo rifampicin (za bakterijske okužbe), fenobarbital (za epilepsijo) ali šentjanževko (Hypericum perforatum, zdravilo rastlinskega izvora za depresijo)) ali,
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.
Učinkovitost in varnost trabektedina pri sarkomu mehkega tkiva 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.
- Albumin ≥ 25 g/l - Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN - Creatinine clearance ≥ 30 ml/min (monotherapy), serum creatinine ≤ 1.5 mg/dl (≤ 132.6 μmol/l)
- Albumin ≥ 25 g/l - Alanin aminotransferaza (ALT) in aspartat aminotransferaza (AST) ≤ 2,5 x ULN - Očistek kreatinina ≥ 30 ml/min (monoterapija), kreatinin v serumu ≤ 1,5 mg/dl (≤ 132,6 μ mol/l)
Parenteral solutions should be inspected visually for particles prior to administration.
Parenteralne raztopine je treba pred dajanjem vizualno pregledati za delce.
• You may experience yellowing of your skin and eyeballs (jaundice), pain in the upper right area of your abdomen, nausea, vomiting, a general sense of not feeling well, difficulty in concentrating, disorientation or confusion, sleepiness.
• Morda boste imeli porumenelo kožo in očesni zrkli (zlatenica), bolečino v zgornjem desnem predelu trebuha, slabost, bruhanje, splošno slabo počutje, težave s koncentracijo, dezorientacijo ali zmedenost ali zaspanost.
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 %).
Patients with elevated serum bilirubin levels must not be treated with trabectedin (see section 4.2).
Bolnikov s povišano osnovno ravnjo serumskega bilirubina ni dovoljeno zdraviti s trabektedinom (glejte poglavje 4.2).
Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/or renal or multiorgan failure.
rabdomiolizi poročajo redko, običajno v povezavi z mielotoksičnostjo, resnimi nenormalnostmi testov delovanja jeter in/ali odpovedjo ledvic ali več organov.
Patients in the trabectedin and dacarbazine arms received a median of 4 and 2 cycles respectively.
Bolniki v kraku s trabektedinom oziroma dakarbazinom so prejeli mediano 4 oziroma 2 cikla zdravljenja.
The requirements for submission of periodic safety update reports of this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
No incompatibilities have been observed between Yondelis and type I glass bottles, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs and titanium implantable vascular access systems.
Med zdravilom Yondelis in stekleničkami iz stekla tipa I, polivinilkloridnimi (PVC) ter polietilenskimi (PE) vrečkami in cevkami, poliizoprenskimi vsebniki ter titanijevimi vsadljivimi žilnimi dostopnimi sistemi niso opazili inkompatibilnosti.
In this case you may experience one or more of the following signs: fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting; see section 4).
V tem primeru boste morda imeli enega ali več od naslednjih znakov: vročina, težave z dihanjem, rdečica ali vročinski oblivi ali izpuščaj, občutek slabosti (navzea) ali bruhanje (glejte poglavje 4).
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.
Ker se trabektedin presnavlja predvsem s CYP3A4, bodo plazemske koncentracije trabektedina verjetno povečane pri bolnikih, ki hkrati dobivajo zdravila, ki lahko zavirajo delovanje tega izoencima.
Concomitant use of trabectedin with phenytoin may reduce phenytoin absorption leading to an exacerbation of convulsions.
Hkratna uporaba trabektedina s fenitoinom lahko zmanjša absorpcijo fenitoina, kar povzroči poslabšanje epileptičnih napadov.
Capillary leak syndrome (CLS) is usually characterized by peripheral oedema, hypotension which is relatively well tolerated, oliguria with acute pre-renal failure.
Za sindrom povečane propustnosti kapilar (CLS) so običajno značilni periferni edem, hipotenzija, ki jo bolnik sorazmerno dobro prenaša, oligurija z akutno ledvično odpovedjo.
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.
There is limited data on the effects of trabectedin overdose.
Podatki o učinkih prevelikega odmerka trabektedina so omejeni.
The table below displays the adverse reactions reported in patients with soft tissue sarcoma and ovarian cancer that were treated with Yondelis recommended regimen in each indication..
Preglednica v nadaljevanju prikazuje neželene učinke, o katerih so poročali pri bolnikih s sarkomom mehkega tkiva in karcinomom jajčnikov, ki so bili zdravljeni z zdravilom Yondelis s priporočenim režimom za vsako indikacijo.
For the treatment of ovarian cancer Yondelis is administered every three weeks as a 3-hour infusion at a dose of 1.1 mg/m2, immediately after PLD 30 mg/m2.
Za zdravljenje karcinoma jajčnikov se zdravilo Yondelis daje vsake tri tedne v obliki 3-urne infuzije z odmerkom 1,1 mg/m2, takoj po PLD 30 mg/m2.
Results from an expanded access program for patients with STS (study ET743-SAR- 3002) show that among the 903 subjects assessed for OS, the median survival time was 11.9 months (95% CI: 11.2, 13.8).
Rezultati programa razširjenega dostopa pri bolnikih s sarkomom mehkega tkiva (študija ET743-SAR3002) kažejo, da je med 903 bolniki, pri katerih je bila ocenjena splošna stopnja preživetja, mediana preživetja 11,9 meseca (95-odstotni IZ: 11,2; 13,8).
Yondelis should not be used during pregnancy.
Nosečnost Zdravilo Yondelis se v nosečnosti ne sme uporabljati.
Overall survival in platinum-sensitive population (Final analysis n=316 events) n=218
Splošno preživetje v populaciji, občutljivi na platino (končna analiza n = 316 dogodkov)
Yondelis is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised during handling.
Zdravilo Yondelis je citotoksično zdravilo proti raku, zato je treba z njim, kot z drugimi potencialno toksičnimi snovmi, ravnati previdno.
Yondelis is used for the treatment of patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful or the patients are unsuited to receive them.
Zdravilo Yondelis se uporablja za zdravljenje bolnikov z napredovalim sarkomom mehkega tkiva, če prejšnja zdravila niso učinkovala, ali če za bolnika njihova uporaba ni primerna.
Rare: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri do 1 od 1.000 bolnikov
Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Vsebuje tudi: saharozo, kalijev dihidrogenfosfat, fosforno kislino in kalijev hidroksid.
Duration of the response was 6.5 months No responses were observed for Ewing sarcoma and NRSTS, [RR: 0% CI95% (0%-30.9%)].
Za sarkom Ewing in NRSTS ni bilo opaziti nobenega odziva [RR: 0 % pri IZ 95 % (0 %-30,9 %)].
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 diferencialno 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).
Patients with elevated serum bilirubin levels at baseline must not be treated with Yondelis.
Bolnikov s povišano izhodiščno ravnjo serumskega bilirubina ni dovoljeno zdraviti z zdravilom Yondelis.
All the previously described, could be a sign of damage to your muscles (rhabdomyolysis).
Vse opisano je lahko znak poškodb mišic (rabdomioliza).
Yondelis with alcohol
Zdravilo Yondelis skupaj z alkoholom
Volume (ml) = BSA (m2) x individual dose (mg/m2) 0.05 mg/ml
Volumen (ml) = PT (m2) x individualen odmerek (mg/m2) 0,05 mg/ml
The effect of hepatic impairment on the pharmacokinetics of trabectedin was assessed in 15 cancer patients at doses ranging from 0.58 to 1.3 mg/m2 administered as 3-hour infusion.
Učinek okvare jeter na farmakokinetiko trabektedina je bil ocenjen pri 15 rakavih bolnikih z odmerki od 0,58 do 1,3 mg/m2, apliciranimi kot triurna infuzija.
Appropriate procedures for proper handling and disposal of cytotoxic medicines must be followed.
Upoštevati je treba postopke za pravilno ravnanje in odstranjevanje citotoksičnih zdravil.
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.
Analiza farmakokinetike na populaciji je pokazala, da se je očistek trabektedina v plazmi pri apliciranju v kombinaciji s PLD zmanjšal za 31 %; sočasna uporaba trabektedina ni vplivala na farmakokinetiko PLD v plazmi.
See the PLD SmPC for more detailed information on PLD dose adjustments.
Glejte povzetek glavnih značilnosti zdravila PLD za podrobnejše informacije o prilagoditvi odmerka PLD.
Median OS with the 24-h q3wk regimen was 13.9 months (CI: 12.5-18.6) and 60.2% of patients were alive at 1 year (CI: 52.0-68.5%).
Mediana stopnja preživetja v režimu 24-h q3wk je bila 13,9 mesecev (IZ: 12,5-18,6) in 60,2% bolnikov je preživelo 1 leto (IZ: 52,0-68,5%).
The primary efficacy endpoint of the study was OS, which included 381 death events (66% of all randomized patients): 258 (67.2%) deaths in the trabectedin group and 123 (63.7%) deaths in the dacarbazine group (HR 0.927 [95% CI: 0.748, 1.150; p=0.4920]).
Primarni opazovani dogodek učinkovitosti v študiji je bilo celokupno preživetje, ki je vključevalo 381 smrtnih dogodkov (66 % vseh randomiziranih bolnikov): 258 smrti (67,2 %) v skupini s trabektedinom in 123 smrti (63,7 %) v skupini z dakarbazinom (HR 0,927 [95-odstotni IZ: 0,748, 1,150; p = 0,4920]).
- 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
- Nevtropenija < 500/mm3, ki traja več kot 5 dni ali jo spremlja zvišana telesna temperatura ali okužba - Trombocitopenija < 25.000/mm3 - Zvišan bilirubin > ULN in/ali alkalna fosfataza > 2,5 x ULN
The effects of trabectedin on cardiovascular and respiratory function have been investigated in vivo (anesthetised Cynomolgus monkeys).
Učinki trabektedina na kardiovaskularne in dihalne funkcije so bili preiskani in vivo (opice
Yondelis monotherapy and combination regimens must not be used in patients with creatinine clearance < 30 ml/min and < 60 ml/min respectively (see section 4.2).
Monoterapija zdravila Yondelis in kombinirani režim pri bolnikih z očistkom kreatinina < 30 ml/min oziroma < 60 ml/min nista dovoljena (glejte poglavje 4.2).
The PR corresponded to a patient with an alveolar rhabdomyosarcoma.
PR se je pojavil pri bolniku z alveolarnim rabdomiosarkomom.
or creatinine clearance ≥ 60 ml/min (combination therapy) - Creatine phosphokinase (CPK) ≤ 2.5 x ULN - Haemoglobin ≥ 9 g/dl
ali očistek kreatinina ≥ 60 ml/min (kombinirano zdravljenje) - Kreatin fosfokinaza (CPK) ≤ 2,5 x ULN - Hemoglobin ≥ 9 g/dl
Yondelis infusion may leak out of your vein while you are being given it, leading to damage and death of your tissue cells around the injection site (tissue necrosis, see also section 2 “Warnings and precautions”) which may require surgery.
Infuzija zdravila Yondelis lahko med dajanjem izteka iz vaše vene, kar lahko povzroči poškodovanje in smrt tkivnih celic okoli mesta injiciranja (nekroza tkiva, glejte tudi poglavje 2 „Opozorila in previdnostni ukrepi“), zaradi katere bo morda potrebna operacija.
Adverse reactions, included reversible elevation of liver enzymes and haematological events; in addition, fever, infection, dehydration and thrombosis/embolism were also reported.
Neželeni učinki so bili med drugim reverzibilno zvišanje jetrnih encimov in hematološki neželeni učinki; poleg tega so poročali o zvišani telesni temperaturi, okužbi, dehidraciji in trombozi/emboliji.
Furthermore, you could feel like your heart is beating too hard or too fast in your chest (palpitations), have a weakness in the ventricles, the heart's major pumping chambers (left ventricular dysfunction), or a sudden blockage in a lung artery (pulmonary embolism).
Morda boste v prsnem košu začutili tudi premočno ali prehitro bitje srca (palpitacije), ali se bo pojavila oslabelost prekatov, ki so glavne črpalne komore srca (disfunkcija levega prekata), ali nenadna blokada pljučne arterije (pljučni embolizem).