FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Appropriate procedures for proper handling and disposal of cytotoxic medicines must be followed.
Slovenian: Upoštevati je treba postopke za pravilno ravnanje in odstranjevanje citotoksičnih zdravil.
English: A population pharmacokinetic analysis showed that when administered in combination with PLD, the plasma clearance of trabectedin was decreased by 31%; the plasma pharmacokinetics of PLD were not influenced by the concomitant administration of trabectedin.
Slovenian: 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.
English: See the PLD SmPC for more detailed information on PLD dose adjustments.
Slovenian: Glejte povzetek glavnih značilnosti zdravila PLD za podrobnejše informacije o prilagoditvi odmerka PLD.
English: 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%).
Slovenian: 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%).
English: 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]).
Slovenian: 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]).
English: - Neutropenia < 500/mm3 lasting for more than 5 days or associated with fever or infection - Thrombocytopenia < 25,000/mm3 - Increase of bilirubin > ULN and/or alkaline phosphatase > 2.5 x ULN
Slovenian: - 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
English: The effects of trabectedin on cardiovascular and respiratory function have been investigated in vivo (anesthetised Cynomolgus monkeys).
Slovenian: Učinki trabektedina na kardiovaskularne in dihalne funkcije so bili preiskani in vivo (opice
English: 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).
Slovenian: Monoterapija zdravila Yondelis in kombinirani režim pri bolnikih z očistkom kreatinina < 30 ml/min oziroma < 60 ml/min nista dovoljena (glejte poglavje 4.2).
English: The PR corresponded to a patient with an alveolar rhabdomyosarcoma.
Slovenian: PR se je pojavil pri bolniku z alveolarnim rabdomiosarkomom.
English: or creatinine clearance ≥ 60 ml/min (combination therapy) - Creatine phosphokinase (CPK) ≤ 2.5 x ULN - Haemoglobin ≥ 9 g/dl
Slovenian: ali očistek kreatinina ≥ 60 ml/min (kombinirano zdravljenje) - Kreatin fosfokinaza (CPK) ≤ 2,5 x ULN - Hemoglobin ≥ 9 g/dl
English: 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.
Slovenian: 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.
English: Adverse reactions, included reversible elevation of liver enzymes and haematological events; in addition, fever, infection, dehydration and thrombosis/embolism were also reported.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: What Yondelis looks like and contents of the pack
Slovenian: Izgled zdravila Yondelis in vsebina pakiranja
English: The lesions may either dry out and desquamate, or blister with ulceration.
Slovenian: Lezije se lahko bodisi posušijo ali odluščijo, ali pa nastanejo mehurji z razjedami.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Skin hyperpigmentation*
Slovenian: izpuščaj alopecija hiperpigmentacija kože*
English: The concomitant use of trabectedin with alcohol must be avoided (see section 4.5).
Slovenian: Preprečite hkratno uporabo trabektedina z alkoholom (glejte poglavje 4.5).
English: • If you notice unexplained partial or general swelling (oedema), with possible lightheadedness, dizziness or thirst (low blood pressure).
Slovenian: • Če opazite delno ali splošno oteklino (edem) hkrati z morebitno omotičnostjo, vrtoglavico ali žejo (nizek krvni tlak).
English: Median OS (95% CI) (months)
Slovenian: Mediani OS (95 % IZ) (mesecev)
English: Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Slovenian: Preprečiti je treba sočasno dajanje zdravila Yondelis z močnimi inhibitorji encima CYP3A4 (glejte poglavje 4.5).
English: • You may experience, loss of water from the body, weight loss, digestive discomfort and a change in your sense of taste.
Slovenian: • Morda boste izgubljali vodo iz telesa, telesno maso, imeli težave s prebavo in spremenjen občutek za okus.
English: 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.
Slovenian: 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.
English: Trabectedin extravasation may cause tissue necrosis requiring debridement.
Slovenian: Ekstravazacija trabektedina lahko povzroči nekrozo tkiva, zaradi katere je potrebna njegova odstranitev.
English: Yondelis must not be used in patients with elevated bilirubin.
Slovenian: Zdravila Yondelis ni dovoljeno uporabljati pri bolnikih s povišano ravnjo bilirubina.
English: 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,
Slovenian: 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.
English: - The active substance is trabectedin.
Slovenian: - Učinkovina je trabektedin.
English: Patients in the trabectedin arm were required to receive dexamethasone 20 mg intravenous injection prior to each trabectedin infusion.
Slovenian: Bolniki v kraku s trabektedinom so morali pred vsako infuzijo trabektedina prejeti intravensko injekcijo 20 mg deksametazona.
English: For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m2 of body surface area.
Slovenian: Za zdravljenje sarkoma mehkega tkiva je običajni odmerek 1,5 mg/m2 površine telesa.
English: Yondelis must be administered under the supervision of a physician experienced in the use of chemotherapy.
Slovenian: Zdravilo Yondelis se mora dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
English: It seems that plasma clearance and distribution volume of trabectedin are not influenced by age.
Slovenian: Kaže, da starost ne vpliva na plazemski očistek in porazdelitveni volumen trabektedina.
English: 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).
Slovenian: 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).
English: • Patients receiving Yondelis plus PLD for ovarian cancer may also have the hand and foot syndrome.
Slovenian: • Pri bolnicah, ki prejemajo zdravilo Yondelis in PLD za raka na jajčnikih, se lahko pojavi sindrom roke in noge.
English: Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Slovenian: Ugotovili so, da sta mielosupresija in hepatotoksičnost glavna toksična učinka trabektedina.
English: The following criteria are required to allow treatment with Yondelis:
Slovenian: Za odobritev zdravljenja z zdravilom Yondelis je treba izpolniti naslednje pogoje:
English: Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Slovenian: Zdravilo Yondelis v kombinaciji s pegiliranim liposomalnim doksorubicinom (PLD) je indicirano za zdravljenje bolnic, občutljivih na platino, s ponovljenim karcinomom jajčnikov.
English: Yondelis should not be used in children below 18 years of age with paediatric sarcomas.
Slovenian: Pri otrocih pod 18 let s pediatričnimi sarkomi zdravila Yondelis ne smemo uporabljati.
English: This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially “potassium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na vialo, kar v bistvu pomeni 'brez kalija'.
English: No data are available in patients with a creatinine clearance of less than 30.3 ml/min.
Slovenian: Pri bolnikih z očistkom kreatinina manj kot 30,3 ml/min, ni podatkov.
English: If you develop any of these symptoms you should seek medical attention immediately.
Slovenian: Če razvijete katerekoli od teh simptomov, morate nemudoma poiskati zdravniško pomoč.
English: Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of water for injections.
Slovenian: Vsaka viala, ki vsebuje 1 mg trabektedina, se rekonstituira z 20 ml vode za injekcije.
English: • You may experience an abnormal build-up of fluid in the lungs, which leads to swelling (pulmonary oedema).
Slovenian: • Pojavi se lahko kopičenje tekočine v pljučih, kar povzroči oteklost (pljučni edem).
English: Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Slovenian: Vsa neporabljena zdravila ali odpadni material je treba odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila.
English: If you get any of these symptoms or signs, tell your nurse or doctor immediately.
Slovenian: Če opazite katerega koli od teh simptomov ali znakov, o tem nemudoma obvestite medicinsko sestro ali zdravnika.
English: The reconstituted solution results in a clear, colourless or slightly yellowish solution, essentially free of visible particles.
Slovenian: Rekonstituirana raztopina postane bistra, brezbarvna in nekoliko rumenkasta, praviloma brez vidnih delcev.
English: Palpitations* Left ventricular dysfunction*
Slovenian: Srčne bolezni palpitacije* disfunkcija levega prekata*
English: Log rank test b Fisher's test
Slovenian: Test log rank b
English: • You may feel severe muscle aches and pain, stiffness and muscle weakness.
Slovenian: • Morda boste občutili resne bolečine v mišicah (mialgija), otrdelost in slabotnost mišic.
English: 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.
Slovenian: Pred zdravljenjem se je treba posvetovati o konzervaciji jajčec ali sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
English: Anti-emetic prophylaxis with corticosteroids such as dexamethasone must be administered to all patients (see section 4.2).
Slovenian: Vsi bolniki morajo prejemati antiemetično profilakso s kortikosteroidi, kot je na primer deksametazon (glejte poglavje 4.2).
English: Similarly, the co-administration of trabectedin with potent inducers of CPY3A4 may increase the metabolic clearance of trabectedin.
Slovenian: Podobno lahko hkratno dajanje trabektedina in močnih spodbujevalcev CYP3A4 poveča presnovni očistek trabektedina.
English: The efficacy of Yondelis/PLD combination in relapsed ovarian cancer is based on ET743-OVA-301, a randomized phase 3 study of 672 patients who received either trabectedin (1.1 mg/m2) and PLD (30 mg/m2) every 3 weeks or PLD (50 mg/m2) every 4 weeks.
Slovenian: 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.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Slovenian: 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:
English: Discard any unused product or waste material in accordance with local requirements.
Slovenian: Neuporabljen ali odpadni material odstranite v skladu z lokalnimi predpisi.
English: Secondary analyses of PFS and response rate also favoured the combination arm.
Slovenian: Tudi sekundarne analize PBN in stopnje odzivnosti so v prid kraku s kombinirano terapijo.
English: How to use Yondelis
Slovenian: Kako uporabljati zdravilo Yondelis
English: • You may also have blood infections (sepsis) if your immune system is greatly compromised.
Slovenian: • Če je vaš imunski sistem močno ogrožen, imate morda okužbo krvi (sepso).
English: Yondelis must be reconstituted and further diluted prior to intravenous infusion.
Slovenian: Zdravilo Yondelis je treba rekonstituirati in nato še razredčiti pred intravensko infuzijo.
English: The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion may cause precipitation of PLD.
Slovenian: Uporaba drugih redčil kot 50 mg/ml (5-odstotna) raztopina glukoze za infundiranje lahko povzroči obarjanje PLD.
English: Yondelis contains the active substance trabectedin.
Slovenian: Zdravilo Yondelis vsebuje učinkovino trabektedin.
English: Each vial containing 0.25 mg of trabectedin is reconstituted with 5 ml of water for injections.
Slovenian: Vsaka viala, ki vsebuje 0,25 mg trabektedina, se rekonstituira s 5 ml vode za injekcije.
English: 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.
Slovenian: ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: Patients should seek advice on ovules or sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Slovenian: Bolniki se naj pred zdravljenjem posvetujejo o konzervaciji jajčec ali sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
English: - The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for pH-adjustment) and potassium hydroxide (for pH-adjustment).
Slovenian: - Pomožne snovi so saharoza, kalijev dihidrogenfosfat, fosforna kislina (za prilagoditev pH) in kalijev hidroksid (za prilagoditev pH).
English: 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.
Slovenian: 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.
English: The percentages of patients anaemic at baseline were 46% and 35% respectively.
Slovenian: Odstotek slabokrvnih bolnikov ob izhodišču je bil 46 % oziroma
English: 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.
Slovenian: 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.
English: Dizziness Dysgeusia Peripheral sensory neuropathy Syncope*
Slovenian: Psihiatrične motnje nespečnost Bolezni živčevja glavobol vrtoglavica disgevzija periferna senzorična nevropatija sinkopa*
English: • You could also experience dizziness, low blood pressure and flushing or skin rash.
Slovenian: • Lahko se pojavi vrtoglavica, nizek krvni tlak in oblivanje ali kožni izpuščaj.
English: • 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)).
Slovenian: 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)).
English: 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.
Slovenian: 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.
English: Instructions for reconstitution
Slovenian: Navodila za rekonstituiranje
English: 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).
Slovenian: 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).
English: • You may present some digestive symptoms such as loss of appetite, sick (nausea) or vomit, pain in the abdomen, diarrhoea or constipation.
Slovenian: • Pojavijo se lahko prebavni simptomi, kot so izguba teka, slabost (navzea) ali bruhanje, bolečina v trebuhu, driska ali zaprtost.
English: 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.
Slovenian: Pogosto so nastali kot posledica kombinacije dogodkov, ki so vključevali pancitopenijo, febrilno nevtropenijo, nekateri med njimi so dobili sepso, jetrne zaplete,
English: Intravenous administration through a central venous line is strongly recommended (see sections 4.4 and 6.6).
Slovenian: Močno se priporoča intravensko dajanje zdravila skozi centralno vensko linijo (glejte poglavji 4.4 in
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Ti izsledki so bili sekundarni po resnih lokalnih reakcijah na mestu odmerjanja, zato jih ni možno z gotovostjo pripisati trabektedinu.
English: Yondelis 0.25 mg: Inject 5 ml of sterile water for injections into the vial.
Slovenian: Yondelis 0,25 mg: Injicirajte 5 ml sterilne vode za injekcije v viale.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/417/001
English: Grades 3 or 4 neutropenia and thrombocytopenia associated with Yondelis therapy have been very commonly reported.
Slovenian: Zelo pogosto so poročali o nevtropeniji in trombocitopeniji stopnje 3 ali 4, povezani s terapijo z zdravilom Yondelis.
English: Both adverse reactions and laboratory values have been used to provide frequencies.
Slovenian: Za navedbo pogostosti so uporabljeni neželeni učinki in laboratorijske vrednosti.
English: 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.
Slovenian: To bi lahko povzročilo poškodovanje in smrt tkivnih celic okoli mesta injiciranja (nekroza tkiva, glejte tudi poglavje 4), zaradi katere bo morda potrebna operacija.
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 1mg of trabectedin.
Slovenian: Viala iz brezbarvnega stekla tipa I z zamaškom iz butilne gume, pokritim z aluminijastim tesnilom tipa „flip-off“, ki vsebuje 1 mg trabektedina.
English: 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.
Slovenian: Infuzijo boste prejeli vsake 3 tedne, vendar pa lahko vaš zdravnik včasih odmerek prestavi in zagotovi,