FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver function tests should be monitored during treatment with Yondelis as dose adjustments may be indicated (see Table 1 and section 4.4).
Maltese: Waqt it-trattament b'Yondelis, it-testijiet tal-funzjoni tal-fwied għandhom jiġu mmonitorjati peress li jistgħu jiġu indikati aġġustamenti fid-doża (ara Tabella 1 u sezzjoni 4.4).
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.
Maltese: L-effikaċja tat-taħlita ta' Yondelis/PLD f'kanċer tal-ovarju li rkada hija bbażata fuq ET743-OVA-301, studju li fih il-pazjenti ntgħażlu b'mod każwali ta' fażi 3 fuq 672 pazjent li rċivew trabectedin (1.1 mg/m2) u PLD (30 mg/m2) kull 3 ġimgħat jew PLD (50 mg/m2) kull 4 ġimgħat.
English: The major anticipated toxicities are gastrointestinal, bone marrow suppression and hepatic toxicity.
Maltese: It-tossiċitajiet maġġuri antiċipati kienu gastrointestinali, soppressjoni tal-mudullun u tossiċità epatika.
English: 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).
Maltese: trabectedin ma' indutturi qawwija ta' CYP3A4 (eż., rifampicin, phenorbarbital, Saint John's Wort) għandu jiġi evitat kemm jista' jkun (ara sezzjoni 4.4).
English: ANNEX II
Maltese: It-3
English: There is limited data on the effects of trabectedin overdose.
Maltese: Hemm dejta ristretta dwar l-effetti ta' doża eċċessiva ta' trabectedin.
English: PLD Hazard/Odds ratio p-value Progression Free Survival
Maltese: Proporzjoni ta' Periklu (Hazard Ratio) /Proporzjon ta' Probabilità (Odds Ratio)
English: Palmar-plantar erythrodysaesthesia syndrome*
Maltese: eritrodisasteżija palmari-plantari
English: de los Reyes, 1 E-28770 Colmenar Viejo Madrid
Maltese: Polígono Industrial La Mina Avda. de los Reyes, 1 E-28770 Colmenar Viejo Madrid
English: Other P450 enzymes may contribute to metabolism.
Maltese: Enzimi oħra P450 jistgħu jikkontribwixxu għal metaboliżmu.
English: This reconstituted solution contains 0.05 mg/ml of trabectedin.
Maltese: Din is-soluzzjoni rikostitwita fiha 0.05 mg/ml ta' trabectedin.
English: In clinical trials, there were no pre-defined limits to the number of cycles administered.
Maltese: Fi provi kliniċi, m'hemm l-ebda limiti definiti minn qabel għan-numru ta' ċikli mogħtija.
English: 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).
Maltese: Il-livelli ta' trabectedin fil-plażma li intlaħqu kienu 10.6 ± 5.4 (Cmax), ogħla minn dawk milħuqa f'pazjenti wara infużjoni ta' 1500 µg/m2 għal 24 (Cmax ta' 1.8 ± 1.1 ng/ml) u simili għal dawk milħuqa wara għoti tal-istess doża minn infużjoni ta' 3 sigħat (Cmax ta' 10.
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.
Maltese: Is-sopravivenza medjana skont it-tip tal-istoloġija tat-tumur kienet 16.2 xhur [95% CI: 14.1, 19.5] għal suġġetti b'lejomajosarkomi u b'liposarkomi u 8.4 xhur [95% CI: 7.1, 10.7] għal suġġeti b'tipi ta' sarkomi oħrajn.
English: Rhabdomyolysis
Maltese: Soluzzjoni rikostitwita
English: Most patients treated with Yondelis can be expected to have adverse reactions of any grade (91% in monotherapy and 99% in combination therapy) and less than one third serious adverse reactions of grade 3 or 4 severity (10% in monotherapy and 25% in combination therapy).
Maltese: Il-biċċa l-kbira tal-pazjenti kkurati b'Yondelis jistgħu jkunu mistennija li jkollhom reazzjonijiet avversi ta' kwalunkwe grad (91% waqt monoterapija u 99% waqt terapija kombinata) u inqas minn terz reazzjonijiet avversi serji ta' grad 3 jew 4 fis-severità tagħhom (10% waqt monoterapija u 25% waqt terapija kombinata).
English: Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Maltese: Yondelis 0.25 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: 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).
Maltese: Riżultati minn programm ta' aċċess wiesgħa għal pazjenti b'STS (studju ET743-SAR-3002) juru li fost 903 suġġetti studjati għal OS, iż-żmien medjan ta' sopravivenza kien ta' 11.9 xhur (95% CI: 11.2, 13.8).
English: Trabectedin pharmacokinetic profile is consistent with a multiple-compartment disposition model.
Maltese: Il-profil farmakokinetiku ta' trabectedin huwa konsistenti ma'
English: Similarly, the co-administration of trabectedin with potent inducers of CPY3A4 may increase the metabolic clearance of trabectedin.
Maltese: trabectedin ma' indutturi qawwijin ta' CPY3A4 tista' żżid l-eliminazzjoni metabolika ta' trabectedin.
English: • feel an excess of fluid in the body (oedema)
Maltese: • ikollok eċċess ta' fluwidu f'ġismek (edima)
English: - Platelet count ≥ 100,000/mm - Bilirubin ≤ upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 x ULN (consider hepatic isoenzymes 5-nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin).
Maltese: - Għadd assolut ta' newtrofili (ANC) ≥ 1,500/mm3 - Għadd tal-plejtlits ≥ 100,000/mm3 - Bilirubin ≤ limitu ta' fuq tan-normal (ULN) - Alkaline phosphatase ≤ 2.5 x ULN (ikkonsidra iżoenzimi tal-fwied 5-nucleotidase jew gamma glutamyl transpeptidase (GGT), jekk l-elevazzjoni tista' tkun ta' oriġini mill-għadam).
English: 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.
Maltese: Riżultati osservati kienu jinkludu tossiċità ematopoetika (lewkopenija severa, anemija, u tnaqqis limfojde u tal mudullun) kif ukoll żidiet fit-testijiet tal-funzjoni tal-fwied, deġenerazzjoni epatoċellulari, nekrożi epiteljali intestinali u reazzjonijiet severi fis-sit tal-injezzjoni.
English: 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).
Maltese: Fil-grupp ta' Yondelis+PLD, pazjenti mhux bojod (il-biċċa l-kbira Asjatiċi) kellhom inċidenza ogħla minn pazjenti bojod ta' reazzjonijiet avversi ta' grad 3 jew 4 (96% kontra 87%), u reazzjonijiet avversi serji (44% kontra 23% f'kull grad).
English: Each vial of powder contains 0.25 mg of trabectedin.
Maltese: Kull kunjett fih 0.25 mg ta' trabectedin.
English: • If you have an allergic reaction (hypersensitivity).
Maltese: • Jekk għandek reazzjoni allerġika (sensittività eċċessiva).
English: Additional monitoring of haematological parameters bilirubin, alkaline phosphatase, aminotransferases and CPK should occur weekly during the first two cycles of therapy, and at least once between treatments in subsequent cycles.
Maltese: Monitoraġġ addizzjonali ta' parametriċi ematoloġiċi ta' bilirubin, alkaline phosphatase, aminotransferases u CPK għandu jittieħed kull ġimgħa waqt l-ewwel żewġ ċikli ta' terapija, u talanqas darba bejn trattamenti f'ċikli sussegwenti.
English: Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove.
Maltese: Trabectedin jorbot max-xaqq minuri tal-aċidu deoxyribonukleiku (DNA), u jgħawweġ l-elika lejn ixxaqq maġġur.
English: When rifampicin was co-administered with trabectedin, it resulted in reduced plasma exposure of trabectedin by approximately 22% for Cmax and 31% for AUC.
Maltese: trabectedin fil-plasma b'madwar 22% għal Cmax u 31% għall-AUC.
English: 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.
Maltese: Peress li trabectedin huwa mmetabolizzat prinċipalment minn CYP3A4, il-konċentrazzjonijiet ta' trabectedin fil-plasma huma probabbli li jiżdiedu f'pazjenti li jingħataw fl-istess ħin mediċini li jinibixxu b'mod qawwi l-attività ta' dan l-isoenzim.
English: The 3 assessors are independent, have no conflict of interest, are all specialists on CLS, and they provided a relevant description of their methodology and criteria, a distinction between possible and probable CLS and for the probable CLS cases, that are fatal, an evaluation of trabectedin causality.
Maltese: valutaturi huma indipendenti, ma għandhom ebda kunflitt ta' interess, huma lkoll speċjalisti fuq isCLS, u pprovdew deskrizzjoni relevanti tal-metodoloġija u l-kriterji tagħhom, distinzjoni bejn CLS possibbli u probabbli u għall-każijiet ta' CLS probabbli, li huma fatali, evalwazzjoni tal-każwalità ta' trabectedin.
English: BSA = Body Surface Area
Maltese: BSA = Erja Superfiċjali tal-Ġisem
English: • You may experience an abnormal build-up of fluid in the lungs, which leads to swelling (pulmonary oedema).
Maltese: • Tista' tesperjenza akkumulazzjoni anormali ta' fluwidu fil-pulmun, li twassal għal nefħa (edima pulmonari).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg trabectedin
Maltese: INDIVIDWALI 0.25 mg trabectedin
English: Capillary leak syndrome
Maltese: Sindrome ta' Tnixxija Kapillari
English: Patients in the trabectedin and dacarbazine arms received a median of 4 and 2 cycles respectively.
Maltese: Il-pazjenti fil-fergħat ta' trabectedin u dacarbazine irċevew medja ta' 4 u 2 ċikli rispettivament.
English: Based on independent oncology review, patients with platinum-free interval (PFI) < 6 months (35% in Yondelis+PLD and 37% in PLD arm) had similar PFS in the two arms with both showing median PFS of 3.7 months (HR=0.89, CI: 0.67-1.20).
Maltese: ta' < 6 xhur (35% b'Yondelis+PLD u 37% fil-grupp ta' PLD) kellhom PFS simili fiż-żewġ gruppi bittnejn juru PFS medjan ta' 3.7 xhur (HR=0.89, CI: 0.67 - 1.20).
English: The study primary endpoint was PFS, that showed a statistically significant improvement in favour of trabectedin over BSC [HR=0.07; 95% CI: 0.03-0.16; p<0.0001], with a median PFS in the trabectedin group of 5.6 months [95% CI: 4.1-7.5] and in the BSC group of 0.9 months [95% CI: 0.7-1.0].
Maltese: 03-0.16; p<0.0001], b'PFS medjan fil-grupp ta' trabectedin ta' 5.6 xhur [95% CI: 4.1-7.5] u fil-grupp tal-BSC ta' 0.9 xhur
English: Mucosal inflammation
Maltese: Infezzjoni newtropenika
English: Considering the pharmacokinetic characteristics of trabectedin (see section 5.2), no dose adjustments are warranted in patients with mild or moderate renal impairment.
Maltese: Meta tikkunsidra l-karatteristiċi tal-farmakokinetika ta' trabectedin (ara sezzjoni 5.2), l-ebda aġġustamenti fid-doża ma huma ġustifikati f'pazjenti b'indeboliment tal-kliewi ħafif sa moderat.
English: Sucrose
Maltese: Trabectedin
English: Some potential risk factors that may have contributed to increased trabectedin toxicity observed in these cases were dose management inconsistent with recommended guidelines, potential CYP3A4 interaction due to multiple competing CYP3A4 substrates or CYP3A4 inhibitors, or lack of dexamethasone prophylaxis.
Maltese: Xi fatturi ta' riskju potenzjali li setgħu kkontribwixxew għal żieda fit-tossiċità bi trabectedin osservati f'dawn il-każijiet kienu l-għoti ta' dożi mhux skont il-linji gwida, interazzjoni tas-CYP3A4 potenzjalment minħabba substrati multipli tasCYP3A4 li jkunu qed jikkompetu,jew inibituri tas-CYP3A4, jew nuqqas ta' profilassi b'dexamethasone.
English: Concomitant administration of inhibitors of P-gp, e.g. cyclosporine and verapamil, may alter trabectedin distribution and/or elimination.
Maltese: impedituri ta' P-gp, eż. cyclosporine u verapamil, jistgħu jbiddlu l-firxa u/jew l-eliminazzjoni ta'
English: Capillary Leak Syndrome (CLS): Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes) (see section 4.4).
Maltese: Sindrome ta' Tnixxija Kapillari (CLS, Capillary Leak Syndrome): Ġew irrappurtati każijiet tasSindrome ta' Tnixxija Kapillari (CLS) bi trabectedin (inkluż każijiet b'riżultati fatali) (ara s-sezzjoni
English: Treatment continued whilst clinical benefit was noted.
Maltese: Il-kura tkompliet dment li kien hemm benefiċċju kliniku.
English: Adverse reactions, included reversible elevation of liver enzymes and haematological events; in addition, fever, infection, dehydration and thrombosis/embolism were also reported.
Maltese: Reazzjonijiet avversi inkludew żieda riversibbli ta' enzimi tal-fwied u avvenimenti ematoloġiċi; barra minn hekk, ġew irrapportati wkoll deni, infezzjoni, deidratazzjoni u trombożi/emboliżmu.
English: Anti-emetic prophylaxis with corticosteroids such as dexamethasone must be administered to all patients (see section 4.2).
Maltese: Profilassi antiemetika b'kortikosterojdi bħal dexamethasone għandha tingħata lill-pazenti kollha (ara sezzjoni 4.2).
English: In some patients, a compartment syndrome can occur.
Maltese: F'xi pazjenti jista' jseħħ sindrome ta' kompartiment.
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: This medicine contains potassium, less than 1 mmol (39 mg) per vial, i.e. essentially “potassium-free”.
Maltese: Din il-mediċina fiha ammont ta' potassium, anqas minn 1 mmol (39 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mill-potassium'.
English: • be more prone to infections.
Maltese: • tkun suxxettibbli aktar għal infezzjonijiet.
English: All randomised n=337
Maltese: Magħżula b'mod każwali kollha n=337
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.
Maltese: L-effett tal-indeboliment tal-fwied fuq il-farmakokinetika ta' trabectedin ġie vvalutat fi 15-il pazjent bil-kanċer f'dożi li jvarjaw minn 0.58 sa 1.3 mg/m mogħtija bħala infużjoni ta' 3 sigħat.
English: In the final analysis, the effect of the Yondelis+PLD combination vs. PLD alone on overall survival was more pronounced in patients with PFI ≥ 6 months (platinum-sensitive population: 27.0 vs. 24.1 months, HR=0.83, CI: 0.67-1.04) than in those with PFI < 6 months (platinum-resistant population: 14.2 vs. 12.4 months, HR=0.92, CI: 0.
Maltese: Fl-analiżi finali, l-effett tat-taħlita ta' Yondelis+PLD vs PLD waħdu, is-sopravivenza globali kienet aktar qawwija f'pazjenti b'PFI ta' ≥ 6 xhur (popolazzjoni sensittiva għall-platinum 27.0 vs. 24.1 xahar, HR=0.83, CI: 0.67 - 1.04) minn f'dawk b'PFI ta' < 6 xhur (popolazzjoni reżistenti għall-platinum 14.2 vs.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal trabectedin, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: - Increase of aminotransferases (AST or ALT) > 2.5 x ULN (monotherapy) or > 5 x ULN
Maltese: - Żieda tal-bilirubin > ULN u/jew alkaline phosphatase > 2.5 x ULN - Żieda fl-aminotransferases (AST jew ALT) > 2.5 x ULN (monoterapija) jew > 5 x ULN
English: 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.
Maltese: Yondelis kombinat ma' pegylated liposomal doxorubicin (PLD: mediċina oħra kontra l-kanċer) jintuża għall-kura ta' pazjenti b'kanċer tal-ovarju li jitfaċċa mill-ġdid wara tal-inqas terapija waħda minn qabel u li mhumiex reżistenti għall-mediċini kontra l-kanċer li fihom komposti tal-platinum.
English: Septic shock
Maltese: Xokk settiku
English: If intravenous administration is to be made via a central venous line, add the reconstituted solution to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion), the concentration of trabectedin in the infusion solution being ≤ 0.030 mg/ml.
Maltese: Jekk l-għoti ġol-vini għandu jsir permezz ta' linja ċentrali fil-vina, żid is-soluzzjoni rrikostitwita fil-borża tal-infużjoni li jkun fiha ≥ 50 ml tad-dilwent (soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) jew soluzzjoni għall-infużjoni ta' glucose 50 mg/ml (5%)), biex b'hekk il-konċentrazzjoni ta' trabectedin fis-soluzzjoni għall-infużjoni tkun ≤ 0.030 mg/ml.
English: Of the 333 patients with ovarian cancer who received trabectedin in combination with PLD, 24% were 65 years of age or older and 6% were over 75 years.
Maltese: Minn 333 pazjent b'kanċer tal-ovarju li ngħataw trabectedin flimkien ma' PLD, 24% kellhom 65 sena jew aktar u 6% kellhom aktar minn 75 sena.
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.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni wriet li meta mogħti flimkien ma' PLD, it-tneħħija millplażma ta' trabectedin naqset b'31%; il-farmakokinetika fil-plażma ta' PLD ma kinitx influwenzata mill-għoti fl-istess waqt ta' trabectedin.
English: Table 1 Dose modification table for Yondelis (as single agent for soft tissue sarcoma (STS) or in combination for ovarian cancer) and PLD
Maltese: Tabella 1 Tabella tal-modifikazzjoni tad-doża għal Yondelis (bħala sustanza waħedha għassarkoma tat-tessut l-artab (STS) jew f'taħlita għall-kanċer tal-ovarju) u PLD
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Maltese: Konsultazzjoni ġenetika għandha tkun rakkomandata għal pazjenti li jixtiequ li jkollhom it-tfal wara t-terapija.
English: Unopened vials
Maltese: Insuffiċjenza tal fwied
English: Considering the nature of the compound (cytotoxic and mutagenic), it is likely to affect the reproductive capacity.
Maltese: B'konsiderazzjoni tan-natura tat-taħlita (ċitotossika u mutaġenika), x'aktarx li taffettwa l-kapaċita riproduttiva.
English: 1 ml of reconstituted solution contains 0.05 mg of trabectedin.
Maltese: 1 ml ta' soluzzjoni rikostitwita fiha 0.05 mg ta' trabectedin.
English: A total of 76 Japanese patients were enrolled in the study, among which 73 patients were included in the final analysis set.
Maltese: (q3wk 24-h)]. Total ta' 76 pazjent Ġappuniż kienu rreġistrati fl-istudju, fosthom 73 pazjent li ġew inklużi fis-sett tal-analiżi finali.
English: 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.
Maltese: Meta ketoconazole ingħata fl-istess ħin ma' trabectedin, l-esponiment fil-plasma ta' trabectedin żdied b'madwar 21% għal Cmax u 66% għall-AUC, iżda ma ġie identifikat ebda tħassib ġdid dwar is-sigurtà.
English: Yondelis should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3.
Maltese: Yondelis m'għandux jingħata lil pazjenti b'għadd tan-newtrofili fil-linja bażi ta' inqas minn 1,500 ċellula/mm3 u għadd tal-plejtlits ta' inqas minn 100,000 ċellula/mm3.
English: Each vial of powder contains 1 mg of trabectedin.
Maltese: Kull kunjett fih 1 mg ta' trabectedin.
English: The secondary endpoints included objective response analysed using the RECIST and Choi criteria.
Maltese: Il-punti aħħarin sekondarji inkludew rispons oġġettiv analizzat bl-użu ta' kriterji
English: The Pharmacovigilance and Risk Assessment Committee (PRAC) considered the results of the IAC report highly credible.
Maltese: Il-Kumitat ta' Farmakoviġilanza u ta' Valutazzjoni tar-Riskji (Pharmacovigilance and Risk Assessment Committee, PRAC) qies ir-riżultati tar-rapport tal-IAC bħala kredibbli ħafna.
English: Bleeding events associated to thrombocytopenia occurred in < 1% of patients treated with the monotherapy regimen.
Maltese: Avvenimenti ta' fsada assoċjati ma' tromboċitopenija seħħew f < 1% tal-pazjenti kkurati bil-kors ta' monoterapija.
English: Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regimen.
Maltese: Hemm dejta tal-effikaċja addizzjonali minn 3 provi Fażi ta' II b'parti waħda ta' studju b'popolazzjonijiet simili bl-istess kors.
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jista' jaffettwa sa persuna 1 minn kull 100
English: The patients received the trabectedin dose of 1.2 mg/m2 recommended for Japanese patients [1.2 mg/m2 once every 3 weeks (q3wk 24-h)].
Maltese: trabectedin ta' 1.2 mg/m2 rakkomandata għal pazjenti Ġappuniżi [1.2 mg/m2 darba kull 3 ġimgħat
English: - Keep this leaflet.
Maltese: tkabbir terapewtiku.
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%).
Maltese: L-ebda differenzi sinifikattivi ma dehru fis-sopravivenza totali (OS). OS medjana bil-kors ta' 24 siegħa kull 3 ġimgħat kienet 13.9 xhur (CI: 12.5 - 18.6) u 60.2% tal-pazjenti kienu ħajjin f'sena 1 (CI: 52.0 - 68.5%).
English: In order to avoid irritation at the site of injection it is recommended that Yondelis is given to you through a central venous line.
Maltese: Sabiex jiġi evitat li jkun hemm irritazzjoni fis-sit tal-injezzjoni huwa rakkomandat li Yondelis jingħata minn linja venuża ċentrali.
English: The following safety profile of Yondelis is based on adverse reactions reported in clinical trials, postauthorisation safety studies and spontaneous reporting.
Maltese: Il-profil tas-sigurtà li ġej ta' Yondelis huwa bbażat fuq reazzjonijiet avversi rrappurtati fil-provi kliniċi, studji dwar is-sigurtà wara l-awtorizzazzjoni għat-tqegħid fis-suq u rappurtar spontanju.
English: All patients must receive corticosteroids e.g. 20 mg of dexamethasone intravenously 30 minutes prior to PLD (in combination therapy) or Yondelis (in monotherapy); not only as anti-emetic prophylaxis, but also because it appears to provide hepatoprotective effects.
Maltese: minuta qabel PLD (waqt terapija kombinata) jew Yondelis (waqt monoterapija); mhux biss bħala profilassi antiemetika, iżda ukoll minħabba li tidher li tipprovdi effetti epatoprotettivi.
English: Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Maltese: Mediċini li fihom statins (li jnaqqsu l-livelli ta' kolesterol u li jipprevjenu mard kardjovaskulari) huma eżempji ta' mediċini li jistgħu jagħmlu ħsara lil muskolu.
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.
Maltese: L-analiżi finali ma wriet l-ebda differenza sinifikanti b'segwitu ta' sopravivenza medjana ta' 21.2 xahar, li rriżultat f'medjan ta' 13.7 xahar (95% CI: 12.2, 16.0) għal fergħa ta' trabectedin, u 13.1 xahar [95% CI: 9.1, 16.2] għall-fergħa ta' dacarbazine.
English: Soft tissue sarcoma
Maltese: Sarkoma tat-tessut l-artab
English: During postmarketing experience, hypersensitivity reactions with very rare occurrence of fatal outcome, have been reported in association with trabectedin administration either alone or in combination with PLD (see sections 4.3 and 4.8).
Maltese: Matul esperjenza ta' wara t-tqegħid fis-suq, ġew irrapportati reazzjonijiet ta' sensittività eċċessiva, b'okkorrenza rari ħafna ta' riżultat fatali, f'assoċjazzjoni mal-għoti ta' trabectedine jew waħdu jew flimkien ma' PLD (ara sezzjonijiet 4.3 u 4.8).