FrancophonIA/ELRC3.0 huggingface dataset:
English: A second laboratory study involved 15 gilts (female pigs that have not yet had piglets) which were vaccinated according to the basic vaccination schedule with a booster dose six months later.
Maltese: It-tieni studju tal-laboratorju involva 15-il majjal mara mgħammra (majjali nisa li għad ma kellhomx qżieqeż) li ġew imlaqqma skont l-iskeda ta' tilqim bażika b'doża booster sitt xhur wara.
English: The onset of immunity was shown to be three weeks.
Maltese: Il-bidu tal-immunità intwera li huwa ta' tliet ġimgħat.
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Maltese: Il-majjali ġew sfidati sitt xhur aktar tard b'injezzjonijiet ta' batterju Erysipelothrix rhusiopathiae serotip 1 u 2 u l-kejl tal-effikaċja kien il-perċentwal ta' majjali protetti bit-tilqima.
English: In the future, if the animals are exposed to Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Maltese: jekk l-annimali jiġu esposti għal batterja Erysipelothrix rhusiopathiae, is-sistema immunitarja se tkun tista' tirrispondi iktar malajr.
English: What benefit has Eryseng shown during the studies?
Maltese: Liema benefiċċju wera Eryseng matul l-istudji?
English: Fax: +34 91 846 60 01
Maltese: Faks: +34 91 846 60 01
English: Date of latest renewal: 03 August 2012
Maltese: Data tal-aħħar tiġdid: 03 ta' Awwissu 2012
English: - The active substance is trabectedin.
Maltese: - Is-sustanza attiva hi trabectedin.
English: Overall Survival (Final analysis - n=522 events)
Maltese: Sopravivenza Globali (Analiżi finali - n=522 avveniment)
English: Pulmonary embolism*
Maltese: Emboliżmu pulmonari*
English: Overall Response Rate (ORR)
Maltese: Rata ta' Rispons Globali (ORR)
English: Electrocardiogram (ECG) investigations
Maltese: Investigazzjonijiet bl-elettrokardjogramma (ECG)
English: Anaemia:
Maltese: Anemija:
English: Yondelis contains the active substance trabectedin.
Maltese: Yondelis fih is-sustanza attiva trabectedin.
English: Volume (ml) = BSA (m2) x individual dose (mg/m2)
Maltese: Volum (ml) = BSA (m2) x dożaġġ individwali (mg/m2)
English: PFS (months; 95% CI) ORR, n (%); Odds ratio (95% CI) DOR (months; 95% CI) CBR, n (%); Odds ratio (95% CI)
Maltese: PFS (xhur; 95% CI) ORR, n (%); Proporzjon ta' probabbiltà (Odds ratio) (95% CI) DOR (xhur; 95% CI) CBR, n (%); Proporzjon ta' probabbiltà (Odds ratio) (95% CI)
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jista' jaffettwa sa persuna 1 minn kull 1,000
English: Insomnia
Maltese: Insonnja
English: The percentages of patients anaemic at baseline were 46% and 35% respectively.
Maltese: Il-persentaġġ ta' pazjenti anemiċi fil-linja bażi kien 46% u 35% rispettivament.
English: Log rank test b Fisher's test
Maltese: * Analiżi primarja tal-effikaċja a Test log rank b Test ta' Fisher
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Settembru 2007
English: Duration of the response was 6.5 months No responses were observed for Ewing sarcoma and NRSTS, [RR: 0% CI95% (0%-30.9%)].
Maltese: Ebda rispons ma ġie osservat għal sarkoma ta' Ewing u NRSTS, [RR: 0% CI95% (0%-30.9%)].
English: Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Maltese: Fih ukoll: sucrose, potassium dihydrogen phosphate, phosphoric acid u potassium hydroxide.
English: • You may:
Maltese: • Tista':
English: (fever).
Maltese: (rimettar).
English: The differences were mainly observed in relation with neutropenia (93% versus 66%), anaemia (37% versus 14%) and thrombocytopenia (41% versus 19%).
Maltese: Id-differenzi kienu osservati l-aktar meta kien hemm newtropenija (93% kontra 66%), anemija (37% kontra 14%) u tromboċitopenija (41% kontra 19%).
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Sucrose
English: One partial response (PR) centrally confirmed was observed: overall RR: 2.5% CI95% (0.1%-13.2%).
Maltese: RR ġenerali: 2.5% CI95% (0.1%-13.2%).
English: The median patient age was 56 years (range 17 to 81), 30% were male, 77% Caucasian, 12% African American and 4% Asian.
Maltese: L-età medjana tal-pazjenti kienet ta' 56 sena (medda ta' 17 sa 81), 30% kienu rġiel, 77% Kawkasi, 12 % Afrikani Amerikani u 4% Asjatiċi.
English: Pulmonary oedema
Maltese: Edima pulmonari
English: Liver Function Test (LFT) abnormalities
Maltese: Anormalitajiet fit-Testijiet tal-Funzjoni tal-Fwied (LFT)
English: The frequencies are classified as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1000).
Maltese: (≥ 1/1,000 sa < 1/100) u rari (≥ 1/10,000 sa < 1/1000).
English: Do not use Yondelis:
Maltese: Tiħux Yondelis:
English: Pol. Ind. La Mina 28770 Colmenar Viejo (Madrid) Spain
Maltese: Ind. La Mina 28770 Colmenar Viejo (Madrid) Spanja
English: Trabectedin is genotoxic both in vitro and in vivo.
Maltese: Trabectedin huwa ġenotossiku kemm in vitro u in vivo.
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Median TTP values were 3.7 months (CI: 2.1-5.4 m) in the 24-h q3wk group and 2.3 months (CI: 2.0-3.5 m) in the 3-h qwk group (p=0.0302).
Maltese: TTP medjani kienu 3.7 xhur (CI: 2.1 - 5.4 m) fil-grupp ta' 24 siegħa kull 3 ġimgħat u 2.3 xhur (CI: 2.0 - 3.5 m) filgrupp ta' 3 sigħat kull ġimgħa (p=0.0302).
English: Eight patients were treated with a dose of 1.3 mg/m2 and 42 with 1.5 mg/m2.
Maltese: Tmien pazjenti ġew ikkurati b'doża ta' 1.3 mg/m2 u 42 b'1.5 mg/m2.
English: Palpitations* Left ventricular dysfunction*
Maltese: Palpitazzjonijiet* Disfunzjoni talventrikulu taxxellug*
English: Rhabdomyolysis and severe CPK elevations (> 5 x ULN)
Maltese: Rabdomijolisi u żidiet severi ta' CPK (> 5 x ULN)
English: Overall 20% of the 1,164 patients in the integrated safety analysis of monotherapy clinical trials were over 65 years.
Maltese: Total globali ta' 20% tal-1,164 pazjent fl-analiżi ta' sigurtà integrata tal-provi kliniċi b'monoterapija kienu fuq il-65 sena.
English: Efficacy analyses from ET743-OVA-301 Yondelis+PLD
Maltese: Analiżi tal-effikaċja minn ET743-OVA-301
English: Overall survival, n (%) Secondary endpoints n=345
Maltese: Punti aħħarin sekondarji n=345
English: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Maltese: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spanja
English: Most frequent adverse reactions
Maltese: Reazzjonijiet avversi l-aktar frekwenti
English: Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
Maltese: Kull kunjett ta' trab fih 8 mg ta' potassium u 0.4 g ta' sucrose.
English: Yondelis with alcohol
Maltese: Yondelis mal-alkoħol
English: Yondelis contains potassium
Maltese: Yondelis fih il-potassium
English: Additional efficacy data are available from a randomized, open-label, multicenter phase II study [JapicCTI-121850] conducted in Japanese patients with translocation-related sarcoma (TRS), most common being myxoid round-cell liposarcoma (n=24), synovial sarcoma (n=18), mesenchymal chondrosarcoma (n=6), and extraskeletal Ewing sarcoma/PNET, alveolar soft part sarcoma, alveolar rhabdomyosarcoma and clear cell sarcoma (n=5 each).
Maltese: TRS), bl-aktar komuni tkun liposarkoma myxoid taċ-ċelluli tondi (myxoid round-cell liposarcoma) (n=24), sarkoma sinovjali (n=18), kondrosarkoma mesenkimali (mesenchymal chondrosarcoma)(n=6), u sarkoma extraskeletali Ewing/PNET, sarkoma tal-parti ratba alveolari (alveolar soft part sarcoma), rabdomijosarkoma alveolari u sarkoma taċ-ċelluli ċari (clear cell sarcoma ) (n=5 kull waħda).
English: Neutropenia:
Maltese: Iperbilirubinimja:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for the oxidative metabolism of trabectedin at clinically relevant concentrations.
Maltese: Ċitokroma P450 3A4 hija ċ-ċitokroma P450 iżoenzima maġġura responsabbli għal metaboliżmu ossidattiv ta' trabectedin f'konċentrazzjonijiet klinikament rilevanti.
English: Alanine aminotransferase increased
Maltese: Żieda flalanine aminotransf erase
English: Reversible acute increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been reported in most patients.
Maltese: Żidiet akuti riversibbli f'aspartate aminotransferase (AST) u alanine aminotrasferase (ALT) ġew irrappurtati fil-maġġoranza tal-pazjenti.
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).
Maltese: Kura b'terapija kombinata wasslet għal tnaqqis fir-riskju ta' progressjoni tal-marda ta' 21% meta mqabbla ma' PLD waħdu (HR=0.79, CI: 0.65 - 0.96, p=0.0190).
English: Thrombocytopenia:
Maltese: Tromboċitopenija:
English: 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.
Maltese: Ma ġiet osservata l-ebda inkompatibilità bejn Yondelis u polyvinylchloride (PVC) u l-boroż tal-polyethylene (PE) u l-pajpijiet, u sistemi t'aċċess vaskulari impjantabbli tat-titanju.
English: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Maltese: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spanja
English: Capillary leak syndrome (CLS) is usually characterized by peripheral oedema, hypotension which is relatively well tolerated, oliguria with acute pre-renal failure.
Maltese: Is-sindrome ta' tnixxija kapillari (CLS) huwa normalment ikkaratterizzat b'edema periferali, pressjoni baxxa li hija relattivament ittollerata tajjeb, oligurja b'indeboliment pre-renali akut.
English: Median PFS (95% CI) (months)
Maltese: PFS medjana (95% CI) (xhur)
English: Other medicines and Yondelis
Maltese: Mediċini oħra u Yondelis
English: Instructions for use - preparation, handling and disposal
Maltese: Istruzzjonijiet dwar l-użu - preparazzjoni, manipulazzjoni u rimi
English: - 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)
Maltese: - Albumin ≥ 25 g/l. - Alanine aminotransferase (ALT) u Aspartate aminotransferase (AST) ≤ 2.5 x ULN - Tneħħija tal-krejatinina ≥ 30 ml/min (monoterapija), krejatinina fis-serum
English: Independent radiology review, all randomised n=337
Maltese: Evalwazzjoni indipendenti tarradjoloġija, kollox b'mod każwali n=337
English: The most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increase in AST/ALT, anaemia, fatigue, thrombocytopenia, anorexia and diarrhoea.
Maltese: L-aktar reazzjonijiet avversi komuni ta' kwalunkwe severità kienu newtropenija, tqalligħ, rimettar, żieda fl-AST/ALT, anemija, għeja, tromboċitopenija, anoressija u dijarea.
English: The relevance of this interaction e.g. central nervous system (CNS) toxicity has not been established.
Maltese: Ir-rilevanza ta' din l-interazzjoni eż. tossiċità tas-sistema nervuża ċentrali (SNĊ) ma ġietx stabbilita.
English: Yondelis 1 mg: Inject 20 ml of sterile water for injections into the vial.
Maltese: Yondelis 1 mg: Injetta 20 ml ta' ilma sterili għall-injezzjonijiet ġol-kunjett.
English: Myelosupression and hepatoxicity were identified as the primary toxicity for trabectedin.
Maltese: Majelosoppressjoni u epatossiċità kienu identifikati bħala tossiċità primarja għal trabectedin.
English: The distribution volume at steady state of trabectedin in human subjects exceeds 5,000 l.
Maltese: Il-volum ta' distribuzzjoni ta' trabectedin fi stat fiss f'suġġetti umani jaqbeż 5,000 litru.
English: Dizziness Dysgeusia Peripheral sensory neuropathy Syncope*
Maltese: Newropatija sensorjali periferali
English: 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].
Maltese: 2.6% fir-riskju relattiv ta' progressjoni għal pazjenti kkurati fil-grupp ta' 24 siegħa kull 3 ġimgħat [Proporzjon ta' Riskju (HR)= 0.734, Intervall ta' fiduċja (CI): 0.554 - 0.974].
English: Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
Maltese: Kull kunjett ta' trab fih 2 mg ta' potassium u 0.1 g ta' sucrose.
English: Yondelis has been administered for 6 or more cycles in 29.5% and 52% of patients treated with the monotherapy and combination dose and schedule respectively.
Maltese: Yondelis ingħata għal 6 ċikli jew aktar f'29.5% u 52% tal-pazjenti kkurati bid-doża u skeda ta' monoterapija u ta' terapija kombinata rispettivament.
English: Co-administration of Yondelis with potent inhibitors of the enzyme CYP3A4 should be avoided (see section 4.5).
Maltese: L-għoti ta' Yondelis flimkien ma' impedituri potenti tal-enzima CYP3A4 għandu jiġi evitat (ara sezzjoni 4.5).
English: Yondelis 0.25 mg: Inject 5 ml of sterile water for injections into the vial.
Maltese: Yondelis 0.25 mg: Injetta 5 ml ta' ilma sterili għall-injezzjonijiet ġol-kunjett.
English: 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%).
Maltese: Wara doża ta' trabectedin radjutikkettat mogħti lil pazjenti bil-kanċer, l-irkupru medju (SD) fl-ippurgar tarradjuattività totali kien ta' 58% (17%), u l-irkupru medju (SD) fl-awrina kien ta' 5.8% (1.73%).
English: 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).
Maltese: Wara l-għoti ġol-vini, trabectedin juri volum ta' distribuzzjoni apparenti għoli, konsistenti ma' irbit estensiv ta' proteini fit-tessuti u fil-plażma (94 sa 98% ta' trabectedin fil-plażma huwa marbut malproteini).
English: The monotherapy and combination regimens have been used for up to 38 and 21 cycles respectively.
Maltese: Ilkorsijiet ta' monoterapiji u ta' terapija kombinata ntużaw għal sa 38 u 21 ċiklu rispettivament.
English: Skin hyperpigmentation*
Maltese: Iperpigmentazzjoni tal-ġilda*
English: Median OS (95% CI) (months)
Maltese: OS medjan (95% CI) (xhur)
English: Using the RECIST criteria the ORR among patients treated with trabectedin was 3 (8.1%; 95% CI: 1.7.21.9%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 24 (64.9%, 95% CI: 47.5-79.9%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Maltese: Bl-użu ta' kriterji RECIST, l-ORR fost il-pazjenti kkurati bi trabectedin kienet ta'3 (8.1%; 95% CI: 1.7.21.9%) u 0 (0%, 95% CI: 0.0-9.7%) fost pazjenti kkurati bl-aħjar kura ta' appoġġ, filwaqt li s-CBR kienet ta' 24 (64.9%, 95% CI: 47.
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).
Maltese: Fl-analiżi ta' diversi fatturi inkluż PFI, l-effett tal-kura fuq is-sopravivenza globali kien jiffavorixxi b'mod statistikament sinifikanti t-taħlita ta' Yondelis+PLD fuq PLD waħdu (kollha b'mod każwali; p=0.0285; popolazzjoni sensittiva għall-platinum p=0.0319).
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil metaboliżmu u n nutrizzjoni
English: Serious side effects caused by the treatment with Yondelis:
Maltese: Effetti sekondarji serji kkawżati minn kura b'Yondelis:
English: The geometric mean dose normalized trabectedin exposure (AUC) increased by 97% (90% CI: 20%, 222%) in 6 patients with moderate hepatic impairment (increased serum bilirubin levels from 1.5 to 3 x ULN and increase of aminotransferases (AST or ALT) < 8 x ULN) following administration of a single trabectedin dose of 0.58 mg/m2 (n=3) or 0.9 mg/m2 (n=3) compared to 9 patients with normal liver function following administration of a single trabectedin dose of 1.3 mg/m2 (see sections 4.2 and 4.4).
Maltese: 20%, 222%) f'6 pazjenti b'indeboliment moderat tal-fwied (livelli ta' bilirubina fis-serum miżjudin minn 1.5 sa 3 x ULN u żieda tal-aminotransferases (AST jew ALT) ta' < 8 x ULN) wara l-għoti ta' doża waħda ta' trabectedin ta' 0.58 mg/m2 (n=3) jew ta' 0.9 mg/m2 (n=3) meta mqabbel ma' 9 pazjenti b'funzjoni normali tal-fwied wara l-għoti ta' doża waħda ta' trabectedin ta' 1.3 mg/m2 (ara sezzjonijiet 4.2 u 4.4).
English: Nervous System Disorders
Maltese: Disturbi fis-sistema nervuża
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Yondelis 0.25 mg
Maltese: U KWANTITATTIVA Yondelis 0.25 mg
English: Based on an ad-hoc review of CLS cases performed by an External Independent Adjudication Committee (IAC), it was determined possible or probable trabectedin causality in 5 out of 6 fatal cases among 14 probable CLS cases.
Maltese: Indipendenti (IAC, Independent Adjudication Committee), ġie stabbilit li huwa possibbli jew probabbli li jkun hemm każwalità ta' trabectedin f'5 minn 6 każijiet fatali fost 14-il każ ta' CLS
English: Trabectedin can have genotoxic effects.
Maltese: Trabectedin jista' jkollu effetti ġenotossiċi.
English: It followed a predictable pattern of rapid onset and reversibility, and was rarely associated with fever or infection.
Maltese: In-newtropenija segwiet sekwenza prevedibbli ta' bidu rapidu u riversibbilità, u rari kienet assoċjata ma' deni jew infezzjoni.
English: A population pharmacokinetic analysis indicated that the plasma clearance of trabectedin is not influenced by age (range 19-83 years), gender, total body weight (range: 36 to 148 kg) or body surface area (range: 0.9 to 2.8 m2).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni indikat li r-rata ta' tneħħija ta' trabectedin mhix influwenzata mill-età (firxa 19 - 83 sena), sess, piż totali tal-ġisem (firxa: 36 sa 148 kg) jew erja tas superfiċje tal-ġisem (firxa: 0.9 sa 2.8 m2).
English: Using the Choi criteria the ORR among patients treated with trabectedin was 4 (10.8%; 95% CI: 3.0-25.4%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 7 (18.9%, 95% CI: 8.0-35.2%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Maltese: 8%; 95% CI: 3.0-25.4%) u 0 (0%, 95% CI: 0.0-9.7%) fost pazjenti kkurati bl-aħjar kura ta' appoġġ, filwaqt li s-CBR kienet ta' 7 (18.9%, 95% CI: 8.0-35.2%) kontra 0 (0%, 95% CI: 0.0-9.7%), rispettivament.
English: Pharmacotherapeutic group: Antineoplastic agent, ATC code: L01CX01.
Maltese: Mediċina antineoplastika, Kodiċi ATC:
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]).
Maltese: Il-punt aħħari primarju tal-effikaċja tal istudju kien OS, li inkluda 381 avveniment ta' mewt (66% tal-pazjenti kollha li ntgħażlu b'mod każwali): 258 (67.2%) mewt fil-grupp ta' trabectedin u 123 (63.7%) mewt fil-grupp ta' dacarbazine (HR 0.927 [95% CI: 0.748, 1.150; p=0.4920]).
English: or creatinine clearance ≥ 60 ml/min (combination therapy) - Creatine phosphokinase (CPK) ≤ 2.5 x ULN - Haemoglobin ≥ 9 g/dl
Maltese: ≤ 1.5 mg/dl (≤ 132.6 μmol/l) jew tneħħija tal-krejatinina ≥ 60 ml/min (terapija kombinata) - Creatine phosphokinase (CPK) ≤ 2.5 x ULN - Emoglobina ≥ 9 g/dl
English: Trabectedin must not be used in patients with CPK > 2.5 x ULN (see section 4.2).
Maltese: Trabectedin m'għandux jintuża f'pazjenti b'CPK > 2.5 x ULN (ara sezzjoni 4.2).
English: Dehydration Hypokalaemia
Maltese: Deidratazzjoni Ipokalamija
English: Alcohol consumption must be avoided during treatment with trabectedin due to the hepatotoxicity of the medicinal product (see section 4.4).
Maltese: Konsum ta' alkoħol għandu jiġi evitat waqt kura bi trabectedin minħabba l-epatotossiċità ta' dan ilprodott mediċinali (ara sezzjoni 4.4).
English: 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.
Maltese: Is-sindrome ta' tnixxija kapillari (CLS, Capillary Leak Syndrome) hija entità rari kkaratterizzata minn attakki rikorrenti u mhux prevedibbli ta' tnixxija kapillari ta' fluwidu tal-plasma u proteini madwar l-endotilju kollu.
English: Uncommon Rare
Maltese: Komuni Ħafna
English: Cases of Capillary Leak Syndrome (CLS) have been reported with trabectedin (including cases with fatal outcomes).
Maltese: Sindrome ta' Tnixxija Kapillari (CLS, Capillary Leak Syndrome) Ġew irrappurtati każijiet tas-Sindrome ta' Tnixxija Kapillari (CLS) bi trabectedin (inkluż każijiet b'riżultati fatali).
English: The terminal half-life is long (population value of the terminal elimination phase: 180-hr).
Maltese: Il-halflife terminali hija twila (valur tal-popolazzjoni tal-fażi ta' eliminazzjoni terminali: 180 siegħa).
English: Aspartate aminotransferase increased
Maltese: Żieda fl aspartate aminotran sferase
English: Gamma-glutamyltransferase increased
Maltese: Żieda fil gamma-glutamyltra nsferase
English: In patients with PFI ≥ 6 months (65% in Yondelis+PLD and 63% in PLD arm), median PFS was 9.7 months in the Yondelis+PLD arm compared with 7.2 months in the PLD monotherapy arm (HR=0.66, CI: 0.52-0.85).
Maltese: F'pazjenti b'PFI ta' ≥ 6 xhur (65% b'Yondelis+PLD u 63% fil-grupp ta' PLD), PFS medjana kienet 9.7 xhur fil-grupp ta' Yondelis+PLD meta mqabbel ma' 7.2 xhur fil-grupp ta' monoterapija b'PLD (HR=0.66, CI: 0.52 - 0.85).
English: Dilute the reconstituted solution with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Maltese: (0.9%) jew soluzzjoni ta' glucose għal infużjoni 50 mg/ml (5%).
English: 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).
Maltese: Jekk ikun hemm newtropenija severa (ANC < 500 ċellula/mm3) li ddum aktar minn ħamest ijiem jew assoċjata ma' deni jew infezzjoni, huwa rakkomandat li titnaqqas id-doża (ara sezzjoni 4.2).
English: Anaemia occurred in 93% and 94% of patients treated with the monotherapy and combination regimens respectively.
Maltese: Anemija seħħet f'93% u f'94% tal-pazjenti kkurati b'korsijiet ta' monoterapija u ta' terapija kombinata rispettivament.
English: There is no relevant influence of renal function measured by creatinine clearance on trabectedin pharmacokinetics within the range of values (≥ 30.3 ml/min) present in the patients included in the clinical studies.
Maltese: Ma hemm l-ebda influwenza rilevanti fuq funzjoni renali mkejla bir-rata ta' tneħħija ta' krejatinina fuq il-farmakokinetika ta' trabectedin fi ħdan il-medda ta' valuri (≥ 30.3 ml/min) preżenti f'pazjenti li kienu inklużi fl-istudji kliniċi.
English: Trabectedin does not induce or inhibit major cytochrome P450 enzymes.
Maltese: Trabectedin ma jinduċix jew jinibixxix enzimi ċitokromi P450 maġġuri.
English: The low recovery (< 9% in all studied patients) of total radioactivity in the urine after a single dose of 14C-labelled trabectedin indicates that renal impairment has little influence on the elimination of trabectedin or its metabolites.
Maltese: L-irkupru baxx (<9% ta' pazjenti studjati) tar-radjuattività totali fl-awrina wara doża waħda ta' trabectedin ittikketat b'14C indikat li indeboliment renali għandu ftit influwenza fuq l-eliminazzjoni ta' trabectedin jew il-metaboliti tiegħu.
English: The median survival for subjects with liposarcoma was 18.1 months [95% CI: 15.0, 26.4] and for subjects with leiomyosarcoma 16.2 months [95% CI: 11.7, 24.3].
Maltese: Is-sopravivenza medjana għal suġġetti b'liposarkoma kienet 18.1 xhur [95% CI: 15.0, 26.4] u għal suġġetti b'lejomajosarkoma kienet 16.2 xhur [95% CI: 11.7, 24.3].