FrancophonIA/ELRC3.0 huggingface dataset:
English: Nadir platelets <50,000/mm3
Maltese: Livell minimu ta' plejtlits ta' < 50,000/mm3
English: Gastrointestinal symptoms
Maltese: Sintomi gastrointestinali
English: 16% had a Karnofsky Performance Status of 100; 42% had a KPS of 90; 35% had a KPS of 80; 7% had a KPS of 70; and <1% of patients had a KPS of below 70.
Maltese: 35% kellhom KPS ta' 80; 7% kellhom KPS ta' 70; u <1% tal-pazjenti kellhom KPS ta' inqas minn 70.
English: Peripheral Neuropathy:
Maltese: Newropatija Periferali:
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Maltese: Eċċipjenti: Soluzzjoni tal-albumina umana (li fiha sodium, sodium caprylate u N-acetyl DL tryptophanate)
English: Dose of carboplatin (AUC mg•min/mL)1
Maltese: Doża ta' carboplatin (AUC mg•min/mL)1
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Maltese: Il-metaboliżmu ta' paclitaxel hu kkatalizzat, parzjalment, mill-isoenzimi CYP2C8 u CYP3A4 ta' ċitokrom P450 (ara sezzjoni 5.2).
English: Nadir ANC <500/mm3 with neutropenic fever > 38°C
Maltese: Livell minimu ta' ANC ta' < 500/mm3 b'deni newtropeniku ta' > 38°C
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Maltese: ANC = Għadd Assolut tan-Newtrofili (ANC=Absolute Neutrophil Count); WBC=għadd ta' ċelluli bojod
English: Pazenir Dose
Maltese: Tużax Pazenir
English: 2D bar code carrying the unique identifier
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: The very rare side effects may affect up to 1 in 10,000 people:
Maltese: L-effetti sekondarji rari ħafna jistgħu jaffettwaw sa persuna waħda minn kull 10,000:
English: At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
Maltese: Fil-medda klinika tad-doża ta' 80 sa 300 mg/m2, it-tneħħija medja ta' paclitaxel mill-plażma tvarja minn 13 sa 30 L/siegħa/m2, u l-medja tal-half-life terminali tvarja minn 13 sa 27 siegħa.
English: Gemcitabine dose (mg/m2)
Maltese: Doża ta' gemcitabine (mg/m2)
English: Solvent-based paclitaxel (175 mg/m2)
Maltese: Paclitaxel ibbażat fuq is solvent (175 mg/m2)
English: MedDRA = Medical Dictionary for Regulatory Activities.
Maltese: MedDRA = Medical Dictionary for Regulatory Activities (Dizzjunarju Mediku għal Attivitajiet Regolatorji).
English: Survival Rate % (95% CI) at
Maltese: Rata ta' Sopravivenza % (95% CI) wara
English: The response rates in all patients were 39.5% (95% CI: 24.9%54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Maltese: 6% (CI ta' 95%: 35.3%-60.0%), rispettivament.
English: Patients weighing 50 kg had paclitaxel AUC approximately 25% lower than those weighing 75 kg.
Maltese: Persuni li jiżnu 50 kg kellhom l-AUC ta' paclitaxel li kienet madwar 25% iktar baxxa minn dawk li jiżnu 75 kg.
English: Uncommon: Thrombotic thrombocytopenic purpura
Maltese: Mhux komuni: Purpura trombotika tromboċitopenika
English: CI = confidence interval, HRA+G/G = hazard ratio of Paclitaxel human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Maltese: CI = Intervall ta' kunfidenza, HRA+G/G = proporzjon ta' periklu ta' Nanopartiċelli ta' albumina tas-serum uman paclitaxel+gemcitabine/gemcitabine, pA+G/pG=proporzjon tar-rata ta' rispons ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel+gemcitabine/gemcitabine a mudell stratifikat ta' Cox tal-proporzjon ta' periklu b test log-rank stratifikat, stratifikat skont ir-reġjun ġeografiku (Amerika ta' Fuq kontra l-oħrajn), KPS (70 sa 80 kontra 90 sa
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Maltese: Għal pazjenti b'linja bażi normali tal-livelli ta' CA 19-9, is-sopravivenza HR kienet ta' 1.07 (95% CI 0.692,
English: GA-2031 Haarlem Netherlands
Maltese: GA-2031 Haarlem L-Olanda
English: Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Maltese: Intwera li paclitaxel kien ġenotossiku in vivo (test tal-mikronukleu fil-ġrieden), iżda ma kkawżax mutaġeniċità fit-test ta' Ames jew fl-assaġġ tal-mutazzjoni tal-ġeni tal-ovarju tal-ħamster Ċiniż/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT - Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase).
English: Central nervous system metastases
Maltese: Metastasi fis-sistema nervuża ċentrali
English: • Anxiety
Maltese: • Irrikwetezza
English: ≥ 1000 AND ≥ 75,000
Maltese: U ≥ 75,000
English: The formation of these hydroxylated metabolites is catalysed by CYP2C8, CYP3A4, and both CYP2C8 and CYP3A4 isoenzymes, respectively.
Maltese: Il-formazzjoni ta' dawn ilmetaboliti hydroxylated hi katalizzata minn CYP2C8, CYP3A4, u ż-żewġ isoenzimi CYP2C8 u CYP3A4, rispettivament.
English: Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Maltese: Pazenir 5 mg/ml trab għal dispersjoni għall-infużjoni paclitaxel
English: Alternative light-protection may be used in the clean room.
Maltese: Tista' tintuża protezzjoni alternattiva mid-dawl fil-clean room.
English: The paclitaxel exposure (AUC) increased linearly from 2653 to 16736 ng.hr/ml following dosing from 80 to 300 mg/m2.
Maltese: L-espożizzjoni għal paclitaxel (AUC) żdiedet b'mod lineari minn 2,653 sa 16,736 ng.siegħa/ml wara dożaġġ minn 80 sa 300 mg/m2.
English: There was no difference in ORR between the treatment arms in patients with non-squamous histology (N=602, 26% vs 25%, p=0.808).
Maltese: Ma kien hemm l-ebda differenza fl-ORR bejn il-partijiet tal-istudju dwar it-trattament f'pazjenti b'istoloġija mhux skwamuża (N = 602, 26% vs 25%, p = 0.808).
English: Day 15
Maltese: Ġurnata 15:
English: Rare: Cystoid macular oedema2
Maltese: Edima makulari ċistojde2
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group
Maltese: Tromboċitopenija b,ċ a 405 pazjenti evalwati fil-grupp ittrattat b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel/gemcitabine b 388 pazjenti evalwati fil-grupp ittrattat b'gemcitabine ċ
English: Cutaneous Toxicity:
Maltese: Tossiċità tal-Ġilda:
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of human serum albumin-paclitaxel nanoparticles at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Maltese: Il-farmakokinetika ta' paclitaxel totali wara infużjonijiet ta' 30 u 180 minuta ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel f'livelli ta' doża ta' 80 sa 375 mg/m2 kienu stabbiliti fl-istudji kliniċi.
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and preexisting mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Maltese: Analiżi farmakokinetika tal-popolazzjoni kienet tinkludi pazjenti b'funzjoni normali tal-kliewi (n = 65), u indeboliment tal-kliewi li kien jeżisti minn qabel, ħafif (n = 61), moderat (n = 23), jew sever (n = 1) (skont l-abbozz tal-kriterji gwida tal-FDA 2010).
English: Pazenir 5 mg/ml powder for dispersion for infusion.
Maltese: Pazenir 5 mg/ml trab għal dispersjoni għall-infużjoni.
English: Uncommon: Metastatic pain, tumour necrosis
Maltese: Mhux komuni: Uġigħ metastatiku, nekrosi tat-tumur
English: Limiting the infusion of Pazenir to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Maltese: Jekk tillimita l-infużjoni ta' Pazenir għal 30 minuta, skont l-istruzzjonijiet, tnaqqas ilpossibbilità ta' reazzjonijiet relatati mal-infużjoni.
English: Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI)
Maltese: Numru ta' mwiet, n (%) OS medjana (CI ta' 95%) (xhur) HRA/T (CI ta' 95.1%)
English: The rare side effects may affect up to 1 in 1,000 people:
Maltese: L-effetti sekondarji rari jistgħu jaffettwaw sa persuna waħda minn kull 1,000:
English: Pancreatic adenocarcinoma
Maltese: Adenokarċinoma tal-frixa
English: In addition, elimination of paclitaxel shows an inverse correlation with total bilirubin and a positive correlation with serum albumin.
Maltese: Flimkien ma' dan, l-eliminazzjoni ta' paclitaxel turi korrelazzjoni inversa b'bilirubina totali u korrelazzjoni pożittiva mal-albumina tas-serum.
English: Alopecia was observed in >80% of the patients treated with human serum albumin-paclitaxel nanoparticles.
Maltese: Alopeċja kienet osservata f'> 80% tal-pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum umanpaclitaxel.
English: Neutropenia is dose-dependent and a dose-limiting toxicity.
Maltese: In-newtropenija tiddependi mid-doża u t-tossiċità tillimita d doża.
English: Paclitaxel has been shown to be clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice).
Maltese: (aberrazzjonijiet tal-kromosomi f'limfoċiti umani) u in vivo (test tal-mikronukleu fil-ġrieden).
English: Third
Maltese: III.
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Maltese: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a *Żmien medjan għall-progressjoni tal-marda [CI ta' 95%](ġimgħat) > Terapija tal-ewwel għażla
English: Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Pazenir and gemcitabine (see section 5.1).
Maltese: Għalkemm dejta limitata hi disponibbli, ma ntwera l-ebda benefiċċju ċar f'termini ta' sopravivenza globali fit-tul f'pazjenti b'adenokarċinoma pankreatika b'livelli normali ta' CA 19-9 qabel il-bidu tat trattament b'Pazenir u gemcitabine (ara sezzjoni 5.1).
English: Gemcitabine Dose
Maltese: Doża ta' gemcitabine
English: • Bruising
Maltese: • Sturdament
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD01
Maltese: Sustanzi antineoplastiċi, alkalojdi tal-pjanti u prodotti naturali oħrajn, taxanes, Kodiċi ATC:
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on human serum albumin-paclitaxel nanoparticles, and was severe (Hb < 8 g/dl) in three cases.
Maltese: L-anemija (Hb < 10 g/dl) kienet osservata f'46% tal-pazjenti li kienu fuq nanopartiċelli ta' albumina tas-serum uman-paclitaxel, u kienet severa (Hb < 8 g/dl) fi tliet każijiet.
English: SMQ = Standardized MedDRA Query; SMQ is a grouping of several MedDRA preferred terms to capture a medical concept.
Maltese: SMQ = Standardized MedDRA Query (Stħarriġ standardizzat tal-MedDRA); SMQ hu ġabra ta' diversi termini ppreferuti talMedDRA biex jinkiseb kunċett mediku.
English: 1The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Maltese: 1 Il-frekwenza ta' reazzjonijiet ta' sensittività eċċessiva hi kkalkulata fuq il-bażi ta' każ wieħed definittivament relatat f'popolazzjoni ta' 789 pazjent.
English: Anemia and thrombocytopenia were more commonly reported in the human serum albumin-paclitaxel nanoparticles arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Maltese: Anemija u tromboċitopenija kienu rrappurtati b'mod aktar komuni fil-parti tal-istudju dwar nanopartiċelli ta' albumina tas-serum uman-paclitaxel milli fil-parti tal-istudju dwar Taxol (54% kontra 28% u 45% kontra 27% rispettivament).
English: Mild to moderate renal impairment (creatinine clearance ≥30 to <90 ml/min) has no clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Maltese: Indeboliment minn ħafif sa moderat talkliewi (tneħħija tal-krejatinina ta' ≥ 30 sa < 90 ml/min) m'għandu l-ebda effett klinikament importanti fuq ir-rata massima ta' eliminazzjoni u l-esponiment sistemiku (AUC u Cmax) ta' paclitaxel.
English: • Infection in the lungs
Maltese: • Infezzjoni fil-pulmun
English: There were no clinically relevant pharmacokinetic interactions between human serum albumin-paclitaxel nanoparticlesand carboplatin.
Maltese: Ma kien hemm l-ebda interazzjonijiet klinikament rilevanti bejn nanopartiċelli ta' albumina tas-serum uman-paclitaxel u carboplatin.
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Maltese: Data farmakokinetika mhijiex disponibbli għal pazjenti b'bilirubina totali ta' > 5 x ULN jew gako pazjenti b'adenokar bnetika mhijiex dispo-frixa (ara sezzjoni 4.2).
English: Common: Acute renal failure Uncommon: Haemolytic uraemic syndrome
Maltese: Mhux komuni: Sindrome emolitiku uremiku
English: Pazenir is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2).
Maltese: Pazenir hu formulazzjoni ta' nanopartiċelli ta' paclitaxel marbut mal-albumina li jista' jkollu kwalitajiet farmakoloġiċi li huma differenti b'mod sostanzjali meta mqabbla ma' formulazzjonijiet oħrajn ta' paclitaxel (ara sezzjonijiet 5.1 u 5.2).
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α-hydroxypaclitaxel; and to two minor metabolites, 3'-phydroxypaclitaxel and 6α-3'-p-dihydroxypaclitaxel.
Maltese: tessut juru li paclitaxel hu mmetabolizzat primarjament għal 6α-hydroxypaclitaxel; u għal żewġ metaboliti żgħar, 3'-p-hydroxypaclitaxel u 6α-3'-p-dihydroxypaclitaxel.
English: Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2.
Maltese: Wara r-rikorrenza ta' newtropenija severa jew newropatija sensorja severa, għandu jsir aktar tnaqqis fid-doża għal 180 mg/m2.
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Maltese: Mhux komuni: Kandidajasi tal-ħalq, nażofarinġite, ċellulite, herpes simplex, infezzjoni virali, pnewmonja, infezzjoni marbuta mal-kateter, infezzjoni fungali, herpes zoster, infezzjoni fis-sit tal-injezzjoni, sepsis2, sepsis newtropenika2
English: There was a significant difference in overall response rate in the human serum albumin-paclitaxel nanoparticles/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Maltese: Kien hemm differenza sinifikanti fir-rata ta' rispons globali filparti tal-istudju ta' pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum umanpaclitaxel/carboplatin meta mqabbla mal-parti tal-istudju dwar il-kontroll f'pazjenti li kellhom kanċer tal-pulmun ta' ċelluli mhux żgħar ta' istoloġija skwamuża (N = 450, 41% kontra 24%, p < 0.001),
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with human serum albuminpaclitaxel nanoparticles.
Maltese: Kien hemm newtropenija ta' Grad 4 (< 500 ċellula/mm3) f'9% tal-pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel.
English: For patients ≥ 75 years of age in the human serum albumin-paclitaxel nanoparticles/gemcitabine and gemcitabine arms the survival Hazard Ratio (HR) was 1.08 (95% CI 0.653, 1.
Maltese: F'pazjenti ta' ≥ 75 sena fil-partijiet tal istudju dwar nanopartiċelli ta' albumina tas-serum uman-paclitaxel/gemcitabine u gemcitabine, ilProporzjon ta' Periklu tas-sopravivenza (HR) kien ta' 1.08 (95% CI 0.653, 1. 797).
English: Lymphopenia was observed in 45% of the patients.
Maltese: Il-limfopenija kienet osservata f'45% tal-pazjenti.
English: 4.6 Fertility, pregnancy and breast-feeding
Maltese: 4.6 Fertilità, tqala u treddigħ
English: Pazenir dose (mg/m2)
Maltese: Doża ta' Pazenir (mg/m2)
English: Powder for dispersion for infusion.
Maltese: Trab għal dispersjoni għall-infużjoni.
English: There was a statistically significant improvement in OS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Maltese: Kien hemm titjib statistikament sinifikanti fl-OS għal pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel/gemcitabine meta mqabbla ma' gemcitabine waħdu, b'żieda ta' 1.8 xhur fil-medjan tal-OS, tnaqqis globali ta' 28% fir-riskju ta' mewt, 59% ta' titjib fis-sopravivenza wara sena, u titjib ta' 125% fir-rati ta' sopravivenza wara sentejn.
English: The recommended dose of Pazenir in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Maltese: Id-doża rrakkomandata ta' Pazenir flimkien ma' gemcitabine hi ta' 125 mg/m2 li tingħata ġol-vina fuq 30 minuta fi Ġranet 1, 8 u 15 ta' kull ċiklu ta' 28-ġurnata.
English: Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Maltese: Ġurnata 8 ≥ 500 iżda < 1000 JEW ≥ 50,000 iżda < 75,000
English: Non-haematologic Toxicity
Maltese: Tossiċità Ematoloġika
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Maltese: Mewt jew progressjoni, n (%) PFS medjana (CI ta' 95%) (xhur) HRA/T (CI ta' 95%)
English: Gastrointestinal disorders
Maltese: Gastrointestinali
English: In patients aged 75 years and older who received human serum albumin-paclitaxel nanoparticles and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation (see section 4.4).
Maltese: F'pazjenti li kellhom 75 sena u iktar li rċivew nanopartiċelli ta' albumina tas-serum uman-paclitaxel u gemcitabine, kien hemm inċidenza ogħla ta' reazzjonijiet avversi serji u ta' reazzjonijiet avversi li wasslu għal waqfien tat-trattament (ara sezzjoni 4.4).
English: For ≥ Grade 3 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1.
Maltese: Għal newropatija periferali ta' ≥ Grad 3, waqqaf it-trattament sakemm ikun hemm titjib għal ≤ Grad 1.
English: Occurrence Dose of Pazenir (mg/m2)1
Maltese: Okkorrenza Doża ta' Pazenir (mg/m2)1
English: For treatment of advanced pancreatic cancer, Pazenir is given on days 1, 8 and 15 of each 28day treatment cycle with gemcitabine being given immediately after the Pazenir.
Maltese: Gual trattament ta' kanrattamentiklu ta-frixa, Pazenir jingirtamentiklu t 1, 8 u 15 ta' kull 15 tati' trattament ta' 28-ġurnata b'gemcitabine li jinga-frixa, ull tliPazenir.
English: The key secondary endpoints were progression- free survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Maltese: Il-punt aħħari tal-effikaċja primarja kienet is-sopravivenza globali (OS). Il-punti aħħarin sekondarji ewlenin kienu sopravivenza mingħajr progressjoni (PFS) u r-rata ta' rispons globali (ORR), it-tnejn evalwati minn evalwazzjoni radjoloġika indipendenti, ċentralizzata, u blinded bl-użu ta' linji gwida ta' RECIST (Verżjoni 1.0).
English: CI = confidence interval; HRA/T = hazard ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solventbased paclitaxel/carboplatin; pA/pT = response rate ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solvent-based paclitaxel/carboplatin.
Maltese: CI = intervall ta' kunfidenza; HRA/T = proporzjon ta' periklu ta' Nanopartiċelli ta' albumina tas-serum uman paclitaxel/carboplatin meta mqabbel ma' paclitaxel/carboplatin ibbażat fuq is-solvent; pA/pT = proporzjon ta' rata ta' rispons ta' Nanopartiċelli ta' albumina tas-serum uman-paclitaxel/carboplatin għal paclitaxel/carboplatin ibbażat fuq is-solvent.
English: Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Maltese: In-newtropenija kienet l-iktar tossiċità ematoloġika importanti notevoli (irrappurtata f'79% tal pazjenti), u kienet riversibbli fi żmien qasir u skont id-doża; il-lewkopenija kienet irrappurtata f'71%
English: Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Maltese: Paclitaxel hu eliminat primarjament permezz ta' metaboliżmu epatiku u tneħħija mill-marrara.
English: Pazenir is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Maltese: Pazenir mhuwiex rakkomandat f'pazjenti li jkollhom bilirubina totali ta' > 5 x ULN jew AST > 10 x ULN.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In a repeat dose study with 12 patients receiving human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%37.70%).
Maltese: Fi studju b'dożi ripetuti fuq 12-il pazjent li ngħataw nanopartiċelli ta' albumina tas-serum uman paclitaxel minn ġol-vina b'doża ta' 260 mg/m2, il-varjabilità bejn il-pazjenti fl-AUC kienet ta' 19% (medda = 3.21%-37.
English: CNS metastases are generally not well controlled by systemic chemotherapy.
Maltese: Metastasi fis-CNS ġeneralment mhumiex ikkontrollati tajjeb permezz ta' kimoterapija sistemika.
English: Uncommon: Sepsis, oral candidiasis
Maltese: Mhux komuni: Sepsis, kandidijasi tal-ħalq
English: There was a statistically significant improvement in PFS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS.
Maltese: Kien hemm titjib statistikament sinifikanti fil-PFS għal pazjenti ttrattati b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel/gemcitabine kontra gemcitabine waħdu, b'żieda ta' 1.8 xhur fil-medjan tal-PFS.
English: Pancreatic adenocarcinoma (Pazenir administered in combination with gemcitabine)
Maltese: Adenokarċinoma tal-frixa (Pazenir mogħti flimkien ma' gemcitabine)
English: Table 9: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with carboplatin (N = 514)
Maltese: Tabella 9: Reazzjonijiet avversi rrappurtati b'nanopartiċelli ta' albumina tas-serum umanpaclitaxel flimkien ma' carboplatin (N = 514)
English: The median relative dose intensity of human serum albumin-paclitaxel nanoparticles was 81%.
Maltese: Il-medjan tal-intensità tad doża relattiva ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel kienet ta' 81%.
English: In patients with metastatic breast cancer, after a 30-minute infusion of human serum albuminpaclitaxel nanoparticles at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6α-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Maltese: F'pazjenti b'kanċer metastatiku tas-sider, wara infużjoni ta' 30 minuta ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel b'doża ta' 260 mg/m2, il-valur medju ta' tneħħija kumulattiva tas-sustanza attiva mhux mibdula fl-awrina kienet ta' 4% tad-doża totali mogħtija, b'inqas minn 1% bħala l metaboliti 6α-hydroxypaclitaxel u 3'-p-hydroxypaclitaxel, li jindika tneħħija estensiva mhux mill kliewi.