FrancophonIA/ELRC3.0 huggingface dataset:
English: Myelosuppression events, peripheral neuropathy events, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years of age.
Maltese: Avvenimenti ta' majelosoppressjoni, avvenimenti ta' newropatija periferali, u artralġja kienu iktar frekwenti f'pazjenti li kellhom 65 sena jew aktar meta mqabbla ma' pazjenti iżgħar minn 65 sena.
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 notevoli (irrappurtata f'79% tal-pazjenti), u kienet riversibbli fi żmien qasir u skont id-doża; il-lewkopenija kienet irrappurtata f'71% tal-pazjenti.
English: Each drug was administered on Day 1 of each 21-day cycle.
Maltese: Kull mediċina ngħatat f'Jum 1 ta' kull ċiklu ta' 21 jum.
English: Rare: Pancytopenia
Maltese: Mhux komuni: Panċitopenija
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with Abraxane.
Maltese: Kien hemm rapporti rari ta' tnaqqis fiċ-ċarezza tal-vista minħabba edema makulari ċistojde matul ilkura b'Abraxane.
English: Reconstitution of 100 mg:
Maltese: Rikostituzzjoni ta' 100 mg
English: Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Maltese: Erbgħa u sittin fil-mija tal-pazjenti kellhom indeboliment fl-istat tal-prestazzjoni (ECOG 1 jew 2) filbidu tal-istudju; 79% kellhom metastasi vixxerali; u 76% kellhom >3 siti ta' metastasi.
English: The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Maltese: L-iktar reazzjonijiet avversi komuni assoċjati mal-użu ta' Abraxane kienu newtropenija, newropatija periferali, artralġja/mijalġja u disturbi gastrointestinali.
English: Uncommon: Pneumonitis3
Maltese: Komuni ħafna: Newtropenija
English: Abraxane contains sodium
Maltese: Abraxane fih is-sodium
English: The generation of foam must be avoided.
Maltese: Il-formazzjoni tar-ragħwa għandha tkun evitata.
English: A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare Abraxane/gemcitabine versus gemcitabine monotherapy as first-line treatment in patients with metastatic adenocarcinoma of the pancreas.
Maltese: Studju multiċentriku, multinazzjonali, u open-label, li fih il-parteċipanti ntgħażlu b'mod każwali, twettaq fi 861 pazjent biex jiġi pparagunat Abraxane/gemcitabine ma' monoterapija b'gemcitabine bħala l-kura primarja f'pazjenti b'adenokarċinoma metastatika tal-frixa.
English: Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Maltese: Paclitaxel ibbażat fuq is-solvent ingħata lill-pazjenti (N=531) f'doża ta' 200 mg/m bħala infużjoni ġol-vini fuq perjodu ta' 3 sigħat bi premedikazzjoni standard, immedjatament segwit minn carboplatin mogħti ġol-vina f'AUC = 6 mg•min/mL.
English: Table 8: Haematologic laboratory-detected abnormalities in pancreatic adenocarcinoma trial
Maltese: Tabella 8: Anormalitajiet ematoloġiċi osservati fil-laboratorju fil-prova dwar adenokarċinoma tal-frixa
English: 1 Peripheral neuropathy evaluated using the SMQ (broad scope).
Maltese: Newropatija periferali evalwata bl-użu tal-SMQ (ambitu wiesgħa).
English: • Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis
Maltese: • Tnaqqis jew nuqqas ta' riflessi, movimenti involontarji, uġigħ tul xi nerv, tintilef minn sensik,
English: In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Maltese: F'pazjenti anzjani ħafna (≥75 sena) li rċivew Abraxane u gemcitabine, kien hemm inċidenza ogħla ta' reazzjonijiet avversi serji u reazzjonijiet avversi li wasslu għall-waqfien tal-kura, inklużi tossiċitajiet ematoloġiċi, newropatija periferali, nuqqas ta' aptit u deidrazzjoni.
English: Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Maltese: Abraxane fih, bħala s-sustanza attiva tiegħu, paclitaxel imwaħħal mal-albumina tal-proteina umana, fil-forma ta' partikuli żgħar ħafna magħrufa bħala nanopartikuli.
English: For ≥ Grade 3 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1.
Maltese: Għal newropatija periferali ta' ≥ Grad 3, waqqaf il-kura sakemm ikun hemm titjib għal ≤ Grad 1.
English: Lung Cancer
Maltese: Kanċer tal-Pulmun
English: Population pharmacokinetic analysis for Abraxane included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Maltese: Analiżi farmakokinetika tal-popolazzjoni għal Abraxane kienet tinkludi pazjenti b'etajiet li kienu jvarjaw minn 24 sa 85 sena u turi li l-età ma tinfluwenzax b'mod sinifikanti r-rata massima ta' eliminazzjoni l-esponiment sistemiku (AUC u Cmax) ta' paclitaxel.
English: Beginning immediately after the end of Abraxane administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Maltese: B'bidu immedjatament wara t-tmiem tal-għoti ta' Abraxane, carboplatin f'doża ta' AUC = 6 mg•min/mL ingħata ġol-vini f'Jum 1 biss ta' kull ċiklu ta' 21 jum.
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Maltese: Il-kriterju ta' noninferjorità ġie ssodisfat kemm għal PFS kif ukoll għal OS bl-upper bound tal-intervall ta' kunfidenza ta' 95% għal proporzjonijiet ta' periklu assoċjati li kien inqas minn 1.176 (Tabella 13).
English: 50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Kunjett ta' 50 ml (ħġieġ ta' tip 1) b'tapp (lastku tal-butyl), b'siġill fuqu (aluminju), li fih 100 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla mal-albumina.
English: Excipients: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Maltese: Eċċipjenti: Soluzzjoni ta' albumina umana (li fiha sodium, sodium caprylate u N-acetyl DL tryptophanate).
English: Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Abraxane jiġi f'kunjetti talħġieġ li fihom 100 mg jew 250 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla malalbumina.
English: The recommended dose of Abraxane is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Maltese: Id-doża rakkomandata ta' Abraxane hi ta' 100 mg/m li tingħata bħala infużjoni ġol-vini fuq perjodu ta' 30 minuta f'Jiem 1, 8 u 15 ta' kull ċiklu ta' 21 jum.
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Maltese: Hu maħsub li dan it-trasport kaveolari mtejjeb transendoteljali hu mmedjat mir-riċettur tal-albumina gp-60, u li hemm akkumulazzjoni mtejba ta' paclitaxel fiż-żona tat-tumur minħabba l-proteina li teħel mal-albumina Secreted Protein Acidic Rich in Cysteine (SPARC).
English: Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Maltese: Studji fuq l-annimali b'Abraxane wrew effetti tossiċi mhux riversibbli fuq l-organi riproduttivi tal-irġiel f'livelli ta' espożizzjoni klinikament rilevanti.
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Maltese: Għal pazjenti b'kanċer metastatiku tas-sider b'kanċer tal-pulmun ta' ċelluli mhux żgħar b'indeboliment moderat sa sever tal-fwied (bilirubina totali ta' > 1.5 sa ≤ 5 x ULN u AST ta' ≤ 10 x ULN), tnaqqis ta' 20% fid-doża hu rakkomandat.
English: In addition, Abraxane is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x ULN) (see section 5.2).
Maltese: Flimkien ma' dan, Abraxane mhuwiex rakkomandat f'pazjenti b'adenokarċinoma metastatika tal-frixa li jkollhom indeboliment moderat sa sever tal-fwied (bilirubina totali ta' > 1.5 x ULN u AST ta' ≤ 10 x ULN) (ara sezzjoni 5.2).
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in Abraxane/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in Abraxane/gemcitabine-treated group
Maltese: 405 pazjenti evalwati fil-grupp ikkurat b'Abraxane/gemcitabine b
English: a P-value is based on a chi-square test.
Maltese: Il-valur p hu bbażat fuq chi-square test.
English: 1On Day 1 of the 21-day cycle reduce the dose of Abraxane and carboplatin simultaneously.
Maltese: F'Jum 1 taċ-ċiklu ta' 21 jum, naqqas id-doża ta' Abraxane u carboplatin fl-istess ħin.
English: • People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Maltese: • Persuni b'kanċer metastatiku fis-sider li rċivew Abraxane meta terapija oħra ma tkunx irnexxiet, kienu iktar probabbli li jkollhom tnaqqis fid-daqs tat-tumur, u għexu aktar min-nies li għamlu terapija alternattiva.
English: Human albumin solution (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Maltese: Soluzzjoni tal-albumina umana (li fiha sodium, sodium caprylate u N-acetyl DL tryptophanate).
English: Neurotoxicity to paclitaxel was evaluated through improvement by one grade for patients experiencing Grade 3 peripheral neuropathy at any time during therapy.
Maltese: In-newtrossiċità għal paclitaxel kienet evalwata permezz ta' titjib bi grad wieħed għall-pazjenti li kellhom newropatija periferali ta' Grad 3 fi kwalunkwe ħin matul it-terapija.
English: Table 7: Adverse reactions reported with Abraxane in combination with gemcitabine (N =421) Infections and infestations
Maltese: Reazzjonijet avversi rrappurtati b'Abraxane flimkien ma' gemcitabine (N = 421) Infezzjonijiet u infestazzjonijiet
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose.
Maltese: Mill-pazjenti li kellhom il-kura interrotta minħabba newropatija periferali, 44% (31/70 pazjent) kienu kapaċi jkomplu b'Abraxane b'doża mnaqqsa.
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Maltese: Din l-analiżi kienet tinkludi pazjenti b'funzjoni normali tal-fwied (n=130), u b'indeboliment tal-fwied li kien jeżisti minn qabel, ħafif (n=8), moderat (n=7), jew sever (n=5) (skont il-kriterja tal-NCI
English: Nadir platelets <50,000/mm3
Maltese: Livell minimu ta' plejtlits ta' <50,000/mm
English: What Abraxane is
Maltese: Doża ta' Abraxane
English: Uncommon: Breast pain
Maltese: Komuni: Pulmonite interstizjali
English: Paclitaxel clearance is primarily determined by CYP2C8 and CYP3A4 mediated metabolism followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase followed by urinary excretion.
Maltese: It-tneħħija ta' Paclitaxel tiġi stabbilita primarjament mill-metaboliżmu medjat minn CYP2C8 u CYP3A4 segwita mit-tneħħija millmarrara, filwaqt li gemcitabine jiġi ddiżattivat minn cytidine deaminase segwit mit-tneħħija millawrina.
English: The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of Abraxane administration.
Maltese: Id-doża rakkomandata ta' carboplatin hi AUC = 6 mg•min/mL f'Jum 1 biss ta' kull ċiklu ta' 21 jum, li jibda immedjatament wara t-tmiem talgħoti ta' Abraxane.
English: For the treated population, the median relative dose intensity for gemcitabine was 75% in the Abraxane/gemcitabine arm and 85% in the gemcitabine arm.
Maltese: Għall-popolazzjoni kkurata, il-medjan tal-intensità tad-doża relattiva kienet ta' 75% fil-parti talistudju b'Abraxane/gemcitabine u 85% fil-parti tal-istudju b'gemcitabine.
English: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.
Maltese: Bl-użu ta' siringa sterili, 50 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni għandha tkun injettata bil-mod ġol-kunjett ta' 250 mg ta' Abraxane fuq perijodu minimu ta' minuta.
English: Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases.
Maltese: Kien hemm artralġja fi 32% tal-pazjenti li kienu fuq Abraxane, u kienet severa f'6% tal-każijiet.
English: Abraxane is not recommended in patients that have total bilirubin > 5 x ULN or AST > 10 x ULN.
Maltese: Abraxane mhuwiex rakkomandat f'pazjenti li jkollhom bilirubina totali ta' >5 x ULN jew AST >10
English: How often will you receive Abraxane?
Maltese: Kemm ta' spiss ser tingħata Abraxane?
English: However, a subsequent analysis in 981 patients receiving Abraxane monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Maltese: Madankollu, analiżi sussegwenti fost 981 pazjent li rċivew monoterapija ta' Abraxane għal kanċer tas-sider metastatiku, u li minnhom 15% kellhom ≥ 65 sena u 2% kellhom ≥ 75 sena, uriet inċidenza ogħla li tinfaraġ dijarea, deidrazzjoni, għajja u edema periferali f'pazjeni ≥ 65 sena.
English: Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine.
Maltese: Pulmonite ġiet irrappurtata f'rata ta' 4% bl-użu ta' Abraxane flimkien ma' gemcitabine.
English: The recommended dose of Abraxane 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: Adenokarċinoma tal-frixa Id-doża rrakkomandata ta' Abraxane flimkien ma' gemcitabine hi ta' 125 mg/m li tingħata ġol-vina fuq 30 minuta fi Ġranet 1, 8 u 15 ta' kull ċiklu ta' 28-ġurnata.
English: Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Maltese: Kien hemm dardir f'29% tal-pazjenti u dijarea f'25% tal-pazjenti.
English: nevirapine)
Maltese: efavirenz, nevirapine)
English: Breast cancer (Abraxane administered as monotherapy)
Maltese: Kanċer tas-sider (Abraxane mogħti bħala monoterapija)
English: Uncommon1: Hypersensitivity Rare: Severe hypersensitivity
Maltese: Mhux komuni: Kontużjoni Rari:
English: *Median progression free survival [95% CI] (weeks)
Maltese: *Medjan tal-progressjoni tas-sopravivenza ħielsa [95% CI] (ġimgħat)
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Maltese: Palsi tan-nervituri tal-kranju, paresi tal-kordi vokali, u rapporti rari ta' reazzjonijiet severi ta' sensittività eċċessiva waqt is-sorveljanza ta' wara t-tqegħid fis-suq ta' Abraxane.
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.
Maltese: Bl-użu ta' siringa sterili, 20 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni għandha tkun injettata bil-mod ġol-kunjett ta' 100 mg ta' Abraxane fuq perijodu minimu ta' minuta.
English: For treatment of advanced pancreatic cancer, Abraxane is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Abraxane.
Maltese: Għall-kura ta' kanċer avvanzat tal-frixa, Abraxane jingħata fi ġranet 1, 8 u 15 ta' kull ċiklu ta' kura ta' 28-ġurnata b'gemcitabine li jingħata eżatt wara Abraxane.
English: Overall Survival Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Maltese: Rispons globali kkonfermat sħiħ jew parzjali, n (%) 95% CI pA+G/pG (95% CI) valur-P (chi-square test)
English: Overall Response Rate (independent review) Confirmed complete or partial overall response, n (%) 95% CI (%) pA/pT (95.1% CI)
Maltese: Rata ta' Rispons Globali (Evalwazzjoni Indipendenti) Rispons sħiħ jew rispons parzjali globali kkonfermat, n (%) 95% CI (%) pA/pT (95.
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle.
Maltese: Mudell ta' farmakokinetika/farmakodinamika bl-użu ta' dejta minn 125 pazjent b'tumuri solidi avvanzati jindika li pazjenti ≥ 65 sena jafu jkunu iktar suxxettibbli għall-iżvilupp ta' newtropenija matul l-ewwel ċiklu ta' kura.
English: In patients aged 75 years and older who received Abraxane 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 Abraxane u gemcitabine, kien hemm inċidenza ogħla ta' reazzjonijiet avversi serji u ta' reazzjonijiet avversi li wasslu għal waqfien tal-kura (ara sezzjoni 4.4).
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Maltese: Ir-riżultati juru li indeboliment ħafif tal-fwied (bilirubina totali ta' >1 sa ≤1.5 x ULN) m'għandu l-ebda effett klinikament importanti fuq il-farmakokinetika ta' paclitaxel.
English: A higher median cumulative dose of gemcitabine was delivered in the Abraxane/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Maltese: Irriżulta medjan ogħla tad-doża kumulattiva ta' gemcitabine fil-parti tal-istudju b'Abraxane/gemcitabine (11,400 mg/m2) meta mqabbel mal-parti tal istudju b'gemcitabine (9000 mg/m
English: Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Maltese: Paclitaxel hu eliminat primarjament permezz tal-metaboliżmu tal-fwied u tneħħija mill-marrara.
English: Use of filters with a pore size less than 15 µm may result in blockage of the filter.
Maltese: L-użu ta' filtri b'daqs ta' pori ta' inqas minn 15 µm jista' jirriżulta fl-imblukkar tal-filtru.
English: Table 6: Adverse reactions reported with Abraxane monotherapy at any dose in clinical studies Infections and infestations
Maltese: Tabella 6: Reazzjonijiet avversi rrappurtati b'monoterapija ta' Abraxane fi kwalunkwe doża fi studji kliniċi
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, weight decreased
Maltese: Komuni: Żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase, żieda ta' alkaline phosphatase fid-demm, tnaqqis fil-piż
English: Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Maltese: Abraxane flimkien ma' carboplatin hu indikat għall-kura primarja ta' kanċer tal-pulmun ta' ċelluli mhux żgħar f'pazjenti adulti li mhumiex kandidati għal operazzjoni potenzjalment kurattiva u/jew terapija ta' radjazzjoni.
English: CI = confidence interval; HRA/T = hazard ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin; pA/pT = response rate ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin.
Maltese: CI = Intervall ta' kunfidenza, HRA+G/G = proporzjon ta' periklu ta' Abraxane+gemcitabine/gemcitabine, pA+G/pG=proporzjon tar-rata ta' rispons ta' Abraxane+gemcitabine/gemcitabine,
English: Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel albumin, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal paclitaxel albumin, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: The rare side effects may affect up to 1 in 1,000 people:
Maltese: L-effetti sekondarji rari jistgħu jaffettwaw sa 1 minn kull 1000 persuna:
English: Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Maltese: Erlotinib m'għandux jingħata flimkien ma' Abraxane u gemcitabine (ara sezzjoni 4.5).
English: Cutaneous Toxicity: Grade 2 or 3
Maltese: Tossiċità tal-ġilda ta' Grad 2 jew 3 Dijarea ta' Grad 3
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Maltese: SMQ = Standardized MedDRA Query (Stħarriġ standardizzat tal-MedDRA - ġabra ta' diversi termini ppreferuti tal-MedDRA biex jinkiseb kunċett mediku).
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni, il-volum totali tad-distribuzzjoni hu ta' madwar 1741 L; il-volum il-kbir tad-distribuzzjoni jindika distribuzzjoni extravaskulari estensiva u/jew twaħħil ta' paclitaxel mat-tessut.
English: Delay of next cycle due to persistent neutropenia2 (Nadir ANC <1500/mm3)
Maltese: Dewmien taċ-ċiklu li jkun imiss minħabba newtropenija persistenti (livell minimu ta' ANC ta' <1500/mm
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Maltese: L-użu ta' kontenituri speċjalizzati għas-soluzzjoni, ħielsa minn di(2-ethylhexyl)phthalate (DEHP), jew settijiet tal-għoti, mhumiex meħtieġa biex tipprepara jew tagħti infużjonijiet ta' Abraxane.
English: Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Kull kunjett fih 250 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla mal-albumina.
English: 250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Maltese: Kunjett ta' 250 mg: Bl-użu ta' siringa sterili, 50 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni għandhom ikunu injettati bil-mod fil-kunjett ta' Abraxane fuq perijodu minimu ta' minuta.
English: Adjustment of the starting Abraxane dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Maltese: Aġġustament tad-doża tal-bidu ta' Abraxane mhuwiex meħtieġ għal pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi (tneħħija stmata tal-krejatinina minn ≥30 sa <90 ml/min).
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome,
Maltese: • Infjammazzjoni severa/joħorġu leżjonijiet tal-ġilda u tal-membrani mukużi (sindrome ta'