FrancophonIA/ELRC3.0 huggingface dataset:
English: Solvent- based 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) b'doża ta' 200 mg/m2 bħala infużjoni ġol-vini fuq perjodu ta' 3 sigħat bi premedikazzjoni standard, immedjatament segwit minn carboplatin mogħti ġol-vina b'AUC = 6 mg•min/mL.
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 Pazenir over a minimum of 1 minute.
Maltese: Bl-użu ta' siringa sterili, 20 ml ta' soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride għandhom ikunu injettati bil-mod fil-kunjett ta' 100 mg ta' Pazenir fuq perjodu minimu ta' minuta.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored human serum albuminpaclitaxel nanoparticles and carboplatin (p ≤ 0.002).
Maltese: Bl-użu ta' analiżi ta' kejl ripetut, 3 mill-4 sottoskali (newropatija periferali, uġigħ tal-idejn/saqajn, u smigħ) kienu favur nanopartiċelli ta' albumina tas-serum uman paclitaxel u carboplatin (p ≥ 0.002).
English: Peripheral neuropathy evaluated using the SMQ (broad scope).
Maltese: 1 Newropatija periferali evalwata bl-użu tal-SMQ (ambitu wiesgħa).
English: Common: Lacrimation increased Uncommon: Cystoid macular oedema
Maltese: Komuni: Żieda fid-dmugħ Mhux komuni: Edema makulari ċistojde
English: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Maltese: Ġurnata 15 ≥ 500 iżda < 1000 JEW ≥ 50,000 iżda < 75,000
English: Efficacy variable human serum albuminpaclitaxel nanoparticles (260 mg/m2)
Maltese: Nanopartiċelli ta' albumina tas-serum uman-paclitaxel (260 mg/m2)
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Maltese: Pazjenti b'indeboliment moderat (bilirubina totali ta' > 1.5 sa ≤ 3 x ULN) jew sever (bilirubina totali ta' > 3 sa ≤ 5 x ULN) tal-fwied ikollhom tnaqqis ta' 22% sa 26% fir-rata massima ta'
English: In the very elderly (≥75 years) who received Pazenir 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 Pazenir u gemcitabine, kien hemm inċidenza ogħla ta' reazzjonijiet avversi serji u reazzjonijiet avversi li wasslu għall-waqfien tat-trattament, inklużi tossiċitajiet ematoloġiċi, newropatija periferali, nuqqas ta' aptit u deidrazzjoni.
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Maltese: ≥ 500 iżda < 1000 JEW ≥ 50,000 iżda < 75,000
English: Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Maltese: Erbatax fil mija tal-pazjenti ma kinux ħadu kimoterapija fil-passat; 27% kienu ħadu l-kimoterapija biss bħala trattament addizzjonali, 40% f'ambjent ta' metastasi biss, u 19% kemm f'ambjent ta' metastasi kif ukoll bħala trattament addizzjonali.
English: Day 15: If Day 8 doses were reduced:
Maltese: Jekk id-dożi ta' Ġurnata 8 kienu twaqqfu:
English: Adverse reactions were assessed in 421 patients treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas in a phase III randomized, controlled, open-label trial.
Maltese: Reazzjonijiet avversi ġew evalwati f'421 pazjent ittrattati b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel flimkien ma' gemcitabine u f'402 pazjenti ttrattati b'monoterapija ta' gemcitabine li kienu qed jirċievu trattament sistemiku inizjali għal adenokarċinoma metastatika tal-frixa filprova ta' fażi
English: Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 non- haematologic toxicity
Maltese: Newropatija periferali ta' ≥ Grad 3 Kwalunkwe tossiċità mhux ematoloġika oħra ta' Grad 3 jew 4
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Maltese: Komuni: Takikardija, arritmija, takikardija supraventrikulari Rari: bradikardija, waqfien kardijaku, disfunzjoni ventrikulari fuq ix xellug, insuffiċjenza konġestiva tal-qalb, imblokk atrijoventrikulari2
English: Response rate [95% CI] (%) > 1st-line therapy
Maltese: Rata ta' rispons [CI ta' 95%] (%) > Terapija tal-ewwel għażla
English: Very common: Arthralgia, myalgia.
Maltese: Komuni ħafna: Artralġja, mijalġja
English: Common: Insomnia, depression, anxiety Uncommon: Restlessness
Maltese: Insomnja, depressjoni, ansjetà Mhux komuni: Irrikwetezza
English: Uncommon: Hepatomegaly
Maltese: Mhux komuni: Epatomegalija
English: The frequencies of adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles are listed in Table 6 (human serum albumin-paclitaxel nanoparticles as monotherapy) and Table 7 (human serum albumin-paclitaxel in combination with gemcitabine), and Table 9 (human serum albumin-paclitaxel nanoparticles in combination with carboplatin).
Maltese: Il-frekwenzi ta' reazzjonijiet avversi assoċjati mal-għoti ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel huma elenkati f'Tabella 6 (nanopartiċelli ta' albumina tas-serum uman-paclitaxel bħala monoterapija), u Tabella 7 (nanopartiċelli ta' albumina tas-serum uman-paclitaxel flimkien ma' gemcitabine), u Tabella 9 (nanopartiċelli ta' albumina tas-serum uman-paclitaxel flimkien ma' carboplatin).
English: • People with metastatic breast cancer who received paclitaxel attached to the human protein albumin 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 paclitaxel imwaħħal mal-albumina tal-proteina umana meta terapija oħra ma tkunx irnexxiet, kienu iktar probabbli li jkollhom tnaqqis fid-daqs tat-tumur, u għexu aktar min-nies li kellhom terapija alternattiva.
English: ULN) (see section 5.2).
Maltese: (ara sezzjoni 4.2 u 4.8)
English: For febrile neutropenia, withhold Pazenir and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Maltese: Għal newtropenija bid-deni, waqqaf Pazenir u gemcitabine sakemm jgħaddi d-deni u ANC ≥ 1500 ċellula/mm3, imbagħad erġa' ibda t-trattament b'livelli ta' doża mnaqqsa (ara sezzjoni 4.2).
English: Population pharmacokinetic analysis for human serum albumin-paclitaxel nanoparticles 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 nanopartiċelli ta' albumina tas-serum uman-paclitaxel 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 u l-esponiment sistemiku (AUC u Cmax) għal paclitaxel.
English: human serum albuminpaclitaxel nanoparticles were administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Maltese: 30-40 minuta b'doża ta' 125 mg/m2 segwit minn gemcitabine bħala infużjoni ġol-vina fuq perjodu ta' 30-40 minuta b'doża ta' 1000 mg/m2 mogħtija f'Jiem 1, 8 u 15 ta' kull ċiklu ta'
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Pazenir over a minimum of 1 minute.
Maltese: Bl-użu ta' siringa sterili, 20 ml ta' soluzzjoni għall-infużjoni ta' 9 mg/ml (0.9%) sodium chloride għandhom ikunu injettati bil-mod fil-kunjett ta' Pazenir fuq perjodu minimu ta' minuta.
English: The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate), see section 2 “Pazenir contains sodium”.
Maltese: Is-sustanza l-oħra hi l-albumina umana (li fiha sodium, sodium caprylate u l-N-acetyl DL tryptophanate), ara sezzjoni 2 “Pazenir fih sodium”.
English: • medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
Maltese: • mediċini li jintużaw għat-trattament ta' aċċessjonijiet (epilessija) (eż. carbamazepine,
English: Discontinue treatment
Maltese: Waqqaf it-Trattament
English: Discontinue Treatment
Maltese: Waqqaf it-trattament
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: In-natura tal-kontenitur u ta' dak li hemm ġo fih 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 nanopartiċelli mwaħħla mal-albumina.
English: Each ml of Pazenir contains approximately 4.2 mg of sodium.
Maltese: Kull ml ta' Pazenir fih madwar 4.2 mg ta' sodium.
English: Lung cancer
Maltese: Kanċer tal-pulmun
English: Pregnancy breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilità
English: (PT at Risk) ABX/GEM:
Maltese: (PT f'Riskju)
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 ta' prestazzjoni (ECOG 1 jew 2) fil bidu tal-istudju; 79% kellhom metastasi vixxerali; u 76% kellhom > 3 siti ta' metastasi.
English: Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G(95% Cl)a
Maltese: Sopravivenza Globali, xhur (95% CI) HRA+G/G(95% Cl)
English: *Median time to disease progression [95% CI] (weeks) > 1st-line therapy
Maltese: *Medjan tas-sopravivenza mingħajr progressjoni [CI ta' 95%] (ġimgħat) > Terapija tal-ewwel għażla
English: Very common: Neutropenia, anaemia, thrombocytopenia Common: Pancytopenia
Maltese: Komuni ħafna: Newtropenija, anemija, tromboċitopenija Komuni: Panċitopenija
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Maltese: Tnaqqis fil-piż, żieda f'alanine aminotransferase Komuni: Żieda f'aspartate aminotransferase, żieda fil-bilirubina fid-demm,
English: A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine monotherapy as firstline 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 nanopartiċelli ta' albumina tas-serum uman-paclitaxel/gemcitabine ma' monoterapija b'gemcitabine bħala t-trattament primarju f'pazjenti b'adenokarċinoma metastatika tal-frixa.
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of human serum albumin-paclitaxel nanoparticles.
Maltese: Palsi tan-nervituri tal-kranju, paresi tal-kordi vokali, u rapporti rari ta' reazzjonijiet severi ta' sensittività eċċessiva kienu rrappurtati waqt is-sorveljanza ta' wara t-tqegħid fis-suq ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel.
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Maltese: Fit-tieni prova, intużat doża ta' 300 mg/m2 bħala infużjoni fuq perjodu ta' 30 minuta fi 63 pazjent b'kanċer metastatiku tas-sider.
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 determinata primarjament mill-metaboliżmu medjat minn CYP2C8 u CYP3A4 segwita minn tneħħija mill-marrara, filwaqt li gemcitabine jiġi ddiżattivat minn cytidine deaminase segwit mit-tneħħija millawrina.
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on human serum albuminpaclitaxel nanoparticleswith 10% being Grade 3, and no cases of Grade 4.
Maltese: (ġeneralment newropatija sensorja ta' Grad 1 jew 2) kienet osservata fi 68% tal-pazjenti li kienu fuq nanopartiċelli ta' albumina tas-serum uman-paclitaxel, b'10% li kienu ta' Grad 3, u l-ebda każ ta' Grad 4.
English: ANC count (cells/mm3)
Maltese: Għadd ta' ANC (ċelluli/mm3)
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, sturdament meta tqum bilwieqfa, rogħda, paralisi fin-nerv tal-wiċċ
English: The fraction of free paclitaxel was significantly higher with human serum albumin-paclitaxel nanoparticles (6.2%) than with solventbased paclitaxel (2.3%).
Maltese: paclitaxel ħieles kien ogħla b'mod sinifikanti b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel (6.2%) milli bi paclitaxel ibbażat fuq is-solvent (2.3%).
English: Common: Stomatitis, intestinal obstruction, colitis, dry mouth
Maltese: Komuni: Stomatite, ostruzzjoni intestinali, kolite, ħalq xott
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
Maltese: • mediċini li jintużaw għat-trattament tal-HIV u AIDS (eż. ritonavir, saquinavir, indinavir,
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Maltese: Komuni ħafna: Newtropenija, anemija, lewkopenija, tromboċitopenija, limfopenija, soppressjoni tal-mudullun
English: Uncommon: Drug hypersensitivity, hypersensitivity
Maltese: Mhux komuni: Sensittività eċċessiva għall-mediċina, sensittività eċċessiva
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: 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: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Maltese: L-għoti ta' paclitaxel fl-istess ħin ma' mediċini li huma magħrufa li jinduċu CYP2C8 jew CYP3A4 (eż. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) mhuwiex rakkomandat minħabba li l-effikaċja tista' tiġi kompromessa minħabba esponimenti għal paclitaxel iktar baxxi.
English: a P-value is based on a chi-square test.
Maltese: a Il-valur p hu bbażat fuq test chi-square.
English: Patient-reported taxane toxicity was assessed using the 4 subscales of the Functional Assessment of Cancer Therapy (FACT)-Taxane questionnaire.
Maltese: Tossiċità għal taxane irrappurtata mill-pazjenti ġiet evalwata bl-użu tal-4 sottoskali tal-kwestjonarju dwar l-Evalwazzjoni Funzjonali tat-Terapija Kontra l-Kanċer (FACT - Functional Assessment of
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: 2 As reported in the post-marketing surveillance of human serum albumin-paclitaxel nanoparticles 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving human serum albumin-paclitaxel nanoparticlesmonotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Maltese: 3 Il-frekwenza ta' pulmonite hija kkalkulata abbażi ta' data miġbura f'daqqa minn 1,310 pazjent fi provi kliniċi li rċivew monoterapija b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel għall-kanċer fis-sider u għal indikazzjonijiet oħra bl użu ta' MedDRA SMQ Mard tal-interstizju tal-pulmun.
English: P-valuea
Maltese: Valur-p
English: Reconstituted dispersion For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: The clinical relevance of this finding is uncertain.
Maltese: Ir-rilevanza klinika ta' din is-sejba hi inċerta.
English: Occurrenc e
Maltese: NUMRU(I)
English: HRA+G/G (95%Cl)
Maltese: xhur (95% CI) HRA+G/G (95%Cl) a valur-Pb
English: (independent review)
Maltese: (Intent-to-treat population)
English: Very common: Decreased appetite Common: Dehydration
Maltese: Nuqqas ta' aptit Komuni: Deidratazzjoni
English: ANC <1500/mm3)
Maltese: (livell minimu ta' ANC ta' < 1,500/mm3)
English: Metabolism and nutrition disorders
Maltese: Disturbi fil- metaboliżmu u n-nutrizzjoni
English: Package leaflet: Information for the user Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Maltese: Informazzjoni għall-utent Pazenir 5 mg/ml trab għal dispersjoni għall-infużjoni paclitaxel
English: (mg/m2)1
Maltese: (100 mg/m2/ġimgħa)
English: Pneumonitis has been reported at a rate of 4% with the use of human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine.
Maltese: Pulmonite ġiet irrappurtata f'rata ta' 4% bl-użu ta' nanopartiċelli ta' albumina tas-serum umanpaclitaxel flimkien ma' gemcitabine.
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: For the treated population, the median relative dose intensity for gemcitabine was 75% in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 85% in the gemcitabine arm.
Maltese: Għall-popolazzjoni ttrattata, il-medjan tal-intensità tad doża relattiva kienet ta' 75% fil-parti tal-istudju b' nanopartiċelli ta' albumina tas-serum uman paclitaxel /gemcitabine u 85% fil-parti tal-istudju b'gemcitabine.
English: Arthralgia occurred in 32% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 6% of cases.
Maltese: Kien hemm artralġja fi 32% tal-pazjenti li kienu fuq nanopartiċelli ta' albumina tas-serum uman paclitaxel, u kienet severa f'6% tal-każijiet.
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume human serum albumin-paclitaxel nanoparticlesat a reduced dose.
Maltese: Mill-pazjenti li kellhom it-trattament interrott minħabba newropatija periferali, 44% (31/70 pazjent) kienu kapaċi jkomplu b'nanopartiċelli ta' albumina tas-serum uman-paclitaxel b'doża mnaqqsa.
English: Adjustment of the starting Pazenir 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' Pazenir mhuwiex meħtieġ għal pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi (tneħħija stmata tal-krejatinina minn ≥ 30 sa < 90 ml/min).
English: R Nadir ANC <500/mm3 for > 1 week
Maltese: JEW Livell minimu ta' ANC ta' < 500/mm3
English: The most common clinically significant adverse reactions associated with the use of human serum albumin-paclitaxel nanoparticles have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Maltese: L-iktar reazzjonijiet avversi komuni ta' sinifikanza klinika assoċjati mal-użu ta' nanopartiċelli ta' albumina tas-serum uman-paclitaxel kienu newtropenija, newropatija periferali, artralġja/mijalġja u disturbi gastrointestinali.
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 Pazenir administration.
Maltese: carboplatin b'doża ta' AUC = 6 mg•min/mL ingħata ġol-vini f'Jum 1 biss ta' kull ċiklu ta' 21 jum.
English: Excipients
Maltese: iponatrimija
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: In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Maltese: Fi studju f'pazjenti b'tumuri solidi avvanzati, il-karatteristiċi farmakokinetiċi ta' paclitaxel wara li nanopartiċelli ta' albumina tas-serum uman-paclitaxel ingħataw fil-vina b'rata ta' 260 mg/m2 fuq perjodu ta' 30 minuta, tqabblu ma dawk wara l-għoti ta' 175 mg/m2 ta' injezzjoni ta' paclitaxel ibbażata fuq is-solvent, mogħtija fuq perjodu ta' 3 sigħat.
English: Pazenir 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: ċelluli mhux żgħar f'pazjenti adulti li mhumiex kandidati għal operazzjoni potenzjalment kurattiva u/jew terapija ta' radjazzjoni.
English: Human serum albumin-paclitaxel nanoparticles induced infertility in male rats (see section 5.3).
Maltese: Fertilità Nanopartiċelli ta' albumina tas-serum uman-paclitaxel ikkaġunaw infertilità fil-firien maskili (ara sezzjoni 5.3).
English: Dose adjustments during treatment of non-small cell lung cancer Pazenir should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Maltese: Aġġustamenti fid-doża matul it-trattament ta' kanċer tal-pulmun ta' ċelluli mhux żgħar Pazenir m'għandux jingħata f'Jum 1 ta' ċiklu sakemm l-għadd assolut tan-newtrofili (ANC - absolute neutrophil count) ikun ta' ≥ 1,500 ċellula/mm3 u l-għadd tal-plejtlits ikun ta' ≥ 100,000 ċellula/mm3.
English: Dose of Pazenir
Maltese: X'inhu Pazenir
English: Uncommon: Nail bed tenderness, urticaria, skin pain, photosensitivity reaction, pigmentation disorder, pruritic rash, skin disorder, hyperhidrosis, onychomadesis, erythematous rash, generalised rash, dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail discomfort, generalized pruritus, macular rash, papular rash, skin lesion, swollen face
Maltese: reazzjoni ta' sensittività għad-dawl, disturbi tal-pigmentazzjoni, raxx pruritiku, disturbi fil-ġilda, iperidrosi, onikomadesi, raxx bil-ħmura, raxx ġeneralizzat, dermatite, għaraq matul il-lejl, raxx makulopapulari,
English: Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24
Maltese: Tel: +40 21 230 65 24
English: • Acute kidney failure
Maltese: • Insuffiċjenza akuta tal-kliewi