FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel did not influence the binding of digitoxin.
Maltese: Docetaxel ma kellux effetti fuq ir-rabta ta' digitoxin mal-proteina.
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Maltese: Majalġja (G3/4: 2%); Artralġja (G3/4: 1%)
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/ or cyclophosphamide (see section 4.8).
Maltese: Ġiet irrapportata arritmija ventrikulari inkluż takikardija ventrikulari (xi kultant fatali) f'pazjenti ttrattati b'docetaxel f'skedi ta' dożaġġi li fihom taħlita ta' doxorubicin, 5-fluorouracil u/ jew cyclophosphamide (ara sezzjoni 4.8).
English: Infection (G3/4: 7.8%)
Maltese: Infezzjoni (G3/4: 7.8%)
English: Hypersensitivity (no severe)
Maltese: Sensittività eċċessiva (mhux severa)
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Maltese: Newtropenija (G3/4: 32%); Anemija (G3/4: 4.9%)
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Maltese: Fl-istudju GEICAM 9805, 3 pazjenti (0.6 %) fil-fergħa ta' TAC u 3 pazjenti (0.6 %) fil-fergħa ta' FAC żviluppaw insuffiċjenza konġestiva tal-qalb (congestive heart failure-CHF) waqt il-perjodu ta' osservazzjoni.
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Maltese: Il-fażi ta' l-aħħar hija dovuta partjalment għall-effluss relattivament bil-mod ta' docetaxel mill-kompartiment periferika.
English: †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: 0175 **PSA: Prostate-Specific Antigen
English: Infection (G3/4: 5.7%)
Maltese: Infezzjoni (G3/4: 5.7%)
English: Hypersensitivity (G3/4: 2.5%)
Maltese: Sensittività eċċessiva (G3/4: 2.5%)
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4:0.6%);
English: Complicated neutropenia
Maltese: Disturbi vaskulari
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Maltese: III, 1218-il pazjent li kellhom tumur li ma jistax jitneħħa kiruġikament, kategorija IIIB jew IV NSCLC, b'KPS ta' 70% jew akbar, u li ma rċevewx kimoterapija preċedenti għal din ilkundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa it-docetaxel (T) f'doża ta' 75 mg/m2 bħala infużjoni tul siegħa, segwita immedjatament b'cisplatin (Sis) 75 mg/m2 li ngħata fuq perjodu ta' bejn 30 sa 60 minuta kull 3 ġimgħat (TCis), jew docetaxel 75 mg/m2 bħala infużjoni fil vini f'tul ta' siegħa, flimkien ma' carboplatin (AUC 6 mg/ml.minuta) li ngħata f'30 sa 60 minuta kull 3 ġimgħat, jew vinorelbine (V) 25 mg/m2, mogħti tul 6 sa 10 minuti fil-jiem 1, 8, 15 u 22, segwit b'cisplatin 100 mg/m2 li ngħata fl-ewwel jum taċ-ċikli tal-kura, repetuti kull 4 ġimgħat (VCis).
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: • 174 u 251pazjent b'kanċer tar-ras u ta' l-għonq li ħadu docetaxel flimkien ma'cisplatin u 5fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma rrapportati).
English: The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
Maltese: Il-profil farmakokinetiku ta' cisplatin, li ngħata ftit wara l-infużjoni ta' docetaxel, huwa simili għal dak osservat b'cisplatin waħdu.
English: G3/4 Blood bilirubin increased (< 2.5%);
Maltese: G3/4 Żieda fil-bilirubin fid-demm (< 2.5%);
English: Neutropenia (G3/4: 32%);
Maltese: Newtropenija (G3/4: 32%);
English: • Risk Management Plan (RMP)
Maltese: Pjan tal-immaniġġar tar-riskju (RMP)
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Maltese: FAC = 5-fluorouracil, doxorubicin u cyclophospamide
English: Abdominal pain;
Maltese: Uġigħ addominali;
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Maltese: Is-sindrome majilodisplastik ġie rrappurtat f'2 minn 744 pazjenti fuq TAC (0.3 %) u f'1 minn 736 pazjent fuq FAC(0.1 %).
English: 2-year estimate (%)
Maltese: Estimu ta sentejn (%)
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Maltese: Newtropenija (G3/4: 63%); Anemija (G3/4: 10%)
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Maltese: • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX
English: Pyrexia (G3/4: 1%);
Maltese: Stitikezza (G3/4: 1%);
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Maltese: Sturdament (G3/4: 2.3%); Newropatija periferika talmovimenti (G3/4: 1.3%)
English: • hearing impaired
Maltese: *Unstratified logrank test
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Maltese: Il-pazjenti ittrattati b'TCF kellhom żmien itwal biex jaslu għal-deterjorament definittiv ta' 5% ta' l-istat globali ta' saħħa fil-kwestjonarju QLQ-C30 (p = 0.0121) u żmien itwal biex jeħżienu definittivament skont il-performance status ta' Karnofsky (p = 0.0088), meta mqabbla ma' pazjenti ittrattati b'CF.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000)
English: Infection (G3/4: 3.3%)
Maltese: Infezzjoni (G3/4: 3.3%)
English: Diarrhoea grade 3
Maltese: Dijarea ta' Grad 3
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Maltese: Fiż-żmien medjan ta' osservazzjoni ta' 10 snin u 5 xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 16.5% fir-riskju ta' rikaduta meta mqabbla ma dawk ikkurati b'FAC (proporzjon ta' periklu = 0.84, 95% CI (0.65-1.08), p=0.1646).
English: Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Maltese: Is-sopravivenza totali kienet ukoll b'mod sinifikattiv itwal (p = 0.0201) favur il-fergħa TCF b'riskju mnaqqas ta' mortalità ta' 22.7%.
English: Rare cases of myocardial infarction have been reported.
Maltese: Każijiet rari ta' infart mijokardijaku kienu irrapportati.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi) Ġew irrapportati malinji primarji sussegwenti (frekwenza mhux magħrufa), inkluż limfoma mhux ta' Hodgkin b'relazzjoni ma' docetaxel meta jintuża flimkien ma' trattamenti oħra kontra l-kanċer magħrufa li huma assoċjati ma' malinji primarji sussegwenti.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Maltese: Wara t-tqassim tal-pazjenti skont in-numru ta' glandoli limfatiċi effettwati (1-3, 4+), 1491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/m2 siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa FAC).
English: Other medicines and DOCETAXEL KABI
Maltese: Mediċini oħra u DOCETAXEL KABI
English: Musculoskeletal, connective tissue bone disorders
Maltese: Disturbi muskoluskeletrali,tal-connective tissue
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Maltese: • 92 pazjent ittrattati b'docetaxel flimkien ma' trastuzumab.
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Maltese: Meta ntużaw flimkien, doetaxel ma jeffetwax it-tneħħija ta' doxorubicin u anqas l-livelli tal-plasma ta' doxorubicinol (prodott metaboliku tad-doxorubicin).
English: Arrhythmia (G3/4: 0.2%)
Maltese: Arritmija (G3/4: 0.2%)
English: Thrombocytopenia (G3/4: 3%)
Maltese: Tromboċitopenija (G3/4: 3%)
English: Cases of permanent alopecia (frequency not known) have been reported.
Maltese: Ġew irrapportati każijiet ta' alopeċja permanenti (frekwenza mhux magħrufa).
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Maltese: Ir-riskju fit tnaqqis ta' l-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-fergħa TCF.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Maltese: Pazjenti tal-fergħa kompettitiva rċevew cisplatin (P) 100 mg/m2 segwit minn 5-fluorouracil (F) 1000 mg/m2 kuljum għal 5 ijiem.
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Maltese: L-aħħar stadju primarju effikaċju tal-proċess f'dan l-istudju, l-aħjar sopravivenza (OS), kien b'mod sinifikattiv itwal (log-rank test, p=0.0058) fil-fergħa ta' docetaxel, meta mqabbel mal-grupp ta' PF (OS medjan: 70.6 kontra 30.1 xhur rispettivament) b'tnaqqis tar-riskju ta' mortalità b'30% meta mqabbel ma' dak tal-fergħa PF ( Il-proporzjon tar-riskju (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) l-aħjar tul medjan tal-perijodu ta' osservazzjoni ta' 41.9 xhur.
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons
Maltese: Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + fluorouracil *Log-rank test mhux aġġustat **Logrank test mhux aġġustat, mhux aġġustat għal paraguni multipli ***Chi-square test, mhux aġġustat għal paraguni multipli NA - Ma jgħoddx f'dan il-każ.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: Ir-reazzjonijiet avversi l-aktar komunement irrapportati ta' docetaxel innifsu huma: newtropenija (li kienet riversibbli u mhux kumulattiva: il-jum medjan biex jintlaħaq in-nadir kien ta' 7 ijiem u ż-żmien medju ta' dewmien tan-newtropenija severa (< 500 ċelluli/mm3) kien ta' 7 ijiem), anemija, alopeċja, tqalligħ, rimettar, stomatite, dijarea u astenja.
English: Prostate cancer
Maltese: Kanċer tal-prostata
English: Median PFS (months) (95% CI)
Maltese: PFS madjana (xhur) (95%CI)
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value
English: Vascular disorders Lymphoedema Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Maltese: Ġew irrapportati s-sindromu ta' distress respiratorju akut, pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja u li dawn jistgħu jwasslu għallmewt.
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Maltese: Prednisone jew prednisolone meħud orali f'doża ta' 5 mg darbtejn kuljum, jingħata bla waqfien (ara sezzjoni 5.1).
English: • indigestion
Maltese: • indiġistjoni
English: Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Maltese: Pazjenti li diġà kellhom reazzjoni ta' sensittività eċċessiva għal paclitaxel jistgħu jkunu f'riskju li jiżviluppaw reazzjoni ta' sensittività eċċessiva għal docetaxel, inkluż reazzjoni ta' sensittività eċċessiva aktar severa.
English: Clinical benefit parameters
Maltese: Il-parametri tal-benefiċċju kliniku
English: • 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Maltese: 316 u GEICAM 9805 rispettivament) li ħadu docetaxel flimkien ma' doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Maltese: Majalġja (G3/4: 0.7%); Artralġja (G3/4: 0.2%)
English: Grade1 (includes grade not assessed)
Maltese: Grad 1 (jinkludi meta ma ġiex valutat il-grad)
English: Discontinue treatment if these toxicities persist (see section 4.4).
Maltese: It-trattament għandu jitwaqqaf jekk dawn l-effetti tossiċi jippersistu (ara sezzjoni 4.4).
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Maltese: Il-pazjenti li qed jieħdu TCF għandhom ikunu immoniterjati mill-qrib (ara sezzjonijiet 4.2 u 4.8).
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Maltese: Jekk jinqalgħu episodji oħra sussegwenti ta' newtropenija b' komplikazzjonijiet, id-doża ta' docetaxel għandha tiġi mnaqqsa minn 60 għal 45 mg/m2.
English: The following adverse reactions are frequently observed with docetaxel:
Maltese: Ir-reazzjonijiet avversi li jmissu huma ikkaġunati spiss b'docetaxel:
English: Exfoliative rash (G3/4: 0.3%)
Maltese: Raxx esfoljattiv (G3/4: 0.3%)
English: Yes
Maltese: FAC
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Maltese: Meta jintuża għall-kura preferita, docetaxel 75 mg/m2 jingħata flimkien ma' doxorubicin (50 mg/m2).
English: Hypersensitivity (G3/4: 1.2%)
Maltese: Sensittività eċċessiva (G3/4: 1.2%)
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
Maltese: Sinkope (G3/4: 0%): Newrotossiċità (G3/4:0 %)
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Maltese: Il-valuri medji tat-tneħħija totali mill-ġisem u l-volum ta' distribuzzjoni meta jintlaħaq stat stabbli u miżmum kienu 21 l/siegħa/m2 u 1131 l, rispettivament.
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: • Imbagħad, injetta permezz ta' injezzjoni waħda (titqiba waħda) ġo flixkun jew borża ta' infużjoni ta' 250 ml li jkun fihom jew soluzzjoni ta' 5 % glucose jew soluzzjoni għall-injezzjoni ta' 9 mg/ml sodium chloride (0.9 %).
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Maltese: L-Effikaċja ta' docetaxel fit-trattament induttiv ta' pazjenti b'SCCHN inoperabbli u lokalmentavvanzat (Analiżi bl-Iskop li Titratta)
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Maltese: Ir-rata ta' sopravivenza kienet 93.7% fil-fergħa ta' TAC u 91.4 % fil-fergħa ta' FAC, fil-punt tat-8 sena ta' osservazzjoni, u 91.3 % fil-fergħa ta' TAC u 89 % fil-fergħa ta' FAC, fil-punt tal-10 sena ta' osservazzjoni.
English: Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Maltese: Letarġija (G3/4: 19.0%); Deni (G3/4: 2.3%);
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Maltese: F'TAX316, l-amenorreja li bdiet matul il-perijodu ta' trattament u li baqgħet tippersisti fil-perijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet irrapportata f'202 minn 744 pazjent TAC (27.2 %) u f'125 minn 736 pazjent FAC (17.0 %).
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Maltese: Docetaxel jappartjeni għall-klassi ta' mediċini kontra l-kanċer li jissejħu taxoids.
English: Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Maltese: Tqalligħ (G3/4: 5%); Stomatite (G3/4: 7.8%);
English: Anorexia (G3/4: 1%); Decreased appetite
Maltese: Anoreksja(G3/4: 1%); Tnaqqis fl-aptit
English: B. PACKAGE LEAFLET
Maltese: Il-grupp talpazjenti
English: Myocardial ischemia (G3/4: 1.7%)
Maltese: Mard iskemiku talmijokardju (G3/4:1.7%)
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Maltese: Iż-żmien biex jintlaħaq il-mard progressiv kien superjuri bid-docetaxel u capecitabine flimkien (p < 0.0001).
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Maltese: Ġew irrapportati każijiet rari ta' enterokolite, inkluż kolite, kolite iskemika u enterokolite newtropenika li jistgħu jirriżultaw fatali (frekwenza mhux magħrufa).
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Maltese: Artralġja (G3/4: 0.3%); Majalġja (G3/4: 0.3%)
English: DOCETAXEL KABI in combination with capecitabine
Maltese: DOCETAXEL KABI użat flimkien ma' capecitabine
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Maltese: Ittieni analisi temporanja saret wara li ġew irrekordjati b'kollox 400 ġrajja DFS, li wassal għal perijodu ta' osservazzjoni ta' wara t-trattament medjan ta' 55 xahar.
English: 36.0) in AC arm.
Maltese: - 36.0) fil-fergħa AC.
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Maltese: F'madwar 20 % ta' dawn ilkażijiet ma kien hemm ebda fatturi ta' riskju għad-disfunzjoni renali severa akuta bħal prodotti mediċinali nefrotossiċi li ttieħdu fl-istess ħin u distrubi gastro-intestinali.
English: 1060 patients were randomised to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).).
Maltese: 1060 pazjent ġew magħżula b'mod arbitrarju biex jirċievu jew DOCETAXEL KABI 75 mg/m2 mogħti siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclosphosphamide 500 mg/m2 (521 pazjent fil-fergħa tal-FAC ), bħala kura miżjuda f'pazjenti b'kanċer operabbli fis-sider li ma nfirixx fil-glandoli limfatiċi tas-sider u li għandhom riskju għoli ta' rikaduta skont il-kriterji St.Gallen tal1998 (daqs tat-tumur >2 cm u/jew RE u RP negattivi u/jew Grad għoli istoloġiku/nukleari (Grad 2 sa 3) u /jew età <35 sena).
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Maltese: L-Incidenza relatata ma'deni, dijarea, anoreksja u edima periferika li ġraw b'rati ≥ 10% ogħla fil-pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m2, segwit minn cisplatin (P) 75 mg/m2, segwit minn 5-fluorouracil (F) 750 mg/m2 kuljum bħala infużjoni kontinwa għal 5 ijiem.
English: Number of patients PSA** response rate (%) 95% CI p-value*
Maltese: Numru ta' pazjenti PSA** ir-rata tar-rispons (%) 95% CI p-value*
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Maltese: Il-komportament farmakokinetiku ta' docetaxel kien studjat f'pazjenti bil-kanċer wara l-għoti ta' 20 sa 115 mg/m2 fil-fażi I ta' l-istudji.
English: p = Hazard ratio*
Maltese: Ilproporzjo n tarriskju*
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Maltese: Riskju Proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Trattament: 5.4% [95% CI: -1.1; 12.0] Differenza fit-Trattament: 6.2% [95% CI: 0.2; 12.3]
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Maltese: Fil-pazjenti li kienu ħadu t-trattament b'anthracycline, li kien falla, docetaxel kien ikkomparat ma' lużu ta' mitomycin C u l-vinblastine flimkien (12 mg/m2 kull 6 ġimgħat u 6 mg/m2 kull 3 ġimgħat).
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Maltese: Il-profil kinetiku ta' docetaxel huwa indipendenti mid-doża użata u huwa konsistenti ma' mudell farmakokinetiku bi tliet oqsma, biż-zmien kemm idum biex jonqos binnofs fil-livell tad-demm għall-fażijiet α, β u γ huwa ta' 4 minuti, 36 minuta u 11.1 sigħat, rispettivament.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/