FrancophonIA/ELRC3.0 huggingface dataset:
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 rapportati ta' docetaxel innifsu huma: newtropenija (li kienet riversibbli u mhux kumulattiva: il-jum medjan biex jintlaħaq in-nadir kien ta' 7 ijiem u żżmien medju ta' dewmien tan-newtropenija severa (< 500 ċelluli/mm3) kien ta' 7 ijiem), anemija, alopeċja, tqalligħ, rimettar, stomatite, dijarea u astenja.
English: Lethargy
Maltese: docetaxel
English: - Keep this leaflet.
Maltese: Proporzjon ta' Periklu*
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 tal-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-fergħa TCF.
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Maltese: 316 26 pazjent (3.5%) fil-fergħa tat-TAC u 17-il pazjent (2.3%) fil-fergħa tal-FAC esperjenzaw insuffiċjenza konġestiva tal-qalb .
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 il każijiet ma kien hemm ebda fatturi ta' riskju għad-disfunzjoni renali severa akuta bħal prodotti mediċinali nefrotossiċi li ttieħdu fl-istess ħin u disturbi gastrointestinali.
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 għaldeterjorament definittiv ta' 5% tal-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: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Maltese: Pazjenti li jirċievu TAC għandhom jiġu monitorati mill-qrib (ara sezzjonijiet 4.2 u 4.8).
English: Lymphoedema (G3/4:
Maltese: limfoedema (G3/4:
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: 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) 1,000 mg/m2 kuljum għal 5 ijiem.
English: See also section ”Docetaxel Teva contains ethanol (alcohol)” below.
Maltese: Ara wkoll sezzjoni "Docetaxel Teva ethanol (alkoħol)" hawn taħt.
English: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Bilirubin fid demm ogħla (< 5%);
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: The solvent for Docetaxel Teva is water for injections.
Maltese: Is-solvent ta' Docetaxel Teva ilma għall-injezzjonijiet.
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: Asthenia (severe: 9.9%); Fluid retention (severe:
Maltese: Astenja (severa: 9.9%); Żamm tal-fluwidu (sever:
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 malużu ta' mitomycin C u l-vinblastine flimkien (12 mg/m2 kull 6 ġimgħat u 6 mg/m2 kull 3 ġimgħat).
English: TTP=time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Maltese: (26.8-ne) TTP=iż-żmien għal progressjoni; “ne” jindika li ma setax ikun stmat jew li ma kienx għadu milħuq
English: Best overall response (CR + PR) to chemotherapy (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bil-kimoterapija (%) (95%CI) ***p-value
English: Inject the required premix volume into a non-PVC 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Injetta l-volum meħtieġ tas-soluzzjoni inizjali tal-bidu f'borża mhux tal-PVC ta' 250 ml għallinfużjoni, li għandha soluzzjoni jew ta' 5% glukosju jew 9 mg/ml (0.9%) sodium chloride għall infużjonijiet.
English: Without primary G-CSF prophylaxis
Maltese: Ilma għall-injezzjonijiet
English: Constipation
Maltese: PREżENTAZZJONI
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Maltese: Disturbi gastrointestinali Stomatite (G3/4: 5.3%); Dijarea (G3/4: 4%);
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).
Maltese: snin) f'121 pazjent minn 744 pazjent TAC (16.3 %) u f'86 pazjent FAC (11.7 %).
English: Hepatic impairment In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Maltese: F'numru żgħir ta' pazjenti (n=3) li kellhom data bijokimiku kliniku suġġestiv ta' indeboliment tal-fwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi tal-OLN assoċjat ma' livelli talenzima alkaline phosphatase ≥ 2.5 drabi tal-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni 4.2).
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: Myocardial ischemia (G3/4: 1.7%)
Maltese: Mard iskemiku talmijokardju (G3/4: 1.7%)
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Maltese: Meta cisplatin u 5-fluorouracil intużaw flimkien għat-trattament ta' pazjenti li kellhom adenokarċinoma tal-istonku, l-istudju kliniku ewlenieni eskludiet pazjenti b'ALT u/jew AST > 1.5 x ULN assoċjat ma' alkaline phosphatase ta' > 2.5 x ULN, u bilirubin ta' > 1 x ULN; għal dawn il-pazjenti ma jistgħux ikunu rakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Maltese: Iż-żmien biex jintlaħaq ilmard progressiv kien superjuri bid-docetaxel u capecitabine flimkien (p < 0.0001).
English: Ischemia myocardial
Maltese: aġent waħdieni
English: 2.1 Docetaxel Teva 20 mg/0.72 ml vial:
Maltese: 2.1 Kunjett ta' Docetaxel Teva 20 mg/0.
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4:
Maltese: Stitikezza (G3/4: 1.0 %); Ugigħ gastro-intestinali (G3/4:
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Maltese: Iddiskuti mat-tabib tiegħek jekk inti tbati minn dipendenza alkoħol, epilessija jew indeboliment tal-fwied.
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Maltese: Meta jintuża għallkura preferita, docetaxel 75 mg/m2 jingħata flimkien ma' doxorubicin (50 mg/m2).
English: • Induction chemotherapy followed by radiotherapy (TAX323)
Maltese: • Kimoterapija Induttiva segwita bi radjuterapija (TAX323)
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Maltese: Sopravivenza ħielsa mill-mard (DFS - disease-free survival) kien l iskop finali ta' effikaċja primarju u s-sopravivenza globali (OS - Overall survival) kien l-iskop finali ta' effikaċja sekondarju.
English: VIAL LABEL - CONCENTRATE 80 mg/2.88 ml
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT - KONĊENTRAT 80 mg/2.88 ml
English: Cases of permanent alopecia (frequency not known) have been reported.
Maltese: Ġew irrappurtati każijiet ta' alopeċja permanenti(frekwenza mhux magħrufa) .
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Maltese: Profilassi primarja b'G-CSF għandu jiġi kkonsidrat f'pazjenti li jirċievu terapija adjuvanti b'docataxel, doxorubicin u cyclophospahamide (TAC) għal kanċer tas-sider.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
Maltese: • Ir-rata tar-rispons globali (RTTR) kienet b'mod sinifikattiv ogħla fil-fergħa AT kontra ilfergħa AC, p = 0.009.
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Maltese: Il-farmakokinetika ta' Docetaxel fil-preżenza ta' prednisone ġiet studjata f'pazjenti b'kanċer metastatiku tal-prostata.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
Maltese: Studji in vitro wrew li l-metaboliżmu ta' docetaxel jista' jkun immodifikat meta jittieħed ma' sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma metaboliżżati (u, għalhekk, jistgħu jinibixxu lenzima kompetittivament) minn ċitokroma P450-3A, bħal ciclosporine, terfenadine, ketoconazole, erythromycin u troleandomycin.
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Maltese: It-tabella f'hawn isfel turi li l-inċidenza ta' newtropenja ta' Grad 4, newtropenija bid-deni u infezzjoni newtropenika naqsu f'pazjenti li ħadu profilassi primarja b'G-CSF wara li din saret obbligatorja fid-driegħ ta' TAC - studju GEICAM.
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders)
Maltese: • tnaqqis tas-sodju, Potassju, manjeżju, u / jew kalċju fid-demm tiegħek (Disturbi tal-bilanċ tal elettroliti)
English: Very common adverse reactions Common adverse reactions
Maltese: Reazzjonijiet avversi komuni hafna
English: Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
Maltese: Terapija b'radjazzjoni adjuvanti ġiet amministrata skont il-linji gwida li jinsabu mqegħda fl-istituzzjonijiet parteċipanti u ngħata lil 57.3 % ta' pazjenti li rċevew TAC u 51.2% ta' pazjenti li rċevew FAC.
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF, (see section 4.2).
Maltese: Newtropenija bid-deni u infezzjonijiet assoċjati man-newtropenija ġraw, rispettivament, fi 12.1% u 3.4% tal-pazjenti, meta dawn irċevew il-profilassi b'G-CSF, fil-waqt li 15.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients.
Maltese: Wara 10 snin ta' osservazzjoni fl-istudju GEICAM 9805, lewkimja akuta seħħet f'pazjent 1 minn 532 pazjent (0.2 %) fil-fergħa TAC.
English: 2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial:
Maltese: 2.2 Kunjett Docetaxel Teva 20 mg/0.
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Maltese: 72 ml ta' soluzzjoni ta' docetaxel, b'konċentrazzjoni ta' 27.73 mg/ml filpolysorbate 80 (volum attwali: 24.4 mg/0.88 ml ).
English: Other medicines and Docetaxel Teva
Maltese: Mediċini oħra u Docetaxel Teva
English: 75 to 60 mg/m².
Maltese: KARTUNA- 20 mg/0.
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Maltese: Tqalligħ (G3/4: 13.9%); Stomatite (G3/4: 20.
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Maltese: • mard interstizjali tal-pulmun (infjammazzjoni fil-pulmuni li tikkawża soghla u diffikultà biex tieħu n-nifs.Infjammazzjoni tal-pulmuni tista' wkoll tiżviluppa meta t-terapija b'docetaxel tintuża mar-radjuterapija)
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hija probabbli stima baxxa għax docetaxel waħdu f'doża ta'100 mg/m2 hu magħruf li jġib in-newtropenija f'97% tal-pazjenti, 76% fi grad 4, meta ibbażata fuq in-nadir talgħadd taċ-ċelluli fid-demm.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Maltese: • Kimoterapija induttiva segwita bi kimoradjuterapija (TAX324)
English: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Maltese: Għall-każijiet ta' kanċer tas-sider, tal-istonku, tal-pulmun mhux mikroċitoma, u tar-ras u tal-għonq, il-premedikazzjoni, b'corticosteroid orali bħal dexamethasone 16 mg kuljum (e.g. 8 mg BID) għal 3 ijiem, mibdija jum 1 qabel it-teħid ta' docetaxel, sakemm mhux kontraindikat, tista' tintuża (ara sezzjoni 4.4).
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 1131l, rispettivament.
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'
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p=0.0043).
Maltese: L-inċidenza tar-rikaduta hekk kif għaddew 10 snin tnaqqas fil-pazjenti li rċevew TAC meta mqabbel ma' dawk li rċevew FAC (39% kontra 45%, rispettivament) li tfisser riskju assolut imnaqqas b'6% (p = 0.
English: A study of 14C-docetaxel has been conducted in three cancer patients.
Maltese: Studju b' 14C-docetaxel sar fi tliet pazjenti bil-kanċer.
English: 4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: 4.2.2 Injetta l-volum meħtieġ tas-soluzjoni inizjali f'borża jew flixkun tal-infużjoni ta' 250 ml, li għandha/għandu soluzzjoni ta' 5% glukosju jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-infużjonijiet.
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 bennini, malinni u mhux speċifiċi (li jinkludu ċisti u polipi) Ġew irrappurtati tumuri malinni primarji sussegwenti (frekwenza mhux magħrufa), inkluża limfoma mhux ta' Hodgkin b'relazzjoni ma' docetaxel meta jintuża flimkien ma' trattamenti oħra kontra l-kanċer magħrufa li huma assoċjati ma' tumuri malinni primarji sussegwenti.
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Maltese: Ma kienx hemm effett statistikament sinifikanti ta' prednisone fuq il famakokinetika ta' docetaxel.
English: • Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Maltese: Madankollu, l-istabbiltà kimika u fiżika tas-soluzzjoni inizjali ntweriet li ddum għal 8 sigħat meta tkun maħzuna bejn 2°Ċ u 8°Ċ jew f'temperatura ambjentali (taħt 25°Ċ).
English: In a phase III study, 1,218 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.
Maltese: III, 1,218-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 il-kundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa 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), 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: Fluid retention (G3/4: 1.2%); Oedema (G3/4: 1.2%)
Maltese: (G3/4: 1.2%); Edima (G3/4: 1.2%)
English: The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Maltese: Cisplatin u 5-fluorouracil L-għoti flimkien ta' docetaxel, cisplatin u 5-fluorouracil fi 12-il pazjent b'tumuri solidi ma kellux effett fuq il-komportament farmakokinetiku ta' kull prodott mediċinali individwali.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Maltese: Fit-trattament induttiv ta' kanċer inoperabbli tat-tip ta'ċellula skwamuża tal-ġilda, li huwa lokalment avvanzat, fir-ras u fl-għonq (SCCHN), id-doża rakkomandata ta' docetaxel hija 75 mg/m2 bħala infużjoni fuq tul ta' siegħa, segwita minn cisplatin 75 mg/m2 f'tul ta' aktar minn siegħa, fl-ewwel jum, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 750 mg/m2 kuljum għal ħamest ijiem.
English: In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Maltese: Fl-istudju TAX316, l-astinja li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti filperijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet irrapportata f'236 minn 744 pazjent fuq TAC (31.7%) u f'180 minn 736 pazjent fuq FAC (24.5 %).
English: A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Maltese: Analiżi aġġornata ta' sopravivenza, maħduma fuq osservazzjoni wara l-kura, fuq medda ta' żmien medjan ta' 41.6 xhur, ma baqgħetx turi differenza statistikament sinifikanti, iżda dejjem iffavorixiet it-tip ta' trattament b'TCF, u wriet li l-benefiċċju ta' TCF fuq CF kien jidher sew bejn it-18 u t-30 xahar tal-perijodu ta' osservazzjoni wara l-kura.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5.
Maltese: Pazjenti tal-fergħa kompettitiva rċevew cisplatin (P) 100 mg/m2 bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat f'jum 1, segwit minn 5fluorouracil (F) 1,000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 5.
English: Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Maltese: PREPARAZZJONI TAL-PRODOTT GĦALL-GĦOTI ĠOL-VINA 4.1 Preparazzjoni ta' Docetaxel Teva, soluzzjoni inizjali (10 mg docetaxel/ml)
English: Vomiting (G3/4: 8.4%);
Maltese: Rimettar (G3/4: 8.4%);
English: 3 weeks for 4 cycles.
Maltese: kuljum minn jum 1 sa jum 4.
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Maltese: Injetta l-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' Docetaxel Teva.
English: Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion docetaxel
Maltese: Docetaxel Teva 80 mg/2.88 ml konċentrat għal soluzzjoni għall-infużjoni Docetaxel
English: TCF n=221
Maltese: n = 221
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 jwasslu għal riżultat fatali (frekwenza mhux magħrufa).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Maltese: Wara 10 snin ta' osservazzjoni ta' wara t-trattament fl-istudju TAX316, il-lewkimja akuta ġiet irrappurtata f'3 minn 744 pazjent fuq TAC (0.4 %)u f'1 minn 736 pazjent fuq FAC (0.1 %).