FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Maltese: Total ta' 445 pazjent b'KPS > 70 kienu ittrattati b'docetaxel (T) (75 mg/m2 fl-ewwel jum) flimkien ma' cisplatin (C) (75 mg/m2 fl-ewwel jum) u 5-fluorouracil (F) (750 mg/m2 kuljum għal 5 ijiem), jew cisplatin (100 mg/m2 fl-ewwel jum) u
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Maltese: Ebda effett statistikament sinifikanti ta' prednisone fuq il-farmakokinetika ta' docetaxel ma ġie osservat.
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Maltese: Kull kunjett ta' konċentrat fih 2 ml ta' ethanol anhydrous (1.58 g).
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Maltese: Sindromu ta' dieqa respiratorja akuta u każijiet ta' pulmonite/pnewmonja tal-interstizjum, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja, xi kultant fatali, kienu rarament irrapportati.
English: Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%.
Maltese: Aġġustament tad-doża Dijarea ta' grad 3 L-ewwel episodju: naqqas id-doża ta' 5-FU b'20%.
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 (0.64-1.08), 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: • 1,276 patients (744 and 532 in TAX 316 and GEICAM 9,805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Maltese: 316 u GEICAM 9,805 rispettivament) li ħadu docetaxel flimkien ma' doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Diarrhoea (G3/4: 1.2%);
Maltese: Dijarea (G3/4: 1.2%);
English: OTHER CYTOTOXIC
Maltese: Ħalq xott
English: 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 = 23) li kellhom data bijokimiku kliniku suġġestiv ta' indebolimenttalfwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi ta' l-OLN assoċjat ma' livelli ta' l-enzima alkaline phosphatase ≥ 2.5 drabi ta' l-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni 4.2).
English: What Docetaxel Accord contains - The active substance is docetaxel.
Maltese: X'fih il-kunjett ta' Docetaxel Accord konċentrat - Is-sustanza attiva hi docetaxel.
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag 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: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: Febrile neutropenia
Maltese: Newtropenija (G3/4: 83.2%); Tromboċitopenija (G3/4:
English: Asthenia (severe:
Maltese: Esofaġite (severa:
English: (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Maltese: Docetaxel żied r-rata tar-rispons (33% vs 12%, p < 0.0001), ittardja l-avvanz tat-tumur (19-il ġimgħa vs 11-il ġimgħa, p = 0.0004) u tawwal iż-żmien totali tas-sopravivenza (11-il xahar vs 9 xhur, p = 0.01).
English: Nausea (G3/4: 0.6%);
Maltese: Disgewżja (G3/4: 0.6%);
English: Fluid retention (severe: Asthenia (severe: 11.2%); Pain
Maltese: Astenja (severa: 11.2%); Uġigħ
English: For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Maltese: It-trattament induttiv ta' pazjenti li kellhom kanċer tat-tip squamous cell tar-ras u l-għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta' kura kirurġika u bi skop ta' preservazzjoni ta' l-organi), id-doża rrakkomandata ta' docetaxel hija 75 mg/m2 bħala infużjoni tul ta' siegħa, segwita minn cisplatin 100 mg/m2 f'tul ta' 30-minuta sa 3 sigħat, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 1000 mg/m2 kuljum minn jum 1 sa jum 4.
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 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: 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 ta' l-istonku, l-istudju kliniku tal-pern 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 ilpazjenti ma jistgħux ikunu irrakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
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, erythromycin.
Maltese: Studji in vitro urew li l-metaboliżmu ta' docetaxel jista' jkun immodifikat meta jittieħed ma' sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma metaboliżżati (u, għalhekk, jistgħu jinibixxu l-enzima kompetittivament) minn ċitokroma P450-3A, bħal ciclosporine, ketoconazole u erythromycin.
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: IL-PRODOTT MEDIĊINALI Docetaxel Accord 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni Docetaxel Accord 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni Docetaxel Accord 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bit-trattament studjat [kimoterapija +/- radjuterapija] (%) (95%CI) ***p-value
English: Infusion site reaction
Maltese: Mhux applikabbli
English: Hypersensitivity (G3/4: 1.7%)
Maltese: Sensittività eċċessiva (G3/4: 1.2%)
English: 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Maltese: 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 395 mg ethanol anhydrous kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml inbid għal.
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: Gastrointestinal pain (G3/4: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Maltese: Stitikezza (G3/4: 1.0 %); Ugigħ gastro-intestinali (G3/4: Esofaġite/disfaġja/odinofaġja (G3/4: 0.7%)
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'
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 160 mg/8 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Accord 160 mg/8 ml konċentrat sterili docetaxel
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%);
Maltese: Stomatite (G3/4: 1.7%); Rimettar (G3/4: 0.8%) Dijarea (G3/4: 1.7%);
English: It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Accord infusion solution.
Maltese: Huwa importanti li taqra l-kontenut kollu ta' din gwida qabel ma ssir il-preparazzjoni tas-soluzzjoni ta' infużjoni Docetaxel Accord
English: Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: †Stratified log rank test *Threshold for statistical significance=0.
English: See also section “Docetaxel Accord contains ethanol (alcohol)” below.
Maltese: Ara wkoll is-sezzjoni “Docetaxel Accord fih l-ethanol (lalkoħol)” hawn taħt.
English: Lethargy; Pain
Maltese: Pabianice, Il-Polonja
English: Pack size:
Maltese: Sewqan u tħaddim ta' magni:
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Maltese: Għejja (G3/4: 3.9%); Żamm tal-fluwidu (sever: 0.6%)
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 twice daily) 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, ta' l-istonku, tal-pulmun fejn iċ-ċelluli mhux żgħar, u tar-ras u ta' lgħonq, il-premedikazzjoni, b'corticosteroid orali bħal dexamethasone 16 mg kuljum (e.g. 8 mg darbtejn kuljum) għal 3 ijiem, mibdija jum 1 qabel it-teħid ta' docetaxel, sakemm mhux kontra-indikat, tista' tintuża (ara sezzjoni 4.4).
English: (G3/4: 1.2%)
Maltese: Deni (G3/4: 1.2%)
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Maltese: Iddiskuti mat-tabib tiegħek jekk tbati minn dipendenza ta'l- alkoħol, epilessija jew indeboliment tal-fwied.
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Maltese: 12.4%); Żamm tal-fluwidu (sever: 0.8%) Uġigħ
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'GCSF, fil-waqt li 15.
English: 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: 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: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anhydrous (alkoħol), jiġifieri sa 395 mg ethanol anhydrous għal kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml ta' inbid għal.
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
Maltese: L-amenorreja ġiet osservata li kienet għadha hemm fl-aħħar tal-perijodu ta' osservazzjoni ta' wara t-trattament (żmien medjan ta' osservazzjoni ta' 8 snin) f'121 pazjent minn 744 pazjent TAC (16.3 %) u f'86 pazjent FAC (11.7 %).
English: Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal docetaxel 100 mg/m2 bħala sustanza użata waħedha
English: The name of this medicine is Docetaxel Accord.
Maltese: L-isem ta' din il-mediċina huwa Docetaxel Accord.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Accord 20 mg/1ml konċentrat sterili docetaxel
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 20mg docetaxel.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Maltese: Vasodilatazzjoni (G3/4: 0.5%) Pressjoni baxxa (G3/4: 0%); Flebite (G3/4: 0%);
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Maltese: Majalġja (G3/4: 0.7%); Artralġja (G3/4: 0.2%)
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate.
Maltese: Docetaxel Accord 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni Kunjett magħmul minn ħġieġ ċar (tip I) b'tapp tal-lasktu tal-flourtec plus (ethylene tetrafluoroethylene film) u b'siġill tal-aluminju u għatu oranġjo li jista' jitneħħa, li fih 1 ml ta' konċentrat.
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin) -containing chemotherapy.
Maltese: Insuffiċjenza tal-qalb intweriet f'pazjenti li hadu docetaxel flimkien ma' trastuzumab, specjalment wara l-kimoterapija li fiha anthracycline (doxorubicin jew epirubicin).
English: Stomatitis (G3/4: 2%)
Maltese: Deidrazzjoni (G3/4: 2%);
English: 95% CI p-value†*
Maltese: Il-proporzjon tar-riskju 95% CI p-value†*
English: Hazard ratio (TAC/FAC) (95% CI)
Maltese: Sopravivenza madjana (xhur) (95%CI)
English: Dysgeusia (G3/4: 0%)
Maltese: Disgewzja (G3/4: 0%)
English: Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Maltese: Stitikezza (G3/4: 1%); Uġigħ ta' żaqq (G3/4: 2%); Dispepsja
English: General disorders and administration site conditions In study TAX316 peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Fl-istudju TAX316, l-edima periferika li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti filperijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet osservata f'119 minn 744 pazjent fuq TAC (16%) u f'23 pazjent minn 736 pazjent fuq FAC (3.1 %).
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Maltese: Kull ml ta' konċentrat fih 20mg docetaxel.
English: Keep this leaflet.
Maltese: Reazzjoni fis-sit ta' linfuzjoni
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 8 ml of concentrate.
Maltese: Docetaxel Accord 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni Kunjett magħmul minn ħġieġ ċar (tip I) b'tapp tal-lasktu tal-flourtec plus (ethylene tetrafluoroethylene film) u b'siġill tal-aluminju u għatu aħmar li jista' jitneħħa, li fih 8 ml ta' konċentrat.
English: Dyspnoea (severe: 2.7%)
Maltese: Disgewżja(severa: 0.07%)
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Żieda fl-AST G3/4 Żieda flalkaline phosphatase fid-demm (0.3%)
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Maltese: Ġew irrapportati każijiet rari ta' enterokolite, inkluż kolite, kolite iskemika u enterokolite newtropenika li jistgħu jirriżultaw fatali (frekwenza mhux magħrufa).
English: In Docetaxel Accord 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' Docetaxel Accord 20 mg/1 ml, il-konċentrat ta' docetaxel huwa 20mg/ml.
English: Uncommon adverse reactions disorders
Maltese: Reazzjonijiet Avversi komuni hafna
English: Common adverse reactions
Maltese: Reazzjonijiet Avversi
English: Tabulated list of adverse reactions in prostate cancer for docetaxel 75 mg/m2 in combination with prednisone or prednisolone
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tal-prostata għal docetaxel 75 mg/m² użat flimkien ma' prednisone jew prednisolone
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tar-ras u tal-għonq għal docetaxel 75 mg/m² użat flimkien ma' cisplatin and 5-fluorouracil
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Maltese: Docetaxel Accord 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed ta' 4 ml ta' konċentrat fih 80 mg ta' docetaxel.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: Docetaxel Accord 160 mg/8 ml konċentrat għall-infużjoni docetaxel
English: (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Maltese: F'pazjenti ikkurati b'docetaxel waħdu b'doża ta' 100 mg/m2, u li għandhom livelli ta' l-enzimi transaminase (l-ALT u/jew l-AST) fis-serum tad-demm aktar minn 1.5 drabi l-ULN, flimkien ma' livelli ta' l-enżima alkaline phosphatase fis-serum aktar minn 2.5 drabi l-ULN, ghandhom riskju akbar li jiżviluppaw reazzjonijiet avversi u severi, bħall-mewt ta' natura tossika inkluża s-sepsis, emoraġija gastro-intestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
English: Peripheral motor neuropathy (G3/4:
Maltese: Newropatija periferika talmovimenti (G3/4:
English: Elderly treated with TCF should be closely monitored.
Maltese: Anzjani ttrattati b'TCF għandhom ikunu immoniterjati mill-qrib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/769/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/769/001
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Maltese: Ġiet studjata l-farmakokinetika ta' docetaxel fil-preżenza ta' prednisone f'pazjenti b'kanċer talprostata metastatiku.
English: Thrombocytopenia (G4:
Maltese: Newtropenija (G4:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel
Maltese: U MNEJN GĦANDU JINGĦATA Docetaxel Accord 80 mg/4 ml konċentrat sterili docetaxel
English: Histological grade Grade1 (includes grade not assessed) Grade 2
Maltese: Grad istoloġiku Grad 1 (jinkludi meta ma ġiex valutat il-grad) Grad 2
English: Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Maltese: Docetaxel Accord 160 mg/8 ml huwa fornut minn kunjett ta' 10 ml magħmul minn ħġieġ ċar , b'tapp tal-gomma fluorotec plus u siġill tal-aluminju u kappa li tista' tgħolliha biex tiftaħha kulur aħmar.
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 4 ml of concentrate.
Maltese: Docetaxel Accord 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni Kunjett magħmul minn ħġieġ ċar (tip I) b'tapp tal-lasktu tal-flourtec plus (ethylene tetrafluoroethylene film) u b'siġill tal-aluminju u għatu aħmar li jista' jitneħħa, li fih 4 ml ta' konċentrat.
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 squamous cell tal-ġilda, li huwa lokalment avvanzat, fir-ras u fl-għonq (SCCHN), id-doża irrakkomandata ta' docetaxel hija 75 mg/m2 bħala infużjoni tul ta' siegħa, segwita minn cisplatin 75 mg/m2 f'tul ta' siegħa, fl-ewwel jum, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 750 mg/m2 kuljum għal ħamest ijiem.
English: One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m2) in combination with docetaxel (75 mg/m2) (AT arm) versus doxorubicin (60 mg/m2) in combination with cyclophosphamide (600 mg/m2) (AC arm).
Maltese: Dawn ingħataw doxorubicin (50 mg/m2) flimkien ma' docetaxel (75 mg/m2) (il-fergħa AT) kontra doxorubicin (60 mg/m2) flimkien ma' cyclophosphamide (600 mg/m2) (il-fergħa AC).
English: Hypersensitivity (G3/4: 0.6%)
Maltese: Ġilda esfoljattiva (G3/4:0.6%)
English: Vomiting (G3/4: 4%);
Maltese: Anemija (G3/4: 3%);