FrancophonIA/ELRC3.0 huggingface dataset:
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) 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: 324) 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: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Maltese: Koagulazzjoni intrvasculari mifruxa (DIC), spiss assoċjata ma' sepsis u insuffiċjenza ta' organi multipli, kienet irrapportata.
English: Uncommon adverse reactions
Maltese: Reazzjonijiet Avversi komuni ħafna
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Maltese: Fl-istudju TAX 316, alopeċja li ppersistit matul il-perijodu ta' osservazzjoni ta' wara t-trattament fittmiem tal-kimoterapija ġiet irrappurtata f'687 minn 744 pazjent fuq TAC (92.3 %) u 645 minn 736 pazjent (87.6 %) fuq FAC.
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients(87.6%).
Maltese: Fl-istudju TAX 316, alopeċja li ppersistit matul il-perijodu ta' osservazzjoni ta' wara t-trattament fittmiem tal-kimoterapija ġiet irrappurtata f'687 minn 744 pazjent fuq TAC(92.3 %) u 645 minn 736 pazjent (87.6 %) fuq FAC.
English: Peripheral motor neuropathy (G3/4: 0%)
Maltese: Newropatija periferika talmovimenti (G3/4: 0%)
English: Hearing impaired
Maltese: Pazjenti speċjali
English: • non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Maltese: • limfoma mhux ta' Hodgkin (kanċer li jaffettwa s-sistema immuni) u kanċers oħra jistgħu jseħħu f'pazjenti kkurati b'docetaxel flimkien ma' ċerti trattamenti oħra kontra l-kanċer.
English: Peripheral motor neuropathy (G3/4: 4%);
Maltese: Newropatija periferika talmovimenti (G3/4: 4%);
English: Histological grade
Maltese: Grad istoloġiku
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Maltese: TTP=iż-żmien għal progressjoni; “ne” jindika li ma setax ikun stmat jew li ma kienx għadu milħuq 1Sett sħiħ ta' l-analiżi (bit-tir ta' fejqan)
English: Hypotension;
Maltese: Artralġja;
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: Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Maltese: Astenja (severa: 8.1%); Żamm tal-fluwidu (sever:1.2%);
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: Peripheral motor neuropathy (G3/4: 2.5%)
Maltese: Newropatija periferika talmovimenti (G3/4: 2.5%);
English: In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (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: Hazard ratio
Maltese: TAGĦRIF
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: 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: Baseline cardiac assessment is recommended.
Maltese: Huwa rrakkomandat li jkun hemm evalwazzjoni kardijaka bħala linja bażi.
English: See also section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Maltese: Ara wkoll is-sezzjoni “DOCETAXEL KABI fih l-ethanol (l-alkoħol)” hawn taħt.
English: MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Fresenius Kabi Deutschland GmbH
English: Myalgia (G3/4: 0.4%)
Maltese: Majalġja (G3/4: 0.4%)
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Maltese: Newropatija periferika tassensazzjoni (G3/4: 8.7%)
English: Lethargy
Maltese: Stitikezza
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Maltese: Stomatite (G3/4: 23.7%); Rimettar (G3/4: 14.
English: Peripheral sensory neuropathy (G3: 4.1%);
Maltese: Newropatija periferika tassensazzjoni (G3: 4.1%);
English: One hundred eighty six patients were randomised to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Maltese: Mija sitta u tmenin (186) pazjent kienu mqassma mingħajr għażla biex jieħdu docetaxel (100 mg/m2) bi trastuzumab jew mingħajru; 60% tal-pazjenti rċevew preċedentement kimoterapija miżjuda b'tip ta' anthracycline.
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) 1000 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 5-fluorouracil (F) 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 5.
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Maltese: Il-komportament farmakokinetinu ta' docetaxel fil-preżenza ta' prednisone kien studjat f'pazjenti b'kanċer metastatiku tal-prostata.
English: • Induction chemotherapy followed by radiotherapy (TAX 323)
Maltese: • Kimoterapija Induttiva segwita bi radjuterapija (TAX
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: • acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Maltese: • lewkimja mijelojde akuta u sindrome mijelodisplastika (tipi ta' kanċer tad-demm) jistgħu jseħħu f'pazjenti kkurati b'docetaxel flimkien ma' ċerti trattamenti oħra kontra l-kanċer.
English: The name of this medicine is DOCETAXEL KABI.
Maltese: L-isem ta' din il-mediċina huwa DOCETAXEL KABI.
English: Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Maltese: Ġiet irrapportata arritmija ventrikulari inkluż takikardija ventrikulari (frekwenza mhux magħrufa) ,xi kultant fatali, f'pazjenti ttrattati b'docetaxel f'skedi ta' dożaġġi li fihom taħlita ta' doxorubicin, 5fluorouracil u/ jew cyclophosphamide.
English: Pregnancy, breast-feeding and fertility
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Maltese: Pazjenti li ħadu TAC, imqassma fi gruppi żgħar, skont fatturi pronostiċi maġġuri, definiti prospettivament, ġew analiżżati:
English: 95% CI p-value† *
Maltese: Il-proporzjon tar-riskju 95% CI p-value†*
English: • swelling of the hands, feet, legs
Maltese: • nefħa ta' l-idejn, saqajn u riġlejn
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Maltese: L-inċidenza tal-ġrajjiet avversi li jmissu (fil-gradi kollha): telqa, stomatite u infezzjonijiet assoċjati man-newtropenija, graw f'rati ta' ≥ 10% ogħla f'pazjenti li kellhom 65 sena jew aktar, meta mqabbla ma' pazjenti iżgħar.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine .
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anidru (alkoħol), jiġifieri sa 1.58 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 40 ml ta' birra jew 17 ml ta' nbid .
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: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial, equivalent to 60 ml of beer or 24 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anidru (alkoħol), jiġifieri sa 2.37 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 60 ml ta' birra jew 24 ml ta' nbid .
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Maltese: Infezzjoni assoċjata ma' G4 newtropenija (G3/4: 4.6%)
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 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, 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 BID) għal 3 ijiem, mibdija jum 1 qabel it-teħid ta' docetaxel, sakemm mhux kontra-indikat, tista' tintuża (ara sezzjoni 4.4).
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Maltese: Fl-istudju TAX316, il-limfoedima li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti filperijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet irrapportata f'11 minn 744 pazjent fuq TAC (1.5%) u f'pazjent 1 minn 736 pazjent fuq FAC (0.1 %).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u talconnective tissue
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anidru (alkoħol), jiġifieri sa 3.16 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 80 ml ta' birra jew 32 ml ta' nbid .
English: Myalgia (G3/4: 0.6%)
Maltese: Majalġja (G3/4: 0.6%)
English: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Maltese: Pazjenti fejn il-livell basiku tan-numru taċ-ċelluli newtrofiliċi fid-demm huwa < 1,500 ċelluli/mm3.
English: Myocardial ischemia
Maltese: Qabel il-menopawża
English: Cough; Rhinorrhoea
Maltese: Oħrajn
English: One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Maltese: Pazjent 1 fuq TAC (0.1 %) u pazjent 1 fuq FAC 90.1 %) mietu minħabba AML matul il-perijodu ta' osservazzjoni (żmien medjan ta' osservazzjoni ta' 8 snin).
English: Dehydration (G3/4: 2%)
Maltese: Deidrazzjoni (G3/4: 2%);
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 il-pazjenti ma jistgħux ikunu irrakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: Each ml of concentrate contains 20 mg docetaxel anhydrous.
Maltese: Kull ml ta' konċentrat fih 20 mg ta' docetaxel anidru.
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: III ta' l-istudju u 79 pazjent filfażi II), li ħadu docetaxel flimkien ma' cisplatin u 5-fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Maltese: Ilpazjenti fil-fergħa TAC irċevew profilassi bl-antibijotiku ciprofloxacin 500 mg oralment, darbtejn kuljum, ghal 10 ijiem, mibdi f'jum 5 ta' kull ċikli, jew ekwivalenti.
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Maltese: Il-capecitabine m'uriex effett fuq il-komportament farmakokinetiku ta' docetaxel (Cmax u l-AUC) u ma kien hemm l-ebda effett minn docetaxel fuq il-komportament farmakokinetiku ta' prodott metaboliku 5'-DFUR, rilevanti għal capecitabine.
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Maltese: Metodu ta' kif għandu jingħata Għal istruzzjonijiet dwar il-preparazzjoni u l-għoti tal-prodott, ara sezzjoni 6.6.
English: Hypersensitivity (G3/4: 0.6%)
Maltese: Sensittività eċċessiva (G3/4: 0.6%)
English: In case of combination with CYP3A4 inhibitors, the occurrence of docetaxel adverse reactions may increase, as a result of reduced metabolism.
Maltese: F'każ ta' teħid flimkien ma' inibituri ta' CYP3A4, jistgħu jiżdiedu n-numru ta' reazzjonijiet avversi ta' docetaxel, minħabba t-tnaqqis fil-metaboliżmu.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Maltese: Madankollu, m'induċix mutaġeniċita fit-test t'Ames jew fi studju mutaġeniku tal-ġene CHO/HGPRT.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Maltese: Minn 333 pazjent ittrattati b'docetaxel kull tliet ġimgħat fi studju fiq il-kanċer tal-prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
English: The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Maltese: Ir-rata ta' sopravivenza ta' sena kienet b'mod sinifikattiv itwal b'docetaxel (40%) kontra l-AKS (16%).
English: G3/4 Blood bilirubin increased (< 2%)
Maltese: G3/4 Żieda fil-bilirubin fiddemm (9%)
English: The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Maltese: L-inċidenza tan-newtropenija bid-deni/tan-newtropenija bis-sepsis kienet żdiedet ukoll f'pazjenti ittrattati b'Herceptin flimkien ma' docetaxel (23% kontra 17% għal pazjenti ittrattati b'docetaxel biss).
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI DOCETAXEL KABI 180 mg/9 ml konċentrat għall-infużjoni docetaxel
English: DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI DOCETAXEL KABI 120 mg/6 ml konċentrat għall-infużjoni docetaxel
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4: 20.7%); Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 12.0%);
Maltese: Rimettar (G3/4: 8.4%) Dijarea (G3/4: 6.8%); Esofaġite/disfaġja/ odinofaġja (G3/4:
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Maltese: Analiżi tal-gruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement ilfergħa TCF meta mqabbla mal-fergħa CF.
English: Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Maltese: Ir-radjazzjoni kienet mogħtija permess ta' apparat megavoltage b'użu kuljum ta frazzjoni (2 Gy kull jum, 5 jiem fil-ġimgħa għal 7 ġimgħat, għad doża totali ta' 70-72 Gy).
English: Gastrointestinal haemorrhage (G3/4: 0.6%)
Maltese: Emoraġija gastrointestinali (G3/4:0.6%);
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Maltese: Għall-modifikazzjonijiet fid-dożi ta' cisplatin u 5-fluorouracil, ara s-sommarju tal-karatteristiċi talprodott li tikkorrispondi.
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 fil-perijodu 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: Skin reaction (G3/4: 5.9%);
Maltese: Reazzjonijiet tal-ġilda (G3/4: 5.9%);
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: Cases of electrolyte imbalance have been reported.
Maltese: Ġew irrapportati każijiet ta' żbilanċ fl-elettroliti.
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: Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Maltese: Qtugħ ta' nifs (G3/4: 1%); Sogħla (G3/4: < 1%);
English: Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Maltese: Il-pazjenti ittrattati b'TPF kellhom b'mod sinifikattiv anqas ta' deterjorazzjoni fil-kejl tas-saħħa Globali, meta mqabbla ma' dawk ittrattati bi PF (p = 0.01, meta tintuża l-iskala EORTC QLQ-C30).
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 mannewtropenija ġraw, rispettivament, fi 12.1% u 3.4% tal-pazjenti, meta dawn irċevew il-profilassi b'GCSF, fil-waqt li 15.
English: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting).
Maltese: • arritmija ventrikulari jew takikardija ventrikulari (li jidhru bħala tħabbit tal-qalb irregolari u/jew mgħaġġel, qtugħ sever tan-nifs, sturdament u/jew ħass ħażin).
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Maltese: Data ta' riversibbiltà hija disponibbli f'35.3% tal-pazjenti li żviluppaw newrotossiċità wara ttrattament b'docetaxel waħdu f'doża ta' 100 mg/m².
English: DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI DOCETAXEL KABI 160 mg/8 ml konċentrat għall-infużjoni docetaxel
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Maltese: Per eżempju, għal doża ta' 140 mg docetaxel ikollok bżonn ta' 7 ml docetaxel konċentrat għal soluzzjoni.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: Il-pazjenti ittrattati b'TCF għandhom jingħataw il-profilassi b'G-CSF biex jonqos ir-riskju tan-newtropenija komplikata (newtropenija bid-deni, newtropenija fit-tul jew in-newtropenija assoċjata ma' infezzjoni).
English: KABI could be administered in combination with doxorubicin and cyclophosphamide.
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 20 mg ta'docetaxel anidru.
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Maltese: Tqalligħ (G3/4:0.6%) Stomatite (G3/4:4.0%) Dijarea (G3/4:2.9%) Rimettar (G3/4:0.6%)
English: Skin exfoliative (G3/4: 0.6%)
Maltese: Ġilda esfoljattiva (G3/4:0.6%)
English: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Maltese: Docetaxel instab li huwa ċitotossiku in vitro għall-linji ċellulari ta' tumuri li huma derivati millġrieden u l-bniedem, u kontra ċelluli umani meħudin minn tumuri hekk kif dawn ikunu tneħħew, fi studji klonoġeniċi fil-laboratorju.
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Maltese: Ġew irrapportati lewkimja mijelojde akuta u sindrome mijelodisplastika (frekwenza mhux komuni) f'studji kliniċi prinċipali f'kanċer tassider bl-iskeda ta' trattament TAC.