FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: G-CSF kien ingħata bħala profilassi sekondarja lill-pazjenti li żviluppaw newtropenija komplikata (newtropenija bid-deni, newtropenija fit-tul jew infezzjoni).
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Maltese: 12.4%); Żamm tal-fluwidu (sever: 0.8%)
English: Common adverse reactions
Maltese: Reazzjonijiet Avversi komuni
English: In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Maltese: F'pazjenti kkurati b'docetaxel flimkien ma' doxorubicin u cyclophosphamide (TAC), ir-rati ta' newtropenja bid-deni u/jew infezzjoni newtropenika kienu inqas fil-pazjenti li rċevew prevenzjoni primarja permezz ta' G-CSF.
English: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Maltese: Fi studji mhux kliniċi, docetaxel għandu effetti ġenotossiċi u jista' jibdel il-fertilità maskili (ara sezzjoni 5.3).
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: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.55 g ethanol anhydrous per vial, equivalent to 90 ml of beer or 36 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anidru (alkoħol), jiġifieri sa 3.55 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 90 ml ta' birra jew 36 ml ta' nbid .
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Maltese: Għal kanċer tal-prostata, il-premedikazzjoni hija t-teħid orali ta' dexamethasone ta' 8 mg, 12-il siegħa, 3 sigħat u siegħa qabel l-infużjoni ta'docetaxel (ara sezzjoni 4.2).
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Maltese: Fl-istudju TAX316, in-newropatija periferika tas-sensazzjoni bdiet matul il-perijodu ta' trattament u baqgħet tippersisti fil-perijodu ta' osservazzjoni f'84 pazjent (11.3%) fil-fergħa TAC u fi 15-il pazjent (2 %) fil-fergħa FAC.
English: In DOCETAXEL KABI 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' DOCETAXEL KABI 160 mg/8 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: In DOCETAXEL KABI 180 mg/9 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' DOCETAXEL KABI 180 mg/9 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Maltese: Anqas spiss, sintomi qawwija bħal raxxijiet segwiti minn msiemer tal-ġilda li jitqaxxru kienu innotati li rarament wassal għal interruzjoni jew waqfien fittrattament ta' docetaxel (ara sezzjonijiet 4.2 u 4.4).
English: Tabulated list of adverse reactions in prostate cancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tal-prostata għal DOCETAXEL KABI 75 mg/m² użat flimkien ma' prednisone jew prednisolone
English: Mitoxantrone every 3 weeks
Maltese: Mitoxantrone Kull tliet ġimgħat
English: Pharyngolaryngeal pain (G3/4: 2%)
Maltese: Uġigh fil-farinġi u l-larinġi (G3/4: 2%)
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Maltese: Il-prevenzjoni primarja permezz ta' G-CSF għandha tiġi kkunsidrata f'pazjenti li qed jirċievu docetaxel, doxorubicin u cyclophosphamide (TAC) bħala terapija miżjuda għall-kanċer tas-sider.
English: Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Maltese: Docetaxel intwera, in vitro, li jħarbat is-sistema komplessa tal-mikrotubuli fiċ-ċelluli.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Maltese: L-Effikaċja ta' docetaxel fit-trattament induttiv ta' pazjenti b'SCCHN inoperabbli u lokalment avvanzat (Analiżi bl-Iskop li Titratta)
English: Cough (G3/4: 0%)
Maltese: Sogħla (G3/4: 0%)
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental anti-tumour activity against advanced murine and human grafted tumours.
Maltese: In vivo, docetaxel jaħdem indipendentement mill-iskeda ta' kif jingħata u għandu firxa wiesgħa t'attivita fuq it-tumuri esperimentali, kontra tumuri mlaqqmin u avvanzati derivati mill-ġrieden u mill-bnedmin.
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: 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: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Maltese: • taqlib ta' l-istonku inklużi t-tqalligħ, rimettar u d-dijarea, stitikezza
English: It is important that you read the entire contents of this guide prior to the preparation of the DOCETAXEL KABI infusion solution.
Maltese: Huwa importanti li taqra l-kontenut kollu ta' din il-gwida qabel ma ssir il-preparazzjoni tas-soluzzjoni ta' infużjoni DOCETAXEL KABI
English: Stomatitis (G3/4: 23.7%);
Maltese: Dijarea (G3/4: 19.7%);
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Maltese: Pressjoni baxxa; Pressjoni għolja; Emoraġija
English: Abdominal pain
Maltese: Newtropenja bid-deni
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal DOCETAXEL KABI 100 mg/m2 flimkien ma' trastuzumab
English: In DOCETAXEL KABI 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' DOCETAXEL KABI 80 mg/4 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI DOCETAXEL KABI 80 mg/4 ml konċentrat għall-infużjoni docetaxel
English: Tabulated list of adverse reactions in gastric adenocarcinoma center for DOCETAXEL KABI 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 KABI 75 mg/m² użat flimkien ma' cisplatin and 5-fluorouracil
English: Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Maltese: Wara l-għoti ta' doża ta' 100 mg/m2 li ngħatat bħala infużjoni fi żmien siegħa, l-ogħla livell medju filplażma kien ta' 3.7 μg/ml b'AUC korrispondenti ta' 4.6 sigħat.μg/ml.
English: This medicine 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 anidru (alkoħol), jiġifieri sa 395 mg t'ethanol anidru f'kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml ta' nbid .
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 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: Alopecia (G3/4: 4.0%); Rash pruritic
Maltese: Alopeċja (G3/4: 4.0%); Raxx bil-ħakk;
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI DOCETAXEL KABI 20 mg/1 ml konċentrat għall-infużjoni docetaxel
English: Alopecia; Erythema; Rash; Nail disorders
Maltese: Mard bħall-influwenza; Uġigħ fis-sider; Riħ bid-deni
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC.
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: Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
Maltese: Ġew osservati ipokalimja, ipomanjesimja u ipokalċimja, ħafna drabi assoċjati ma' disturbi gastrointestinali u b'mod partikolari mad-dijarea.
English: In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' DOCETAXEL KABI 20 mg/1 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Maltese: Dawn ġraw fi żiem sebgħat ijiem u l-ammont imneħħi fl-awrina u fl-ippurgar kienu ta' madwar 6% u 75% tar-radjuattività li ngħatat, rispettivament.
English: In DOCETAXEL KABI 120 mg/6 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' DOCETAXEL KABI 120 mg/6 ml, il-konċentrat ta' docetaxel hu 20 mg/ml
English: Dizziness;
Maltese: Astenja;
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m2 bħala infużjoni fil-vini fl-ewwel jum segwit minn cisplatin (P) 100 mg/m2 li jingħata bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat, segwit minn 5fluorouracil (F) 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
Maltese: G3/4 Żieda fl-AST (< G3/4 Żieda fl-ALT (<
English: Febrile neutropenia (G3/4: NA)
Maltese: Sensittività eċċessiva (G3/4:
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/ odynophagia (G3/4: 0.7%)
Maltese: Stitikezza (G3/4: 1.0 %); Ugigħ gastro-intestinali (G3/4:
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: 323) 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: Very common adverse reactions Common adverse reactions disorders
Maltese: Reazzjonijiet Avversi komuni hafna Reazzjonijiet Avversi
English: A final analysis was performed with an actual median follow up of 96 months.
Maltese: L-analisi finali saret b'perijodu ta' osservazzjoni medjan attwali ta' 96 xahar.
English: Pyrexia (G3/4: 3.6%);
Maltese: Tqalligħ (G3/4: 3.3%);
English: For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Maltese: Għall-kanċer tal-prostata, sakemm l-użu konkomittanti ta' prednisone jew prednisolone jista' jsir, ilmod irrakkomandat tal-premedikazzjoni, huwa t-teħid ta' 8 mg dexamethasone oralment, 12-il siegħa, 3 sigħat u siegħa 1, qabel l-infużjoni ta' docetaxel (ara sezzjoni 4.4).
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Maltese: Mingħajr ma kienet effettwata r-rata totali tar-riżultati u l-punt ewlieni tal-waqfien (32% kontra 25%, p = 0.10), docetaxel tawwal iż-żmien medjan ghall-avvanz (24.6 ġimgħat kontra 15.6 ġimgħat;
English: In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805 in-newropatija periferika tas-sensazzjoni li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjonif'10 pazjenti (1.9%) fil-fergħa TAC u f'4 pazjenti (0.8 %) fil-fergħa FAC.
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Maltese: • Docetaxel 30 mg/m2 li ngħata kull ġimgħa, ghall-ewwel 5 ġimgħat, f'ċiklitwil ta' 6 ġimghat,
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Maltese: Ma kienx hemm effett statistikament sinifikanti ta' prednisone fuq ilkomportament famakokinetiku ta' docetaxel.
English: DOCETAXEL KABI in combination with doxorubicin
Maltese: DOCETAXEL KABI użat flimkien ma' doxorubicin
English: Hormonal receptor
Maltese: TAL-PRODOTT MEDIĊINALI
English: MARKETING AUTHORISATION NUMBER EU/1/12/770/004
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/770/004
English: The binding of docetaxel to microtubules does not alter the number of protofilaments.
Maltese: Ir-rabta ta' docetaxel mal-mikrotubuli ma jibdilx in-numru tal-protofilamenti.
English: Pre-Menopausal
Maltese: Il-Ġermanja
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Maltese: Newtropenija bid-deni (tinkludi nnewtropenija assoċjata mad-deni u lużu ta' l-antibijotiċi) jew newtropenija bis-sepsis
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Maltese: Fl-aħħar tal-perijodu ta' osservazzjoni (żmien medjan attwali ta' osservazzjoni ta' 8 snin), l-edima periferika kienet għada għaddejja f'19-il pazjent TAC (2.6%) u f'4 pazjenti (0.5%) fil-fergħa FAC.
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Maltese: Fil-każ ta' tromboċitopenija ta' Grad 4 id-doża ta' docetaxel għandha titnaqqas minn 75 għal 60 mg/m2.
English: Neutropenic infection; Infection (G3/4: 11.7%)
Maltese: Infezzjoni (G3/4: 11.7%)
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Maltese: • fibrożi tal-pulmuni (titrabba bħal qoxra u r-rita tal-pulmun tiħxien b'konsegwenza li jkun hemm qtugħ ta' nifs).
English: 1-year Survival (%)
Maltese: Sopravivenza ta' Sena (%)
English: Nausea (G3/4: 6%);
Maltese: Alopeċja (G3/4: 6%);
English: Vomiting (G3/4: 1.2%)
Maltese: Edima (G3/4: 1.2%)
English: DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Maltese: DOCETAXEL KABI flimkien ma' cisplatin u 5-fluorouracil huwa indikat fit-trattament ta' pazjenti li għandhom adenokarċinoma metastatika ta' l-istonku, inkluż l-adenokarċinoma tal-parti fejn l-istonku jingħaqad ma' l-esofagu, u li ma kienux ħadu l-kimoterapija qabel, għal mard metastatiku.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Maltese: Il-kwalità sħiħa tal-ħajja (QoL) u r-riżultati tal-benefiċċju kliniku konsistentement indikaw titjib favur il-fergħa ta' TCF.
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Maltese: It-total ta' 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/m2 li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/m2 bħala infużjoni tul ta' 3 sigħat.
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Maltese: 3% tal-pazjenti (10.7% taċ-ċikli).
English: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Maltese: F'pazjenti ittrattati b'docetaxel flimkien ma' cisplatin u 5-fluorouracil (TCF), in-newtropenija bid-deni jew in-newtropenija assoċjata ma' infezzjoni ġraw f'rati aktar baxxi f'pazjenti li ngħataw il-profilassi bil-G-CSF.
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Maltese: Id-doża irrakkomandata ta' docetaxel hija 75 mg/m2 mogħtija bħala infużjoni tul siegħa, segwita minn cisplatin 75 mg/m2, bħala infuzjoni tul ta' 1 sa 3 sigħat (it-tnejn fl-ewwel jum biss), segwita minn 5fluorouracil 750 mg/m2kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5 ijiem, mibdija fit-tmiem ta' l-infużjoni ta' cisplatin.It-trattament għandu jiġi ripetut kull tlett ġimgħat.
English: Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Maltese: Is-sopravivenza totali u medjana kienet anke b'mod sinifikattiv itwal fil-każ tal-grupp TPF, meta mqabbel ma' dak tal-fergħa PF (OS medjan: 18.6 kontra 14.5 xhur, rispettivament), b'tnaqqis tar-riskju ta' mortalità b'28%, p = 0.0128.
English: Elderly treated with TCF should be closely monitored.
Maltese: Anzjanittrattati b'TCF għandhom ikunu immoniterjati mill-qrib.
English: Second primary malignancies (including acute myeloid leukemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Maltese: Malinji primarji sussegwenti( li jinkludu lewkimja mijelojde akuta, sindrome mijelodisplastika u limfoma mhux ta' Hodgkin) jistgħu jseħħu ħafna xhur jew snin wara t-terapija li jkun fiha docetaxel.
English: Fever (G3/4: 1.2%)
Maltese: Deni (G3/4: 1.2%)
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Maltese: Newtropenija (G3/4: 83.2%); Tromboċitopenija (G3/4:
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Maltese: L-aħħar stadju primarju tal-proċess f'dan l-istudju, is-sopravivenza mingħajr l-avvanz (PFS), kien b'mod sinifikattiv itwal tal-fergħa ta' TPF, meta mqabbel mal-grupp ta' PF, p = 0.0042 (PFS medjan: 11.4 kontra 8.3 xhur, rispettivament) b'tul ta' żmien sħiħ u medjan ta' osservazzjoni wara l-kura ta' 33.7 xhur.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bit-trattament studjat [kimoterapija +/- radjuterapija] (%) (95%CI) ***p-value
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Maltese: Kull kaxxa fiha kunjett wieħed ta' 8 ml ta' konċentrat (docetaxel 160 mg).
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Maltese: Kull kaxxa fiha kunjett wieħed ta' 4 ml ta' konċentrat (docetaxel 80 mg).
English: Lymphoedema (G3/4: 0%)
Maltese: Tidmigħ miżjud (G3/4: 0%)
English: DOCETAXEL KABI in combination with trastuzumab
Maltese: Kif jidher DOCETAXEL KABI u l-kontenut tal-pakkett
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Maltese: • Iż-żmien tal-progressjoni (ŻTP) kien sinifikament itwal fil-fergħa AT kontra l-fergħa AC, p = 0.
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-edima periferika li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjoni f'4 pazjenti (0.8 %) fil-fergħa TAC u f'2 pazjenti (0.4 %) filfergħa FAC.
English: Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Maltese: Tromboċitopenija (G3/4: 4.0%) Newtropenija bid-deni
English: Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Maltese: Kull kaxxa fiha kunjett wieħed ta' 6 ml ta' konċentrat (docetaxel 120 mg).
English: Data from onemulti-centre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Maltese: III, ta' studju kliniku, u li sar mingħajr għażla u li kien ikkontrollat, issostni l-użu ta' docetaxel flimkien ma' capecitabine għat-trattament ta' pazjenti b'kanċer tas-sider avvanzat lokalment jew dak metastatiku, wara li falliet il-kimoterapija ċitotossika, inkluża anthracycline.