FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Maltese: Docetaxel użat flimkien ma' trastuzumab kien studjat fit-trattament ta' pazjenti b'kanċer metastatiku tas-sider, liema tumuri kienu jipproduċu HER 2, u li precedentement ma rċevewx il-kimoterapija għal mard metastatiku.
English: Oedema
Maltese: MedDRA
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Maltese: Ilpazjenti li jiżviluppaw stomatite ta' Grad 3 jew 4 għandhom ikollhom id-doża tagħhom imnaqqsa għal 60 mg/m2.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/005
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/770/005
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Maltese: Il-modifikazzjonijiet tad-dożi li huma irrakkomandati f'pazjenti b'tossiċita gastrointestinali ittrattati b'docetaxel meta jintuża flimkien ma' cisplatin u 5-fluorouracil (5-FU):
English: At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Maltese: Fil-medjan taż-żmien ta' osservazzjoni ta' 77 xahar, is-sopravivenza totali (OS -overall survival) kienet itwal fil-fergħa ta' TAC, bil-pazjenti kkurati b'TAC ikollhom tnaqqis ta' 24 % fir-riskju ta' mewt meta mqabbel ma' dawk ta' FAC (proporzjon ta' riskju = 0.76, 95% CI (0.46-1.26, p = 0.29).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3of 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' minn 744 pazjent fuq TAC (0.4 %) u f'1 minn 736 pazjent fuq FAC (0.1 %).
English: Stomatitis (G3/4: 5.3%);
Maltese: Tromboċitopenija (G3/4: 5.2%)
English: Its common name is docetaxel.
Maltese: L-isem komuni tagħha huwa docetaxel.
English: Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Maltese: In-newtropenija hija l-aktar reazzjoni avversa u komuni ta' docetaxel.
English: Alopecia ( persisting: <3%); Skin disorder (G3/4: 0.6%);
Maltese: Fġir l-imnieħer (G3/4: 0%); Dispneja (G3/4: 0.6%);
English: In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Maltese: F'dan l-istudju, 87% tal-pazjenti kellhom mard li kien IHC 3+, u 95% tal-pazjenti li dahlu fl-istudju kellhom mard li kien IHC 3+ u/jew FISH pożittiv.
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 ittip ta' trattament b'TCF, u uriet 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: Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Maltese: III ta' l-istudju u 79 pazjent fil-fażi II) ittrattati b'docetaxel flimkien ma' cisplatin u 5-fluorouracil fl-istudju fuq il-kanċer ta' l-istonku, 74 pazjenti kellhom 65 sena jew aktar u 4 pazjenti kellhom 75 sena jew aktar.
English: Dysgeusia/Parosmia;
Maltese: Dijarea; Rimettar;
English: Vomiting (G3/4: 4%);
Maltese: Rimettar (G3/4: 4%);
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with doxorubicin
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal DOCETAXEL KABI 75 mg/m² użat flimkien ma' doxorubicin:
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomised to one of two treatment arms.
Maltese: F'dan l-istudju, 358 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miżżewġ friegħi tat-trattament mingħajr għażla.
English: Nail disorders (severe: 0.8%)
Maltese: Mard tad-dwiefer (sever: 0.8%)
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal DOCETAXEL KABI 100 mg/m2 bħala sustanza użata waħedha
English: Nausea (G3/4: 9.6%);
Maltese: Dijarea (G3/4: 6.4%);
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Maltese: Ilbidu taż-żamm moderat u sever ittardja (doża kumulattiva medjana: 818.9 mg/m2) f'pazjenti li ħadu lpremedikazzjoni, meta mqabbel ma' dawk li ma ħadux il-premedikazzjoni (doża kumulattiva medjana: 489.7 mg/m2).
English: Anaemia (G3/4: 3%); Neutropenia (G3/4: 59.2%);
Maltese: Stomatite (G3/4: 5.3%); Dijarea (G3/4: 4%);
English: Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Maltese: Anemija (G3/4: 3%); Newtropenija (G3/4:
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX oħra mediċina ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan ilmediċina (DOCETAXEL KABI 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Maltese: Il-komportament farmakokinetiku ta' docetaxel, doxorubicin u cyclophosphamide ma kienx effetwat meta ngħataw flimkien.
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Maltese: Matul ir-radjuterapija, carboplatin (AUC 1.5) kien jingħata kull ġimgħa bħala infużjoni fil-vini fuq tul ta' siegħa sa massimu ta' 7 dożi.
English: All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Maltese: Il-pazjenti kollha fejn it-tumur m'avvanzax, ingħataw (CRT), skont il-protokol (TPF/CRT).
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għat-terapija miżjuda b'DOCETAXEL KABI 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: DOCETAXEL KABI in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Maltese: DOCETAXEL KABI flimkien ma' trastuzumab huwa indikat għat-trattament ta'pazjenti b'kanċer metastatiku tas-sider, liema tumuri jesprimu bil-qawwa HER2, u li preċedentement ma kienux ħadu kimoterapija għall-mard metastatiku.
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI DOCETAXEL KABI 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni
English: In this study, 501 patients, with locally advancedSCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Maltese: F'dan l-istudju, 501 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tat-trattament mingħajr għażla.
English: Hazard ratio (95% CI) *p-value
Maltese: Il-proporzjon tar-riskju (95% CI) *p-value
English: Combination therapy
Maltese: Artralġja
English: Nausea (G3/4: 5%);
Maltese: Rimettar (G3/4: 5%);
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Maltese: Fl-aħħar tal-perijodu ta' osservazzjoni (żmien medjan attwali ta' osservazzjoni ta' 8 snin), limfoedima kienet osservata li kienet għada għaddejja f'6 pazjenti TAC (0.8%) u f'pazjent 1 (0.1%) fil-fergħa FAC.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/002
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/770/002
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Maltese: Reazzjonijiet qawwija kienu ikkaratteriżżati minn pressjoni baxxa u/jew spasmu tal-bronki bi qtugħ ta' nifs jew raxx/ħmura ġeneraliżżat(a) (ara sezzjoni 4.4).
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX oħra mediċina ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan ilmediċina (DOCETAXEL KABI 120 mg/6 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Maltese: Letarġija (G3/4:3.4%); Deni (G3/4: 0.6%);
English: Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Maltese: Tul medjan ta' sopravivenza mingħajr it-tumur javvanza (xhur) (95%CI)
English: Hazard ratio (95% CI) **p-value
Maltese: Il-proporzjon tar-riskju (95%CI) **p-value
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-amenorreja li bdiet matul il-perijodu ta' trattament u li baqgħet tippersisti fil-perijodu ta' osservazzjoni ġiet osservata li kienet baqgħet għaddejja fi 18-il pazjent (3.4 %) filfergħa ta' TAC u f'5 pazjenti (1.0 %) fil-fergħa ta' FAC.
English: Febrile neutropenia
Maltese: Disturbi psikjatriċi
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari f'kanċer gastriku tat-tip adenokarċinoma għal DOCETAXEL KABI 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil
English: Quality of life parameters
Maltese: GĦAMLA KWALITATTIVA
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: Każijiet rari ta' ileus u ostruzzjoni tal-intestin ġew irrapportati.
English: MARKETING AUTHORISATION NUMBER EU/1/12/770/003
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/770/003
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Id-doża medjana kumulattiva għall-waqfien tat-trattament kienet aktar minn 1,000 mg/m2, u z-żmien medjan għar-riversibbilità taż-żamm tal-fluwidu kien ta' 16.4 ġimghat (medda 0 sa 42 ġimghat).
English: In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Maltese: F'pazjenti li kellhom jew id-deni flimkien man-newtropenija, l-għadd taċ-ċelluli newtrofiliċi ta' < 500 ċelluli/mm3 għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil-ġilda, jew newropatija severa u periferika, waqt it-terapija bid-docetaxel, id-doża ta' docetaxel trid titnaqqas minn 100 mg/m2 għal 75 mg/m2 u/jew minn 75 għal 60 mg/m2.
English: Ischemia myocardial
Maltese: OĦRAJN Ċitotossiku
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX oħra mediċina ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan ilmediċina (DOCETAXEL KABI 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Maltese: Insuffiċjenza tal-ventrikolu taxxellug tal-qalb (G3/4: 0.3%)
English: Nausea (G3/4: 3.3%);
Maltese: Astenja (G3/4: 3%);
English: Tabulated list of adverse reactions in head and neck cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi f' kanċer gastriku tat-tip adenokarċinoma għal DOCETAXEL KABI 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil
English: At the median follow-up time of 77 months overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Maltese: mewt meta mqabbel ma' dawk ta' FAC (proporzjon ta' riskju = 0.76, 95% CI (0.46-1.26, p = 0.29).
English: Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Maltese: 6.0%); Rimettar (G3/4: 4.2%); Dijarea (G3/4: 3.4%);
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Maltese: It-tul ta' ċiklu ta' trattament kien ta' 3 ġimgħat fil fergħa TCF u 4 ġimgħat għal fergħa CF.
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Maltese: Kull kaxxa fiha kunjett wieħed ta' 9 ml ta' konċentrat (docetaxel 180 mg).
English: There is no known antidote for docetaxel overdose.
Maltese: M'hemmx antidot magħruf kontra doża eċċessiva ta'docetaxel.
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Maltese: L-ewwel episodju: waqqaf 5-FU biss, fil-korsijiet kollha sussegwenti It-tieni episodju: naqqas id-doża ta' docetaxel b'20%.
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Maltese: G3/4 Żieda flalkaline phosphatase fid-demm (0.3%)
English: In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
Maltese: Fiż-żewġ fergħat, wara l-aħħar ċiklu ta' kimoterapija, il-pazjenti b'tumuri RE+ u/jew RPg+ irċevew tamoxifen 20 mg darba kuljum għal 5 snin.
English: Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Maltese: Newtropenija (G4: 76.4%); Anemija (G3/4: 8.9%);
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Disturbi fis-sistema nervuża Parasteżija; Ugigħ ta' ras; Disgewżja;
English: The carcinogenic potential of docetaxel has not been studied.
Maltese: Il-potenzjal karċinoġeniku ta' docetaxel ma kienx studjat.
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Maltese: Il-profilassi b'G-CSF tista' tintuża biex tnaqqas ir-riskju ta' effetti tossiċi ematoloġiċi.
English: DOCETAXEL KABI will be administered to you by a healthcare professional.
Maltese: DOCETAXEL KABI sejjer jingħatalek minn professjonist fil-qasam tas-saħħa.
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain;
Maltese: Tromboċitopenija (G3/4: 0.6%); Newtropenija bid-deni
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Maltese: Fil-qasam ta' l-istudji fejn DOCETAXEL KABI intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Maltese: 0043). Sopravivenza totali wara 10 snin kienet kibret b'mod sinifikattiv b'TAC meta mqabbla ma' FAC (76% kontra 69% rispetivament) li tfisser riskju assolut tal-mewt imnaqqas b'7% (p = 0.002).
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal DOCETAXEL KABI 75 mg/m² użat flimkien ma' capecitabine
English: Single-use vial.
Maltese: 1 ġimgħat.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Fresenius Kabi Deutschland GmbH Pfingstweide 53
English: Thrombocytopenia (G3/4: 0.6%);
Maltese: Uġigħ tal-kanċer (G3/4: 0.6%)
English: In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
Maltese: F'studju farmakokinetiku b'7 pazjenti, it-teħid flimkien ta' docetaxel mal-inibitur qawwi ta' CYP3A4 ketoconazole wassal għal tnaqqis sinfikanti fit-tneħħija ta' docetaxel b'49 %.
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: Ġiet miżjuda t-terapija ta' radjazzjoni skont il-linji gwida li kien hemm flistituzzjonijiet li ħadu parti fl-istudju u ġiet mogħtija lis-57.3% tal-pazjenti li rċevew it-TAC u lill51.2% tal-pazjenti li rċevew il-FAC.
English: Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Maltese: B'docetaxel, ġew irrapportati tibdil tat-tip sklerodermali, ħafna drabi wara limfedima periferali.
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 ta' l-għadd taċċelluli fid-demm.
English: For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Maltese: Għal aġġustamenti fid-dożi, fil-każ ta' cisplatin u 5-fluorouracil, ara s-sommarji tal-karatteristiċi talprodotti .
English: Rash erythematous (G3/4: < 1%);
Maltese: Fġir l-imnieħer (G3/4: < 1%)
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI DOCETAXEL KABI 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/770/001
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary ana lysis (at the median follow-up time of 77 months) (see table below):
Maltese: Gruppi sekondarji ta' pazjenti kkurati bit-TAC ġew analizzati skont fatturi pronjostiċi ewlenin li ġew stabbiliti b'mod prospettiv fl-analiżi primarja (fil-medjan taż-żmien ta' osservazzjoni ta' 77 xahar) (ara t-tabella hawn taħt):
English: One vial of 6 ml of concentrate contains 120 mg of docetaxel.
Maltese: Kunjett wieħed ta' 6 ml ta' konċentrat fih 120 mg ta' docetaxel
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
Maltese: INDIVIDWALI 120 mg/6 ml OĦRAJN Ċitotossiku
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Maltese: III, t'għamla komparattiva u magħmula mingħajr għażla, fejn kien hemm total ta' 326 suġġetti fejn it-trattament oriġinali kien b'sustanzi ċitotossiċi alkylating u 392 oħra li kienu ittrattati oriġinarjament b'sustanza anthracycline, b'falliment tal-kura fiż-żewġ gruppi u li t-tnejn kellhom kanċer tas-sider metastatiku.
English: Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Maltese: Id-data minn studju f'ċentri multipli, fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu x'mediċini qed jintużaw, u l-pazjenti tqassmu mingħajr għażla, isaħħu l-użu ta' docetaxel għattrattament miżjud f'pazjenti li għandhom kanċer tas-sider li nfirex fil-glandoli limfatiċi u li huwa operabbli b'KPS ta' ≥80%, minn 18 sa 70 sena fl-età.
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: Sintomi bħal uġigħ addominali bikri u sensibilità, deni, dijarea, bin-newtropenija u mingħajrha, jistgħu jkunu l-ewwel sinjali ta' tossiċità serja gastro-intestinali u għandhom ikunu evalwati u ittrattati filpront.
English: Overall response rate (%):
Maltese: Sopravivenza ta' Sentejn (%)
English: Uncommon adverse reactions neuropathy (G3/4: 1.2%) neuropathy (G3/4: 0.4%)
Maltese: Newropatija periferika tassensazzjoni (G3/4: 1.2%); Disgewzja (G3/4: 0%)
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Maltese: Għalhekk, id-doża irrakkomandata ta' docetaxel f'dawk il-pazjenti li għandhom livelli għolja fit-testijiet tal-funzjoni tal-fwied (LFTs) huwa 75 mg/m2 u l-LFTs irid jiġi meqjus fil-bidu u qabel kull ċiklu ta' trattament (ara sezzjoni 4.2).
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX oħra mediċina ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan ilmediċina (DOCETAXEL KABI 180 mg/9 ml konċentrat għal soluzzjoni għall-infużjoni, li jkun fih biss kunjett wieħed).
English: If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Maltese: Jekk hija meħtieġa doża akbar minn 190 mg ta' docetaxel, uża volum t'infużjoni akbar biex tiżgura li ma teċċedix il-konċentrazzjoni ta' 0.74 mg/ml ta' docetaxel.