FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with docetaxel at 100 mg/m 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,
English: Hypersensitivity (G3/4:
Maltese: Sensittività eċċessiva (G3/4:
English: b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first.
Maltese: b Żmien sa kanċer tal-prostata reżistenti għall-kastrazzjoni = żmien mill-għażla b'mod arbitrarju sa progressjoni tal-PSA jew progressjoni klinika (jiġifieri żieda f'metastasi sintomatika fl għadam,progressjoni fil-kriterji ta' Response Evaluation Criteria in Solid Tumours (RECIST) , jew deterjorament mill-aspett kliniku minħabba l-kanċer skont l-opinjoni tal-investigatur), liema minnhom seħħ l-ewwel.
English: PSA** response rate (%) 95% CI p-value*
Maltese: Numru ta' pazjenti PSA** ir-rata tar-rispons (%) 95% CI p-value*
English: Thrombocytopenia (G3/4:
Maltese: Tromboċitopenija (G3/4:
English: Common adverse reactions disorders Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Disgewżja /Parosmja
English: SOLVENT for TAXOTERE 80 mg/2 ml
Maltese: SOLVENT għal TAXOTERE 80 mg/2 ml
English: The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.
Maltese: Is-solvent ta' TAXOTERE huwa taħlita ta' 13% (w/w) ethanol 95% fl-ilma għall injezzjonijiet.
English: Nausea (G3/4: 2.4%);
Maltese: Infezzjoni (G3/4: 2.4%);
English: SOLVENT for TAXOTERE 20 mg/0.5 ml
Maltese: SOLVENT għal TAXOTERE 20 mg/0.5 ml
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 t trattament b'docetaxel waħdu f'doża ta' 100 mg/m².
English: TAXOTERE 20 mg/1 ml sterile concentrate docetaxel
Maltese: TAXOTERE 20 mg/1 ml konċentrat għall-infużjoni docetaxel
English: combined with capecitabine at 1250 mg/m twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Maltese: flimkien ma' capecitabine 1250 mg/m2 darbtejn kuljum (fi żmien ta' 30 minuta wara l-ikel ) għal ġimgħatejn, segwit b'perijodu ta' waqfien għal ġimgħa.
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Maltese: Disturbi respiratorji Ġew irrapportati s-sindromu ta' distress respiratorju akut, pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja u li dawn jistgħu jwasslu għallmewt.
English: Fever (G3: 1%)
Maltese: Rimettar (G3: 1%)
English: The infusion solution should be used within 4 hours at room temperature (below 25°C).
Maltese: jew f'temperatura ambjentali (taħt 25°Ċ).
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: Il pazjenti 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: Dyspepsia; Abdominal pain
Maltese: Pressjoni għolja; Emoraġija
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Maltese: Madankollu, l-istabilità kimika u fiżika tas-soluzzjoni inizjali ntweriet li ddum għal 8 sigħat meta tkun maħzuna bejn 2°Ċ u 8°Ċ jew f'temperatura ambjentali (taħt 25°Ċ).
English: • hearing impaired
Maltese: **Logrank test
English: Diarrhoea (G3/4: 1.2%);
Maltese: Dijarea (G3/4: 1.7%);
English: TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.
Maltese: TAXOTERE flimkien ma' prednisone jew prednisolone huwa indikat għat-trattament tal-kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni.
English: 75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Maltese: fluorouracil 750 mg/m2kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5 ijiem, mibdija fit-tmiem ta' l-infużjoni ta' cisplatin.
English: Ischemia myocardial
Maltese: Qabel il-menopawża
English: Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Maltese: minuti f'temperatura ambjentali (taħt 25°Ċ) u ara li t-taħlita hija omoġenja u ċara (il-formazzjoni tar-ragħwa hija ħaġa normali u tista' tibqa' anke wara 5 minuti dovuta għall preżenza tal-polysorbate 80 fil-formulazzjoni).
English: VIAL LABEL / TAXOTERE 80 mg/4 ml
Maltese: TIKKETTA TAL-KUNJETT/ TAXOTERE 80 mg/4 ml
English: Paresthesia; Headache;
Maltese: Stitikezza; Stomatite;
English: Paediatric population
Maltese: Poloazzjoni pedjatrika
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%);
Maltese: Tqalligħ (G3/4: 5.0%); Stomatite (G3/4: 6.0%);
English: Common adverse reactions
Maltese: Reazzjonijiet Avversi komuni hafna
English: Congestive heart failure (CHF)
Maltese: Pazjenti b'indeboliment tal-fwied
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Maltese: Kien hemm inqas użu tal-morfina għall uġigħ (p <0.01), sustanzi ghall-ugigħ mhux tat-tip tal-morfina (p <0.01), prodotti mediċinali oħra relatati mal-marda (p = 0.06) u r-radjuterapija (p <0.01), f'pazjenti ittrattati b'docetaxel b'doża ta' 75 mg/m2, komparat ma dawk fuq l-AKS.
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 TAXOTERE intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 1.5 ml (Fill 1.98 ml)
Maltese: INDIVIDWALI 13% (w/w) t'ethanol 95% fl-ilma għall-injezzjonijiet 1.5 ml (volum attwali 1.98 ml)
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 6 ml (Fill 7.33 ml)
Maltese: INDIVIDWALI 13% (w/w) t'ethanol 95% fl-ilma għall-injezzjonijiet ta' 6 ml 1.5 ml (Volum attwali 7.33 ml)
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates  10% higher in patients who were 75 years of age or greater versus less than 65 years.
Maltese: L-Incidenza relatata ma'deni, dijarea, anoreksja u edima periferika li ġraw b'rati ≥ 10% ogħla fil-pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: II), li ħadu docetaxel flimkien ma' cisplatin u 5-fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: G3/4 Blood bilirubin increased
Maltese: G3/4 Żieda fil-bilirubin fid-demm
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Maltese: m'induċix mutaġeniċita fit-test t'Ames jew fi studju mutaġeniku tal-ġene CHO/HGPRT.
English: Myalgia (G3/4: 0.6%)
Maltese: Majalġja (G3/4:0.6%)
English: Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
Maltese: Kull folja tal-pakkett ta' TAXOTERE 20 mg/0.5 ml konċentrat u solvent għal soluzzjoni għall infużjoni fiha:
English: Cautions for use in castration-resistant prostate cancerOf the 333 patients treated with docetaxel every three weeks in a prostate cancer study (TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Maltese: Twissijiet dwar l-użu f'kanċer tal-prostata reżistenti għall-kastrazzjoni 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: Solvent vial:
Maltese: Kunjett bis-solvent:
English: Solvent vial: ethanol 95% (see leaflet for further information), water for injections.
Maltese: Kunjett ta' solvent: ethanol 95% (ara l-fuljett għal aktar informazzjoni), ilma għall-injezzjonijiet.
English: Arrhythmia (G3/4:
Maltese: Arritmija (G3/4:
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: Lymphoedema (G3/4:
Maltese: Edima limfatika (G3/4:
English: The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Maltese: Is-sigurtà u l-effikaċja ta' docetaxel mogħti fl-istess ħin ma' kura standard (ADT) f'pazjenti b'kanċer tal-prostata sensittiv għall-ormon lokalment avvanzat jew metastatiku ġew evalwati f'studju (MAMSmulti-arm multi-stage) b'ħafna gradi, ħafna fergħat, multiċentriku u magħmul b'mod arbitrarju biddisinni ta' fażi
English: Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m every 3 weeks for 6 cycles.
Maltese: Kanċer tal-prostata metastatiku sensittiv għall-ormoni Id-doża rakkomandata ta' docetaxel hija 75 mg/m2 kull 3 ġimgħat għal 6 ċikli.
English: • Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Maltese: • Sindromu ta' Stevens-Johnson (SJS, Stevens-Johnson Syndrome) u Nekroliżi Tossika talEpidermide (TEN, Toxic Epidermal Necrolysis) (il-formazzjoni ta' nfafet, taqxir jew dmija minn kwalunkwe parti tal-ġilda tiegħek (inkluż xufftejk, għajnejk, ħalqek, imnieħrek, ġenitali, idejn jew saqajn) b'raxx jew mingħajru.
English: (TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Maltese: (75 mg/m2) (il-fergħa AT) kontra doxorubicin (60 mg/m2) flimkien ma' cyclophosphamide
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 years).
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m
Maltese: Meta jintuża għall-kura preferita, docetaxel 75 mg/m2 jingħata flimkien ma' doxorubicin (50 mg/m2).
English: Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Maltese: Kull kaxxa fiha kunjett wieħed ta' TAXOTERE (20 mg/0.5 ml) u kunjett wieħed ta' solvent korrispondenti għal TAXOTERE, f'pakketti bil-fojl.
English: - For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
Maltese: − Għat-trattament ta' kanċer tal-prostata, TAXOTERE jingħata flimkien ma' prednisone jew prednisolone.
English: Nail discolouration; Onycholysis (G3/4: 1%)
Maltese: Bidla fil-kulur tad-dwiefer; onikolizi(G3/4: 1%)
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Maltese: Kien hemm inqas użu tal-morfina għall uġigħ (p < 0.01), sustanzi ghall-ugigħ mhux tat-tip tal-morfina (p < 0.01), mediċini oħra relatati malmarda (p = 0.06) u r-radjuterapija (p < 0.01), f'pazjenti ittrattati b'docetaxel b'doża ta' 75 mg/m2,
English: A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Maltese: Analiżi aġġornata ta' sopravivenza, maħduma fuq osservazzjoni wara l-kura, fuq medda ta' żmien medjan ta' 41.6 xhur, ma baqgħetx turi differenza statistikament sinifikanti, iżda dejjem iffavorixiet it tip ta' trattament b'TCF, u 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: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
Maltese: TAXOTERE 20 mg/0.5 ml konċentrat u solvent għal soluzzjoni għall-infużjoni
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: Għal kanċer tas-sider u dak tal-pulmun li mhux ta' l-għamla ta' ċelluli żgħar, , trid tingħata lpremedikazzjoni li tikkonsisti f'corticsteroid orali, bħal dexamethasone 16 mg kuljum (e.g. 8 mg BID) għal 3 ijiem, mibdi jum qabel ma jingħata docetaxel, sakemm mhux kontra-indikat.
English: TAXOTERE 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: TAXOTERE 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: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Maltese: *Log-rank test mhux aġġustat **Logrank test mhux aġġustat, mhux aġġustat għal paraguni multipli ***Chi-square test, mhux aġġustat għal paraguni multipli NA - Ma jgħoddx f'dan il-każ.
English: Gastric adenocarcinoma
Maltese: Ugigħ addominali
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Maltese: TAXOTERE 80 mg/2 ml konċentrat għal soluzzjoni għall-infużjoni, hija taħlita ċara u magħquda, safra jew safra tagħti fil-kannella, u li għandha 40 mg/ml ta' docetaxel (anidru) fil-polysorbate 80 u citric acid.
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4:
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva (G3/4:
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with doxorubicin
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal TAXOTERE 75 mg/m² użat flimkien ma' doxorubicin
English: Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
Maltese: prova b Sopravivenza mingħajr ebda inċident: iż-żmien mill-għażla b'mod arbitraju sal-ewwel evidenza ta' mill-inqas wieħed ta': inċident bijokemikali (definit bħala żieda fil-PSA ta' aktar minn 50% tal-inqas livell f'24 ġimgħa u aktar minn 4 ng/mL u kkonfermat minn test ieħor millġdid jew mit-trattament);progressjoni jew lokali fil-glandoli limfatiċi jew f'metastasi fil bogħod; avveniment relatat mal-skeletru jew mewt mill-kanċer tal-prostata.
English: Anaemia (G3/4: 10.8%);
Maltese: Tromboċitopenija (G3/4: 8.8%);
English: None of these increases in frequency reached 10% difference with the control arm.
Maltese: L-ebda waħda minn dawn iż-żidiet fil-frekwenza ma laħqet differenza ta' 10% mal-fergħa ta' kontroll.
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella f'kanċer tal-prostata b'riskju ogħli avvanzat b'mod lokali jew metastatiku sensittiv għall-ormoni għal TAXOTERE 75 mg/m² flimkien ma' prednisone jew prednisolone u ADT (studju STAMPEDE)
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF
Maltese: F'dan l-istudju, l-fergħa AT uriet inċidenza ogħla ta' newtropenija severa (90% kontra 68.6%), newtropenija bid-deni (33.3% kontra 10%), infezzjoni (8% kontra 2.4%), dijareja (7.5% kontra 1.4%),
English: OTHER
Maltese: Le
English: Acute myeloid leukaemia 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 tas sider bl-iskeda ta' trattament TAC.
English: 23 of 736 FAC patients (3.1%).
Maltese: 736 pazjent (87.6 %) fuq FAC.
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Maltese: G-CSF kien ingħata bħala profilassi sekondarja lill-pazjenti li żviluppaw newtropenija komplikata (newtropenija bid-deni, newtropenija fit-tul jew infezzjoni).
English: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion docetaxel
Maltese: TAXOTERE 20 mg/0.5 ml konċentrat u solvent għal soluzzjoni għall-infużjoni docetaxel
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Maltese: *Cox model (aġġustament għas-sit tat-tumur Primarju, T and N stadji kliniċi u PSWHO)
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Maltese: glandoli limfatiċi effettwati (1-3, 4+), 1491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/m2 siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide
English: TAXOTERE concentrate
Maltese: X'fih TAXOTERE
English: Bone marrow suppression and other haematologic adverse reactions have been reported.
Maltese: fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma rrapportati).
English: Rash pruritus (G3/4: 0.7%);
Maltese: Raxx bil-ħakk (G3/4: 0.7%);
English: (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel.
Maltese: • Pustullożi Eksantematuża Akuta Mifruxa (AGEP, Acute Generalized Exanthematous Pustulosis)
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Maltese: l-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-fergħa
English: Its common name is docetaxel.
Maltese: waqqaf id-doża ta' docetaxel.
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 5-fluorouracil (F) 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: CARTON/TAXOTERE 20 mg/0.5 ml
Maltese: KAXXA TAL-KARTUN/TAXOTERE 20 mg/0.5 ml
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: kimoterapija, il-pazjenti b'tumuri RE+ u/jew RPg+ irċevew tamoxifen 20 mg darba kuljum għal 5
English: Pain
Maltese: Jew
English: 5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days.
Maltese: 5-fluorouracil (1000 mg/m2 kuljum għal 5 ijiem).
English: Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Maltese: docetaxel għandha titnaqqas minn 75 għal 60 mg/m2.
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Maltese: Newropatija periferika tassensazzjoni (G3/4: 0.8%)
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Maltese: Dispneja (G3/4: 0.6%);
English: Febrile neutropenia (G3/4: NA)
Maltese: Newtropenija bid-deni (G3/4: NA)
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Maltese: 4.1.2 Uża siringa b'labra mwaħħla magħha u tella' l-kontenut sħiħ tas-solvent ta'TAXOTERE, b'mod asettiku, billi taqleb ilkunjett tas-solvent partjalment rasu 'l isfel.