FrancophonIA/ELRC3.0 huggingface dataset:
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Kura: 5.4% [95% CI: -1.1; 12.0] Differenza fil-Kura: 6.2% \[95% CI: 0.2; 12.3]
English: Overall survival was also significantly longer (p=0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
Maltese: Is-sopravivenza totali kienet ukoll b'mod sinifikattiv itwal (p = 0.0201) favur il-parti tal-istudju dwar TCF b'riskju mnaqqas ta' mortalità ta' 22.7%.
English: This volume of concentrate should be injected into a 250 ml infusion bag or bottle containing either glucose 50 mg/ml (5%) solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Dan il-volum ta' konċentrat għandu jiġi injettat ġo borża tal-infużjoni ta' 250 ml jew flixkun li jkun fih jew soluzzjoni ta' glucose 50 mg/ml (5%) jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Maltese: Newropatija periferali tas-sensazzjoni (G3/4: 0.8%)
English: Docetaxel 100 mg/m² single agent
Maltese: Docetaxel 100 mg/m2 użat flimkien ma' trastuzumab
English: Uncommon side effects:
Maltese: Effetti sekondarji oħra komuni ħafna:
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 kkurati b'docetaxel waħdu b'doża ta' 100 mg/m2, u li għandhom livelli tal-enzimi transaminase (l-ALT u/jew l-AST) fis-serum aktar minn 1.5 darbiet l-ULN, flimkien ma' livelli tal-enzima alkaline phosphatase fis-serum aktar minn 2.5 darbiet l-ULN, għandhom riskju akbar li jiżviluppaw reazzjonijiet avversi u severi, bħal mewt ta' natura tossika inkluża s-sepsis, emorraġija gastrointestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
English: Docetaxel every week Mitoxantrone every 3 weeks
Maltese: Mitoxantrone kull 3
English: Abdominal pain; Dyspepsia;
Maltese: Edema periferali;
English: Anaemia (G3/4: 8.9%); Febrile neutropenia
Maltese: Anemija (G3/4: 8.9%); Newtropenja bid-deni
English: • The solvent vial for Docefrez 20 mg is a 1 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm dark blue flip-off aluminium seal.
Maltese: • Il-kunjett bis-solvent għal Docefrez 20 mg ml hu kunjett tubulari ta' 1 ml magħmul minn ħġieġ bla kulur ta' tip 1 b'tapp griż tal-lastku tal-bromobutyl ta' 20 mm issi ġillat b'siġill blu skur tal-aluminju tat-tip flip-off.
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Maltese: Il-farmakokinetika ta' Docetaxel fil-preżenza ta' prednisone kienet studjata f'pazjenti b'kanċer metastatiku tal-prostata.
English: 4 ml (35.4% w/w ethanol in polysorbate 80)
Maltese: 4% w/w ethanol f'polysorbate 80)
English: Patients on the docetaxel arm received docetaxel 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days .
Maltese: Pazjenti fil-parti tal-istudju dwar docetaxel ingħataw docetaxel (T) 75 mg/m2, segwit minn cisplatin (P) 75 mg/m2, segwit minn 5-fluorouracil (F) 750 mg/m2 kuljum bħala infużjoni kontinwa għal 5 ijiem.
English: Peripheral oedema was observed to be ongoing during follow-up time in 18 patients out of the 112 patients with peripheral oedema at the end of the chemotherapy in study TAX 316, whereas lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy in the study GEICAM 9805.
Maltese: L-edima periferika kienet għadha hemm matul il-perijodu ta' osservazzjoni ta' wara t-trattament fi 18- il pazjent minn 112 pazjent bl-edima periferika fit-tmiem tal-kimoterapija fl-istudju TAX 316, waqt li l-edima limfatika ġiet osservata li kienet għada hemm f'4 pazjenti mill-5 pazjenti li kellhom l-edima limfatika fit-tmiem il-kimoterapija fl-istudju GEICAM 9805.
English: 2.2 Docefrez 20 mg solvent vials
Maltese: 2.2 Kunjetti bis-solvent ta' Docefrez 20 mg
English: Peripheral sensory neuropathy (G3/4: 8.7%).
Maltese: Newropatija periferali tas-sensazzjoni (G3/4: 8.7%)
English: Ischemia myocardial
Maltese: U MA JIDHIRX MIT-TFAL
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna tal-prodott mediċinali rrikostitwit u dilwit, ara sezzjoni 6.3. 6.5
English: You will be given Docefrez by a healthcare professional in the hospital.
Maltese: Ser tingħata Docefrez fl-isptarminn professjonist fil-qasam tas-saħħa.
English: Disposal
Maltese: Dispepsja
English: 2.1 Docefrez 80 mg powder vials
Maltese: 2.1 Kunjetti bit-trab ta' Docefrez 80 mg
English: Nail disorders (severe 0.8%)
Maltese: Mard tad-dwiefer (sever 0.8%)
English: Arrythmia (G3/4:0.7%)
Maltese: Arritmija (G3/4:0.7%)
English: Conjunctivitis (G3/4:
Maltese: Astenja (G3/4:
English: Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer MedDRA system organ classes Very common adverse reactions Common adverse reactions Infections and infestations
Maltese: Docetaxel 75 mg/ m2 użat flimkien ma' cisplatin u 5-fluorouracil għal kanċer tat-tip adenokarċinoma tal-istonku Sistema tal-klassifika tal-organi fid-database MedDRA
English: The solvent for Docefrez is a solution of 35.4% w/w Ethanol (anhydrous) in Polysorbate 80.
Maltese: Is-solvent għal Docefrez hu soluzzjoni ta' 35.4% w/w Ethanol (anhydrous) f'Polysorbate 80.
English: Diarrhoea (G3/4: 3.4%);
Maltese: Dijarea (G3/4: 3.4%);
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Għejja; Infjammazzjoni tal-mukoża; Uġigħ; Mard bħall-influwenza; Uġigħ fis-sider; Riħ bid-deni
English: A drug interaction study performed in patients receiving ketoconazole and docetaxel showed that the clearance of docetaxel was reduced by half by ketoconazole, probably because the metabolism of docetaxel involves CYP3A4 as a major (single) metabolic pathway.
Maltese: Studju ta' interazzjoni bejn il-mediċini magħmul f'pazjenti li qegħdin jirċievu ketoconazole u docetaxel wera li t-tneħħija ta' docetaxel tnaqqset bin-nofs minħabba ketoconazole u dan probabbilment għaliex il-metaboliżmu ta' docetaxel jinvolvi lil CYP3A4 bħala l-mezz ewlieni (waħdieni) ta' metaboliżmu.
English: Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Maltese: 69% tal-pazjenti li ħadu TAC u 72% tal-pazjenti li ħadu FAC.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Maltese: Meta jintuża flimkien ma' trastuzumab, l-avvenimenti avversi (il-gradi kollha) irrappurtati f ` > 10%
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Maltese: Jekk iseħħu episodji oħra sussegwenti ta' newtropenija b'kumplikazzjonijiet, id-doża ta' docetaxel għandha titnaqqas minn 60 għal 45 mg/m2.
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 kkurati b'docetaxel kull tliet ġimgħat fi studju fuq il-kanċer tal-prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
English: The infusion should be used within 4 hours below 25 ºC.
Maltese: sigħat f'temperatura taħt 25°C .
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Maltese: L-Effikaċja ta' docetaxel għall-kura induttiva ta' pazjenti b'SCCHN inoperabbli u lokalment avanzat (Analiżi bl-Iskop li Tikkura)
English: After reconstitution, 1 ml of concentrate contains 24 mg docetaxel
Maltese: konċentrat ikun fih 24 mg ta' docetaxel
English: Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Maltese: Pressjoni baxxa; Pressjoni għolja; Emorraġija
English: HOW TO STORE DOCEFREZ
Maltese: Infużjoni Docetaxel
English: • Each solvent vial of Docefrez 80 mg contains 4 ml of 35.4% w/w ethanol in Polysorbate 80.
Maltese: Kull kunjett bis-solvent ta' Docefrez 80 mg fih 4 ml ta' 35.4% w/w ethanol f'Polysorbate 80.
English: After reconstitution, 1 ml of concentrate contains 24 mg docetaxel.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' konċentrat ikun fih 24 mg ta' docetaxel.
English: Dizziness (G3/4: Peripheral motor neuropathy (G3/4: 0.4%)
Maltese: Pyrexia (G3/4: NA) Edema periferika (G3/4: 0.2%)
English: Neutropenic infection
Maltese: Infezzjoni newtropenika;
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 tal-istudji fejn Docetaxel intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija addizzjonali, meta mqabbel ma' 55% fil-parti tal-istudju dwar ta' docetaxel biss.
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: Globali, meta mqabbla ma' dawk kkurati bi PF (p = 0.01, meta tintuża l-iskala EORTC QLQ-C30).
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Maltese: L-iżvilupp ta' newrotossiċità periferali u severa jirrikjedi tnaqqis fid-doża (ara sezzjonijiet 4.2 u 4.4).
English: Oesophagitis (severe:
Maltese: Reazzjoni tal-ġilda (mhux severa)
English: Anaemia (G3/4: 9.4%); Febrile neutropenia;
Maltese: Anemija(G3/4: 9.4%); Newtropenija bid-deni;
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF, (see section 4.2).
Maltese: Newtropenija bid-deni u infezzjonijiet assoċjati man-newtropenija seħħew, rispettivament, fi 12.1% u 3.4% tal-pazjenti, meta dawn irċivew il-profilassi b'G-CSF, fil-waqt li 15.
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 kumplessa tal-mikrotubuli fiċ-ċelluli.
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Kura: 5.4% [95% CI: -1.1; 12.0] Differenza fil-Kura: 6.2% [95% CI: 0.2; 12.3]
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 fil-plażma kien ta' 3.7 ug/ml b'AUC korrispondenti ta' 4.6 sigħat.
English: One large randomized 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-parti tal-istudju dwar AT) kontradoxorubicin (60 mg/m2) flimkien ma' cyclophosphamide (600 mg/m2) (il-parti tal-istudju dwar AC).
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: The Docefrez 20 mg powder is a white to off white lyophilised powder containing 20 mg (plus 22% overfill: 24.4 mg) of docetaxel (anhydrous).
Maltese: -griż li fih 20 mg (flimkien ma' 22% overfill: 24.4 mg) ta' docetaxel (anhydrous).
English: Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Maltese: Reazzjonijiet tal-ġilda riversibbli kienu innotati u kienu ġeneralment meqjusa bħala ħfief sa moderati.
English: Oral candidiasis (G3/4: <1%)
Maltese: Tinfaġar (G3/4: < 1%)
English: Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil for head and neck cancer
Maltese: Docetaxel 75 mg/m2 użat flimkien ma' cisplatin u 5-fluorouracil (għal kanċer tar-ras u tal-għonq)
English: Pain
Maltese: Analiżi
English: Docetaxel 75 mg/m² in combination with doxorubicin: MedDRA system organ classes
Maltese: Docetaxel 75 mg/m2 użat flimkien ma' doxorubicin:
English: G3/4 Blood bilirubin increased
Maltese: G3/4 Żieda tal-bilirubina fid-demm
English: Vomiting (G3/4: 4.2%);
Maltese: Rimettar (G3/4:4.2%);
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 daħlu 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 iffavorixxiet it-tip ta' kura b'TCF, u wriet 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: Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Maltese: Sinkope (G3/4: 0%) Newrotossiċità (G3/4:0 %)
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 hi disponibbli f'35.3% tal-pazjenti li żviluppaw newrotossiċità wara l-kura b'docetaxel waħdu f'doża ta' 100 mg/m2.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini (EMA) http://www.ema.europa.eu/
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion Docetaxel
Maltese: Docefrez 80 mg trab u solvent għal konċentrat għal soluzzjoni għall-infużjoni:
English: • decreased number of platelets (increased risk of unexpected bleedings)
Maltese: • tnaqqis fin-numru ta' plejtlits (żieda fir-riskju ta' ħruġ ta' demm mhux mistenni)
English: Infection associated with G4 neutropenia (G3/4:4.6%)
Maltese: Infezzjoni assoċjata ma' newtropenija G4 (G3/4:4.6%)
English: Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Maltese: Pressjoni baxxa (G3/4: Flebite (G3/4: 0%)
English: Congestive Heart Failure (CHF) has been reported in 18 of 1276 patiens during the follow-up period.
Maltese: L-insuffiċjenza konġestiva tal-qalb (CHF) ġiet irrapportata fi 18-il pazjent minn 1276 pazjent waqt ilperijodu ta' osservazzjoni ta' wara t-trattament.
English: Tell your doctor if you have: - heart problems - liver problems - kidney problems
Maltese: problemi fil-qalb problemi fil-fwied problemi fil-kliewi
English: The solvent for Docefrez is 35.4% w/w Ethanol in Polysorbate 80.
Maltese: Is-solvent għal Docefrez hu 35.4% w/w Ethanol f'Polysorbate 80.
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Maltese: Stomatite (G3/4:4.0%); Dijarea (G3/4:2.9%);
English: Docetaxel in combination with trastuzumab
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bil-kura studjat [kimoterapija +/-radjuterapija] (%) (95%CI) ***p-value
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 rrakomandata ta' docetaxel hi 75 mg/m2 mogħtija bħala infużjoni ta' siegħa, segwita minn cisplatin 75 mg/m2, bħala infuzjoni ta' minn' siegħa sa 3 sigħat (it-tnejn fl-ewwel jum biss), segwita minn 5-fluorouracil 750 mg/m2 kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5
English: • one single-dose powder vial with 20 mg docetaxel (plus 22% overfill: 24.4 mg), and
Maltese: • kunjett wieħed bit-trab għal doża waħda b'20 mg ta' docetaxel (flimkien ma' 22% overfill: 24.4 mg), u
English: The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
Maltese: Il-profil farmakokinetiku ta' cisplatin, li ngħata ftit wara l-infużjoni ta' docetaxel, hu simili għal dak osservat b'cisplatin waħdu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 20 mg
Maltese: 80 mg u tliet pakketti ta' 20 mg.
English: Asthenia (severe: 8.1%); Fluid retention (severe:
Maltese: (severa: 6.5%); Astenja (severa:
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m
Maltese: 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-parti tal-istudju dwar TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide 500 mg/m2 (il-parti tal-istudju dwar
English: One hundred eighty six patients were randomized 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 rċivew fil-passat kimoterapija addizzjonali b'tip ta' anthracycline.
English: Infection (G3/4: 3.3%)
Maltese: Infezzjonijiet (G3/4: 3.3%
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 kumplikata (newtropenija bid-deni, newtropenija fit-tul jew infezzjoni).
English: Dysgeusia (G3/4: 0%)
Maltese: Disġewżja (G3/4: 0%)
English: • fungal infection of the mouth (oral candidiasis)
Maltese: • infezzjoni fungali tal-ħalq (kandidijasi tal-ħalq)
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 ta' siegħa sa massimu ta' 7 dożi.
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Maltese: Artralġja (G3/4: 0.3%);
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Maltese: Newropatija periferali tas-sensazzjoni (G3/4: 1.2%);
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 kkurati b'Herceptin flimkien ma' docetaxel (23% kontra 17% g ħal pazjenti kkurati b'docetaxel biss).
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 rrakkomandati f'pazjenti b'tossiċita kkurati b'docetaxel meta jintuża flimkien ma' cisplatin u 5-fluorouracil (5-FU):
English: Median overall survival was also significantly longer in favor 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 fil-parti tal-istudju dwar PF (OS medjan: 18.6 kontra 14.5 xhur, rispettivament), b'tnaqqis tar-riskju ta' mortalità b'28%, p = 0.0128.
English: Lethargy (G3/4:
Maltese: Stitikezza (G3/4:
English: Amenorrhoea was observed to be ongoing during follow-up in 140 patients out of the 251 patients with amenorrhoea at the end of the chemotherapy.
Maltese: L-amenorreja kienet ghadha hemm matul il-perijodu ta' osservazzjoni ta' wara t-trattament f'140 pazjent minn 251 pazjent b'amenorreja fit-tmiem tal-kimoterapija.
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: u bi skop ta' preservazzjoni tal-organi), id-doża rrakomandata ta' docetaxel hi 75 mg/m bħala infużjoni ta' siegħa f'jum 1, segwita minn cisplatin 100 mg/m2 mogħti bħala infużjoni ta' minn 30 minuta sa 3 sigħat, segwita minn 5-fluorouracil 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: Docefrez 20 mg powder and solvent for concentrate for solution for infusion
Maltese: Docefrez 20 mg konċentrat u solvent għal soluzzjoni għall-infużjoni
English: Patients on the TPF 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-parti tal-istudju dwar TAC irċivew profilassi bl-antibijotiku ciprofloxacin 500 mg oralment, darbtejn kuljum, għal 10 ijiem, mibdi f'jum 5 ta' kull ċikli, jew ekwivalenti.
English: G3/4 Blood bilirubin G3/4 AST increased increased (<2.5%);
Maltese: G3/4 Żieda fl-ALT (< 2%)
English: Docetaxel 75 mg/m² single agent
Maltese: doxorubicin (75 mg/m2 kull 3 ġimgħat).
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 seħħew fi żmien sebat ijiem u l-ammont imneħħi fl-awrina u fl-ippurgar kien ta' madwar 6% u 75% tar-radjuattività li ngħatat, rispettivament.
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 nnotati, li rarament wasslu għal interruzjoni jew waqfien fil-kura ta' docetaxel (ara sezzjonijiet 4.2 u 4.4).
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Maltese: Fil-pazjenti li kienu ħadu t-kura b'anthracycline, li kienet falliet, docetaxel kien imqabbel mal-użu ta' mitomycin C u l-vinblastine flimkien (12 mg/m2 kull 6 ġimgħat u 6 mg/m2 kull 3 ġimgħat).
English: Gastrointestinal
Maltese: Uġigħ gastrointestinali