FrancophonIA/ELRC3.0 huggingface dataset:
English: Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bil-kura studjata [kimoterapija +/-kimoradjuterapija] (%) (95%CI) ***p-value tal-pazjent.
English: Lethargy
Maltese: Docetaxel
English: Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Maltese: Ir-radjazzjoni ingħatat permess ta' apparat megavoltage b'użu kuljum ta frazzjoni (2 Gy kuljum, 5 jiem fil-ġimgħa għal 7 ġimgħat, għad doża totali ta' 70-72 Gy).
English: Neutropenia (Grade 4)
Maltese: Stomatite/mukożite ta' grad 4
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari: avvenimenti emorraġiċi assoċjati ma' grad 3/4 ta' tromboċitopenija
English: Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Maltese: Docetaxel intwera li hu mutaġeniku in vitro fil-mikronukleju u fit-test għall-aberrazzjoni tal-kromosomi fiċ-ċelluli CHO-K1 u fit-test in vivo fuq il-mikronukleju fil-ġurdien.
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-avvenimenti avversi li jmiss (fil-gradi kollha): telqa, stomatite u infezzjonijiet assoċjati man-newtropenija, seħħet f'rati ta' ≥ 10% ogħla f'pazjenti li kellhom 65 sena jew aktar, meta mqabbla ma' pazjenti iżgħar.
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Maltese: Il-pazjenti li qed jieħdu TCF għandhom ikunu immonitorjati mill-qrib (ara sezzjonijiet 4.2 u 4.8).
English: 1-year Survival (%)
Maltese: n (%)
English: Patients with 4+ nodes
Maltese: Pazjenti b ' 4+ glandoli
English: Docetaxel should be administered with caution in patients concomitantly receiving potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, azole antifungals like ketoconazole or itraconazole).
Maltese: (eż. inibituri ta' protease bħal ritonavir, mediċini antifungali tat-tip azole bħal ketoconazole jew itraconazole).
English: (FAC arm).
Maltese: FAC).
English: Batch
Maltese: MHUX
English: Docetaxel in combination with doxorubicin
Maltese: Docetaxel użat flimkien ma' doxorubicin
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Maltese: Dijarea ta' grad 3 L-ewwel episodju: naqqas id-doża ta' 5-FU b'20%.
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Maltese: It-tliet gruppi ħadu l-kimoterapija flimkien ma' prednisone jew prednisolone 5 mg darbtejn kuljum, kontinwament.
English: Rash pruritic;
Maltese: Reazzjoni fis-sit talinfuzjoni;
English: In combination with cisplatin and 5-fluorouracil
Maltese: Meta jintuża flimkien ma' cisplatin u 5-fluorouracil
English: 1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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: 500 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclosphosphamide 500 mg/m2 (521 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 tal-1998 (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: 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 għall-uġigħ mhux tat-tip tal-morfina (p < 0.01), mediċini oħra relatati mal-marda (p = 0.06) u r-radjuterapija (p < 0.01), f'pazjenti kkurati b'docetaxel b'doża ta' 75 mg/m2, imqabbel ma dawk fuq l-AKS.
English: • Each solvent vial of Docefrez 20 mg contains 1 ml of 35.4% w/w Ethanol in Polysorbate 80
Maltese: • Kull kunjett bis-solvent ta' Docefrez 20 mg ml fih 1 ml ta' 35.4% w/w Ethanol f'Polysorbate 80
English: Docefrez is incompatible with PVC equipment or devices.
Maltese: Docefrez hu inkompatibbli ma' tag ħmir jew strumenti tal-PVC.
English: A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil
Maltese: Proporzjon ta' riskju ta' anqas minn 1 hu favur docetaxel + cisplatin + fluorouracil *Log-rank test mhux aġġustat
English: Each pack of Docefrez 20 mg powder for concentrate for solution for infusion contains one single-dose vial of docetaxel (anhydrous) (20 mg with corresponding fill of 24.4 mg as lyophilised powder) and a corresponding single-dose vial with 1 ml of solvent consisting of 35.4% (w/w)of Ethanol (anhydrous) in Polysorbate 80.
Maltese: Kull pakkett ta' Docefrez 20 mg trab għal konċentrat għal soluzzjoni għall-infużjoni fih kunjett wie ħed b'doża waħda ta' docetaxel (anhydrous) (20 mg b'fill li jikkorrispondi għal 24.4 mg) bħala trab lajofilizzat flimkien ma'kunjett b'doża waħda ta'1 ml ta' solvent li jikkonsisti f'35.4% (w/w) ta' Ethanol (anhydrous) f'Polysorbate 80.
English: Do not use Docefrez
Maltese: Tużax Docefrez
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Maltese: Iż-żmien biex jintlaħaq il-mard progressiv kien superjuri b'docetaxel u capecitabine flimkien (p < 0.0001).
English: Rhinorrhoea
Maltese: Oħrajn
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Maltese: Il farmakokinetika ta' docetaxel kienet studjata f'pazjenti bil-kanċer wara l-għoti ta' 20 sa 115 mg/m2 fil-fażi I tal-istudji.
English: • one single-dose solvent vial with 1 ml solvent for Docefrez
Maltese: • kunjett wieħed bis-solvent għal doża waħda b'1 ml ta' solvent għal Docetaxel
English: • nausea, vomiting, indigestion*, bellyache* • diarrhoea, constipation*
Maltese: • nawseja, rimettar, indiġestjoni*, uġigħ ta' żaqq*
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Maltese: Newtropenija bid-deni u infezzjonijiet assoċjati man-newtropenija seħħew, rispettivament, f'17.2% u 13.5% tal-pazjenti, u dan irrispettivament jekk intużax G-CSF.
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favor of the TCF arm.
Maltese: Ir-riskju fit-tnaqqis tal-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-parti tal-istudju dwar TCF.
English: Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Maltese: Komuni ħafna: Tossiċità ematoloġika żdiedet f'pazjenti li ħadu trastuzumab u docetaxel, meta mqabbla ma' docetaxel waħdu (32% grad 3/4 newtropenija kontra 22%, meta ntużaw il-kriterji
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Maltese: Tnaqqis fil-funzjoni ventrikulari kardijaka tax-xellug (G3/4: 0.3%)
English: 4.2.2 Inject the required volume of reconstituted solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: 4.2.2 Injetta l-volum meħtieġ tas-soluzjoni inizjali fborża jew flixkun tal-infużjoni ta' 250 ml, li għandha/għandu soluzzjoni ta' 5% glukosju jew kloridu tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-infużjoni.
English: Solvent vial
Maltese: Soluzzjoni rrikostitwita
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 anemia (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 decrease ≥ 20% (13.1 % versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Maltese: 8% kontra 8.5%) mill-parti tal-istudju dwar AT, kif ukoll inċidenza ogħla ta' tossiċita severa kardijaka: insuffiċjenza konġestiva tal-qalb (3.8% kontra 2.8%), ir-rata assoluta tal-LVEF tnaqqset ≥ 20% (13.1% kontra 6.1%), ir-rata assoluta tal-LVEF tnaqqset ≥ 30% (6.2% kontra 1.1%).
English: • Each vial of Docefrez 80 mg contains 80 mg docetaxel (anhydrous) (plus 18% overfill: 94.4 mg
Maltese: • Kull kunjett ta' Docefrez 80 mg trab fih 80 mg ta' docetaxel (anhydrous) (flimkien ma' 18% overfill: 94.4 mg docetaxel).
English: • Each vial of Docefrez 20 mg contains 20 mg docetaxel (anhydrous) (plus 22% overfill: 24.4 mg
Maltese: • Kull kunjett ta' Docefrez 20 mg trab fih 20 mg ta' docetaxel (anhydrous) (flimkien ma' 22% overfill: 24.4 mg docetaxel).
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Maltese: .8 Effetti mhux mixtieqa Ir-reazzjonijiet avversi li jitqiesu possibbilment jew probabbilment relatati mat-teħid ta' docetaxel inġabru minn:
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Maltese: Stitikezza (G3/4: 1.0 %); Uġigħ gastrointestinali (G3/4: 1.0%);
English: ER/PR-negative or Grade 3 or tumor size >5 cm
Maltese: RP = riċettur tal-proġesteron a RE/RP-negattiv jew Grad 3 jew daqs tat-tumur >5 cm
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Maltese: Il-pazjenti kkurati b'TCF kellhom żmien itwal biex jaslu għal-deterjorament definittiv ta' 5% tal-istat globali ta' saħħa fil-kwestjonarju QLQ-C30 (p = 0.0121) u żmien itwal biex jeħżienu definittivament skont il-performance status ta' Karnofsky (p = 0.0088), meta mqabbla ma' pazjenti kkurati b'CF.
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Recall phenomena tar-radjazzjoni kienu rarament irrappurtati.
English: Abdominal pain upper;
Maltese: Newtropenija bid-deni;
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either Docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Maltese: bejn 30 sa 60 minuta kull 3 ġimgħat (TCis), jew docetaxel 75 mg/m2 bħala infużjoni fil-vini ta' siegħa, flimkien ma' carboplatin (AUC 6 mg/ml.minuta) li ngħata f'minn 30 sa 60 minuta kull 3 ġimgħat, jew vinorelbine (V) 25 mg/m2, mogħti fuq tul ta' minn 6 sa 10 minuti fil-jiem 1, 8, 15 u 22, segwit b'cisplatin 100 mg/m2 li ngħata fl-ewwel jum taċ-ċikli tal-kura, ripetuti kull 4 ġimgħat (VCis).
English: Ethanol, anhydrous
Maltese: Ethanol, anhydrous Polysorbate 80
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Maltese: Meta jintuża għall-trattament primarja, docetaxel 75 mg/m2 jingħata flimkien ma' doxorubicin (50 mg/m2).
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Maltese: Tqalligħ (G3/4: 13.9%); Stomatite (G3/4:
English: Hazard ratio
Maltese: AKT TAGĦRIF
English: (95% CI) ***p-value Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value A hazard ratio of less than 1 favors 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: [kimoterapija +/-kimoradjuterapija] (%) (95%CI) ***p-value fl-ippurgar titneħħa waqt l-ewwel 48 siegħa bħala prodott metaboliku inattiv, wieħed ewlieni u tliet prodotti oħra inattivi u minuri, kif ukoll ammonti żgħar ħafna tal-prodotti mediċinali mhux mibdula.
English: Median TTP (months) (95%CI)
Maltese: TTP medjan (xhur) (95%CI)
English: A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Maltese: Total ta' 445 pazjent b'KPS > 70 kienu kkurati b'docetaxel (T) (75 mg/m2 fl-ewwel jum) flimkien ma' cisplatin (C) (75 mg/m2 fl-ewwel jum) u 5-fluorouracil (F) (750 mg/m2 kuljum għal 5 ijiem), jew cisplatin (100 mg/m2 fl-ewwel jum) u
English: Solvent for Docefrez 80 mg, Powder for Solution for Infusion
Maltese: Solvent għal Docefrez 80 mg, Trab għal soluzzjoni għall-infużjoni
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Maltese: Reazzjonijiet severi kienu kkaratterizzati minn pressjoni baxxa u/jew bronkospażmu jew raxx/eritema ġeneralizzati (ara sezzjoni 4.4).
English: • dry mouth, difficulty or painful swallowing, inflammation of the gullet (oesophagitis)
Maltese: • ħalq xott, diffikultà jew uġigħ meta tibla', infjammazzjoni tal-gerżuma (esofaġite)
English: Each pack of Docefrez 80 mg powder for concentrate for solution for infusion contains one single-dose vial of docetaxel (anhydrous) (80 mg with corresponding fill of 94.4 mg as lyophilised powder) and a corresponding single-dose vial with 4.0 ml of solvent consisting of 35.4% (w/w) of Ethanol (anhydrous) in Polysorbate 80.
Maltese: Kull pakkett ta' Docefrez 80 mg trab għal konċentrat għal soluzzjoni għall-infużjoni fih kunjett wie ħed b'doża waħda ta' docetaxel (anhydrous) (80 mg b'fill li tikkorrispondi ghal 94.4 mg) bħala trab lajofilizzat flimkien ma'kunjett b'doża waħda ta'4.0 ml ta' solvent li jikkonsisti f'35.4% (w/w) ta' Ethanol (anhydrous) f'Polysorbate 80.
English: Peripheral motor neuropathy (G3/4: 2.5%)
Maltese: Newropatija periferali tal-movimenti (G3/4: 2.5%)
English: 2.1 Docefrez 20 mg powder vials
Maltese: 2.1 Kunjetti bit-trab ta' Docefrez 20 mg
English: Overall survival (OS) was also 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: Is-sopravivenza totali (ST) kienet ukoll itwal fil-fergħa tat-TAC, bil-pazjenti kkurati bit-TAC ikollhom tnaqqis ta' 24 % firriskju ta' mewt meta mqabbel ma' dawk tal-FAC (proporzjon ta' riskju = 0.76, 95% CI (0.46-1.26, p = 0.29).
English: • Induction chemotherapy followed by radiotherapy(TAX323).
Maltese: Kimoterapija Induttiva segwita bi radjuterapija (TAX323)
English: Arrhythmia (G3/4:
Maltese: Infezzjoni (G3/4:
English: • decreased number of red bloods cells (anaemia, with symptoms of such as paleness, weakness)
Maltese: • tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija, b'sintomi bħal sfura, dgħufija)
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, terfenadine, ketoconazole, erythromycin and troleandomycin.
Maltese: Studji in vitro urew li l-metaboliżmu ta' docetaxel jista' jkun immodifikat meta jittieħed ma' sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma mmetabolizzati (u, għalhekk, jistgħu jinibixxu l-enzima kompetittivament) minn ċitokrom P450-3A, bħal ciclosporine, terfenadine, ketoconazole, erythromycin u troleandomycin.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Maltese: Pazjenti fil-parti komparatur tal-istudju rċivew cisplatin (P) 100 mg/m2 segwit minn 5-fluorouracil (F) 1000 mg/m2 kuljum għal 5 ijiem.
English: Solvent for Docefrez 20 mg, Powder for Solution for Infusion
Maltese: Solvent għal Docefrez 20 mg, Trab għal Soluzzjoni għall-Infużjoni
English: Immune system disorders Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126).
Maltese: Is-sopravivenza kienet superjuri fil-parti tal-istudju dwar flimkien bit-kura ta' docetaxel + capecitabine flimkien (p = 0.0126).
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Maltese: • 92 pazjent kkurati b'docetaxel flimkien ma' trastuzumab.
English: Solvent for Docefrez 80 mg
Maltese: 2.2 Kunjetti bis-solvent ta' Docefrez 80 mg
English: Dehydration (G3/4: 2%);
Maltese: Deidratazzjoni (G3/4: 2%);
English: After reconstitution, 1 ml of concentrate contains 24 mg docetaxel (anhydrous).
Maltese: Wara r-rikostituzzjoni, 1 ml ta' konċentrat ikun fih 24 mg ta' docetaxel (anhydrous).
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Maltese: Il farmakokinetika ta' docetaxel, doxorubicin u cyclophosphamide ma kienitx affettwata meta ngħataw flimkien.
English: PSA** response rate (%) 95% CI p-value*
Maltese: Numru ta' pazjenti PSA** ir-rata tar-rispons ( % ) 95% CI p-value*
English: The Docefrez 80 mg powder is a white to off white lyophilised powder containing 80 mg (plus 18% overfill: 94.4 mg) of docetaxel (anhydrous).
Maltese: It-trab ta' Docefrez 80 mg hu trab lajofilizzat ta' lewn minn abjad sa abjad jagħti fil-griż li fih 80 mg (flimkien ma' 18% overfill: 94.4 mg) ta' docetaxel (anhydrous).
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Maltese: Meta ntużaw flimkien, doetaxel ma jaffettwax it-tneħħija ta' doxorubicin u anqas il-livelli tal-plasma ta' doxorubicinol (prodott metaboliku tad-doxorubicin).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Maltese: Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection
Maltese: Newtropenja (Grad 4) Newtropenja bid-deni Infezzjoni newtropenika Infezzjoni newtropenika (Grad 3-4)
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone,phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Maltese: l-interazzjonijiet in-vitro b'sustanzi li huma marbuta sew mal-proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole, u sodium valproate, m'affetwawx ir-rabta ta' docetaxel mal-proteina; hekk ukoll dexamethasone m'affettwax l-effetti fuq ir-rabta ta' Docetexal mal-proteina.
English: Dyspepsia (G3/4:
Maltese: Dispepsja (G3/4:
English: (FISH).
Maltese: PF).
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Maltese: In vivo, docetaxel jaħdem indipendentement mill-iskeda ta' kif jingħata u għandu firxa wiesgħa ta' attivita fuq it-tumuri esperimentali, kontra tumuri mlaqqmin u avanzati derivati mill-ġrieden u mill-bnedmin.
English: Alopecia (G3/4: 4.0%).
Maltese: Alopeċja (G3/4: 4.0%);
English: In this leaflet:
Maltese: Pazjenti speċjali:
English: Anorexia (G3/4: 0.6%)
Maltese: Anoreksja (G3/4:0.6%)
English: Anorexia (G3/4:0.6%)
Maltese: Anoreksja (G3/4: 0.6%)
English: Median PFS (months) (95% CI)
Maltese: PFS medjana (xhur) (95%CI)
English: • decrease in blood pressure (hypotension), heart failure; irregular heart beat (arrhythmia)
Maltese: • tnaqqis fil-pressjoni tad-demm (ipotensjoni), insuffiċjenza tal-qalb; taħbit irregolari tal-qalb (arritmija)
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxelcontaining regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Maltese: (OS), kien b'mod sinifikattiv itwal (log-rank test, p=0.0058) fil-parti tal-istudju dwar docetaxel, meta mqabbel mal-grupp ta' PF (OS medjan: 70.6 kontra 30.1 xhur rispettivament) bi tnaqqis tar-riskju ta' mortalità b'30% meta mqabbel ma' dak fil-parti tal-istudju dwar PF (Il-proporzjon tar-riskju (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) l-aħjar tul medjan tal-perijodu ta' osservazzjoni ta' 41.9 xhur.
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Maltese: It-tul ta' żmien medjan għal progressjoni kien ta' 186 jum (docetaxel + capecitabine) kontra ta' 128 jiem
English: Sverige Sun Pharmaceutical Industries Europe B.V.
Maltese: Magyarország Sun Pharmaceutical Industries Europe B.V.
English: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%).
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4:0.6%); Uġigħ addominali;
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/001
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GHAT-TQEGĦID FIS-SUQ EU/1/10/630/001
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 hi 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: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Żieda tal-bilirubina fid-demm (< 5%);
English: • tiredness, pain, flu-like symptoms*
Maltese: • sturdament, indeboliment fis-smigħ
English: Dyspnoea; Cough;
Maltese: Sogħla;
English: Oedema (G3/4: 1.2%)
Maltese: Rimettar (G3/4: 1.2%)
English: • one single-dose solvent vial with 4 ml solvent for docefrez (35.4% (w/w) ethanol in polysorbate 80) .
Maltese: • kunjett wieħed bis-solvent għal doża waħda b'4 ml ta' solvent għal Docetaxel (35.4% (w/w) ethanol f'polysorbate 80) .
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Maltese: Avvenimenti tromboemboliċi venużi kienu rrappurtati b'mod rari.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/002
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/630/002
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 snin.
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Maltese: Il-fażi tal-aħħar hi dovuta parzjalment għall-effluss relattivament bil-mod ta' docetaxel mill-kompartiment periferiku.