FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions after dilution of the diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3. 6.5
English: Infection (G3/4: 3.6%) Neutropenic infection
Maltese: Infezzjoni (G3/4: 6.3%) Infezzjoni newtropenika
English: A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
English: EU/1/11/748/002 - 5 vials
Maltese: EU/1/11/748/002 - 5 kunjetti
English: EU/1/11/748/004 - 5 vials
Maltese: EU/1/11/748/004 - 5 kunjetti
English: Renal insufficiency and renal failure have been reported.
Maltese: Ġew rapportati każijiet ta' insuffiċjenza renali u disfunżjoni renali severa.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
Maltese: Fl-istudju TAX 316, alopeċja li ppersistit matul il-perijodu ta' osservazzjoni ta' wara t-trattament fittmiem tal-kimoterapija ġiet irrappurtata f'687 minn 744 pazjent fuq TAC u 645 minn 736 pazjent fuq FAC.
English: One vial of 10 ml of concentrate contains 3,95 g of ethanol anhydrous.
Maltese: Kull kunjett ta' 10 ml ta' konċentrat fih 3.95 g t'ethanol anidru.
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Maltese: Każijiet rari ħafna ta' lupus erythematosus tal-ġilda u nfafet kbar bħal erythema multiforme, is-sindrome ta' Stevens-Johnson, u toxic epidermal necrolysis, kienu ġew irrapportati b'docetaxel.
English: 1Full analysis set (intent-to-treat)
Maltese: Sett sħiħ tal-analiżi (bit-tir ta' fejqan)
English: 5 vials of 1 ml
Maltese: 5 kunjetti ta' 1 ml
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Maltese: 316 u GEICAM 9805 rispettivament) li ħadu docetaxel flimkien ma' doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat trattament huma irrapportati).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Musculoskeletal, connective tissue bone disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi connective tissue
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), mediċini 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: Each ml of concentrate for solution for infusion contains 395 mg of ethanol anhydrous.
Maltese: Kull ml ta' konċentrat ta' soluzzjoni għall-infużjoni fih 395 mg t'ethanol anidru.
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Maltese: Pazjenti li jirċievu TAC għandhom jiġu monitorati mill-qrib (ara sezzjonijiet 4.2 u 4.8).
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Maltese: • 1312 u 121 pazjent li ħadu 100 mg/m² u 75 mg/m² ta' docetaxel bħala sustanza waħedha,
English: Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: *Threshold for statistical significance=0.0175 **PSA:
English: Neutropenic complications
Maltese: Newtropenija komplikata
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Maltese: Fl-istudju GEICAM 9805, 3 pazjenti (0.6 %) fil-fergħa ta' TAC u 3 pazjenti (0.6 %) fil-fergħa ta' FAC żviluppaw insuffiċjenza konġestiva tal-qalb waqt il-perjodu ta' osservazzjoni.
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, 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: III, 1218-il pazjent li kellhom tumur li ma jistax jitneħħa kiruġikament, kategorija IIIB jew IV NSCLC, b'KPS ta' 70% jew akbar, u li ma rċevewx kimoterapija preċedenti għal din ilkundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa docetaxel (T) f'doża ta' 75 mg/m² bħala infużjoni tul siegħa, segwita immedjatament b'cisplatin (Sis) 75 mg/m² li ngħata fuq perjodu ta' bejn 30 sa 60 minuta kull 3 ġimgħat (Tcis), Docetaxel 75 mg/m² bħala infużjoni fil vini f'tul ta' siegħa, flimkien ma' carboplatin (AUC 6 mg/ml.minuta) li ngħata f'30 sa 60 minuta kull 3 ġimgħat, jew vinorelbine (V) 25 mg/m², mogħti tul 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, repetuti kull 4 ġimgħat (VCis)
English: Docetaxel Mylan contains alcohol.
Maltese: Docetaxel Mylan fih l-alkoħol.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Maltese: Il-profilattiku primarju G-CSF kien obbligatorju fid-driegħ TAC wara li 230 pazjent kienu magħżula b'mod każwali.
English: Disposal:
Maltese: Doża rakkomandata:
English: Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Maltese: Issopravivenza kienet superjuri tal-fergħa fliemkien bit-trattament ta' docetaxel + capecitabine flimkien (p = 0.0126).
English: One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
Maltese: Kull kunjett ta' 1 ml ta' konċentrat fih 395 mg t'ethanol anidru.
English: In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Maltese: F'madwar 20% ta' dawn il-każijiet ma kien hemm l-ebda fatturi ta' riskju għad-disfunzjoni renali severa bħal prodotti mediċinali nefrotossiċi li ttieħdu fl-istess ħin u disturbi gastrointestinali.
English: Immune system
Maltese: Disturbi fis-sistema immuni
English: Pain response rate (%)
Maltese: Estimu ta sentejn (%)
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma jistax jiġi stmat mit-tagħrif dispobibbli).
English: Each vial contains 1 ml of concentrate.
Maltese: Kull kunjett fih 1 ml ta' konċentrat.
English: Anorexia (G3/4:
Maltese: Anemija (G3/4:
English: • Induction chemotherapy followed by radiotherapy (TAX 323)
Maltese: • Kimoterapija induttiva segwita b'radjuterapija (TAX323)
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/m² (FAC arm).
Maltese: Wara t-tqassim tal-pazjenti skont in-numru ta' 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 500 mg/m² (ilfergħa FAC).
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89% in the FAC arm, at the 10-year follow-up timepoint.
Maltese: Ir-rata ta' sopravivenza kienet 93.7% fil-fergħa ta' TAC u 91.4 % fil-fergħa ta' FAC, fil-punt tat-8 sena ta' osservazzjoni, u 91.3 % fil-fergħa ta' TAC u 89 % fil-fergħa ta' FAC, fil-punt tal-10 sena ta' osservazzjoni.
English: Arrhythmia (G3/4: 0.7%) Cardiac failure
Maltese: Arritmija (G3/4:0.7%) Falliment kardijaku
English: At the median follow up time of 10 years and 5 months, TAC treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Maltese: Fiż-żmien medjan ta' osservazzjoni ta' 10 snin u 5 xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 16.5% fir-riskju ta' rikaduta meta mqabbla ma dawk ikkurati b'FAC (proporzjon ta' periklu = 0.84, 95% CI (0.65-1.08), p=0.1646).
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 decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Maltese: 8% kontra 8.5%) mill-fergħa AT, kif ukoll inċidenza ogħla ta' tossiċita severa kardijaka: insuffiċenza konġestiva tal-qalb (3.8% kontra 2.8%), ir-rata assoluta talLVEF tnaqqset ≥ 20% (13.1% kontra 6.1%), ir-rata assoluta tal-LVEF tnaqqset ≥ 30% (6.2%
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 ikkurati b'docetaxel waħdu b'doża ta' 100 mg/m², u li għandhom livelli tal-enzimi transaminase (l-ALT u/jew l-AST) fis-serum tad-demm aktar minn 1.5 drabi l-ULN, flimkien ma' livelli tal-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, emorraġija gastrointestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
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 ittrattati 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 ittrattati b'CF.
English: Each vial contains 4 ml of concentrate.
Maltese: Kull kunjett fih 4 ml ta' konċentrat.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Maltese: • Ir-rata tar-rispons globali (RTTR) kienet b'mod sinifikattiv ogħla fil-fergħa AT kontra l-fergħa AC, p = 0.009.
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***valur p
English: Number
Maltese: LISTA
English: Second episode: reduce docetaxel dose by 20%.
Maltese: It-tieni episodju: mbagħad naqqas id-doża ta' docetaxel b'20%.
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: Ir-riskju fit tnaqqis tal-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-fergħa TCF.
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: Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + fluorouracil *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: One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Maltese: Kull kunjett ta' 4 ml ta' konċentrat fih 80 mg docetaxel.
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: (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 5-fluorouracil (1000 mg/m² kuljum għal 5 ijiem).
English: Lymphoedema (G3/4: 0%)
Maltese: limfoedema (G3/4: 0%)
English: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Bilirubin fid-demm ogħla (< 5%);
English: Frequency unknown:
Maltese: Frekwenza mhux magħrufa:
English: Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
Maltese: Sinkope (G3/4: 0%) Newrotossiċità (G3/4:
English: See also section “Docetaxel Mylan contains ethanol” below.
Maltese: Ara wkoll is-sezzjoni “Docetaxel Mylan fih l-ethanol” hawn isfel.
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-każijiet avversi li ġejjin (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: 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: It-tabella f'hawn isfel turi li l-inċidenza ta' newtropenja ta' Grad 4, newtropenija bid-deni u infezzjoni newtropenika naqsu f'pazjenti li ħadu profilassi primarja b'G-CSF wara li din saret obbligatorja fiddriegħ ta' TAC - studju GEICAM.
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Maltese: Meta cisplatin u 5-fluorouracil intużaw flimkien għat-trattament ta' pazjenti li kellhom adenokarċinoma tal-istonku, l-istudju kliniku ewlenieni eskludiet pazjenti b'ALT u/jew AST > 1.5 x ULN assoċjat ma' alkaline phosphatase ta' > 2.5 x ULN, u bilirubin ta' > 1 x ULN; għal dawn il-pazjenti ma jistgħux ikunu rakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Maltese: Il-profil kinetiku ta' docetaxel huwa indipendenti mid-doża użata u huwa konsistenti ma' mudell farmakokinetiku bi tliet oqsma, biż-zmien kemm idum biex jonqos bin-nofs fillivell tad-demm għall-fażijiet α, β u γ huwa ta' 4 minuti, 36 minuta u 11.1 sigħat, rispettivament.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m² administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4.
Maltese: It-trattament induttiv ta' pazjenti li kellhom kanċer tat-tip squamous cell tar-ras u l-għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta' kura kirurġika u bi skop ta' preservazzjoni tal-organi), id-doża rrakkomandata ta' docetaxel hija 75 mg/m² bħala infużjoni tul ta' siegħa, segwita minn cisplatin 100 mg/m² f'tul ta' 30-minuta sa 3 sigħat, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 1000 mg/m² kuljum minn jum 1 sa jum 4.
English: This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 1.58 g per vial, equivalent to 40 ml of beer or 17 ml wine per vial.
Maltese: Dan il-prodott mediċinali fih 50 vol % ta' ethanol (alkoħol), i.e sa 1.58 g kull kunjett, ekwivalenti għal 40 ml ta' birra jew 17 ml ta' inbid kull kunjett.
English: Patients on the docetaxel arm received docetaxel (T) 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 tal-fergħa ta' 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: Thrombocytopenia
Maltese: Komplikazzjonijiet newtropeniċi
English: Inject the required volume of concentrate for 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: Injetta l-volum meħtieġ tas-soluzzjoni għall-infużjoni ġo borża tal-infużjoni jew flixkun ta' 250 ml li jkun fih jew 5% glukosju jew 9 mg/ml (0.9%) sodium chloride għall-infużjonijiet.
English: One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Maltese: Kull kunjett ta' 10 ml ta' konċentrat fih 200 mg docetaxel.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin .
Maltese: Studji in vitro wrew li l-metaboliżmu ta' docetaxel jista' jkun immodifikat meta jittieħed ma' sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma metaboliżżati (u, għalhekk, jistgħu jinibixxu l-enzima kompetittivament) minn ċitokroma P450-3A, bħal cyclosporine, ketoconazole u erythromycin.
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 tal-fergħa kompettitiva rċevew cisplatin (P) 100 mg/m² segwit minn 5-fluorouracil (F) 1000 mg/m² kuljum għal 5 ijiem.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy
Maltese: Neoplażmi bennini, malinni u mhux speċifiċi (li jinkludu ċisti u polipi) Każijiet ta' lewkimja majelojdi akuta u sindromu majelodisplastiku ġew rapportati flimkien ma' docetaxel meta intuża flimkien ma' sustanzi kimoterapewtiċi u/jew radjuterapija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat ta' soluzzjoni għall-infużjoni fih 20 mg ta' docetaxel (anidru).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Maltese: Wara 10 snin ta' osservazzjoni ta' wara t-trattament fl-istudju TAX316, il-lewkimja akuta ġiet irrappurtata f'4 minn 744 pazjent fuq TAC u f'1 minn 736 pazjent fuq FAC.
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% talpazjenti li dahlu fl-istudju kellhom mard li kien IHC 3+ u/jew FISH pożittiv.
English: Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Maltese: L-amenorreja kienet ghadha hemm waqt il-perijodu ta' osservazzjoni ta' wara t-trattament f'121 pazjent minn 202 pazjent b'amenorreja fi żmien it-tmiem tal-kimoterapija tal-istudju TAX316.
English: Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bil-kimoterapija (%) (95%CI) ***valur p
English: One vial contains 20 mg of docetaxel.
Maltese: Kunjett wieħed fih 20 mg ta' docetaxel.
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m² in phase I studies.
Maltese: Il-komportament farmakokinetiku ta' docetaxel kien studjat f'pazjenti bil-kanċer wara l-għoti ta' 20 sa 115 mg/m² fil-fażi I tal-istudji.
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-trattament b'anthracycline, li kien falla, docetaxel kien ikkomparat mal-użu ta' mitomycin C u l-vinblastine flimkien (12 mg/m² kull 6 ġimgħat u 6 mg/m² kull 3 ġimgħat).
English: • Then, inject via a single injection (one shot) 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: • Imbagħad, Injetta l-volum meħtieġ tas-soluzjoni inizjali f'borża jew flixkun tal-infużjoni ta' 250 ml, li għandha/għandu soluzzjoni ta' 5% glukosju jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-infużjoni.
English: Gastrointestinal pain (G3/4: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Maltese: Esofaġite/disfaġja/odinofaġja (G3/4: 0.7%)
English: Following the administration of a 100 mg/m² dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Maltese: Wara l-għoti ta' doża ta' 100 mg/m² li ngħatat bħala infużjoni fi żmien siegħa, l-ogħla livell medju filplażma kien ta' 3.7 μg/ml b'AUC korrispondenti ta' 4.6 sigħat.μg/ml.
English: How to store Docetaxel Mylan 200 mg/10 ml
Maltese: Kif taħżen Docetaxel Mylan 200 mg/10 ml