FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Maltese: Ir-rati totali u oġġettivi ta' rispons fil-popolazzjoni mqassma mingħajr għażla (kif stmat mill-investigatur) kienu 41.6% (docetaxel + capecitabine) kontra 29.7% (docetaxel waħdu); p = 0.0058.
English: Arrhythmia (no severe)
Maltese: Arritmija (mhux severa)
English: The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Maltese: L-użu fl-istess ħin ta' docetaxel ma' inibituri qawwijin ta' CYP3A4 (eż. ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole) għandu jiġi evitat (ara sezzjoni 4.5).
English: Docetaxel is highly protein bound (> 95%).
Maltese: Docetaxel huwa marbut sew mal-proteina (>95%).
English: • dehydration
Maltese: • deidrazzjoni
English: • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
Maltese: • Mitoxantrone 12 mg/m2 mogħti kull 3 ġimghat għal 10 ċikli.
English: Previous therapy should have included an anthracycline.
Maltese: inkluża anthracycline.
English: Overall Response Rate (CR+PR) (%) p-value
Maltese: Ir-rata totali ta' rispons (CR+PR) (%) p-value
English: DOCETAXEL KABI contains ethanol (alcohol).
Maltese: DOCETAXEL KABI fih l-ethanol (l-alkoħol)
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: Għalkemm il-possibbiltà t'interazzjoni in vivo ta' docetaxel ma' prodott mediċinali ieħor li ngħata konkomittantement ma kienx investigat formalment, l-interazzjonijiet in-vitro b'sustanzi li huma marbuta sew mal-proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole u sodium valproate, m'effetwawx ir-rabta ta' docetaxel mal-proteina.
English: Myalgia (severe: 0.5%)
Maltese: Majalġja (severa: 0.5%)
English: Pharmacotherapeutic group: antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD02
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, alkalojdi tal-pjanti u prodotti naturali oħrajn taxanes, Kodiċi ATC:
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Maltese: Laħħar stadju sekondarju , PFS, wera tnaqqis tar-riskju mingħajr avvanz u mortalità ta' 29% u titjib ta' 22 xhur tal-medjan PFS (35.5 xhur għal TPF u 13.1 ta' PF).
English: 61352 Bad Homburg v.d.Höhe Germany
Maltese: 61352 Bad Homburg v.d.Höhe Il-Ġermanja
English: • Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
Maltese: • Docetaxel 75 mg/m2 kull 3 ġimgħat għal 10 ċikli.
English: Response rate (95% CI)
Maltese: Rata ta' rispons (95% CI)
English: Two interim analyses and one final analysis were performed.
Maltese: Saru żewġ analisi temporanji u analisi finali waħda.
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Maltese: Differenza fit-Trattament: 7.1% [95% CI: 0.7; 13.5] *Ikkoreġġuti għal paraguni multipli u aġġustati għall-fatturi stratifikanti (stadju tal-marda u l-post tattrattament), ibbażati fuq il-popolazzjoni ta' pazjenti evalwati.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Maltese: Ġew irrapportati okkorrenzi rari ta' deidrazzjoni bħala konsegwenza ta' ġrajjiet gastro-intestinali, inkluż enterokolite u perforament gastro-intestinali.
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Maltese: • 332 pazjent li ħadu docetaxel flimkien ma' prednisone jew prednisolone (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Maltese: Disturbi vaskulari Ġrajjiet tromboemboliċi kienu rarament irrapportati.
English: Neutropenic complications
Maltese: Newtropenija Komplikata
English: Renal insufficiency and renal failure have been reported.
Maltese: Ġew irrapportati l-insuffiċjenza renali u d-disfunzjoni renali severa.
English: Anaemia (G3/4: 20.9%);
Maltese: Anemija (G3/4: 20.9%);
English: 6.2 Incompatibilities
Maltese: .2 Inkompatabbilitajiet
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC
Maltese: Ir-RTTR kienet 59.3% (95% CI: 52.8 - 65.9) fil-fergħa AT versu 46.5% (95%
English: CF n = 224
Maltese: n = 224
English: Dyspepsia;
Maltese: Dispepsja;
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Maltese: Il-pazjenti kkurati b'TAC kellhom tnaqqis ta' 32 % fir-riskju ta' rikaduta meta mqabbla ma' dawk ikkurati b'FAC (proporzjon ta' riskju = 0.68, 95% CI (0.49-0.93), p = 0.01).
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Maltese: Kull kunjett ta' konċentrat fih 4 ml ta ethanol anhydrous (3.16 g).
English: Asthenia; Oedema peripheral;
Maltese: Edima periferika;
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).
Maltese: Eċċipjenti: polysorbate 80, ethanol anidru (ara l-fuljett għal aktar informazzjoni), citric acid anidru (għal aġġustament tal-pH).
English: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Maltese: Kull kunjett ta' konċentrat fih 2 ml ta' ethanol anidru (1,58 g).
English: Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p= 0.0004) and prolonged overall survival (11 months vs. 9 months, p= 0.01).
Maltese: Docetaxel żied r-rata tar-rispons (33% vs 12%, p < 0.0001), ittardja l-avvanz tat-tumur (19-il ġimgħa vs 11-il ġimgħa, p = 0.0004) u tawwal iż-żmien totali tas-sopravivenza (11-il xahar vs 9 xhur, p = 0.01).
English: Neutropenia (G4: 54.2%);
Maltese: Newtropenija (G4: 54.2%);
English: DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: DOCETAXEL KABI użat flimkien ma' doxorubicin u cyclophosphamide: terapija miżjuda
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4
Maltese: Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI: 34.4 - 42.1) fil-fergħa AT u 31.9 ġimgħat (95% CI: 27.4
English: These results are consistent with the pharmacological activity of docetaxel.
Maltese: Dawn irriżultati huma konsistenti ma' l-attività farmakoloġika ta' docetaxel.
English: Dysgeusia (severe: 0.07%)
Maltese: Disgewżja(severa: 0.07%)
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta'eċċipjenti, ara sezzjoni 6.1.
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Maltese: Infezzjonijiet (G3/4: 5.7%; li jinkludu sepsis u pulmonite, fatali f'1.7%)
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-organi fiddatabase MedDRA
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Maltese: Insuffiċjenza tal-qalb sintomatika kienet irrapportata f'2.2% tal-pazjenti li ħadu DOCETAXEL KABI flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw DOCETAXEL KABI wahdu.
English: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Maltese: Kull kunjett ta' konċentrat fih 0,5 ml ta' ethanol anidru (395 mg).
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Maltese: Kien hemm żieda fl-inċidenza ta' SAEs (40% kontra 31%) u Grad 4 AEs (34% kontra 23%) fil-fergħa ta' dawk li ħadu iż-żewġ sustanzi meta mqabbla ma' dik li ħadu docetaxel waħdu.
English: A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Maltese: Analiżi farmakokinetika tmexxiet f'popolazzjoni ta' 577 pazjent fuq 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: Il-proporzjon tar-riskju (95%CI) **p-value Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + 5-FU *Cox model (aġġustament għas-sit tat-tumur Primarju, T and N stadji kliniċi u PSWHO) **Logrank test ***Chi-square test
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Maltese: Differenza fit-Trattament: 7.1% [95% CI: 0.7; 13.5]
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Maltese: Fl-istudju TAX 316, 26 pazjent (3.5%) fil-fergħa tat-TAC u 17-il pazjent (2.3%) fil-fergħa tal-FAC esperjenzaw insuffiċjenza konġestiva tal-qalb.
English: Headache (G3/4: < 1%); Neuropathy peripheral
Maltese: Uġigħ ta' ras (G3/4: < 1%); Newropatija periferika
English: • 1,312 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, rispettivament.
English: Overall survival (Primary end-point):
Maltese: Sopravivenza totali (L-aħħar stadju primarju tal-proċess):
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 ittrattati 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 5-fluorouracil (1000 mg/m2 kuljum għal 5 ijiem).
English: Unopened vial 2 years.
Maltese: Kunjett mhux miftuħ 2 snin.
English: Infection (G3/4: 6.3%); Neutropenic infection
Maltese: Infezzjoni (G3/4:6.3%); Infezzjoni binnewtropenija
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 għalluġigħ (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: Acute leukaemia / Myelodysplastic syndrome
Maltese: Lewkimja akuta/ Sindrome ta' majilodisplastik.
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: Il-frekwenzi huma kif spjegat: 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 tistax tittieħed stima mid-data disponibbli).
English: 1 vial with 180 mg/9 ml
Maltese: INDIVIDWALI 180 mg/9 ml
English: Exp:
Maltese: Rimi:
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, issindrome ta' Stevens-Johnson, u toxic epidermal necrolysis, kienu ġew irrapportati b'docetaxel.
English: Neutropenic infection
Maltese: Infezzjoni newtropenika
English: Thrombocytopenia (G4: 1.7%)
Maltese: Tromboċitopenija (G4: 1.7%)
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 NCICTC).
English: The recommended dose of docetaxel is 75 mg/m2.
Maltese: Id-doża irrakkomandata ta' docetaxel hija 75 mg/m2.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Maltese: • vista mċajpra minħabba nefħa tar-retina ġewwa l-għajn (edima makulari ċistojde)
English: Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Maltese: Kull kunjett ta' konċentrat fih 3 ml ta' ethanol anidru (2,37 g).
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 jiem (docetaxel + capecitabine) kontra ta' 128 jiem (b'docetaxel biss).
English: Consideration should be given to possible effects on the central nervous system.
Maltese: Wieħed għandu jagħti kas tal-effetti possibbli fuq is-sistema nervuża ċentrali.
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Maltese: Linċidenza ta' newtropenja ta' Grad 4, newtropenja bid-deni u infezzjoni newtropenika naqset filpazjenti li rċevew il-prevenzjoni primarja permezz ta' G-CSF (ara sezzjoni 4.8).
English: Anorexia (G3/4: 11.7%)
Maltese: Anoreksja (G3/4: 11.7%)
English: 1 vial with 20 mg/1 ml
Maltese: INDIVIDWALI 20 mg/1 ml
English: Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Maltese: Data limitat minn studju wieħed mhux ikkontrollat, issuġġerixxa xi interazzjoni bejn docetaxel u carboplatin.
English: • 406 patients who received docetaxel in combination with cisplatin.
Maltese: • 406 pazjent li ħadu docetaxel flimkien ma' cisplatin.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
Maltese: - Is-sustanza l-oħra huma polysorbate 80, ethanol anidru (ara sezzjoni 2) u citric acid anidru (għal aġġustament tal pH).
English: Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Maltese: Is-sopravivenza kienet superjuri tal-fergħa fliemkien bittrattament ta' docetaxel + capecitabine flimkien (p = 0.0126).
English: Diarrhoea grade 4
Maltese: Dijarea ta' Grad 4
English: status
Maltese: LISTA
English: Asthenia (severe: 9.9%); Fluid retention (severe: 0.7%);
Maltese: Astenja (severa: 9.9%); Żamm tal-fluwidu (sever: 0.7%);
English: • oesophagitis
Maltese: • esofaġite
English: G3/4 ALT increased
Maltese: G3/4 Żieda fl-AST
English: Anorexia (G3/4: 0.6%)
Maltese: Anorexja (G3/4: 0.6%)
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Maltese: Aktar ġrajjiet avversi ta' Grad 3/4 kienu innotati b'docetaxel bħala monoterapija (55.4%) meta mqabbel ma' paclitaxel (23%).
English: Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Maltese: Deni; Għejja; Infjammazzjoni tal-mukoża; Uġigħ;
English: Alopecia (G3/4: 4.0%)
Maltese: Alopeċja (G3/4: 4.0%)
English: • 258 patients who received docetaxel in combination with doxorubicin.
Maltese: • 258 pazjent li ħadu docetaxel flimkien ma' doxorubicin.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Maltese: Dawn ir-reazzjonijiet kienu deskritti bl-użu ta' NCI Kriterji ta' Tossiċità Komuni (Grad 3 = G3; Grad 3-4 = G3/4;
English: G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Żieda fl-alkaline phosphatase fid-demm
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Maltese: Stomatite (G3/4: 1.7%); Rimettar (G3/4: 0.8%) Dijarea (G3/4: 1.7%);
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%);
Maltese: Stomatite (G3/4: 18%); Dijarea (G3/4: 14%);
English: Median TTP (months) (95% CI)
Maltese: TTP medjan (xhur) (95%CI)
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 ġraw, rispettivament, f'17.2% u 13.5% tal-pazjenti, u dan irrispettiv jekk intużax G-CSF.
English: If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Maltese: (eż., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole) ma jistax jiġi evitat, għandu jkun hemm sorveljanza klinika tajba u jista' jkun hemm il-bżonn ta' aġġustament fid-doża ta' docetaxel waqt il-kura bl-inibitur qawwi ta' CYP3A4
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Maltese: Ma nstabux differenzi statistikament validi bejn iż-żewġ gruppi ta' trattament rigward il Kwalità talĦajja Globali.
English: Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Maltese: Kull kunjett ta' konċentrat fih 4,5 ml ta ethanol anidru (3,55 g).
English: Arrhythmia (G3/4: 1.0%)
Maltese: Arritmija (G3/4: 1.0%).
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Maltese: Disgewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: Nervous system
Maltese: Sistema nervuża
English: Docetaxel + Cis + 5-FU n = 177
Maltese: L-aħħar stadju tal-proċess docetaxel + Cis + 5-FU n = 177
English: 1 vial with 80 mg/4 ml
Maltese: INDIVIDWALI 80 mg/4 ml
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p= 0.007).
Maltese: Mingħajr m'affettwa iż-żmien totali tas-sopravivenza (għal docetaxel 15-il xahar kontragħal doxorubicin 14-il xahar, p = 0.38), jew iż-zmien sakemm javvanza ttumur (b'docetaxel 27 ġimgħa kontra li d-doxorubicina kien ta' 23 ġimgħa, p = 0.54), docetaxel wera rata ta' rispons aktar għolja (52% kontra 37%, p = 0.01) u qassar iż-żmien għar-rispons (12-il ġimgħa vs 23 ġimgħa, p = 0.007).
English: Thrombocytopenia (G3/4: 1.6%);
Maltese: Tromboċitopenija (G3/4: 1.6%);
English: The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Maltese: It-teħid flimkien ta' docetaxel, cisplatin u 5-fluorouracil fi 12-il pazjent b'tumuri solidi ma kellhux effett fuq il-komportament farmakokinetiku ta' kull prodott mediċinali individwali.
English: • 255 patients who received docetaxel in combination with capecitabine.
Maltese: • 255 pazjent li ħadu docetaxel flimkien ma' capecitabine.
English: DOCETAXEL KABI contains alcohol.
Maltese: DOCETAXEL KABI fih l-alkoħol.
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 huwa mutaġeniku in vitro fil-mikronukleju u fit-test għall-aberrazzjoni talkromosomi fiċ-ċelluli CHO-K1 u fit-test in vivo fuq il-mikronukleju fil-ġurdien.
English: First episode: reduce 5-FU dose by 20%.
Maltese: L-ewwel episodju: naqqas id-doża ta' 5-FU b'20%.
English: Second episode: then reduce docetaxel dose by 20%.
Maltese: It-tieni episodju: imbagħad naqqas id-doża ta' docetaxel b'20%.
English: Thrombocytopenia (G4: 0.2%)
Maltese: Tromboċitopenija (G4: 0.2%)
English: • swelling caused by faulty lymphatic drainage
Maltese: • nefħa dovuta għal difett fil-funzjoni tas-sistema limfatika
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Maltese: Disturibi ġenerali u kondizzjonijiet ta' mnejn jingħata Recall phenomena tar-radjazzjoni kienu rarament irrapportati.
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Maltese: Kumplikazzjonijiet newtropeniċi f'pazjenti li rċevew it-TAC flimkien ma' prevenzjoni primarja permezz ta' G-CSF u mingħajr prevenzjoni primarja (GEICAM 9805)
English: G3/4 AST increased G3/4 ALT increased
Maltese: G3/4 Żieda fl-ALT
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Maltese: Disgewżja /Parosmja (G3/4: 0.4%);
English: Patients with 4+ nodes
Maltese: Pazjenti b' 4+ glandoli
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Maltese: Reazzjonijiet avversi komuni ħafna ≥ 10% tal-pazjenti
English: Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Maltese: Tliet pazjenti fuq docetaxel (2%) ma komplewx il-kura minħabba żamm ta' fluwidu, waqt li 15-il pazjent fuq id-doxorubicin (9%) waqfu l-kura minħabba tossiċità kardijaka (tliet każijiet fatali ta' insuffiċenza konġestiva tal-qalb).
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Maltese: L-ewwel episodju: naqqas id-dożi ta' docetaxel u 5-FU b'20%.
English: Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)
Maltese: Deni (G3/4: NA); Edima periferika (G3/4: 0.2%)
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 tal-LVEF tnaqqset ≥ 20% (13.1% kontra 6.1%), ir-rata assoluta tal-LVEF tnaqqset ≥ 30% (6.2% kontra1.1%).
English: Diarrhoea (G3/4: 6.2%);
Maltese: Dijarea (G3/4: 6.2%);
English: - Keep this leaflet.
Maltese: Stat ta' menopawża
English: 1 vial with 120 mg/6 ml
Maltese: Kunjett 1 b'120 mg/6 ml
English: Number of patients in TAC group
Maltese: Numru ta' pazjenti filgrupp tat-TAC
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Maltese: Sindromu ta' distress respiratorju akut u każijiet ta' pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja, xi kultant fatali, kienu rarament irrapportati.