FrancophonIA/ELRC3.0 huggingface dataset:
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: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Żieda fl-AST G3/4 Żieda fl-alkaline phosphatase fid-demm
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: aħħar 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: 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 20mg docetaxel (bħala trihydrate).
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Maltese: • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/003
Maltese: EU/1/07/384/003
English: Meeting relative indication for chemotherapy a
Maltese: RP = riċettur tal-proġesteron a
English: LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Maltese: Eċċipjenti: polysorbate 80, ethanol anhydrous (ara il-fuljett għal aktar informazzjoni ) u citric acid.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 395 mg ethanol anhydrous kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml inbid.
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/004
Maltese: EU/1/07/384/004
English: 1000 mg/m2 per day for 5 days.
Maltese: 55 mg/m2.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anhydrous (alkoħol), jiġifieri sa 3.16 g ethanol anhydrous f'kull kunjett, ekwivalenti għal 80 ml ta' birra jew 33 ml ta' nbid.
English: LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid..
Maltese: Eċċipjenti: polysorbate 80, ethanol anhydrous (ara il-fuljett għal aktar informazzjoni) u citric acid.
English: What Docetaxel Zentiva contains - The active substance is docetaxel (as trihydrate).
Maltese: - Is-sustanza attiva hi docetaxel (bħala trihydrate).
English: MedDRA System Organ classes
Maltese: Sistema tal-klassifika tal-organi fiddatabase MedDRA
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/005
Maltese: EU/1/07/384/005
English: Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Maltese: (SJS-Stevens-Johnson Syndrome), Nekroliżi Tossika tal-Epidermide (TEN, Toxic Epidermal Necrolysis) u Pustullożi Eksantematuża Akuta Mifruxa (AGEP, Acute Generalized Exanthematous Pustulosis):
English: Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Maltese: Ipofosfatimja (G3-4: 1%) Ipokalimja (G3: 0%)
English: In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher).
Maltese: F'pazjenti li kellhom 75 sena jew aktar, meta tqabblu ma' pazjenti iżgħar fl-età, newtropenija, anemija, dijarea, qtugħ ta' nifs, u infezzjoni fil-parti ta' fuq tal-apparat tan-nifs ġew irrappurtati b'inċidenza akbar (tal-inqas 10% aktar).
English: Myalgia (severe: 1.4%) Arthralgia
Maltese: Majalġja (severa: 1.4%)
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: 8 mg dexamethasone oralment, 12-il siegħa, 3 sigħat u siegħa 1, qabel l-infużjoni ta' docetaxel (ara sezzjoni 4.4).
English: Reporting of adverse effects
Maltese: Rappurtar tal-effetti sekondarji
English: Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel.
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Każijiet ta' lupus erythematosus tal-ġilda u nfafet kbar bħal erythema multiforme u reazzjonijiet avversi serji fil-ġilda bħas-Sindromu ta' Stevens-Johnson (SJS- Stevens-Johnson Syndrome), Nekroliżi Tossika tal-Epidermide (TEN, Toxic Epidermal Necrolysis) u Pustullożi Eksantematuża Akuta Mifruxa (AGEP, Acute Generalized Exanthematous Pustulosis), kienu ġew irrapportati b'docetaxel.
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tal-prostata metastatiku reżistenti għallkastrazzjoni għal Docetaxel Zentiva 75 mg/m² użat flimkien ma' prednisone jew prednisolone:
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: Cisplatin u 5-fluorouracil 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: Docetaxel Zentiva contains alcohol.
Maltese: Docetaxel Zentiva fih l-alkoħol.
English: More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years.
Maltese: Aktar pazjenti li kellhom ≥65 sena fil-fergħa ta' docetaxel irrappurtaw reazzjoni ta' sensittività eċċessiva, newtropenija, anemija, żamma tal-fluwidu, qtugħ ta' nifs, u bidliet fid-dwiefer meta mqabbla ma' pazjenti li kellhom anqas minn 65 sena.
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Maltese: osservazzjoni wara li spiċċat il-kimoterapija ġiet irrapportata f'202 minn 744 pazjent TAC (27.2 %) u f'125 minn 736 pazjent FAC (17.0 %).
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bit-trattament studjat [kimoterapija +/radjuterapija] (%) (95%CI) ***p-value
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: 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 it-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), jew 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,
English: EXP:
Maltese: Tel.:
English: • decrease of the potassium, calcium and/or phosphate in your blood.
Maltese: • tnaqqis fil-potassium, fil-calcium u/jew fil-phosphate fid-demm
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 ma' l użu ta' mitomycin C u l-vinblastine flimkien (12 mg/m2 kull 6 ġimgħat u 6 mg/m2 kull 3 ġimgħat).
English: How to use Docetaxel Zentiva
Maltese: Docetaxel Zentiva
English: Cautions for use in hormone-sensitive prostate cancer Of the 545 patients treated with docetaxel every 3 weeks in a hormone-sensitive prostate cancer study (STAMPEDE), 296 patients were 65 years of age or older, and 48 patients were 75 years of age or older.
Maltese: Mill-545 pazjent ittrattati b'docetaxel kull 3 ġimgħat fl-istudju dwar kanċer tal-prostata sensittiv għallormoni (STAMPEDE), 296 pazjent kellhom 65 sena jew aktar, u 48 pazjent kellhom 75 sena jew aktar.
English: • Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
Maltese: • Kura standard + docetaxel 75 mg/m², mogħti kull 3 ġimgħat għal 6 `ċikli
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
Maltese: EWLENINTIKKETTA TAL-KUNJETT/ Docetaxel Zentiva 160 mg/8 ml
English: (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, segwit minn cisplatin (P) 75 mg/m2, segwit minn 5-fluorouracil (F) 750 mg/m2 kuljum bħala infużjoni kontinwa għal 5 ijiem.
English: Other medicines and Docetaxel Zentiva
Maltese: Mediċini oħra u Docetaxel Zentiva
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Maltese: glandoli limfatiċi effettwati (1-3, 4+), 1491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/m2 siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide
English: Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by20%.
Maltese: Stomatite/mukożite ta' grad 3 L-ewwel episodju: naqqas id-doża ta' 5-FU b'20%.
English: Docetaxel Zentiva in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormonesensitive prostate cancer.
Maltese: Docetaxel Zentiva flimkien ma' terapija ta' deprivazzjoni tal-androġeni (AD, androgen-deprivation therapy), flimkien ma' prednisone jew prednisolone jew mingħajrhom, huwa indikat għat-trattament ta' pazjenti b'kanċer tal-prostata metastatiku sensittiv għall-ormoni.
English: Alopecia (G3: 3%)a Nail changes (G3: 1%)
Maltese: Alopeċja (G3: 3%)a Bidliet fid-dwiefer (G3: 1%)
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: (eż., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir,
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: infużjoni ta' 250 ml li jkun fihom jew soluzzjoni ta' 5 % glucose jew soluzzjoni għall-injezzjoni ta' 9 mg/ml sodium chloride (0.9 %).
English: Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
Maltese: Ġiet miżjuda t-terapija ta' radjazzjoni skont il-linji gwida li kien hemm fl istituzzjonijiet li ħadu parti fl-istudju u ġiet mogħtija lis-57.3% tal-pazjenti li rċevew it-TAC u lill51.
English: The marketing authorisation holder shall submit PSUR 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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSURs) 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 tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Docetaxel Zentiva in combination with doxorubicin
Maltese: Docetaxel Zentiva użat flimkien ma' doxorubicin
English: Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m2 every 3 weeks for 6 cycles.
Maltese: Kanċer tal-prostata metastatiku sensittiv għall-ormoni Id-doża rakkomandata ta' docetaxel hija 75 mg/m2 kull 3 ġimgħat għal 6 ċikli.
English: It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Zentiva infusion solution.
Maltese: Huwa importanti li taqra l-kontenut kollu ta' din il-gwida qabel ma ssir il-preparazzjoni tas-soluzzjoni ta' infużjoni Docetaxel Zentiva
English: The name of this medicine is Docetaxel Zentiva.
Maltese: L-isem ta' din il-mediċina huwa Docetaxel Zentiva.
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Maltese: Sinkope (G3/4: 0%): Newrotossiċità (G3/4:0 %)
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Maltese: Analiżi tal-gruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement il fergħa TCF meta mqabbla mal-fergħa CF.
English: Median survival (months) 95% CI
Maltese: Medjan (xhur) 95% CI
English: Myocardial ischemia (G3/4:1.7%)
Maltese: Mard iskemiku talmijokardju (G3/4:1.7%) Arritmija
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 ta' l-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: Dose adjustment Diarrhoea 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: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
Maltese: TIKKETTA TAL-KUNJETT/Docetaxel Zentiva 20 mg/1 ml
English: Marketing Authorisation Holder Zentiva k.s.
Maltese: Detentur tal-Awtorizzazzjoni ghat-Tqegħid fis-Suq Zentiva k.s.
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 ta' l-enzimi transaminase (l-ALT u/jew l-AST) fis-serum tad-demm aktar minn 1.5 drabi l-ULN, flimkien ma' livelli ta' l-enżima alkaline phosphatase fis-serum aktar minn 2.5 drabi l-ULN, ghandhom riskju akbar li jiżviluppaw reazzjonijiet avversi u severi, bħall-mewt ta' natura tossika inkluża s-sepsis, emoraġija gastro-intestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite,
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Maltese: [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
Maltese: TIKKETTA TAL-KUNJETT/ Docetaxel Zentiva 80 mg/4 ml
English: See also section “Docetaxel Zentiva contains ethanol (alcohol)” below.
Maltese: Ara wkoll is-sezzjoni hawn taħt fuq “Docetaxel Zentiva fih ethanol (alkoħol)”.
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST  1.5 times the ULN associated with alkaline phosphatase  2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Maltese: F'numru żgħir ta' pazjenti (n = 23) li kellhom data bijokimiku kliniku suġġestiv ta' indebolimenttalfwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi ta' l-OLN assoċjat ma' livelli ta' l-enzima alkaline phosphatase ≥ 2.5 drabi ta' l-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni
English: In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Maltese: 500 ċelluli/mm3 għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil-ġilda, jew newropatija severa u periferika, waqt it-terapija bid-docetaxel, id-doża ta' docetaxel trid titnaqqas minn 100 mg/m2 għal 75 mg/m2 u/jew minn 75 għal 60 mg/m2.
English: Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Zentiva: - SJS/TEN sympoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Maltese: • Sindromu ta' Stevens-Johnson (SJS, Stevens-Johnson Syndrome) u Nekroliżi Tossika talEpidermide (TEN, Toxic Epidermal Necrolysis) (il-formazzjoni ta' nfafet, taqxir jew dmija minn kwalunkwe parti tal-ġilda tiegħek (inkluż xufftejk, għajnejk, ħalqek, imnieħrek, ġenitali, idejn jew saqajn) b'raxx jew mingħajru.
English: Docetaxel Zentiva in combination with trastuzumab
Maltese: Kif jidher Docetaxel Zentiva u l-kontenut tal-pakkett
English: Blurred vision
Maltese: Newropatija periferika
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Zentiva 160 mg/8 ml konċentrat għall-infużjoni docetaxel
English: Disease-free survival (DFS) was the primary efficacy endpoint and overall survival (OS) was the secondary efficacy endpoint.
Maltese: Sopravivenza ħielsa mill-mard (DFS - disease-free survival) kien l-iskop finali ta' effikaċja primarju u s-sopravivenza globali (OS - Overall survival) kien l-iskop finali ta' effikaċja sekondarju.
English: Alopecia; Erythema; Rash; Nail disorders
Maltese: Mard bħall-influwenza; Uġigħ fis-sider; Riħ bid deni
English: A final analysis was performed with an actual median follow-up of 96 months.
Maltese: L-analisi finali saret b'perijodu ta' osservazzjoni medjan attwali ta' 96 xahar.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Zentiva 20 mg/1 ml konċentrat għall-infużjoni docetaxel
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: TAL-PRODOTT MEDIĊINALI Docetaxel Zentiva 80 mg/4 ml konċentrat għall-infużjoni docetaxel
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: wara l-aħħar ċiklu ta' kimoterapija, il-pazjenti b'tumuri RE+ u/jew RPg+ irċevew tamoxifen 20 mg darba kuljum għal 5 snin.
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: Sintomi bħal uġigħ addominali bikri u sensibilità, deni, dijarea, bin-newtropenija u mingħajrha, jistgħu jkunu l-ewwel sinjali ta' tossiċità serja gastro-intestinali u għandhom ikunu evalwati u ittrattati fil pront.
English: Mitoxantrone every 3 weeks
Maltese: Mitoxantrone
English: At the median follow-up time of 77 months, overall survival (OS) was 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: Fil-medjan taż-żmien ta' osservazzjoni ta' 77 xahar, is-sopravivenza totali (OS -overall survival) kienet itwal fil-fergħa ta'TAC, bil-pazjenti kkurati b'TAC ikollhom tnaqqis ta' 24 % fir-riskju ta' mewt meta mqabbel ma' dawk ta' FAC (proporzjon ta' riskju = 0.76, 95% CI (0.46-1.26, p = 0.29).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
Maltese: Docetaxel Zentiva 160 mg/8 ml konċentrat sterili docetaxel
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for DOCETAXEL 75 mg/m² in combination with prednisone prednisolone and ADT (STAMPEDE study)
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella f'kanċer tal-prostata b'riskju ogħli avvanzat b'mod lokali jew metastatiku sensittiv għall-ormoni għal TAXOTERE 75 mg/m² flimkien ma' prednisone jew prednisolone u ADT (studju STAMPEDE)
English: PV-France@zentiva.com
Maltese: PV-Germany@zentiva.com
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel
Maltese: Docetaxel Zentiva 80 mg/4 ml konċentrat sterili docetaxel
English: One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Maltese: fuq TAC (0.1 %) u pazjent 1 fuq FAC 90.1 %) mietu minħabba AML matul il-perijodu ta' osservazzjoni (żmien medjan ta' osservazzjoni ta' 8 snin).