FrancophonIA/ELRC3.0 huggingface dataset:
English: • Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml.
Maltese: • Kull kunjett tas-solvent, li tmur ma' kunjett ta' TAXOTERE 20 mg/0.5 ml, fiha 1.98 ml.
English: 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: 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 (congestive heart failure-CHF) waqt il-perjodu ta'
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: 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'effetwawx ir-rabta ta' docetaxel mal-proteina.
English: Stomatitis (G3/4:
Maltese: Stomatite (G3/4:
English: Abdominal pain;
Maltese: Newtropenija bid-deni;
English: The median overall survival was significantly longer in docetaxel treatment group than in the ADT alone group, with a median overall survival 13.6 months longer with the addition of docetaxel to ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.47-0.80, p=0.0003).
Maltese: Il-medjan ta' sopravivenza totali kien sinifikament itwal fil-grupp ta' trattament b'docetaxel milli filgrupp ta' ADT waħdu, b'medjan ta' sopravivenza totali ta' 13.6 xhur itwal biż-żieda ta' docetaxel ma' ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.
English: • Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml.
Maltese: • Kull kunjett tas-solvent, li tmur ma' kunjett ta' TAXOTERE 80 mg/2 ml, fiha 7.33 ml.
English: CYTOTOXIC
Maltese: Mitoxantrone
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 TAXOTERE flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw TAXOTERE wahdu.
English: Number of patients in TAC group
Maltese: Numru ta' pazjenti fil-grupp tat-TAC
English: Cough; Rhinorrhoea
Maltese: Il-pazjenti kollha
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m 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 ta' l-istudji.
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Maltese: Recall phenomena tar-radjazzjoni kienu rarament irrapportati.
English: VIAL/TAXOTERE 20 mg/0.5 ml
Maltese: KUNJETT /TAXOTERE 20 mg/0.5 ml
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 932 mg ethanol 95% v/v per solvent vial, equivalent to 23 ml of beer or 9.5 ml wine.
Maltese: Dan il-prodott mediċinali fih 13 % (w/w) ethanol 95% v/v (alkoħol), jiġifieri sa 932 mg ethanol 95% v/v għal kull kunjett ta' solvent, ekwivalenti għal 23 ml ta' birra jew 9.5 ml ta' nbid.
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in
Maltese: Infezzjonijiet (G3/4: 5.7%; li jinkludu sepsis u pulmonite, fatali f'1.7%)
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.
Maltese: Dan il-prodott mediċinali fih 13 % (w/w) ethanol 95% v/v (alkoħol), jiġifieri sa 252 mg ethanol 95% v/v għal kull kunjett ta' solvent, ekwivalenti għal 6 ml ta' birra jew 2.6 ml ta' nbid.
English: Peripheral motor neuropathy (G3/4: 2.5%)
Maltese: Newropatija periferika talmovimenti (G3/4: 2.5%)
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 għall ormoni (STAMPEDE), 296 pazjent kellhom 65 sena jew aktar, u 48 pazjent kellhom 75 sena jew aktar.
English: • acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Maltese: • lewkimja mijelojde akuta u sindrome mijelodisplastika (tipi ta' kanċer tad-demm) jistgħu jseħħu f'pazjenti kkurati b'docetaxel flimkien ma' ċerti trattamenti oħra kontra l-kanċer.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.
Maltese: - Is-sustanza l-oħra huma polysorbate 80, ethanol anidru (ara sezzjoni 2) u aċidu ċitriku.
English: For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Maltese: docetaxel tirrikjedi 14 ml ta' soluzzjoni inizjali ta' docetaxel .
English: • 3 years.
Maltese: • 3 snin
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 t tumur (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: 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: newtropenja ta' Grad 4, newtropenja bid-deni u infezzjoni newtropenika naqset fil-pazjenti li rċevew il-prevenzjoni primarja permezz ta' G-CSF (ara sezzjoni 4.8).
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol % ethanol anidru (alkoħol), jiġifieri sa 1.58 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 40 ml ta' birra jew 17 ml ta' nbid.
English: Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Maltese: Kull ml ta' konċentrat fih 20mg docetaxel li huwa trihydrate.
English: Docetaxel + standard of care Standard of care alone
Maltese: Docetaxel + kura standard Kura standard waħidha
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 anidru (alkoħol), jiġifieri sa 3.16 g ta' ethanol anidru f'kull kunjett, ekwivalenti għal 80 ml ta' birra jew 33 ml inbid.
English: Dysgeusia (G3/4: < 1%); Pareaesthesia (G3/4: < 1%)
Maltese: Disgewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: 4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Maltese: PREPARAZZJONI TAL-PRODOTT GĦALL-GĦOTI ĠOL-VINA 4.1 Preparazzjoni ta' TAXOTERE, soluzzjoni inizjali (10 mg docetaxel/ml)
English: 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m 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/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 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 f'tul ta' siegħa, flimkien ma' carboplatin (AUC 6 mg/ml.minuta) li ngħata f'30 sa 60 minuta kull 3 ġimgħat,
English: Neutropenic infection; Infection (G3/4: 11.7%)
Maltese: Infezzjoni assoċjata man newtropenija; Infezzjoni (G3/4: 11.7%)
English: More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anaemia, 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: Infection (G3/4: 3.6%) Neutropenic infection
Maltese: Infezzjoni (G3/4:6.3%) Infezzjoni binnewtropenija
English: VIAL LABEL / TAXOTERE 20 mg/1 ml
Maltese: TIKKETTA TAL-KUNJETT/ TAXOTERE 20 mg/1 ml
English: Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone.
Maltese: Fost l-1776 pazjent magħżula b'mod arbitrarju 1086 (61%) kellhom mard metastatiku, 362 ġew mogħtija b'mod arbitrarju docetaxel flimkien ma' kura standard, 724 irċevew kura standard waħidha.
English: Anaemia (G3/4: 8.9%); Febrile neutropenia
Maltese: Anemija (G3/4: 8.9%); Newtropenija bid-deni
English: • Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml).
Maltese: • Kull kunjett ta' TAXOTERE 20 mg/0.5 ml fih 0.5 ml ta' soluzzjoni ta' docetaxel, b'konċentrazzjoni ta' 40 mg/ml fil-polysorbate 80 (volum attwali: 24.4 mg/0.61 ml ).
English: Uncommon (may affectup to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: Dysgeusia; Hypoaesthesia
Maltese: Esofaġite/disfaġja/
English: Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Maltese: Il-preparazzjoni tal-prodott għall-għoti ġol-vini a) Preparazzjoni ta'TAXOTERE, soluzzjoni inizjali (10 mg docetaxel/ml)
English: Contains anhydrous ethanol (see leaflet)
Maltese: Fih ethanol anidrat ( ara l-fuljett)
English: Metastatic hormone-sensitive prostate cancer
Maltese: Kanċer tal-prostata metastatiku sensittiv għall-ormon
English: Oedema (G3/4: 1.2%)
Maltese: Edima (G3/4: 1.2%)
English: Median (months) 95% CI
Maltese: Medjan (xhur) 95% CI
English: TAXOTERE in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Maltese: TAXOTERE 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: Inject the required premix volume 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: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Maltese: Anemija (G3/4: 3%); Newtropenija (G3/4:
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, qabel l-infużjoni ta' docetaxel (ara sezzjoni 4.4).
English: 1 vial of TAXOTERE 80 mg/2 ml concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ml) Fill: 94.4 mg/2.36 ml
Maltese: 80 mg docetaxel f'2 ml polysorbate 80 (40 mg/ml) Volum attwali: 94.4 mg/2.36 ml
English: Myocardial ischemia (G3/4:1.7%)
Maltese: Mard iskemiku talmijokardju (G3/4:1.7%)
English: Diabetes (G3-4: 1%)
Maltese: Dijabete (G3-4: 1%)
English: (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: 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: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v).
Maltese: Kull kunjett b'doża waħda ta' solvent huwa magħmul minn 13% (w/w) t'ethanol 95% v/v fl-ilma għall-injezzjonijiet (932 mg t'ethanol 95% v/v).
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m on day 1) in combination with cisplatin (C) (75 mg/m on day 1) and 5-fluorouracil (F)
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
English: TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Maltese: TAXOTERE flimkien ma' doxorubicin u cyclophosphamide huwa indikat għat-trattament miżjud f'pazjenti li għandhom:
English: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v).
Maltese: Kull kunjett b'doża waħda ta' solvent huwa magħmul minn 13% (w/w) t'ethanol 95% v/v fl-ilma għall-injezzjonijiet (252 mg ta' ethanol 95% v/v).
English: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Żieda fil-bilirubin fid-demm (< 5%);
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
Maltese: Każijiet ta' lupus erythematosus tal-ġilda, infafet 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: TAXOTERE in combination with trastuzumab
Maltese: TAXOTERE użat flimkien ma' trastuzumab
English: VIAL/TAXOTERE 80 mg/2 ml
Maltese: KUNJETT/TAXOTERE 80 mg/2 ml
English: Second episode: reduce docetaxel dose by 20%.
Maltese: It-tieni episodju: naqqas id-doża ta' docetaxel b'20%.
English: In combination with cisplatin and 5-fluorouracil
Maltese: użat flimkien ma' cisplatin and 5-fluorouracil
English: • Periodic Safety Update Reports (PSURs)
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSURs)
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Maltese: Anqas spiss, sintomi qawwija bħal raxxijiet segwiti minn msiemer tal-ġilda li jitqaxxru kienu innotati li rarament wassal għal interruzjoni jew waqfien fit trattament ta' docetaxel (ara sezzjonijiet 4.2 u 4.4).
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/m as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m 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: Hypertension; Haemorrhage
Maltese: Infjammazzjoni tal-mukoża; Uġigħ;
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.
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 ta' l-istonku, l-istudju kliniku tal-pern 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 irrakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2.
Maltese: Id-doża rakkomandata ta' docetaxel hija 75 mg/m2.
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: Disturbi fil-qalb Fl-istudju TAX 316, 26 pazjent (3.5%) fil-fergħa tat-TAC u 17-il pazjent (2.3%) fil-fergħa tal-FAC
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Maltese: Tqalligħ (G3/4: 9.6%); Rimettar (G3/4: 7.6%); Dijarea (G3/4: 6.4%);
English: Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Maltese: Newtropenija (G3/4: 32%); Newtropenija bid-deni (tinkludi n newtropenija assoċjata mad-deni u l-użu ta' l-antibijotiċi) jew newtropenija bis sepsis
English: Epistaxis (G3/4: 0%);
Maltese: Żieda fil-piż (G3/4: 0 %);
English: • dizziness
Maltese: • Sentejn
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 anidru (alkoħol), jiġifieri sa 395 mg t'ethanol anidru f'kull kunjett, ekwivalenti għal 10 ml ta' birra jew 4 ml ta' nbid.
English: 1 vial of TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ml) Fill: 24.4 mg/0.61 ml
Maltese: 20 mg docetaxel f'0.5 ml polysorbate 80 (40 mg/ml) Volum attwali: 24.4 mg/0.61 ml
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Maltese: F'madwar 20 % ta' dawn il każijiet ma kien hemm ebda fatturi ta' riskju għad-disfunzjoni renali severa akuta bħal prodotti mediċinali nefrotossiċi li ttieħdu fl-istess ħin u distrubi gastro-intestinali.
English: Metastatic castration-resistant prostate cancer
Maltese: Kanċer tal-prostata metastatiku reżistenti għall-kastrazzjoni
English: Constipation;
Maltese: Stomatite;
English: Hypotension (G3: 0%)
Maltese: Ipokalċimja (G3: 0%)
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 4.2).
English: Special populations
Maltese: Ġilda esfoljattiva
English: Sanofi-Aventis Zrt.
Maltese: Sanofi-Aventis
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: clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole)
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni u l-għoti tal-prodott, ara sezzjoni 6.6.
English: Nail disorders (severe: 0.8%)
Maltese: Disgewżja(severa: 0.07%)
English: Special populations:
Maltese: Pazjenti speċjali:
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Maltese: Stomatite (G3/4: 18%); Dijarea (G3/4: 14%);
English: • Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml).
Maltese: • Kull kunjett ta' TAXOTERE 80 mg/2 ml fih 2.0 ml ta' soluzzjoni ta' docetaxel, b'konċentrazzjoni ta' 40 mg/ml fil-polysorbate 80 (volum attwali: 99.4 mg/2.36 ml ).
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Maltese: Alopeċja (G3/4:10.9%) Raxx bil-ħakk Ġilda xotta
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for TAXOTERE 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 TAXOTERE 75 mg/m² użat flimkien ma' prednisone jew prednisolone