FrancophonIA/ELRC3.0 huggingface dataset:
English: For metastatic castration-resistant prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Maltese: Għal kanċer tal-prostata, il-premedikazzjoni hija t-teħid orali ta' dexamethasone ta' 8 mg, 12-il siegħa, 3 sigħat u siegħa qabel l-infużjoni ta'docetaxel (ara sezzjoni 4.2).
English: ADT alone p-valuea
Maltese: • ADT waħdu
English: Tabulated list of adverse reactions in head and neck cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: TAXOTERE 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil
English: 24.4 mg/0.61 ml).
Maltese: (Il-volum attwali huwa ta' 24.4 mg/0.61 ml).
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Maltese: [kimoterapija +/- radjuterapija] (%) (95%CI) ***p-value
English: Nausea (G3/4: 3.3%);
Maltese: Dijarea (G3/4: 3.4%);
English: One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Maltese: Dawn ingħataw doxorubicin (50 mg/m2) flimkien ma' docetaxel (75 mg/m2) (il-fergħa AT) kontra doxorubicin (60 mg/m2) flimkien ma' cyclophosphamide
English: c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion).
Maltese: c Iż-żmien sa progressjoni klinika = iż-żmien mill-għażla b'mod arbitrarju sa progressjoni klinika (jiġifieri żieda fis-sintomi ta' metastasi fl-għadam; progressjoni skont RECIST; jew deterjorament mill-aspett kliniku minħabba l-kanċer skont l-opinjoni tal-investigatur).
English: See also section “ TAXOTERE contains ethanol (alcohol)” below.
Maltese: Ara wkoll is-sezzjoni “TAXOTERE fih l-ethanol (l alkoħol)” hawn taħt.
English: Infusion site reaction
Maltese: Mhux applikabbli.
English: Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
Maltese: U KONTENUT Kull folja tal-pakkett ta' TAXOTERE 80 mg/2 ml konċentrat u solvent għal soluzzjoni għall-infużjoni fiha:
English: Second primary malignancies (including acute myeloid leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Maltese: Malinji primarji sussegwenti( li jinkludu lewkimja mijelojde akuta, sindrome mijelodisplastika u limfoma mhux ta' Hodgkin) jistgħu jseħħu ħafna xhur jew snin wara t-terapija li jkun fiha docetaxel.
English: Alopecia; Erythema; Rash; Nail disorders
Maltese: Uġigħ fis-sider; Riħ bid-deni
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Maltese: TUŻAX prodotti oħra mediċinali ta' docetaxel li fihom zewġ kunjetti (konċentrat u solvent) ma' dan il-prodott mediċinali (TAXOTERE 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni,
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Maltese: 12.4%); Żamm tal-fluwidu (sever: 0.8%)
English: How to store TAXOTERE Contents of the pack and other information
Maltese: Kif taħżen TAXOTERE Kontenut tal-pakkett u informazzjoni oħra
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 lill-51.2% tal-pazjenti li rċevew il-FAC.
English: Diarrhoea (G3/4: 4%); Nausea (G3/4: 4%);
Maltese: Stomatite (G3/4: 5.3%); Dijarea (G3/4: 4%);
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Maltese: Kull ml tal-konċentrat għal soluzzjoni għallinfużjoni ta' docetaxel fih 20 mg ta' docetaxel.
English: Do not store above 25°C or below 2°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°Ċ jew taħt 2°Ċ.
English: • The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.
Maltese: • Is-solvent għal TAXOTERE hu magħmul minn 13% (w/w) ethanol 95% fl-ilma għall injezzjonijiet.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Maltese: F'dan l-istudju, 501 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta'
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m in combination with cisplatin and 5-fluorouracil
Maltese: 75 mg/m² użat flimkien ma' cisplatin and 5-fluorouracil
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: Reazzjonijiet gastro-intestinali 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: Pharyngolaryngeal pain (G3/4:
Maltese: Infezzjonijiet (G3/4:
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Maltese: docetaxel titqabbel ma' pacilitaxel fit-trattament ta' kanċer tas-sider avvanzat, f'pazjenti li t-terapija preċedenti kellha tinkludi xi anthracycline.
English: Meeting relative indication for chemotherapy a
Maltese: Jissodisfaw l-indikazzjoni relattiva għal kimoterapija a
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml vial ensures a premix concentration of 10 mg/ml docetaxel.
Maltese: Iż-żieda tal-kontenut sħiħ tas-solvent mill-kunjett, għall-kontenut tal-kunjett ta'TAXOTERE 20 mg/0.5 ml, jiżgura konċentrazzjoni tas-soluzzjoni inizjali ta' 10 mg/ml ta' docetaxel.
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Maltese: Newtropenija bid-deni u infezzjonijiet assoċjati man newtropenija ġraw, rispettivament, fi 12.1% u 3.4% tal-pazjenti, meta dawn irċevew il-profilassi b'G
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Maltese: avvenimenti avversi li jseħħu fuq perjodu ta' 6 ċikli ta' trattament b'docetaxel u li jkollhom inċidenza ta' mill-inqas 2% aktar fil-fergħa tat-trattament b'docetaxel meta mqabbla mal-fergħa ta' kontroll, huma ppreżentati bl-użu tal-iskala tal-gradi CTCAE.
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-trattament: 5.4% [95% CI: -1.1; 12.0] Differenza fit-trattament: 6.2% [95% CI: 0.2; 12.3]
English: Elderly
Maltese: Prednisone
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'din il-prova, 87% tal-pazjenti kellhom mard li kien IHC 3+, u 95% tal-pazjenti li dahlu fl-istudju kellhom mard li kien IHC 3+ u/jew FISH pożittiv.
English: Gastrointestinal pain (G3/4: 1.2%);
Maltese: Emoraġija gastrointestinali (G3/4:0.6%);
English: Cautions for use in gastric adenocarcinoma cancer Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Maltese: III ta' l-istudju u 79 pazjent fil-fażi II) ittrattati b'docetaxel flimkien ma' cisplatin u 5-fluorouracil fl-istudju fuq il-kanċer ta' l-istonku, 74 pazjenti kellhom 65 sena jew aktar u 4 pazjenti kellhom 75 sena jew aktar.
English: Median duration of response to chemotherapy  radiotherapy (months) (95% CI)
Maltese: Tul medjan ta' sopravivenza mingħajr it-tumur javvanza (xhur) (95%CI)
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  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 binnofs fil-livell tad-demm għall-fażijiet α, β u γ huwa ta' 4 minuti, 36 minuta u 11.1 sigħat,
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Maltese: Taxanes, Kodiċi ATC:
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2 ml per vial.
Maltese: Din iż-żieda ċkejkna tal-kontenut tiżgura li wara li jiżdied is-solvent kollu fil-kunjett ta' TAXOTERE ikun hemm volum minimu li jista' jittella' ta' 8 ml, li jkun fih 10 mg/ml ta' soluzzjoni inizjali ta' docetaxel.
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Maltese: Terapija flimkien ma' prodotti oħra Doxorubicin
English: VIAL/SOLVENT FOR TAXOTERE 80 mg/2 ml
Maltese: KONĊENTRAT u SOLVENT/TAXOTERE 80 mg/2 ml
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Maltese: *Unstratified logrank test Analiżi tal-gruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement il fergħa TCF meta mqabbla mal-fergħa CF.
English: Dyspepsia (G3/4:
Maltese: Alopeċja (G3/4:
English: There are no data available in patients with severely impaired renal function treated with docetaxel.
Maltese: M'hemmx data disponibbli f'pazjenti li għandhom indeboliment sever fil-funzjoni tal-kliewi u li kienu ittrattati b'docetaxel.
English: Neutropenia (G4:
Maltese: Newtropenija (G4:
English: In TAXOTERE 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' TAXOTERE 20 mg/1 ml, il-konċentrat ta' docetaxel huwa 20mg/ml
English: This vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume:
Maltese: Dan il-kunjett fih 0.5 ml ta' soluzzjoni ta' 40 mg/ml ta' docetaxel f'polysorbate 80.
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Maltese: TAXOTERE 80 mg/2 ml konċentrat u solvent għal soluzzjoni għall-infużjoni docetaxel
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with TAXOTERE 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi għat-terapija miżjuda b'TAXOTERE 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: Peripheral sensory neuropathy (G3: 0.4%)
Maltese: Newropatija periferika tas-sensazzjoni (G3/4:0.6%)
English: • The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
Maltese: • Is-solvent għal TAXOTERE 80 mg/2 ml huwa f'kunjett tal-ħġieġ ċar ta' 15 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
English: Vomiting (G3/4: 3%)
Maltese: Rimettar (G3/4: 3%)
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express HER2, and who previously had not received chemotherapy for metastatic disease.
Maltese: Docetaxel użat flimkien ma' trastuzumab kien studjat fit-trattament ta' pazjenti b'kanċer metastatiku tas-sider, liema tumuri kienu jipproduċu HER 2, u li precedentement ma rċevewx il-kimoterapija għal mard metastatiku.
English: Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous).
Maltese: Kull kunjett b'doża waħda ta' TAXOTERE 20 mg/0.5ml, konċentrat, fih docetaxel (bħala tri-idrat) li jikkorrispondi għal 20 mg ta' docetaxel (anidru).
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion
Maltese: TAXOTERE 80 mg/4 ml konċentrat u solvent għal soluzzjoni għall-infużjoni
English: OUTER CARTON / TAXOTERE 160 mg/8 ml
Maltese: KAXXA TA' BARRA/TAXOTERE 160 mg/8 ml
English: In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' TAXOTERE 160 mg/8 ml, il-konċentrat ta' docetaxel hu 20mg/ml
English: including more severe hypersensitivity reaction.
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Maltese: p < 0.01) u ż-zmien medjan ta' kemm għexu (15.3 xhur kontra 12.7 xhur; p = 0.03).
English: In these metastatic prostate cancer patients, the median overall survival was significantly longer in docetaxel treatment groups than in the standard of care alone group, with a median overall survival 19 months longer with the addition of docetaxel to standard of care (HR = 0.76, 95% CI = 0.62-0.92, p=0.005).
Maltese: F'dawn il-pazjenti b'kanċer tal-prostata metastatiku , il-medjan tas-sopravivenza totali kien sinifikament itwal fil-gruppi ta' trattament b'docetaxel milli fil-grupp ta' kura standard waħidha, b'medjan ta' sopravivenza totali ta' 19-il xahar iżjed biz-zieda ta' docetaxel mal-kura standard (HR = 0.76, 95% CI = 0.62-0.92, p=0.005).
English: Post-Menopausal
Maltese: Il-Ġermanja
English: Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED)
Maltese: L-effikaċja ta' docetaxel u ADT fit-trattament ta' pazjenti b'kanċer tal-prostata metastatiku sensittiv għall-ormon (CHAARTED)
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal TAXOTERE 100 mg/m2 flimkien ma' trastuzumab
English: Data from a multi-centre open label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS  80%, between 18 and 70 years of age.
Maltese: Id-data minn studju f'ċentri multipli, fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu x'mediċini qed jintużaw, u l-pazjenti tqassmu mingħajr għażla, isaħħu l-użu ta' docetaxel għattrattament miżjud f'pazjenti li għandhom kanċer tas-sider li nfirex fil-glandoli limfatiċi u li huwa operabbli b'KPS ta' ≥80%, minn 18 sa 70 sena fl-età.
English: Oedema
Maltese: Dispepsja
English: 3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: tqalligħ, rimettar, stomatite, dijarea u astenja.
English: • nasal drainage; inflammation of the throat and nose; cough
Maltese: Għejja; Infjammazzjoni talmukoża; Uġigħ;
English: Overall survival (Primary end-point):
Maltese: (L-aħħar stadju primarju tal-proċess):
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion
Maltese: TAXOTERE 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni
English: It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Maltese: Huwa importanti li taqra l-kontenut kollu ta' din gwida qabel ma ssir il-preparazzjoni tas-soluzzjoni ta' infużjoni TAXOTERE
English: Marketing Authorisation Holder Sanofi Mature IP
Maltese: Detentur tal-Awtorizzazzjoni ghat-Tqegħid fis-Suq Sanofi Mature IP
English: Dizziness (G3/4:
Maltese: Konġuntivite (G3/4:
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Maltese: Il-modifikazzjonijiet tad-dożi li huma irrakkomandati f'pazjenti b'tossiċita ittrattati b' docetaxel meta jintuża flimkien ma' cisplatin u 5-fluorouracil (5-FU):
English: TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Maltese: Tużax TAXOTERE wara d-data ta' skadenza li tidher fuk il-kartuna, il-folja tal-pakkett u l-kunjetti.
English: Tabulated list of adverse reactions in gastric adenocarcinoma center for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal TAXOTERE 75 mg/m² użat flimkien ma' doxorubicin:
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: L-ammont ta' alkoħol f'dan il-prodott mediċinali jista' jkollu effetti fuq is-sistema nervuża ċentrali (ilparti tas-sistema nervuża li tinkludi l-moħħ u n-nervituri li jgħaddu mis-sinsla tad-dahar).
English: Package leaflet: Information for the patient TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Maltese: Informazzjoni għall-pazjent TAXOTERE 80 mg/2ml konċentrat u solvent għal soluzzjoni għall-infużjoni docetaxel
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Maltese: (żmien medjan attwali ta' osservazzjoni ta' 8 snin), limfoedima kienet osservata li kienet għada għaddejja f'6 pazjenti TAC (0.8%) u f'pazjent 1 (0.1%) fil-fergħa FAC.
English: In TAXOTERE 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Maltese: Fil-kunjett ta' TAXOTERE 80 mg/4 ml, il-konċentrat ta' docetaxel huwa 20mg/ml
English: Peripheral sensory neuropathy (G3/4:
Maltese: Newropatija periferika tas-sensazzjoni (G3/4:
English: Diarrhoea (G3/4:
Maltese: Letarġija (G3/4:
English: Common (may affectup to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10):
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Maltese: Il-komportament farmakokinetiku ta' docetaxel, doxorubicin u cyclophosphamide ma kienx effetwat meta ngħataw flimkien.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Maltese: Rimettar (G3/4: 8.4%) Dijarea (G3/4: 6.8%);
English: G3/4 ALT increased
Maltese: G3/4 Żieda fl-AST G3/4 Żieda fl-ALT
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Fġir l-imnieħer; Uġigħ fil-farinġi u l-larinġi; Farinġite tal-parti nażali; Qtugħ ta' nifs; Sogħla; Tnixxija mill-imnieħer
English: Solvent vial contains 1.5 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 1.98 ml).
Maltese: Il-kunjett tas-solvent għandu volum ta' 1.5 ml ta' 13% (w/w) ta' soluzzjoni ta' ethanol fl-ilma għallinjezzjonijiet.
English: Lethargy; Pain
Maltese: Newtropenja bid-deni
English: These measures will help protect the environment.
Maltese: li tista' tkun aktar severa.
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel
Maltese: TAXOTERE 160 mg/8 ml konċentrat għall-infużjoni docetaxel
English: 2-year estimate (%) Hazard ratio (95% CI) *p-value
Maltese: Estimu ta sentejn (%) Il-proporzjon tar-riskju (95%CI) *p-value
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion vial
Maltese: TAXOTERE 80 mg/2 ml konċentrat u solvent għal soluzzjoni għall-infużjoni
English: Docetaxel should be administered when the neutrophil count is  1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm 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/m to 75 mg/m and/or from 75 to
Maltese: F'pazjenti li kellhom jew id-deni flimkien man-newtropenija, b'numru ta' <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: Thrombocytopenia (G3/4: 4.0%);
Maltese: Tromboċitopenija (G3/4: 0.6%);
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Maltese: Anemija (G3/4: 20.9%); Newtropenija (G3/4: 83.2%);
English: Asthenia (G3/4:
Maltese: Infezzjoni (G3/4:
English: This vial contains 2 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume:
Maltese: Dan il-kunjett fih 2 ml ta' soluzzjoni ta' 40 mg/ml ta' docetaxel f'polysorbate 80.
English: Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml).
Maltese: Il-kunjett tas-solvent għandu volum ta' 6 ml ta' 13% (w/w) ta' soluzzjoni ta' ethanol 95% fl-ilma għall-injezzjonijiet.
English: For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4).
Maltese: Għall-kanċer tal-prostata metastatiku sensittiv għall-ormoni, irrispettivament mill-użu konkomittanti ta' prednisone jew prednisolone, il-mod irrakkomandat tal-premedikazzjoni, huwa t-teħid ta' 8 mg dexamethasone oralment, 12-il siegħa, 3 sigħat u siegħa, qabel l-infużjoni ta' docetaxel (ara sezzjoni
English: TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Maltese: TAXOTERE flimkien ma' trastuzumab huwa indikat għat-trattament ta'pazjenti b'kanċer metastatiku tas-sider, liema tumuri jesprimu bil-qawwa HER2, u li preċedentement ma kienux ħadu kimoterapija għall-mard metastatiku.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Maltese: L-Effikaċja ta' docetaxel fit-trattament induttiv ta' pazjenti b'SCCHN
English: Description of selected adverse reactions in breast cancer for adjuvant therapy with TAXOTERE 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari għat-terapija miżjuda b'TAXOTERE 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Maltese: GWIDA TA' PREPARAZZJONI GĦALL-UŻU MA' TAXOTERE 20 mg/1 ml KONĊENTRAT
English: 1060 patients were randomised to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Maltese: 1060 pazjent ġew magħżula b'mod arbitrarju biex jirċievu jew TAXOTERE 75 mg/m2 mogħti siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide 500 mg/m2 (521