FrancophonIA/ELRC3.0 huggingface dataset:
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-toTreat Analysis)
Maltese: Analiżi ta' sottosetts-terapija adjuvanti f'pazjenti fi studju tal-kanċer tas-sider negattiv għal glandoli (Analiżi maħsuba għal kura)
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal Docetaxel 100 mg/m2
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel 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/2.88 ml per vial.
Maltese: Din iż-żieda fil-volum tiżgura li, wara li ssir ittaħlita tal-kontenut sħiħ tal-kunjett tas-solvent mal-kontenut tal-kunjett ta'docetaxel, ikun hemm ammont minimu li jista' jittella' ta' 8 ml, li għandu 10 mg/ml docetaxel, li jikkorrispondi għallammont indikat fuq it-tabella ta' 80 mg/2.88 ml kull kunjett.
English: General disorders and administration site conditions In study TAX316 peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Fl-istudju TAX316, l-edima periferika li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti fil-perijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet osservata f'119 minn 744 pazjent fuq TAC (16%) u f'23 pazjent minn 736 pazjent fuq FAC (3.1 %).
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Maltese: Fl-istudju TAX316, in-newropatija periferika tas-sensazzjoni bdiet matul il-perijodu ta' trattament u baqgħet tippersisti fil-perijodu ta' osservazzjoni f'84 pazjent (11.3%) fil-fergħa TAC u fi 15-il pazjent (2 %) fil-fergħa FAC.
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Maltese: 316) u negattivi għal glandoli (GEICAM 9805) - tagħrif ippuljat
English: Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p=0.01, using the EORTC QLQ-C30 scale).
Maltese: Il-pazjenti ittrattati b'TPF kellhom b'mod sinifikattiv anqas ta' deterjorazzjoni fil-kejl tas-saħħa Globali, meta mqabbla ma' dawk ittrattati bi PF (p = 0.01, meta tintuża l-iskala EORTC QLQ-C30).
English: Rash pruritic;
Maltese: Reazzjoni fis-sit tal-infuzjoni;
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Maltese: osservazzjoni (żmien medjan attwali ta' osservazzjoni ta' 8 snin), l-edima periferika kienet għada għaddejja f'19-il pazjent TAC (2.6%) u f'4 pazjenti (0.5%) fil-fergħa FAC.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Maltese: Fwawar sħan (G3/4: 0.5%) Pressjoni baxxa (G3/4: 0%); Flebite (G3/4: 0%)
English: Lymphoedema
Maltese: jingħata
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
Maltese: F'pazjenti li qatt ma ħadu l-kimoterapija qabel u li qed jiġu ikkurati għall-kanċer tal-pulmun mhux mikroċitoma, il-programm tad-dożi rakkomandati huwa docetaxel 75 mg/m2 segwit immedjatament b'cisplatin 75 mg/m2 fuq perjodu ta' bejn 30 u 60 minuta.
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 rrakkomandati f'pazjenti b'tossiċita gastrointestinali ittrattati b'docetaxel meta jintuża flimkien ma' cisplatin u 5-fluorouracil (5-FU):
English: Nausea (G3/4: 2.4%);
Maltese: Deni (G3/4: 2.3%);
English: Dehydration (G3/4: 2%)
Maltese: Diżidrazzjoni (G3/4: 2%)
English: Thrombocytopenia (G3/4: Febrile neutropenia
Maltese: Alopeċja (li tippersisti Tossiċità tal-ġilda (G3/4: Disturbi tad-dwiefer
English: Previous therapy should have included an anthracycline.
Maltese: Itterapija preċedenti kellha tinkludi xi anthracycline.
English: Stomatitis (G3/4: 20.7%);
Maltese: Dijarea (G3/4: 19.7%);
English: Cough; Rhinorrhoea
Maltese: OĦRAJN
English: All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Maltese: Il-pazjenti kollha tal-fergħa ta' docetaxel fl-istudji TAX323 u TAX324 irċevew profilassi bl-antibijotiċi.
English: Number of patients in TAC group
Maltese: Għadd ta' pazjenti fil-grupp TAC
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Maltese: Fil-każ ta' tromboċitopenija ta' Grad 4 iddoża ta' docetaxel għandha titnaqqas minn 75 għal 60 mg/m2.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
Maltese: 0.72 ml (Mili: 0.88 ml)
English: Anaemia (G3/4:
Maltese: Anoreksja (G3/4:
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: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil:
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil:
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
Maltese: It-trattament induttiv ta' pazjenti li kellhom kanċer tat-tip squamous cell tar-ras u l-għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta' kura kirurġika u bi skop ta' preservazzjoni tal-organi), id-doża rrakkomandata ta' docetaxel hija
English: Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tal-prostata għal Docetaxel 75 mg/m² użat flimkien ma' prednisone jew prednisolone:
English: Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Maltese: Newtropenija (G3/4: 83.5%); Anemija (G3/4: 12.4%);
English: Meeting relative indication for chemotherapya
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
Maltese: Analiżi tas-sottogruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement il-ergħa TCF meta mqabbla mal-fergħa CF.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva 80 mg/2.88 ml
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal Docetaxel Teva 80 mg/2.88 ml
English: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Maltese: Docetaxel ma jistax jintuża f'pazjenti fejn il-livell ta' riferiment bażiku tal-għadd taċ-ċelluli newtrofiliċi fid-demm huwa < 1,500 ċelluli/mm3.
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Maltese: Fil-każ ta' trattament miżjud ta' kanċer operabbli tas-sider, pożittiv u negattiv għal glandoli, id-doża ta' docetaxel hija ta' 75 mg/m2 li trid tingħata siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2, kull 3 ġimgħat għal 6 ċikli (programm ta' kura b'TAC) (ara wkoll Aġġustamenti fid-doża waqt it-trattament).
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Maltese: Ġew irrappurtati lewkimja mijelojde akuta u sindrome mijelodisplastika (frekwenza mhux komuni) fi studji kliniċi prinċipali f'kanċer tas-sider bl-iskeda ta' trattament TAC.
English: Esophagitis/dysphagia/odynophagia (G3/4: 12.0%);
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4: 0.6%); Uġigħ addominali;
English: Following the administration of a 100 mg/m2 dose given as a one hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Maltese: Wara l-għoti ta' doża ta' 100 mg/m2 li ngħatat bħala infużjoni fi żmien siegħa, l-ogħla livell medju fil-plażma kien ta' 3.7 μg/ml b'AUC korrispondenti ta' 4.6 sigħat.μg/ml.
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: 1 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).
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1-to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Maltese: Id-doża rakkomandata ta' docetaxel hija 75 mg/m2 mogħtija bħala infużjoni tul siegħa, segwita minn cisplatin 75 mg/m2, bħala infuzjoni tul ta' 1 sa 3 sigħat (it-tnejn fl-ewwel jum biss), segwita minn 5-fluorouracil 750 mg/m2 kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5 ijiem, mibdija fit-tmiem tal-infużjoni ta' cisplatin.
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Maltese: Tqalligħ (G3/4: 6%); Rimettar (G3/4: 4%); Stitikezza (G3/4: 1%); Uġigħ ta' żaqq (G3/4: 2%); Dispepsja
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing docetaxel in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jissottometti r-riżultati ta 'studji bilprodott mediċinali ta' referenza li fih docetaxel fis-sottogruppi kollha tal-popolazzjoni pedjatrika f'kanċer tas-sider, kanċer tal-pulmun mhux żgħir taċ-ċelluli, kanċer tal-prostata, karċinoma gastrika u kanċer tar- Li ma jinkludux it-tip II u III karċinoma nasofarinġjali inqas differenzjata (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m2 bħala infużjoni fil-vini fl-ewwel jum segwit minn cisplatin (P) 100 mg/m2 li jingħata bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat, segwit minn 5-fluorouracil (F) 1,000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Maltese: 72 ml konċentrat għal soluzzjoni għall-infużjoni, is-soluzzjoni inizjali li tirriżulta tkun ta' 10 mg/ml docetaxel.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Maltese: Newropatija periferika tas-sensazzjoni (G3: 4.1%); Newropatija periferika tal-movimenti (G3/4: 4%);
English: For 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: Għall-kanċer tal-prostata, sakemm l-użu konkomittanti ta' prednisone jew prednisolone jista' jsir, il-mod irrakkomandat tal-premedikazzjoni, huwa t-teħid ta' 8 mg dexamethasone oralment, 12-il siegħa, 3 sigħat u siegħa 1, qabel l-infużjoni ta' docetaxel (ara sezzjoni 4.4).
English: • The solvent for Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Maltese: • Is-solvent għal Docetaxel Teva 80 mg/2.88 ml huwa f'kunjett tal-ħġieġ ċar ta' 15 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
English: • The solvent for Docetaxel Teva composition is water for injections.
Maltese: • Is-solvent għal Docetaxel Teva huwa ilma għall-injezzjonijiet.
English: Conjunctivitis
Maltese: Globali
English: Oedema
Maltese: BŻONN
English: Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)
Maltese: Astenja (G3/4: 10%); Deni (G3/4: NA); Edima periferika (G3/4: 0.2%)
English: In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Maltese: F'dan l-istudju , 87% tal-pazjenti kellhom mard li kien IHC 3+, u 95% tal-pazjenti li dahlu fl-istudju kellhom mard li kien IHC 3+ u/jew FISH pożittiv.
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Maltese: Filqasam tal-istudji fejn Docetaxel Teva intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Maltese: L-aħħar stadju primarju tal-proċess f'dan l-istudju, is-sopravivenza mingħajr lavvanz (PFS), kien b'mod sinifikattiv itwal tal-fergħa ta' TPF, meta mqabbel mal-grupp ta' PF, p = 0.0042 (PFS medjan: 11.4 kontra 8.3 xhur, rispettivament) b'tul ta' żmien sħiħ u medjan ta' osservazzjoni wara l-kura ta' 33.7 xhur.
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Maltese: Tqalligħ (G3/4: 0.6%); Stomatite (G3/4: 4.0%);
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari f'kanċer gastrikuk tat-tip adenokarċinoma għal Docetaxel 75 mg/m2 użat flimkien ma' cisplatin u 5-fluorouracil
English: Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Maltese: Docetaxel Teva 80 mg/2.88 ml konċentrat u solvent għal soluzzjoni 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: Fiż-żewġ dirgħajn, wara l-aħħar ċiklu ta' kimoterapija, pazjenti b'pazjenti ER+ u/jew PgR+ irċevew tamoxifen 20 mg darba kuljum għal sa 5 snin.
English: Data from one multi-centre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Maltese: III, u li sar b'mod każwali b'kontrolli, ssostni l-użu ta' docetaxel flimkien ma' capecitabine għat-trattament ta' pazjenti b'kanċer tas-sider avvanzat lokalment jew dak metastatiku, wara li falliet il-kimoterapija ċitotossika, inkluża anthracycline.
English: Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel.
Maltese: 72 ml fih 20 mg ta' docetaxel.
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'WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tat-trattament mingħajr għażla.
English: Febrile neutropenia (G3/4: NA)
Maltese: Newtropenija bid-deni *G3/4: NA)
English: • One vial of solvent
Maltese: • kunjett bis-solvent .
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: osservazzjoni (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: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Maltese: Meta jiżdied is-solvent kollu fil-kunjett ta'Docetaxel Teva 80 mg konċentrat għal soluzzjoni għall-infużjoni, is-soluzzjoni inizjali li tirriżulta tkun ta' 10 mg/ml docetaxel.
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Maltese: Deskirzzjoni ta' reazzjonijiet avversi partikulari f'kanċer gastrikuk tat-tip adenokarċinoma għal Docetaxel 75 mg/m2 użat flimkien ma' cisplatin u 5-fluorouracil
English: Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, Docetaxel Teva could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Maltese: Docetaxel Teva kien preskritt mit-tabib tiegħek għat-trattament tal-kanċer tas-sider, xi tipi speċjali ta' kanċer tal-pulmun (dak it-tip ta' kanċer tal-pulmun li mhux mikroċitoma), kanċer tal-prostata, kanċer tal-istonku jew kanċer tar-ras u tal-għonq:
English: Tumour size <2 cm >2 cm
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C
English: Scleroderma-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Maltese: B'docetaxel, ġew irrapportati tibdil li jixbah skleroderma, ħafna drabi wara limfoedima periferali.
English: With primary G-CSF prophylaxis
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM
English: Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Maltese: Docetaxel Teva flimkien ma' cisplatin u 5-fluorouracil huwa indikat fit-trattament ta' pazjenti li għandhom adenokarċinoma metastatika tal-istonku, li tinkludi l-adenokarċinoma tal-parti fejn listonku jingħaqad mal-esofagu, u li ma kinux ħadu l-kimoterapija qabel, għal mard metastatiku.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1,250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Maltese: Flimkien ma' capecitabine, id-doża rakkomandata ta' docetaxel hija 75 mg/m2 kull tliet ġimgħat, flimkien ma' capecitabine 1,250 mg/m2 darbtejn kuljum (fi żmien ta' 30 minuta wara l-ikel ) għal ġimagħatejn, segwit b'perijodu ta' waqfien għal ġimgħa.
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2%) in TAC arm and 35 patients (6.7%) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9%) in TAC arm and 30 patients (5.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, alopeċja li bdiet matul il-perijodu ta' trattament u li ppersistiet waqt il perjodu ta' osservazzjoni ġiet osservata li kienet baqgħet għaddejja f'49 pazjent (9.2 %) fil-fergħa ta' TAC u f'35 pazjent (6.7 %) fil-fergħa ta' FAC.
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Maltese: Ibbażat fuq tagħrif farmakokinetiku b'docetaxel f'doża ta' 100 mg/m2 meta mogħti waħdu, ilpazjenti li għandhom livelli għoljin tal-enżimi trasaminażi (ALT u/jew AST) aktar minn 1.5 drabi tal-ogħla livell tal-firxa normali (ULN) u l-livell tal-enzima alkaline phosphatase aktar minn 2.5 drabi tal-ULN, id-doża rakkomandata ta' docetaxel hija ta' 75 mg/m2 (ara sezzjonijiet 4.4 u 5.2).
English: Lethargy (G3/4: 4.0%);
Maltese: Letarġija (G3/4: 19.0%);
English: Neutropenia (G3/4:
Maltese: Sensittività eċessiva (G3/4:
English: Second primary malignancies
Maltese: Tumuri malinni primarji sussegwenti
English: In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805 in-newropatija periferika tas-sensazzjoni li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjonif'10 pazjenti (1.9%) fil-fergħa TAC u f'4
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: 3-4 = G3/4; grad 4 = G4), it-terminoloġija COSTART u l-MedDRA.
English: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4:
Maltese: Newtropenija (G3/4: 83.2%); Tromboċitopenija (G3/4: 8.8%); Newtropenija bid-deni
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4%) in FAC arm. At the end of the follow-up period lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-edima periferika li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjoni f'4 pazjenti (0.8 %) fil-fergħa TAC u f'2 pazjenti (0.4 %)