FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 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: Lethargy; Pain
Maltese: Dijarea; Rimettar;
English: 7.8%); Diarrhoea (G3/4: 6.2%);
Maltese: Dijarea (G3/4: 6.2%);
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 ilFAC.
English: EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
Maltese: EU/1/15/1017/001 20 mg/1 ml kunjett x 1 kunjett
English: Ischemia myocardial
Maltese: Mard tad-dwiefer
English: Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized 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: 316) 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: EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
Maltese: EU/1/15/1017/002 80 mg/4 ml kunjett x 1 kunjett
English: Onycholysis (G3/4: 1%)
Maltese: Edima periferika (G3/4: 1%)
English: MedDRA System Organ classes
Maltese: Sistema tal-klassifika talorgani fid-database MedDRA
English: Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
Maltese: Fil-każ ta' tromboċitopenija ta' Grad 4 id-doża ta' docetaxel għandha titnaqqas minn 75 għal 60 mg/m2.
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7 % of the cycles).
Maltese: 3% tal-pazjenti (10.7% taċ-ċikli).
English: Tel: +34 91 490 99 00
Maltese: Pfizer GEP, S.L. Tel: +34 91 490 99 00
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hija probabbli stima baxxa għax docetaxel waħdu f'doża ta'100 mg/m2 hu magħruf li jġib in-newtropenija f'97% tal-pazjenti, 76% fi grad 4, meta ibbażata fuq in-nadir tal-għadd taċ-ċelluli fid-demm.
English: (G3/4: 0%)
Maltese: Ngħas (G3/4:0%)
English: Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Maltese: Kunjetti li fihom 20mg/1ml, 80mg/4ml, 120mg/6ml, 140mg/7ml jew 160mg/8ml huma disponibbli f'pakketti li fihom kunjett wieħed
English: Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Maltese: Taxespira flimkien ma' doxorubicin u cyclophosphamide huwa indikat għat-trattament miżjud f'pazjenti li għandhom:
English: Infections (G3/4: 5%)
Maltese: Infezzjonijiet (G3/4: 5%)
English: PC:
Maltese: p=
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
Maltese: Stitikezza (G3/4: 1.0 %); Ugigħ gastro-intestinali (G3/4:
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Maltese: Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + fluorouracil *Log-rank test mhux aġġustat
English: 0.8%); Gastrointestinal pain (G3/4: 1.2%);
Maltese: 8%) Trombocitopenija (G4:1.7%)
English: Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Maltese: Qtugħ ta' nifs (G3/4: 1%); Sogħla (G3/4: < 1%);
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
Maltese: L-amenorrea ġiet osservata li kienet għadha hemm fl-aħħar talperijodu ta' osservazzjoni ta' wara t-trattament (żmien medjan ta' osservazzjoni ta' 8 snin) f'121 pazjent minn 744 pazjent TAC (16.3 %) u f'86 pazjent FAC (11.7%).
English: Median OS was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Maltese: Is-sopravivenza totali u medjana kienet anke b'mod sinifikattiv itwal fil-każ tal-grupp TPF, meta mqabbel ma' dak tal-fergħa PF (OS medjan: 18.6 kontra 14.5 xhur, rispettivament), b'tnaqqis tar-riskju ta' mortalità b'28%, p = 0.0128.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Maltese: L-Effikaċja ta' docetaxel fit-trattament induttiv ta' pazjenti b'SCCHN inoperabbli u lokalment avvanzat (Analiżi bl-Iskop li Titratta)
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Maltese: Ir-riskju fit tnaqqis ta' l-avvanz kien ta' 32.1%, u kien assoċjat ma' TPP b'mod sinifikattiv itwal (p = 0.0004) favur il-fergħa TCF.
English: In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Maltese: Fil-pazjenti ittrattati b'docetaxel, doxorubicin u cyclophosphamide (TAC), ir-riskju li jiżviluppaw myelodysplasia jew lewkimija tat-tip myeloid, fit-tard, jirrikjedi l-immoniterjar ematoloġiku wara ttrattament.
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=3) li kellhom data bijokimiku kliniku suġġestiv ta' indeboliment tal-fwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi tal-OLN assoċjat ma' livelli tal-enzima alkaline phosphatase ≥ 2.5 drabi tal-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni
English: 3 -hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day
Maltese: fluorouracil (1000 mg/m2 kuljum għal 5 ijiem).
English: Pre-Menopausal
Maltese: Pressjoni baxxa
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: Mingħajr ma kienet effettwata r-rata totali tar-riżultati u l-punt ewlieni tal-waqfien (32% kontra 25%, p = 0.10), docetaxel tawwal iż-żmien medjan ghall-avvanz (24.6 ġimgħat kontra 15.6 ġimgħat;
English: Full analysis set (intent-to-treat)
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Taxespira 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'Taxespira 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: Lymphoedema (G3/4:
Maltese: Edema limfatika (G3/4:
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Maltese: Disgewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Maltese: L-inċidenza tan-newtropenija bid-deni/tan-newtropenija bis-sepsis kienet żdiedet ukoll f'pazjenti ttrattati b'Herceptin flimkien ma' docetaxel (23% kontra 17% għal pazjenti ttrattati b'docetaxel biss).
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal Docetaxel 100 mg/m 2 bħala sustanza użata waħedha
English: Dyspepsia (G3/4:
Maltese: Sturdament (G3/4:
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m2, segwit minn 5-fluorouracil (F) 750 mg/m2 kuljum bħala infużjoni kontinwa għal 5 ijiem.
English: Pfizer Polska Sp. z o.o.
Maltese: Pfizer PFE Finland Oy Puh/Tel:
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Maltese: G3/4 Alkaline phosphatase fiddemm ogħla (0.3%)
English: At the median follow-up time of 77 months, 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: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
Maltese: Sinkope (G3/4: 0%); Newrotossiċità (G3/4:
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 ilperjodu ta' osservazzjoni u ġie osservat li kienet baqgħet għaddejja f'49 pazjent (9.2 %) fil-fergħa ta' TAC u f'35 pazjent (6.7 %) fil-fergħa ta' FAC.
English: Data from one multicenter, 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, ta' studju kliniku, u li sar mingħajr għażla u li kien ikkontrollat, issostni 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: 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 pazjenti (0.8 %) fil-fergħa FAC.
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%);
Maltese: Fġir l-imnieħer (G3/4: 0%); Dispneja (G3/4: 0.6%);
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
Maltese: F'dan l-istudju, 358 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miżżewġ friegħi tat-trattament mingħajr għażla.
English: Ear and labyrinth disorders Cardiac disorders
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Disturbi fil-qalb
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Maltese: Dawn ġraw fi żmien sebgħat ijiem u l-ammont imneħħi fl-awrina u fl-ippurgar kienu ta' madwar 6% u 75% tar-radjuattività li ngħatat, rispettivament.
English: Taxespira in combination with platinum agents in chemotherapy-naïve patients 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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
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/m bħala infużjoni tul siegħa, segwita immedjatament b'cisplatin (Cis) 75 mg/m2 li ngħata fuq perjodu ta'
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Maltese: Newtropenija (G3/4: 63%); Anemija (G3/4: 10%)
English: Pack size:
Maltese: Pazjenti speċjali:
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Maltese: Disturbi ġenerali u kondizzjonijietta' mnejn jingħata Id-doża medjana kumulattiva għall-waqfien tat-trattament kienet aktar minn 1,000 mg/m2, u z-żmien medjan għar-riversibbilità taż-żamma tal-fluwidu kien ta' 16.4 ġimghat (medda minn 0 sa 42 ġimghat).
English: Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Maltese: Stomatite/mukożite ta' grad 4 L-ewwel episodju: waqqaf 5-FU biss, fil-korsijiet
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Maltese: Ġiet irrappurtata edima makulari ċistojde (CMO) f'pazjenti kkurati b'docetaxel.
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Maltese: Ilpazjenti li jkollhom newtropenija bid-deni u/jew infezzjoni newtropenika għandhom ikollhom id-doża ta' docetaxel imnaqqsa għal 60 mg/m2 f'kull ċiklu ieħor li jkun imiss (ara sezzjonijiet 4.4 u 4.8).
English: Constipation (G3/4: 1.0%);
Maltese: Dijarea (G3/4: 1.2%);
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: Każijiet rari ta' ileus u ostruzzjoni ta' l-intestin ġew irrapportati.
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Maltese: Stomatite (G3/4: 18%); Dijarea (G3/4: 14%);
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Maltese: Polysorbate 80 Ethanol (anhydrous) (ara l-fuljett għal aktar tagħrif)Citric acid monohydrate konċentrat għal soluzzjoni għall-infużjoni kunjett wieħed
English: Taxespira 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: Taxespira flimkien ma' cisplatin u 5-fluorouracil huwa indikat fit-trattament ta' pazjenti li għandhom adenokarċinoma metastatika ta' l-istonku, inkluż l-adenokarċinoma tal-parti fejn l-istonku jingħaqad ma' l-esofagu, u li ma kienux ħadu l-kimoterapija qabel, għal mard metastatiku.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%)patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Maltese: Wara 10 snin ta' osservazzjoni fl-istudju GEICAM 9805, lewkimja akuta seħħet f'pazjent 1 minn 532 pazjent (0.2 %) fil-fergħa TAC.
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-amenorrea li bdiet matul il-perijodu ta' trattament u li baqgħet tippersisti fil-perijodu ta' osservazzjoni ġiet osservata li kienet baqgħet għaddejja fi 18-il pazjent (3.4 %) filfergħa ta' TAC u f'5 pazjenti (1.0 %) fil-fergħa ta' FAC.
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: Fl-aħħar tal-perijodu ta' osservazzjoni (żmien medjan attwali ta' osservazzjoni ta' 8 snin), limfoedima kienet osservata li kienet għadha għaddejja f'6 pazjenti TAC (0.8%) u f'pazjent 1 (0.1%) fil-fergħa FAC.
English: Patients with renal impairment 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: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%)
Maltese: Newtropenija (G4:54.2%) Anemija (G3/4: 10.
English: Thrombocytopenia (G3/4:
Maltese: Uġigh tal-kanċer (G3/4:
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi fl-għajnejn Disturbi respiratorji, toraċiċi u medjastinali
English: Epistaxis (G3/4: 0%);
Maltese: Astenja (G3/4: 3%);
English: Frequency not known (cannot be estimated from available data):
Maltese: It-tieni episodju: imbagħad naqqas id-doża ta'
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Taxespira 100 mg/m 2 bħala sustanza użata waħedha
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Maltese: It-tul ta' ċiklu ta' trattament kien ta' 3 ġimgħat filfergħa TCF u 4 ġimgħat għal fergħa CF.
English: Lacrimation increased (G3/4: <0.1%)
Maltese: Żieda fid-dmugħ (G3/4: < 0.1%)
English: G3/4 Blood bilirubin increased (<2%)
Maltese: G3/4 Alkaline phosphatase fid-demm ogħla (<2.5%)
English: There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Maltese: Huwa limitat it-tagħrif disponibbli f'pazjenti li ghandhom >70 sena u li kienu fuq docetaxel flimkien ma' doxorubicin u cyclophosphamide.
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m immediately followed by cisplatin 75 mg/m over 30-60 minutes.
Maltese: F'pazjenti li qatt ma ħadu l-kimoterapija qabel u li qed jiġu ikkurati għall-kanċer tal-pulmun li mhux ta' ċelluli żgħar, is-sistema tad-dożi irrakkomandata hija docetaxel 75 mg/m2 segwit immedjatament b'cisplatin 75 mg/m 2 fuq perjodu ta' bejn 30 u 60 minuta.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Maltese: • Iż-żmien tal-progressjoni (ŻTP) kien sinifikament itwal fil-fergħa AT kontra l-fergħa AC, p = 0.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Maltese: • fibrożi tal-pulmuni (titrabba bħal qoxra u r-rita tal-pulmun tiħxien b'konsegwenza li jkun hemm qtugħ ta' nifs)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial.
Maltese: 120mg/6ml Dan il-prodott mediċinali fih 50 % (w/w) ethanol anhydrous (alkoħol), jiġifieri sa 2370 mg ethanol anhydrous għal kull kunjett ta' 6 mL.
English: Peripheral motor neuropathy (G3/4:
Maltese: Newropatija periferika tal-movimenti (G3/4:
English: Histological grade
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: • oesophagitis (inflammation of the gullet)
Maltese: Mard tad-dwiefer (mhux sever)
English: Maidenhead,
Maltese: Sturdament;
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized 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: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Maltese: Tqalligħ (G3/4: 9.6%); Rimettar (G3/4: 7.6%); Dijarea (G3/4: 6.4%);
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: Fil-qasam tal-istudji fejn Taxespira intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin
Maltese: Wara t-tqassim tal-pazjenti skont in-numru ta' 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
English: Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel 75 mg/m² użat flimkien ma' prednisone jew prednisolone:
English: Venous disorder (G3/4:
Maltese: Għejja/indeboliment (G3/4:
English: Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Maltese: Reazzjoni f'sit tal-injezzjoni ta' titqiba preċedenti (terġa' sseħħ reazzjoni f'sit ta' estravażjoni preċedenti wara l-għoti ta' docetaxel f'sit differenti) ġiet osservata f'sit ta' estravażjoni preċedenti (frekwenza mhux magħrufa).
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m
Maltese: • Għal dawk il-pazjenti li titfaċċalhom għat-tieni darba t-tossiċità ta' Grad 2, jew it-tossiċità ta' Grad 3 għall-ewwel darba, f'kwalunkwe ħin waqt iċ-ċiklu tat-trattament , ittardja it-trattament sakemm it-tossiċità tinżel għal Grad 0 sa 1, u mbagħad kompli t-trattament b'docetaxel 55 mg/m
English: Description of selected adverse reactions for adjuvant therapy with Taxespira 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'Docetaxel 75 mg/m2 użat flimkien ma' doxorubicin u cyclophospahmide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: Vial label
Maltese: Żieda fil-piż
English: In combination with cisplatin and 5-fluorouracil
Maltese: Meta jintuża flimkien ma' cisplatin u 5-fluorouracil: