FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Maltese: Minn 333 pazjent ittrattati b'docetaxel kull tliet ġimgħat fi studju fuq il-kanċer tal-prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 20 mg
Maltese: Solvent għal Docetaxel Teva Pharma 20 mg
English: In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy.
Maltese: Fl-istudju GEICAM 9805, limfoedema ġiet osservata f'4 mill-5 pazjenti b'limfoedema fi tmiem il kimoterapija.
English: Each box contains one Docetaxel Teva Pharma vial (20 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Maltese: Kull kaxxa fiha kunjett wieħed ta' Docetaxel Teva Pharma (20 mg) u kunjett wieħed ta' solvent korrispondenti għal Docetaxel Teva Pharma, f'kartuna.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
Maltese: Fl-istudju TAX 316, alopeċja li kienet għadha hemm ppersistiet matul il-perijodu ta' osservazzjoni ta' wara t-trattament fit-tmiem tal-kimoterapija ġiet irrappurtata f'687 pazjent fuq TAC u 645 pazjent fuq FAC.
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Maltese: Injetta l-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' Docetaxel Teva Pharma.
English: Arrhythmia (G3/4: 0.7%)
Maltese: Arritmija (G3/4:0.7%)
English: The binding of docetaxel to microtubules does not alter the number of protofilaments.
Maltese: Ir-rabta ta' docetaxel mal-mikrotubuli ma jibdilx in-numru talprotofilamenti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 80 mg
Maltese: Solvent għal Docetaxel Teva Pharma 80 mg
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Maltese: 13.5% tal-pazjenti, u dan irrispettiv jekk intużax G-CSF.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg
Maltese: TIKKETTA TAL-KUNJETT - KONĊENTRAT 20 mg
English: Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4:0.6%); Uġigħ addominali;
English: Ischemia myocardial
Maltese: TWISSIJA/IET SPEĊJALI
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.
Maltese: 1% (w/w) t'ethanol anidru.
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Maltese: Madankollu, l-istabbiltà kimika u fiżika tas-soluzzjoni inizjali ntweriet li ddum għal 8 sigħat meta tkun maħzuna bejn 2°Ċ u 8°Ċ jew f'temperatura ambjentali (taħt 25°Ċ).
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: Il-pazjenti trattati b'TCF għandhom jingħataw il-profilassi b'G-CSF biex jonqos ir-riskju tan-newtropenija komplikata (newtropenija bid-deni, newtropenija fit-tul jew innewtropenija assoċjata ma' infezzjoni).
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Maltese: Qtugħ ta' nifs (G3/4: 1%); Sogħla (G3/4: < 1%);
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Maltese: Il-komportament farmakokinetinu ta' Docetaxel fil-preżenza ta' prednisone kien studjat f'pazjenti b'kanċer metastatiku tal-prostata.
English: • swelling of the hands, feet, legs
Maltese: • nefħa tal-idejn, saqajn u riġlejn
English: Anaemia (G3/4: 9.2%); Thrombocytopenia
Maltese: Tromboċitopenija (G3/4: 0.6%); Newtropenija bid-deni
English: Arrhythmia (G3/4: 0.6%)
Maltese: Arritmija (G3/4: 0.6%)
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Maltese: • taqlib tal-istonku inklużi t-tqalligħ, rimettar u d-Dijarea, stitikezza
English: Lymphoedema (G3/4: 0%)
Maltese: Edima limfatika (G3/4:0%)
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/m 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.
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-programm 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: 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: It-tabella t'hawn isfel turi li l-inċidenza ta' newtropenija ta' grupp 4, newtropenija bid-deni u infezzjoni newtropenika tnaqqset f'pazjenti li rċevew profilassi primarja ta' G-CSF wara li din saret obbligatorja fid-driegħ ta' TAC - studju GEICAM.
English: Myalgia (severe: 0.5%)
Maltese: Majalġja (severa: 1.4%)
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART and the MedRA terms.
Maltese: 3-4 = G3/4; grad 4 = G4) u t-terminoloġija COSTART u ta' MedDRA.
English: 75 to 60 mg/m².
Maltese: 175 mg/m bħala infużjoni tul ta' 3 sigħat.
English: For breast and non-small cell lung cancer, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Maltese: b'corticosteroid orali bħal dexamethasone 16 mg kuljum (e.g. 8 mg BID) għal 3 ijiem, mibdija jum 1 qabel it-teħid ta' docetaxel, sakemm mhux kontraindikat, tista' tintuża (ara sezzjoni 4.4).
English: Each vial of concentrate contains 20 mg of docetaxel.
Maltese: Kull kunjett ta' konċentrat ta' fih 20 mg ta' docetaxel.
English: For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Maltese: Ghall-pazjenti li jiżviluppaw newtropenija komplikata (newtropenija fit-tul, newtropenija bid-deni jew b'infezzjoni), għandhom jitqiesu l-użu ta' G-CSF u t-tnaqqis fid-doża (ara sezzjoni 4.2).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Maltese: Lewkimja akuta/sindromu majelodisplastiku Wara 10 snin ta' osservazzjoni ta' wara t-trattament fl-istudju TAX316, il-lewkimja akuta ġiet irrappurtata f'4 minn 744 pazjent fuq TAC u f'1 minn 736 pazjent fuq FAC.
English: Each vial of concentrate contains 80 mg of docetaxel.
Maltese: Kull kunjett ta' konċentrat ta' fih 80 mg ta' docetaxel.
English: General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Maltese: il pazjent minn 119-il pazjent b'edema periferali fil-fergħa tat-TAC u f'4 pazjenti minn 23 pazjent bl edima periferika fil-fergħa tal-FAC.
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4: 1.2%);
Maltese: Tqalligħ (G3/4: 6%); Rimettar (G3/4: 4%); Stitikezza (G3/4: 1%);
English: Peripheral motor neuropathy (G3/4: 0%)
Maltese: Newropatija periferika tal-movimenti (G3/4: 0%)
English: Neutropenic infection (G3/4: 2.6%)
Maltese: 2.4 %); Infezzjoni newropenika (G3/4: 2.6%)
English: Weight decreased; G3/4 Blood bilirubin increased
Maltese: Tnaqqis fil-piż; G3/4 Bilirubin fid-demm ogħla
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' 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: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Maltese: F'pazjenti ittrattati b'docetaxel flimkien ma' cisplatin u 5-fluorouracil (TCF), in-newtropenija biddeni jew in-newtropenija assoċjata ma' infezzjoni ġraw f'rati aktar baxxi f'pazjenti li ngħataw ilprofilassi bil-G-CSF.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Maltese: Letarġija (G3/4:3.4%); Deni (G3/4:0.6%); Żamm tal-fluwidu; Edima
English: Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)
Maltese: Deni (G3/4: NA); Edima periferika (G3/4:
English: Infusion site reaction
Maltese: • Soluzzjoni għall-infuzjoni:
English: Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
Maltese: Deni; Għejja; Infjammazzjoni tal-mukoża; Uġigħ;
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: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: Neoplażmi bennini, malinni u mhux speċifiċi (li jinkludu ċisti u polipi)
English: Febrile neutropenia (G3/4: NA)
Maltese: Amenorreja (G3/4: NA)
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20 mg 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 Pharma 20 mg konċentrat għal soluzzjoni għall-infużjoni, is-soluzzjoni inizjali li tirriżulta tkun ta' 10 mg/ml docetaxel.
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/m segwit immedjatament b'cisplatin 75 mg/m fuq perjodu ta' bejn 30 u 60 minuta.
English: • One vial of solvent
Maltese: • kunjett bis-solvent.
English: Cases of persisting alopecia have been reported.
Maltese: Ġew irrappurtati każijiet ta' alopeċja persistenti.
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 f'kanċer tar-ras u tal-għaonq għal Docetaxel 75 mg/m² użat flimkien ma' cisplatin and 5-fluorouracil
English: In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Maltese: F'pazjenti kkurati b'docetaxel flimkien ma' doxorubicin u cyclophosphamide (TAC) innewtropenija bid-deni u/jew infezzjoni newtropenika seħħew f'rati aktar baxxi meta pazjenti rċevew profilassi primarja b'G-CSF.
English: Hypersensitivity (G3/4: 0.6%)
Maltese: Sensittivita eċċessiva (G3/4: 0.6%)
English: Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%);
Maltese: Newtropenija (G4:54.2%) Anemija (G3/4: 10.
English: b) Preparation of the infusion solution
Maltese: b) Preparazzjoni ta' soluzzjoni għall-infużjoni
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Maltese: • Docetaxel 30 mg/m li ngħata kull ġimgħa, ghall-ewwel 5 ġimgħat, f'ċiklitwil ta' 6 ġimghat,
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: interstizjali tal-pulmun, pulmonite ta' l-interstizjum u fibrożi tal-pulmuni u insuffiċjenza respiratorja ,, xi kultant fatali, kienu rarament irrapportati.
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4: 1.0%);
Maltese: Ugigħ gastro-intestinali (G3/4: 1.2%); Emoraġija gastrointestinali (G3/4:
English: G3/4 Blood bilirubin increased
Maltese: G3/4 Bilirubin fid-demm ogħla
English: Pyrexia (G3/4: 1%);
Maltese: Deni (G3/4: 1%);
English: Neurotoxicity(G3/4: 0%); Somnolence (G3/4: 0%)
Maltese: Newrotossiċità (G3/4: 0%) Ħedla (G3/4: 0%)
English: Docetaxel Teva Pharma 80 mg concentrate and solvent for solution for infusion docetaxel
Maltese: Docetaxel Teva Pharma 80 mg konċentrat u solvent għal soluzzjoni għall-infużjoni docetaxel
English: (G3/4: 2.4%);
Maltese: Dijarea (G3/4:2.9%);
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: 3) kien ta' 7 ijiem), anemija, alopeċja, tqalligħ, rimettar, stomatite, dijarea u astenja.
English: Alopecia; Erythema; Rash; Nail disorders
Maltese: Mard bħall-influwenza; Uġigħ fis-sider; Riħ
English: Oesophagitis (severe: 0.4%)
Maltese: Mard tad-dwiefer (sever: 0.8%)
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Maltese: Tqalligħ (G3/4:0.6%); Stomatite (G3/4:4.0%);
English: Anaemia (G3/4: 3%); Neutropenia (G3/4: 59.2%);
Maltese: Newtropenija (G4: 51.5%); Anemija (G3/4: 6.9%);
English: Nausea (G3/4: 4%);
Maltese: Anemija (G3/4: 3%);
English: • The solvent for Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Maltese: • Is-solvent għal Docetaxel 20 mg huwa f'kunjett tal-ħġieġ ċar ta' 6 ml u li għandu tapp tal-lastku tal-bromobutyl b'għatu li jinqala' bis-saba'.
English: Solvent for Docetaxel Teva Pharma 20 mg vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Maltese: Kunjett ta' Docetaxel Teva Pharma 20 mg Kunjett ta' 6 ml magħmul minn ħġieġ ċar tat-Tip I u li għandu tapp tal-lastku tal-bromobutyl u
English: Docetaxel Teva Pharma has been prescribed by your doctor for the treatment of advanced breast cancer, special forms of lung cancer (non-small cell lung cancer) and prostate cancer: - For the treatment of advanced breast cancer, Docetaxel Teva Pharma could be administered alone.
Maltese: Docetaxel Teva Pharma 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 talprostata, kanċer tal-istonku jew kanċer tar-ras u tal-għonq:
English: Skin exfoliative (G3/4:0.6%)
Maltese: Ġilda esfoljattiva (G3/4:0.6%)
English: Metabolism and nutrition disorders Nervous system disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Maltese: Dispepsja (G3/4: 0.8%);
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 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Maltese: Din iż-żieda fil-volum tiżgura li, wara li ssir it-taħlita tal-kontenut kollu tal-kunjett tas-solvent mal-kontenut tal-kunjett ta'docetaxel, ikun hemm ammont minimu li jista' jittella' ta' 2 ml, li għandu 10 mg/ml docetaxel, li jikkorrispondi għall-ammont indikat fuq it-tabella ta' 20 mg kull fjala.
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
Maltese: Pressjoni baxxa (G3/4: 0%); Flebite (G3/4: 0%);
English: Thrombocytopenia (G4: 1.7%)
Maltese: 8%) Trombocitopenija (G4:1.7%)
English: Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Maltese: Newropatija sensorjali periferika kienet osservata li baqgħet għadejja waqt il-follow-up f'10 pazjenti mill-84 pazjent b'newropatija sensorjali periferika fi tmiem il-kimoterapija fl-istudju talkanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX316).
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Maltese: • l-enżimi għoljin tal-fwied (għalhekk, meħtieġa t-testijiet regolari tad-demm)
English: The most commonly reported adverse reactions of Docetaxel Teva Pharma alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Maltese: Ir-reazzjonijiet avversi l-aktar komunement irrapportati ta' Docetaxel Teva Pharma waħdu huma: tnaqqis fl-għadd taċ-ċelluli ħomor jew bojod tad-demm, allopeċja, tqalligħ, rimettar, selħiet tal-ħalq, Dijarea u għeja.
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Maltese: III, t'għamla komparattiva u magħżula b'mod każwali, li kienu jinvolvu total ta' 326 individwu ttrattati b'sustanzi alkylating u 392 oħra li kienu ttrattati b'anthracycline, b'falliment tal-kura fiż-żewġ gruppi u li t-tnejn kellhom kanċer tas-sider metastatiku li ngħataw docetaxel f'doża u tul ta' żmien irrakkomandati, ta'100 mg/m kull 3 ġimgħat.
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 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: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Maltese: Fi studji mhux kliniċi, decetaxel għandu effetti ġenotossiċi u jista' jibdel il-fertilità tar-raġel (ara sezzjoni 5.3).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/662/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/662/001
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Maltese: Każijiet ta' lewkimja majelojdi akuta u sindromu majelodisplastiku ġew rapportati flimkien ma' docetaxel meta intuża flimkien ma' sustanzi kimoterapewtiċi u/jew radjuterapija.
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: Għalhekk, id-doża rakkomandata ta' docetaxel f'dawk ilpazjenti li għandhom livelli għolja fit-testijiet tal-funzjoni tal-fwied (LFTs) huwa 75 mg/m u l-LFTs irid jiġi meqjus fil-bidu u qabel kull ċiklu ta' trattament (arasezzjoni 4.2).
English: Rash erythematous (G3/4: <1%);
Maltese: Fġir l-imnieħer (G3/4: < 1%)
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Maltese: Ma kienx hemm effett statistikament sinifikanti ta' prednisone fuq il-komportament famakokinetiku ta' docetaxel.
English: For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Maltese: Għal kanċer tas-sider u dak tal-pulmun li mhux mikroċitoma, trid tingħata l-premedikazzjoni li tikkonsisti f'corticsteroid orali, bħal dexamethasone 16 mg kuljum (eż. 8 mg BID) għal 3 ijiem, mibdi jum qabel ma jingħata docetaxel, sakemm dan mhux kontraindikat.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Docetaxel 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 fil-kanċer tas-sider għat-terapija adjuvanti b'docetaxel 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tassider pożittivi għall-għoqda (TAX
English: Abdominal pain upper; Dry mouth
Maltese: Mard tad-dwiefer (mhux sever)
English: Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
Maltese: Sturdament (G3/4:2.0%) Newropatija periferika tal-movimenti (G3/4:
English: Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion docetaxel
Maltese: Docetaxel Teva Pharma 20 mg konċentrat u solvent għal soluzzjoni għall-infużjoni docetaxel
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Fġir l-imnieħer; Uġigh fil farinġi u l-larinġi; Farinġite tal-parti nażali; Qtugħ ta' Nifs; Sogħla; Tnixxija mill-imnieħer
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Maltese: Ilprofilassi b'G-CSF tista' tintuża biex tnaqqas ir-riskju ta' effetti tossiċi ematoloġiċi.
English: Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Maltese: Docetaxel Teva Pharma huwa indikat għat-trattament ta' pazjenti b'kanċer tal-pulmun lokalment avvanzat jew dak metastatiku mhux mikroċitoma wara falliment ta' kimoterapija ċitotossika li ngħatat qabel.
English: Do not shake.
Maltese: Nuqqas ta' smigħ
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 AST ogħla (0.5%); G3/4 Alkaline phosphatase fid-demm ogħla (0.3%)
English: Epistaxis (G3/4: 0%);
Maltese: Astenja (G3/4: 10%);
English: Description of selected 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/m użat flimkien ma' cisplatin u 5-fluorouracil
English: G3/4 Blood bilirubin increased (2.1%);
Maltese: G3/4 Bilirubin fid-demm ogħla (2.1%) G3/4
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: II), li ħadu docetaxel flimkien ma' cisplatin u 5-fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: Dyspepsia; Abdominal pain
Maltese: Uġigħ addominali
English: Neutropenia (G3/4: 76.3%);
Maltese: Dijarea (G3/4: 19.7%);
English: Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe 0.07%)
Maltese: Newropatija periferika tassensazzjoni (G3/4: 1.2%); Disgewzja (G3/4: 0%)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Maltese: Kanċer tal-prostata Id-doża rakkomandata ta' docetaxel hija 75 mg/m2.