FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Maltese: It-total ta' 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/m2 li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/m2 bħala infużjoni tul ta' 3 sigħat.
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
Maltese: • Ir-rata totali tar-rispons (RTTR) kienet b'mod sinifikattiv ogħla fil-parti tal-istudju dwar AT kontra l-parti tal-istudju dwar AC, p = 0.009.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 6 (dated January 2010) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: kif deskritta f'verżjoni 6 bid-data ta Jannar 2010, ippreżentat f'Modulu 1.8.1. ta' l-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq, tkun fis-seħħ u implimentata qabel u waqt li l-prodott ikun tqiegħed fis-suq.
English: Constipation (G3/4: 0.5%)
Maltese: Vasodilatazzjoni (G3/4:0.5%)
English: Infection (G3/4: 5%)
Maltese: Infezzjonijiet (G3/4: 5%)
English: Neutropenia G3/4: Anaemia (G3/4:
Maltese: odinofaġja (G3/4: Stitikezza (G3/4:
English: Pyrexia (G3/4: 1%);
Maltese: Tqalligħ (G3/4: 4%);
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% talpazjenti li rċevew it-TAC u lill-51.2% tal-pazjenti li rċevew il-FAC.
English: In particular, tell your doctor if you are using medicines containing any of the following active substances: - ritonavir and other protease inhibitors, used to treat HIV infection/AIDS - ketoconazole and itraconazole, used to treat fungal infections - ciclosporin, used to suppress your immune system (e.g. after transplants) - erythromycin, antibiotic used for bacterial infections
Maltese: - ketoconazole u itraconazole, li jintużaw biex jikkuraw infezzjonijiet bil-fungi - ciclosporin, li jintuża biex irażżan is-sistema immuni tiegħek (eż. wara t-trapjanti) - erythromycin, antibijotiku li jintuża għal infezzjonijiet bil-batterji
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Maltese: Majalġja (G3/4: Artralġja (G3/4: 0.2%)
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Maltese: Għall-kura induttiva ta' karċinoma inoperabbli taċ-ċelluli skwamużi lokalment avanzat, fir-ras u fl-għonq (SCCHN), id-doża rrakomandata ta' docetaxel hi 75 mg/m2 bħala infużjoni ta' siegħa, segwita minn cisplatin 75 mg/m2 fuq medda ta' siegħa, fl-ewwel jum, segwita minn 5-fluorouracil bħala infużjoni kontinwa ta' 750 mg/m2 kuljum għal ħamest ijiem.
English: Docetaxel 100 mg/m² in combination with trastuzumab: MedDRA system organ classes
Maltese: Docetaxel 100 mg/m2 użat flimkien ma' trastuzumab:
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Maltese: 5-fluorouracil għall-kura ta' pazjenti b'adenokarċinoma tal-istonku, l-istudju importanti ħafna eskluda pazjenti b'ALT u/jew AST > 1.5 x ULN, assoċjat ma' alkaline phosphatase ta' > 2.5 x ULN, u bilirubina > 1 x ULN; għal dawn il-pazjenti, tnaqqis fid-dożi ma jistgħux ikunu rrakomandata u docetaxel m'għandux jintuża, sakemm hu strettament indikat.
English: • The solvent vial for Docefrez 80 mg is a 5 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm brown flip-off aluminium seal.
Maltese: • Il-kunjett bis-solvent għal Docefrez 80 mg hu kunjett tubulari ta' 5 ml magħmul minn ħġieġ bla kulur ta' tip 1 b'tapp griż tal-lastku tal-bromobutyl ta' 20 mm issi ġillat b'siġill blu skur tal-aluminju ta tat-tip flip-off.
English: • one single-dose powder vial with 80 mg docetaxel (plus 18% overfill: 94.4 mg) and
Maltese: • kunjett wieħed bit-trab għal doża waħda b'80 mg ta' docetaxel (flimkien ma' 18% overfill: 94.4 mg),
English: Stomatitis/Pharyngitis (G3/4:
Maltese: Tromboċitopenija (G3/4:
English: In the pivotal SCCHN studies, patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g. day 6-15) in all subsequent cycles.
Maltese: Fl-istudji importanti ħafna SCCHN, il-pazjenti li kellhom newtropenija b'kumplikazzjonijiet (li jinkludu newtropenija fit-tul, newtropenija bid-deni, jew infezzjoni), kien irakkomandat l-użu ta' G-CSF biex jipprovdi protezzjoni profilattika (eż. is-6 jum sal-15) fiċ-ċikli kollha sussegwenti.
English: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Maltese: Il-kura għandha titwaqqaf jekk dawn l-effetti tossiċi jippersistu (ara sezzjoni 4.4).
English: Docetaxel 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 flimkien ma' cisplatin u 5-fluorouracil hu indikat għall-kura ta' pazjenti li għandhom adenokarċinoma metastatika tal-istonku, inkluż adenokarċinoma tal-parti fejn l-istonku jingħaqad mal-esofagu, u li ma kinux ħadu l-kimoterapija qabel għal mard metastatiku.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade3-4 = G3/4; grade 4 = G4) and the COSTART terms and the MedDRA terms.
Maltese: = G3/4; grad 4 = G4),il-COSTART u t-termini MedDRA.
English: For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs.
Maltese: Pereżempju, doża ta' 140 mg ta' docetaxel ikollha bżonn pakkett wieħed ta' 80 mg u tliet pakketti ta'
English: In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT,
Maltese: F'numru żgħir ta' pazjenti (n = 23) li kellhom data bijokimiku kliniku suġġestiv ta' indebolimenttal-fwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 darbiet tal-OLN assoċjat ma'
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI
English: Elderly
Maltese: Totali
English: Fluid retention is cumulative in incidence and severity (see section 4.4).
Maltese: Iż-żamma tal-fluwidu tista' tkun kumulattiva fl-inċidenza u s-severità (ara sezzjoni 4.4).
English: Diarrhoea (G3/4:
Maltese: Stomatite (G3/4:
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, il-pazjenti li għandhom livelli għoljin tal-enżimi transaminażi (ALT u/jew AST) aktar minn 1.5 darbiet tal-ogħla livell tal-firxa normali (ULN) u l-livell tal-enzima alkaline phosphatase aktar minn 2.5 darbiet tal-ULN, id-doża rrakkomandata ta' docetaxel hi 75 mg/m2 (ara sezzjonijiet 4.4 u 5.2).
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance 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 avanzat u b'performance status ta' WHO ta' 0 jew 1, intgħażlu b'mod każwali f'wieħed minn żewġ partijiet tal-istudju dwar il-kura.
English: Alopecia; Erythema; Rash; Nail disorders
Maltese: • nefħa fl-idejn, saqajn jew riġlejn
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Maltese: • Docetaxel 30 mg/m2 li ngħata kull ġimgħa, għall-ewwel 5 ġimgħat, f'ċiklitwil ta' 6 ġimghat, mogħti għal 5 ċikli.
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 avanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tal-kura mingħajr għażla.
English: Nausea (G3/4: 3.3%);
Maltese: Għeja (G3/4: 3.9%);
English: White lyophilised powder.
Maltese: -kura bil-kimoterapija
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hi 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: 5 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with brown colour flip-off with aluminium seal.
Maltese: Kunjett ta' 5 ml ta' ħġieġ ta' tip I, bla kulur, b'tapp tal-lastku griż tal-bromobutyl, u ssiġillat b'siġill tal-aluminju ta' kulur aħdar skur tat-tip flip-off. Kunjett bis-solvent:
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Maltese: anoreksja u edema periferali li seħħew b'rati ≥ 10% ogħla fil-pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
English: Febrile neutropenia
Maltese: Newtropenija kkomplikata
English: Nausea (G3/4: 9.6%);
Maltese: Tqalligħ (G3/4: 9.6%);
English: Median duration of response to chemotherapy ± radiotherapy (months) (95%CI)
Maltese: Tul medjan ta' sopravivenza mingħajr it-tumur javvanza(xhur) (95%CI)
English: Pre-Menopausal
Maltese: Il-popolazzjoni
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 affettwata r-rata totali tar-riżultati u l-punt ewlieni tal-waqfien (32% kontra 25%, p = 0.10), docetaxel tawwal iż-żmien medjan għall-avvanz (24.6 ġimgħat kontra 15.6 ġimgħat;
English: Lacrimation increased Conjunctivitis
Maltese: Effetti mhux mixtieqa mhux komuni
English: Data from one multicenter, randomised, controlled phase III clinical studysupport 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 għall-kura ta' pazjenti b'kanċer tas-sider avanzat lokalment jew metastatiku, wara li ma tkunx irnexxiet il-kimoterapija ċitotossika, inkluża anthracycline.
English: 1 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with dark blue flip-off with aluminium seal.
Maltese: Kunjett ta' 1 ml ta' ħġieġ ta' tip I, bla kulur, b'tapp tal-lastku griż tal-bromobutyl, u ssiġillat b'siġill tal-aluminju ta' kulur blu skur tat-tip flip-off
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Maltese: tal-istudju hi magħmula minn pazjenti b'marda li teknikament ma tistax titneħħa, minn pazjenti bi probabilita baxxa ta' kura kirurġika u minn pazjenti bi skop ta' preservazzjoni tal-organi.
English: Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Maltese: In-newtropenija hi l-aktar reazzjoni avversa u komuni ta' docetaxel.
English: 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: Pazjenti b'kanċer operabbli fis-sider li ma nfirixx fil-glandoli limfatiċi tas-sider u li huma eliġibbli biex jirċievu l-kimoterapija (GEICAM 9805).
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 kkurati b'docetaxel.
English: Hazard ratio (95%CI) *p-value
Maltese: Il-proporzjon tar-riskju (95%CI) *p-value
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Maltese: Dijarea (G3/4: 19.7%); Tqalligħ (G3/4: 16%); Stomatite (G3/4:
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4: 0.6%)
Maltese: Dispepsja; Emorraġija gastrointestinali (G3/4:0.6%)
English: Previous chemotherapy should have included an anthracycline or an alkylating agent.
Maltese: It-terapija preċedenti kellha tinkludi xi anthracycline jew xi sustanza alkylating.
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 l-avvanz (PFS), kien b'mod sinifikattiv itwal fil-parti tal-istudju dwar 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: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Maltese: Il-kumplikazzjonijiet primarji u antiċipati ta' doża eċċessiva jikkonsistu fi trażżin tal-mudullun tal-għadam, newrotossiċità periferali u infjammazjoni tal-mukoża.
English: Side effects may occur with certain frequencies, which are defined as follows: - very common: affects more than 1 user in 10 - common: affects 1 to 10 users in 100 - uncommon: affects 1 to 10 users in 1,000 - rare: affects 1 to 10 users in 10,000 - very rare: affects less than 1 user in 10,000 - not known: frequency cannot be estimated from the available data.
Maltese: - rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10,000 - mhux magħruf: ma tistax tittieħed stima mid-data disponibbli.
English: Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm.
Maltese: Analiżi tal-gruppi meta wieħed jikkonsidra l-età, is-sess u r-razza tiffavorixxi konsistentement il-parti tal-istudju dwar TCF meta mqabbla mal-parti tal-istudju dwar CF.
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 kkurati b'docetaxel, doxorubicin u cyclophosphamide (TAC), ir-riskju li jiżviluppaw myelodysplasia jew lewkimija tat-tip myeloid, fit-tard, jirrikjedi l-immonitorjar ematoloġiku wara l-kura.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Maltese: sigħat, segwita minn 5-fluorouracil 1000 mg/m kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
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 waqt l-użu tas-soluzzjoni tat-taħlita bil-lest intweriet għal 8 sigħat meta tinħażen f'temperatura jew ta' bejn 2°C u 8°C jew fit-temperatura tal-kamra (taħt 25°C).
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
Maltese: Għal kanċer tal-prostata, il-premedikazzjoni hi t-teħid orali ta' dexamethasone ta' 8 mg, 12-il siegħa, 3
English: • The Docefrez 20 mg vial contains a white to off white lyophilised powder in a 5 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with dark green flip-off aluminium seal.
Maltese: Docetaxel instab li hu ċitotossiku in vitro għal-linji ċellulari ta' tumuri li huma derivati mill-ġrieden u l-bniedem, u kontra ċelluli umani meħudin minn tumuri hekk kif dawn ikunu tneħħew, fi studji klonoġeniċi fil-laboratorju.
English: Hazard ratio (95%CI) **p-value
Maltese: Il-proporzjon tar-riskju (95%CI) **p-value
English: The overfill ensures that after dilution with the entire extractable volume of the accompanying solvent vial for Docefrez, there is a minimal extractable reconstituted solution of 0.84 ml containing 20 mg docetaxel (anhydrous).
Maltese: L-overfill jiżgura li wara d-dilwizzjoni bil-volum kollu li jista' jin ġibed mill-kunjett bis-solvent li jkun miegħu għal Docefrez, ikun hemm soluzzjoni minima rrikostitwita li tista' tinġibed ta' 0.84 ml li jkun fiha 20 mg ta' docetaxel (anhydrous).
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Maltese: Għall modifikazzjonijiet fid-dożi ta' cisplatin u 5-fluorouracil, ara s-Sommarju tal-Karatteristiċi tal-Prodott speċifiku.
English: Docefrez 20 mg powder and solvent for concentrate for solution for infusion Docetaxel
Maltese: Docefrez 20 mg trab u solvent għal konċentrat għal soluzzjoni għall-infużjoni:
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Maltese: Il-bidu taż-żamma moderat u sever ittardja (doża kumulattiva medjana: 818.9 mg/m2) f'pazjenti li ħadu l-premedikazzjoni, meta mqabbel ma' dawk li ma ħadux il-premedikazzjoni (doża kumulattiva medjana: 489.7 mg/m2).
English: CLINICAL PARTICULARS
Maltese: KLASSIFIKA ĠENERALI
English: Docetaxel 75 mg/m² in combination with cisplatin: MedDRA system organ classes
Maltese: Docetaxel 75 mg/m2 użat flimkien ma' cisplatin:
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 kkurati b'docetaxel flimkien ma' cisplatin u 5-fluorouracil (TCF), in-newtropenija bid-deni jew in-newtropenija assoċjata ma' infezzjoni seħħew f'rati aktar baxxi f'pazjenti li ngħataw il-profilassi b'G-CSF.
English: • The Docefrez 80 mg vial contains a white to off white lyophilised powder in a 15 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with red flip-off aluminium seal.
Maltese: • Il-kunjett b'Docefrez 80 mg fih trab lajofilizzat ta' lewn minn abjad sa abjad jagħti fil-griż f'kunjett tubulari ta' 15 ml magħmul minn ħġieġ bla kulur b'tapp griż tal-lastku ta' 20 mm u ssiġillat b'siġill flip-off aħmar tal-aluminju.
English: Hazard ratio: (95% CI) **p-value
Maltese: bil-kimoterapija (%) (95%CI) ***p-value
English: Nausea (G3/4: 5.0%);
Maltese: Letarġija (G3/4: 4.0%);
English: Hypotension (G3/4: 0%); Phlebitis (G3/4: 0%)
Maltese: Żieda fil-piż (G3/4: 0 %); Tnaqqis fil-piż (G3/4:
English: Neutropenic infection; Infection (G3/4: 11.7%)
Maltese: Infezzjoni (G3/4: 11.7%).
English: Cardiac disorders Rare cases of myocardial infarction have been reported.
Maltese: Każijiet rari ta' infart mijokardijaku kienu rrappurtati.
English: Diarrhoea (G3/4: 1.2%);
Maltese: (G3/4: 1.2%);
English: Constipation (G3/4:
Maltese: Disgewżja (G3/4:
English: Nausea (G3/4: 0.6%);
Maltese: Arritmija (G3/4: 0.2%);
English: Adjusted Hazard ratio (95%CI) *p-value
Maltese: Il-proporzjon tar-riskju (95% CI) *p-value
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and
Maltese: Il-profil kinetiku ta' docetaxel hu indipendenti mid-doża użata u hu konsistenti ma' mudell farmakokinetiku bi tliet oqsma, biż-żmien kemm idum biex jonqos bin-nofs fil-livell tad-demm għall-fażijiet α β, u γ hu ta' 4 minuti, 36 minuta u 11.1 sigħat, rispettivament.
English: Haemorrhage
Maltese: Lewkimja
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or below 25°C and for the final solution for infusion for 4 hours at room temperature.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita ntweriet għal 8 sigħat meta tinħażen f'temperatura jew ta' bejn 2°C u 8°C jew taħt 25°C, u għas-soluzzjoni finali għall-infużjoni għal 4 sigħat fit-temperatura tal-kamra.
English: Hypotension
Maltese: Tossiċità
English: Adjusted hazard ratio
Maltese: Sopravivenza mingħajr mard
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-kumpartament famakokinetiku ta' Docetaxel.
English: Peripheral sensory neuropathy (G3: 0.4%)
Maltese: Newropatija periferali tas-sensazzjoni (G3/4:0.6%)
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system Very common
Maltese: • Kimoterapija Induttiva segwita bir-radjuterapija (TAX
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion: Powder vial: Docefrez is a white lyophilised powder, supplied in a colourless glass vial with a grey non-latex rubber stopper and a red aluminium seal.
Maltese: Madwar 80% tar-radjuattività irkuprata fl-ippurgar titneħħa waqt l-ewwel 48 siegħa bħala prodott metaboliku inattiv, wieħed ewlieni u tliet prodotti oħra inattivi u minuri, kif ukoll ammonti żgħar ħafna tal-prodotti mediċinali mhux mibdula.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 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 rrakomandata ta' docetaxel hi 75 mg/m kull tliet ġimgħat, flimkien ma' capecitabine 1250 mg/m2 darbtejn kuljum (fi żmien 30 minuta wara l-ikel) għal ġimagħtejn, segwit b'perijodu ta' waqfien ta' ġimgħa.
English: Best overall response (CR + PR) to chemotherapy
Maltese: L-aħjar rizultat sħiħ (CR + PR)
English: Constipation (severe Abdominal pain (severe Gastrointestinal haemorrhage (severe
Maltese: Newtropenija bid-deni (tinkludi n-newtropenija assoċjata mad-deni u l-użu tal-antibijotiċi) jew newtropenija bis-sepsis
English: For example, a dose of 140 mg docetaxel would require one 80 mg and three 20 mg packs.
Maltese: Pereżempju, doża ta' 140 mg docetaxel tkun teħtieġ pakkett wieħed ta' 80 mg u tliet pakketti ta' 20 mg.
English: What Docefrez looks like and contents of the pack
Maltese: Id-dehra ta' Docefrez u l-kontenuti tal-pakkett