FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall response rate (CR+PR) (%) p-value
Maltese: Ir-rata globali ta' rispons (CR+PR) (%) p-value
English: Taxespira contains ethanol (alcohol)
Maltese: Taxespira fih l-ethanol (l-alkoħol)
English: With primary G-CSF prophylaxis (n = 421) n (%)
Maltese: Bi profilassi primarja b'G-CSF (n = 421) n (%)
English: Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Maltese: Stratified log rank test *Threshold for statistical significance=0.
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Maltese: Mingħajr profilassi primarja b'G-CSF (n = 111) n (%)
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Maltese: Ġew irrapportati o kkorrenzi rari ta' deidrazzjoni bħala konsegwenza ta' ġrajjiet gastrointestinali, inkluż enterokolite u perforament gastro-intestinali.
English: • heart failure
Maltese: • Falliment kardijaku
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in
Maltese: Ir-RTTR kienet 59.3% (95% CI: 52.8 - 65.9) fil-fergħa AT versu 46.5% (95%
English: Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Maltese: Il-pazjenti għandhom jiġu mħarsa mill-viċin għal manifestazzjonijiet bikrija ta' tossiċità gastrointestinali serja (ara sezzjonijiet 4.2, 4.4 Ematoloġija u 4.8).
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3.
English: In the case of severe neutropenia (<500 cells/mm
Maltese: F'każi ta' newtropenija severa (< 500 ċelluli/mm
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Maltese: 28 Awissu 2015
English: Consideration should be given to possible effects on the central nervous system.
Maltese: Wieħed għandu jikkonsidra l-effetti possibbli fuq is-sistema nervuża ċentrali.
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: Dawn ir-reazzjonijiet kienu deskritti bl-użu ta' NCI Kriterji ta' Tossiċità Komuni (grad 3 = G3; grad 3-4 = G3/4; grad 4=G4) ,il-COSTART u t-termini MedDRA.
English: Docetaxel is highly protein bound (>95%).
Maltese: Docetaxel huwa marbut sew mal-proteina (>95%).
English: • oral candidiasis (thrush)
Maltese: • candidiasis orali
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Maltese: Is-sindrome majilodisplastik ġie rrappurtat f'2 minn 744 pazjenti fuq TAC (0.3%) u f'1 minn 736 pazjent fuq FAC (0.1 %).
English: Taxespira in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: Taxespira użat flimkien ma' doxorubicin u cyclophosphamide: terapija miżjuda
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-organi
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Maltese: Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + 5-FU *Cox model (aġġustament għas-sit tat-tumur Primarju, T and N stadji kliniċi u PSWHO)
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.
Maltese: • Is-sustanzi l-oħra huma polysorbate 80, ethanol anhydrous (ara sezzjoni 2) u citric acid monohydrate
English: - The active substance is docetaxel (as trihydrate).
Maltese: • Is-sustanza attiva hi docetaxel (bħala tri-idrat).
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Maltese: Stomatite/mukożite ta' grad 3 L-ewwel episodju: naqqas id-doża ta' 5-FU b'20%.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni a' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Maltese: 316 alopeċja li ppersistit matul il-perijodu ta' osservazzjoni ta' wara t-trattament fittmiem tal-kimoterapija ġiet irrappurtata f'687 minn 744 pazjent fuq TAC (92.3%) u 645 minn 736 pazjent (87.6%) fuq FAC.
English: A total of 1006 patients with KPS ≥60 were randomized to the following treatment groups:
Maltese: Total ta' 1006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
English: 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Maltese: bejn 30 sa 60 minuta kull 3 ġimgħat (TCis), jew docetaxel 75 mg/m2 bħala infużjoni fil vini f'tul ta' siegħa, flimkien ma' carboplatin (AUC 6 mg/ml.minuta) li ngħata f'30 sa 60 minuta kull 3 ġimgħat, jew vinorelbine (V) 25 mg/m2, mogħti tul 6 sa 10 minuti fil-jiem 1, 8, 15 u 22, segwit b'cisplatin 100
English: These results are consistent with the pharmacological activity of docetaxel.
Maltese: Dawn ir-riżultati huma konsistenti mal-attività farmakoloġika ta' docetaxel.
English: Diarrhoea grade 4
Maltese: Dijarrea ta' grad 4
English: Dyspnoea (severe:
Maltese: Esofaġite (severa:
English: 140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg).
Maltese: 140mg/7 ml Kull kunjett wieħed ta' 7 ml fih 3.5 ml ta' ethanol anhydrous (2765 mg).
English: Gastric adenocarcinoma
Maltese: Adenokarċinoma tal-istonku
English: Docetaxel plus trastuzumab n = 92
Maltese: Docetaxel flimkien ma' trastuzumab1 n = 92
English: Dizziness; Headache (G3/4: <1%); Neuropathy peripheral
Maltese: Uġigħ ta' ras (G3/4: < 1%); Newropatija periferika
English: 3 (see section 4.2).
Maltese: (ara sezzjoni 4.4).
English: 120mg/6 ml contains 6 ml of concentrate.
Maltese: 120mg/6 ml fih 6 ml ta' konċentrat.
English: Constipation;
Maltese: Dermatite;
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma kif spjegat: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
Maltese: 120mg/6 ml Kull kunjett wieħed ta' 6 ml fih 3 ml ta' ethanol anhydrous (2370 mg).
English: Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Maltese: Komuni ħafna: Tossiċità ematoloġika żdiedet f'pazjenti li ħadu trastuzumab u docetaxel, meta mqabbla ma' docetaxel waħdu (32% grad 3/4 newtropenija kontra 22%, meta ntużaw il-kriterji NCI-CTC).
English: Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Maltese: L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value
English: Taxespira in combination with doxorubicin
Maltese: Taxespira użat flimkien ma' doxorubicin
English: There was less use of morphinic analgesic (p <0.01), non-morphinic analgesics (p <0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p <0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Maltese: Kien hemm inqas użu tal-morfina għalluġigħ (p <0.01), sustanzi ghall-ugigħ mhux tat-tip tal-morfina (p <0.01), mediċini oħra relatati malmarda (p = 0.06) u r-radjuterapija (p <0.01), f'pazjenti ittrattati b'docetaxel b'doża ta' 75 mg/m komparat ma dawk fuq l-AKS.
English: Stomatitis/Pharyngitis (G3/4:
Maltese: Stomatite/Farinġite (G3/4:
English: 140mg/7 ml contains 7 ml of concentrate.
Maltese: 140mg/7 ml fih 7 ml ta' konċentrat.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Maltese: • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
English: Weight decreased; G3/4 Blood bilirubin increased
Maltese: Tnaqqis fil-piż; G3/4 Żieda fil-bilirubin fiddemm
English: Acute leukaemia /Myelodysplastic syndrome
Maltese: Sindrome ta' Lewkimja akuta/Majilodisplastik.
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
Maltese: Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI: 34.4 - 42.1) fil-fergħa AT u 31.9 ġimgħat
English: Arrhythmia (G3/4: 1.0%)
Maltese: Arritmiji (G3/4: 1.0%)
English: Gastrointestinal haemorrhage (severe:
Maltese: emorraġija gastro intestinali (severa:
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Maltese: 316 26 pazjent (3.5%) fil-fergħa tat-TAC u 17-il pazjent (2.3%) fil-fergħa tal-FAC esperjenzaw insuffiċjenza konġestiva tal-qalb.
English: In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
Maltese: F'kunjetti ta' Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml u 160 mg/8 ml ilkonċentrazzjoni ta' docetaxel hija 20 mg/ ml.
English: 160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg).
Maltese: 160mg/8 ml Kull kunjett wieħed ta' 8 ml fih 4 ml ta' ethanol anhydrous (3160 mg).
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Maltese: Aktar ġrajjiet avversi ta' grad 3/4 kienu innotati b'docetaxel bħala monoterapija (55.4%) meta mqabbel ma' paclitaxel (23%).
English: 160mg/8 ml contains 8 ml of concentrate.
Maltese: 160mg/8 ml fih 8 ml ta' konċentrat.
English: Stomatitis (G3/4: 2%)
Maltese: Stomatite (G3/4: 2%)
English: 20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Maltese: 20mg/1 ml Kull kunjett wieħed ta' 1 ml fih 0.5 ml ta' ethanol anhydrous (395 mg).
English: 20mg/1 ml contains 1 ml of concentrate.
Maltese: 20mg/1 ml fih 1 ml ta' konċentrat.
English: Anorexia (G3/4: 0.6%)
Maltese: Anoreksja (G3/4: 0.6%)
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy, or liver impairment.
Maltese: Iddiskuti mat-tabib tiegħek jekk tbati minn dipendenza ta'l- alkoħol, epilessija, jew indeboliment tal-fwied.
English: Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Maltese: Docetaxel intwera li huwa mutaġeniku in vitro fil-mikronukleju u fit-test għall-aberrazzjoni tal-kromosomi fiċ-ċelluli CHO-K1 u fit-test in vivo fuq il-mikronukleju fil-ġurdien.
English: Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Maltese: Mingħajr m'affettwa iż-żmien totali tas-sopravivenza (għal docetaxel 15-il xahar kontragħal doxorubicin 14-il xahar, p = 0.38), jew iż-zmien sakemm javvanza ttumur (b'docetaxel 27 ġimgħa kontra li d-doxorubicina kien ta' 23 ġimgħa, p = 0.54), docetaxel wera rata ta' rispons aktar għolja (52% kontra 37%, p = 0.01) u qassar iż-żmien għar-rispons (12-il ġimgħa vs 23 ġimgħa, p = 0.007).
English: Docetaxel increased response rate (33% vs. 12%, p <0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged OS (11 months vs. 9 months, p = 0.01).
Maltese: Docetaxel żied r-rata tar-rispons (33% vs 12%, p < 0.0001), ittardja l-avvanz tat-tumur (19-il ġimgħa vs 11-il ġimgħa, p = 0.0004) u tawwal iż-żmien totali tas-sopravivenza (11-il xahar vs 9 xhur, p =
English: 80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
Maltese: 80mg/4 ml Kull kunjett wieħed ta' 4 ml fih 2 ml ta' ethanol anhydrous (1580 mg).
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Recall phenomena tar-radjazzjoni kienu rarament irrapportati.
English: The name of this medicine is Taxespira.
Maltese: L-isem ta' din il-mediċina huwa Taxespira.
English: This is equivalent to 70 ml of beer or 29 ml of wine.
Maltese: Dan hu ekwivalenti għal 70 ml ta' birra jew 29 ml ta' nbid.
English: A total of 445 patients with KPS >70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F)
Maltese: Total ta' 445 pazjent b'KPS > 70 kienu ittrattati b'docetaxel (T) (75 mg/m2 fl-ewwel jum) flimkien ma' cisplatin (C) (75 mg/m2 fl-ewwel jum)
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥20% (13.1% versus 6.1%), absolute LVEF decrease ≥30% (6.2% versus 1.1%).
Maltese: 8% kontra 8.5%) mill-fergħa AT, kif ukoll inċidenza ogħla ta' tossiċita severa kardijaka: insuffiċenza konġestiva tal-qalb (3.8% kontra 2.8%), ir-rata assoluta tal-LVEF tnaqqset ≥ 20% (13.1% kontra 6.1%), ir-rata assoluta tal-LVEF tnaqqset ≥ 30% (6.2% kontra1.1%).
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Maltese: • 174 u 251 pazjent b'kanċer tar-ras u ta' l-għonq li ħadu docetaxel flimkien ma'cisplatin u 5fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma rrapportati).
English: This is equivalent to 80 ml of beer or 33 ml of wine.
Maltese: Dan hu ekwivalenti għal 80 ml ta' birra jew 33 ml ta' nbid.
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Maltese: Falliment kardijaku sintomatika kienet irrapportata f'2.2% tal-pazjenti li ħadu Taxespira flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw Taxespira wahdu.
English: 50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
Maltese: 1060 pazjent ġew magħżula b'mod arbitrarju biex jirċievu jew Taxespira 75 mg/m2 mogħti siegħa wara doxorubicin 50 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 u cyclosphosphamide 500 mg/m pazjent fil-fergħa tal-FAC ), bħala kura miżjuda f'pazjenti b'kanċer operabbli fis-sider li ma nfirixx fil-glandoli limfatiċi tas-sider u li għandhom riskju għoli ta' rikaduta skont il-kriterji St.Gallen tal1998 (daqs tat-tumur >2 cm u/jew RE u RP negattivi u/jew grad għoli istoloġiku/nukleari (grad 2 sa 3) u /jew età <35 years).
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide (see section 4.8).
Maltese: Ġiet irrapportata arritmija ventrikulari inkluż takikardija ventrikulari (xi kultant fatali) f'pazjenti ttrattati b'docetaxel f'skedi ta' dożaġġi li fihom taħlita ta' doxorubicin, 5-fluorouracil u/ jew cyclophosphamide (ara sezzjoni 4.8).
English: Hypotension; Hypertension; Haemorrhage
Maltese: Deni; Għejja; Infjammazzjoni tal-mukoża; Uġigħ;
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
Maltese: F'madwar 20 % ta' dawn ilkażijiet ma kien hemm ebda fatturi ta' riskju għad-disfunzjoni renali severa akuta bħal prodotti mediċinali nefrotossiċi li ttieħdu fl-istess ħin u distrubi gastro-intestinali.
English: In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to
Maltese: Addizzjonalment, l-istabbiltà kimika u fiżika tas-soluzzjoni għall-infużjoni preparata b' sodium chloride 9 mg/ml (0.9%) jew 5% glucose soluzzjoni għall-infużjoni f'boroż li huma non-PVC jew b'5% glucose fi fliexken tal-hġieġ ġiet murija sa 48 siegha maħżuna bejn 2°C sa 8°C u sa 6 siegħat meta maħżuna inqas minn 25°C.
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: Sindromu ta' distress respiratorju akut u każijiet ta' pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja , xi kultant fatali, kienu rarament irrapportati.
English: • Induction chemotherapy followed by radiotherapy (TAX 323)
Maltese: • Kimoterapija Induttiva segwita bi radjuterapija (TAX323)
English: C-docetaxel has been conducted in three cancer patients.
Maltese: C-docetaxel sar fi tliet pazjenti bil-kanċer.
English: Treatment must be discontinued if these toxicities persist (see section 4.4).
Maltese: It-trattament għandu jitwaqqaf jekk dawn l-effetti tossiċi jippersistu ara sezzjoni 4.4).
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Maltese: L-inċidenza ta' newtropenja ta' Grad 4, newtropenja bid-deni u infezzjoni newtropenika naqset fil-pazjenti li rċevew il-prevenzjoni primarja permezz ta' G-CSF (ara sezzjoni 4.8).
English: Grade 2
Maltese: Kategorija tal-età 2
English: The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
Maltese: Il-profil farmakokinetiku ta' cisplatin, li ngħata ftit wara l-infużjoni ta'docetaxel, huwa simili għal dak osservat b'cisplatin waħdu.
English: Taxespira 20 mg/1 ml concentrate for solution for infusion
Maltese: Taxespira 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni
English: Peripheral motor neuropathy (G3/4: 2.5%)
Maltese: Newropatija periferika tal-movimenti (G3/4: 2.5%);
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Maltese: Meta ntużaw flimkien, docetaxel ma jeffetwax it-tneħħija ta' doxorubicin u anqas l-livelli tal-plasma ta' doxorubicinol (prodott metaboliku tad-doxorubicin).
English: This is equivalent to 60 ml of beer or 25 ml of wine.
Maltese: Dan hu ekwivalenti għal 60 ml ta' birra jew 25 ml ta' nbid.
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: Pazjent 1 fuq TAC (0.1 %) u pazjent 1 fuq FAC (0.1%) mietu minħabba AML matul il-perijodu ta' osservazzjoni (żmien medjan ta' osservazzjoni ta' 8 snin).
English: Metabolism and nutrition disorders Nervous system disorders
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: See also section “Taxespira contains ethanol (alcohol)” below.
Maltese: Ara wkoll is-sezzjoni “Taxespira fih l-ethanol (l-alkoħol)” hawn taħt.
English: Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
Maltese: Tromboċitopenija (G3/4: 0.6%); Newtropenija bid-deni
English: Efficacy of docetaxel in the induction treatment of patients with inoperable 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 requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
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: Meta cisplatin u 5-fluorouracil intużaw flimkien għat-trattament ta' pazjenti li kellhom adenokarċinoma ta' l-istonku, l-istudju klinikutal-pern eskludiet pazjenti b'ALT u/jew AST > 1.5 x ULN assoċjat ma' alkaline phosphatase ta' > 2.5 x ULN, u bilirubin ta' > 1 x ULN; għal dawn ilpazjenti ma jistgħux ikunu irrakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up timepoint.
Maltese: Ir-rata ta' sopravivenza kienet 93.7% fil-fergħa ta' TAC u 91.4 % fil-fergħa ta' FAC, fil-punt tat-8 sena ta' osservazzjoni, u 91.3 % fil-fergħa ta' TAC u 89 % fil-fergħa ta' FAC, fil-punt tal-10 sena ta' osservazzjoni.
English: Each 1 ml of concentrate contains 20 mg docetaxel (as trihydrate).
Maltese: Kull 1 ml ta' konċentrat, fih 20mg docetaxel (bħala tri-idrat).
English: Febrile neutropenia
Maltese: Infezzjoni newtropenika
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: L-Incidenza relatata ma'deni, dijarea, anoreksja u edima periferika li ġraw b'rati ≥ 10% ogħla fil-pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
English: Uncommon adverse reactions
Maltese: Reazzjonijiet avversi komuni ħafna
English: In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Maltese: F'TAX316, l-amenorreja li bdiet matul il-perijodu ta' trattament u li baqgħet tippersisti fil-perijodu ta' osservazzjoni wara li spiċċat il-kimoterapija, ġiet irrappurtata f'202 minn 744 pazjent TAC (27.2 %) u f'125 minn 736 pazjent FAC (17.0 %).
English: Musculoskeletal, connective tissue bone disorders
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: G3/4 AST increased
Maltese: G3/4 żieda fl-AST
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Maltese: Il-komportament farmakokinetiku ta' docetaxel kien studjat f'pazjenti bil-kanċer wara l-għoti ta' 20 sa 115 mg/m2 fil-fażi I tal-istudji.