FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with liver impairment In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Maltese: Pazjenti b'indeboliment tal-fwied F'pazjenti ikkurati b'docetaxel waħdu b'doża ta' 100 mg/m2, u li għandhom livelli ta' l-enzimi transaminase (l-ALT u/jew l-AST) fis-serum tad-demm aktar minn 1.5 drabi l-ULN, flimkien ma' livelli ta' l-enżima alkaline phosphatase fis-serum aktar minn 2.5 drabi l-ULN, ghandhom riskju akbar li jiżviluppaw reazzjonijiet avversi u severi, bħall-mewt ta' natura tossika inkluża s-sepsis, emoraġija gastro-intestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Maltese: Sturdament (G3/4: 2.3%); Newropatija periferika tal-movimenti (G3/4: 1.3%)
English: Leukaemia
Maltese: Letarġija
English: Myocardial ischemia (G3/4:1.7%)
Maltese: Mard iskemiku talmijokardju (G3/4: 1.7%) Arritmija
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Maltese: Il-fażi tal-aħħar hija dovuta partjalment għall-effluss relattivament bil-mod ta' docetaxel mill-kompartiment periferika.
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Maltese: Iż-żmien biex jintlaħaq il-mard progressiv kien superjuri bid-docetaxel u capecitabine flimkien (p < 0.0001).
English: 140mg/7 ml One vial of 7 ml concentrate contains 140 mg docetaxel.
Maltese: 140mg/7 ml Kunjett wieħed ta' 7 ml konċentrat fih 140mg docetaxel.
English: Distribution 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: Distribuzzjoni Wara l-għoti ta' doża ta' 100 mg/m2 li ngħatat bħala infużjoni fi żmien siegħa, l-ogħla livell medju filplażma kien ta' 3.7 μg/ml b'AUC korrispondenti ta' 4.6 sigħat.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 3160mg ethanol anhydrous kull kunjett ta' 8mL, ekwivalenti għal 80 ml ta' birra jew 33 ml inbid.
English: Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4: 0.6%); Uġigħ addominali;
English: G3/4 Blood bilirubin increased (<5%); G3/4 Blood alkaline phosphatase increased (<4%); G3/4 AST increased (<3%); G3/4 ALT increased (<2%)
Maltese: G3/4 Bilirubin fiddemm ogħla (< 5%); G3/4 alkaline phosphatase fiddemm ogħla (< 4 %) G3/4 AST ogħla
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-fergħa AT kontra il-fergħa AC, p = 0.009.
English: Pain response rate (%)
Maltese: Sopravivenza ta' Sentejn (%)
English: Gastrointestinal haemorrhage (G3/4:
Maltese: Emoraġija; gastrointestinali (G3/4:
English: 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Maltese: 20mg/1 ml Kunjett wieħed ta' 1 ml konċentrat fih 20mg docetaxel.
English: Dehydration (G3/4: 2%)
Maltese: Deidrazzjoni (G3/4: 2%)
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4 % of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Maltese: Newtropenija bid-deni u infezzjonijiet assoċjati man-newtropenija ġraw, rispettivament, fi 12.1% u 3.4% tal-pazjenti, meta dawn irċevew il-profilassi b'G-CSF, fil-waqt li 15.
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 11.1 h, respectively.
Maltese: Il-profil kinetiku ta' docetaxel huwa indipendenti mid-doża użata u huwa konsistenti ma' mudell farmakokinetiku bi tliet oqsma, biż-zmien kemm idum biex jonqos bin-nofs fil-livell tad-demm għall-fażijiet α, β u γ huwa ta' 4 minuti, 36 minuta u 11.1 sigħat, rispettivament.
English: Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Maltese: Il-pazjenti kollha fejn it-tumur m'avvanzax, ingħataw (CRT), skont il-protokol (TPF/CRT).
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Maltese: Koagulazzjoni intrvasculari mifruxa (DIC), spiss assoċjata ma' sepsis u insuffiċjenza ta' organi multipli, kienet irrapportata.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 395 mg ethanol anhydrous kull kunjett ta' 1mL, ekwivalenti għal 10 ml ta' birra jew 4 ml inbid.
English: Other medicines and Taxespira
Maltese: Mediċini oħra u Taxespira
English: 80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
Maltese: 80mg/4 ml Kunjett wieħed ta' 4 ml konċentrat fih 80mg docetaxel.
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Maltese: Fil-medjan taż-żmien ta' ossevazzjoni ta' 10 snin u 5 xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 9% fir-riskju ta' mewt meta mqabbla ma' pazjenti kkurati b' FAC (proporzjon ta' periklu = 0.91, 95% CI (0.63-1.32)).
English: Hypersensitivity (G3/4:
Maltese: Sensittivita eċċessiva (G3/4:
English: 120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
Maltese: 120mg/6 ml Kunjett wieħed ta' 6 ml konċentrat fih 120mg docetaxel.
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: Neoplażmi bennini, malinni u mhux speċifiċi (li jinkludu ċisti u polipi) Każijiet ta' lewkimja majelojdi akuta u sindromu majelodisplastiku ġew rapportati flimkien ma' docetaxel meta intuża flimkien ma' sustanzi kimoterapewtiċi u/jew radjuterapija.
English: EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Maltese: EU/1/15/1017/005 160 mg/8 ml kunjett x 1 kunjett
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Maltese: [95% CI: 0.7; 13.5] *Ikkoreġġuti għal paraguni multipli u aġġustati għall-fatturi stratifikanti (stadju tal-marda u l-post tattrattament), ibbażati fuq il-popolazzjoni ta' pazjenti evalwati.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Maltese: TTP=iż-żmien għal progressjoni; “ne” jindika li ma setax ikun stmat jew li ma kienx għadu milħuq Sett sħiħ tal-analiżi (bit-tir ta' fejqan)
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Maltese: Fl-istudju TAX316, il-limfoedima li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti filperijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet irrappurtata f'11 minn 744 pazjent fuq TAC (1.5%) u f'pazjent 1 minn 736 pazjent fuq FAC (0.1 %).
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 1580 mg ethanol anhydrous kull kunjett ta' 4mL, ekwivalenti għal 40 ml ta' birra jew 17 ml inbid.
English: G3/4 Blood bilirubin increased (2.1%);
Maltese: G3/4 Bilirubin fid-demm ogħla (2.1%)
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 2370mg ethanol anhydrous kull kunjett ta' 6mL, ekwivalenti għal 60 ml ta' birra jew 25 ml inbid.
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/m 2 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: Fit-trattament induttiv ta' kanċer inoperabbli tat-tip squamous cell tal-ġilda, li huwa lokalment avvanzat, fir-ras u fl-għonq (SCCHN), id-doża irrakkomandata ta' docetaxel hija 75 mg/m bħala infużjoni tul ta' siegħa, segwita minn cisplatin 75 mg/m2 f'tul ta' siegħa, fl-ewwel jum, segwit minn 5-fluorouracil bħala infużjoni mingħajr waqfien ta' 750 mg/m2 kuljum għal ħamest ijiem.
English: Dry skin; Desquamation
Maltese: Reazzjoni fis-sit tal-infuzjoni; Uġigħ
English: 50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
Maltese: mg/m 2) (il-fergħa AT) kontra doxorubicin (60 mg/m 2) flimkien ma' cyclophosphamide (600 mg/m (il-fergħa AC).
English: This is equivalent to 10 ml of beer or 4 ml of wine.
Maltese: Dan hu ekwivalenti għal 10 ml ta' birra jew 4 ml ta' nbid.
English: EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
Maltese: EU/1/15/1017/004 140 mg/7 ml kunjett x 1 kunjett
English: Epistaxis (G3/4: <1%)
Maltese: Kandidjasi orali (G3/4: < 1%)
English: Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Maltese: Taxespira 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 120 mg/6 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 140 mg/7 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Maltese: Wara 10 snin ta' osservazzjoni ta' wara t-trattament fl-istudju TAX316, il-lewkimja akuta ġiet irrappurtata f'3 minn 744 pazjent fuq TAC (0.4 %) u f'1 minn 736 pazjent fuq FAC (0.1 %).
English: General disorders and administration site conditions In study TAX316, peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Fl-istudju TAX316, l-edima periferika li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti filperijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet osservata f'119 minn 744 pazjent fuq TAC (16%) u f'23 pazjent minn 736 pazjent fuq FAC (3.1 %).
English: 80mg/4 ml One vial of 4 ml concentrate contains 80 mg docetaxel.
Maltese: 80mg/4 ml Kunjett wieħed ta' 4 ml fih 80mg docetaxel.
English: In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Maltese: Fl-istudju TAX316, l-astinja li bdiet matul il-perijodu ta' trattament u baqgħet tippersisti fil-perijodu ta' osservazzjoni wara li spiċċat il-kimoterapija ġiet irrappurtata f'236 minn 744 pazjent fuq TAC (31.7%) u f'180 minn 736 pazjent fuq FAC (24.5 %).
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16.5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Maltese: Fiż-żmien medjan ta' osservazzjoni ta' 10 snin u 5 xhur, pazjenti kkurati b'TAC kellhom tnaqqis ta' 16.5% fir-riskju ta' rikaduta meta mqabbla ma dawk ikkurati b'FAC (proporzjon ta' periklu = 0.84, 95% CI (0.65-1.08), p=0.1646).
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4:
Maltese: Fwawar sħan (G3/4: 0.5%) Pressjoni baxxa (G3/4: 0%); Flebite (G3/4: 0%)
English: 80mg/4 ml contains 4 ml of concentrate
Maltese: 80mg/4 ml fih 4 ml ta' konċentrat.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine.
Maltese: Dan il-prodott mediċinali fih 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 2765mg ethanol anhydrous kull kunjett ta' 7mL, ekwivalenti għal 70 ml ta' birra jew 29 ml inbid.
English: 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 1250 mg/m2 darbtejn kuljum (fi żmien ta' 30 minuta wara l-ikel ) għal ġimgħatejn, segwit b'perijodu ta' waqfien għal ġimgħa.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial.
Maltese: Dan il-prodott mediċinali fih 50 % (w/w) ethanol anhydrous (alkoħol), jiġifieri sa 2765 mg ethanol anhydrous għal kull kunjett ta' 7 mL.
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Maltese: Falliment kardijaku intweriet f'pazjenti li hadu docetaxel flimkien ma' trastuzumab, specjalment wara l-kimoterapija li fiha anthracycline (doxorubicin jew epirubicin).
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Maltese: Dan il-prodott mediċinali fih 50 % (w/w) ethanol anhydrous (alkoħol), jiġifieri sa 3160 mg ethanol anhydrous għal kull kunjett ta' 8 mL.
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Maltese: Data ta' riversibbiltà hija disponibbli f'35.3% tal-pazjenti li żviluppaw newrotossiċità wara t-trattament b'docetaxel waħdu f'doża ta' 100 mg/m².
English: In non-clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Maltese: Fi studji mhux kliniċi, docetaxel għandu effetti ġenotossiċi u jista' jibdel il-fertilità maskili (ara sezzjoni 5.3).
English: • Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle.
Maltese: • Imbagħad, injetta permezz ta' injezzjoni waħda (titqiba waħda) ġo flixkun jew borża ta' infużjoni ta' 250 ml li jkun fihom jew soluzzjoni ta' 5 % glucose jew soluzzjoni għall-injezzjoni ta' 9 mg/ml sodium chloride (0.9 %).
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Maltese: Infezzjoni newtropenika (Grad 3-4)
English: The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-volum meħtieg ta' Taxespira konċentrat għal soluzzjoni għall-infużjoni għandu jigi injettat f'infużjoni waħda (titqiba wahda) ġo 250mL borża ghall- infużjoni jew flixkun li fih soluzzjoni ta' 5% glucose jew sodium chloride 9 mg/ml (0.9%) solzzjoni għall-infużjoni.
English: Hazard ratio*
Maltese: Ilproporzjo n tar- riskj u*
English: (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Maltese: u 5-fluorouracil (F) (750 mg/m 2 kuljum għal 5 ijiem), jew cisplatin (100 mg/m 2 fl-ewwel jum) u 5
English: Fever (G3/4: 1.2%)
Maltese: Rimettar (G3/4: 1.2%)
English: • 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent
Maltese: • 1312 u 121 pazjent li ħadu 100 mg/m2 ta' docetaxel bħala sustanza waħedha,
English: EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Maltese: EU/1/15/1017/003 120 mg/6 ml kunjett x 1 kunjett
English: Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Maltese: Ġiet irrappurtata arritmija ventrikulari inkluż takikardija ventrikulari (frekwenza mhux magħrufa), xi kultant fatali, f'pazjenti ttrattati b'docetaxel f'skedi ta' dożaġġi li fihom taħlita ta' doxorubicin, 5fluorouracil u/ jew cyclophosphamide.
English: Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Maltese: Kull ml ta' konċentrat, fih 20mg docetaxel (bħala tri-idrat)
English: 160mg/8 ml One vial of 8 ml concentrate contains 160 mg docetaxel.
Maltese: 160mg/8 ml Kunjett wieħed ta' 8 ml konċentrat fih 160mg docetaxel.
English: Previous therapy should have included an anthracycline.
Maltese: It-terapija preċedenti kellha tinkludi xi anthracycline.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Maltese: Il-valuri medji tat-tneħħija totali mill-ġisem u l-volum ta' distribuzzjoni meta jintlaħaq stat stabbli u miżmum kienu 21 l/siegħa/m 1131l, rispettivament.
English: Taxespira in combination with trastuzumab
Maltese: Kif taħżen Taxespira
English: Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Maltese: Taxespira 80 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 120 mg/6 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 140 mg/7 ml konċentrat għal soluzzjoni għall-infużjoni Taxespira 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni docetaxel
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) 1,000 mg/m²/day from day 1 to day 5.
Maltese: Pazjenti tal-fergħa kompettitiva rċevew cisplatin (P) 100 mg/m2 bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat f'jum 1, segwit minn 5-fluorouracil (F) 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 5.
English: Common adverse reactions
Maltese: Reazzjonijiet avversi
English: In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m
Maltese: Meta jintuża għall-kura preferita, docetaxel 75 mg/m2 jingħata flimkien ma' doxorubicin (50 mg/m
English: Ready to add to infusion solution.
Maltese: Preparazzjoni ta' soluzzjoni għall-infużjoni
English: One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Maltese: Mija sitta u tmenin (186) pazjent kienu mqassma mingħajr għażla biex jieħdu docetaxel (100 mg/m2) bi trastuzumab jew mingħajru; 60% tal-pazjenti rċevew preċedentement kimoterapija miżjuda b'tip ta' anthracycline.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
Maltese: Dan il-prodott mediċinali fih 50 % (w/w) ethanol anhydrous (alkoħol), jiġifieri sa 395 mg ethanol anhydrous għal kull kunjett ta' 1 mL.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Maltese: Pazjenti tal-fergħa ta' docetaxel ingħataw docetaxel (T) 75 mg/m2 bħala infużjoni fil-vini fl-ewwel jum segwit minn cisplatin (P) 100 mg/m2 li jingħata bħala infużjoni fil-vini fuq tul ta' 30 minuta sa 3 sigħat, segwit minn 5-fluorouracil (F) 1000 mg/m2 kuljum bħala infużjoni kontinwa minn jum 1 sa jum 4.
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Maltese: In vivo, docetaxel jaħdem indipendentement mill-iskeda ta' kif jingħata u għandu firxa wiesgħa t'attivita fuq it-tumuri esperimentali, kontra tumuri mlaqqmin u avvanzati derivati mill-ġrieden u mill-bnedmin.
English: G3/4 ALT increased
Maltese: G3/4 żieda fl-ALT
English: Hepatic impairment
Maltese: Infezzjoni u infestazzjonijiet
English: Diarrhoea (G3/4:
Maltese: Anoreksja (G3/4:
English: Taxespira in combination with capecitabine
Maltese: Docetaxel użat flimkien ma' capecitabine
English: Vomiting (G3/4: 5%);
Maltese: Rimettar (G3/4: 5%);
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/m bħala infużjoni tul ta' 3 sigħat.
English: In study TAX316, peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Maltese: Fl-istudju TAX316, in-newropatija periferika tas-sensazzjoni bdiet matul il-perijodu ta' trattament u baqgħet tippersisti fil-perijodu ta' osservazzjoni f'84 pazjent (11.3%) fil-fergħa TAC u fi 15-il pazjent (2 %) fil-fergħa FAC.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m administered as a 30-minute to
Maltese: It-trattament induttiv ta' pazjenti li kellhom kanċer tat-tip squamous cell tar-ras u l-għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta' kura kirurġika u bi skop ta' preservazzjoni ta' l-organi), id-doża rrakkomandata ta' docetaxel hija 75
English: The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Maltese: L-għoti flimkien ta' docetaxel, cisplatin u 5-fluorouracil fi 12-il pazjent b'tumuri solidi ma kellux effett fuq il-komportament farmakokinetiku ta' kull prodott mediċinali individwali.
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Maltese: Infezzjoni (G3/4: 2.4%); Infezzjoni newropenika (G3/4: 2.6%)
English: Elimination A study of
Maltese: Eliminazzjoni Studju b'
English: s r.o.
Maltese: μg/ml.
English: Cardiac failure
Maltese: Falliment kardijaku