FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC reviewed all available data from published literature, pre-clinical and clinical studies and post-marketing experience on the safety of methadone medicinal products for oral use containing povidone, responses submitted by the marketing authorisation holders (MAHs) in writing and during the oral explanations, the outcome of the ad-hoc expert advisory group meeting as well as stakeholders' submissions in particular with regards to the risks associated with the misuse of the products by injection which is a well-known risk in the target population;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli mil-letteratura ppubblikata, minn studji prekliniċi u kliniċi u mill-esperjenza ta' wara tqegħid fis-suq dwar is-sigurtà tal-prodotti mediċinali tal-methadone għall-użu orali li fihom povidon, it-tweġibiet ippreżentati mid-detenturi tal-awtorizzazzjoni għattqegħid fis-suq (MAHs) bil-miktub u waqt l-ispjegazzjonijiet orali, l-eżitu tal-laqgħa tal-grupp konsultattiv espert ad-hoc kif ukoll il-preżentazzjonijiet tal-partijiet interessati, b'mod partikolari firrigward tar-riskji assoċjati mal-użu ħażin tal-prodotti permezz ta' injezzjoni li huwa riskju magħruf fil-popolazzjoni fil-mira;
English: • The PRAC considered that the potential for harm was likely to be associated with the misuse of methadone oral solutions containing high molecular weight povidone K90;
Maltese: • Il-PRAC qies li l-potenzjal għall-ħsara kien probabbli li jkun marbut mal-użu ħażin ta' soluzzjonijiet orali ta' methadone li fihom povidon b'piż molekulari għoli K90;
English: • The PRAC considered that the proposed risk minimisation measures to update the product information could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90);
Maltese: • Il-PRAC qies li l-miżuri għall-minimizzazzjoni tar-riskji proposti biex tiġi aġġornata l-informazzjoni dwar il-prodott ma setgħux inaqqsu r-riskju magħruf ta' użu ħażin mill-popolazzjoni fil-mira maħsuba u l-ħsara serja potenzjali assoċjata kkawżata mill-injezzjoni ta' povidon b'piż molekulari għoli (K90);
English: Additional warnings in the label were further considered, but a direct information to the patients is challenging and according to the experts, such measures are unlikely to further minimise the risk of injection.
Maltese: Kien ulterjorment ikkunsidrat li jkun hemm twissijiet addizzjonali fit-tikketta, iżda informazzjoni diretta lill-pazjenti hija ta' sfida u skont l-esperti, miżuri bħal dawn mhumiex probabbli li jkomplu jnaqqsu r-riskju ta' injezzjoni.
English: As a consequence, following the provisions under Article 107j(3) of Directive 2001/83/EC, the PRAC recommends the variation of marketing authorisations for methadone tablets containing low molecular weight povidone (K25 or K30).
Maltese: Bħala konsegwenza, skont id-dispożizzjonijiet skont l-Artikolu 107j(3) tad-Direttiva 2001/83/KE, ilPRAC jirrakkomanda l-varjazzjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-pilloli talmethadone li fihom povidon b'piż molekulari baxx (K25 jew K30).
English: Fourteen (14) cases of renal failure were reported.
Maltese: Kienu rrapportati erbatax (14)-il każ ta' insuffiċjenza renali.
English: Although the brand of methadone cannot be confirmed with certainty it is suspected, based on the availability of the product and pattern of usage in Western Norway that the observed serious adverse reactions (e.g. anaemia and bone marrow disorder) were caused by povidone deposition in drug abusers who have misused methadone oral solutions containing povidone K90.
Maltese: F'disa' każijiet, kien speċifikat li kien hemm storja ta' abbuż mid-droga b'sustanzi li ġew injettati u fi tmienja minn dawn id-disa' każijiet kienet irrapportata storja ta' injettar ta' methadone maħsub għall-użu orali.
English: The CMDh also reached an agreement on the variation to the terms of the Marketing Authorisations for methadone tablets containing low molecular weight povidone (K25 or K30) for which the amendments to be introduced to the Summary of Product Characteristics and package leaflet are set out in Annex III.
Maltese: Methadone jintuża fil-kura ta' uġigħ moderat għal qawwi u jintuża wkoll bħala medikazzjoni ta' manutenzjoni/sostituzzjoni fil-ġestjoni tad-dipendenza fuq l-opjojdi.
English: Should this oral solution be repeatedly injected, povidone would be permanently retained and accumulate within organs and tissues, leading to potential serious harm.
Maltese: Jekk din is-soluzzjoni orali tiġi injettata ripetutament, povidon jinżamm b'mod permanenti u jakkumula fl-organi u t-tessuti, li jwassal għal ħsara serja potenzjali.
English: Available data from the scientific literature suggests that an association between deposits of povidone and renal impairment has not been well established.
Maltese: Madankollu, id-dejta disponibbli ma turix l-effikaċja ta' povidon fil-mitigazzjoni ta' dan ir-riskju.
English: In most cases, prescription or use of methadone can be confirmed, while some of them also have admitted injecting oral methadone.
Maltese: F'ħafna każijiet, ilpreskrizzjoni jew l-użu ta' methadone jista' jiġi kkonfermat, filwaqt li wħud minnhom ammettew ukoll li injettaw methadone orali.
English: For the other eight cases, renal biopsies were lacking, but povidone deposits were detected in biopsies from other tissues.
Maltese: Għat-tmien każijiet l-oħra, ma kienx hemm bijopsiji renali, iżda instabu depożiti ta' povidon f'bijopsiji minn tessuti oħra.
English: As a consequence, following the provisions under Article 107j (3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Maltese: Bħala konsegwenza, b'segwitu tad-dispożizzjonijiet skont l-Artikolu 107j (3) tad-Direttiva 2001/83/KE, il-PRAC jirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għas-soluzzjoni orali ta' methadone li fiha povidon b'piż molekulari għoli (K90).
English: Magyarország Teva Gyógyszergyár Zrt.
Maltese: Teva Gyógyszergyár Zrt.
English: H-2100 Gödöllő,
Maltese: H-2100 Gödöllő l-Ungerija
English: NN: {number]
Maltese: {numru} NN: {numru]
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Maltese: Minoranza ta' pazjenti kienu ittestjati bl-użu ta' fluorescence in-situ hybridization (FISH).
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Maltese: Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
English: MARKETING AUTHORISATION NUMBER EU/1/09/611/002
Maltese: EU/1/09/611/002
English: Deutschland Teva GmbH Tel: +49 731 402 08
Maltese: Teva GmbH Tel: +49 731 402 08
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophospamide CI = confidence interval - intervall ta' kunfidenza; ER = oestrogen receptor - riċettatur tal-estroġen PR = progesterone receptor - riċettatur tal-progesterone a ER/PR-negattiv jew Grade 3 jew daqs tat-tumur >5 cm
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Maltese: Docetaxel huwa metabolizzat minn CYP3A4 u prednisone huwa magħruf li jinduċi CYP3A4.
English: 2031 GA Haarlem The Netherlands
Maltese: 2031 GA Haarlem l-Olanda
English: Tél: +33 1 55 91 78 00
Maltese: Teva Santé Tél: +33 1 55 91 78 00
English: Menopausal status
Maltese: Stat Menopawsali
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Il-barcode 2D li jġorr l-identifikatur uniku inkluż.
English: Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Maltese: Newtropenjia (Grade 4) Newtropenija bid-deni Infezzjoni newtropenika Infezzjoni newtropenika (Grad 3-4)
English: G3/4 Blood alkaline phosphatase increased
Maltese: G3/4 Alkaline phosphatase fid
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA
English: Docetaxel Teva contains ethanol (alcohol)
Maltese: Docetaxel Teva fih ethanol (alkoħol)
English: Consideration should be given to possible effects on the central nervous system.
Maltese: Għandha tingħata konsiderazzjoni għall-effetti possibbli fuq is-sistema nervuża ċentrali.
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).
Maltese: - Is-sustanza l-oħra hi polysorbate 80 u 25.1% (w/v) ethanol anidru (ara sezzjoni 2).
English: Docetaxel Teva contains alcohol.
Maltese: Docetaxel Teva fiha alkoħol.
English: Hungary
Maltese: Magyarország
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 mmonitorjati millviċin għal manifestazzjonijiet bikrija ta' tossiċità gastro-intestinali serja (ara sezzjonijiet 4.2, 4.4 Ematoloġija, u 4.8).
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/.
Maltese: Aġenzija Ewropeja għall-Mediċini http://www.ema.europa.eu/.
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) **Log rank 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) **Logrank test ***Chi-square test
English: A total of 1,006 patients with KPS≥60 were randomised to the following treatment groups:
Maltese: Total ta' 1,006 pazjenti b'KPS ≥ 60 kienu mqassma mingħajr għażla fi gruppi ta' trattament kif deskritt hawn taħt:
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 AC arm.
Maltese: Ir-RTTR kienet 59.3% (95% CI: 52.8-65.9) fil-fergħa AT versu 46.5% (95% CI: 39.8 - 53.2) fil-fergħa AC.
English: ≥35 years
Maltese: <35 sena
English: Diarrhoea grade 4
Maltese: Stomatite/mukożite ta' grad 4
English: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Maltese: rispons fil-popolazzjoni mqassma mingħajr għażla (kif stmat mill-investigatur) kienu 41.6% (docetaxel + capecitabine) kontra 29.7% (docetaxel waħdu); p = 0.0058.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Maltese: Ġew irrapportati każijiet rari ta' deidrazzjoni bħala konsegwenza ta' ġrajjiet gastro-intestinali inkluż enterokolite u perforament gastro-intestinali.
English: ≥50 years
Maltese: <50 sena
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Maltese: Numru ta' pazjenti Ir-rata tar-rispons tattumur 95% CI †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA:
English: Hazard ratio (95% CI) **p-value n=128
Maltese: Il-proporzjon tar-riskju (95%CI) **p-value n = 128
English: Age category 2 <35 years
Maltese: Kategorija tal-età 2
English: • 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Maltese: • 1,312 u 121 pazjent li ħadu 100 mg/m2 u 75 mg/m2 ta' docetaxel bħala sustanza waħedha, rispettivament.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-organi fid-Database MedDRA
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Maltese: Għalkemm il-possibbiltà t'interazzjoni in vivo ta' docetaxel ma' mediċini oħra li ngħatat konkomittantement ma kinux investigati formalment, l-interazzjonijiet in-vitro b'sustanzi li huma marbuta sew mal-proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole, u sodium valproate, m'effetwawx ir-rabta ta' docetaxel mal-proteina; hekk ukoll dexamethasone m'effetwawx l-effetti fuq ir-rabta ta' docetaxel mal-proteina.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Maltese: • vista mċajpra minħabba nefħa fir-retina tal-għajn (edima makulari taċ-ċistojde)
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: Differenza fit-trattament: 7.1% [95% CI: 0.7; 13.5] *Ikkoreġġuti għal paraguni multipli u aġġustati għall-fatturi stratifikanti (stadju tal-marda u l-post tat trattament), ibbażati fuq il-popolazzjoni ta' pazjenti evalwati.
English: Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
Maltese: Esofaġite/disfaġja/odinofaġja (G3/4: 0.7%)
English: very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000
Maltese: Il-frekwenzi huma kif spjegat: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Maltese: 4.1.3 Injetta il-kontenut sħiħ tas-siringa fil-kunjett korrispondenti ta' Docetaxel Teva.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/611/001
Maltese: EU/1/09/611/001
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol).
Maltese: 1% (w/w) t'ethanol anidru (723 mg ta 'anhydrous ethanol).
English: Overall Age category 1 <50 years
Maltese: Kategorija tal-età 1
English: Polysorbate 80
Maltese: Polysorbate 80 Ethanol, anidru
English: Date of latest renewal: 22 May 2014
Maltese: Data tal-aħħar tiġdid: 14 ta' Lul 2014
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Maltese: Aġenti antineoplastiċi, Taksanes, Kodiċi ATC:
English: How to use Docetaxel Teva
Maltese: Docetaxel Teva
English: Tel: +44 1977 628 500
Maltese: Teva UK Limited Tel: +44 1977 628 500
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
Maltese: 1% (w/w) t'ethanol anidru (181 mg ta 'anhydrous ethanol).
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Maltese: It-tul ta' żmien medjan għal progressjoni kien ta' 186 jiem (docetaxel + capecitabine) kontra ta' 128 jum (b'docetaxel biss).
English: The recommended dose of docetaxel is 75 mg/m2.
Maltese: Id-doża rakkomandata ta' docetaxel hija 75 mg/m2.
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) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1,000 mg/m2 per day for 5 days).
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) u 5-fluorouracil (F) (750 mg/m2 kuljum għal 5 ijiem), jew cisplatin (100 mg/m2 fl-ewwel jum) u 5fluorouracil (1,000 mg/m2 kuljum għal 5 ijiem).
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Maltese: L-aħħar stadju sekondarju , PFS, wera tnaqqis tar-riskju mingħajr avvanz u mortalità ta' 29% u titjib ta' 22 xhur tal-medjan PFS (35.5 xhur għal TPF u 13.1 ta' PF).
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).
Maltese: Il-pazjenti kkurati b'TAC kellhom tnaqqis ta' 32 % fir-riskju ta' rikaduta meta mqabbla ma' dawk ikkurati b'FAC (proporzjon ta' riskju = 0.68, 95% CI (0.49-0.93), p = 0.01).
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised.
Maltese: Il profilattiku primarju G-CSF kien obbligatorju fid-driegħ TAC wara li 230 pazjent kienu magħżula b'mod każwali.
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: Insuffiċjenza tal-qalb sintomatika kienet irrapportata f'2.2% tal-pazjenti li ħadu Docetaxel Teva flimkien ma' trastuzumab meta mqabbel ma' 0% tal-pazjenti li ngħataw Docetaxel Teva wahdu.
English: Diarrhoea grade 3
Maltese: Stomatite/mukożite ta' grad 3
English: The name of this medicine is Docetaxel Teva.
Maltese: L-isem ta' din il-mediċina huwa Docetaxel Teva.
English: Neutropenic infection
Maltese: Infezzjoni newtropenika,
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' newtropenija ta' Grad 4, newtropenija bid-deni u infezzjoni newtropenika naqsu f'pazjenti li rċevew profilassi primarja b'G-CSF (ara sezzjoni 4.8).
English: 2.1 Docetaxel Teva 80 mg/2.88 ml vial:
Maltese: 2.1 Kunjett ta' Docetaxel Teva 80 mg/2.88 ml 80 mg/2.88 ml
English: G3/4 AST increased G3/4 ALT increased
Maltese: G3/4 żieda fl-AST G3/4 żieda fl-ALT
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: Diarrhoea (G3/4: 6.8%);
Maltese: Dijarea (G3/4: 6.8%);
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 723 mg ethanol, anhydrous per concentrate vial, equivalent to 18.3 ml beer or 7.6 ml wine.
Maltese: 1% (w / w) ethanol, anhydrous (alkoħol), jiġifieri sa 723 mg ethanol, anhydrous f'kull kunjett konċentrat, ekwivalenti għal 18.3 ml birra jew 7.6 ml inbid.
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Maltese: Infezzjoni (G3/4: 2.4%); Infezzjoni newropenika (G3/4: 2.6%)
English: What Docetaxel Teva concentrate vial contains: - The active substance is docetaxel.
Maltese: - Is-sustanza attiva hi docetaxel.
English: Gastrointestinal pain (G3/4: 1.2%); Gastrointestinal haemorrhage (G3/4:
Maltese: Ugigħ gastro-intestinali (G3/4: 1.2%); Emoraġija gastrointestinali (G3/4:
English: Acute leukaemia / Myelodysplastic syndrome.
Maltese: Lewkemja akuta/Sindrome ta' majelodisplastiku
English: • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Maltese: • Kull kunjett tas-solvent fih 1.28 ml tailma għall-injezzjonijiet (volum tal-mili: 1.71 ml).
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Maltese: Disgewżja (G3/4: < 1%); Parasteżija (G3/4: < 1%)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' Jannar 2010
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Maltese: definiti prospettivament, kienu analizzati:
English: Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Maltese: ilma għall-injezzjonijiet 5.12 ml (Mili: 6.29 ml)
English: The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Maltese: itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole) għandu jiġi evitat (ara sezzjoni 4.5).
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Maltese: Stomatite (G3/4: 1.7%); Rimettar (G3/4: 0.8%) Dijarea (G3/4:
English: You must NOT be given Docetaxel Teva:
Maltese: Ma jistax jingħatalek Docetaxel Teva:
English: Teл.
Maltese: Τel:
English: 1.28 ml (Fill: 1.71 ml)
Maltese: ilma għall-injezzjonijiet 1.28 ml (Mili:1.71 ml)
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Maltese: Wara t-tqassim tal-pazjenti skont in-numru ta' glandoli limfatiċi effettwati (1-3, 4+), 1,491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/m2 siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (ilfergħa TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa FAC).
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: Fl-istudju TAX 316, alopeċja li kienet għadha hemm ppersistiet waqt il-perijodu ta' osservazzjoni ta' wara t-trattament fit-tmiem tal-kimoterapija ġiet irrappurtata f'687 minn 744 pazjent fuq TAC (92.3 %) u 645 minn 736 pazjent (87.6 %) fuq FAC.
English: Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126).
Maltese: Is-sopravivenza kienet superjuri tal-fergħa fliemkien bit-trattament ta' docetaxel + capecitabine flimkien (p = 0.0126).
English: Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Maltese: Il-preparazzjoni tal-prodott għall-għoti ġol-vini a) Preparazzjoni ta'Docetaxel Teva, soluzzjoni mħallta bil-lest (10 mg docetaxel/ml)
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine.
Maltese: 1% (w / w) ethanol, anhydrous (alkoħol), jiġifieri sa 181 mg ethanol, anhydrous f'kull kunjett konċentrat, ekwivalenti għal 4.6 ml birra jew 1.9 ml inbid.
English: Complicated neutropenia
Maltese: Sensittivita eċċessiva
English: G3/4 AST increased
Maltese: G3/4 AST ogĦla
English: Hazard ratio*
Maltese: Ilproporzjo n tarriskju*
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 anemia (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%).