FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided fro under Article 107c(7) of Directive 2001/83/EC and 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: At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Maltese: F'follow-up medjan ta' 77 xahar, il-lewkimja akuta seħħet f'1 minn 532 (0.2 %) pazjent li rċieva docetaxel, doxorubicin, u cyclophosphamide fl-istudju ta' GEICAM 9805.
English: Without affecting overall survival 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 t-tumur (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: Infection (G3/4: 6.3%); Neutropenic infection
Maltese: Infezzjoni (G3/4: 6.3%); Infezzjoni newtropenika
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION 4.1 Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml) 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Maltese: PREPARAZZJONI TAL-PRODOTT GĦALL-GĦOTI ĠOL-VINA 4.1 Preparazzjoni ta' Docetaxel Teva Pharma, soluzzjoni inizjali (10 mg docetaxel/ml) 4.1.1 Jekk il-kunjetti kienu maħżuna fil-friġġ, ħalli n-numru ta' kaxex ta' Docetaxel Teva Pharma li għandek bżonn f'temperatura ambjentali (taħt 25°Ċ) għal 5 minuti.
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Maltese: Il-pazjenti li qed jieħdu TCF għandhom ikunu immoniterjati mill-qrib (ara sezzjonijiet 4.2 u 4.8).
English: Inject the required premix volume into a non-PVC 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Injetta l-volum meħtieġ tas-soluzzjoni inizjali tal-bidu f'borża mhux tal-PVC ta' 250 ml għallinfużjoni, li għandha soluzzjoni jew ta' 5% glukosju jew 9 mg/ml (0.9%) sodium chloride għallinfużjonijiet.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Maltese: L-inċidenza talkażijiet avversi li ġejjin (fil-gradi kollha): telqa, stomatite u infezzjonijiet assoċjati mannewtropenija, graw f'rati ta' ≥ 10% ogħla f'pazjenti li kellhom 65 sena jew aktar, meta mqabbla ma' pazjenti iżgħar.
English: There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease related medications (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 għall-uġigħ (p <0.01), sustanzi ghall-ugigħ mhux tat-tip tal-morfina (p <0.01), mediċini oħra relatati mal-marda (p = 0.06) u r-radjuterapija (p <0.01), f'pazjenti ittrattati b'docetaxel b'doża ta' 75 mg/m2, komparat ma dawk fuq l-AKS.
English: Syncope (G3/4: 0%);
Maltese: Sinkope (G3/4: 0%);
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Maltese: • kunjett wieħed ta' konċentrat ta' 2.88 ml (80 mg ta' docetaxel),
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 the 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 jistax jiġi stmat mittagħrif dispobibbli).
English: Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Maltese: • Kull kunjett tas-solvent fih 5.12 ml ilma għall-injezzjonijiet (volum tal-mili: 6.29 ml).
English: No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Maltese: Ebda każ ma ġie rrapportat f'pazjenti li rċevew fluorouracil, doxorubicin u cyclophosphamide.
English: H-2100 Gödöllő
Maltese: Gödöllő l-Ungerija
English: What Docetaxel Teva Pharma concentrate vial contains: - The active substance is docetaxel.
Maltese: X'fih il-kunjett ta' Docetaxel Teva Pharma konċentrat - Is-sustanza attiva hi docetaxel.
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Maltese: Taksanes, Kodiċi ATC:
English: Previous chemotherapy should have included an anthracycline or an alkylating agent.
Maltese: Kimoterapija preċedenti tkun inkludiet sustanza ta' antracycline jew alkylating.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Maltese: Studji in vitro wrew li l-metaboliżmu ta' docetaxel jista' jkun immodifikat meta jittieħed ma' sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma metaboliżżati (u, għalhekk, jistgħu jinibixxu lenzima kompetittivament) minn ċitokroma P450-3A, bħal ciclosporine, terfenadine, ketoconazole, erythromycin u troleandomycin.
English: 4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: 4.2.2 Injetta l-volum meħtieġ tas-soluzjoni inizjali f'borża jew flixkun tal-infużjoni ta' 250 ml, li għandha/għandu soluzzjoni ta' 5% glukożju jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-infużjoni.
English: The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir.
Maltese: Ir-raġuni ta' din l-interazzjoni hija l-inibizzjoni ta' CYP3A4, l-isoenzima prinċipali involuta fil-metaboliżmu ta' docetaxel minn ritonavir.
English: How to use Docetaxel Teva Pharma
Maltese: Docetaxel Teva Pharma
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Maltese: Fil-pazjenti li kienu ħadu t-trattament b'anthracycline, li kien falla, docetaxel kien ikkomparat malużu ta' mitomycin C u l-vinblastine flimkien (12 mg/m kull 6 ġimgħat u 6 mg/m kull 3 ġimgħat).
English: • oesophagatis
Maltese: • esofaġite
English: Neutropenic infection; Infection (G3/4: 11.7%)
Maltese: Infezzjoni newtropenika, Infezzjoni (G3/4:11.7%)
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Maltese: • 300 pazjent b'adenokarċinoma tal-istonku (221 pazjent fil-fażi
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Maltese: Kumplikazzjonijiet newtropeniċi f'pazjenti li qed jirċievu TAC bi jew migħajr profilassi primarja ta' G-CSF (GEICAN 9805)
English: G3/4 ALT increased
Maltese: G3/4 ALT ogħla
English: In about 20% of these cases there were no risk factors for acute renal failure 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 disturbi gastrointestinali.
English: Oral candidiasis (G3/4: < 1%)
Maltese: Kandidjasi orali (G3/4: < 1%)
English: • heart failure
Maltese: Falliment kardijaku
English: Oedema (G3/4:1.2%)
Maltese: Edima (G3/4: 1.2%)
English: MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Maltese: Id-Detentur tal-Awtorizzazzjoni ghat-Tqegħid fis-Suq Teva Pharma B.V.
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 UNL; 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 tal-istonku, l-istudju kliniku ewlenieni 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 il-pazjenti ma jistgħux ikunu rakkomandati tnaqqis fid-dożi u docetaxel m'għandux jintuża sakemm mhux strettament indikat.
English: Renal insufficiency and renal failure have been reported.
Maltese: Ġew irrappurtati l-insuffiċjenza renali u d-disfunzjoni renali severa.
English: 4.2 Preparation of the infusion solution
Maltese: .2 Preparazzjoni tal-infużjoni
English: Infection (G3/4: 3.3%)
Maltese: Infezzjoni (G3/4: 3.3 %)
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Maltese: • 1312 u 121 pazjent li ħadu 100 mg/m ta' docetaxel bħala sustanza waħedha,
English: Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Maltese: Każijiet rari ta' deidrazzjoni bħala konsegwenza ta' ġrajjiet gastro-intestinali, perforament gastrointestinali, kolite iskemika, kolite u enterokolite newtropenika kienu irrapportati.
English: CYTOTOXIC.
Maltese: ĊITOTOSSIKU.
English: Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Maltese: Għejja/indeboliment (G3/4: Edima periferika (G3/4: 1%)
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Maltese: Differenza fit-trattament: 7.1% [95% CI: 0.7; 13.5] *:
English: Infection (G3/4: 3.6%) Neutropenic infection
Maltese: Infezzjoni G3/4: 3.6% Infezzjoni newtropenika
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
Maltese: INDIVIDWALI 0.72 ml (Mili: 0.88 ml)
English: 2.1 Docetaxel 20 mg vial:
Maltese: 2.1 Kunjett ta' Docetaxel 20 mg
English: MedDRA system organ classes
Maltese: Sistema tal-klassifika tal-Organi fid-Database MedDRA
English: • one vial of 0.72 ml concentrate (20 mg of docetaxel),
Maltese: 72 ml (20 mg ta' docetaxel),
English: 747 70 Opava-Komárov Czech Republic
Maltese: Opava-Komárov Ir-Repubblika Ċeka
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: • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Maltese: • Kull kunjett tas-solvent fih 1.88 ml ta' ilma għall-injezzjonijiet (volum tal-mili: 1.71 ml).
English: Mitoxantrone every 3 weeks
Maltese: Mitoxantrone kull 3 ġimgħat
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
Maltese: INDIVIDWALI 2.88 ml (Mili: 3.40 ml)
English: In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Maltese: F'numru żgħir ta' pazjenti (n=3) li kellhom data bijokimiku kliniku suġġestiv ta' indeboliment tal-fwied minn grad ħafif sa moderat , (ALT, AST ≥ 1.5 drabi tal-OLN assoċjat ma' livelli talenzima alkaline phosphatase ≥ 2.5 drabi tal-OLN), it-tneħħija totali tbaxxiet b'medja ta' 27% (ara sezzjoni 4.2).
English: Anaemia (G3/4: 20.9%); Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: 8.8%);
Maltese: Newtropenija (G3/4: 83.2%); Tromboċitopenija (G3/4: 8.8%); Newtropenija bid-deni
English: G3/4 Blood bilirubin increased (< 2.5%);
Maltese: G3/4 Bilirubin fid-demm ogħla (<2.5%);
English: For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Maltese: Biex nieħdu eżempju, doża ta' 140 mg ta' docetaxel tirrikjedi 14 ml ta' soluzzjoni inizjali ta' docetaxel .
English: The recommended dose of docetaxel is 75 mg/m2.
Maltese: • Docetaxel 75 mg/m
English: Musculoskeletal, connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessut konnettiv
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 251pazjent b'kanċer tar-ras u tal-għonq li ħadu docetaxel flimkien ma'cisplatin u 5-fluorouracil (effetti avversi klinikament importanti relatati mat-trattament huma irrapportati).
English: • one vial of 1.28 ml solvent (water for injections).
Maltese: • kunjett wieħed ta' solvent ta' 1.28 ml (ilma għall-injezzjonijiet).
English: • one vial (5.12 ml) of solvent (water for injections).
Maltese: • kunjett wieħed ta' solvent ta' 5.12 ml (ilma għall-injezzjonijiet).
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Maltese: III, 1218-il pazjent li kellhom tumur li ma jistax jitneħħa kiruġikament, kategorija IIIB jew IV NSCLC, b'KPS ta' 70% jew akbar, u li ma rċevewx kimoterapija preċedenti għal din il-kundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa docetaxel (T) f'doża ta' 75 mg/m bħala infużjoni tul siegħa, segwita immedjatament b'cisplatin (Sis) 75 mg/m li ngħata fuq perjodu ta' bejn 30 sa 60 minuta kull 3 ġimgħat (Tcis), docetaxel 75 mg/m 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/m 2, mogħti tul 6 sa 10 minuti fil-jiem 1, 8, 15 u 22,
English: Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Maltese: L-amenorreja kienet ghadha hemm waqt il-perijodu ta' osservazzjoni ta' wara t-trattament f'121 pazjent minn 202 pazjenti b'amenorreja fit-tmiem tal-kimoterapija fl-istudju TAX 316.
English: Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require coadministrtion of a stron CYP3A4 inhibitor such as azole antifungals, ritonavir and some macrolides (clarithromycin, telithromycin).
Maltese: Fuq bażi ta' estrapolazzjoni minn studju farmakokinetiku b'ketokonazole f'7 pazjenti, wieħed għandu jikkunsidra li jnaqqas id-doża ta' docetaxel b'50% jekk xi pazjenti jkollhom bżonn jieħdu xi inibitur qawwi ta' CYP3A4 fl-istes ħin bħal antifungali azole, ritonavir'u xi makrolidi (clarithyromycin, telithyromycin).
English: Cardiac failure; Arrhythmia (no severe)
Maltese: Falliment kardijaku; Arritmija (mhux severa)
English: Stomatitis (G3/4: 2%)
Maltese: Diżidrazzjoni (G3/4: 2%)
English: MARKETING AUTHORISATION NUMBER EU/1/10/662/002
Maltese: EU/1/10/662/002
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Disturbi fis-sistema Nervuża
English: • haemorrhage
Maltese: • emorraġija
English: Č.p.
Maltese: B.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Maltese: Reazzjonijiet severi kienu kkaraterizzati minn pressjoni baxxa u/jew bronkospażmu jew raxx/eritema ġenerali (ara sezzjoni 4.4).
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-inċidenza relatata ma'deni, dijarea, anoreksja u edima periferika ġraw b'rati ta' ≥ 10% ogħla fil-pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: Il-profilassi primarja b'G-CSF għandha tiġi kkonsidrata f'pazjenti li jirċievu terapija adjuvanti b'TAC għal kanċer tas-sider sabiex jiġi mitigat ir-riskju ta' newtropenija kkumplikata (newtropenija bid-deni, newtropenija prolongata jew infezzjoni newtropenika).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Trattament: 5.4% [95% CI: -1.1; 12.0] Differenza fit-Trattament: 6.2% [95% CI: 0.2; 12.3]
English: Hypersensitivity (no severe)
Maltese: Sensittivita eċċessiva (mhux severa)
English: Nervous system disorders
Maltese: Disturbi fis-sistema Nervuża
English: 2.2 Solvent for Docetaxel 80 mg vial:
Maltese: 2.2 Solvent għall-kunjett ta' Docetaxel 80 mg:
English: Each vial contains 80 mg/2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Maltese: • Kull kunjett fih 80 mg/2.88 ml ta' 27.73 mg/ml soluzzjoni ta' docetaxel, fil-polysorbate 80 (volum attwali: 99.4 mg/3.40 ml).
English: 2.2 Solvent for Docetaxel 20 mg vial:
Maltese: 2.2 Solvent għall-kunjett ta' Docetaxel 20 mg:
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 talplasma ta' doxorubicinol (prodott metaboliku tad-doxorubicin).
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hija probabbli stima baxxa għax docetaxel waħdu f'doża ta'100 mg/m hu magħruf li jġib in-newtropenija f'97% tal-pazjenti, 76% fi grad 4, meta ibbażata fuq in-nadir talgħadd taċ-ċelluli fid-demm.
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Maltese: Prednisone jew prednisolone meħud oralment f'doża ta' 5 mg darbtejn kuljum, jingħata bla waqfien (ara sezzjoni 5.1).
English: At the end of the follow-up period, alopecia was observed to be ongoing in 29 TAC patients (4.2%) and 16 FAC patients (2.4%).
Maltese: pazjent fuq TAC (4.2%) u 16-il pazjent fuq FAC (2.4%).
English: The name of this medicine is Docetaxel Teva Pharma.
Maltese: L-isem ta' din il-mediċina huwa Docetaxel Teva Pharma.
English: Neutropenic infection;
Maltese: Infezzjoni newtropenika
English: Uncommon adverse organ classes reactions reactions reactions
Maltese: Reazzjonijiet avversi komuni hafna Reazzjonijiet avversi komuni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg
Maltese: TIKKETTA TAL-KUNJETT - KONĊENTRAT 80 mg
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Maltese: Anqas spiss, sintomi qawwija bħal raxxijiet segwiti minn msiemer tal-ġilda li jitqaxxru kienu innotati li rarament wassal għal interruzjoni jew waqfien fit-trattament ta' docetaxel (ara sezzjonijiet 4.2 u 4.4).
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitital lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Maltese: Ġew irrapportati s-sindromu ta' distress respiratorju akut, pnewmonite/pnewmonja interstizjali, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja u li dawn jistgħu jwasslu għall-mewt.
English: (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: F'pazjenti ikkurati b'docetaxel waħdu b'doża ta' 100 mg/m2, u li għandhom livelli tal-enzimi transaminase (l-ALT u/jew l-AST) fis-serum tad-demm aktar minn 1.5 drabi l-ULN, flimkien ma' livelli tal-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, emorraġija gastrointestinali li tista' tkun fatali, newtropenija bid-deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
English: Other medicines and Docetaxel Teva Pharma
Maltese: Mediċini oħra u Docetaxel Teva Pharma
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal Docetaxel 100 mg/m aġent waħdieni
English: The solvent for Docetaxel Teva Pharma is water for injections.
Maltese: Is-solvent ta' Docetaxel Teva Pharma ilma għall-injezzjonijiet.
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Maltese: 72 ml ta' soluzzjoni ta' 27.73 mg/ml ta' docetaxel f'polysorbate 80 (ilvolum attwali huwa ta' 24.4 mg/0.88 ml).
English: Gastrointestinal haemorrhage (G3/4: 0.6%)
Maltese: Emoraġija gastrointestinali (G3/4:0.6%)
English: Anaemia (G3/4: 10.8%);
Maltese: Anemija (G3/4: 20.9%);
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 trattati b'docetaxel, doxorubicin u cyclophosphamide (TAC), ir-riskju li jiżviluppaw myelodysplasia jew lewkimija tat-tip myeloid tardivi, jirrikjedi l-immoniterjar ematoloġiku wara t-trattament.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriku u tat-tessut konnettiv
English: 2.1 Docetaxel 80 mg vial:
Maltese: 2.1 Kunjett ta' Docetaxel 80 mg
English: Tel: +44 1977 628 500
Maltese: United Kingdom Teva UK Limited Tel: +44 1977 628 500
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 u 1131l, rispettivament.
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Maltese: Ma nstabux differenzi statistikament validi bejn iż-żewġ gruppi ta' trattament rigward il-kwalità tal-Ħajja Globali.