FrancophonIA/ELRC3.0 huggingface dataset:
English: Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Maltese: L-akkumulazzjoni ta' ara-GTP f'ċelluli embrijoniċi tal-lewkemja tippermetti l-inkorporazzjoni preferenzjali ta' ara-GTP f'deoxyribonucleic acid (DNA) u twassal għal inibizzjoni ta' sintesi ta' DNA.
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid, sodium hydroxide (see section 2 “Atriance contains sodium”).
Maltese: • Is-sustanzi mhux attivi l-oħra huma sodium chloride, ilma għall-injezzjonijiet, hydrochloric acid, sodium hydroxide (ara sezzjoni 2 “Atriance fih sodium”).
English: The majority of side effects reported with Atriance were seen in adults, children and adolescents.
Maltese: Xi effetti sekondarji kienu rrapurtati aktar spiss f'pazjenti adulti.
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that the clearance (Cl) and Vss values for nelarabine and ara-G are comparable between the two groups.
Maltese: Tagħrif farmakokinetiku kombinat Fażi I ta' dożi ta' nelarabine minn 104 sa 2,900 mg/m indikaw li lvaluri ta' tneħħija (CI) u Vss għal nelarabine u ara-G huma komparabbli bejn iż-żewġ gruppi.
English: Time to complete response in both classifications of response ranged from 2.9 to 11.7 weeks.
Maltese: Iż-żmien għal rispons komplet fiż-żewġ klassifikazzjoniet ta' rispons kienu bejn 2.9 u 11.7 ġimgħa.
English: Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients (see sections 4.4 and 5.2).
Maltese: Ġew ikkurati numru insuffiċjenti ta' pazjenti ta' 65 sena u fuqhom b'nelarabine biex jiġi deċiż jekk dawn il-pazjenti jirrejaġġixxux b'mod differenti minn pazjenti iżgħar (ara sezzjoni 4.4 u 5.2).
English: In clinical studies, the 650 mg/m and 1,500 mg/m dose have both been used in patients in the age range 16 to 21 years.
Maltese: Fi studji kliniċi, kemm id-doża ta' 650 mg/m kif ukoll id-doża ta' 1,500 mg/m intużaw f'pazjenti bejn l-eta' ta' 16 u 21 sena.
English: Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Maltese: Lewkopenija, tromboċitopenija, anemija u newtropenja (li tinkludi newtropenja b'deni) ġew assoċjati ma' trattament b'nelarabine.
English: Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
Maltese: In-newrotossiċita' assoċjata ma' trattament b'nelarabine hija t-tossiċita' li tillimita d-doża (ara sezzjoni 4.4).
English: Children and adolescents (aged 21 years and younger) The recommended dose is 650 mg/m of body surface area per day.
Maltese: Adulti u adolexxenti (eta' ta' 16-il sena u aktar) Id-doża normali hija ta' 1,500 mg/m2tas-superfiċje tal-ġisem kuljum.
English: Compared to controls, nelarabine caused increased incidences of foetal malformations, anomalies, and variations in rabbits when given at doses approximately 24 % of the adult human dose on a mg/m basis during the period of organogenesis.
Maltese: Meta mqabbel ma' kontrolli, nelarabine kellu inċidenza akbar ta' malformazzjonijiet fetali, anomaliji u varjazzjonijiet fi fniek meta ingħata f'dożi ta' 24 % tad-doża ta' bniedem adult fuq bażi ta' mg/m waqt il-perjodu ta' organoġenesi.
English: The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine.
Maltese: Ir-rotta prinċipali ta' metaboliżmu ta' nelarabine hija O-demetilizzazzjoni b'adensoine deaminase biex jifforma ara-G, li jgħaddi minn idroliżi biex jifforma guanine.
English: • Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
Maltese: • Marda serja li teqred il-muskoli skeletali kkaratterizzata mill-preżenza ta' mijoglobina (prodott mit-tkissir taċ-ċelluli tal-muskoli) fl-awrina (rabdomijolisi), żjieda fil-creatine phosphokinase fid-demm.
English: Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Maltese: Sintomi fil-bidu jinkludu dardir u rimettar, qtugħ ta' nifs, taħbit irregolari tal-qalb, tissaħħab l-urina, telqa u/jew uġigħ ħafif fil-ġogi.
English: Ataxia
Maltese: Lewkopenja
English: It is likely that nelarabine overdose would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression and potentially death.
Maltese: Hemm probabbilta' li doża eċċessiva b'nelarabine tirriżulta f'newrotossiċita' qawwija (li tinkludi possibilment paraliżi, koma) soppressjoni tal-mudullun u potenzjalment il-mewt.
English: This is to be taken into consideration if you are on a controlled sodium diet.
Maltese: Għandha tingħata konsiderazzjoni ta' dan f'pazjenti fuq dieta kkontrollata ta' sodju.
English: These findings were demonstrated in patients with refractory leukaemia or lymphoma given a dose of 1,500 mg/m nelarabine (adults) or a 650 mg/m
Maltese: Dawn is-sejbiet intwerew f'pazjenti b'lewkemja jew limfoma refrattorja meta ngħataw doża ta' 1,500 mg/m ta' nelarabine (adulti) jew 650 mg/m
English: Peripheral neurological disorders (sensory and motor)
Maltese: Disturbi newroloġiċi periferali (tas-sensi u motorji) Komuni ħafna: 22
English: • Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
Maltese: • Żieda fil-livelli tal-kreatinina fid-demm (sinjal ta' problemi fil-kliewi li jistgħu iwasslu għal nuqqas ta' urinazzjoni).
English: Yearly
Maltese: Anzjani
English: Each vial contains 50 ml of solution.
Maltese: Kull kunjett fiha 50 ml ta' soluzzjoni.
English: Clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Maltese: Studji kliniċi b'nelarabine ma nkludewx numru suffiċċjenti ta' pazjenti ta' u 'l fuq minn 65 sena biex ikun determinat jekk jirrispondux differenti minn pazjenti iżgħar.
English: (32 %) and 32.1 l/m
Maltese: (32 %) u 32.1 l/m f'pazjenti adulti u pedjatriċi rispettivament.
English: This being an approval under exceptional circumstance and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Concomitant administration may reduce the efficacy of nelarabine and/or change the adverse event profile of either active substance.
Maltese: L-użu konkomitanti jista' jnaqqas l-effikaċja ta' nelarabine u/jew jibdel il-profil tal-effetti avversi ta' sustanza attiva jew oħra.
English: Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-infużjoni.
English: Atriance is not recommended for pregnant women.
Maltese: Atriance mhuwiex rakkomandat għal nisa tqal.
English: The appropriate dose of nelarabine must be transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered intravenously as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Maltese: Id-doża xierqa ta' nelarabine għandha tiġi trasferita f'boroż ta' infużjoni ta' polyvinylchloride (PVC) jew ethyl-vinylacetate (EVA) jew kontenituri tal-ħġieġ u tingħata fil-vini bħala infużjoni fuq medda ta' sagħtejn f'pazjenti adulti u bħala infużjoni fuq medda ta' siegħa f'pazjenti pedjatriċi.
English: See the leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Solution for infusion.
Maltese: Mhux applikabbli..
English: Thirteen (42 %) of the 31 patients treated with one prior induction regimen achieved a complete response overall.
Maltese: Tlettax (42 %) mill-31 pazjent trattati b'sistema ta' induzzjoni waħda qabel laħqu rispons komplet ġenerali.
English: Each ml contains 5 mg of nelarabine.
Maltese: Atriance fih 5 mg ta' nelarabine.
English: Renal and urinary disorders Blood creatinine increased
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Żieda tal-kreatinina fid-demm
English: Further data with respect to nelarabine and ara-G pharmacokinetics in the paediatric population are provided in other subsections.
Maltese: Aktar tagħrif fuq il-farmakokinetika ta' nelarabine u ara-G fil-popolazzjoni pedjatrika issibu f'subsezzjonijiet oħra.
English: Breast-feeding must be discontinued while you are taking Atriance.
Maltese: Għandek tieqaf tredda' waqt li tkun qed tieħu Atriance.
English: Wheezing
Maltese: UŻU
English: Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Maltese: Tilqim b'vaċċin ta' organiżmu ħaj għandu l-potenzjal li jikkawża infezzjoni f'pazjenti bl-immunita' kompromessa.
English: (25 %) in adult and paediatric patients, respectively.
Maltese: (35 %) f'pazjenti adulti u 10.
English: • a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: Stable for up to 8 hours at up to 30ºC once the vial is opened.
Maltese: Stabbli sa 8 sigħat sa temperatura ta' 30°Ċ la darba l- kunjett tkun infetħet.
English: Nelarabine at a dose of 1500 mg/m2/day was administered intravenously over two hours on days 1, 3 and 5 of a 21 day cycle.
Maltese: B'doża ta' 2200 mg/m2li ngħataw fi ġranet 1, 3 u 5 kull 21 ġurnata, 2 pazjenti żviluppaw newropatija tas-sensi axxendenti ta' grad 3.
English: The dose of Atriance you are given will be based on:
Maltese: Id-doża ta' Atriance li tingħata tkun ibbażata fuq:
English: Carcinogenicity testing of nelarabine has not been performed.
Maltese: Ma sarux testijiet fuq il-karċinoġeniċita' ta' nelarabine.
English: Dyspnoea
Maltese: Atassja
English: • Muscle weakness (possibly associated with peripheral neuropathy - see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Maltese: • Debbulizza tal-muskoli (li tista' tkun assoċjata ma' newropatija periferali - ara fuq), uġigħ fil ġogi, uġigħ fid-dahar; uġigħ fl-idejn u s-saqajn li jinkludi sensazzjoni ta' tnemnim u titrix.
English: Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents, used in chemotherapy to kill some types of cancer cells.
Maltese: Atriance jista' jġib ħedla jew ngħas, kemm waqt it-trattament u għal xi ftit ġranet wara t-trattament.
English: Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events (see section 4.2 - dose modification) and therefore concomitant intrathecal therapy and/or craniospinal irradiation is not recommended.
Maltese: Studji f'annimali wrew tossiċità fis-sistema riproduttiva (ara s-sezzjoni 5.3). Mhuwiex magħruf irriskju potenzjali fil-bnedmin; madankollu hemm ċans kbir li esponiment waqt it-tqala jwassal għal anomaliji u malformazzjonijiet tal-fetu.
English: Each ml of solution contains 5 mg of nelarabine.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 5 mg ta' nelarabine.
English: • Low blood levels of some substances: low calcium levels, which may cause muscle cramps, abdominal cramps or spasms low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels.
Maltese: • Nuqqas fil-livelli tad-demm ta' xi sustanzi: livelli baxxi ta' kalċju, li jistgħu jikkawżaw bugħawwieġijiet fil-muskoli, bugħawwieġijiet fiż-żaqq jew spażmi livelli baxxi ta' manjesju, li jistgħu jikkawżaw indebboliment fil-muskoli, konfużjoni, movimenti "mhux kontrollati", pressjoni għolja tad-demm, ritmi irregolari tal-qalb u indebboliment tar-riflessi meta l-livelli tal-manjesju fid-demm ikunu baxxi ħafna. livelli baxxi ta' potassju li jistgħu jikkawżaw sensazzjoni ta' indebboliment livelli baxxi ta' zokkor li jistgħu jikkawżaw dardir, għaraq, indebboliment, ħass ħażin, konfużjoni u alluċinazzjonijiet.
English: • Changes in the sense of feeling in hands or feet, muscle weakness appearing as difficulty getting up from a chair, or difficulty walking (peripheral neuropathy); reduced sensitivity to light touch, or pain; abnormal sensations such as burning and, prickling, a sensation of something crawling on the skin.
Maltese: • Bidla fis-sensazzjoni tal-idejn jew is-saqajn, debbulizza fil-muskoli li tidher bħal diffikulta' biex tqum minn fuq siġġu, jew diffikulta' biex timxi (newropatija periferali); nuqqas ta' sensittivita'
English: EU/1/07/403/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/403/001-002
English: Hepatobiliary disorders Hyperbilirubinaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika Newtropenja bid-deni
English: In a cross-study analysis using data from four Phase I studies, the pharmacokinetics of nelarabine and ara-G were characterized in patients aged less than 18 years and adult patients with refractory leukaemia or lymphoma.
Maltese: F'analiżi ta' studji differenti bl-użu ta' data minn erbgħa studji ta' Fażi I, il-farmakokinetika ta' nelarabine u ara-G kienu kkaraterizzati f'pazjenti ta' eta' ta' anqas minn 18-il sena u f'pazjenti adulti b'lewkemja jew limfoma refrattarja.
English: Rare: N/A
Maltese: IL-PROVVISTA U L
English: These may affect up to 1 in 1,000 people treated with Atriance
Maltese: Dawn jistgħu jaffettwaw sa 1 f'kull 1,000 minn nies trattati b'Atriance:
English: In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Maltese: O-demetilizzat biex jifforma guanine.
English: Novartis Farma S.p.A. Tel: +39 02 96 54 1
Maltese: Tel: +39 02 96 54 1
English: Tumour size ≤ 2 cm >2 cm
Maltese: Daqs tat-tumur 2 cm >2 cm
English: North Harrow, Middlesex HA1 4HF United Kingdom
Maltese: North Harrow, Middlesex HA1 4HF Ir-Renju Unit
English: Date of latest renewal: 23rd February 2017
Maltese: Data tal-aħħar tiġdid: Frar 23, 2017
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
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: FAC (n=521)
Maltese: (n=521)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Mejju 2012
English: • pneumonia (infection of the lungs)
Maltese: • pulmonite (infezzjoni fil-pulmuni)
English: Accord Healthcare Limited Sage House
Maltese: Accord Healthcare Limited
English: TAC (n=539)
Maltese: (n=539)
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; RE = riċettur tal-estroġenu RP = riċettur tal-proġesteron a RE/RP-negattiv jew Grad 3 jew daqs tat-tumur >5 cm
English: Overall Age category 1 <50 years ≥50 years Age category 2 <35 years ≥35 years
Maltese: Kategorija ta' età 2 <35 sena ≥35 sena
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Maltese: Docetaxel hu metabolizzat minn CYP3A4 u prednisone hu magħruf li jinduċi CYP3A4.
English: Docetaxel Accord contains ethanol (alcohol)
Maltese: Docetaxel Accord fih l-ethanol (l-alkoħol)
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid anhydrous.
Maltese: Eċċipjenti: polysorbate 80, ethanol anhydrous (ara l-fuljett għal aktar informazzjoni) u citric acid anhydrous.
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, Taxanes, ATC Code: L01CD02
Maltese: Aġenti antineoplastiċi, alkalojdi tal-pjanti u prodotti naturali oħra, Taxanes, Kodiċi ATC:
English: Consideration should be given to possible effects on the central nervous system.
Maltese: Għandha tingħata kunsiderazzjoni għall-effetti possibbli fuq is-sistema nervuża ċentrali.
English: Summary of the safety profile for all indications
Maltese: Sommarju tal-profil ta' sigurtà għall-indikazzjonijiet kollha
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%
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,
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Maltese: Docetaxel użat flimkien ma' doxorubicin u cyclophosphamide: terapija miżjuda
English: Other medicines and Docetaxel Accord
Maltese: Mediċini oħra u Docetaxel Accord
English: Acute leukaemia / Myelodysplastic syndrome
Maltese: Lewkimja akuta/Sindrome ta' majilodisplastik.
English: Docetaxel Accord 160 mg/8 ml contains
Maltese: Docetaxel Accord 160 mg/8 ml fih
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 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: Docetaxel Accord 20 mg/1 ml contains
Maltese: Docetaxel Accord 20 mg/1 ml fih
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: (eż. ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin u voriconazole) għandu jiġi evitat (ara sezzjoni 4.5).
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), prodotti mediċinali 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: Docetaxel Accord contains alcohol.
Maltese: Docetaxel Accord fih l-alkoħol.
English: Alopecia (G3/4: 10.9%)
Maltese: Alopeċja (G3/4:10.9%)
English: Docetaxel Accord 80 mg/4 ml contains
Maltese: Docetaxel Accord 80 mg/4 ml fih
English: Dyspnoea;
Maltese: Dispepsja;
English: Oral candidiasis (G3/4: < 1%)
Maltese: Candidiasis orali(G3/4: <
English: Infections and infestations Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Maltese: Infezzjonijiet (G3/4: 5.7%; li jinkludu sepsis u pulmonite, fatali f'1.7%)
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid anhydrous.
Maltese: - Is-sustanzi l-oħra huma polysorbate 80, ethanol anidru (ara sezzjoni 2) u aċidu ċitriku anhydrous.
English: Neutropenia (G3/4: Anaemia (G3/4:
Maltese: Newtropenija (G3/4: Anemija (G3/4:
English: Hazard ratio*
Maltese: Il-proporzjon tar-riskju*
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Maltese: Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI: 34.4 - 42.1) fil-fergħa AT u 31.9 ġimgħat (95% CI: 27.4
English: Stomatitis/Pharyngitis (G3/4: Vomiting (G3/4: 1.2%)
Maltese: Stomatite/Farinġite (G3/4: Rimettar (G3/4: 1.2%)
English: Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
Maltese: L-ewwel episodju: naqqas id-dożi ta' docetaxel u 5-FU b'20%.
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 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 Accord 20 mg/1 ml concentrate for solution for infusion Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Maltese: Docetaxel Accord 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni Kull kunjett ta' konċentrat fih 0.5ml ta' ethanol anhydrous (395mg).
English: Docetaxel in combination with capecitabine
Maltese: Docetaxel użat flimkien ma' capecitabine
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: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Maltese: Docetaxel Accord 160 mg/8 ml konċentrat għal soluzzjoni għall-infużjoni Kull kunjett ta' konċentrat fih 4 ml ta' ethanol anhydrous (3.16 g).
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Maltese: Għejja/indeboliment (G3/4: 5%); Edima periferika (G3/4: 1%);
English: Neutropenia (G4: 76.4%); Anaemia (G3/4: 8.9%);
Maltese: Newtropenija (G4: 76.4%); Anemija (G3/4: 8.9%);
English: 1060 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
Maltese: 1060 pazjent ġew magħżula b'mod arbitrarju biex jirċievu jew docetaxel 75 mg/m2 mogħti siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (539 pazjent fil-fergħa tat-TAC ), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclosphosphamide 500 mg/m2 (521
English: 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Maltese: 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 3.16 g ethanol anhydrous kull kunjett, ekwivalenti għal 80 ml ta' birra jew 33 ml inbid għal.
English: 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Maltese: 50 vol% ethanol anhydrous (alkoħol), jiġifieri sa 1.58 g ethanol anhydrous kull kunjett, ekwivalenti għal 40 ml ta' birra jew 17 ml inbid għal.
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Maltese: Ġew irrapportati s-sindromu ta' dieqa respiratorja akuta, pulmonite/pnewmonja tal-interstizjum, mard interstizjali tal-pulmun, fibrożi tal-pulmun u insuffiċjenza respiratorja u li dawn jistgħu jkunu assoċjati ma' riżultat fatali.