FrancophonIA/ELRC3.0 huggingface dataset:
English: The following convention has been utilised for the classification of frequency: 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), and not known (cannot be estimated from the available data).
Maltese: Il-konvenzjoni li ġejja kienet utilizzata għall-klassifikazzjoni ta' frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Nelarabine u ara-G ma tellfux b'mod sinifikanti l-attivitajiet tal-isoenżimi CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4 in vitro taċ-ċitokroma ewlenija talfwied, P450 (CYP).
English: This medicinal product contains 1.725 mg/ml (75 micromols/ml) of sodium.
Maltese: Dan il-prodott mediċinali fih 1.725 mg/ml (75 micromols/ml) ta' sodium.
English: Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Maltese: Data tal-aħħar tiġdid: 16 ta' Ġunju 2017
English: • Muscle pain.
Maltese: • Uġigħ fil-muskoli.
English: (36 %) in paediatric patients] on day 1.
Maltese: (36%) f'pazjenti pedjatriċi] f'jum 1.
English: Excipients: Sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Maltese: Sodium chloride, ilma għall-injezzjoni, hydrochloric acid, sodium hydroxide.
English: Atriance contains sodium
Maltese: Atriance fih sodium
English: For ara-G, mean VSS/F values were 44.8 l/m
Maltese: Għal ara-G, il-valuri medja VSS/F kienu ta' 44.8 l/m
English: • Problems with memory, feeling disoriented; blurred vision; altered or loss of sense of taste (dysgeusia).
Maltese: • Problemi bil-memorja, sensazzjoni ta' disorjentament; vista mċajpra; nuqqas jew bdil fis sens tat-togħma (dysgeusia).
English: Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Maltese: Il-valuri medji fil-plażma ta' ara-G Cmax u AUCinf kienu 115 μM (16 %) u 571 μM.h (30 %) rispettivament.
English: The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders (somnolence, peripheral neurological disorders [sensory and motor], dizziness, hypoaesthesia, paraesthesia, headache); and pyrexia.
Maltese: L-aktar effetti avversi li seħħew spiss kienu għejja, disturbi gastrointestinali, disturbi ematoloġiċi, disturbi respiratorji, disturbi tas-sistema nervuża (ngħas, disturbi newroloġiċi periferali [sensorji u motorji], sturdament, ipoesteżija, parasteżija, uġigħ ta' ras); u deni.
English: Metabolism and nutrition disorders Hypoglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipogliċemija
English: Mean (%CV) intracellular araGTP Cmax and AUC values were 95.6 µM (139 %) and 2214 µM.h (263 %) at this dose.
Maltese: Il-medja (%CV) ta' ara-GTP Cmax fiċ-ċellula u l-valuri AUC kienu 95.6 μM (139 %) u 2214 μM.h (263 %) b'din id-doża.
English: A total of 6 patients (21 %) [95 % CI: 8 %-41 %] achieved a complete response with or without haematological recovery.
Maltese: Total ta' 6 pazjenti (21 %) [95 % CI 8 %-41 %} waslu għal fejqan komplet bi jew mingħajr rkupru fid-demm.
English: Adults and children in clinical studies were categorized into the three groups according to renal impairment: normal with Clcr greater than 80 ml/min (n = 56), mild with Clcr equalling 50 to 80 ml/min (n = 12), and moderate with Clcr less than 50 ml/min (n = 2).
Maltese: Fi studju kliniċi adulti u tfal kienu maqsuma fi tlett gruppi skont l-indeboliment fil-kliewi: normali b'CIcr aktar minn 80 ml/min (n =56), ħafif b'CIcr minn 50 sa 80 ml/min (n =12), u moderat b'CIcr ta' anqas minn 50 ml/min (n =2).
English: Data from NCI studies/compassionate use programme and phase I studies
Maltese: Data minn studji tal-NCI/programm dwar l-użu kompassjonali u studji Fażi I
English: Each ml of solution contains 1.725 mg (75 micromols) of sodium.
Maltese: Kull ml ta' soluzzjoni fih 1.725 mg (75 micromols) ta' sodju.
English: Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome - 7 cases (see sections 4.2 and 4.4)
Maltese: Neoplażmi beninni u malinni (inklużi ċesti u polipi) Is-sindromu ta' diżintegrazzjoni tat-tumur - 7 każijiet (ara sezzjonijiet 4.2 u 4.4)
English: Mean plasma ara-G Cmax and AUCinf values were 60.1 µM (17 %) and 212 µM.h (18 %), respectively.
Maltese: Il-valuri medji fil-plażma ta' ara-G Cmax u AUCinf kienu 60.1 μM (17 %) u 212 μM.h (18 %) rispettivament.
English: Adult clinical study in relapsed or refractory T-ALL and T-LBL In an open-label study carried out by the Cancer and Leukaemia Group B and the Southwest Oncology Group, the safety and efficacy of nelarabine were evaluated in 39 adults with T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL).
Maltese: Studju kliniku fost l-adulti b'T-ALL u T-LBL b'rikaduta jew refrattorja Fi studju open-label li sar mill Cancer and Leukemia Group B u s-Southwest Oncology Group,, issigurta' u l-effikaċja ta' nelarabine kienu evalwati f'39 adult b'lewkemja likfoblastika akuta taċ-ċellola T (T-ALL) jew limfoma limfoblastika (T-LBL).
English: You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment.
Maltese: Ikollok infużjoni (taqtir) darba kuljum f'jiem 1, 3 u 5 tat-trattament.
English: Atriance 5 mg/ml solution for infusion nelarabine
Maltese: Atriance 5 mg/ml soluzzjoni għall-infużjoni nelarabine
English: Nelarabine has been administered in clinical studies up to a dose of 75 mg/kg (approximately 2,250 mg/m2) daily for 5 days to a paediatric patient, up to a dose of 60 mg/kg (approximately 2,400 mg/m2) daily for 5 days to 5 adult patients and up to 2,900 mg/m in a further 2 adults on days 1,
Maltese: Nelarabine ingħata fi studji kliniċi sa doża ta' 75 mg/kg (bejn wieħed u ieħor 2,250 mg/m2) kuljum għal ħamest ijiem lil pazjent pedjatriku wieħed, sa doża ta' 60 mg/kg (bejn wieħed u ieħor 2,400 mg/m kuljum għal ħamest ijiem lil 5 pazjenti adulti u sa 2,900 mg/m lil 2 adulti oħra f'jiem 1,
English: Atriance 5 mg/ml solution for infusion
Maltese: Atriance 5 mg/ml soluzzjoni għall-infużjoni
English: Musculoskeletal and connective tissue disorders Muscle weakness
Maltese: Disturbi muskolu-skeltriċiu tat-tessuti konnettivi Debbolizza fil-muskoli
English: Clinical efficacy and data
Maltese: Effikaċja klinika u dejta
English: Of the 39 patients who had received two or more prior induction regimens, 5 (13 %) [95 % CI: 4 %27 %] achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts) and 9 (23 %) [95 % CI: 11 %-39 %] achieved complete responses with or without full haematological recovery.
Maltese: Mit-39 pazjent li qabel kienu rċevew żewġ sistemi ta' kura ta' induzzjoni jew aktar qabel 5 (13 %) [95 % CI: 4 %-27 %] kisbu rispons komplet (numru ta' ċelluli embrijoniċi tal-mudullun ≤ 5 %, ebda evidenza oħra ta' mard u rkupru komplet tal-għadd taċ-ċelluli tad-demm periferali) u 9 (23 %) [95 %] CI: 11 %-39 %] kisbu rispons komplet bi jew mingħajr irkupru ematoloġiku komplet.
English: Renal clearance averaged 9.0 l/h/m
Maltese: It-tneħħija mill-kliewi kienet medja ta' 9.0 l/siegħa/m
English: The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m2) and children (650 mg/m2) is based on data from 103 adults and 84 paediatric patients respectively.
Maltese: Il-profil ta' sigurta' minn studji kliniċi prinċipali dwar-dożi ta' nelarabine rakkommandati fl-adulti (1,500 mg/m u t-fal (650 mg/m huwa bbażat fuq data minn 103 pazjent adult u 84 pazjenti pedjatriċi rispettivament.
English: The apparent clearance of ara-G (Cl/F) is comparable between the two groups [9.5 l/h/m
Maltese: It-tneħħija evidenti ta' ara-G (CI/F) jista' jitqabbel bejn iż-żewġ gruppi [9.5 l/siegħa/m
English: The mean apparent clearance (Cl/F) of ara-G was about 7 % lower in patients with mild renal impairment than in patients with normal renal function (see section 4.2).
Maltese: Il-medja ta' tneħħija evidenti (CI/F) ta' ara-G kienet bejn wieħed u ieħor 7% anqas f'pazjenti b'indeboliment tal-kliewi ħafif minn pazjenti b'funzjoni normali tal-kliewi (ara sezzjoni 4.2).
English: Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by adenosine deaminase (ADA) to ara-G and then phosphorylated intracellularly by deoxyguanosine kinase and deoxycytidine kinase to its 5'-monophosphate metabolite.
Maltese: Nelarabine jiġi demetilizzat malajr minn adenosine deaminase (ADA) għal ara-G u mbagħad fosforat fiċ-ċellula b'deoxyguanosine kinase u deoxycytidine kinase għall- prodott tal-metaboliżmu tiegħu 5' monophoshate.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01B B 07
Maltese: Aġenti antineoplastiċi, aġenti kontra sustanzi ffurmati filmetaboliżmu, analogi tal-purine, Kodiċi ATC:
English: Other medicines and Atriance
Maltese: Mediċini oħra u Atriance
English: • Lowered blood pressure.
Maltese: • Pressjoni tad-demm li tbaxxiet.
English: Nelarabine showed in vitro cytotoxicity to monocytes and macrophages.
Maltese: Nelarabine wera ċitotossiċita' in vitro għall-monocytes u l-macrophages.
English: Nelarabine and 9-β-Darabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2).
Maltese: Nelarabine u 9-β-Darabinofuranosylguanine (ara-G) jitneħħew mil-ġisem parzjalment mill-kliewi (ara sezzjoni 5.2).
English: Respiratory, thoracic and mediastinal disorders Pleural effusion
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Effużjoni fil-plewra
English: Nelarabine and ara-G are rapidly eliminated from plasma with a half-life of approximately 30 minutes and 3 hours, respectively.
Maltese: Nelarabine u ara-G jitneħħew malajr mill-plażma b'half life ta' bejn wieħed u ieħor 30 minuta u 3 sigħat rispettivament.
English: Four (44 %) of the nine refractory patients experienced a complete response to nelarabine.
Maltese: Erbgħa (44 %) mid-disa' pazjenti refrattarji esperjenzaw rispons komplet għal nelarabine.
English: • Feeling of an upset stomach (nausea); being sick/throwing up (vomiting); diarrhoea; constipation
Maltese: • Sensazzjoni ta' taqligħ fl-istonku (dardir); tirremetti (rimettar); dijarrea; stitikezza
English: • Feeling generally weak and tired (temporary anaemia).
Maltese: • Sensazzjoni ġenerali ta' debbolizza u għejja (anemija temporanja).
English: Nelarabine was mutagenic to L5178Y/TK mouse lymphoma cells with and without metabolic activation.
Maltese: Nelarabine instab li jikkawża mutaġeniċità f'ċelluli ta' limfoma L5178Y/TK fil-ġurdien bi u mingħajr attivazzjoni metabolika.
English: This medicine contains at least 23 mg sodium per dose.
Maltese: Din il-mediċina fiha mill-inqas 23 mg ta' sodium kull doża.
English: 250 mg/50 ml
Maltese: Soluzzjoni għall-infużjoni 250 mg/50 ml
English: Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
Maltese: Ilma għall-injezzjonijiet Hydrochloric acid (biex jaġġusta l-pH) Sodium hydroxide (biex jaġġusta l-pH)
English: In addition to the adverse reactions seen in the pivotal clinical studies, there are also data from 875 patients from NCI studies/compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Maltese: Barra r-reazzjonijiet avversi li kien hemm fl-istudji kliniċi prinċipali, hemm ukoll data minn 875 pazjent minn studji tal-NCI/ programm dwar l-użu kompassjonali (694 pazjent) u dwar nelarabine Fażi I (181 pazjent).
English: Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater.
Maltese: Nelarabine għandu jitwaqqaf ma' l-ewwel sinjal ta' effetti newroloġiċi tal-Eventi Avversi tal-Kriterji Komuni ta' Terminoloġija' tal-Istitut Nazzjonali tal-Kanċer (NCI-CTCAE) grad 2 jew aktar.
English: Nelarabine and ara-G are extensively distributed throughout the body based on combined Phase I pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m2.
Maltese: Nelarabine u ara-G jinfirxu mal-ġisem kollu b'mod estensiv ibbażat fuq data farmakokinetika kombinata f'Fażi I b'dożi ta nelarabine ta' 104 sa 2,900 mg/m2.
English: • High body temperature (fever); tiredness; feeling weak/loss of strength.
Maltese: • Temperatura għolja tal-ġisem (deni); għeja; sensazzjoni ta' debbulizza/nuqqas ta' saħħa.
English: How to store Atriance
Maltese: X'fih Atriance
English: Paediatric clinical study in relapsed or refractory T-ALL and T-LBL In an open-label, multicenter study carried out by Childrens Oncology Group, nelarabine was administered intravenously over 1 hour for 5 days to 151 patients ≤ 21 years of age, 149 of whom had relapsed or refractory T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Maltese: Studju kliniku fost it-tfal b'T-ALL u T-LBL b'rikaduta jew refrattorja Fi studju open-label li sar f'aktar minn ċentru wieħed miċ-Children's Oncology Group, nelarabine ingħata fil-vina fuq siegħa għal 5 ijiem lil 151 pazjent ≤ 21 sena, li minnhom 149 rkadew jew baqgħu b'lewkemja taċ-ċellula T limfoblastika akuta (T-ALL) jew limfoma limfoblastika taċ-ċellula T (T-LBL).
English: Neurotoxicity is the dose-limiting toxicity of nelarabine.
Maltese: Newrotossiċità hija t-tossiċità li tillimita d-doża ta' nelarabine.
English: Atriance is supplied in packs of 1 vial or 6 vials.
Maltese: Atriance issibu f'pakketti ta' kunjett 1 jew 6 kunjetti.
English: These reactions have included altered mental states including severe somnolence, confusion and coma, central nervous system effects including convulsions, ataxia and status epilepticus, and peripheral neuropathy including hypoesthesia ranging from numbness and paresthesias to motor weakness and paralysis.
Maltese: Dawn ir-reazzjonijiet inkludew bdil fl-istat mentali bħal ħedla severa ta' nagħas, konfużjoni u koma, effetti fis-sistema nervuża ċentrali li jinkludu aċċessjonijiet, atassja u l-istatus epilepticus,u newropatija periferali inkluża ipoestesija minn nuqqas ta' sensazzjoni u parasteżiji sa indeboliment tas-sistema motorja u paraliżi.
English: Decreased renal function, which is more common in the elderly, may reduce ara-G clearance (see section 4.2).
Maltese: Funzjoni mnaqqsa talkliewi, li hija aktar komuni fl-anzjani, tista' tnaqqas it-tneħħija ta' ara-G (ara sezzjoni 4.2).
English: Each vial contains 250 mg of nelarabine.
Maltese: Kull kunjett fiha 250 mg ta' nelarabine.
English: Infections and infestations Infection (including but not limited to; sepsis, bacteraemia, pneumonia, fungal infection)
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni (li tinkludi imma mhux limitata għal sepsis, il-preżenza ta' batterji fid-demm, pnewmonja, u infezzjoni fungali)
English: Rhabdomyolysis, blood creatine phosphokinase increased (see “Postmarketing data”)
Maltese: Rabdomijolisi, żjieda ta' creatine phosphokinase fid-demm (ara “Dejta ta' wara t-tqegħid fis-suq”)
English: There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Maltese: Kien hemm rapporti ta' avvenimenti assoċjati ma' demajelinizzazzjoni u newropatiji periferali axxendenti li jixbħu fid-dehra lis-Sindrome ta' Guillain Barré.
English: 6 x 50 ml vials
Maltese: 6 x 50 ml kunjetti
English: Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Maltese: Atriance huwa stabbli sa 8 sigħat f'temperatura ta' 30°Ċ la darba l- kunjett tkun infetħet.
English: In 28 adult patients, 24 hours after nelarabine infusion on day 1, mean urinary excretion of nelarabine and ara-G was 5.3 % and 23.2 % of the administered dose, respectively.
Maltese: Fi 28 pazjent adult, 24 siegħa wara infużjoni b'nelarabine f'jum 1, il-medja ta' tneħħija fl-awrina ta' nelarabine u ara-G kienet ta' 5.3 % u 23.2 % taddoża meħuda, rispettivament.
English: In a pharmacokinetic/pharmacodynamic cross study analysis, race had no apparent effect on nelarabine, ara-G, or intracellular ara-GTP pharmacokinetics.
Maltese: F'analiżi ta' studji farmakokinetiċi/farmakodinamiċi differenti ir-razza ma kellha ebda effett evidenti fuq ilfarmakokinetika ta' nelarabine, ara-G jew ara-GTP ġewwa ċ-ċellula.
English: (%CV) VSS values were 115 l/m
Maltese: Speċifikament, għal nelarabine, il valuri medja (%CV) VSS kienu ta' 115 l/m
English: Infection and infestations
Maltese: Infezzjonijiet u infestazzjonijiet
English: Five of the 28 patients (18 %) [95 % CI: 6 %-37 %] treated with nelarabine achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts).
Maltese: Ħamsa mit-tmienja u għoxrin pazjent (18 %) [95 % CI 6 %-37 %] trattati b'nelarabine waslu għal fejqan komplet (numru ta' ċelluli embrijoniċi fil-mudullun ta' ≤ 5%, lebda evidenza oħra ta' mard, u rkupru komplet tal-għadd periferali tad-demm).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Tumour lysis syndrome (see also data from compassionate use programme and nonpivotal studies)
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi) Sindromu ta' diżintegrazzjoni tat-tumur (ara wkoll data minn programm għal użu kompassjonali u studji mhux prinċipali)
English: Cytotoxic
Maltese: Ċittotossiku
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Madankollu huwa magħruf li nelarabine huwa ġenotossiku għal ċelluli mammiferi (ara sezzjoni 5.3).
English: 1 x 50 ml vial
Maltese: 1 x 50 ml kunjett
English: Median overall survival was 20.6 weeks [95 % CI: 10.4-36.4].
Maltese: Il-medja totali ta' sopravivenza kienet ta' 20.6 ġimgħa [95 % CI: 10.
English: Nelarabine and ara-G are not substantially bound to human plasma proteins (less than 25 %) in vitro, and binding is independent of nelarabine or ara-G concentrations up to 600 µM.
Maltese: Nelarabine u ara-G ma jintrabtux b'mod sostanzjali mal-proteini fil-plażma tal-bniedem (anqas minn 25 %) in vitro u r-rabta hija indipendenti mill-livelli ta' nelarabine jew ara-G sa 600 μM.
English: Paediatric patients After infusion of 400 or 650 mg/m nelarabine over one hour in 6 paediatric patients, mean (%CV) plasma nelarabine Cmax and AUCinf values, adjusted to a 650 mg/m dose, were 45.0 µM (40 %) and
Maltese: Wara infużjoni ta' 400 jew 650 mg/m ta' nelarabine f'siegħa f'sitt pazjenti pedjatriċi, il-valuri medja (%CV) Cmax u AUCinf ta' nelarabine fil-plażma, aġġustati għal doża ta' 650 mg/m kienu ta' 45.0 μM (40 %) u 38.0 μM.h (39 %) rispettivament.
English: Duration of response in both classifications of response ranged between 4.7 and 36.4 weeks and median overall survival was 13.1 weeks [95 % CI: 8.7-17.4] and survival at one year was 14 % [95 % CI: 3 %-26 %].
Maltese: Id-dewmien tarrispons fiż-żewġ klassifikazzjonijiet ta' rispons kien ta' bejn 4.7 u 36.4 ġimgħat u l-medja ta' sopravivenza totali kienet ta' 13.1 ġimgħa [95 % CI: 8.7-17.4] u s-sopravivenza wara sena kienet ta' 14 % [95 % CI: 3 %-26 %].
English: Plasma ara-G Cmax values generally occurred at the end of the nelarabine infusion and were generally higher than nelarabine Cmax values, suggesting rapid and extensive conversion of nelarabine to ara-G. After infusion of 1,500 mg/m nelarabine over two hours in adult patients, mean (%CV) plasma nelarabine Cmax and AUCinf values were 13.9 µM (81 %) and 13.5 µM.h (56 %) respectively.
Maltese: Wara l-infużjoni ta' 1,500 mg/m ta' nelarabine fuq sagħtejn f'pazjenti adulti, il-valuri medja (%CV) ta' Cmaxu AUCinf ta' nelarabine fil-plażma kienu 13.9 μM (81 %) u 13.5 μM.h (56 %) rispettivament.
English: On the day 1, 3, and 5 schedule, Cmax and AUC(0-t) values on day 3 were approximately 50 % and 30 %, respectively, greater than Cmax and AUC(0-t) values on day 1.
Maltese: Fl-iskeda tal-1, 3. u 5 ġurnata, il-valuri Cmax u AUC(0-t) f'jum 3 kienu bejn wieħed u ieħor ta' 50 % u 30 % rispettivament, akbar mill-valuri Cmax u AUC(0-t) f'jum 1.
English: Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens and 31 whom had received one prior induction regimen, were treated with 650 mg/m2/day of nelarabine administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.
Maltese: Erba' u tmenin (84) pazjent, li 39 minnhom kienu ħadu tnejn jew aktar sistemi ta' induzzjoni qabel u 31 minnhom kienu ħadu sistema ta' induzzjoni waħda qabel, kienu ttrattati b'650 mg/m kuljum ta' nelarabine li ingħatat fuq siegħa ġol-vina kuljum għal ħamest ijiem konsekuttivi b'ripetizzjoni kull 21 ġurnata.
English: • Staff should be trained in how to handle and transfer the medicinal product.
Maltese: • L-impjegati għandhom jiġu mħarrġa kif jimmaniġġjaw u jittrasferixxu il-prodott mediċinali.
English: The monophosphate metabolite is subsequently converted to the active 5'-triphosphate from, ara-GTP.
Maltese: Il-prodott talmetaboliżmu monophosphate imbagħad jinbidel fil-5' triphosphate attiv ara-GTP.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused histopathological changes to the central nervous system (white matter vacuolation and degenerative changes in cerebrum, cerebellum and spinal cord) of monkeys after daily treatment with nelarabine for 23 days, at exposures below the human therapeutic exposure.
Maltese: Reazzjonijiet avversi li ma kienux osservati fi studji kliniċi, imma li dehru f'annimali f'livelli ta' esponimenti simili għall-livelli ta' esponiment kliniku u bil-possibilta' ta' rilevanza possibli għall-użu kliniku kienu kif ġej: nelarabine ikkawża bidliet istopatoloġiċi fis-sistema nervuża ċentrali (materja bajda waqt il-formazzjoni ta' spazji żgħar fiċ-ċitoplażma taċ-ċellula, u bidliet diġenerattivi fiċ-ċerebru, ċervellett, u spina dorsali) ta' xadini wara trattament kuljum b'nelarabine għal 23 ġurnata, b'esponimenti anqas mill-esponimenti terapewtiċi fil-bniedem.
English: There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Maltese: Kien hemm rapporti ta' infezzjonijiet opportunistiċi xi kultant fatali f'pazjenti li kienu qed jirċievu terapija b'nelarabine.
English: Signs of an infection include: fever serious deterioration of your general condition local symptoms such as sore throat, sore mouth or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection) Tell your doctor immediately if you get any of these.
Maltese: Sinjali ta' infezzjoni jinkludu: deni deterjorament serju fil-kundizzjoni ġenerali tiegħek sintomi lokali bħal uġigħ fil-griżmejn, uġigħ fil-ħalq jew problemi urinarji (per eżempju, sensazzjoni ta' ħruq waqt l-urinazzjoni li tista' tkun infezzjoni fl-urina)
English: Two paediatric patients had fatal neurological events.
Maltese: Żewġ pazjenti pedjatriċi kellhom avvenimenti newroloġiċi fatali.
English: Cleft palate was seen in rabbits given a dose approximately 2-fold the adult human dose, absent pollices in rabbits given a dose approximately 79 % of the adult human dose while absent gall bladder, accessory lung lobes, fused or extra sternebrae and delayed ossification was seen at all doses.
Maltese: Kien innutat cleft palate fi fniek li ngħataw doża ta' bejn wieħed u ieħor darbtejn id-doża ta' bniedem adult, swaba nieqsa fi fniek li ngħataw doża ta' bejn wieħed u ieħor 79 % tad-doża ta' bniedem adult filwaqt li nuqqas ta' marrara, lobi supplementari tal-pulmun, għadam tannofs tas-sider magħqud jew żejjed u ttardjar fl-ossifikazzjoni dehru bid-dożi kollha.
English: Ara-G is excreted by the kidney to a greater extent (20 to 30 % of the administered nelarabine dose).
Maltese: Ħafna minn ara-G jitneħħa mill-kliewi (minn 20 sa 30 % tad-doża ta' nelarabine meħuda).