FrancophonIA/ELRC3.0 huggingface dataset:
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Maltese: Data disponibbli attwalment hija deskritta fis-sezzjonijiet 4.8, 5.1, u 5
English: Excipients: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid.
Maltese: Eċċipjenti: potassium dihydrogen phosphate (E340), sodium hydroxide (E524), u hydrochloric acid.
English: Serious bleeding-related adverse drug reactions, some of which lead to a fatal outcome, such as central nervous system (CNS) haemorrhage (2%) and gastrointestinal (GI) haemorrhage (2%), in the context of severe thrombocytopaenia, were reported in patients receiving decitabine.
Maltese: Reazzjonijiet avversi serji għall-mediċina marbuta mal-fsada, li xi wħud minnhom iwasslu għal mewt, bħal emorraġija fis-sistema nervuża ċentrali (CNS) (2%) u emorraġija gastrointestinali (GI) (2%), filkuntest ta' tromboċitopenija qawwija, kienu rrappurtati f'pazjenti li kienu qed jieħdu decitabine.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: 9 DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: Decitabine (5-aza-2-deoxycytidine) is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death.
Maltese: Decitabine (5-aza-2'-deoxycytidine) huwa analogu ta' cytidine deoxynucleoside li jimpedixxi b'mod selettiv il-methyltransferases tad-DNA f'dożi baxxi, li jwassal għal hypomethylation tal-promutur talġene li tista' twassal għall-attivazzjoni mill-ġdid tal-ġeni li jrażżnu t-tumur, induzzjoni tad-divrenzjar taċ-ċelluli jew xjuħija taċ-ċellula segwit minn mewt programmat taċ-ċellula.
English: Table 3: Summary of population PK analysis for a typical patient receiving daily 1-hour infusions of Dacogen 20 mg/m2 over 5 days every 4 weeks
Maltese: Tabella 3: Sommarju tal-analiżi tal-PK tal-popolazzjoni għal pazjent tipiku li jirċievi infużjonijiet ta' siegħa ta' 20 mg/m2 ta' Dacogen kuljum fuq perijodu ta' 5 ijiem kull
English: This medicine contains 0.29 mmol (6.67 mg) sodium per vial.
Maltese: Din il-mediċina fiha 0.29 mmol (6.67 mg) ta' sodium f'kull kunjett.
English: 5 PHARMACOLOGICAL PROPERTIES
Maltese: 5 PROPRJETAJIET FARMAKOLOĠIĊI
English: The reasons for treatment discontinuation included disease progression (12 [70.6%] subjects), subjects proceeding to transplant (3 [17.6%]), investigator decision (1 [5.9%]), and “other” (1 [5.9%]).
Maltese: 6%] individwu), individwi li pproċedew għal trapjant (3 [17.6%]), deċiżjoni tal-investigatur (1 [5.9%]), u “oħrajn” (1 [5.9%]).
English: After reconstitution, 1 ml concentrate contains 5 mg decitabine.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' konċentrat 5 mg ta' decitabine.
English: Each vial contains 50 mg decitabine.
Maltese: Kull kunjett fih 50 mg decitabine.
English: Population pharmacokinetic analysis showed that decitabine pharmacokinetics are not dependent on age (range studied 40 to 87 years; median 70 years).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni uriet li l-farmakokinetika ta' decitabine mhijiex dipendenti fuq l-età (ġiet studjata medda ta' etajiet bejn 40 u 87 sena; medjan ta' 70 sena).
English: Other medicines and Dacogen
Maltese: Mediċini oħra u Dacogen
English: Overall survival and complete remission rates in pre-specified disease-related sub-groups (i.e., cytogenetic risk, Eastern Cooperative Oncology Group [ECOG] score, age, type of AML, and baseline bone marrow blast count) were consistent with results for the overall study population.
Maltese: Sopravivenza globali u rati ta' kontroll sħiħ tal-marda f'sottogruppi speċifikati minn qabel marbuta mal-marda (ie, ir-riskju ċitoġeniku, il-Punteġġ tal-Koperattiva tal-Grupp tal-Onkoloġija tal-Lvant [ECOG-Eastern Cooperative Oncology Group], l-età, it-tip ta' AML, u l-linja bażi tal-għadd tal-blasts fil-mudullun tal-għadam) kienu konsistenti mar-riżultati għall-popolazzjoni globali tal-istudju.
English: It is used in adults.
Maltese: Huwa jintuża fl-adulti.
English: Excipients with known effect Each vial contains 0.5 mmol potassium (E340) and 0.29 mmol sodium (E524).
Maltese: Eċċipjenti b'effett magħruf Kull kunjett fih 5 mmol ta' potassium (E340) u 0.29 mmol ta' sodium (E524).
English: Excluding pneumonia, urinary tract infection, sepsis, septic shock and sinusitis.
Maltese: Li teskludi pnewmonja, infezzjoni fil-passaġġ tal-awrina, sepsis, xokk settiku u sinusite.
English: What Dacogen is Dacogen is an anti-cancer medicine.
Maltese: X'inhu Dacogen Dacogen huwa mediċina kontra l-kanċer.
English: Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (for pH adjustment)
Maltese: Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (għal aġġustament tal-pH)
English: Based on the initial analysis in the ITT population, a statistically significant difference in complete remission rate (CR + CRp) was achieved in favour of subjects in the Dacogen arm, 17.8% (43/242) compared to the TC arm, 7.8% (19/243); treatment difference 9.9% (95% CI: 4.07; 15.83), p = 0.0011.
Maltese: ITT, inkisbet differenza statistikament sinifikanti fir-rata ta' kontroll sħiħ tal-marda (CR + CRp) favur l-individwi fil-fergħa ta' Dacogen, 17.8% (43/242) meta mqabbla mal-fergħa TC, 7.8% (19/243); differenza fil-kura ta' 9.9% (95% CI: 4.07; 15.
English: After preparing the medicine, it contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Maltese: Wara li tipprepara l-mediċina, hija jkun fiha inqas minn 1 mmol (39 mg) ta' potassium f'kull doża, i.e. hija essenzjalment ‘ħielsa mill-potassium'.
English: There is the potential for a drug-drug interaction with other agents which are also activated by sequential phosphorylation (via intracellular phosphokinase activities) and/or metabolised by enzymes implicated in the inactivation of decitabine (e.g., cytidine deaminase).
Maltese: Hemm potenzjal ta' interazzjoni ta' bejn il-mediċini ma' aġenti oħra li li jiġu attivati huma wkoll b'fosforilazzjoni sekwenzjali (permezz tal-attivitajiet intraċellulari ta' phosphokinase) u/jew li huma mmetabolizzati b'enżimi implikati fil-inattivazzjoni ta' decitabine (e.ż. cytidine deaminase).
English: Very common febrile neutropaenia* neutropaenia* thrombocytopaenia*
Maltese: Komuni ħafna newtropenija bid-deni* newtropenija tromboċitopenija
English: Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Maltese: Dacogen huwa indikat għall-kura ta' pazjenti adulti b'lewkimja majelojde akuta (AML - acute myeloid leukaemia) de novo jew sekondarja, skont il-klassifikazzjoni tal-Organizzazzjoni Dinjija tasSaħħa (WHO - World Health Organisation) li ma jistgħux jieħdu kimoterapija standard ta' induzzjoni.
English: The difference did not reach statistical significance, however, there was a trend for improvement in survival with a 15% reduction in the risk of death for subjects in the Dacogen arm (Figure 1).
Maltese: Id-differenza ma laħqitx sinifikat statistiku, madankollu, kien hemm tendenza ta' titjib fis-sopravivenza bi tnaqqis ta' 15% fir-riskju ta' mewt għall-individwi fil-fergħa ta' Dacogen (Figura 1).
English: Progression-free survival was significantly longer for subjects in the Dacogen arm, 3.7 months (95% CI: 2.7, 4.6) compared with subjects in the TC arm, 2.1 months (95% CI: 1.9, 3.1); hazard ratio 0.75 (95% CI: 0.62, 0.91), p = 0.0031.
Maltese: Is-sopravivenza mingħajr avvanz talmarda kien itwal b'mod sinifikanti għal individwi fil-fergħa ta' Dacogen, 3.7 xhur (95% CI: 2.7; 4.6) meta mqabbla ma' individwi fil-fergħa TC, 2.1 xhur (95% CI: 1.9; 3.1); proporzjon ta' periklu 0.75 (95% CI: 0.62; 0.91), p = 0.
English: Intracellularly, decitabine is activated through sequential phosphorylation via phosphokinase activities to the corresponding triphosphate, which is then incorporated by the DNA polymerase.
Maltese: Ġewwa ċ-ċellula, decitabine jiġi attivat b'fosforilazzjoni sekwenzjali permezz ta' attivitajiet ta' phosphokinase għat-triphosphate ekwivalenti, li mbagħad jiġi inkorporat mill-polymerase tad-DNA.
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg-138 mg (0.6-6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7-7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Wara r-rikostituzzjoni u ddilwizzjoni tas-soluzzjoni għall-infużjoni ġol-vina, din il-mediċina jkun fiha bejn 13.8 mg-138 mg (0.6-6 mmol) sodium f'kull doża (skont il-fluwidu tal-infużjoni għad-dilwazzjoni), ekwivalenti għal 0.7-7% tad-doża massima ta' kuljum rakkomandata mill-WHO ta' 2 g sodium għal persuna adulta.
English: In the Dacogen treatment group, there was a higher incidence of treatment discontinuation due to adverse events in women compared to men (43% versus 32%).
Maltese: Fil-fergħa tal-grupp ikkurati b'Dacogen, kien hemm inċidenza ogħla ta' twaqqif ta' trattament minħabba avvenimenti avversi f'nisa meta mqabbla ma' l-irġiel (43% kontra 32%).
English: For a typical patient (weight 70 kg/body surface area 1.73 m2) the decitabine pharmacokinetic parameters are listed in the Table 3 below.
Maltese: Għal pazjenti tipiku (piż ta' 70 kg/1.73 m erja tas-superfiċje tal-ġisem) il-parametri farmakokinetiċi ta' decitabine huma elenkati fit-Tabella 3 hawn taħt.
English: • This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial.
Maltese: • Din il-mediċina fiha 0.29 mmol (6.67 mg) ta' sodium (il-komponent prinċipali tal-melħ tattisjir/tal-mejda) f'kull kunjett.
English: Within 15 minutes of reconstitution, the concentrate (in 10 ml of sterile water for injections) must be further diluted with cold (2°C - 8°C) infusion fluids.
Maltese: Fi żmien 15-il minuta minn wara r-rikostituzzjoni, il-konċentrat (f'10 ml ta' ilma sterili għall-injezzjoni) għandu jiġi ddilwit aktar bi fluwidi tal-infużjoni mkessħin (2°C - 8°C).
English: The most common Grade 3/4 adverse drug reactions (≥ 20%) included pneumonia, thrombocytopaenia, neutropaenia, febrile neutropaenia and anaemia.
Maltese: L-aktar reazzjonijiet avversi komuni tal-Grad 3/4 għall-mediċina (≥ 20%) kienu jinkludu pulmonite, tromboċitopenija, newtropenija, newtropenija bid-deni u anemija.
English: In vitro studies show that decitabine does not inhibit nor induce CYP 450 enzymes up to more than 20-fold of the therapeutic maximum observed plasma concentration (Cmax).
Maltese: Studji in vitro juru li decitabine la jimpedixxi u lanqas jinduċi enzimi CYP 450 sa aktar minn 20 darba l-ogħla konċentrazzjoni terapewtika osservata filplażma (Cmax).
English: Very common pneumonia* urinary tract infection* All other infections (viral, bacterial, fungal)*
Maltese: Kull infezzjoni oħra (virali, batterika, fungali)
English: This medicine contains 0.5 mmol potassium per vial.
Maltese: Din il-mediċina fiha 0.5 mmol ta' potassium f'kull kunjett.
English: Dacogen is contraindicated during breast-feeding; therefore, if treatment with this medicine is required, breast-feeding must be discontinued (see section 4.3).
Maltese: Dacogen huwa kontraindikat waqt it-treddigħ; għalhekk, jekk tkun meħtieġa kura b'din il-mediċina, ittreddigħ għandu jitwaqqaf (ara sezzjoni 4.3).
English: (thrombocytopaenia)
Maltese: Żmien (Xhur)
English: • an infection,
Maltese: • infezzjoni.
English: Decitabine Vdss in cancer patients is large indicating distribution into peripheral tissues.
Maltese: IlVdss ta' decitabine f'pazjenti bil-kanċer huwa kbir, li jindika distribuzzjoni fit-tessuti periferali.
English: In an analysis with an additional 1 year of mature survival data, the effect of Dacogen on overall survival demonstrated a clinical improvement compared to the TC arm (7.7 months vs. 5.0 months, respectively, hazard ratio = 0.82, 95% CI: 0.68, 0.99, nominal p-value = 0.0373, Figure 2).
Maltese: F'analiżi b'sena addizzjonali ta' dejta matura ta' sopravivenza, l-effett ta' Dacogen fuq is-sopravivenza globali wera titjib kliniku meta tqabbel mal-fergħa TC (7.7 xhur vs. 5.0 xhur, rispettivament, proporzjon ta' periklu = 0.82, 95% CI: 0.68, 0.99, valur p nominali = 0.
English: Impact of co-administered medicinal products on decitabine Cytochrome (CYP) 450-mediated metabolic interactions are not anticipated as decitabine metabolism is not mediated by this system but by oxidative deamination.
Maltese: Impatt fuq decitabine ta' prodotti mediċinali mogħtija flimkien miegħu Interazzjonijiet metaboliċi tal-mediċina medjati miċ-ċitokroma (CYP) 450 mhumiex mistennija minħabba li l-metaboliżmu ta' decitabine mhuwiex medjat minn din is-sistema iżda minn deaminazzjoni ossidattiva.
English: Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min).
Maltese: Għandu jkun hemm kawtela fl-għoti ta' Dacogen lil pazjenti b'indeboliment qawwi tal-kliewi (Tneħħija tal-Krejatinina [CrCl] < 30 ml/min).
English: The adverse drug reactions are listed by frequency category.
Maltese: Ir-reazzjonijiet avversi għall-mediċina huma elenkati skont ilkategorija ta' frekwenza.
English: In addition, the limited data from the population PK analysis indicated no significant PK parameter dependencies on total bilirubin concentration despite a wide range of total bilirubin levels.
Maltese: Barra dan, id-dejta limitata mill-analiżi PK tal-popolazzjoni ma indikat l-ebda dipendenzi sinifikanti ta' parametri PK fuq ilkonċentrazzjoni tal-bilirubin totali minkejja varjazzjoni kbira ta' livelli ta' bilirubin totali.
English: In clinical studies in AML and myelodysplastic syndrome (MDS), the reporting frequency for hyperbilirubinaemia was 11% for All Grades and 2% for Grade 3-4.
Maltese: Fi studji kliniċi f'AML u s-sindrome mijelodisplastiku (MDS, myelodysplastic syndrome), il-frekwenza ta' rappurtar għal iperbilirubinimja kienet ta' 11% għal Gradi Kollha u 2% għal Grad 3-4. * Tinkudi każijiet b'riżultat fatali.
English: The population pharmacokinetic (PK) parameters of decitabine were pooled from 3 clinical studies in 45 patients with AML or myelodysplastic syndrome (MDS) utilizing the 5-Day regimen.
Maltese: Il-parametri farmakokinetiċi tal-popolazzjoni (PK) ta' decitabine nġabru minn 3 studji kliniċi fuq 45 pazjent b'AML jew b'sindrome majelodisplatiku (MDS) li użaw l-iskeda ta' għoti għal ħamestijiem.
English: Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Maltese: Inklużi termini preferiti sensittività eċċessiva, sensittività eċċessiva għall-mediċina, reazzjoni anafilattika, xokk anafilattiku, reazzjoni anafilaktojda, xokk anafilaktojdu.
English: Within 15 minutes of reconstitution, the solution must be further diluted with cold (2C - 8C) infusion fluids (sodium chloride 9 mg/ml [0.9%] solution for injection or 5% glucose solution for injection) to a final concentration of 0.15 to 1.0 mg/ml.
Maltese: Fi ħdan 15-il minuta wara r-rikostituzzjoni, is-soluzzjoni trid tiġi ddilwita aktar bi fluwidi tal-infużjoni mkessħin (soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml [0.9%] jew soluzzjoni għall-injezzjoni ta' 5% glucose) għal konċentrazzjoni finali ta' 0.15 sa 1.0 mg/ml.
English: Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3.
Maltese: B'din irrikostituzzjoni, kull ml jkun fih madwar 5 mg ta' decitabine f'pH ta' 6.7 sa 7.3.
English: Supportive treatments include, administration of prophylactic antibiotics and/or growth factor support (e.g., G-CSF) for neutropaenia and transfusions for anaemia or thrombocytopaenia according to institutional guidelines.
Maltese: Kuri ta' sostenn jinkludu, għoti ta' antibijotiċi profilattiċi u/jew sostenn b'fattur ta' tkabbir (eż. G-CSF) għal newtropenija u trasfużjonijiet għal anemija jew tromboċitopenija skont il-gwidi instituzzjonali.
English: The safety assessment in paediatric patients is based on the limited safety data from a Phase I/II study to evaluate pharmacokinetics, safety and efficacy of Dacogen in paediatric patients (aged 1 to 14 years) with relapsed or refractory AML (n = 17) (see section 5.1).
Maltese: I/II biex jevalwa l-farmakokinetika, is-sigurtà u l-effikaċja ta' Dacogen f'pazjenti pedjatriċi (b'età minn 1 sa 14-il sena) b'AML li rkadiet jew li ma rrispondietx għat-trattament (n = 17) (ara sezzjoni 5.1).
English: The most frequently reported "other infections" in study DACO-016 were: oral herpes, oral candidiasis, pharyngitis, upper respiratory tract infection, cellulitis, bronchitis, nasopharyngitis.
Maltese: “Infezzjonijiet oħra” li kienu l-aktar irrapportati fl-istudju DACO-016 kienu herpes orali, kandidijasi orali, farinġite, infezzjoni tal-passaġġ respiratorju ta' fuq, ċellulite, bronkite, nasofarinġite.
English: This is called a ‘treatment cycle' and it is repeated every 4 weeks.
Maltese: Dan huwa msejjaħ ‘ċiklu ta' kura' u jiġi ripetut kull 4 ġimgħat.
English: The median time to CR was 4.1 months, and the median duration of CR was 18.2 months.
Maltese: Iż-żmien medjan sa CR kien ta' 4.1 xhur, u ż-żmien medjan ta' CR kien 18.2 xahar.
English: PFS
Maltese: PFSa
English: The available data from in vitro and in vivo studies provide sufficient evidence that decitabine has genotoxic potential.
Maltese: Id-dejta disponibbli minn studji in vitro u in vivo tipprovdi evidenza biżżejjed li decitabine jista' jikkaġuna tossiċità fil-ġeni.
English: This prepared diluted solution can be stored refrigerated at 2°C - 8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C - 25°C) before administration.
Maltese: Din is-soluzzjoni dilwita ppreparata tista' tinżamm fi friġġ f'temperatura ta' bejn 2°C - 8°C għal massimu ta' 3 sigħat, u sa siegħa f'temperatura ambjentali tal-kamra (20°C - 25°C) qabel ma tingħata.
English: No formal clinical drug interaction studies with decitabine have been conducted.
Maltese: Ma sar l-ebda studju kliniku formali dwar interazzjonijiet ta' mediċini ma' decitabine.
English: After preparing the medicine, it contains between 13.8 mg-138 mg sodium per dose , equivalent to 0.7-7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Wara li tipprepara l-mediċina, hija jkun fiha bejn 13.8 mg-138 mg sodium f'kull doża, ekwivalenti għal 0.7-7% tat-teħid massimu ta' sodium mid-dieta kuljum għal adult.
English: In clinical studies, 30% of patients treated with Dacogen and 25% of patients treated in the comparator arm had adverse events with an outcome of death during treatment or within 30 days after the last dose of study drug.
Maltese: Fi studji kliniċi, 30% tal-pazjenti ikkurati b'Dacogen u 25% tal-pazjenti ikkurati fil-fergħa talkomparatur kellhom avvenimenti avversi b'eżitu ta' mewt waqt it-trattament jew fi żmien 30 ġurnata wara l-aħħar doża tal-mediċina tal-istudju.
English: There was no evidence of dependencies on age, creatinine clearance, total bilirubin, or disease.
Maltese: Ma kien hemm l-ebda evidenza ta' dipendenza fuq l-età, it-tneħħija tal-krejatinina, il-bilirubin totali, jew mard.
English: Information on special populations was derived from pharmacokinetic data from the 3 studies noted above, and from one Phase I study in MDS subjects, (N = 14; 15 mg/m2 x 3-hours q8h x 3 days).
Maltese: Informazzjoni dwar popolazzjonijiet speċjali inkisbet minn dejta farmakokinetika mit-tliet studji msemmija hawn fuq, u minn studju wieħed talFażi I f'individwi b'MDS (N = 14; 15 mg/m2 għal tlitt sigħat kull tmin sigħat għal tlitt ijiem).
English: Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.
Maltese: Każijiet ta' mard tal-interstizju tal-pulmun (ILD, interstitial lung disease) (inklużi infiltrati fil-pulmun, pulmonite sistematizzata u fibrożi fil-pulmun) mingħajr sinjali ta' etjoloġija infettiva ġew irrappurtati f'pazjenti li kienu qed jirċievu decitabine.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: When censored for potentially disease modifying subsequent therapy (i.e., induction chemotherapy or hypomethylating agent) the analysis for overall survival showed a 20% reduction in the risk of death for subjects in the Dacogen arm [HR = 0.80, (95% CI: 0.64, 0.99), p-value = 0.0437)].
Maltese: Meta minn dan tneħħew persuni li ħadu terapija sussegwenti li setgħet immodifikat il-marda (jiġifieri, kimoterapija ta' induzzjoni jew sustanza hypomethylating) l-analiżi għas-sopravivenza globali uriet tnaqqis ta' 20% fir-riskju ta' mewt għal individwi fil-fergħa ta' Dacogen [HR = 0.80, (95% CI: 0.64; 0.99), valur p = 0.
English: • You will receive Dacogen every day for 5 days, then 3 weeks without the medicine.
Maltese: • Inti se tirċievi Dacogen kuljum għal 5 ijiem, imbagħad 3 ġimgħat mingħajr il-mediċina.
English: Very common diarrhoea vomiting nausea Common stomatitis Not known enterocolitis, including neutropaenic colitis, caecitis*
Maltese: Mhux magħruf enterokolite, inkluż kolite newtropenika, ċekite*
English: Population PK analysis of decitabine showed that after accounting for body size, there is no difference between decitabine PK parameters in paediatric AML patients versus adults with AML or MDS.
Maltese: Analiżi PK ta' popolazzjoni ta' decitabine uriet li wara li jitqies id-daqs tal-ġisem, ma hemm l-ebda differenza bejn il-parametri PK ta' decitabine f'pazjenti pedjatriċi b'AML versus adulti b'AML jew MDS.
English: Dacogen 50 mg powder for concentrate for solution for infusion decitabine
Maltese: Dacogen 50 mg trab għal konċentrat għal soluzzjoni għall-infużjoni decitabine
English: • Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care)
Maltese: • Infezzjoni attiva ikkawżata minn virusis, batterji jew fungi (jiġifieri, teħtieġ mediċini antiinfettivi mill-vini jew kura estensiva ta' sostenn)
English: The pharmacokinetics of decitabine following intravenous administration as a 1-hour infusion were described by a linear two-compartment model, characterised by rapid elimination from the central compartment and by relatively slow distribution from the peripheral compartment.
Maltese: Il-farmkokinetika ta' decitabine wara għoti minn ġol-vina bħala infużjoni ta' siegħa ġew deskritti permezz ta' mudell lineari b'żewġ kompartimenti, kienet ikkaratterizzata bit-tneħħija malajr millkompartiment ċentrali u d-distribuzzjoni relattivament bil-mod mill-kompartiment periferali.
English: C-decitabine in cancer patients showed that 90% of the administered dose of decitabine (4% unchanged drug) is excreted in the urine.
Maltese: C f'pazjenti bil-kanċer urew li 90% tad-doża ta' decitabine mogħtija (4% tal-mediċina mhux mibdula) titneħħa fl-awrina.
English: • After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids.
Maltese: • Wara r-rikostituzzjoni, il-konċentrat għandu jiġi dilwit aktar fi żmien 15-il minuta permezz ta' fluwidi tal-infużjoni kesħin.
English: Evidence from the literature indicates that decitabine has carcinogenic potential.
Maltese: Evidenza mill-litteratura turi li decitabine jista' jikkaġuna kanċer.