FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer(s) responsible for batch release Jazz Pharmaceuticals Ireland Limited 5th Floor
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Jazz Pharmaceuticals Ireland Limited 5th Floor
English: EU/1/18/1308/001 1 vial EU/1/18/1308/002 2 vials EU/1/18/1308/003 5 vials
Maltese: EU/1/18/1308/003 5 kunjetti
English: FLT3 mutation was identified in 15% (43/279) of patients tested and NPM1 mutation was identified in 9% (25/283) patients tested.
Maltese: Il-mutazzjoni FLT3 ġiet identifikata fi 15 % (43/279) tal-pazjenti ttestjati u l-mutazzjoni NPM1 ġiet identifikata f'9 % (25/283) tal-pazjenti ttestjati.
English: The incidence of fatal haemorrhage was 2.1%.
Maltese: L-inċidenza ta' emorraġija fatali kienet 2.1 %.
English: Cytarabine is metabolised by cytidine deaminase to the inactive metabolite 1-β (beta)-D-arabinofuranosyluracil (AraU).
Maltese: Cytarabine jiġi mmetabolizzat minn cytidine deaminase għall-metabolit inattiv 1-β (beta)-D-arabinofuranosyluracil (AraU).
English: The most frequently occurring adverse reactions (ADRs) were hypersensitivity including rash (66.9%), febrile neutropenia (63.5%), oedema (52.3%), diarrhoea/colitis (49.9%), mucositis (49.9%), fatigue (46.4%), musculoskeletal pain (44.5%), abdominal pain (36.3%), decreased appetite (33.9%), cough (33.9%), headache (32.3%), chills (31.2%), arrhythmia (30.4%), pyrexia (29.6%), sleep disorders (25.1%), and hypotension (23.7%).
Maltese: Ir-reazzjonijiet avversi (ADRs) li seħħew bl-aktar mod frekwenti kienu sensittività eċċessiva inkluż raxx (66.9 %), newtropenja bid-deni (63.5 %), edema (52.3 %), dijarea/kolite (49.9 %), mukożite (49.9 %), għeja (46.4 %), uġigħ muskolu-skeletriku (44.5 %), uġigħ addominali (36.3 %), tnaqqis fl-aptit (33.9 %), sogħla (33.9 %), uġigħ ta' ras (32.3 %), dehxiet ta' bard (31.2 %), aritmija (30.4 %), deni (29.6 %), disturbi tal-irqad (25.1 %), u ipotensjoni (23.7 %).
English: The concentration of the reconstituted solution is 44 mg/20 mL (2.2 mg/mL) daunorubicin and 100 mg/20 mL (5 mg/mL) cytarabine.
Maltese: Il-konċentrazzjoni tas-soluzzjoni rikostitwita hija 44 mg/20 mL (2.2 mg/mL) daunorubicin u 100 mg/20 mL (5 mg/mL) cytarabine.
English: The overall rate of HSCT was 34% (52/153) in the Vyxeos liposomal arm and 25% (39/156) on the control arm.
Maltese: Ir-rata globali ta' HSCT kienet 34 % (52/153) fil-fergħa ta' Vyxeos liposomali u 25 % (39/156) fil-fergħa tal-kontroll.
English: Grade 3-5 ADRs/Frequency (%)
Maltese: ADRs ta' Grad 3-5/Frekwenza
English: Metabolism and biotransformation
Maltese: Metaboliżmu u bijotrasformazzjoni
English: Delirium (2.4)
Maltese: Komuni Delirju (2.4)
English: Pleural effusion (0.8)
Maltese: Mhux komuni Effużjoni plewrali (0.8)
English: Infection (58.7)
Maltese: Komuni Ħafna Infezzjoni (58.7)
English: The frequency of fatal hypersensitivity events was 0 (see section 4.4).
Maltese: Il-frekwenza ta' avvenimenti ta' sensittività eċċessiva fatali kienet 0 (ara sezzjoni 4.4).
English: The randomised patients had a median age of 68 (range 60-75 years), 61% were male, and 88% had an ECOG performance status of 0-1.
Maltese: Il-pazjenti randomizzati kellhom età medjana ta' 68 (medda 60-75 sena), 61 % kienu rġiel, u 88 % kellhom status tal-prestazzjoni ECOG ta' 0-1.
English: The clearance (%CV) is 0.16 L/h (53.3%) for daunorubicin and 0.13 L/h (60.2%) for cytarabine.
Maltese: It-tneħħija (%CV) hija 0.16 L/h (53.3%) għal daunorubicin u 0.13 L/h (60.2%) għal cytarabine.
English: Kaplan-Meier curve for overall survival, ITT population
Maltese: Figura 1: Kurva ta' Kaplan-Meier għal sopravivenza globali, popolazzjoni ITT
English: Thrombocytopenia (3.7) Neutropenia (3.5) Anaemia (2.1)
Maltese: Tromboċitopenja (3.7) Newtropenja (3.5) Anemija (2.1)
English: The 1:5 molar ratio has been shown in vitro and in vivo to maximise synergistic antitumour activity in AML.
Maltese: Il-proporzjon molari 1:5 intwera in vitro u in vivo li jimmassimizza attività kontra t-tumur sinerġistika f'AML.
English: Diarrhoea/colitis (6.1) Abdominal pain (2.9) Mucositis (2.1) Decreased appetite (1.6) Constipation (1.1) Nausea (1.1)
Maltese: Dijarea/kollite (6.1) Uġigħ addominali (2.9) Mukożite (2.1) Tnaqqis fl-aptit (1.6) Stitikezza (1.1) Nawsja (1.1)
English: The volume of distribution (%CV) for daunorubicin is 6.6 L (36.8%) and cytarabine is 7.1 L (49.2%).
Maltese: Il-volum tad-distribuzzjoni (%CV) għal daunorubicin huwa 6.6 L (36.8%) u għal cytarabine huwa 7.1 L (49.2%).
English: Dyspnoea (36.5) Cough (33.9) Pleural effusion (13.9)
Maltese: Komuni Ħafna Dispnea (36.5) Sogħla (33.9) Effużjoni plewrali (13.9)
English: The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage (13.1%).
Maltese: L-ADRs l-aktar serji u li seħħew bl-aktar mod frekwenti kienu infezzjoni (58.7 %), kardjotossiċità (18.7 %) u emorraġija (13.1 %).
English: The incidence of infection events was 78.1%; the incidence of non-serious events of infections was 73.1%, the incidence of serious events of infections was 28.5%; the incidence of infections which led to discontinuation is 0.5%.
Maltese: L-inċidenza ta' avvenimenti ta' infezzjoni kienet 78.1 %; l-inċidenza ta' avvenimenti mhux serji ta' infezzjoni kienet 73.1 %, l-inċidenza ta' avvenimenti serji ta' infezzjoni kienet 28.5 %; l-inċidenza ta' infezzjonijiet li wasslu għat-twaqqif hija 0.5 %.
English: The accumulation ratio was 1.3 for daunorubicin and 1.4 for cytarabine.
Maltese: Il-proporzjon ta' akkumulazzjoni kien 1.3 għal daunorubicin u 1.4 għal cytarabine.
English: Daunorubicin is mostly catalysed by hepatic and non-hepatic aldo-keto reductase and carbonyl reductase to the active metabolite daunorubicinol.
Maltese: Daunorubicin jiġi l-aktar katalizzat minn riduttażi aldoketo mhux epatika u riduttażi carbonyl għall-metabolit attiv daunorubicinol.
English: Also contains: Distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine, and sucrose.
Maltese: Fih ukoll: distearoylphosphatidylcholine, distearoylphosphatidylglycerol, kolesterol, glukonat tar-ram, trolamine, u sukrożju.
English: There were 153 patients randomised to Vyxeos liposomal and 156 patients randomised to the 7+3 control arm.
Maltese: Kien hemm 153 pazjent randomizzati għal Vyxeos liposomali u 156 pazjent randomizzati għall-fergħa ta' kontroll 7+3.
English: Each consolidation
Maltese: Kull konsolidazzjoni
English: Pruritus (17.3) Hyperhidrosis (10.1)
Maltese: Komuni Ħafna Prurite (17.3) Iperidrożi (10.1)
English: Abbreviations: CI = Confidence interval; CR= Complete response; CRi= Complete response with incomplete recovery a p-value from stratified log rank test stratifying by age and AML sub-type b p-value from stratified Cochran-Mantel-Haenszel test stratified by age and AML sub-type
Maltese: CI = Intervall ta' kunfidenza; CR = Rispons komplet; CRi = Rispons komplet bi rkupru mhux komplet a valur p minn test log rank stratifikat li jikklassifika skont l-età u s-sottotip ta' AML
English: Study 301 was a Phase 3 randomised, multicentre, open-label, parallel-arm, superiority study which evaluated Vyxeos liposomal vs. a standard combination of cytarabine and daunorubicin (7+3) in 309 patients between 60 to 75 years of age with untreated high risk AML.
Maltese: Studju 301 f'pazjenti b'AML ta' riskju għoli mhux ikkurata Studju 301 kien studju ta' Fażi 3, randomizzat, multiċentriku, open-label, ta' fergħa parallela, ta' superjorità li evalwa Vyxeos liposomali kontra kombinazzjoni standard ta' cytarabine u daunorubicin (7+3) fi 309 pazjenti bejn età ta' 60 u 75 sena b'AML ta' riskju għoli mhux ikkurata.
English: Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP), which is the active metabolite.
Maltese: Fiċ-ċelluli, cytarabine jinbidel f'cytarabine-5-triphosphate (ara-CTP), li huwa l-metabolit attiv.
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); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: 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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Night sweats (8.3) Alopecia (3.2)
Maltese: Għaraq billejl (8.3) Alopeċja (3.2)
English: Infection (78.1)
Maltese: Komuni Ħafna Infezzjoni (78.1)
English: The median survival for the Vyxeos liposomal treatment group was 9.56 months compared with 5.95 months for the 7+3 treatment group (Hazard Ratio = 0.69, 95% CI = 0.52, 0.90, two-sided log-rank test p = 0.005).
Maltese: Is-sopravivenza medjana għall-grupp ta' kura ta' Vyxeos liposomali kienet 9.56 xhur meta mqabbla ma' 5.95 xhur għall-grupp ta' kura 7+3 (Proporzjon ta' Periklu = 0.69, 95% CI = 0.52, 0.90, test log-rank ta' p miż-żewġ naħat
English: • The other ingredients are distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine and sucrose.
Maltese: • Is-sustanzi mhux attivi l-oħra huma distearoylphosphatidylcholine, distearoylphosphatidylglycerol, kolesterol, glukonat tar-ram, trolamine u sukrożju.
English: Prior therapy with anthracyclines (including patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride), pre-existing cardiac disease (including impaired cardiac function), previous radiotherapy of the mediastinum, or concomitant use of cardiotoxic products may increase the risk of daunorubicin-induced cardiac toxicity.
Maltese: Qabel it-terapija b'antraċiklini (inkluż pazjenti li preċedentement irċivew id-dożi kumulattivi massimi rakkomandati ta' doxorubicin jew daunorubicin hydrochloride), mard kardijaku pre-eżistenti (inkluż funzjoni kardijaka indebolita), radjoterapija preċedenti tal-mediastinum, jew użu konkomitanti ta' prodotti kardjotossiċi jistgħu jżidu r-riskju ta' kardjotossiċità indotta minn daunorubicin.
English: • on days 1, 3, and 5 as the first course of induction therapy.
Maltese: • f'jiem 1, 3, u 5 bħala l-ewwel kors ta' terapija tal-induzzjoni;
English: Nervous system disorders Very Common
Maltese: Disturbi fis-sistema nervuża
English: Nausea (51.7) Diarrhoea/colitis (49.9) Mucositis (49.9) Constipation (42.7) Abdominal pain (36.3) Decreased appetite (33.9) Vomiting (27.7)
Maltese: Komuni Ħafna Nawsja (51.7) Dijarea/kollite (49.9) Mukożite (49.9) Stitikezza (42.7) Uġigħ addominali (36.3) Tnaqqis fl-aptit (33.9) Rimettar (27.7)
English: Musculoskeletal pain (5.1)
Maltese: Komuni Uġigħ muskolu-skeletriku (5.1)
English: • The active substances are daunorubicin and cytarabine.
Maltese: • Is-sustanzi attivi huma daunorubicin u cytarabine.
English: Gastrointestinal mucositis and diarrhoea
Maltese: Mukożite gastrointestinali u dijarea
English: Hypersensitivity (including rash) (66.9)
Maltese: Disturbi fis-sistema immuni Komuni Ħafna Sensittività eċċessiva (inkluż raxx) (66.9)
English: First induction
Maltese: It-tieni induzzjoni
English: Date of first authorisation: 23 August 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta 'Awwissu 2018
English: • Store in a refrigerator (2°C to 8°C).
Maltese: • Aħżen fi friġġ (2°C - 8°C).
English: At baseline 20% had t-AML, 54% had AML with an antecedent haematological disorder and 25% had de novo AML with myelodysplasia-related cytogenetic abnormalities; 34% had been treated previously with a hypomethylating agent for MDS;54% had an adverse karyotype.
Maltese: Fil-linja bażi 20 % kellhom t-AML, 54 % kellhom AML b'disturb ematoloġiku anteċedent u 25 % kellhom AML de novo b'anormalitajiet ċitoġenetiċi relatati mal-majelodisplażija; 34 % kienu ġew ikkurati preċedentement b'aġent ipometilatanti għal MDS; 54 % kellhom karijotip avvers.
English: Tumour lysis syndrome (7.5)
Maltese: Komuni Sindrome ta' liżi tat-tumur (7.5)
English: The incidence of all hypersensitivity events was 66.9%; the incidence of non-serious events of hypersensitivity was 66.4 %, of which 38.9 % were rash; the incidence of serious events of hypersensitivity is 1.1%; the frequency of hypersensitivity which led to discontinuation is 0.
Maltese: L-inċidenza tal-avvenimenti kollha ta' sensittività eċċessiva kienet 66.9 %; l-inċidenza ta' avvenimenti mhux serji ta' sensittività eċċessiva kienet 66.4 %, li minnhom 38.9 % kienu raxx; l-inċidenza ta' avvenimenti serji ta' sensittività eċċessiva hija 1.1 %; il-frekwenza ta' sensittività eċċessiva li wasslet għat-twaqqif hija 0.
English: The potential effects of severe renal impairment (CrCL 15 mL/min ≥ to ≤ 29 mL/min, C-G) and end-stage renal disease on the pharmacokinetics of daunorubicin and cytarabine administered as Vyxeos liposomal are unknown (see section 4.2).
Maltese: L-effetti potenzjali ta' indeboliment tal-kliewi sever (CrCL 15 mL/min ≥ sa ≤ 29 mL/min, C-G) u marda tal-kliewi fl-aħħar stadju fuq il-farmakokinetika ta' daunorubicin u cytarabine mogħtija bħala Vyxeos liposomali mhumiex magħrufa (ara sezzjoni 4.2).
English: Pyrexia (3.2) Oedema (2.7)
Maltese: Komuni Deni (3.2) Edema (2.7)
English: • Aseptically withdraw the calculated volume of reconstituted Vyxeos liposomal from the vial(s) with a sterile syringe and transfer it to an infusion bag containing 500 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, or 5% glucose.
Maltese: • B'mod asettiku iġbed il-volum ikkalkulat ta' Vyxeos liposomali rikostitwit mill-kunjett(i) b'siringa sterili u ttrasferih f'borża tal-infużjoni li jkun fiha 500 mL ta' klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, jew 5 % glukożju.
English: (equivalent to 44 mg/ m² of daunorubicin and 100 mg/m² of cytarabine).on days 1, 3, and 5 show the mean AUClast metabolite:parent ratio for daunorubicinol and AraU were 1.79% and 3.22% to that for daunorubicin and cytarabine, respectively; which are lower than those typically reported for non-liposomal products, ~40-60% for daunorubicinol:daunorubicin and ~80% for AraU:cytarabine.
Maltese: Il-profili taż-żmien tal-konċentrazzjoni fil-plażma miksuba minn 13 sa 26 pazjent li rċivew Vyxeos liposomali 100 unità/m² (ekwivalenti għal 44 mg/m² ta' daunorubicin u 100 mg/m² ta' cytarabine) f'jiem 1, 3 u 5 urew li l-aħħar proporzjon metabolit:oriġinarju medju f'AUC għal daunorubicinol u AraU kien 1.79 % u 3.22 % għal dak għal daunorubicin u cytarabine, rispettivament; li huma aktar baxxi minn dawk tipikament irrappurtati għal prodotti mhux lipożomali, ~40-60 % għal daunorubicinol:daunorubicin u ~80 % għal AraU:cytarabine.
English: Vyxeos liposomal is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio.
Maltese: Vyxeos liposomali huwa formulazzjoni lipożomali ta' kombinazzjoni fissa ta' daunorubicin u cytarabine fi proporzjon molari 1:5.
English: Daunorubicin was mutagenic in in vitro tests (Ames assay, V79 hamster cell assay), and clastogenic in vitro (CCRF-CEM human lymphoblasts) and in vivo (SCE assay in mouse bone marrow) tests.
Maltese: Daunorubicin kien mutaġeniku f'testijiet in vitro (Assaġġ ta' Ames, assaġġ taċ-ċellula tal-ħamster V79), u klastoġeniku in vitro (limfoblasts fil-bniedem CCRF-CEM) u f'testijiet in vivo (assaġġ SCE fil-mudullun tal-ġurdien).
English: Cardiac function should be closely monitored.
Maltese: Il-funzjoni kardijaka għandha tiġi mmonitorjata mill-qrib.
English: Pharmacotherapeutic group: other antineoplastic agents, combinations of antineoplastic agents, ATC code: L01XY01.
Maltese: Kategorija farmakoterapewtika: aġenti neoplastiċi oħra, kombinazzjonijiet ta' aġenti antineoplastiċi, Kodiċi ATC:
English: Tumour lysis syndrome (2.7)
Maltese: Komuni Sindrome ta' liżi tat-tumur (2.7)
English: Cytarabine was clastogenic to meiotic cells.
Maltese: Cytarabine kien klastoġeniku għaċ-ċelluli mejotiċi.
English: • Calculate the volume of reconstituted Vyxeos liposomal required using the following formula: [volume required (mL) = dose of daunorubicin (mg/m 2) x patient's BSA (m 2)/2.2 (mg/mL)].
Maltese: [volum meħtieġ (mL) = doża ta' daunorubicin (mg/m²) x BSA tal-pazjent (m²)/2.2 (mg/mL)].
English: This medicinal product could have potential risk for the environment due to the cytotoxic and antimitotic activities, which could induce possible reproductive effects.
Maltese: Dan il-prodott mediċinali jista' jkollu riskju potenzjali għall-ambjent minħabba l-attivitajiet ċitotossiċi u antimitotiċi, li jistgħu jinduċu effetti possibbli fuq is-sistema riproduttiva.
English: The pharmacokinetics of total daunorubicin and cytarabine were not altered in patients with bilirubin ≤ 50 µmol/L.
Maltese: Il-farmakokinetika tat-total ta' daunorubicin u cytarabine ma nbidlitx f'pazjenti b'bilirubina ≤ 50 µmol/L.
English: 50 mL vial (type 1 glass) with a stopper (chlorobutyl rubber), and an overseal (aluminium) containing 44 mg daunorubicin and 100 mg cytarabine.
Maltese: Kunjett ta' 50 mL (ħġieġ tat-tip 1) b'tapp (gomma chlorobutyl), u siġill (aluminju) li fih 44 mg daunorubicin u 100 mg cytarabine.
English: Intravenous diphenhydramine (20-25 mg or equivalent) and intravenous dexamethasone (10 mg) should be given.
Maltese: Għandu jingħata diphenhydramine ġol-vini (20-25 mg jew ekwivalenti) u dexamethasone ġol-vini (10 mg).
English: Consolidation daunorubicin 29 mg/m and cytarabine 65 mg/m on days 1 and 3
Maltese: Konsolidazzjoni daunorubicin 29 mg/m² u cytarabine 65 mg/m² f'jiem 1 u 3
English: • Flush the line after administration with sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: • Flaxxja l-linja wara l-għoti bi klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine.
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva serji, inkluż reazzjonijiet anafilattiċi b'daunorubicin u cytarabine.
English: Serious or fatal haemorrhagic events, including fatal central nervous system (CNS) haemorrhages, associated with severe thrombocytopenia were seen in patients treated with Vyxeos liposomal (see section 4.4).
Maltese: Dehru avvenmienti emorraġiċi serji jew fatali, inkluż emorraġiji tas-sistema nervuża ċentrali (CNS) fatali, assoċjati ma' tromboċitopenja severa f'pazjenti kkurati b'Vyxeos liposomali (ara sezzjoni 4.4).
English: The safety and efficacy of Vyxeos liposomal in children aged 0-18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vyxeos liposomali fit-tfal minn età 0-18-il sena għadhom ma ġewx determinati s'issa.
English: Dose adjustment is not required for patients with mild (creatinine clearance [CrCL] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]) or moderate (CrCL 30 mL/min to 59 mL/min) renal impairment.
Maltese: Mhuwiex meħtieġ aġġustament fid-doża għal pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina [CrCL] 60 mL/min sa 89 mL/min skont l-ekwazzjoni ta' Cockcroft Gault [C-G]) jew moderat (CrCL 30 mL/min sa 59 mL/min).
English: Cytarabine was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and SCE in human leukocytes) and in vivo (chromosome aberrations and SCE assay in rodent bone marrow, mouse micronucleus assay).
Maltese: Cytarabine kien mutaġeniku f'testijiet in vitro u klastoġeniku in vitro (aberrazzjonijiet kromożomiċi u SCE fil-lewkoċiti tal-bniedem) u in vivo (aberrazzjonijiet kromożomiċi u assaġġ SCE fil-mudullun tar-roditur, assaġġ tal-mikronukleu tal-ġurdien).
English: • shortness of breath, cough, fluid in the lungs
Maltese: • taqta' nifsek, sogħla, fluwidu fil-pulmun
English: Tissue necrosis
Maltese: Nekrożi tat-tessut
English: Cardiotoxicity (18.7)
Maltese: Komuni Ħafna Kardjotossiċità (18.7)
English: Hyperhidrosis (0.3)
Maltese: .5) Rimettar (0.3)
English: In clinical studies only, Vyxeos liposomal 100 units/m2/day (equivalent to 44 mg/100 mg/m2) was administered intravenously over 90 minutes on days 1, 3, and 5 for the first induction and on days 1 and 3 for patients requiring a second induction.
Maltese: Fl-istudji kliniċi biss, Vyxeos liposomali 100 unità/m²/jum (ekwivalenti għal 44 mg/100 mg/m²) ingħata ġol-vini għal 90 minuta f'jiem 1, 3 u 5 għall-ewwel induzzjoni u f'jiem 1 u 3 għall-pazjenti li kienu jeħtieġu t-tieni induzzjoni.
English: Thrombocytopenia (4.5) Neutropenia (3.7) Anaemia (3.2)
Maltese: .5) Newtropenja (3.7) Anemija (3.2)
English: The study included 2 phases, 1) Treatment Phase during which patients received up to 2 induction and 2 consolidation courses, and 2) a Follow-up Phase, which began 30 days after the last induction or consolidation course and continued for up to 5 years from randomisation.
Maltese: L-istudju inkluda 2 fażijiet, 1) Fażi ta' Kura li matulha l-pazjenti rċievew sa 2 korsijiet tal-induzzjoni u 2 tal-konsolidazzjoni, u 2) Fażi ta' Segwitu, li bdiet 30 jum wara l-aħħar kors ta' induzzjoni jew konsolidazzjoni u kompliet sa 5 snin mir-randomizzazzjoni.
English: Vyxeos liposomal is a cytotoxic medicinal product.
Maltese: Vyxeos liposomali huwa prodott mediċinali ċitotossiku.
English: Chest pain (17.6)
Maltese: Uġigħ fis-sider (17.6)
English: • During your first course - you will have an infusion on days 1, 3, and 5.
Maltese: • Matul l-ewwel kors tiegħek - int ser ikollok infużjoni f'jiem 1, 3 u 5.
English: Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved.
Maltese: L-effett tossiku huwa mmarkat bħala ħafif (Grad 1), moderat (Grad 2), sever (Grad 3), jew ta' periklu għall-ħajja (Grad 4), b'parametri speċifiċi skont is-sistema tal-organi involuta.
English: The fatal infections experienced were sepsis and pneumonia (see section 4.4).
Maltese: L-infezzjonijiet fatali esperjenzati kienu sepsis u pulmonite (ara sezzjoni 4.4).
English: Treatment with Vyxeos liposomal should be discontinued in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk (see sections 4.5 and 4.8).
Maltese: Il-kura b'Vyxeos liposomali għandha titwaqqaf f'pazjenti b'funzjoni kardijaka indebolita sakemm il-benefiċċju tal-bidu jew tal-kontinwità tal-kura ma jkunx ikbar mir-riskju (ara sezzjonijiet 4.5 u 4.8).
English: First induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1, 3, and 5
Maltese: L-ewwel induzzjoni daunorubicin 44 mg/m² u cytarabine 100 mg/m² f'jiem 1, 3, u 5
English: Table 4:
Maltese: sa 4 sigħat
English: Vyxeos liposomal may induce hyperuricemia secondary to rapid lysis of leukaemic cells.
Maltese: Vyxeos liposomali jista' jinduċi iperurikemija sekondarja għal liżi rapida ta' ċelluli lewkimiċi.
English: Intravenous diphenhydramine (20-25 mg) and dexamethasone (10 mg) should be given, and an epinephrine (adrenaline) or bronchodilators should be added if indicated.
Maltese: Għandu jingħata diphenhydramine ġol-vini (20-25 mg) u dexamethasone (10 mg), u jekk indikati għandhom jiżdiedu epinefrina (adrenalina) jew bronkodilaturi.
English: • Remove the appropriate number of vials of Vyxeos liposomal from the refrigerator and equilibrate to the room temperature (15°C to 30°C) for 30 minutes.
Maltese: • Neħħi n-numru xieraq ta' kunjetti ta' Vyxeos liposomali mill-friġġ u ħallihom joqogħdu għat-temperatura ambjentali (15°C sa 30°C) għal 30 minuta.
English: Oedema (52.3) Fatigue (46.4) Chills (31.2) Pyrexia (29.6)
Maltese: Komuni Ħafna Edema (52.3) Għeja (46.4) Dehxiet ta' bard (31.2) Deni (29.6)
English: • chills, low body temperature, or high body temperature
Maltese: • dehxiet ta' bard, temperatura tal-ġisem baxxa jew temperatura tal-ġisem għolja