FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on a population pharmacokinetic analysis using data from clinical studies in patients, no significant difference in clearance of daunorubicin or cytarabine was observed in patients with pre-existing mild to moderate renal impairment (60 mL/min ≥ to ≤ 89 mL/min creatinine clearance [CrCL] for mild, and 30 mL/min ≥ to ≤ 59 mL/min creatinine clearance [CrCL] for moderate) compared to patients with baseline normal renal function (CrCL ≥ 90 mL/min).
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni permezz ta' dejta minn studji kliniċi fil-pazjenti, ma ġiet osservata l-ebda differenza sinifikanti fit-tneħħija ta' daunorubicin jew cytarabine f'pazjenti b'indeboliment tal-kliewi ħafif sa moderat preeżistenti (60 mL/min ≥ sa ≤ 89 mL/min tneħħija tal-kreatinina [CrCL] għal ħafif, u 30 mL/min ≥ sa ≤ 59 mL/min tneħħija tal-kreatinina [CrCL] għal moderat) meta mqabbel ma' pazjenti b'funzjoni tal-kliewi normali fil-linja bażi (CrCL ≥ 90 mL/min).
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion daunorubicin/cytarabine
Maltese: Vyxeos liposomali 44 mg/100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni daunorubicin/cytarabine
English: Haemorrhage (13.1)
Maltese: Komuni Ħafna Emorraġija (13.1)
English: Renal insufficiency (6.4)
Maltese: Komuni Insuffiċjenza tal-kliewi (6.4)
English: Vyxeos liposomal demonstrated superiority in overall survival in the ITT population compared with the comparator 7+3 treatment regimen (Figure 1).
Maltese: ITT meta mqabbel mal-komparatur reġimen ta' kura 7+3 (Figura 1).
English: Sleep disorders (25.1) Anxiety (17.3) Delirium (15.5)
Maltese: Ansjetà (17.3) Delirju (15.5)
English: The incidence of haemorrhage events is 69.1%; the incidence of non-serious events of haemorrhage was 67.2 %; the incidence of serious events of haemorrhage is 5.6%; the incidence of haemorrhage which led to discontinuation is 0.
Maltese: L-inċidenza ta' avvenimenti emorraġiċi kienet 69.1 %; l-inċidenza ta' avvenimenti mhux serji ta' emorraġija kienet 67.2 %, l-inċidenza ta' avvenimenti serji ta' emorraġija kienet 5.6 %; l-inċidenza ta' emorraġija li wasslet għat-twaqqif hija 0.
English: The mean (%CV) area under the curve (AUC) during one dosing interval for daunorubicin was 637 (38.4%) mcg.h/mL and cytarabine was 1900 (44.3%) mcg.h/mL.
Maltese: L-erja taħt il-kurva (AUC) medja (%CV) waqt intervall tad-dożaġġ wieħed għal daunorubicin kienet 637 (38.4%) mcg.h/mL u għal cytarabine kienet 1900 (44.3%) mcg.h/mL.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C to 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 4 sigħat f'2°C sa 8°C.
English: Chest pain (1.9)
Maltese: Uġigħ fis-sider (1.9)
English: Cumulative exposure of daunorubicin per course of Vyxeos liposomal Therapy
Maltese: Mediċini oħra u Vyxeos liposomali
English: A baseline cardiac evaluation with an electrocardiogram (ECG) and a multi-gated radionuclide angiography (MUGA) scan or an echocardiography (ECHO) is recommended, especially in patients with risk factors for increased cardiac toxicity.
Maltese: Hija rakkomandata evalwazzjoni kardijaka tal-linja bażi b'elettrokardjograma (ECG) u sken ta' anġjografija radjonuklide skattata f'diversi punti (MUGA) jew ekokardjografija (ECHO), speċjalment f'pazjenti b'fatturi ta' riskju għal effett tossiku miżjud fuq il-qalb.
English: Dizziness (0.8)
Maltese: Mhux komuni Sturdament (0.8)
English: Dyspnoea (13.1)
Maltese: Komuni Ħafna Dispnea (13.1)
English: Haemorrhage (69.1) Hypotension (23.7) Hypertension (17.3)
Maltese: Komuni Ħafna Emorraġija (69.1) Pressjoni baxxa (23.7) Pressjoni għolja (17.3)
English: The most frequently reported serious ADRs were decreased ejection fraction and congestive cardiac failure.
Maltese: L-ADRs serji li ġew irrappurtati bl-aktar mod frekwenti kienu frazzjonijiet ta' ħruġ imnaqqsa u insuffiċjenza kardijaka konġestiva.
English: CR + CRi, n (%) Odds ratio (95% CI) p-value (2-sided)
Maltese: CR + CRi, n (%)
English: • Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds.
Maltese: • B'attenzjoni dawwar il-kontenut tal-kunjett għal 5 minuti filwaqt li bil-mod teqleb il-kunjett kull 30 sekonda.
English: Urinary excretion of daunorubicin and daunorubicinol accounts for 9% of the administered dose of daunorubicin, and urinary excretion of cytarabine and AraU accounts for 71% of the administered dose of cytarabine.
Maltese: L-eliminazzjoni mill-awrina għal daunorubicin u daunorubicinol tammonta għal 9 % tad-doża mogħtija ta' daunorubicin u l-eliminazzjoni mill-awrina ta' cytarabine u AraU tammonta għal 71 % tad-doża mogħtija ta' cytarabine.
English: • itching
Maltese: • fsada
English: When daunorubicin and cytarabine are administered as components of Vyxeos liposomal, the liposomes appear to govern their tissue distribution and rates of elimination; therefore, while the nonliposomal medicinal products have markedly different clearance (CL), volume of distribution (V), and terminal half-life (t1/2) Vyxeos liposomal causes these pharmacokinetic parameters to converge.
Maltese: Meta daunorubicin u cytarabine jingħataw bħala komponenti ta' Vyxeos liposomali, il-lipożomi jidhru li jirregolaw id-distribuzzjoni fit-tessut u r-rati ta' eliminazzjoni tagħhom; għalhekk, filwaqt li l-prodotti mediċinali mhux lipożomali għandhom tneħħija (CL), volum tad-distribuzzjoni (V) u nofs ħajja terminali (t1/2) differenti sew, Vyxeos liposomali jagħmel dawn il-parametri farmakokinetiċi jikkonverġu.
English: The recommended dosing schedule of Vyxeos liposomal 44 mg/100 mg/m 2, administered intravenously over 90 minutes:
Maltese: Skeda tad-dożaġġ rakkomandata għall-induzzjoni ta' remissjoni L-iskeda tad-dożaġġ rakkomandata ta' Vyxeos liposomali hija 44 mg/100 mg/m², mogħti ġol-vini għal 90 minuta:
English: The following information is intended for healthcare professionals only:
Maltese: Kellem lit-tabib jew lill-infermier tiegħek qabel tingħata Vyxeos liposomali:
English: • After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes.
Maltese: • Wara r-rikostituzzjoni, is-soluzzjoni fiha 2.2 mg/mL daunorubicin u 5 mg/mL cytarabine inkapsulati f'lipożomi.
English: Severe myelosuppression
Maltese: Majelosoppressjoni severa
English: An in-line membrane filter may be used for the intravenous infusion of Vyxeos liposomal, provided the minimum pore diameter of the filter is greater than or equal to 15 µm.
Maltese: Jista' jintuża filtru tal-membrana in-line għall-infużjoni ġol-vini ta' Vyxeos liposomali, sakemm id-dijametru minimu tal-por tal-filtru jkun 15 µm jew akbar.
English: Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m have been associated with an increased incidence of treatment-induced congestive heart failure.
Maltese: Dożi kumulattivi totali ta' daunorubicin mhux lipożomali akbar minn 550 mg/m² ġew assoċjati ma' inċidenza miżjuda ta' insuffiċjenza konġestiva tal-qalb indotta mil-kura.
English: Cytarabine is cytotoxic to proliferating mammalian cells in culture.
Maltese: Cytarabine huwa ċitotossiku għal proliferazzjoni taċ-ċelluli tal-mammiferi fil-koltura.
English: Second induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1 and 3
Maltese: It-tieni induzzjoni daunorubicin 44 mg/m² u cytarabine 100 mg/m² f'jiem 1 u 3
English: Purple, lyophilised cake.
Maltese: Kejk vjola lijofilizzat.
English: Each pack contains 1 vial, 2 vials or 5 vials.
Maltese: Kull pakkett fih kunjett 1, 2 kunjetti jew 5 kunjetti.
English: • problems with your sight, blurred vision
Maltese: • problemi bil-vista tiegħek, vista mċajpra
English: Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals.
Maltese: Daunorubicin għandu attività antimitotika u ċitotossika, li tinkiseb bil-formazzjoni ta' kumplessi mad-DNA, li tinibixxi l-attività ta' topoisomerase II, tinibixxi l-attività ta' polimerażi tad-DNA, taffettwa r-regolazzjoni tal-espressjoni ġenika, u tipproduċi radikali ħielsa li jagħmlu ħsara lid-DNA.
English: After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio.
Maltese: Wara r-rikostituzzjoni s-soluzzjoni jkun fiha 2.2 mg/mL daunorubicin u 5 mg/mL cytarabine inkapsulati f'lipożomi f'kombinazzjni fissa fi proporzjon molari 1:5.
English: Hypertension (6.9) Hypotension (4.5)
Maltese: Pressjoni għolja (6.9) Pressjoni baxxa (4.5)
English: Cytotoxic
Maltese: Aġenti kardjotossiċi
English: Concurrent use of cardiotoxic agents may increase the risk of cardiotoxicity.
Maltese: L-użu konkurrenti ta' aġenti kardjotossiċi jista' jżid ir-riskju ta' kardjotossiċità.
English: • Store in an upright position.
Maltese: • jekk taħseb li tista' tkun tqila.
English: Hepatotoxic medicinal products may impair liver function and increase the toxicity.
Maltese: Prodotti mediċinali epatotossiċi jistgħu jindebolixxu l-funzjoni tal-fwied u jżidu l-effett tossiku.
English: Prophylactic anti-infectives (including anti-bacterial, anti-virals, anti-fungals) may be administered during the period of profound neutropenia until ANC returns to 500/μL or greater.
Maltese: Jistgħu jingħataw aġenti kontra l-infezzjoni profilattiċi (inkluż antibatteriċi, antivirali, antifungali) matul il-perjodu ta' newtropenja profonda sakemm l-ANC jirritorna għal 500/μL jew aktar.
English: After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni fiha 2.2 mg/mL daunorubicin u 5 mg/mL cytarabine inkapsulati f'lipożomi
English: How to store Vyxeos liposomal
Maltese: Kif taħżen Vyxeos liposomali
English: Vyxeos liposomal liposomes exhibit a prolonged plasma half-life following intravenous infusion, with greater than 99% of the daunorubicin and cytarabine in the plasma remaining encapsulated within the liposomes.
Maltese: Il-lipożomi ta' Vyxeos liposomali juru nofs ħajja plażmatika mtawla wara infużjoni ġol-vini, b'aktar minn 99 % ta' daunorubicin u cytarabine fil-plażma li jibqa' inkapsulat fil-lipożomi.
English: • kidney failure and abnormal blood tests due to massive death of cancer cells (Tumour lysis syndrome).
Maltese: • insuffiċjenza tal-kliewi u testijiet tad-demm mhux normali minħabba li jmutu ħafna ċelluli tal-kanċer (sindrome ta' liżi tat-tumur).
English: Each 50 ml vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Maltese: Kull kunjett ta' 50 ml fih 44 mg ta' daunorubicin u 100 mg ta' cytarabine.
English: • The infusion is given over one and a half hours (90 minutes).
Maltese: • L-infużjoni tingħata għal siegħa u nofs (90 minuta).
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Mhux komuni Sindrome ta' eritrodisesteżija palmari-plantari (0.8)
English: The pharmacokinetics of Vyxeos liposomal in patients aged > 85 years has not yet been evaluated.
Maltese: Il-farmakokinetika ta' Vyxeos liposomali f'pazjenti li għadhom > 85 sena għadha ma ġietx evalwata s'issa.
English: • bleeding
Maltese: Treddigħ
English: Other medicines and Vyxeos liposomal
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: A subsequent course of consolidation may be administered in patients who do not show disease progression or unacceptable toxicity within the range of 5 to 8 weeks after the start of the first consolidation.
Maltese: Jista' jingħata kors sussegwenti tal-konsolidazzjoni f'pazjenti li ma jurux progressjoni tal-marda jew effett tossiku mhux aċċettabbli fil-medda ta' 5 sa 8 ġimgħat wara l-bidu tal-ewwel konsolidazzjoni.
English: Evaluation of hepatic and renal function using conventional clinical laboratory tests is recommended prior to administration of Vyxeos liposomal and periodically during treatment.
Maltese: Hija rrakkomandata evalwazzjoni tal-funzjoni tal-fwied u tal-kliewi permezz ta' testijiet tal-laboratorju kliniċi konvenzjonali qabel l-għoti ta' Vyxeos liposomali u perjodikament waqt il-kura.
English: Lot
Maltese: Rimi
English: Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation.
Maltese: Daunorubicin ġie assoċjat ma' nekrożi tat-tessut lokali fis-sit tal-ekstravażazzjoni tal-prodott mediċinali.
English: • If the diluted infusion solution is not used immediately, store in a refrigerator (2°C to 8°C) for up to 4 hours.
Maltese: • Jekk is-soluzzjoni tal-infużjoni dilwita ma tintużax immedjatament, aħżen fi friġġ (2°C sa 8°C) sa 4 sigħat.
English: Febrile neutropenia (62.4)
Maltese: Komuni Ħafna Newtropenja bid-deni (62.4)
English: It contains two active substances, called ‘daunorubicin' and ‘cytarabine', in the form of tiny particles known as ‘liposomes'.
Maltese: Dan fih żewġ sustanzi attivi, imsejħa “daunorubicin” u “cytarabine”, fil-forma ta' partikuli żgħar ħafna magħrufa bħala “lipożomi”.
English: Febrile neutropenia (63.5)
Maltese: Komuni Ħafna Newtropenja bid-deni (63.5)
English: Due to substantial differences in the pharmacokinetic parameters, the dose and schedule recommendations for Vyxeos liposomal are different from those for daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection.
Maltese: Minħabba d-differenzi sostanzjali fil-parametri tal-farmakokinetika, ir-rakkomandazzjonijiet tad-doża u tal-iskeda għal Vyxeos liposomali huma differenti minn dawk għal daunorubicin hydrochloride għal injezzjoni, cytarabine għal injezzjoni, lipożomu taċ-ċitrat ta' daunorubicin għal injezzjoni u lipożomu ta' cytarabine għal injezzjoni.
English: Cardiac arrest was reported as a fatal event; the patient experienced thrombocytopenia and neutropenia which contributed to cardiac arrest (see section 4.4).
Maltese: L-arrest kardijaku ġie rrappurtat bħala avveniment fatali; il-pazjent esperjenza tromboċitopenja u newtropenja li kkontribwixxew għal arrest kardijaku (ara sezzjoni 4.4).
English: Serious or fatal haemorrhagic events, including fatal central nervous system (CNS) haemorrhages, associated with severe thrombocytopenia, have occurred in patients treated with Vyxeos liposomal.
Maltese: Seħħew avvenimenti emorraġiċi serji jew fatali, inklużi emorraġiji fatali tas-sistema nervuża ċentrali (CNS), assoċjati ma' tromboċitopenja severa, f'pazjenti kkurati b'Vyxeos liposomali.
English: • Determine the dose and number of vials of Vyxeos liposomal based on the individual patient's BSA as outlined in section 4.2.
Maltese: • Iddetermina d-doża u n-numru ta' kunjetti ta' Vyxeos liposomali abbażi tal-BSA individwali tal-pazjent kif deskritt f'sezzjoni 4.2.
English: Median survival, months (95% CI) Hazard ratio (95% CI) p-value (2-sided)
Maltese: Sopravivenza mingħajr avvenimenti Sopravivenza medjana, xhur (CI ta' 95 %) Proporzjon ta' periklu (CI ta' 95 %) valur-p (miż-żewġ naħat)
English: Furthermore, daunorubicin caused testicular atrophy and total aplasia of spermatocytes in the seminiferous tubules in dogs and cytarabine, sperm-head abnormalities in mice.
Maltese: Barra minn hekk, daunorubicin ikkawża atrofija testikolari u aplażija totali tal-ispermatoċiti fit-tubuli seminiferużi fil-klieb u cytarabine, anormalitajiet fir-ras tal-isperma fil-ġrieden.
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Maltese: Cytarabine kkawża t-trasformazzjoni taċ-ċelluli tal-embrijun tal-ħamster u ċelluli H43 tal-far in vitro.
English: Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Maltese: AML relatata mat-terapija (t-AML), AML ta' sindrome majelodisplastiku (MDS AML) u AML lewkimja majelomonoċitika kronika (CMMoL
English: In the 7+3 arm, first induction consisted of cytarabine 100 mg/m2/day on days 1 to 7 by continuous infusion, and daunorubicin 60 mg/m2/day on days 1, 2, and 3 whereas second induction and consolidation cytarabine was dosed on days 1 to 5 and daunorubicin on days 1 and 2.
Maltese: Għall-korsijiet tal-konsolidazzjoni, fl-istudji kliniċi biss, id-doża ta' Vyxeos liposomali tnaqqset għal 65 unità/m²/jum (ekwivalenti għal 29mg/65 mg/m²) f'jiem 1 u 3. Fil-fergħa 7+3, l-ewwel induzzjoni kienet tikkonsisti minn cytarabine 100 mg/m²/jum f'jiem 1 sa 7 permezz ta' infużjoni kontinwa, u daunorubicin 60 mg/m²/jum f'jiem 1, 2 u 3 filwaqt li fit-tieni induzzjoni u konsolidazzjoni, ġie ddożat cytarabine f'jiem 1 sa 5 u daunorubicin f'jiem 1 u 2.
English: Vyxeos liposomal is administered by intravenous infusion over a period of 90 minutes.
Maltese: Vyxeos liposomali jingħata permezz ta' infużjoni ġol-vini għal perjodu ta' 90 minuta.
English: • fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
Maltese: • uġigħ ta' ras, sturdament, konfużjoni, diffikultà biex torqod, ansjetà
English: CR, n (%) Odds ratio (95% CI) p-value (2-sided)
Maltese: Proporzjon ta' probabbiltà (CI ta' 95 %) valur-p (miż-żewġ naħat)
English: After internalisation, Vyxeos liposomal liposomes undergo degradation, releasing daunorubicin and cytarabine within the intracellular environment, enabling the medicinal products to exert their synergistic antineoplastic activity.
Maltese: Wara l-internalizzazzjoni, il-lipożomi ta' Vyxeos liposomali issirilhom degradazzjoni, billi jirrilaxxaw daunorubicin u cytarabine fl-ambjent intraċellulari, billi jippermettu l-prodotti mediċinali jeżerċitaw l-attività antineoplastika sinerġistika tagħhom.
English: The pharmacokinetics of each medicinal product was based on total plasma concentrations (i.e., encapsulated plus unencapsulated medicinal product).
Maltese: Il-farmakokinetika ta' kull prodott mediċinali ġiet ibbażata fuq il-konċentrazzjonijiet totali fil-plażma (jiġifieri, prodott mediċinali inkapsulat flimkien ma' mhux inkapsulat).
English: Daunorubicin per course
Maltese: Xhur mir-randomizzazzjoni
English: The incidence of all cardiotoxicity events was 72.0%; the incidence of non-serious events of cardiotoxicity was 68.5 %; the incidence of serious events of cardiotoxicity was 9.1%; the incidence of cardiotoxicity which led to discontinuation is 0.
Maltese: L-inċidenza ta' avvenimenti ta' kardjotossiċità kienet 72.0 %; l-inċidenza ta' avvenimenti mhux serji ta' kardjotossiċità kienet 68.5 %, l-inċidenza ta' avvenimenti serji ta' kardjotossiċità kienet 9.1 %; l-inċidenza ta' kardjotossiċità li wasslet għat-twaqqif hija 0. 5 %.
English: Vyxeos liposomal exhibits a prolonged half-life (%CV) of 31.5 h (28.5%) for daunorubicin and 40.4 h (24.2%) for cytarabine with greater than 99% of the daunorubicin and cytarabine in the plasma remaining encapsulated within the liposomes.
Maltese: Vyxeos liposomali jinibixxi nofs ħajja mtawla (%CV) ta' 31.5 h (28.5%) għal daunorubicin u 40.4
English: Use of Vyxeos liposomal in patients who have previously received doxorubicin increases the risk of cardiotoxicity (see section 4.4).
Maltese: L-użu ta' Vyxeos liposomali f'pazjenti li preċedentement irċivew doxorubicin iżid ir-riskju ta' kardjotossiċità (ara sezzjoni 4.4).
English: Since daunorubicin is metabolised by the liver, changes in hepatic function induced by concomitant therapies may affect metabolism, pharmacokinetics, therapeutic efficacy, and/or the toxicity of Vyxeos liposomal (see section 5.2).
Maltese: Peress li daunorubicin jiġi mmetabolizzat mill-fwied, tibdil fil-funzjoni tal-fwied indott minn terapiji konkomitanti jista' jaffettwa l-metaboliżmu, il-farmakokinetika, l-effikaċja terapewtika u/jew l-effett tossiku ta' Vyxeos liposomali (ara sezzjoni 5.2).
English: Severe myelosuppression (including fatal infections and haemorrhagic events) has been reported in patients after administration of a therapeutic dose of Vyxeos liposomal.
Maltese: Ġiet irrappurtata majelosoppressjoni severa (inkluż infezzjonijiet fatali u avvenimenti emorraġiċi fatali) fil-pazjenti wara l-għoti ta' doża terapewtika ta' Vyxeos liposomali.
English: Following the dose administered on day 5, the mean (% coefficient of variation [CV]) maximum plasma concentrations (Cmax) for daunorubicin was 26.0 (32.7%) mcg/mL and cytarabine was 62.2 (33.7%) mcg/mL.
Maltese: (32.7%) mcg/mL u għal cytarabine kienu 62.2 (33.7%) mcg/mL.
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
Maltese: IL-PRODOTT MEDIĊINALI Vyxeos liposomali 44 mg/100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: This limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum.
Maltese: Il-limitu jidher li huwa aktar baxx (400 mg/m²) f'pazjenti li rċivew terapija ta' radjazzjoni għall-mediastinum.
English: Vyxeos liposomal dosing is based on the patient's body surface area (BSA) according to the following schedule:
Maltese: Id-dożaġġ ta' Vyxeos liposomali huwa bbażat fuq l-erja tas-superfiċje tal-ġisem (BSA) skont l-iskeda li ġejja:
English: Visual impairment (10.4)
Maltese: Komuni Ħafna Vista batuta (10.4)
English: Patients with the following AML sub-types were included in the study: therapy-related AML (t-AML), myelodysplastic syndrome AML (MDS AML) and chronic myelomonocytic leukaemia AML (CMMoL AML) with documented history of MDS or CMMoL prior to transformation to AML, and de novo AML with karyotype changes characteristic of myelodysplasia, (per 2008 WHO criteria).
Maltese: AML) bi storja ddokumentata ta' MDS jew CMMoL qabel it-trasformazzjoni għal AML, u AML de novo b'karatteristika ta' tibdil fil-karijotip ta' majelodisplażija, (skont il-kriterji tal-WHO tal-2008).
English: Insufficient pharmacokinetic data were collected in paediatric patients to draw conclusions.
Maltese: Ma nġabritx biżżejjed dejta tal-farmakokinetika f'pazjenti pedjatriċi biex jinstiltu konklużjonijiet.
English: Chills (0.3) a Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonly reported arrhythmia was tachycardia
Maltese: It-termini tal-grupp ta' aritmija jinkludu fibrillazzjoni atrijali, bardikardija, u l-aritmija rrappurtata bl-aktar mod komuni kienet takikardija
English: Vyxeos liposomal belongs to a group of medicines called ‘antineoplastics' used in cancer.
Maltese: Vyxeos liposomali jappartjeni għal grupp ta' mediċini msejħa “antineoplastiċi” li jintużaw fil-kanċer.
English: The recommended dosing schedule of Vyxeos liposomal is 29 mg/65 mg/m2, administered intravenously over 90 minutes: • on days 1 and 3 as subsequent courses of consolidation therapy, if needed.
Maltese: L-iskeda tad-dożaġġ rakkomandata ta' Vyxeos liposomali hija 29 mg/65 mg/m², mogħti ġol-vini għal 90 minuta:
English: For moderate hypersensitivity symptoms (e.g., moderate rash, flushing, mild dyspnoea, chest discomfort) the treatment should be stopped.
Maltese: Għal sintomi ta' sensittività eċċessiva moderati (eż., raxx moderat, vampati, dispnea ħafifa, skumdità fis-sider), il-kura għandha titwaqqaf.
English: Both cytarabine and daunorubicin, tested separately, showed teratogenic and embryotoxic effects in animal studies.
Maltese: Kemm cytarabine kif ukoll daunorubicin, li ġew ittestjati b'mod separat, urew effetti teratoġeniċi u embrijotossiċi fi studji f'annimali.
English: The lower percentages of metabolite:parent ratios after Vyxeos liposomal administration indicate that most of the total daunorubicin and cytarabine in the circulation is trapped inside the Vyxeos liposomal liposomes, where they are inaccessible to medicinal product-metabolising enzymes.
Maltese: Il-perċentwali aktar baxxi ta' proporzjonijiet metabolit:oriġinarju wara l-għoti ta' Vyxeos liposomali jidnikaw li ħafna mit-total ta' daunorubicin u cytarabine fiċ-ċirkolazzjoni jinqabad ġewwa l-lipożomi ta' Vyxeos liposomali, fejn dawn mhumiex aċċessibbli għall-enzimi li jimmetabolizzaw il-prodott mediċinali.
English: • if you have any allergic (hypersensitivity) reactions.
Maltese: • jekk għandek reazzjonijiet allerġiċi (ta' sensittività eċċessiva).
English: Renal insufficiency (10.4)
Maltese: Komuni Ħafna Għeja (10.4)
English: Copper gluconate Trolamine (for pH adjustment) Sucrose
Maltese: Trolamine (għal aġġustament tal-pH) Sukrożju