FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatotoxic medicinal products may impair liver function and increase the toxicity.
Croatian: Hepatotoksični lijekovi mogu oštetiti funkciju jetre i povećati toksičnost.
English: The efficacy of Vyxeos liposomal in the treatment of high risk AML was evaluated in 1 controlled study.
Croatian: Djelotvornost lijeka Vyxeos liposomalni u liječenju visokorizičnog AML-a procijenjena je u 1 kontroliranom ispitivanju.
English: Consolidation therapy is recommended for patients achieving remission who have recovered to absolute neutrophil count (ANC) > 500/µL and the platelet count has recovered to greater than 50,000/µL in the absence of unacceptable toxicity.
Croatian: Terapija konsolidacije preporučuje se za bolesnike koji su postigli remisiju i koji su se oporavili do apsolutnog broja neutrofila (ABN) >500/µl, a broj trombocita se oporavio do više od 50 000/µl u odsutnosti neprihvatljive toksičnosti.
English: • During your first course - you will have an infusion on days 1, 3, and 5.
Croatian: • Tijekom prvog ciklusa - primit ćete infuzije 1., 3. i 5. dana.
English: If a planned dose of Vyxeos liposomal is missed, the dose should be administered as soon as possible and the dosing schedule adjusted accordingly, maintaining the treatment interval.
Croatian: U slučaju propuštanja planirane doze lijeka Vyxeos liposomalni, potrebno je primijeniti dozu što prije i prilagoditi režim doziranja u skladu s time, održavajući interval liječenja.
English: Plasma concentration-time profiles obtained from 13 to 26 patients who received Vyxeos liposomal 100 units/m
Croatian: Profili koncentracije u plazmi naspram vremena dobiveni od 13 do 26 bolesnika koji su dobili Vyxeos liposomalni 100 jedinica/m
English: Care should be taken to ensure there is no extravasation to prevent the risk of tissue necrosis.
Croatian: Potrebno je primijeniti oprez kako ne bi došlo do ekstravazacije radi sprječavanja rizika od nekroze tkiva.
English: The most serious and frequently occurring ADRs were infection (58.7%), cardiotoxicity (18.7%) and haemorrhage (13.1%).
Croatian: Najozbiljnije i najčešće nuspojave bile su infekcije (58,7%), kardiotoksičnost (18,7%) i krvarenja
English: • a fall in the number of red blood cells (anaemia) leading to tiredness and weakness
Croatian: • smanjeni broj crvenih krvnih stanica (anemija) koja dovodi do umora i slabosti
English: Each pack contains 1 vial, 2 vials or 5 vials.
Croatian: Jedno pakiranje sadrži 1 bočicu, 2 bočice ili 5 bočica.
English: Name and address of the manufacturer(s) responsible for batch release Jazz Pharmaceuticals Ireland Limited 5th Floor
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Jazz Pharmaceuticals Ireland Limited
English: The frequency of fatal hypersensitivity events was 0 (see section 4.4).
Croatian: Učestalost fatalnih slučajeva preosjetljivosti bila je 0 (vidjeti dio 4.4).
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.
Croatian: Ukupne kumulativne doze neliposomalnog daunorubicina veće od 550 mg/m povezane su s povećanom incidencijom kongestivnog zatajenja srca prouzročenog liječenjem.
English: Efficacy results for study 301
Croatian: Tablica 4: Rezultati djelotvornosti za ispitivanje 301
English: Repeat-dose toxicity of Vyxeos liposomal was tested in two-cycle intravenous infusion toxicity studies with 28-day recovery periods conducted in rats and dogs.
Croatian: Toksičnost ponovljenih doza lijeka Vyxeos liposomalni ispitana je u ispitivanjima toksičnosti s dva ciklusa intravenske infuzije i razdobljem oporavka od 28 dana provedenih u štakora i pasa.
English: Environmental risk assessment has shown that Vyxeos liposomal is not anticipated to have the potential to be persistent, bioaccumulative, or toxic to the environment.
Croatian: Procjena rizika za okoliš pokazala je da se ne očekuje da Vyxeos liposomalni ima trajno, bioakumulacijsko ili toksično djelovanje na okoliš.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C to 8°C.
Croatian: Kemijska i fizička stabilnost tijekom uporabe dokazana je do 4 sata na temperaturi od 2°C do 8°C.
English: Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops.
Croatian: Potrebno je nadzirati razine mokraćne kiseline u krvi i započeti prikladnu terapiju u slučaju da se razvije hiperuricemija.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Vyxeos liposomal.
Croatian: Ako se bilo koje od gore navedenog odnosi na Vas (ili ako niste sigurni), razgovarajte se svojim liječnikom, ljekarnikom ili medicinskom sestrom prije primanja lijeka Vyxeos liposomalni.
English: Blood counts should be regularly monitored until recovery (see section 4.8).
Croatian: Potrebno je redovito nadzirati krvnu sliku do oporavka (vidjeti dio 4.8).
English: • Flush the line after administration with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: • Isperite liniju nakon primjene otopinom natrijeva klorida 9 mg/ml (0,9%) za injekcije.
English: The incidence of fatal haemorrhage was 2.1%.
Croatian: Incidencija fatalnih krvarenja bila je 2,1%.
English: Do not administer via an intramuscular, intrathecal, or subcutaneous route (see section 4.2).
Croatian: Lijek se ne smije primijeniti intramuskularnim, intratekalnim ili supkutanim putem (vidjeti dio 4.2).
English: Do not administer Vyxeos liposomal in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored.
Croatian: Vyxeos liposomalni se ne smije primijeniti u kombinaciji s drugim kardiotoksičnim lijekovima osim ako se srčana funkcija bolesnika pažljivo nadzire.
English: This is because Vyxeos liposomal may affect the way some other medicines work.
Croatian: Razlog tomu je što Vyxeos liposomalni može utjecati na djelovanje drugih lijekova.
English: While cytarabine is not a carcinogen, daunorubicin is a possible carcinogen, hence, Vyxeos liposomal may be associated with a carcinogenic potential.
Croatian: Dok citarabin nije kancerogen, daunorubicin je potencijalni kancerogen, stoga Vyxeos liposomalni može biti povezan s kancerogenim potencijalom.
English: Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine.
Croatian: Ozbiljne reakcije preosjetljivosti, uključujući anafilaktičke reakcije prijavljene su s daunorubicinom i citarabinom.
English: Vyxeos liposomal is administered by intravenous infusion over a period of 90 minutes.
Croatian: Vyxeos liposomalni se primjenjuje intravenskom infuzijom tijekom razdoblja od 90 minuta.
English: • On further courses - you will have an infusion on days 1 and 3.
Croatian: • U sljedećim ciklusima - primit ćete infuzije 1. i 3. dana.
English: • Determine the dose and number of vials of Vyxeos liposomal based on the individual patient's BSA as outlined in section 4.2.
Croatian: • Odredite dozu i broj bočica lijeka Vyxeos liposomalni na temelju tjelesne površine pojedinog bolesnika onako kako je navedeno u dijelu 4.2.
English: Infection (78.1)
Croatian: Vrlo često Infekcija (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).
Croatian: Medijan preživljenja u terapijskoj skupini lijeka Vyxeos liposomalni bio je 9,56 mjeseci u usporedbi sa 5,95 mjeseci u terapijskoj skupini 7+3 (omjer hazarda = 0,69, 95% CI = 0,52, 0,90, dvostrani log-rang test p = 0,005).
English: Cardiotoxicity (18.7)
Croatian: Vrlo često Kardiotoksičnost (18,7)
English: • Do not throw away any medicines via wastewater.
Croatian: • Nikada nemojte nikakve lijekove bacati u kućni otpad.
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.
Croatian: Prethodno liječenje antraciklinima (uključujući bolesnike koji su prije primali preporučene maksimalne kumulativne doze doksorubicina ili daunorubicinklorida), postojeća bolest srca (uključujući oštećenu srčanu funkciju), prethodna radioterapija medijastinuma, ili istovremena uporaba kardiotoksičnih lijekova mogu povećati rizik od kardiotoksičnosti izazvane daunorubicinom.
English: If myelosuppressive complications occur, appropriate supportive measures should be used, e.g., anti-infectives, colonystimulating factors, transfusions.
Croatian: Ako dođe do komplikacija prouzročenih mijelosupresijom, potrebno je primijeniti prikladne potporne mjere, npr. lijekove protiv infekcije, faktore stimulacije kolonija, transfuzije.
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.
Croatian: • Izvadite odgovarajući broj bočica lijeka Vyxeos liposomalni iz hladnjaka i pričekajte da se prilagode sobnoj temperaturi (od 15°C od 30°C) tijekom 30 minuta.
English: • Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds.
Croatian: • Pažljivo vrtite kružnim pokretom sadržaj bočice tijekom 5 minuta, a svakih 30 sekundi nježno preokrenite bočicu naopako.
English: Hypertension (6.9) Hypotension (4.5)
Croatian: Hipertenzija (6,9) Hipotenzija (4,5)
English: Stability of diluted infusion solution
Croatian: Stabilnost razrijeđene infuzijske otopine
English: • if you are allergic to the active substances (daunorubicin or cytarabine) or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na djelatne tvari (daunorubicin ili citarabin) ili neki drugi sastojak ovog lijeka
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.
Croatian: Kada su daunorubicin i citarabin primijenjeni kao sastojci lijeka Vyxeos liposomalni, čini se da liposomi upravljaju njihovom raspodjelom u tkivima te brzinom eliminacije; stoga, dok neliposomalni lijekovi imaju značajno različit klirens (CL), volumen distribucije (V) i terminalni poluvijek (t1/2), Vyxeos liposomalni izaziva konvergenciju tih farmakokinetičkih parametara.
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).
Croatian: Budući da se daunorubicin metabolizira u jetri, promjene funkcije jetre izazvane istodobno primijenjenim lijekovima mogu utjecati na metabolizam, farmakokinetiku, terapijsku djelotvornost i/ili toksičnost lijeka Vyxeos liposomalni (vidjeti dio 5.2).
English: In clinical studies with Vyxeos liposomal, one event of extravasation occurred, but no necrosis was observed.
Croatian: U kliničkim ispitivanjima s lijekom Vyxeos liposomalni, došlo je do jednog slučaja ekstravazacije, ali nije zabilježena nekroza.
English: It should be taken into consideration that the absorption of oral accompanying medicinal products may be considerably influenced by gastrointestinal mucositis and/or diarrhoea frequently occurring in association with intensive chemotherapy.
Croatian: Potrebno je uzeti u obzir da na apsorpciju popratnih peroralnih lijekova značajan učinak može imati gastrointestinalni mukozitis i/ili proljev koji se često pojavljuje uz intenzivnu kemoterapiju.
English: The fatal infections experienced were sepsis and pneumonia (see section 4.4).
Croatian: Fatalne infekcije koje su se pojavile bile su sepsa i upala pluća (vidjeti dio 4.4).
English: Uncommon side effects (may affect up to 1 in 100 people): • numbness and rash in the hands and feet (palmar-plantar erythrodysaesthesia syndrome).
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): • utrnulost i osip na šakama i stopalima (sindrom palmarno-plantarne eritrodizestezije)
English: Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP), which is the active metabolite.
Croatian: Intracelularno, citarabin se pretvara u citarabin-5-trifosfat (araCTP), koji je aktivni metabolit.
English: There are no data on the use of Vyxeos liposomal in pregnant women.
Croatian: Nema podataka o primjeni lijeka Vyxeos liposomalni u trudnica.
English: Infections and infestations Very Common
Croatian: Infekcije i infestacije
English: • shortness of breath, cough, fluid in the lungs
Croatian: • nedostatak zraka, kašalj, tekućina u plućima
English: • The reconstituted product should be an opaque, purple, homogeneous dispersion, essentially free from visual particulates.
Croatian: • Rekonstituiran lijek treba biti neprozirna, ljubičasta, homogena disperzija, bez vidljivih čestica.
English: • Then, reconstitute each vial with 19 mL of sterile water for injections using a 20 mL syringe and immediately thereafter start a 5-minute timer.
Croatian: • Zatim rekonstituirajte svaku bočicu sa 19 ml sterilne vode za injekcije štrcaljkom od 20 ml, i odmah nakon toga pokrenite brojač vremena na 5 minuta.
English: Vyxeos liposomal must be given to you by a doctor or nurse with experience in treating AML.
Croatian: Vyxeos liposomalni Vam mora dati liječnik ili medicinska sestra s iskustvom u liječenju AML-a.
English: Treatment should be continued as long as the patient continues to benefit or until disease progression, up to maximum of 2 consolidation courses.
Croatian: Liječenje treba nastaviti sve dok bolesnik ima koristi ili do progresije bolesti, do najviše 2 ciklusa konsolidacije.
English: Incorporation into DNA and RNA may also contribute to cytarabine cytotoxicity.
Croatian: Ugrađivanje u DNK i RNK može također doprinositi citotoksičnosti citarabina.
English: The most common haemorrhagic event was epistaxis, and the majority of these were considered not serious (29.1%).
Croatian: Najčešći slučajevi krvarenja bili su epistaksa, a za većinu njih smatralo se da nisu ozbiljni (29,1%).
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.
Croatian: Izlučivanje urinom daunorubicina i daunorubicinola čini 9% primijenjene doze daunorubicina, a izlučivanje urinom citarabina i AraU čini 71% primijenjene doze citarabina.
English: Infection (58.7)
Croatian: Vrlo često Infekcija (58,7)
English: Use an effective method of contraception during and for 6 months after treatment.
Croatian: Koristite učinkovitu metodu kontracepcije tijekom liječenja i još 6 mjeseci nakon liječenja.
English: If the medicinal product is used during pregnancy, or if the patient becomes pregnant while receiving Vyxeos liposomal, the woman should be informed of the potential hazard to the foetus.
Croatian: Ako bolesnica koristi lijek tijekom trudnoće, ili zatrudni za vrijeme uzimanja lijeka Vyxeos liposomalni, mora biti obaviještena o potencijalnom riziku za plod.
English: Preparation instructions
Croatian: Upute za pripremu
English: While you are receiving treatment with Vyxeos liposomal your doctor will perform regular blood tests to assess how you respond to the treatment and to check it is well tolerated.
Croatian: Dok primate terapiju lijekom Vyxeos liposomalni, obavit ćete redovite krvne pretrage kako bi liječnik procijenio Vaš odgovor na liječenje i provjerio da ga dobro podnosite.
English: Second induction
Croatian: Druga indukcija
English: The relationship between cumulative Vyxeos liposomal dose and the risk of cardiac toxicity has not been determined.
Croatian: Odnos između kumulativne doze lijeka Vyxeos liposomalni i rizika od kardiotoksičnosti nije utvrđen.
English: Carcinogenicity, mutagenicity, and reproductive toxicity studies have not been conducted with Vyxeos liposomal.
Croatian: Ispitivanja kancerogenosti, mutagenosti i reproduktivne toksičnosti s lijekom Vyxeos liposomalni nisu provedena.
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.
Croatian: Preporučuje se početna procjena srčane funkcije elektrokardiogramom (EKG) i snimkom višekanalnom radionuklidnom angiografijom (MUGA) ili ehokardiografijom (ECHO), naročito u bolesnika s rizičnim čimbenicima za povećanu kardiotoksičnost.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici nakon „EXP“.
English: Hypersensitivity (including rash) (66.9)
Croatian: Preosjetljivost (uključujući osip) (66,9)
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.
Croatian: Zbog značajnih razlika u farmakokinetičkim parametrima, preporuke doze i režima doziranja za Vyxeos liposomalni razlikuju se od onih za injekcije daunorubicinklorida, injekcije citarabina, injekcije liposomalnog daunorubicincitrata i injekcije liposomalnog citarabina.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C to 8°C when kept in an upright position.
Croatian: Kemijska i fizička stabilnost tijekom uporabe dokazana je do 4 sata na temperaturi od 2°C do 8°C kada se čuva u uspravnom položaju.
English: Hypersensitivity (including rash)
Croatian: Često Preosjetljivost (uključujući osip)
English: • Do not mix Vyxeos liposomal with, or administer as an infusion with, other medicinal products.
Croatian: • Lijek Vyxeos liposomalni nemojte miješati s drugim lijekovima, niti primjenjivati kao infuziju s drugim lijekovima.
English: Male patients and women of childbearing potential must use an effective method of contraception during treatment and for 6 months following the last dose of Vyxeos liposomal (see section 4.6).
Croatian: Muški bolesnici i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i tijekom 6 mjeseci nakon zadnje doze lijeka Vyxeos liposomalni (vidjeti dio 4.6).
English: Daunorubicin is mostly catalysed by hepatic and non-hepatic aldo-keto reductase and carbonyl reductase to the active metabolite daunorubicinol.
Croatian: Daunorubicin većinom kataliziraju jetrene i izvan jetrene aldo-keto reduktaze i karbonil reduktaze u aktivni metabolit daunorubicinol.
English: Patients may be pre-medicated for nausea and vomiting.
Croatian: Bolesnicima se može primijeniti premedikacija protiv mučnine i povraćanja.
English: Both cytarabine and daunorubicin, tested separately, showed teratogenic and embryotoxic effects in animal studies.
Croatian: Citarabin i daunorubicin, ispitani zasebno, pokazali su jedan i drugi teratogene i embriotoksične učinke u ispitivanjima provedenima na životinjama.
English: Store in an upright position.
Croatian: Čuvati u uspravnom položaju.
English: It is given when the leukaemia was caused by previous treatments (known as therapy related acute myeloid leukaemia) or when there are certain changes in the bone marrow (known as acute myeloid leukaemia with “myelodysplasia-related changes”).
Croatian: Daje se kada je leukemija prouzročena prethodnim liječenjima (poznato kao akutna mijeloična leukemija povezana s liječenjem) ili kad su prisutne određene promjene u koštanoj srži (poznato kao akutna mijeloična leukemija s „promjenama povezanima s mijelodisplazijom“).
English: First induction
Croatian: Prva indukcija
English: Because of the potential for serious adverse reactions in breast-feeding children from Vyxeos liposomal, mothers should be advised to discontinue breast-feeding during Vyxeos liposomal therapy.
Croatian: Budući da postoji mogućnost pojave ozbiljnih nuspojava u dojene djece uzrokovanih primjenom lijeka Vyxeos liposomalni, majke treba savjetovati da prekinu dojenje tijekom terapije lijekom Vyxeos liposomalni.
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.
Croatian: Koncentracija rekonstituirane otopine je 44 mg/20 ml (2,2 mg/ml) daunorubicina i 100 mg/20 ml (5 mg/ml) citarabina.
English: Discontinue Vyxeos liposomal in patients with signs or symptoms of acute copper toxicity.
Croatian: Potrebno je prekinuti primjenu lijeka Vyxeos liposomalni u bolesnika sa znakovima ili simptomima akutne toksičnosti od nakupljanja bakra.
English: • if you have ever had a condition known as Wilson's disease or other copper-related disorder, as Vyxeos liposomal contains an ingredient known as 'copper gluconate'.
Croatian: • ako ste ikada oboljeli od Wilsonove bolesti ili drugog poremećaja povezanog s bakrom, jer Vyxeos liposomalni sadrži sastojak koji se naziva „bakrov glukonat“
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%).
Croatian: Najčešće nuspojave bile su preosjetljivost koja uključuje osip (66,9%), febrilna neutropenija (63,5%), edem (52,3%), dijareja/kolitis (49,9%), mukozitis (49,9%), umor (46,4%), bol u mišićno-koštanom sustavu (44,5%), bol u abdomenu (36,3%), smanjen apetit (33,9%), kašalj (33,9%), glavobolja (32,3%), zimica (31,2%), aritmija (30,4%), pireksija (29,6%), poremećaji sna (25,1%) i hipotenzija
English: Hepatic or renal impairment may increase the risk of toxicity associated with daunorubicin and cytarabine.
Croatian: Oštećenje funkcije jetre ili bubrega može povećati rizik od toksičnosti povezane s daunorubicinom i citarabinom.
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.
Croatian: Na početku ispitivanja, 20% imalo je t-AML, 54% imalo je AML s prethodnim hematološkim poremećajem, a 25% imalo je de novo AML s citogenetskim poremećajima povezanima s mijelodisplazijom; 34% prethodno je liječeno hipometilirajućim lijekom za MDS; 54% imalo je nepovoljan kariotip.
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).
Croatian: Mogući utjecaj teškog oštećenja funkcije bubrega (CrCL 15 ml/min ≥ do ≤ 29 ml/min, C-G) i terminalne faze bubrežne bolesti na farmakokinetiku daunorubicina i citarabina primijenjenih kao lijek Vyxeos liposomalni nije poznat (vidjeti dio 4.2).