FrancophonIA/ELRC3.0 huggingface dataset:
English: When the patient is retreated, Vyxeos liposomal should be given at the same dose and rate and with premedication.
Slovenian: Če pride v poštev ponovno zdravljenje, mora bolnik dobivati zdravilo Vyxeos liposomski v enakem odmerku in z enako hitrostjo ob premedikaciji.
English: Vyxeos liposomal is for intravenous use only.
Slovenian: Zdravilo Vyxeos liposomski je namenjeno samo za intravensko uporabo.
English: The dilution of the reconstituted product results in a deep purple, translucent, homogeneous dispersion.
Slovenian: Z razredčitvijo rekonstituiranega zdravila morate dobiti temno vijoličasto, prosojno, homogeno disperzijo.
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%.
Slovenian: Incidenca okužb je bila 78,1 %; incidenca ne-resnih okužb je bila 73,1 %, incidenca resnih okužb je bila 28,5 %; incidenca okužb, zaradi katerih je prišlo do prenehanja zdravljenja, je bila 0,5 %.
English: Women of childbearing potential should undergo pregnancy testing before initiation of Vyxeos liposomal.
Slovenian: Ženske v rodni dobi morajo pred uvedbo zdravljenja z zdravilom Vyxeos liposomski opraviti test nosečnosti.
English: • shortness of breath, cough, fluid in the lungs
Slovenian: • zadihanost, kašelj, tekočina v pljučih;
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.
Slovenian: Ker bi lahko zdravilo Vyxeos liposomski povzročilo resne neželene učinke pri dojenem otroku, je treba materam svetovati, naj med zdravljenjem z zdravilom Vyxeos liposomski prekinejo dojenje.
English: Vyxeos liposomal is used to treat patients with newly diagnosed acute myeloid leukaemia (a cancer of the white blood cells).
Slovenian: Zdravilo Vyxeos liposomski se uporablja za zdravljenje bolnikov z novo diagnosticirano akutno mieloično levkemijo (rakom belih krvnih celic).
English: Vyxeos liposomal may induce hyperuricemia secondary to rapid lysis of leukaemic cells.
Slovenian: Zdravilo Vyxeos liposomski lahko povzroči hiperurikemijo, ki je posledica hitre lize levkemičnih celic.
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.
Slovenian: Priporočeni razpored odmerjanja zdravila Vyxeos liposomski v odmerku 29 mg/65 mg/m 2, danem intravensko v času 90 minut: • na 1. in 3. dan kot dodatni krogi konsolidacijskega zdravljenja, če je potrebno.
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).
Slovenian: V študijo so bili vključeni bolniki z naslednjimi podvrstami AML: AML, povezana z zdravljenjem (t-AML), AML z mielodisplastičnim sindromom (MDS AML) in kronična mielomonocitna AML (CMMoL AML, chronic myelomonocytic leukaemia AML) z dokumentirano anamnezo MDS ali CMMoL pred transformacijo v AML in de novo AML s spremembami kariotipa, ki so značilne za mielodisplazijo (po merilih SZO iz leta 2008).
English: Dyspepsia (0.5) Vomiting (0.3)
Slovenian: Občasni Dispepsija (0,5) Bruhanje (0,3)
English: Other medicines and Vyxeos liposomal
Slovenian: Druga zdravila in zdravilo Vyxeos liposomski
English: • Flush the line after administration with sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: • Po končanem dajanju zdravila sperite infuzijsko linijo z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: Intracellularly, cytarabine is converted into cytarabine-5-triphosphate (ara-CTP), which is the active metabolite.
Slovenian: Znotraj celic se citarabin pretvori v aktivni presnovek citarabin-5-trifosfat (ara-CTP).
English: The pharmacokinetics of total daunorubicin and cytarabine were not altered in patients with bilirubin ≤ 50 µmol/L.
Slovenian: Farmakokinetika skupnega daunorubicina in citarabina se pri bolnikih z ravnjo bilirubina ≤ 50 µmol/l ni spremenila.
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.
Slovenian: Po odmerku, danem na 5. dan, je bila povprečna (% koeficient variacije [CV]) najvišja koncentracija v plazmi (Cmax) za daunorubicin 26,0 (32,7 %) µg/ml in za citarabin 62,2 (33,7 %) µg/ml.
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.
Slovenian: Dodaten konsolidacijski krog pride v poštev pri bolnikih, ki v obdobju od 5 do 8 tednov po začetku prve konsolidacije nimajo znakov napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: You should not use Vyxeos liposomal during pregnancy as it may be harmful to the baby.
Slovenian: Med nosečnostjo zdravila Vyxeos liposomski ne smete uporabljati, ker bi lahko škodovalo otroku.
English: • Store in an upright position.
Slovenian: • Shranjujte v pokončnem položaju.
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.
Slovenian: V obdobju zelo izrazite nevtropenije se lahko dajejo profilaktična zdravila proti okužbam (vključno s protibakterijskimi in protivirusnimi zdravili ter antimikotiki), dokler se absolutno število nevtrofilcev spet ne poveča na 500/μl ali več.
English: Tumour lysis syndrome (2.7)
Slovenian: Pogosti Sindrom tumorske lize (2,7)
English: Hyperhidrosis (0.3)
Slovenian: Občasni Hiperhidroza (0,3)
English: Each course is given as a separate infusion and can be given weeks apart.
Slovenian: Vsak krog zdravljenja se da v ločenih infuzijah in infuzije lahko prejmete v večtedenskih razmakih.
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.
Slovenian: Incidenca vseh preobčutljivostnih dogodkov je bila 66,9 %; incidenca preobčutljivostnih dogodkov, ki niso bili resni, je bila 66,4 %, od katerih je pri 38,9 % šlo za izpuščaj; incidenca resnih preobčutljivostnih dogodkov je bila 1,1 %; pogostnost preobčutljivostnih dogodkov s posledičnim prenehanjem zdravljenja je bila 0.
English: Febrile neutropenia (63.5)
Slovenian: Febrilna nevtropenija (63,5) Pogosti
English: No interaction studies have been performed with Vyxeos liposomal.
Slovenian: Študij medsebojnega delovanja z zdravilom Vyxeos liposomski niso izvedli.
English: • Gently invert the bag to mix the solution.
Slovenian: • Nežno obračajte infuzijsko vrečko, da raztopino zmešate.
English: If this applies to you: your doctor may also give you a medicine to help stop you getting an infection.
Slovenian: Če to velja za vas: - vam bo zdravnik morda predpisal tudi zdravilo za preprečevanje okužb, - bo zdravnik med zdravljenjem tudi preverjal, ali imate kakšno okužbo;
English: Vyxeos liposomal is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio.
Slovenian: Zdravilo Vyxeos liposomski je liposomska formulacija s fiksno kombinacijo daunorubicina in citarabina v molskem razmerju 1 : 5.
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.
Slovenian: Povprečna (% CV) površina pod krivuljo (AUC) med enim odmernim intervalom je bila 637 (38,4 %) µg.h/ml za daunorubicin in 1900 (44,3 %) µg.h/ml za citarabin.
English: A high incidence of mammary tumours was observed about 120 days after a single intravenous dose of daunorubicin in rats (at about 1.7 times the human dose on a mg/m basis).
Slovenian: Približno 120 dni po enkratnem intravenskem odmerku daunorubicina (približno 1,7-kratni odmerek za ljudi po preračunu na mg/m2) so pri podganah opazili visoko incidenco tumorjev mlečnih žlez.
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).
Slovenian: Zdravilo Vyxeos liposomski je indicirano za zdravljenje odraslih z novo diagnosticirano akutno mieloično levkemijo, povezano z zdravljenjem (t-AML, therapy-related acute myeloid leukaemia), ali akutno mieloično levkemijo s spremembami, povezanimi z mielodisplazijo (AML-MRC, AML with myelodysplasia-related changes).
English: Daunorubicin is mostly catalysed by hepatic and non-hepatic aldo-keto reductase and carbonyl reductase to the active metabolite daunorubicinol.
Slovenian: Jetrna in nejetrna aldo-keto reduktaza ter karbonilna reduktaza katalizirata večino daunorubicina v aktivni presnovek daunorubicinol.
English: Febrile neutropenia (62.4)
Slovenian: Febrilna nevtropenija (62,4) Pogosti
English: Patients should be monitored for haematologic response and toxicities.
Slovenian: Priporočeno prilagajanje odmerkov med zdravljenjem Pri bolnikih je treba preverjati hematološki odziv in toksične učinke.
English: Keep the vial in the original carton in order to protect from light.
Slovenian: Vialo je treba shraniti v originalni škatli za zagotovitev zaščite pred svetlobo.
English: - Keep this leaflet.
Slovenian: Ta preostanek zavrzite.
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)
Slovenian: Zelo pogosti Navzea (51,7) Diareja/kolitis (49,9) Mukozitis (49,9) Zaprtost (42,7) Bolečine v trebuhu (36,3) Zmanjšan apetit (33,9) Bruhanje (27,7)
English: Palmar-plantar erythrodysaesthesia syndrome
Slovenian: Sindrom palmarno-plantarne eritrodisestezije (0,8)
English: Also contains: Distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine, and sucrose.
Slovenian: Zdravilo vsebuje tudi: distearoilfosfatidilholin, distearoilfosfatidilglicerol, holesterol, bakrov glukonat, trolamin in saharozo.
English: Stability of diluted infusion solution
Slovenian: Stabilnost razredčene raztopine za infundiranje
English: Your doctor will monitor you during treatment.
Slovenian: Zdravnik bo med zdravljenjem preverjal vaše stanje;
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.
Slovenian: Upoštevati je treba, da lahko gastrointestinalni mukozitis in/ali driska, ki se pogosto pojavita med intenzivno kemoterapijo, močno vplivata na absorpcijo sočasnih peroralnih zdravil.
English: Use of Vyxeos liposomal in patients who have previously received doxorubicin increases the risk of cardiotoxicity (see section 4.4).
Slovenian: Če se zdravilo Vyxeos liposomski uporablja pri bolnikih, ki so prej dobivali doksorubicin, je tveganje za kardiotoksičnost večje (glejte poglavje 4.4).
English: Tumour lysis syndrome (7.5)
Slovenian: Pogosti Sindrom tumorske lize (7,5)
English: Dyspnoea (36.5) Cough (33.9) Pleural effusion (13.9)
Slovenian: Zelo pogosti Dispneja (36,5) Kašelj (33,9) Plevralni izliv (13,9)
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.
Slovenian: Bolnikom z blago okvaro ledvic (očistek kreatinina [CrCL] od 60 ml/min do 89 ml/min po Cockcroft-Gaultovi enačbi [C-G]) ali zmerno okvaro ledvic (CrCL od 30 ml/min do 59 ml/min) ni treba prilagoditi odmerka.
English: The treatment should be restarted slowly once the symptoms have resolved, by halving the rate of infusion and intravenous diphenhydramine (20-25 mg) and intravenous dexamethasone (10 mg) should be given.
Slovenian: Ko so simptomi odpravljeni, je treba počasi ponovno začeti zdravljenje, pri čemer se hitrost infundiranja prepolovi, bolnik pa prejme intravenski difenhidramin (20-25 mg) in intravenski deksametazon (10 mg).
English: Pyrexia (3.2) Oedema (2.7)
Slovenian: Pogosti Pireksija (3,2) Edem (2,7)
English: • pain or swelling of the tissue lining the digestive system (mucositis), or pain in the abdomen (belly), constipation, loss of appetite, diarrhoea, nausea (feeling sick) or vomiting
Slovenian: • bolečine ali oteklost sluznice prebavil (mukozitis) ali bolečine v trebuhu, zaprtost, izguba apetita, driska, slabost s siljenjem na bruhanje ali bruhanje;
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.
Slovenian: Ob izhodišču jih je 20 % imelo t-AML, 54 % je imelo AML s predhodno hematološko boleznijo in 25 % je imelo AML de novo s citogenetskimi nepravilnostmi, povezanimi z MDS.
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”).
Slovenian: Zdravilo se uporablja, če je levkemija posledica predhodnih zdravljenj (t. i. akutna mieloična levkemija, povezana z zdravljenjem) ali v prisotnosti določenih sprememb v kostnem mozgu (t. i. akutna mieloična levkemija »s spremembami, povezanimi z mielodisplazijo«).
English: • fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
Slovenian: • zvišana telesna temperatura, mrzlica, boleče grlo, kašelj, razjede v ustih ali kateri koli drugi simptomi okužbe;
English: Arrhythmia a
Slovenian: Pogosti Aritmija a
English: Chest pain (1.9)
Slovenian: Bolečine v prsnem košu (1,9)
English: Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction is required.
Slovenian: Ali je dodaten krog potreben, se ugotovi z oceno stanja kostnega mozga po okrevanju od prejšnjega kroga indukcijskega zdravljenja.
English: • The other ingredients are distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine and sucrose.
Slovenian: • Pomožne snovi so distearoilfosfatidilholin, distearoilfosfatidilglicerol, holesterol, bakrov glukonat, trolamin in saharoza.
English: Thrombocytopenia (4.5) Neutropenia (3.7) Anaemia (3.2)
Slovenian: Trombocitopenija (4,5) Nevtropenija (3,7) Anemija (3,2)
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.
Slovenian: Samo v kliničnih študijah so zdravilo Vyxeos liposomski dajali v odmerku 100 enot/m2/dan (kar ustreza odmerku 44 mg/100 mg/m2) v obliki 90-minutne intravenske infuzije na 1., 3. in 5. dan, če je šlo za prvo indukcijo, oziroma na 1. in 3. dan pri bolnikih, ki so potrebovali še drugo indukcijo.
English: CR + CRi, n (%) Odds ratio (95% CI) p-value (2-sided)
Slovenian: CR + CRi, n (%) Razmerje obetov (95 % IZ) vrednost p (dvostranska)
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksična učinkovina.
English: Vaccination with a live vaccine should be avoided in patients receiving Vyxeos liposomal.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Vyxeos liposomski, se je treba izogibati cepljenju z živimi cepivi.
English: The recommended dosing schedule of Vyxeos liposomal 44 mg/100 mg/m 2, administered intravenously over 90 minutes:
Slovenian: Priporočeni razpored odmerjanja za indukcijo remisije Priporočeni razpored odmerjanja zdravila Vyxeos liposomski v odmerku 44 mg/100 mg/m2, danem intravensko v času 90 minut:
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).
Slovenian: Pri bolnikih z oslabljenim delovanjem srca je treba opustiti zdravljenje z zdravilom Vyxeos liposomski, razen če koristi uvedbe ali nadaljevanja zdravljenja prevladajo nad tveganji (glejte poglavji 4.5 in 4.8).
English: Fatigue (10.4)
Slovenian: Zelo pogosti Utrujenost (10,4)
English: Thrombocytopenia (3.7) Neutropenia (3.5) Anaemia (2.1)
Slovenian: Trombocitopenija (3,7) Nevtropenija (3,5) Anemija (2,1)
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.
Slovenian: Daunorubicin je bil mutagen v testih in vitro (Amesov test, test na celicah hrčkov V79) ter klastogen v testih in vitro (človeški limfoblasti CCRF-CEM) in in vivo (test izmenjave med sestrskimi kromatidami (SCE, sister cromatid exchange) na mišjem kostnem mozgu).
English: Tissue necrosis
Slovenian: Nekroza tkiva
English: • Store in a refrigerator (2°C to 8°C).
Slovenian: • Shranjujte v hladilniku (2 do 8 °C).
English: Oedema (52.3) Fatigue (46.4) Chills (31.2) Pyrexia (29.6)
Slovenian: Zelo pogosti Edem (52,3) Utrujenost (46,4) Mrzlica (31,2) Pireksija (29,6)
English: For severe/life-threatening hypersensitivity symptoms (e.g., hypotension requiring vasopressor therapy, angioedema, respiratory distress requiring bronchodilation therapy, generalised urticaria), the treatment should be stopped.
Slovenian: Če se pojavijo hudi/življenjsko nevarni simptomi preobčutljivosti (npr. hipotenzija, ki jo je treba zdraviti z vazopresornimi učinkovinami, angioedem, dihalna stiska, ki jo je treba zdraviti z bronhodilatatorji, generalizirana urtikarija), je treba zdravljenje ustaviti.
English: Consolidation daunorubicin 29 mg/m and cytarabine 65 mg/m on days 1 and 3
Slovenian: Konsolidacija daunorubicin 29 mg/m in citarabin 65 mg/m na 1. in 3. dan
English: There is no experience with Vyxeos liposomal in patients with baseline serum bilirubin greater than 50 µmol/L, severe renal impairment (creatinine clearance less than 30 mL/min), or end stage renal disease.
Slovenian: Z zdravilom Vyxeos liposomski ni nobenih izkušenj pri bolnikih z izhodiščnimi serumskimi ravnmi bilirubina, višjimi od 50 µmol/l, hudo okvaro ledvic (očistek kreatinina pod 30 ml/min) ali končno odpovedjo ledvic.
English: Vyxeos liposomal is not recommended for use in children and adolescents under 18 years.
Slovenian: Otroci in mladostniki Uporaba zdravila Vyxeos liposomski pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: Vyxeos liposomal must be given to you by a doctor or nurse with experience in treating AML.
Slovenian: Zdravilo Vyxeos liposomski vam mora dati zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem akutne mieloične levkemije.
English: There is no experience with Vyxeos liposomal in patients with severe renal impairment (CrCL 15 mL/min to 29 mL/min) or end-stage renal disease.
Slovenian: Z zdravilom Vyxeos liposomski ni nobenih izkušenj pri bolnikih s hudo okvaro ledvic (CrCL od 15 ml/min do 29 ml/min) ali končno odpovedjo ledvic.
English: There was no evidence of time-dependent kinetics or major departures from dose proportionality over the range of 1.3 mg/3 mg per m to 59 mg/134 mg per m
Slovenian: V razponu odmerkov od 1,3 mg/3 mg na m do 59 mg/134 mg na m
English: Gastrointestinal mucositis and diarrhoea
Slovenian: Gastrointestinalni mukozitis in driska
English: Evaluation of hepatic and renal function
Slovenian: Ocena delovanja jeter in ledvic
English: This is because Vyxeos liposomal may affect the way some other medicines work.
Slovenian: Zdravilo Vyxeos liposomski namreč lahko vpliva na način delovanja nekaterih drugih zdravil in nekatera druga zdravila lahko vplivajo na način delovanja zdravila Vyxeos liposomski.
English: Cumulative exposure of daunorubicin per course of Vyxeos liposomal Therapy
Slovenian: Preglednica 1: Kumulativna izpostavljenost daunorubicinu na krog zdravljenja z zdravilom Vyxeos liposomski
English: Hypersensitivity reactions were very common ADRs in Vyxeos liposomal clinical studies.
Slovenian: Preobčutljivostne reakcije so bile zelo pogosti neželeni učinki v kliničnih študijah zdravila Vyxeos liposomski.
English: Cardiotoxicities were seen in Vyxeos liposomal clinical studies.
Slovenian: V kliničnih študijah zdravila Vyxeos liposomski so opažali kardiotoksične učinke.
English: Vyxeos liposomal contains daunorubicin, which is known for its profound cardiotoxicity potential, and cytarabine, which is known to be associated with CNS toxicities.
Slovenian: Zdravilo Vyxeos liposomski vsebuje daunorubicin, ki je znan po velikem potencialu za kardiotoksičnost, in citarabin, ki je znano povezan s toksičnimi učinki na osrednje živčevje.
English: Each 50 ml vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Slovenian: Ena 50 ml viala vsebuje 44 mg daunorubicina in 100 mg citarabina.
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.
Slovenian: Incidenca vseh kardiotoksičnih učinkov je bila 72,0 %; incidenca neresnih kardiotoksičnih učinkov je bila 68,5 %; incidenca resnih kardiotoksičnih učinkov je bila 9,1 %; incidenca kardiotoksičnih učinkov, zaradi katerih je prišlo do prenehanja zdravljenja, je bila 0,5 %.
English: Pleural effusion (0.8)
Slovenian: Občasni Plevralni izliv (0,8)
English: Cardiac arrest was reported as a fatal event; the patient experienced thrombocytopenia and neutropenia which contributed to cardiac arrest (see section 4.4).
Slovenian: Eden od dogodkov s smrtnim izidom je bil srčni zastoj; pri zadevnem bolniku sta k srčnemu zastoju prispevali trombocitopenija in nevtropenija (glejte poglavje 4.4).
English: Cytarabine was clastogenic to meiotic cells.
Slovenian: Citarabin je bil klastogen za celice v mejozi.
English: Use an effective method of contraception during and for 6 months after treatment.
Slovenian: Med zdravljenjem in še 6 mesecev po njem morate uporabljati učinkovito kontracepcijsko metodo.
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).
Slovenian: Citarabin je bil mutagen v testih in vitro ter klastogen v testih in vitro (kromosomske aberacije in izmenjava med sestrskimi kromatidami v človeških levkocitih) in in vivo (test kromosomskih aberacij in test SCE v kostnem mozgu glodavcev, mikronukleusni test pri miših).
English: There is no experience with Vyxeos liposomal in patients with hepatic impairment resulting in a bilirubin level greater than 50 µmol/L.
Slovenian: Z zdravilom Vyxeos liposomski ni nobenih izkušenj pri bolnikih, ki imajo zaradi okvare jeter povišano raven bilirubina na več od 50 µmol/l.
English: Vyxeos liposomal should only be used in patients with a history of Wilson's disease or other copperrelated disorder if the benefits outweigh the risks (see section 6.1).
Slovenian: Zdravilo Vyxeos liposomski se sme pri bolnikih z anamnezo Wilsonove bolezni ali druge bolezni, povezane z bakrom, uporabljati samo, če koristi prevladajo nad tveganji (glejte poglavje 6.1).
English: Vyxeos liposomal delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time.
Slovenian: Zdravilo Vyxeos liposomski omogoča dolgotrajno dovajanje sinergistične kombinacije daunorubicina in citarabina v levkemične celice.