FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse effects of Vyxeos liposomal occurred at all tested dose levels (low to null safety margins as based on systemic exposures) and were generally consistent with those known for non-liposomal daunorubicin and/or cytarabine, comprising mainly findings of gastrointestinal and hematological toxicity.
Croatian: Štetni učinci lijeka Vyxeos liposomalni pojavili su se pri svim ispitanim razinama doze (niske do nikakve sigurnosne granice na temelju sustavne izloženosti) i bile su općenito u skladu sa poznatim sigurnosnim granicama za neliposomalni daunorubicin i/ili citarabin, i obuhvaćale su uglavnom gastrointestinalnu i hematološku toksičnost.
English: • a fall in the number of platelets (cells that help blood to clot) which may cause bruising or bleeding
Croatian: • smanjeni broj trombocita (krvne stanice koje pomažu u zgrušavanju krvi) što može prouzročiti modrice ili krvarenje
English: Diarrhoea/colitis (6.1) Abdominal pain (2.9) Mucositis (2.1) Decreased appetite (1.6) Constipation (1.1) Nausea (1.1)
Croatian: Dijareja/kolitis (6,1) Bol u abdomenu (2,9) Mukozitis (2,1) Smanjen apetit (1,6) Konstipacija (1,1) Mučnina (1,1)
English: Based on data in animals, Vyxeos liposomal liposomes accumulate and persist in high concentration in the bone marrow, where they are preferentially taken up intact by leukaemia cells in an active engulfment process.
Croatian: Na temelju podataka u životinja, liposomi lijeka Vyxeos liposomalni akumuliraju se i ostaju u visokim koncentracijama u koštanoj srži, odakle se preferencijalno unose neoštećeni u leukemične stanice tijekom aktivnog procesa unosa.
English: • Do not heat, vortex, or shake vigorously.
Croatian: • Nemojte zagrijavati, miješati ili jako mućkati.
English: History of Wilson's disease or other copper-related disorder Each vial contains 100 mg of copper gluconate, which corresponds to 14 mg of elemental copper.
Croatian: Anamneza Wilsonove bolesti ili drugog poremećaja povezanog s bakrom Jedna bočica sadrži 100 mg bakrova glukonata, što odgovara 14 mg elementarnog bakra.
English: Men with sexual partners of reproductive potential and women should use effective contraception during treatment and for 6 months following the last dose of Vyxeos liposomal.
Croatian: Muškarci s partnericama reproduktivne dobi i žene moraju uzimati učinkovitu kontracepciju tijekom liječenja i tijekom 6 mjeseci nakon zadnje doze lijeka Vyxeos liposomalni.
English: Concurrent use of cardiotoxic agents may increase the risk of cardiotoxicity.
Croatian: Istodobna primjena kardiotoksičnih lijekova može povećati rizik od kardiotoksičnosti.
English: Tell your doctor immediately if you get any of the side effects listed above.
Croatian: Odmah obavijestite svog liječnika ako se pojavi bilo koja od navedenih nuspojava.
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.
Croatian: (što odgovara 44 mg/m daunorubicina i 100 mg/m citarabina) 1., 3. i 5. dana pokazuju da je omjer srednjih AUClast metabolit:ishodišni spoj za daunorubicinol i AraU bio 1,79% za daunorubicin i 3,22% za citarabin; što je niže od onih koji su tipično prijavljivani za neliposomalne lijekove, ~40-60% za daunorubicinol:daunorubicin i ~80% za AraU:citarabin.
English: Treatment should be continued as long as the patient continues to benefit or until disease progression up to maximum of 2 induction courses.
Croatian: Liječenje treba nastaviti sve dok bolesnik ima koristi ili do progresije bolesti do najviše 2 indukcijska ciklusa.
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.
Croatian: Nakon internalizacije, liposomi lijeka Vyxeos liposomalni se razgrađuju, otpuštajući daunorubicin i citarabin unutar unutarstaničnog okruženja, omogućujući lijeku svoju sinergističku antineoplastičnu aktivnost.
English: Daunorubicin has been associated with local tissue necrosis at the site of medicinal product extravasation.
Croatian: Daunorubicin se povezuje s lokalnom nekrozom tkiva na mjestu ekstravazacije lijeka.
English: You should not use Vyxeos liposomal during pregnancy as it may be harmful to the baby.
Croatian: Ne smijete primati Vyxeos liposomalni tijekom trudnoće jer to može naštetiti djetetu.
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)].
Croatian: • Izračunajte potreban volumen rekonstituiranog lijeka Vyxeos liposomalni sljedećom formulom: [potreban volumen (ml) = doza daunorubicina (mg/m 2) x tjelesna površina bolesnika
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.
Croatian: U skupini 7+3, prva indukcija sastojala se od citarabina 100 mg/m 2/dan od 1. do 7. dana kontinuiranom infuzijom i daunorubicina 60 mg/m2/dan 1., 2. i 3. dana, dok je drugi indukcijski i konsolidacijski citarabin doziran od 1. do 5. dana i daunorubicin 1. i 2. dana.
English: Pyrexia (3.2) Oedema (2.7)
Croatian: Pireksija (3,2) Edem (2,7)
English: Use of Vyxeos liposomal in patients who have previously received doxorubicin increases the risk of cardiotoxicity (see section 4.4).
Croatian: Primjena lijeka Vyxeos liposomalni u bolesnika koji su prethodno primili doksorubicin povećava rizik od kardiotoksičnosti (vidjeti dio 4.4).
English: It is not known whether Vyxeos liposomal is excreted in human milk.
Croatian: Nije poznato izlučuje li se Vyxeos liposomalni u majčino mlijeko.
English: An anti-hyperuricemic therapy should be considered (e.g., allopurinol) prior to initiating Vyxeos liposomal.
Croatian: Potrebno je razmotriti terapiju protiv hiperuricemije (npr. alopurinol) prije početka liječenja lijekom Vyxeos liposomalni.
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Croatian: Citarabin je prouzročio transformaciju embrionalnih stanica hrčka i H43 stanica štakora in vitro.
English: The 1:5 molar ratio has been shown in vitro and in vivo to maximise synergistic antitumour activity in AML.
Croatian: Uočeno je in vitro i in vivo da molarni omjer 1:5 maksimizira sinergističku antitumorsku aktivnost u AML-u.
English: Sleep disorders (25.1) Anxiety (17.3) Delirium (15.5)
Croatian: Poremećaji sna (25,1) Anksioznost (17,3) Delirij (15,5)
English: The volume of distribution (%CV) for daunorubicin is 6.6 L (36.8%) and cytarabine is 7.1 L (49.2%).
Croatian: Volumen distribucije (%CV) za daunorubicin je 6,6 l (36,8%), a za citarabin je 7,1 l (49,2%).
English: If this applies to you: your doctor may also give you a medicine to help stop you getting an infection.
Croatian: Ako se to odnosi na vas: liječnik Vam može dati lijek koji pomaže u sprječavanju dobivanja infekcije. liječnik će također provjeravati pojavu infekcija tijekom liječenja.
English: • redness of skin, rashes, muscle aches, headache, bone pain, joint pain, tiredness, generalised swelling including swelling of your arms and legs
Croatian: • crvenilo kože, osip, bolovi u mišićima, glavobolja, bol u kostima, bol u zglobovima, umor, opće oticanje uključujući oticanje ruku i nogu
English: • The active substances are daunorubicin and cytarabine.
Croatian: • Djelatne tvari su daunorubicin i citarabin.
English: Furthermore, daunorubicin caused testicular atrophy and total aplasia of spermatocytes in the seminiferous tubules in dogs and cytarabine, sperm-head abnormalities in mice.
Croatian: Osim toga, daunorubicin je prouzročio atrofiju testisa i potpunu aplaziju spermatocita u sjemenskim kanalićima u pasa, a citarabin abnormalnosti glave spermija u miševa.
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.
Croatian: Vyxeos liposomalni pokazuje produženi poluvijek (% CV) od 31,5 h (28,5%) za daunorubicin i 40,4 h (24,2%) za citarabin, s tim da više od 99% daunorubicina i citarabina u plazmi ostaje inkapsulirano u liposomima.
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
Croatian: • bol ili oticanje sluznice koje oblaže probavni sustav (mukozitis), ili bol u trbuhu, zatvor, gubitak apetita, proljev, mučnina ili povraćanje
English: The delivery of daunorubicin and cytarabine in the Vyxeos liposomal formulation is anticipated to reduce the possibility of interactions, because systemic free-drug concentrations of daunorubicin and cytarabine are much lower than when administered as the non-liposomal formulation.
Croatian: Očekuje se da će isporuka daunorubicina i citarabina u liposomalnoj formulaciji lijeka Vyxeos liposomalni smanjiti mogućnost interakcija jer su sistemske koncentracije daunorubicina i citarabina u slobodnom obliku mnogo niže nego kad se primjenjuju u neliposomalnoj formulaciji.
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.
Croatian: Liječenje treba ponovno polako započeti kada se simptomi povuku, tako da se prepolovi brzina infuzije i daje intravenski difenhidramin (20-25 mg) i intravenski deksametazon (10 mg).
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.
Croatian: Preporučen režim doziranja lijeka Vyxeos liposomalni je 29 mg/65 mg/m 2, primijenjeno intravenski tijekom 90 minuta: • 1. i 3. dana kao sljedeći ciklus terapije konsolidacije, ako je potrebno.
English: The pharmacokinetics in patients with bilirubin greater than 50 µmol/L is unknown.
Croatian: Farmakokinetika u bolesnika s bilirubinom većim od 50 µmol/l nije poznata.
English: Baseline assessment of blood counts should be obtained, and patients should be carefully monitored during treatment with Vyxeos liposomal for possible clinical complications due to myelosuppression.
Croatian: Potrebno je obaviti početnu pretragu krvne slike te pažljivo nadzirati bolesnike tijekom liječenja lijekom Vyxeos liposomalni kako bi se uočile moguće kliničke komplikacije prouzročene mijelosupresijom.
English: Number of doses per course
Croatian: Broj doza po ciklusu
English: ADRs/Frequency (%)
Croatian: Nuspojave/učestalost (%)
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
Croatian: Nije bilo dokaza o kinetici ovisnoj o vremenu niti o većim odstupanjima od proporcionalnosti doze u rasponu od 1,3 mg/3 mg po m do
English: When the patient is retreated, Vyxeos liposomal should be given at the same dose and rate and with premedication.
Croatian: Prilikom ponovnog liječenja bolesnika, Vyxeos liposomalni treba primijeniti u istoj dozi i istom brzinom te uz premedikaciju.
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.
Croatian: Za intravensku infuziju lijeka Vyxeos liposomalni može se koristiti linijski membranski filtar, pod uvjetom da je minimalni promjer pora filtra veći od ili jednak 15 µm.
English: Vaccination with a live vaccine should be avoided in patients receiving Vyxeos liposomal.
Croatian: Treba izbjegavati cijepljenje živim cjepivom u bolesnika koji primaju Vyxeos liposomalni.
English: Chills (0.3) a Arrhythmia group terms includes atrial fibrillation, bradycardia, and the most commonly reported arrhythmia was tachycardia
Croatian: Grupni pojam aritmija obuhvaća fibrilaciju atrija, bradikardiju i najčešće prijavljenu aritmiju, tahikardiju
English: Vyxeos liposomal contains daunorubicin, which is known for its profound cardiotoxicity potential, and cytarabine, which is known to be associated with CNS toxicities.
Croatian: Vyxeos liposomalni sadrži daunorubicin, koji je poznat po svojem velikom kardiotoksičnom potencijalu, i citarabin, za koji se zna da je povezan s toksičnostima SŽS-a.
English: Women of childbearing potential should undergo pregnancy testing before initiation of Vyxeos liposomal.
Croatian: Žene reproduktivne dobi moraju napraviti test na trudnoću prije početka primjene lijeka Vyxeos liposomalni.
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.
Croatian: Liposomi lijeka Vyxeos liposomalni pokazuju produžen poluvijek u plazmi nakon intravenske infuzije, s više od 99% daunorubicina i citarabina u plazmi koji ostaju inkapsulirani unutar liposoma.
English: • chest pain or leg pain
Croatian: • bol u prsnom košu ili bol u nogama
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.
Croatian: • Aseptičkom metodom izvucite izračunat volumen rekonstituiranog lijeka Vyxeos liposomalni iz jedne ili više bočica sterilnom štrcaljkom i prenesite ga u vrećicu za infuziju koja sadrži 500 ml otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5% otopine glukoze.
English: Daunorubicin per course
Croatian: Daunorubicin po ciklusu
English: The pharmacokinetics of total daunorubicin and cytarabine were not altered in patients with bilirubin ≤ 50 µmol/L.
Croatian: Farmakokinetika ukupnog daunorubicina i citarabina nije bila izmijenjena u bolesnika s bilirubinom ≤ 50 µmol/l.
English: Headache (1.1)
Croatian: Često Glavobolja (1,1)
English: • Store in an upright position.
Croatian: • Čuvati u uspravnom položaju.
English: Delirium (2.4)
Croatian: Često Delirij (2,4)
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.
Croatian: Nakon doze primijenjene 5. dana, srednja (% koeficijent varijacije [CV]) maksimalna koncentracija u plazmi (Cmax) daunorubicina bila je 26,0 (32,7%) µg/ml, a citarabina 62,2 (33,7%) µg/ml.
English: Both daunorubicin and cytarabine are genotoxic, therefore, Vyxeos liposomal may be associated with a genotoxic risk.
Croatian: Daunorubicin i citarabin su genotoksični, stoga Vyxeos liposomalni može biti povezan s rizikom od genotoksičnosti.
English: • fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
Croatian: • vrućica, zimica, grlobolja, kašalj, ranice u ustima ili bilo koji drugi simptom infekcije
English: 50 mL vial (type 1 glass) with a stopper (chlorobutyl rubber), and an overseal (aluminium) containing 44 mg daunorubicin and 100 mg cytarabine.
Croatian: Bočica od 50 ml (staklo tipa 1) s čepom (klorobutilna guma) i prstenom (aluminij) koja sadrži 44 mg daunorubicina i 100 mg citarabina.
English: Women of childbearing potential should not receive treatment until pregnancy is excluded.
Croatian: Žene reproduktivne dobi ne smiju započeti terapiju dok se ne isključi trudnoća.
English: Dose adjustment is not required for patients with a bilirubin level less than or equal to 50 µmol/L.
Croatian: Prilagođavanje doze nije potrebno u bolesnika s razinom bilirubina nižom ili jednakom 50 µmol/l.
English: Vyxeos liposomal treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products.
Croatian: Liječenje lijekom Vyxeos liposomalni mora započeti i nadzirati liječnik s iskustvom u primjeni kemoterapijskih lijekova.
English: There may be residual product remaining in the vial.
Croatian: U bočici možda preostane nešto lijeka.
English: You should not breast-feed while you are receiving treatment with Vyxeos liposomal as it may be harmful to the baby.
Croatian: Ne smijete dojiti dok se liječite lijekom Vyxeos liposomalni jer to može biti štetno za dijete.
English: If overdose occurs, exacerbation of adverse reactions associated with Vyxeos liposomal are expected and supportive treatment (incuding anti-infectives, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) should be provided until the patient recovers.
Croatian: Ako dođe do predoziranja, može se očekivati egzacerbacija nuspojava povezanih s lijekom Vyxeos liposomalni i potrebno je pružiti potporno liječenje (uključujući lijekove protiv infekcije, transfuzije krvi i trombocita, faktore stimulacije kolonija i intenzivnu njegu po potrebi) dok se bolesnik ne oporavi.
English: Gastrointestinal mucositis and diarrhoea
Croatian: Gastrointestinalni mukozitis i proljev
English: All materials used for dilution and administration should be disposed of according to local procedures applicable to the discarding of antineoplastic agents.
Croatian: Sav materijal korišten za razrjeđivanje i primjenu treba zbrinuti sukladno nacionalnim propisima primjenjivim za zbrinjavanje antineoplastičnih lijekova.
English: Haemorrhage (69.1) Hypotension (23.7) Hypertension (17.3)
Croatian: Vrlo često Hemoragija (69,1) Hipotenzija (23,7) Hipertenzija (17,3)
English: Also contains: Distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine, and sucrose.
Croatian: Također sadrži: distearoilfosfatidilkolin, distearoilfosfatidilglicerol, kolesterol, bakrov glukonat, trolamin i saharozu
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.
Croatian: Ispitivanje 301 u bolesnika s neliječenim visokorizičnim AML-om Ispitivanje 301 bilo je randomizirano, multicentrično, otvoreno ispitivanje superiornosti faze 3 s paralelnim skupinama u kojemu se procjenjivao Vyxeos liposomalni u odnosu na standardnu kombinaciju citarabina i daunorubicina (7+3) u 309 bolesnika između 60 i 75 godina s neliječenim visokorizičnim AML-om.
English: Dyspnoea (36.5) Cough (33.9) Pleural effusion (13.9)
Croatian: Dispneja (36,5) Kašalj (33,9) Pleuralni izljev (13,9)
English: Febrile neutropenia (62.4)
Croatian: Vrlo često Febrilna neutropenija (62,4)
English: The clearance (%CV) is 0.16 L/h (53.3%) for daunorubicin and 0.13 L/h (60.2%) for cytarabine.
Croatian: Klirens (% CV) je 0,16 l/h (53,3%) za daunorubicin i 0,13 l/h (60,2%) za citarabin.
English: For classification of ADRs which occur at Grades 3-5, a comprehensive listing is available from the NCI at NCI CTCAE.
Croatian: Za klasifikaciju nuspojava stupnjeva 3-5, dostupan je opsežan popis Nacionalnog instituta za rak (National Cancer Institute Common Terminology Criteria Adverse Event, NCI CTCAE).
English: Vyxeos liposomal belongs to a group of medicines called ‘antineoplastics' used in cancer.
Croatian: Vyxeos liposomalni pripada skupini lijekova koja se naziva „antineoplastici“, a primjenjuju se u liječenju raka.
English: Pruritus (17.3) Hyperhidrosis (10.1)
Croatian: Vrlo često Svrbež (17,3) Hiperhidroza (10,1)
English: What you need to know before you are given Vyxeos liposomal 3.
Croatian: Što morate znati prije nego primite Vyxeos liposomalni
English: Vyxeos liposomal delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time.
Croatian: Vyxeos liposomalni isporučuje sinergističku kombinaciju daunorubicina i citarabina u leukemične stanice kroz produženo vrijeme.
English: • stomach cramps or excessive gas
Croatian: • grčevi ili prekomjerna količina plinova u trbuhu
English: No interaction studies have been performed with Vyxeos liposomal.
Croatian: Nisu provedena ispitivanja interakcija s lijekom Vyxeos liposomalni.
English: Cardiac arrest was reported as a fatal event; the patient experienced thrombocytopenia and neutropenia which contributed to cardiac arrest (see section 4.4).
Croatian: Srčani zastoj prijavljen je kao fatalni događaj; u bolesnika su se pojavile trombocitopenija i neutropenija koje su doprinijele srčanom zastoju (vidjeti dio 4.4).
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)
Croatian: Mučnina (51,7) Dijareja/kolitis (49,9) Mukozitis (49,9) Konstipacija (42,7) Bol u abdomenu (36,3) Smanjen apetit (33,9) Povraćanje (27,7)
English: Also, some other medicines may affect the way Vyxeos liposomal works.
Croatian: Osim toga, određeni drugi lijekovi mogu utjecati na djelovanje lijeka Vyxeos liposomalni.
English: • The other ingredients are distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine and sucrose.
Croatian: • Drugi sastojci su distearoilfosfatidilkolin, distearoilfosfatidilglicerol, kolesterol, bakrov glukonat, trolamin i saharoza.
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).
Croatian: U ispitivanje su bili uključeni bolesnici sa sljedećim podvrstama AML-a: AML povezan s terapijom (t-AML), AML iz mijelodisplastičnog sindroma (MDS AML) i AML iz kronične mijelomonocitne leukemije (KMMoL AML) s dokumentiranim MDS-om ili KMMoL-om u anamnezi prije transformacije u AML i de novo AML s promjenama kariotipa karakterističnim za mijelodisplaziju (prema kriterijima SZO iz 2008.).
English: Patients should be monitored until symptoms resolve (see sections 4.2 and 4.8).
Croatian: Potrebno je nadzirati bolesnike dok se simptomi ne povuku (vidjeti dijelove 4.2. i 4.8.).
English: The overall rate of HSCT was 34% (52/153) in the Vyxeos liposomal arm and 25% (39/156) on the control arm.
Croatian: Ukupna stopa transplantacije hematopoetskih matičnih stanica bila je 34% (52/153) u skupini koja je primala lijek Vyxeos liposomalni i 25% (39/156) u kontrolnoj skupini.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should avoid becoming pregnant while receiving Vyxeos liposomal.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene reproduktivne dobi trebaju izbjegavati začeće dok primaju lijek Vyxeos liposomalni.
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.
Croatian: Tijekom razdoblja duboke neutropenije mogu se primijeniti profilaktički lijekovi protiv infekcija (uključujući antibakterijske, antivirusne i antimikotičke lijekove) dok se apsolutni broj neutrofila ne vrati na 500/μl ili više.