FrancophonIA/ELRC3.0 huggingface dataset:
English: The median overall survival in the ITT population was 7.6 months (95% CI: 5.7, 11.5).
Croatian: Medijan sveukupnog preživljenja u ITT populaciji iznosio je 7,6 mjeseci (95% CI: 5,7;
English: Mean plasma clearance following intravenous administration in cancer subjects was > 200 L/h with moderate inter-subject variability (coefficient of variation [CV] is approximately 50%).
Croatian: Prosječna brzina uklanjanja iz plazme nakon intravenske primjene u ispitanika s karcinomom iznosila je > 200 l/h uz umjerenu varijabilnost među ispitanicima (koeficijent varijacije [CV] približno je 50%).
English: Male and female fertility and contraception
Croatian: Plodnost i kontracepcija u muškaraca i žena
English: Dacogen (n = 242) was compared to treatment choice (TC, n = 243) which consisted of patient's choice with physician's advice of either supportive care alone (n = 28, 11.5%) or 20 mg/m cytarabine subcutaneously once daily for 10 consecutive days repeated every 4 weeks (n = 215, 88.5%).
Croatian: Dacogen (n = 242) je uspoređivan s izabranim liječenjem (engl. treatment choice, TC, n = 243) prema izboru bolesnika uz savjet liječnika, a uključivalo je ili samo potpornu skrb (n = 28, 11,5%) ili 20 mg/m2 supkutano primijenjenog citarabina jedanput na dan tijekom 10 uzastopnih dana, ponavljano svaka 4 tjedna (n = 215; 88,5%).
English: • Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici nakon oznake „Rok valjanosti“.
English: In the ITT analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
Croatian: U ITT analizi, CR stopa od 23,6% (95% CI: 13,2; 37) opažena je u 13/55 ispitanika liječenih Dacogenom.
English: Standard procedures for dealing with cytotoxic medicinal products should be adopted.
Croatian: Potrebno je pridržavati se standardnih postupaka za rukovanje citotoksičnim lijekovima.
English: In addition, in vitro data show that decitabine is a poor P-gp substrate.
Croatian: Osim toga, in vitro podaci pokazuju da je decitabin slab supstrat za P-gp.
English: In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression.
Croatian: U kliničkim ispitivanjima, većina bolesnika imala je početnu mijelosupresiju stupnja 3/4.
English: In the presence of myelosuppression or its complications, treatment with Dacogen may be interrupted and/or supportive measures instituted (see sections 4.2 and
Croatian: Pri pojavi mijelosupresije ili povezanih komplikacija, liječenje Dacogenom može se prekinuti i/ili se mogu uvesti potporne mjere (vidjeti dijelove 4.2 i 4.8).
English: Intracellularly, decitabine is activated through sequential phosphorylation via phosphokinase activities to the corresponding triphosphate, which is then incorporated by the DNA polymerase.
Croatian: Unutar stanice, decitabin se aktivira sekvencijskom fosforilacijom aktivnošću fosfokinaze u odgovarajući trifosfat koji se zatim inkorporira u DNK pomoću DNK polimeraze.
English: The presence of these metabolites in urine together with the high total body clearance and low urinary excretion of unchanged decitabine in the urine (~4% of the dose) indicate that decitabine is appreciably metabolized in vivo.
Croatian: Prisutnost tih metabolita u mokraći, zajedno s visokim ukupnim tjelesnim klirensom i malim izlučivanjem nepromijenjenog decitabina u mokraći (~4% doze) ukazuju da se decitabin znatno metabolizira in vivo.
English: Impact of decitabine on co-administered medicinal products Given its low in vitro plasma protein binding ( 1%), decitabine is unlikely to displace co-administered medicinal products from their plasma protein binding.
Croatian: Utjecaj decitabina na istodobno primjenjivane lijekove S obzirom na nisko vezanje na proteine plazme (< 1%) in vitro, nije vjerojatno da će decitabin istisnuti istodobno primjenjivane lijekove s njihovih mjesta vezanja na proteine plazme.
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Croatian: Mora se provesti pažljiva procjena u bolesnika s akutnim nastupom ili neobjašnjivim pogoršanjem plućnih simptoma kako bi se isključila IBP.
English: After preparing the medicine, it contains between 13.8 mg-138 mg sodium per dose , equivalent to 0.7-7% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: Nakon pripreme lijeka, on sadrži između 13,8 mg-138 mg natrija po dozi, što odgovara 0,7-7% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Formal carcinogenicity studies have not been performed with decitabine.
Croatian: Službena ispitivanja kancerogenosti nisu provedena s decitabinom.
English: Multi-cycle repeat-dose toxicity studies in rats and rabbits indicated that the primary toxicity was myelosuppression, including effects on bone marrow, which was reversible on cessation of treatment.
Croatian: Ispitivanja toksičnosti provedena nakon više ciklusa s ponovljenom dozom u štakora i kunića pokazala su da je primarna toksičnost bila mijelosupresija, uključujući učinke na koštanu srž, što je bilo reverzibilno po prestanku liječenja.
English: In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects and manage them accordingly.
Croatian: U slučaju da Vam se primijeni previše lijeka (predoziranje), što nije vjerojatno, liječnik će Vas promatrati radi pojave nuspojava te će sukladno tome postupati s njima.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: The efficacy and safety of Dacogen has not been evaluated in patients with acute promyelocytic leukaemia or CNS leukaemia.
Croatian: Djelotvornost i sigurnost primjene Dacogena nisu procjenjivane u bolesnika s akutnom promijelocitnom leukemijom ili leukemijom u središnjem živčanom sustavu.
English: Table 2: Other efficacy endpoints for Study DACO-016 (ITT population)
Croatian: Tablica 2: Ostali mjere ishoda djelotvornosti u ispitivanju DACO-016 (populacija s namjerom liječenja, eng. ITT populacija)
English: Serious bleeding-related adverse drug reactions, some of which lead to a fatal outcome, such as central nervous system (CNS) haemorrhage (2%) and gastrointestinal (GI) haemorrhage (2%), in the context of severe thrombocytopaenia, were reported in patients receiving decitabine.
Croatian: Ozbiljne nuspojave povezane s krvarenjem, od kojih su neke dovele do smrtnog ishoda, kao što su hemoragija u središnjem živčanom sustavu (SŽS) (2%) i gastrointestinalna (GI) hemoragija (2%), u kontekstu teške trombocitopenije prijavljene su u bolesnika koji su primali decitabin.
English: Patients should be advised that they may experience undesirable effects such as anaemia during treatment.
Croatian: Bolesnicima treba reći da bi za vrijeme liječenja mogli imati nuspojave kao što je anemija.
English: What you need to know before you are given Dacogen
Croatian: Što morate znati prije nego počnete primati Dacogen
English: Common hypersensitivity including anaphylactic reaction
Croatian: Često preosjetljivost uključujući anafilaktičku reakciju
English: Population PK analysis of decitabine showed that after accounting for body size, there is no difference between decitabine PK parameters in paediatric AML patients versus adults with AML or MDS.
Croatian: Populacijska farmakokinetička analiza decitabina pokazala je da nakon uzimanja u obzir veličine tijela, nema razlike između farmakokinetičkih parametara decitabina u pedijatrijskih bolesnika s AML naspram odraslih s AML ili MDS.
English: Supportive treatments include, administration of prophylactic antibiotics and/or growth factor support (e.g., G-CSF) for neutropaenia and transfusions for anaemia or thrombocytopaenia according to institutional guidelines.
Croatian: Potporna liječenja uključuju profilaktičku primjenu antibiotika i/ili potporu s čimbenikom rasta (npr. G-CSF) za neutropeniju te transfuzije za anemiju ili trombocitopeniju, prema smjernicama ustanove.
English: Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3.
Croatian: Nakon rekonstitucije, jedan ml sadrži približno 5 mg decitabina, pH od 6,7 do 7,3.
English: Complete blood and platelet counts should be performed regularly, as clinically indicated and prior to each treatment cycle.
Croatian: Redovito treba kontrolirati kompletnu krvnu sliku i broj trombocita, prema kliničkim indikacijama i prije svakog ciklusa liječenja.
English: If ILD is confirmed, appropriate treatment should be initiated (see section 4.8).
Croatian: Ukoliko se IBP potvrdi, mora se započeti s prikladnim liječenjem (vidjeti dio 4.8).
English: • liver disease,
Croatian: • bolest jetre,
English: Subjects who were considered candidates for standard induction chemotherapy were not included in the study as shown by the following baseline characteristics.
Croatian: Ispitanici koje se smatralo kandidatima za standardnu indukcijsku kemoterapiju nisu bili uključeni u ispitivanje kao što pokazuju sljedeće karakteristike prije početka liječenja.
English: 20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine.
Croatian: Bočica od 20 ml od prozirnog bezbojnog stakla tipa I, zatvorena butilnim gumenim čepom i aluminijskim prstenom s plastičnom „flip-off“ kapicom; bočica sadrži 50 mg decitabina.
English: Tell your doctor or nurse immediately if you notice any of the serious side effects above.
Croatian: Odmah obavijestite svoga liječnika ili medicinsku sestru ako uočite neku od gore navedenih ozbiljnih nuspojava.
English: Dacogen contains potassium and sodium
Croatian: Dacogen sadrži kalij i natrij
English: How Dacogen works Dacogen works by stopping cancer cells from growing.
Croatian: Kako Dacogen djeluje Dacogen djeluje tako da zaustavlja rast stanica raka.
English: However, the population pharmacokinetic analysis of decitabine indicated that race had no apparent effect on the exposure to decitabine.
Croatian: Međutim, analiza populacijske farmakokinetike decitabina pokazala je da rasna pripadnost nema očiti učinak na izloženost decitabinu.
English: Very common pyrexia
Croatian: Vrlo često pireksija
English: Most of the patients studied were Caucasian.
Croatian: Većina bolesnika u ispitivanjima bili su bijelci.
English: Tell your doctor or nurse immediately if you notice any of the following serious side effects
Croatian: Odmah obavijestite svoga liječnika ili medicinsku sestru ako uočite neku od sljedećih ozbiljnih nuspojava
English: , e anaemia leukopaenia
Croatian: *, e anemija leukopenija
English: • mouth or tongue ulcers
Croatian: • ranice u ustima ili na jeziku
English: Decitabine exhibits linear PK and following the intravenous infusion, steady-state concentrations are reached within 0.5 hour.
Croatian: Decitabin pokazuje linearnu farmakokinetiku, a nakon intravenske infuzije koncentracije u stanju dinamičke ravnoteže dosegnute su u roku od 0,5 sata.
English: A Phase I/II open-label, multicentre study evaluated the safety and efficacy of Dacogen in sequential administration with cytarabine in children aged 1 month to < 18 years with relapsed or refractory AML.
Croatian: Otvoreno, multicentrično ispitivanje faze I/II, procijenilo je sigurnost i djelotvornost lijeka Dacogen u sekvencijskoj primjeni s citarabinom u djece u dobi od 1 mjesec do < 18 godina s relapsnom ili refraktornom AML.
English: In vitro metabolism data and the human mass balance study results indicated that the cytochrome P450 system is not involved in the metabolism of decitabine.
Croatian: Podaci za metabolizam in vitro i rezultati ispitivanja masene bilance u ljudi pokazali su da sustav citokroma P450 nije uključen u metabolizam decitabina.
English: Overall survival and complete remission rates in pre-specified disease-related sub-groups (i.e., cytogenetic risk, Eastern Cooperative Oncology Group [ECOG] score, age, type of AML, and baseline bone marrow blast count) were consistent with results for the overall study population.
Croatian: Stope ukupnog preživljenja i potpune remisije u unaprijed određenim podskupinama s obzirom na bolest (tj. citogenetski rizik, Eastern Cooperative Oncology Group [ECOG] zbroj, dob, tip akutne mijeloične leukemije i broj blasta u koštanoj srži prije početka liječenja) bili su u skladu s rezultatima za sveukupnu populaciju ispitivanja.
English: Serious infection-related adverse drug reactions, with potentially fatal outcome, such as septic shock, sepsis, pneumonia, and other infections (viral, bacterial and fungal) were reported in patients receiving decitabine.
Croatian: Ozbiljne nuspojave povezane s infekcijom, s potencijalno smrtnim ishodom, kao što su septički šok, sepsa, pneumonija i druge infekcije (virusna, bakterijska, gljivična) bile su prijavljene u bolesnika koji su primali decitabin.
English: • a drop in the number of red blood cells, white blood cells and platelets (pancytopaenia)
Croatian: • pad broja crvenih krvnih stanica, bijelih krvnih stanica i krvnih pločica (pancitopenija).
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Croatian: Važno je sijediti raspored doziranja kako bi ovaj lijek bio što učinkovitiji.
English: Very common headache
Croatian: Vrlo često glavobolja
English: • a heart disorder.
Croatian: • srčani poremećaj.
English: Method of administration Dacogen is administered by intravenous infusion.
Croatian: Način primjene Dacogen se primjenjuje intravenskom infuzijom.
English: The secondary endpoint of the study was overall survival.
Croatian: Mjera sekundarnog ishoda ispitivanja bilo je sveukupno preživljenje.
English: The primary endpoint of the study was overall survival.
Croatian: Mjera primarnog ishoda ispitivanja bilo je sveukupno preživljenje.
English: For a typical patient (weight 70 kg/body surface area 1.73 m2) the decitabine pharmacokinetic parameters are listed in the Table 3 below.
Croatian: Farmakokinetički parametri decitabina tipičnog bolesnika (težina 70 kg/tjelesna površina 1,73 m2) navedeni su u tablici 3 ispod.
English: Frequency All Grades
Croatian: Svi stupnjevi
English: Patients with favourable cytogenetics were not included in the study.
Croatian: Bolesnici s povoljnim citogenetskim nalazom nisu bili uključeni u ispitivanje.
English: Decitabine Vdss in cancer patients is large indicating distribution into peripheral tissues.
Croatian: Volumen distribucije decitabina u stanju dinamičke ravnoteže (Vdss) velik je u bolesnika s rakom, što ukazuje na distribuciju u periferna tkiva.
English: Information on special populations was derived from pharmacokinetic data from the 3 studies noted above, and from one Phase I study in MDS subjects, (N = 14; 15 mg/m2 x 3-hours q8h x 3 days).
Croatian: Podaci o posebnim populacijama dobiveni su na temelju farmakokinetičkih podataka iz 3 gore spomenuta ispitivanja te iz jednog ispitivanja faze I provedenog u ispitanika s mijelodisplastičnim sindromom (N = 14; 15 mg/m2 x 3-satna primjena svakih 8 sati x 3 dana).
English: Toxicity is likely to manifest as exacerbations of adverse drug reactions, primarily myelosuppression.
Croatian: Toksičnost se može manifestirati kao egzacerbacije nuspojava, prvenstveno mijelosupresije.
English: Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with AML may be exacerbated with Dacogen treatment.
Croatian: Mijelosupresija i komplikacije mijelosupresije, uključujući infekcije i krvarenja koji se javljaju u bolesnika s akutnom mijeloičnom leukemijom, mogu se pogoršati uz liječenje Dacogenom.
English: • an infection of the blood caused by bacteria - this may be a sign of a low level of white blood cells
Croatian: • infekcija krvi prouzročena bakterijom - može biti znak malog broja bijelih krvnih stanica
English: Table 3: Summary of population PK analysis for a typical patient receiving daily 1-hour infusions of Dacogen 20 mg/m2 over 5 days every 4 weeks
Croatian: Tablica 3: Sažetak analize populacijske farmakokinetike za tipičnog bolesnika koji dnevno prima 20 mg/m2 lijeka Dacogen u infuzijama od 1 sata tijekom 5 dana svaka
English: Results from a human mass-balance study and in vitro experiments mentioned above indicated that the CYP enzymes are unlikely to be involved in the metabolism of decitabine.
Croatian: Rezultati ispitivanja masene bilance u ljudi te gore spomenuti in vitro pokusi pokazali su da nije vjerojatno da su CYP enzimi uključeni u metabolizam decitabina.
English: This medicinal product is for single use only.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu primjenu.
English: The use of Dacogen was studied in an open-label, randomised, multicentre Phase III study (DACO-016) in subjects with newly diagnosed de novo or secondary AML according to the WHO classification.
Croatian: Uporaba Dacogena ispitivana je u otvorenom, randomiziranom, multicentričnom ispitivanju faze III (DACO-016) u ispitanika s novo dijagnosticiranom de novo ili sekundarnom akutnom mijeloičnom leukemijom prema SZO klasifikaciji.
English: Impact of co-administered medicinal products on decitabine Cytochrome (CYP) 450-mediated metabolic interactions are not anticipated as decitabine metabolism is not mediated by this system but by oxidative deamination.
Croatian: Ne očekuju se metaboličke interakcije posredovane citokromom (CYP) 450 jer metabolizam decitabina nije posredovan tim sustavom nego putem oksidativne deaminacije.
English: • a serious kidney disorder,
Croatian: • ozbiljan poremećaj bubrega,
English: Thus; CYP-mediated metabolic drug interactions are not anticipated, and decitabine is unlikely to interact with agents metabolized through these pathways.
Croatian: Dakle, ne očekuju se CYP-om posredovane metaboličke interakcije lijeka i nije vjerojatno da bi decitabin stupio u interakciju s lijekovima metaboliziranim tim metaboličkim putovima.
English: Very common hyperglycaemia
Croatian: Vrlo često hiperglikemija
English: No formal clinical drug interaction studies with decitabine have been conducted.
Croatian: Nisu provedena službena klinička ispitivanja interakcija lijekova s decitabinom.
English: • high level of ‘bilirubin' in the blood
Croatian: • povišena razina bilirubina u krvi
English: Excipients with known effect Each vial contains 0.5 mmol potassium (E340) and 0.29 mmol sodium (E524).
Croatian: Pomoćne tvari s poznatim učinkom Jedna bočica sadrži 0,5 mmola kalija (E340) i 0,29 mmola natrija (E524).
English: The use of Dacogen as initial therapy was also evaluated in an open-label, single-arm, Phase II study (DACO-017) in 55 subjects > 60 years with AML according to the WHO classification.
Croatian: Primjena Dacogena kao početne terapije bila je također ispitivana u otvorenom ispitivanju faze II (DACO-017) provedenom na jednoj skupini od 55 ispitanika > 60 godina s akutnom mijeloičnom leukemijom prema SZO klasifikaciji.
English: Other side effects of Dacogen include
Croatian: Druge nuspojave Dacogena uključuju
English: The most common Grade 3/4 adverse drug reactions (≥ 20%) included pneumonia, thrombocytopaenia, neutropaenia, febrile neutropaenia and anaemia.
Croatian: Najčešće nuspojave stupnja 3/4 (≥ 20%) uključivale su pneumoniju, trombocitopeniju, neutropeniju, febrilnu neutropeniju i anemiju.
English: The remainder of the subjects had intermediate-risk cytogenetics.
Croatian: Ostali ispitanici imali su citogenetski nalaz intermedijarne prognoze.
English: Posology In a treatment cycle, Dacogen is administered at a dose of 20 mg/m body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle).
Croatian: Doziranje U jednom ciklusu liječenja, Dacogen se primjenjuje u dozi od 20 mg/m2 tjelesne površine intravenskom infuzijom u trajanju od 1 sata, doza se ponavlja svaki dan tijekom 5 uzastopnih dana (tj. ukupno 5 doza u jednom ciklusu liječenja).
English: You will have blood tests before you start treatment with Dacogen and at the start of each treatment cycle.
Croatian: Prije nego što započnete liječenje Dacogenom, te na početku svakog ciklusa liječenja napravit ćete pretrage krvi.
English: Within 15 minutes of reconstitution, the concentrate (in 10 ml of sterile water for injections) must be further diluted with cold (2°C - 8°C) infusion fluids.
Croatian: Unutar 15 minuta od rekonstitucije, koncentrat se mora dalje razrijediti (u 10 ml sterilne vode za injekcije) hladnom infuzijskom otopinom (2°C - 8°C).
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains between 13.8 mg-138 mg (0.6-6 mmol) sodium per dose (depending on the infusion fluid for dilution), equivalent to 0.7-7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Nakon rekonstitucije i razrjeđivanja otopine za intravensku infuziju, lijek sadrži između 13,8 mg-138 mg (0,6-6 mmola) natrija po dozi (ovisno o vrsti infuzijske otopine za razrjeđivanje), što odgovara 0,7-7% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: After reconstitution, 1 ml concentrate contains 5 mg decitabine.
Croatian: Nakon rekonstitucije, 1 ml koncentrata sadrži 5 mg decitabina.
English: When censored for potentially disease modifying subsequent therapy (i.e., induction chemotherapy or hypomethylating agent) the analysis for overall survival showed a 20% reduction in the risk of death for subjects in the Dacogen arm [HR = 0.80, (95% CI: 0.64, 0.99), p-value = 0.0437)].
Croatian: Kada je cenzurirana buduća terapija koja bi potencijalno promijenila tijek bolesti (tj. indukcijska kemoterapija ili hipometilirajući lijek) analiza sveukupnog preživljenja pokazala je 20% manji rizik od smrti u ispitanika iz skupine koja je primala Dacogen [omjer hazarda (HR) = 0,80, (95% CI: 0,64; 0,99), p-vrijednost = 0,0437)].
English: It is supplied in a 20 ml glass vial containing 50 mg decitabine.
Croatian: Isporučuje se u staklenim bočicama od 20 ml koje sadrže 50 mg decitabina.
English: This medicine contains 0.29 mmol (6.67 mg) sodium per vial.
Croatian: Ovaj lijek sadrži 0,29 mmola (6,67 mg) natrija u jednoj bočici.
English: Dacogen was administered as a 1-hour intravenous infusion of 20 mg/m2 once daily for 5 consecutive days repeated every 4 weeks.
Croatian: Dacogen je primijenjen kao intravenska infuzija u trajanju od 1 sata, 20 mg/m2 jedanput dnevno tijekom 5 uzastopnih dana, ponavljano svaka 4 tjedna.
English: After preparing the medicine, it contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Croatian: Nakon pripreme lijeka, on sadrži manje od 1 mmol (39 mg) kalija po dozi, tj. zanemarive količine kalija.
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Croatian: Nakon rekonstitucije i razrjeđivanja otopine za intravensku infuziju, lijek sadrži manje od 1 mmol (39 mg) kalija po dozi, tj. zanemarive količine kalija.
English: You will be given Dacogen when you are first diagnosed with AML.
Croatian: Dacogen će Vam se primijeniti kad Vam prvi put bude dijagnosticirana akutna mijeloična leukemija (AML).
English: The need for dose adjustment in patients with hepatic impairment has not been evaluated.
Croatian: Potreba za prilagodbom doze u bolesnika s oštećenjem funkcije jetre nije procijenjena.
English: The time period following treatment with Dacogen where it is safe to become pregnant is unknown.
Croatian: Nije poznato koliko vremena treba proteći nakon liječenja Dacogenom kako bi trudnoća bila sigurna.
English: In non-clinical animal studies, decitabine alters male fertility and is mutagenic.
Croatian: U nekliničkim ispitivanjima na životinjama, decitabin je utjecao na plodnost mužjaka te je pokazao mutagena svojstva.