FrancophonIA/ELRC3.0 huggingface dataset:
English: • After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids.
Croatian: • Nakon pripreme, koncentrat se u roku od 15 minuta mora dalje razrijediti hladnom infuzijskom otopinom.
English: Dacogen is contraindicated during breast-feeding; therefore, if treatment with this medicine is required, breast-feeding must be discontinued (see section 4.3).
Croatian: Dacogen je kontraindiciran u razdoblju dojenja; stoga, ako je potrebno liječenje ovim lijekom, dojenje se mora prekinuti (vidjeti dio 4.3).
English: Treatment may be continued as long as the patient shows response, continues to benefit or exhibits stable disease, i.e., in the absence of overt progression.
Croatian: Liječenje se može nastaviti sve dok bolesnik ima odgovor, nastavlja imati korist od liječenja ili je bolest stabilna, tj. u odsutnosti očite progresije bolesti.
English: • Chest pain or shortness of breath (with or without fever or cough): these may be signs of an infection of the lung called “pneumonia” (very common) or inflamed lungs (interstitial lung disease [frequency not known]) or cardiomyopathy (heart muscle disease [uncommon]) which can be accompanied with swelling of ankles, hands, legs and feet.
Croatian: • Bol u prsnom košu ili nedostatak zraka (sa ili bez vrućice ili kašlja): to mogu biti znakovi infekcije pluća koja se naziva “upala pluća” (vrlo često) ili upalne bolesti pluća (intersticijska bolest pluća [učestalost nepoznata]) ili kardiomiopatije (bolest srčanog mišića [manje često]) koja može biti praćena oticanjem gležnjeva, ruku, nogu i stopala.
English: The median time to CR was 4.1 months, and the median duration of CR was 18.2 months.
Croatian: Medijan vremena do potpune remisije bilo je 4,1 mjesec, a medijan trajanja potpune remisije bilo je 18,2 mjeseca.
English: The pharmacokinetics of decitabine following intravenous administration as a 1-hour infusion were described by a linear two-compartment model, characterised by rapid elimination from the central compartment and by relatively slow distribution from the peripheral compartment.
Croatian: Farmakokinetika decitabina nakon intravenske primjene u obliku infuzije u trajanju od 1 sata bila je opisana kao linearni model s dva odjeljka, karakteriziran brzom eliminacijom iz središnjeg odjeljka i relativno sporom distribucijom iz perifernog odjeljka.
English: Breast-feeding (see section 4.6)
Croatian: Dojenje (vidjeti dio 4.6)
English: Eighty-one percent of subjects had significant comorbidities (e.g., infection, cardiac impairment, pulmonary impairment).
Croatian: Osamdeset i jedan posto ispitanika imalo je značajne komorbiditete (npr. infekcija, oštećenje funkcije srca, oštećenje funkcije pluća).
English: Analysis of mature overall survival data (ITT population).
Croatian: Analiza razrađenih podataka sveukupnog preživljenja (ITTpopulacija)
English: Talk to your doctor, pharmacist or nurse before using Dacogen if you have
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Dacogen ako imate
English: Based on model simulation, PK parameters were independent of time (i.e., did not change from cycle to cycle) and no accumulation was observed with this dosing regimen.
Croatian: Na temelju simulacije modela, farmakokinetički parametri nisu ovisili o vremenu (tj. nisu se mijenjali od ciklusa do ciklusa) i uz taj režim doziranja nije opažena akumulacija.
English: CL (L/h)
Croatian: Vdss (l) CL (l/h)
English: In clinical studies in AML and myelodysplastic syndrome (MDS), the reporting frequency for hyperbilirubinaemia was 11% for All Grades and 2% for Grade 3-4.
Croatian: U kliničkim ispitivanjima AML-a i mijelodisplastičnog sindroma (MDS), učestalost prijavljivanja hiperbilirubinemije iznosila je 11% za sve stupnjeve te 2% za stupnjeve 3-4.
English: Including haemorrhage associated with thrombocytopaenia, including fatal cases.
Croatian: Uključuje hemoragiju povezanu s trombocitopenijom, uključujući smrtne slučajeve.
English: If Dacogen is used during pregnancy, or if a patient becomes pregnant while receiving this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Croatian: Ako se Dacogen primjenjuje tijekom trudnoće ili ako bolesnica zatrudni dok prima ovaj lijek, bolesnicu treba informirati o potencijalnoj opasnosti za fetus.
English: • red, raised painful patches on the skin, fever, an increase in white blood cells - these may be signs of ‘Acute Febrile Neutrophilic Dermatosis' or ‘Sweet's Syndrome'
Croatian: • crvene, uzdignute bolne mrlje na koži, vrućica, povećan broj bijelih krvnih stanica - to mogu biti znakovi ‘akutne febrilne neutrofilne dermatoze' ili ‘Sweetova sindroma'.
English: Dacogen is used to treat a type of cancer called ‘acute myeloid leukaemia' or ‘AML'.
Croatian: Dacogen se koristi za liječenje jedne vrste raka koja se naziva 'akutna mijeloična leukemija' ili 'AML'.
English: Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products.
Croatian: Primjena Dacogena mora se započeti pod nadzorom liječnika s iskustvom u primjeni kemoterapijskih lijekova.
English: Men should use effective contraceptive measures and be advised to not father a child while receiving Dacogen, and for 3 months following completion of treatment (see section 5.3).
Croatian: Muškarci trebaju primjenjivati učinkovite mjere kontracepcije i treba im savjetovati da ne začinju dijete dok primaju Dacogen te još 3 mjeseca nakon završetka liječenja (vidjeti dio 5.3).
English: Treatment with Dacogen may be resumed once these conditions have improved or have been stabilised with adequate treatment (anti-infective therapy, transfusions, or growth factors).
Croatian: Liječenje Dacogenom može se nastaviti kada nastupi poboljšanje tih stanja ili kada se ona stabiliziraju odgovarajućim liječenjem (antiinfektivna terapija, transfuzije ili čimbenici rasta).
English: These may be signs of bleeding inside your head (common).
Croatian: To mogu biti znakovi krvarenja u glavi (često).
English: It is not known whether decitabine or its metabolites are excreted in breast milk.
Croatian: Nije poznato izlučuju li se decitabin ili njegovi metaboliti u majčino mlijeko.
English: CR = complete remission; CRp = complete remission with incomplete platelet recovery, EFS = event-free survival, PFS = progression-free survival, OR = odds ratio, HR = hazard ratio - = Not evaluable
Croatian: CR = potpuna remisija; CRp = potpuna remisija s nepotpunim oporavkom trombocita EFS = preživljenje bez događaja, PFS = preživljenje bez progresije bolesti, OR = omjer izgleda (vjerojatnosti), HR = omjer hazarda
English: The use of decitabine with hormonal contraceptives has not been studied.
Croatian: Primjena decitabina uz hormonske kontraceptive nije ispitana.
English: What Dacogen is and what it is used for
Croatian: Što je Dacogen i za što se koristi
English: Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Croatian: Premedikacija za sprječavanje mučnine i povraćanja ne preporučuje se kao standardni postupak, ali može biti primijenjena ako je potrebno.
English: Excluding pneumonia, urinary tract infection, sepsis, septic shock and sinusitis.
Croatian: Isključujući pneumoniju, infekciju mokraćnog sustava, sepsu, septički šok i sinusitis.
English: What Dacogen contains
Croatian: Što Dacogen sadrži
English: Decitabine administration to neonatal/juvenile rats showed a comparable general toxicity profile as in older rats.
Croatian: Primjena decitabina u tek okoćenih/mladih štakora pokazala je profil opće toksičnosti sličan onom u starijih štakora.
English: The total daily dose must not exceed 20 mg/m 2 and the total dose per treatment cycle must not exceed
Croatian: Ukupna dnevna doza ne smije prelaziti 20 mg/m2, a ukupna doza u jednom ciklusu liječenja ne smije prelaziti 100 mg/m2.
English: Based on results from animal studies and its mechanism of action, Dacogen should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: Na temelju rezultata ispitivanja provedenih na životinjama i mehanizma djelovanja, Dacogen se ne smije primjenjivati za vrijeme trudnoće, niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: • Your doctor will work out your dose of Dacogen.
Croatian: • Liječnik će Vam odrediti dozu Dacogena.
English: Decitabine (5-aza-2-deoxycytidine) is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death.
Croatian: Decitabin (5-aza-2-deoksicitidin) je analog citidin deoksinukleozida koji selektivno inhibira DNK metiltransferaze u niskim dozama, rezultirajući hipometilacijom genskog promotora koja za posljedicu može imati reaktivaciju tumor supresorskih gena, indukciju stanične diferencijacije ili starenje stanica nakon čega slijedi programirana smrt stanica.
English: What Dacogen is and what it is used for What you need to know before you use Dacogen How to use Dacogen
Croatian: Što se nalazi u ovoj uputi Što je Dacogen i za što se koristi Što morate znati prije nego počnete primati Dacogen Kako primjenjivati Dacogen Moguće nuspojave
English: Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1.
Croatian: Preosjetljivost na decitabin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: It contains the active substance ‘decitabine'.
Croatian: Sadrži djelatnu tvar 'decitabin'.
English: Infuse the reconstituted solution intravenously over 1 hour.
Croatian: Rekonstituiranu otopinu primijenite intravenskom infuzijom tijekom 1 sata.
English: Haematological adverse drug reactions should be managed by routine monitoring of complete blood counts and early administration of supportive treatments as required.
Croatian: Hematološke nuspojave treba rješavati rutinskim nadzorom kompletne krvne slike i ranom primjenom potpornog liječenja prema potrebi.
English: Gastrointestinal toxicity was also observed and in males, testicular atrophy which did not reverse over the scheduled recovery periods.
Croatian: Gastrointestinalna toksičnost također je bila opažena, a u muškaraca i atrofija testisa koja se za vrijeme planiranih razdoblja oporavka nije promijenila.
English: A vial is for single use only and any remaining solution must be discarded.
Croatian: Bočica je samo za jednokratnu upotrebu i sva preostala otopina mora se prikladno zbrinuti.
English: Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies and therefore, the safety and efficacy of Dacogen in these patients has not been established.
Croatian: Bolesnici koji su u anamnezi imali teško kongestivno zatajenje srca ili klinički nestabilnu bolest srca, isključeni su iz kliničkih ispitivanja, stoga sigurnost primjene i djelotvornost Dacogena u tih bolesnika nije ustanovljena.
English: • low numbers of platelets, red blood cells or white blood cells,
Croatian: • mali broj krvnih pločica, crvenih ili bijelih krvnih stanica,
English: If worsening hepatic function occurs, patients should be carefully monitored (see sections 4.4 and 5.2).
Croatian: Ako nastupi pogoršanje funkcije jetre, bolesnika treba pažljivo nadzirati (vidjeti dijelove 4.4 i 5.2).
English: In vitro studies show that decitabine does not inhibit nor induce CYP 450 enzymes up to more than 20-fold of the therapeutic maximum observed plasma concentration (Cmax).
Croatian: Ispitivanja in vitro pokazuju da decitabin ne inhibira ni ne inducira enzime CYP 450 čak niti pri plazmatskim koncentracijama višim od 20 puta od terapijskog maksimuma (Cmax).
English: The safety assessment in paediatric patients is based on the limited safety data from a Phase I/II study to evaluate pharmacokinetics, safety and efficacy of Dacogen in paediatric patients (aged 1 to 14 years) with relapsed or refractory AML (n = 17) (see section 5.1).
Croatian: Sigurnosna procjena u pedijatrijskih bolesnika temelji se na ograničenim podacima o sigurnosti iz ispitivanja faze I/II u kojem se procjenjivala farmakokinetika, sigurnost i djelotvornost lijeka Dacogen u pedijatrijskih bolesnika (u dobi od 1 do 14 godina) s relapsnim ili refraktornim AML (n = 17) (vidjeti dio 5.1).
English: Worst National Cancer Institute Common Terminology Criteria for Adverse Events Grade.
Croatian: Najteži stupanj prema zajedničkim terminološkim kriterijima nuspojava američkog Nacionalnog instituta za rak (National Cancer Institute).
English: • Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25,000/µL or any central nervous system haemorrhage)
Croatian: • hemoragija (gastrointestinalna, genito-urinarna, pulmonalna uz broj trombocita < 25 000/µl ili hemoragija u bilo kojem dijelu središnjeg živčanog sustava).
English: Skin contact with the solution should be avoided and protective gloves must be worn.
Croatian: Potrebno je izbjegavati dodir otopine s kožom te se moraju nositi zaštitne rukavice.
English: Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
Croatian: Dacogen je indiciran za liječenje odraslih bolesnika s novodijagnosticiranom de novo ili sekundarnom akutnom mijeloičnom leukemijom (AML) prema klasifikaciji Svjetske zdravstvene organizacije (SZO), koji nisu kandidati za standardnu indukcijsku kemoterapiju.
English: Adverse drug reactions reported in 293 AML patients treated with Dacogen are summarised in Table 1.
Croatian: Nuspojave prijavljene u 293 bolesnika s AML liječenih Dacogenom sažeto su navedene u tablici 1.
English: In patients with baseline Grade 2 abnormalities, worsening of myelosuppression was seen in most patients and more frequently than in patients with baseline Grade 1 or 0 abnormalities.
Croatian: U bolesnika s početnim nepravilnostima stupnja 2, uočeno je pogoršanje mijelosupresije u većine bolesnika i to mnogo češće nego u bolesnika s početnim nepravilnostima stupnja 1 ili 0.
English: Because of the possibility of infertility as a consequence of Dacogen therapy, men should seek advice on conservation of sperm and female patients of childbearing potential should seek consultation regarding oocyte cryopreservation prior to initiation of treatment.
Croatian: Zbog moguće neplodnosti kao posljedice liječenja Dacogenom, muškarci bi trebali potražiti savjet za pohranu sperme, a žene reproduktivne dobi trebale bi se posavjetovati o zamrzavanju jajnih stanica prije početka liječenja.
English: There are no adequate data on the use of Dacogen in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Dacogena u trudnica.
English: The available data from in vitro and in vivo studies provide sufficient evidence that decitabine has genotoxic potential.
Croatian: Podaci dobiveni u ispitivanjima in vitro i in vivo pružaju dovoljno dokaza da decitabin ima genotoksični potencijal.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraceptive measures and avoid becoming pregnant while being treated with Dacogen.
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju primjenjivati učinkovite mjere kontracepcije i izbjegavati trudnoću dok se liječe Dacogenom.
English: • Do not store above 25C.
Croatian: • Ne čuvati na temperaturi iznad 25°C
English: • Men should not father a child while using Dacogen.
Croatian: • Muškarci ne smiju začeti dijete za vrijeme primjene Dacogena.
English: Decitabine has been shown to be a weak inhibitor of P-gp mediated transport in vitro and is therefore, also not expected to affect P-gp mediated transport of co-administered medicinal products (see section 5.2).
Croatian: Decitabin se pokazao kao slabi inhibitor transporta posredovanog P-glikoproteinom (P-gp) in vitro, stoga se ne očekuje da će utjecati na P-gp posredovani transport istovremeno primjenjivanih lijekova (vidjeti dio 5.2).
English: The median time to best response and median duration of best response in patients who achieved a CR or CRp were 4.3 months and 8.3 months, respectively.
Croatian: Medijan vremena do najboljeg odgovora u bolesnika koji su postigli CR ili CRp iznosio je 4,3 mjeseca, a medijan trajanja najboljeg odgovora u tih bolesnika iznosio je 8,3 mjeseca.
English: The secondary endpoint was complete remission rate that was assessed by independent expert review.
Croatian: Mjera sekundarnog ishoda bila je stopa potpune remisije procijenjena pregledom od strane nezavisnih stručnjaka.
English: The following table reflects data from AML clinical studies and from post-marketing experience.
Croatian: Tablica pokazuje podatke dobivene u kliničkim ispitivanjima AML i nakon stavljanja lijeka u promet.
English: There is the potential for a drug-drug interaction with other agents which are also activated by sequential phosphorylation (via intracellular phosphokinase activities) and/or metabolised by enzymes implicated in the inactivation of decitabine (e.g., cytidine deaminase).
Croatian: Postoji mogućnost interakcija lijeka s drugim tvarima koje također aktivira sekvencijska fosforilacija (putem intracelularnih aktivnosti fosfokinaze) i/ili koje metaboliziraju enzimi koji sudjeluju u deaktivaciji decitabina (npr. citidin deaminaza).
English: The primary route of metabolism is likely through deamination by cytidine deaminase in the liver, kidney, intestinal epithelium and blood.
Croatian: Primarni put metabolizma vjerojatno je putem deaminacije posredstvom citidin deaminaze u jetri, bubregu, epitelu crijeva i krvi.
English: The population pharmacokinetic (PK) parameters of decitabine were pooled from 3 clinical studies in 45 patients with AML or myelodysplastic syndrome (MDS) utilizing the 5-Day regimen.
Croatian: Parametri populacijske farmakokinetike (PK) decitabina sakupljeni su iz 3 klinička ispitivanja provedena u 45 bolesnika s akutnom mijeloičnom leukemijom ili mijelodisplastičnim sindromom (MDS) uz 5-odnevni režim liječenja.
English: The most frequently reported "other infections" in study DACO-016 were: oral herpes, oral candidiasis, pharyngitis, upper respiratory tract infection, cellulitis, bronchitis, nasopharyngitis.
Croatian: Najčešće prijavljene "ostale infekcije" u ispitivanju DACO-016 bile su: oralni herpes, oralna kandidijaza, faringitis, infekcije gornjih dišnih puteva, celulitis, bronhitis, nazofaringitis.
English: If after 4 cycles, the patient's haematological values (e.g., platelet counts or absolute neutrophil count), have not returned to pre-treatment levels or if disease progression occurs (peripheral blast counts are increasing or bone marrow blast counts are worsening), the patient may be considered to be a non-responder and alternative therapeutic options to Dacogen should be considered.
Croatian: Ako se nakon 4 ciklusa bolesnikove hematološke vrijednosti (npr. broj trombocita ili apsolutni broj neutrofila) nisu vratile na razine prije liječenja ili ako dođe do progresije bolesti (porast broja perifernih blasta ili pogoršanje broja blasta u koštanoj srži), može se smatrati da bolesnik nije odgovorio na liječenje i potrebno je razmotriti druge terapijske mogućnosti umjesto lijeka Dacogen.
English: Patients, especially those with cardiac disease history, should be monitored for signs and symptoms of heart failure.
Croatian: Bolesnike, naročito one s bolesti srca u anamnezi, potrebno je pratiti na znakove i simptome zatajenja srca.
English: Population pharmacokinetic analysis of decitabine did not show any clinically relevant difference between men and women.
Croatian: Analiza populacijske farmakokinetike decitabina nije pokazala klinički relevantnu razliku između muškaraca i žena.
English: Table 1: Adverse drug reactions identified with Dacogen
Croatian: Tablica 1: Nuspojave utvrđene uz Dacogen
English: • Fever: this may be a sign of an infection caused by low levels of white blood cells (very common).
Croatian: • Vrućica: to može biti znak infekcije prouzročene malim brojem bijelih krvnih stanica (vrlo često).
English: These tests are to check that:
Croatian: Tim se pretragama kontrolira:
English: Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako imate pitanja o tome kako Dacogen djeluje ili zbog čega
English: The primary endpoint was complete remission (CR) rate that was assessed by independent expert review.
Croatian: Mjera primarnog ishoda ispitivanja bila je stopa potpune remisije (CR) procijenjena od strane nezavisnih stručnjaka.
English: This may be a sign of bleeding in the stomach or gut (common).
Croatian: To može biti znak krvarenja u želucu ili crijevima (često).
English: Uncommon acute febrile neutrophilic dermatosis (Sweet's syndrome)
Croatian: Manje često akutna febrilna neutrofilna dermatoza (Sweetov sindrom)
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Dacogen.
Croatian: Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, posavjetujte se s liječnikom, ljekarnikom ili medicinskom sestrom prije primjene lijeka Dacogen.
English: Frequency categories are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).
Croatian: rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: No human data on the effect of decitabine on fertility are available.
Croatian: Nema podataka o učinku decitabina na plodnost u ljudi.
English: • This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial.
Croatian: • Ovaj lijek sadrži 0,29 mmola (6,67 mg) natrija (glavni sastojak kuhinjske/stolne soli) u jednoj bočici.
English: The effects of renal or hepatic impairment, gender, age or race on the pharmacokinetics of decitabine have not been formally studied.
Croatian: Učinci oštećenja bubrežne funkcije ili funkcije jetre, spola, dobi ili rasne pripadnosti na farmakokinetiku decitabina nisu službeno proučavani.
English: The median age for the intent-to-treat (ITT) population was 73 years (range 64 to 91 years).
Croatian: Medijan dobi populacije koju se namjeravalo liječiti (engl. intent to treat, ITT) bio je 73 godine (raspon od 64 do 91 godine).
English: Infections and infestations
Croatian: Nuspojave infekcije i infestacije
English: The need for dose adjustment in patients with renal impairment has not been evaluated (see section 4.4 and 5.2).
Croatian: Potreba za prilagodbom doze u bolesnika s oštećenjem funkcije bubrega nije procijenjena (vidjeti dijelove 4.4 i 5.2).
English: How Dacogen is given The solution is given into a vein (as an infusion).
Croatian: Kako se primjenjuje Dacogen Otopina se primjenjuje u venu (kao infuzija).
English: In addition, the limited data from the population PK analysis indicated no significant PK parameter dependencies on total bilirubin concentration despite a wide range of total bilirubin levels.
Croatian: Osim toga, ograničeni podaci analize populacijske farmakokinetike nisu pokazali značajne ovisnosti farmakokinetičkih parametara o ukupnoj koncentraciji bilirubina unatoč velikom rasponu razina ukupnog bilirubina.
English: C-decitabine in cancer patients showed that 90% of the administered dose of decitabine (4% unchanged drug) is excreted in the urine.
Croatian: C-decitabinom u bolesnika s karcinomom, pokazali su da se 90% primijenjene doze decitabina (4% nepromijenjenog lijeka) izlučuje u mokraći.
English: Common septic shock* sepsis* sinusitis
Croatian: Često septički šok sepsa sinusitis