FrancophonIA/ELRC3.0 huggingface dataset:
English: • Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive supportive care)
Slovenian: • aktivna virusna, bakterijska ali glivična okužba (zaradi katere je potrebno intravensko zdravljenje z antiinfektivi ali obsežna podporna oskrba bolnika),
English: Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1.
Slovenian: Preobčutljivost na decitabin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: What Dacogen is Dacogen is an anti-cancer medicine.
Slovenian: Kaj je zdravilo Dacogen Dacogen je zdravilo proti raku.
English: If worsening hepatic function occurs, patients should be carefully monitored (see sections 4.4 and 5.2).
Slovenian: Če pride do poslabšanja jetrne funkcije, je treba bolnika skrbno spremljati (glejte poglavji 4.4 in 5.2).
English: The secondary endpoint of the study was overall survival.
Slovenian: Sekundarni cilj opazovanja v tej študiji je bilo celokupno preživetje.
English: The cycle should be repeated every 4 weeks depending on the patient's clinical response and observed toxicity.
Slovenian: Kroge zdravljenja je treba ponavljati vsake 4 tedne in pri tem upoštevati klinični odziv in toksično delovanje pri posameznem bolniku.
English: Upon reconstitution, each ml contains approximately 5 mg of decitabine at pH 6.7 to 7.3.
Slovenian: Po rekonstituciji en mililiter raztopine vsebuje približno 5 mg decitabina pri pH vrednosti od 6,7 do 7,3.
English: This medicinal product is for single use only.
Slovenian: Zdravilo je namenjeno samo za enkratno uporabo.
English: The total daily dose must not exceed 20 mg/m 2 and the total dose per treatment cycle must not exceed
Slovenian: Celoten dnevni odmerek ne sme preseči 20 mg/m2, celotni odmerek v enem krogu zdravljenja pa ne sme preseči 100 mg/m2.
English: The need for dose adjustment in patients with renal impairment has not been evaluated (see section 4.4 and 5.2).
Slovenian: Potrebe po prilagajanju odmerka pri bolnikih z okvaro ledvic niso ocenili (glejte poglavji 4.4 in 5.2).
English: The primary endpoint of the study was overall survival.
Slovenian: V študiji je bil primarni cilj opazovanja celokupno preživetje.
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.
Slovenian: Pri bolnikih z izhodiščno mielosupresijo stopnje 2 so opazili poslabšanje mielosupresije pri večini bolnikov in pogosteje kot pri bolnikih z izhodiščno mielosupresijo stopnje 1 ali 0.
English: Based on these negative results, Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established (see section 4.2).
Slovenian: Na osnovi teh negativnih rezultatov se zdravila Dacogen ne sme uporabljati pri otrocih z AML, starih manj kot 18 let, ker učinkovitost ni bila dokazana (glejte poglavje 4.2).
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.
Slovenian: Z zdravljenjem je mogoče nadaljevati, dokler je pri bolniku mogoče zaznati odziv, dokler bolniku koristi oziroma je bolezen pri njem stabilna, torej dokler bolezen očitno ne napreduje.
English: The most frequently reported "other infections" in study DACO-016 were: oral herpes, oral candidiasis, pharyngitis, upper respiratory tract infection, cellulitis, bronchitis, nasopharyngitis.
Slovenian: Najpogosteje poročane "druge okužbe" v študiji DACO-016 so bile: oralni herpes, oralna kandidiaza, faringitis, okužba zgornjih dihal, celulitis, bronhitis, nazofaringitis.
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.
Slovenian: Farmakokinetiko decitabina po enourni aplikaciji intravenske infuzije so opisovali s pomočjo linearnega dvoprostornega modela, in sicer jo označuje hitro izločanje iz centralnega prostora in razmeroma počasna porazdelitev iz perifernega prostora.
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).
Slovenian: Ocena varnosti pri pediatričnih bolnikih temelji na omejenih podatkih iz študije faze I/II za oceno farmakokinetike, varnosti in učinkovitosti zdravila Dacogen pri pediatričnih bolnikih (starih od 1 do 14 let) z recidivno ali neodzivno AML (n = 17) (glejte poglavje 5.1).
English: Population pharmacokinetic analysis showed that decitabine pharmacokinetics are not dependent on age (range studied 40 to 87 years; median 70 years).
Slovenian: Rezultati analize populacijske farmakokinetike kažejo, da farmakokinetika decitabina ni odvisna od starosti bolnika (v proučevanem okviru od 40 do 87 let, mediana starost 70 let).
English: Standard procedures for dealing with cytotoxic medicinal products should be adopted.
Slovenian: Upoštevati je treba standardne postopke, ki so predpisani za ravnanje s citotoksičnimi zdravili.
English: Analysis of mature overall survival data (ITT population).
Slovenian: Analiza podatkov preživetja po daljšem času opazovanja (ITT populacija)
English: Patients, especially those with cardiac disease history, should be monitored for signs and symptoms of heart failure.
Slovenian: Bolnike, zlasti tiste z boleznimi srca v anamnezi, je treba spremljati glede znakov in simptomov srčnega popuščanja.
English: Male and female fertility and contraception
Slovenian: Plodnost in kontracepcija pri moških in ženskah
English: A vial is for single use only and any remaining solution must be discarded.
Slovenian: Vsebina viale je namenjena le enkratni uporabi, morebitno neporabljeno raztopino pa je treba zavreči.
English: You will be given Dacogen when you are first diagnosed with AML.
Slovenian: Zdravilo Dacogen boste prejemali, če so vam nedavno postavili diagnozo AML.
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
Slovenian: CR = popolna remisija (complete remission); CRp = popolna remisija z nepopolno normalizacijo vrednosti trombocitov (complete remission with incomplete platelet recovery), OR = razmerje obetov (odds ratio), HR = razmerje tveganja (hazard ratio) - = ni mogoče oceniti podana je mediana vrednost števila mesecev
English: • After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids.
Slovenian: • Koncentrat je treba razredčiti s hladno infuzijsko tekočino v 15 minutah po rekonstituciji.
English: The total dose per cycle was 100 mg/m
Slovenian: celotni odmerek na krog zdravljenja je znašal 100 mg/m
English: What Dacogen looks like and contents of the pack Dacogen is a white to almost white powder for concentrate for solution for infusion.
Slovenian: Izgled zdravila Dacogen in vsebina pakiranja Dacogen je bel do skoraj bel prašek za koncentrat za raztopino za infundiranje.
English: What Dacogen is and what it is used for What you need to know before you use Dacogen How to use Dacogen
Slovenian: Kaj je zdravilo Dacogen in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Dacogen Kako uporabljati zdravilo Dacogen Možni neželeni učinki
English: The following table reflects data from AML clinical studies and from post-marketing experience.
Slovenian: V preglednici so povzeti podatki iz kliničnih študij z AML in v obdobju po prihodu zdravila na trg.
English: Breast-feeding (see section 4.6)
Slovenian: Dojenje (glejte poglavje 4.6).
English: TC (combined group) n = 243
Slovenian: izbrano zdravilo (združeni podatki) n = 243
English: • Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Population pharmacokinetic analysis of decitabine did not show any clinically relevant difference between men and women.
Slovenian: Rezultati analize populacijske farmakokinetike decitabina ne kažejo klinično pomembnih razlik med moškimi in ženskami.
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).
Slovenian: Obstaja možnost medsebojnega delovanja zdravil z drugimi učinkovinami, ki se tudi aktivirajo s sekvenčno fosforilacijo (z intracelularnim delovanjem fosfokinaze) in/ali presnavljajo z encimi, vpletenimi v inaktivacijo decitabina (npr. citidin deaminaza).
English: • low numbers of platelets, red blood cells or white blood cells,
Slovenian: • majhno število krvnih ploščic (trombocitov), rdečih krvnih celic ali belih krvnih celic,
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.
Slovenian: • Bolečine v prsih ali zadihanost (z zvišano telesno temperaturo oziroma s kašljem ali brez njiju): to so lahko znaki okužbe pljuč, ki jo imenujemo "pljučnica" (zelo pogosto) ali vnetje pljuč (intersticijska bolezen pljuč [pogostnost neznana]) ali kardiomiopatije (bolezni srčne mišice [občasno]), ki jo lahko spremlja otekanje gležnjev, rok, nog in stopal.
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).
Slovenian: Pokazalo se je, da decitabin in vitro šibek zaviralec transporta, ki ga posreduje P-glikoprotein, zato tudi ni pričakovati, da bi vplival na transport sočasno uporabljenih zdravil, ki ga posreduje Pglikoprotein (glejte poglavje 5.2).
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.
Slovenian: Po podatkih simulacije z modelom so farmakokinetični parametri neodvisni od časa (kar pomeni, da se ne razlikujejo od kroga do kroga zdravljenja), pa tudi kopičenja niso opažali pri tej shemi odmerjanja.
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.
Slovenian: Prisotnost teh presnovkov v urinu, visoka vrednost celotnega očistka iz telesa in majhen obseg izločanja nespremenjenega decitabina z urinom (~4% odmerka) kažejo, da se in vivo decitabin v precejšnji meri presnovi.
English: Caution should be exercised in the administration of Dacogen to patients with severe renal impairment (Creatinine Clearance [CrCl] < 30 ml/min).
Slovenian: Pri odmerjanju zdravila Dacogen bolnikom s hudo okvaro ledvic (z očistkom kreatinina [CrCl] < 30 ml/min) je potrebna previdnost.
English: The available data from in vitro and in vivo studies provide sufficient evidence that decitabine has genotoxic potential.
Slovenian: Razpoložljivi podatki iz študij in vitro in in vivo vsebujejo dovolj dokazov, ki potrjujejo genotoksični potencial decitabina.
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.
Slovenian: Rezultati študije toksičnega delovanja ponavljajočih odmerkov v več ciklusih na podganah in kuncih kažejo, da je poglavitno toksično delovanje mielosupresija, ki vključuje delovanje na kostni mozeg, ki je po prenehanju zdravljenja reverzibilno.
English: Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products.
Slovenian: Zdravljenje z zdravilom Dacogen mora uvesti in spremljati zdravnik, ki ima izkušnje z uporabo kemoterapevtskih zdravil.
English: The number of patients treated with Dacogen by racial group was White 209 (86.4%) and Asian 33 (13.6%).
Slovenian: Med bolniki, ki so prejemali zdravilo Dacogen, je bilo 209 (86,4%) pripadnikov bele rase in 33 (13,6%) pripadnikov azijske rase.
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.
Slovenian: Če bolnica uporablja zdravilo Dacogen med nosečnostjo ali če zanosi v času uporabe tega zdravila, jo je treba seznaniti z možnim tveganjem za plod.
English: • You should not use Dacogen if you are pregnant as it may harm your baby.
Slovenian: • Če ste noseči, ne smete uporabljati zdravila Dacogen, ker lahko škoduje vašemu otroku.
English: No human data on the effect of decitabine on fertility are available.
Slovenian: O vplivu uporabe decitabina na plodnost pri ljudeh ni podatkov.
English: • Difficulty breathing, swelling of the lips, itching or rash: This may be due to an allergic (hypersensitivity) reaction (common).
Slovenian: • Oteženo dihanje, otekanje ustnic, srbenje ali izpuščaj: do njih lahko pride zaradi alergijske (preobčutljivostne) reakcije (pogosto).
English: In non-clinical animal studies, decitabine alters male fertility and is mutagenic.
Slovenian: V nekliničnih študijah na živalih je decitabin vplival na plodnost samcev in deloval mutageno.
English: • a drop in the number of red blood cells, white blood cells and platelets (pancytopaenia)
Slovenian: • zmanjšanje števila rdečih krvnih celic, belih krvnih celic in krvnih ploščic (pancitopenija)
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.
Slovenian: Podporno zdravljenje vključuje profilaktično odmerjanje antibiotikov in/ali rastnih faktorjev (na primer G-CSF) za preprečevanje nevtropenije ter transfuzij za odpravljanje anemije oziroma trombocitopenije v skladu z bolnišničnimi smernicami.
English: C-decitabine in cancer patients showed that 90% of the administered dose of decitabine (4% unchanged drug) is excreted in the urine.
Slovenian: C-decitabinom pri bolnikih z rakom kažejo, da se z urinom izloči 90% apliciranega odmerka decitabina (4% nespremenjene učinkovine).
English: • Your doctor may delay your dose and change the total number of cycles, depending on how you respond to the treatment.
Slovenian: • Glede na to, kako se boste odzvali na zdravljenje, lahko vaš zdravnik odloži odmerek ali spremeni skupno število krogov zdravljenja, ki jih boste prejeli.
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.
Slovenian: Če se hematološke vrednosti (na primer koncentracija trombocitov ali absolutno število nevtrofilcev) po 4 ciklih ne vrnejo na vrednosti pred zdravljenjem ali če pride do napredovanja bolezni (če se poveča število blastov v periferni krvi ali poslabša število blastov v kostnem mozgu), velja bolnik za neodzivnega, zato je namesto uporabe zdravila Dacogen pri njem treba razmisliti o drugih možnostih zdravljenja.
English: Skin contact with the solution should be avoided and protective gloves must be worn.
Slovenian: Raztopina ne sme priti v stik s kožo, zato je obvezna uporaba zaščitnih rokavic.
English: Myelosuppression caused by Dacogen is reversible.
Slovenian: Mielosupresija, ki jo povzroči zdravilo Dacogen, je reverzibilna.
English: • This medicine contains 0.29 mmol (6.67 mg) sodium (main component of cooking/table salt) in each vial.
Slovenian: • To zdravilo vsebuje 0,29 mmol (6,67 mg) natrija (glavne sestavine kuhinjske soli) v eni viali.
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.
Slovenian: Zdravilo Dacogen je indicirano za zdravljenje odraslih bolnikov z nedavno ugotovljeno de novo ali sekundarno akutno mieloično levkemijo (AML) po razvrstitvi Svetovne zdravstvene organizacije (SZO), za katere standardna indukcijska kemoterapija ni primerna.
English: Toxicity is likely to manifest as exacerbations of adverse drug reactions, primarily myelosuppression.
Slovenian: Toksično delovanje se verjetno lahko pokaže kot poslabšanje neželenih učinkov, predvsem mielosupresije.
English: Dacogen is used to treat a type of cancer called ‘acute myeloid leukaemia' or ‘AML'.
Slovenian: Zdravilo Dacogen uporabljamo za zdravljenje vrste raka, ki ga imenujemo "akutna mieloična levkemija" ali s kratico "AML".
English: The median overall survival in the ITT population was 7.6 months (95% CI: 5.7, 11.5).
Slovenian: V ITT populaciji je znašala mediana celotnega preživetja 7,6 mesecev (95-odstotni IZ: 5,7, 11,5).
English: Dacogen should not be infused through the same intravenous access/line with other medicinal products.
Slovenian: Zdravila Dacogen se ne sme infundirati skupaj z drugimi zdravili po istem intravenskem dostopu/kanalu.
English: Treatment may be delayed at the discretion of the treating physician, if the patient experiences myelosuppression-associated complications, such as those described below:
Slovenian: Po presoji lečečega zdravnika je mogoče zdravljenje odložiti, če pri bolniku pride do spodaj navedenih ali podobnih zapletov zaradi mielosupresije:
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%).
Slovenian: Zdravilo Dacogen (n = 242) so primerjali z drugim zdravilom (izbrano zdravilo, n = 243), ki si ga je bolnik izbral po nasvetu zdravnika izmed naslednjih dveh možnosti: samo podporno zdravljenje (n = 28, 11,5%) ali citarabin enkrat na dan subkutano v odmerku 20 mg/m2 10 zaporednih dni vsake
English: In clinical studies, approximately one-third of patients receiving Dacogen required a dose-delay.
Slovenian: Zakasnitev odmerka je bila potrebna pri približno tretjini bolnikov, ki so v kliničnih študijah prejemali zdravilo Dacogen.
English: This medicine contains 0.29 mmol (6.67 mg) sodium per vial.
Slovenian: To zdravilo vsebuje 0,29 mmol (6,67 mg) natrija na vialo.
English: Frequency All Grades
Slovenian: Pogostnost (vse stopnje)
English: • heart muscle disease
Slovenian: • bolezen srčne mišice
English: • The active substance is decitabine.
Slovenian: • Učinkovina je decitabin.
English: Grades 3-4
Slovenian: Pogostnost vse stopnje stopnji 3-4
English: The efficacy and safety of Dacogen has not been evaluated in patients with acute promyelocytic leukaemia or CNS leukaemia.
Slovenian: Učinkovitosti in varnosti zdravila Dacogen pri bolnikih z akutno promielocitno levkemijo ali z levkemijo centralnega živčevja niso ocenjevali.
English: Gastrointestinal toxicity was also observed and in males, testicular atrophy which did not reverse over the scheduled recovery periods.
Slovenian: Poleg tega so opažali toksično delovanje na prebavila, pri samcih pa tudi atrofijo testisov, ki se v načrtovanih obdobjih okrevanja ni popravila.
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
Slovenian: Če pride do mielosupresije oziroma zapletov, povezanih z njo, je mogoče zdravljenje z zdravilom Dacogen prekiniti in/ali uvesti podporno zdravljenje (glejte poglavji 4.2 in 4.8).
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%).
Slovenian: Pri bolnikih z rakom je bil po intravenski aplikaciji povprečen očistek decitabina iz plazme > 200 l/h pri zmerni stopnji interindividualne variabilnosti (s koeficientom variacije [CV] približno 50%).
English: However, early clinical study data in published literature at doses greater than 20 times higher than the current therapeutic dose, reported increased myelosuppression including prolonged neutropaenia and thrombocytopaenia.
Slovenian: V objavljeni literaturi pa so podatki iz zgodnjih kliničnih študij, po katerih so pri odmerkih, ki so bili več kot 20-krat višji od terapevtskega odmerka, poročali o povečanem obsegu mielosupresije, vključno z dolgotrajno nevtropenijo in trombocitopenijo.
English: • Men should not father a child while using Dacogen.
Slovenian: • Moški v času uporabe zdravila Dacogen ne smejo spočeti otroka.
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Slovenian: Za izključitev ILD je treba skrbno spremljati bolnike z akutnim ali nepojasnjenim poslabšanjem pljučnih simptomov.
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.
Slovenian: V 15 minutah po rekonstituciji je treba koncentrat (v 10 ml sterilne vode za injekcije) razredčiti s hladnimi (2 °C - 8 °C) infuzijskimi tekočinami.
English: Therefore, caution should be exercised if these active substances are combined with decitabine.
Slovenian: Pri kombiniranju teh učinkovin z decitabinom je zato potrebna previdnost.
English: It is used in adults.
Slovenian: Zdravilo uporabljamo samo pri odraslih bolnikih.
English: Infuse the reconstituted solution intravenously over 1 hour.
Slovenian: Rekonstituirano raztopino infundirajte intravensko, infuzija pa naj teče 1 uro.
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki pogostnostni skupini so neželeni učinki navedeni po padajoči resnosti.
English: Excipients with known effect Each vial contains 0.5 mmol potassium (E340) and 0.29 mmol sodium (E524).
Slovenian: Pomožne snovi z znanim učinkom Ena viala vsebuje 0,5 mmol kalija (E340) in 0,29 mmol natrija (E524).
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.
Slovenian: Poleg tega manjši obseg rezultatov analize populacijske farmakokinetike kaže, da farmakokinetični parametri niso v večji meri odvisni od koncentracije celotnega bilirubina kljub širokemu razponu koncentracij celotnega bilirubina.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Dacogen.
Slovenian: Če ne veste zagotovo, ali kaj od navedenega velja za vas, se pred uporabo zdravila Dacogen posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: What Dacogen is and what it is used for
Slovenian: Kaj je zdravilo Dacogen in za kaj ga uporabljamo
English: You will have blood tests before you start treatment with Dacogen and at the start of each treatment cycle.
Slovenian: Pred začetkom zdravljenja z zdravilom Dacogen in na začetku vsakega kroga zdravljenja boste opravili krvne preiskave.