FrancophonIA/ELRC3.0 huggingface dataset:
English: Contraception in males and females Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with Riximyo.
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom Riximyo in še 12 mesecev po njem uporabljati učinkovita kontracepcijska sredstva.
English: • skin disorders such as itching, hives, and benign lumps
Slovenian: • spremembe razpoloženja, kot sta razdražljivost in depresija, • bolezni kože, kot so srbenje, koprivnica in benigne bule,
English: The recommended dose of Riximyo monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
Slovenian: • Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Riximyo za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
English: Progression-free survival (PFS) Number of patients
Slovenian: Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
English: Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Slovenian: Premedikacija z intravenskimi glukokortikoidi je pomembno znižala incidenco in resnost z infuzijo povezanih reakcij
English: Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev citrat polisorbat 80 natrijev klorid natrijev hidroksid klorovodikova kislina voda za injekcije
English: Riximyo is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Slovenian: Zdravilo Riximyo je bistra, brezbarvna do rumenkasta raztopina.
English: Progression-free survival (PFS) 20.6 Overall survival
Slovenian: log-rank p vrednost preživetje brez napredovanja bolezni (PFS) celokupno preživetje
English: You will always be given Riximyo as a drip (intra-venous infusion).
Slovenian: Zdravilo Riximyo boste dobili v intravenski infuziji.
English: Nausea
Slovenian: Dihala
English: General disorders and administratio n site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edemi
English: Very rare atrial fibrillation, heart failure, myocardial infarction
Slovenian: miokardni infarkt atrijska undulacija
English: Table 13 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Slovenian: Popolna remisija po 6 mesecih glede na stanje bolezni Rituksimab
English: Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
Slovenian: Med drugimi simptomi so bili pordevanje, angioedem, bronhospazem, bruhanje, navzea, urtikarija/izpuščaj,
English: You may be asked not to take these other medicines 12 hours before you are given Riximyo.
Slovenian: 12 ur, preden boste dobili zdravilo Riximyo.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti po posegih z infundiranjem povezane reakcije*
English: Treatment with Riximyo uses four separate infusions given at weekly intervals.
Slovenian: c) Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa Zdravljenje z zdravilom Riximyo obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
English: Hypercholestero lemia
Slovenian: Folikularni limfom
English: Patient subpopulations - rituximab combination therapy
Slovenian: Podskupine bolnikov - kombinirano zdravljenje z rituksimabom Starejši bolniki (≥ 65 let)
English: Neutropenia , leucopenia, +febrile neutropenia, +thrombocyt openia
Slovenian: prehladni sindrom, +utrujenost, +drgetanje,
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Riximyo Vsebina pakiranja in dodatne informacije
English: Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Slovenian: Zdravilo Riximyo je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
English: • Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Slovenian: Za indikacije ne-Hodgkinovega limfoma (NHL) in kronične levkocitne levkemije (KLL):
English: Neutropenia1
Slovenian: Neželeni učinek1
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Slovenian: Celokupen odgovor pri bolnikih, pri katerih je prišlo do ponovitve bolezni, je bil boljši pri bolnikih, občutljivih za kemoterapijo (50 %), kot pa pri bolnikih, neodzivnih na kemoterapijo (opredeljeno kot trajanje odgovora < 3 mesece) (22 %).
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalne ga prostora bronhospaze m4, bolezen dihal,
English: pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Slovenian: utrujenost, glavobol, draženje žrela, rinitis, srbenje, bolečina, tahikardija, hipertenzija, hipotenzija,
English: Transient increase in serum IgM levels3
Slovenian: Preiskave zmanjšane koncentracije IgM4
English: Patients with a history of a serious infusion reaction to a biologic therapy for RA were excluded from entry.
Slovenian: Bolniki, ki so imeli v anamnezi resno reakcijo, povezano z infuzijo,
English: Hearing loss5
Slovenian: bolečine v ušesu izguba sluha5
English: Adverse event
Slovenian: Občasni
English: Repeated treatment courses with Riximyo are possible.
Slovenian: Med zdravljenjem z zdravilom Riximyo ne smete dojiti.
English: If this happens, do not drive or use any tools or machines.
Slovenian: Če pride do tega, ne vozite in ne uporabljajte zahtevnih orodij in strojev.
English: Date of first authorisation: 20 September 2012 Date of latest renewal: 22 May 2017
Slovenian: Datum prve odobritve: 20 september 2012 Datum zadnjega podaljšanja: 22. maj 2017
English: * Includes events with a fatal outcome.
Slovenian: * vključuje dogodke s smrtnim izidom
English: 95% confidence intervals
Slovenian: 95-odstotni interval zaupanja
English: This is called a ‘treatment cycle' and it is repeated every 4 weeks.
Slovenian: To se imenuje "krog zdravljenja" in se ponovi vsake 4 tedne.
English: Dose reduction is not recommended.
Slovenian: Zmanjšanje odmerka ni priporočeno.
English: • you have enough blood cells, and
Slovenian: • ali imate dovolj krvnih celic in
English: You will usually receive at least 4 treatment cycles.
Slovenian: Običajno boste prejeli najmanj 4 kroge zdravljenja.
English: Unopened vial 3 years.
Slovenian: Zaprta viala 3 leta
English: These tests are to check that:
Slovenian: S temi preiskavami bo zdravnik preveril:
English: Talk to your doctor about what your blood test results mean.
Slovenian: Z zdravnikom se pogovorite o pomenu rezultatov krvnih preiskav.
English: Cmax (ng/ml) AUCcum (ng.h/ml) t1/2 (min)
Slovenian: Cmax (ng/ml) AUCkum (ng.h/ml) t1/2 (min)
English: Overall survival (ITT population).
Slovenian: Celokupno preživetje (ITT populacija)
English: • You will receive Dacogen every day for 5 days, then 3 weeks without the medicine.
Slovenian: • Zdravilo Dacogen boste 5 dni prejemali vsak dan, nato pa boste 3 tedne brez zdravila.
English: This is a type of cancer that affects your blood cells.
Slovenian: To je vrsta raka, ki prizadene krvne celice.
English: All subjects discontinued the study treatment.
Slovenian: Vsi preiskovanci so prekinili študijsko zdravljenje.
English: • Women must use effective contraception during treatment.
Slovenian: • Ženske morajo uporabljati učinkovito kontracepcijo v času zdravljenja.
English: Tests or checks
Slovenian: Preiskave oziroma pregledi
English: From a microbiological point of view, the product should be used within the time period recommended above.
Slovenian: Z mikrobiološkega vidika je treba zdravilo uporabiti v priporočenem roku, kot je navedeno zgoraj.
English: Results from a mass balance study with radioactive
Slovenian: Rezultati študije masnega ravnovesja z radioaktivno označenim
English: Children and adolescents Dacogen is not for use in children or adolescents under the age of 18.
Slovenian: Otroci in mladostniki Zdravilo Dacogen ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let.
English: • high level of sugar in the blood
Slovenian: • visoke koncentracije sladkorja v krvi
English: Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: Mednje sodijo tudi zdravila, ki ste jih dobili brez recepta in zeliščna zdravila.
English: Table 2: Other efficacy endpoints for Study DACO-016 (ITT population)
Slovenian: Preglednica 2: Drugi cilji opazovanja učinkovitosti v študiji DACO-016 (populacija ITT)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES, invseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov okužbe in jih takoj zdraviti.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
English: • other infection in any part of the body, caused by bacteria, virus or fungi
Slovenian: • druge okužbe kjer koli na telesu, povzročene z bakterijami, virusi ali glivicami
English: The powder should be aseptically reconstituted with 10 ml of water for injections.
Slovenian: Prašek je treba aseptično rekonstituirati z 10 ml vode za injekcije.
English: • if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na decitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: There is no direct experience of human overdose and no specific antidote.
Slovenian: S prevelikim odmerjanjem pri ljudeh ni nobenih neposrednih izkušenj, prav tako ne obstaja specifičen antidot.
English: Evidence from the literature indicates that decitabine has carcinogenic potential.
Slovenian: Podatki iz literature kažejo, da ima decitabin kancerogeni potencial.
English: Enterocolitis may lead to septic complications and may be associated with fatal outcome.
Slovenian: Enterokolitis lahko vodi v septične zaplete in je lahko povezan s smrtnim izidom.
English: It is the responsibility of the user to follow the recommended storage times and conditions and ensure that reconstitution has taken place in aseptic conditions.
Slovenian: Uporabnik je sam odgovoren za ravnanje z zdravilom v skladu s priporočenimi časovnimi roki in pogoji shranjevanja in za zagotavljanje rekonstitucije v aseptičnih pogojih.
English: • Febrile neutropaenia (temperature ≥ 38.5°C and absolute neutrophil count < 1,000/µL)
Slovenian: • febrilna nevtropenija (temperatura ≥ 38,5°C in absolutno število nevtrofilcev < 1.000/µl),
English: • an infection,
Slovenian: • okužbo,
English: Dacogen will be given to you by a doctor or nurse who is trained in giving this type of medicine.
Slovenian: Zdravilo Dacogen vam bosta dala zdravnik ali medicinska sestra, ki sta usposobljena za dajanje tovrstnih zdravil.
English: • Talk to your doctor if you wish to freeze your eggs before starting treatment.
Slovenian: • Pogovorite se z zdravnikom, če bi radi pred začetkom zdravljenja zamrznili jajčeca.
English: • Men should use effective contraception during treatment and for up to 3 months after treatment has stopped.
Slovenian: • Moški morajo uporabljati učinkovito kontracepcijo v času zdravljenja in do 3 mesece po zaključku zdravljenja.
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.
Slovenian: V kliničnih študijah AML in mielodisplastičnega sindroma (MDS) je bila pogostnost poročanja hiperbilirubinemije 11% za vse stopnje in 2% za stopnji 3-4.
English: Do not use Dacogen:
Slovenian: Ne uporabljajte zdravila Dacogen:
English: Results from the human mass-balance study showed that unchanged decitabine in plasma accounted for approximately 2.4% of total radioactivity in plasma.
Slovenian: Rezultati študije masnega ravnovesja pri ljudeh so pokazali, da je nespremenjen decitabin v plazmi prispeval približno 2,4% celotne radioaktivnosti v plazmi.
English: In the Dacogen treatment group, there was a higher incidence of treatment discontinuation due to adverse events in women compared to men (43% versus 32%).
Slovenian: V skupini, ki je prejemala zdravilo Dacogen, je bila pojavnost prekinitve zdravljenja zaradi neželenih učinkov večja pri ženskah kot pri moških (43% proti 32%).
English: Reported adverse events were consistent with the known safety profile of Dacogen in adults (see section 4.8).
Slovenian: Poročani neželeni učinki so se ujemali z znanim varnostnim profilom zdravila Dacogen pri odraslih (glejte poglavje 4.8).
English: NA = Not applicable
Slovenian: NA = navedba ni smiselna
English: If you are given more Dacogen than you should
Slovenian: Če prejmete več zdravila Dacogen, kot bi smeli
English: These may be signs of bleeding inside your head (common).
Slovenian: To so lahko znaki krvavitve v glavi (pogosto).
English: Twenty-five percent of subjects had an ECOG performance status ≥ 2.
Slovenian: Petindvajset odstotkov preiskovancev je imelo ocenjeno stanje zmogljivosti po lestvici ECOG ≥ 2.
English: Therefore, patients are at increased risk for severe infections (due to any pathogen such as bacterial, fungal and viral), with potentially fatal outcome (see section 4.8).
Slovenian: Zato je pri teh bolnikih povečano tveganje za hude okužbe (zaradi katerega koli patogena kot so bakterije, glive ali virusi) z možnim smrtnim izidom (glejte poglavje 4.8).
English: • high level of ‘bilirubin' in the blood
Slovenian: • povečana koncentracija ‘bilirubina' v krvi
English: Dacogen has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Dacogen ima zmeren vpliv na sposobnost vožnje ali upravljanja strojev.
English: The use of decitabine with hormonal contraceptives has not been studied.
Slovenian: Uporabe decitabina s hormonskimi kontraceptivi niso proučevali.
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).
Slovenian: Zdravljenje z zdravilom Dacogen je mogoče nadaljevati, ko se stanje glede navedenih zapletov izboljša ali stabilizira z ustreznim zdravljenjem (antiinfektivna zdravila, transfuzije, rastni faktorji).
English: Studies have shown that decitabine is teratogenic in rats and mice (see section 5.3).
Slovenian: Rezultati študij kažejo teratogeno delovanje decitabina pri podganah in miših (glejte poglavje 5.3).
English: • your liver and kidneys are working properly.
Slovenian: • ali je delovanje vaših jeter in ledvic primerno.
English: There was no evidence of dependencies on age, creatinine clearance, total bilirubin, or disease.
Slovenian: Ni dokazov, da bi šlo pri tem za kakršnokoli odvisnost od starosti bolnika, očistka kreatinina, celotnega bilirubina ali bolezni.
English: No new safety signal was observed in this paediatric study.
Slovenian: V tej pediatrični študiji niso opazili nobenih novih znakov glede varnosti zdravila.
English: Percent of Subjects Alive
Slovenian: odstotek živih preiskovancev
English: If ILD is confirmed, appropriate treatment should be initiated (see section 4.8).
Slovenian: Če je ILD potrjena, je treba uvesti ustrezno zdravljenje (glejte poglavje 4.8)
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.
Slovenian: Bolniki z anamnezo hudega kongestivnega srčnega popuščanja ali s klinično nestabilno boleznijo srca niso bili vključeni v klinične študije, zato varnost in učinkovitost uporabe zdravila Dacogen pri teh bolnikih nista ugotovljeni.
English: The adverse drug reactions are listed by frequency category.
Slovenian: Neželeni učinki zdravila so našteti po kategorijah pogostnosti.
English: Plasma protein binding of decitabine is negligible (< 1%).
Slovenian: Vezava decitabina na proteine v plazmi je zanemarljiva (< 1%).
English: In each study, decitabine PK was evaluated on the fifth day of the first treatment cycle.
Slovenian: V vsaki od teh študij so farmakokinetične lastnosti decitabina ocenjevali 5. dan prvega kroga zdravljenja.
English: It is not known whether decitabine or its metabolites are excreted in breast milk.
Slovenian: Ni znano, ali se decitabin oziroma njegovi presnovki izločajo v materino mleko.
English: It contains the active substance ‘decitabine'.
Slovenian: Vsebuje učinkovino "decitabin".
English: Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Slovenian: Rutinska uporaba premedikacije za preprečevanje navzee in bruhanja se ne priporoča, po potrebi pa jo je mogoče uporabiti.
English: The reasons for treatment discontinuation included disease progression (12 [70.6%] subjects), subjects proceeding to transplant (3 [17.6%]), investigator decision (1 [5.9%]), and “other” (1 [5.9%]).
Slovenian: Med razlogi za prekinitev zdravljenja so bili med drugim napredovanje bolezni (12 preiskovancev [70,6%]), nadaljevanje zdravljenja s presaditvijo (3 preiskovanci [17,6%]), odločitev raziskovalca (1 preiskovanec [5,9%]) in “drugo” (1 preiskovanec [5,9%]).
English: • The dose is 20 mg/m2 body surface area.
Slovenian: • Ustrezen odmerek je 20 mg/m2 telesne površine.
English: For situations where decitabine administration should be delayed, see section 4.2.
Slovenian: Za primere, v katerih je treba odmerjanje decitabina odložiti, glejte poglavje 4.2.
English: The median time to CR was 4.1 months, and the median duration of CR was 18.2 months.
Slovenian: Mediani čas do popolne remisije je znašal 4,1 meseca, mediano trajanje popolne remisije pa 18,2 meseca.
English: Complications of myelosuppression include infections and bleeding.
Slovenian: Zapleti mielosupresije vključujejo okužbe in krvavitve.
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.
Slovenian: Glede na rezultate študij na živalih in mehanizem delovanja se zdravila Dacogen ne sme uporabljati med nosečnostjo in pri ženskah, ki so v rodni dobi in ne uporabljajo učinkovite kontracepcije.
English: Vdss (L)
Slovenian: Vdss (l) očistek (l/h)
English: White to almost white lyophilized powder.
Slovenian: bel do skoraj bel liofiliziran prašek
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.
Slovenian: Decitabin (5-aza-2-deoksicitidin) je analog citidinskega deoksinukleozida, ki v nizkih odmerkih selektivno zavira DNA metiltransferaze in s tem povzroča hipometilacijo promotorjev genov, kar lahko omogoči reaktivacijo tumor zaviralnih genov, sproži celično diferenciacijo ali staranje celic, čemur sledi programirana celična smrt.
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).
Slovenian: do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Decitabine administration to neonatal/juvenile rats showed a comparable general toxicity profile as in older rats.
Slovenian: Pri odmerjanju decitabina neonatalnim/juvenilnim podganam je bil splošni profil toksičnega delovanja podoben kot pri starejših podganah.
English: The difference did not reach statistical significance, however, there was a trend for improvement in survival with a 15% reduction in the risk of death for subjects in the Dacogen arm (Figure 1).
Slovenian: Razlika ni dosegla statistične značilnosti, vendar podatki kažejo trend izboljševanja preživetja s 15-odstotnim zmanjšanjem tveganja za smrt v skupini bolnikov, ki so prejemali zdravilo Dacogen (slika 1).
English: The median age for the intent-to-treat (ITT) population was 73 years (range 64 to 91 years).
Slovenian: V populaciji z namenom zdravljenja (intent-to-treat, ITT) je znašala mediana starost bolnikov 73 let (od 64 do 91 let).
English: These results as well as other endpoints are shown in Table 2.
Slovenian: Ti rezultati so prikazani v preglednici 2, kjer so prikazani tudi drugi cilji opazovanja.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues; ATC Code: L01BC08
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci celične presnove (antimetaboliti), analogi pirimidinskih baz, oznaka ATC: L01BC08
English: This medicine will be given by your doctor or nurse.
Slovenian: To zdravilo vam bosta odmerjala zdravnik in medicinska sestra.
English: Other medicines and Dacogen
Slovenian: Druga zdravila in zdravilo Dacogen
English: This is because Dacogen can affect the way some other medicines work.
Slovenian: To je pomembno zato, ker zdravilo Dacogen lahko vpliva na delovanje nekaterih drugih zdravil, pa tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Dacogen.
English: If a dose is missed, treatment should be resumed as soon as possible.
Slovenian: V primeru izpuščenega odmerka je treba z zdravljenjem nadaljevati čimprej.
English: There are no adequate data on the use of Dacogen in pregnant women.
Slovenian: O uporabi zdravila Dacogen pri nosečnicah ni zadostnih podatkov.
English: • Talk to your doctor if you wish to conserve your sperm before starting treatment.
Slovenian: • Pogovorite se z zdravnikom, če bi radi pred začetkom zdravljenja shranili spermo.
English: Dacogen should not be used in children with AML aged < 18 years, because efficacy was not established.
Slovenian: Zdravila Dacogen se ne sme uporabljati pri otrocih z AML, starih < 18 let, ker učinkovitost ni bila dokazana.