natgillin/translations-raw huggingface dataset:
Vidaza should be reconstituted with water for injections.
Zdravilo Vidaza je treba rekonstituirati z vodo za injekcije.
• The active substance is azacitidine.
• Učinkovina je azacitidin.
The Vidaza suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Suspenzijo zdravila Vidaza lahko pripravite tik pred uporabo, rekonstituirano suspenzijo morate uporabiti v 45 minutah.
Once the suspension has been prepared it should be administered within 45 minutes.
Ko je suspenzija pripravljena, jo morate uporabiti v 45 minutah.
Recommendations for safe handling
Priporočila za varno ravnanje z zdravilom
muscle spasms, myalgia
mišični spazmi, mialgija
On the basis of the scientific conclusions for azacitidine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing azacitidine is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za azacitidin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) azacitidin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
• if you have ever had a heart condition or heart attack or any history of lung disease.
• če ste kdaj imeli bolezen srca ali srčni infarkt ali bolezen pljuč.
Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents.
Zdravljenje z zdravilom Vidaza mora uvesti in spremljati zdravnik, ki ima izkušnje z uporabo kemoterapevtskih zdravil.
In a few pre-specified subgroups, the OS HR reached statistical significance including patients with poor cytogenetic risk, patients with AML with myelodysplasia-related changes, patients < 75 years, female patients and white patients.
Pri nekaj vnaprej določenih podskupinah je OS HR doseglo statistično signifikantnost, vključno z bolniki z velikim citogenetskim tveganjem, bolniki z AML s spremembami, povezanimi z mielodisplazijo, bolniki, mlajšimi od 75 let, bolnicami ženskega spola in bolniki bele rase.
Total dose (mg) = Dose (mg/m2) x BSA (m2)
Celotni odmerek (mg) = odmerek (mg/m2) x BSA (m2)
• A fall in blood pressure when standing (orthostatic hypotension) leading to dizziness when moving to a standing or sitting position.
• padec krvnega tlaka v stoječem položaju (ortostatska hipotenzija), ki pri premiku v stoječi ali sedeči položaj povzroči omedlevico
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
If reconstituted azacitidine comes into contact with the skin, immediately and thoroughly wash with soap and water.
Če pride rekonstituirani azacitidin v stik s kožo, jo takoj in temeljito sperite z milom in vodo.
If large particles are present in the suspension it should be discarded.
Če so v suspenziji prisotni večji delci, jo zavrzite.
Pharmacotherapeutic group: Antineoplastic agents, pyrimidine analogues; ATC code: L01BC07
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), analogi pirimidinskih baz; oznaka ATC: L01BC07
Vidaza is an anti-cancer agent which belongs to a group of medicines called ‘anti-metabolites'.
Zdravilo Vidaza je sredstvo proti raku, ki pripada skupini zdravil, ki se imenujejo 'antimetaboliti'.
As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Kot del vključitvenih kriterijev so morali imeti bolniki stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 0 do 2.
Pericarditis is the most reported PT (n=35 cases) followed by endocarditis (n=10) and myocarditis (n=9).
Najpogosteje so poročali o perikarditisu (n = 35 primerov), ki mu sledita endokarditis (n = 10) in miokarditis (n = 9).
Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles (see section 4.8).
Zdravljenje z azacitidinom je povezano z anemijo, nevtropenijo in trombocitopenijo, še zlasti v prvih 2 ciklih (glejte poglavje 4.8).
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Bolniki s tveganjem sindroma tumorske lize so bolniki, ki imajo pred zdravljenjem veliko tumorsko breme.
Patients with severe hepatic organ impairment should be carefully monitored for adverse events.
Pri bolnikih s hudo okvaro jeter je treba skrbno spremljati pojav neželenih dogodkov.
Due to retention in the vial and needle, it may not be feasible to withdraw all of the suspension from the vial.
Zaradi zadrževanja v viali in igli morda iz viale ne boste mogli izvleči vse suspenzije.
Azacitidine is cleared rapidly from plasma with a mean elimination half-life (t½) after subcutaneous administration of 41 ± 8 minutes.
Azacitidin se hitro očisti iz plazme s povprečnim razpolovnim časom izločanja (t½) po subkutanem dajanju 41 ± 8 minut.
The relative importance of DNA hypomethylation versus cytotoxicity or other activities of azacitidine to clinical outcomes has not been established.
Relativne pomembnosti hipometilacije DNA v primerjavi s citotoksičnostjo ali drugimi aktivnostmi azacitidina na klinični izid niso ugotavljali.
• acute myeloid leukaemia (AML).
• akutne mieloične levkemije (AML).
Driving and using machines Do not drive or use any tools or machines if you experience side effects, such as tiredness.
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila in ne upravljajte z orodji ali stroji, če imate neželene učinke, na primer, če ste utrujeni.
KEY: AZA = azacitidine; CCR = conventional care regimens; CI = confidence interval;
LEGENDA: AZA = azacitidin; CCR = običajni režimi zdravljenja; IZ = interval zaupanja; RO = razmerje ogroženosti
DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancersuppressing functions to cancer cells.
Hipometilacija DNA aberantnih metiliranih genov, ki sodelujejo pri regulaciji normalnega celičnega cikla, diferenciaciji in poti smrti, lahko povzroči ponovno izražanje genov in obnovo funkcij supresije raka za rakaste celice.
There is limited safety information available with azacitidine in patients ≥85 years (with 14 [5.9%] patients ≥85 years in AZA-AML-001 study).
Na voljo je malo podatkov o varnosti azacitidina pri bolnikih, starih ≥85 let (pri 14 [5,9 %] bolnikih, starih ≥85 let, v študiji AZA-AML-001).
The one-year survival rates were 46.5% in patients receiving Vidaza versus 34.3% in patients receiving CCR.
Pogostnosti enoletnega preživetja sta bili 46,5 % pri bolnikih, ki so prejemali zdravilo Vidaza, proti 34,3 % pri bolnikih, ki so prejemali CCR.
After reconstitution, the suspension should not be filtered.
Po rekonstituciji suspenzije ne smete filtrirati.
Do not filter the suspension after reconstitution since this could remove the active substance.
Ne filtrirajte rekonstituirane suspenzije, ker bi s tem lahko odstranili zdravilno učinkovino.
% Dose in the next cycle, if recovery* is not achieved within 14 days
% odmerka v naslednjem ciklu, če ni obnovitve* v 14 dneh
Dose mg/m2
Odmerek mg/m2
In patients with one or more cytogenetic abnormalities at baseline, the percentage of patients with a major cytogenetic response was similar in the azacitidine and combined CCR groups.
Pri bolnikih z eno ali več citogenetskih abnormalnosti ob izhodišču je bil odstotek bolnikov z bistvenim citogenetskim odzivom podoben v skupini z azacitidinom in v kombinirani skupini CCR.
Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely (see section 5.2).
Klinično značilni zaviralni ali spodbujevalni učinki azacitidina na encime citokroma P450 niso verjetni (glejte poglavje 5.2).
One vial contains 100 mg azacitidine.
Ena viala vsebuje 100 mg azacitidina.
New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Nove injekcije je treba dati vsaj 2,5 cm od prejšnjega mesta injiciranja in nikoli na predel, ki je občutljiv, poškodovan, pordel ali otrdel.
The individual baseline parameters were comparable between the Vidaza and CCR groups.
Posamezni izhodiščni parametri so bili med skupino z zdravilom Vidaza in skupino s CCR primerljivi.
These complications are caused by the product of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heartbeat, seizures, and sometimes death.
Te zaplete povzročijo razgradni produkti odmirajočih rakavih celic in lahko vključujejo: spremembe kemijske sestave krvi; visoke vsebnosti kalija, fosforja, sečne kisline in nizke vsebnosti kalcija, ki posledično vodijo do sprememb delovanja ledvic, utripa srca, epileptičnih napadov in včasih smrt.
It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Domneva se, da deluje tako, da spremeni način, na katerega celica vključuje in izključuje gene, in tudi tako, da ovira nastajanje nove RNK in DNK.
Your doctor, pharmacist or nurse are responsible for storing Vidaza.
Za shranjevanje zdravila Vidaza je odgovoren vaš zdravnik, farmacevt ali medicinska sestra.
No specific modification to the starting dose is recommended for patients with hepatic impairment prior to starting treatment; subsequent dose modifications should be based on haematology laboratory values.
Pri bolnikih z okvaro jeter pred začetkom zdravljenja se ne priporoča posebna prilagoditev začetnega odmerka; kasnejše prilagoditve odmerka naj temeljijo na hematoloških laboratorijskih vrednostih.
Therefore, CYP enzyme induction or inhibition by azacitidine at clinically achievable plasma concentrations is unlikely.
Zato ni verjetno, da bi azacitidin induciral ali zaviral encim CYP pri klinično dosegljivih koncentracijah v plazmi.
In addition, although the study was not powered to demonstrate a statistically significant difference when comparing azacitidine to the preselection CCR treatment groups, the survival of Vidaza treated patients was longer when compared to CCR treatment options BSC alone, low-dose cytarabine plus BSC and were similar when compared to standard intensive chemotherapy plus BSC.
Poleg tega, čeprav študija ni bila zasnovana tako, da bi dokazala statistično signifikantno razliko pri primerjavi azacitidina z vnaprej izbranimi skupinami, zdravljenimi s CCR, je bilo preživetje bolnikov, zdravljenih z zdravilom Vidaza, daljše, ko so jih primerjali z opcijama zdravljenja CCR, samo BSC ali citarabin v majhnem odmerku skupaj z BSC, podobne pa so bile, če so jih primerjali s standardno intenzivno kemoterapijo skupaj z BSC.
None of these adverse reactions led to discontinuation of azacitidine, or reduction of azacitidine dose in the pivotal studies.
Noben od teh neželenih učinkov ni bil vzrok za prekinitev zdravljenja z azacitidinom ali zmanjšanja odmerka azacitidina v osrednjih študijah.
Before giving you Vidaza, your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle.
Preden vam bo zdravnik predpisal zdravilo Vidaza, vam bo predpisal druga zdravila za preprečevanje slabosti in bruhanja na začetku vsakega cikla,.
Azacitidine becomes incorporated into the genetic material of cells (ribonucleic acid (RNA) and deoxyribonucleic acid (DNA)).
Azacitidin se vključi v genetski material celic (ribonukleinsko kislino (RNK) in deoksiribonukleinsko kislino (DNK)).
• Injection site reaction including redness, pain or a skin reaction.
• reakcija na mestu injiciranja, vključno s pordelostjo, bolečino ali kožno reakcijo
Azacitidine can be administered to patients with renal impairment without initial dose adjustment (see section 5.2).
Azacitidin lahko dajemo bolnikom z okvaro ledvic brez začetne prilagoditve odmerka (glejte poglavje 5.2).
What Vidaza is and what it is used for What you need to know before you use Vidaza How to use Vidaza
Kaj je zdravilo Vidaza in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vidaza Kako uporabljati zdravilo Vidaza Možni neželeni učinki
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg
Due to the potential serious adverse reactions in the nursing child, breast-feeding is contraindicated during azacitidine therapy.
Zaradi možnih resnih neželenih učinkov pri dojenih otrocih je dojenje med zdravljenjem z azacitidinom kontraindicirano.
Uncommon Rare
Neznana pogostnost
In case of an anaphylactic-like reaction, treatment with azacitidine should be immediately discontinued and appropriate symptomatic treatment initiated.
V primeru reakcije, podobne anafilaktični, je treba zdravljenje z azacitidinom takoj prekiniti in uvesti ustrezno simptomatsko zdravljenje.
• Bleeding inside your head.
• krvavitev v glavi
In studies to assess inhibition of a series of P450 isoenzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) azacitidine up to 100 μM did not produce inhibition.
V študijah za ocenitev zaviranja vrste izoencimov P450 (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4) azacitidin do 100 µM ni povzročil zaviranja.
The Cox PH model adjusted for pre-specified baseline prognostic factors defined a HR for Vidaza versus CCR of 0.80 (95% CI= 0.66, 0.99; p = 0.0355).
Coxov PH model, prilagojen za vnaprej določene izhodiščne prognostične dejavnike, je definiral HR za zdravilo Vidaza proti CCR 0,80 (95 % IZ= 0,66; 0,99; p = 0,0355).
Vidaza plus BSC (n=241) was compared to CCR.
Zdravilo Vidaza skupaj z BSC (n=241) so primerjali s CCR.
• Allergic (hypersensitivity) reaction.
• alergijska (preobčutljivostna) reakcija
Before starting treatment, male patients should be advised to seek counselling on sperm storage.
Priporoča se, da se moški bolniki pred začetkom zdravljenja posvetujejo o shranitvi sperme.
What Vidaza is and what it is used for
Kaj je zdravilo Vidaza in za kaj ga uporabljamo
The most common serious adverse reactions noted from the pivotal study (AZA PH GL 2003 CL 001) included febrile neutropenia (8.0 %) and anaemia (2.3 %), which were also reported in the supporting studies (CALGB 9221 and CALGB 8921).
Najbolj pogosta resna neželena učinka, opažena v osrednji študiji (AZA PH GL 2003 CL 001), sta bila febrilna nevtropenija (8,0 %) in anemija (2,3 %), o katerih so poročali tudi v podpornih študijah (CALGB 9221 in CALGB 8921).
Storage of the reconstituted product
Shranjevanje rekonstituiranega zdravila
Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.
Večino hematoloških neželenih učinkov so obvladovali z rutinskim spremljanjem kompletne krvne slike in preložitvijo zdravljenja z azacitidinom v naslednji cikel, s profilaktičnim dajanjem antibiotikov in/ali podporo rastnih dejavnikov (npr. G-CSF) za nevtropenijo in s transfuzijami za anemijo ali trombocitopenijo, kot je bilo potrebno.
Although there are some confounding factors, e.g. underlying cancerous conditions of the patients and the presence of other risk factors such as infection and history of cardiac disorders, there are other factors that strengthen this signal, including positive re-challenge, and imbalance in the pooled clinical trials between active and control arms.
Kljub nekaterim motečim dejavnikom, npr. obstoječi rakavi bolezni pri bolnikih in prisotnosti drugih dejavnikov tveganja, kot sta okužba in anamneza srčnih bolezni, obstajajo dejavniki, ki ta signal podpirajo, vključno z vnovičnim pojavom neželenega učinka po ponovni uvedbi zdravljenja ter, neravnovesjem med aktivnimi in kontrolnimi skupinami glede na združen e podatkeiz kliničnih preskušanj.
The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
V vsakem posameznem primeru je treba pretehtati prednosti zdravljenja glede na možna tveganja za plod.
To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.
Za ponovno suspendiranje močno kotalite brizgo med dlanmi, da nastane enotna, motna suspenzija.
Area under the curve and maximum plasma concentration (Cmax) of subcutaneous admiminstration of azacitidine were approximately proportional within the 25 to 100 mg/m2 dose range.
Površina pod krivuljo in najvišja koncentracija v plazmi (Cmax) pri subkutanem dajanju azacitidina sta bili v razponu odmerkov 25 do 100 mg/m2 približno proporcionalni.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
If unexplained reductions in serum bicarbonate levels to less than 20 mmol/l occur, the dose should be reduced by 50 % on the next cycle.
Če pride do nepojasnjenega zmanjšanja ravni serumskega hidrogenkarbonata na manj kot 20 mmol/l, je treba odmerek v naslednjem ciklu zmanjšati za 50 %.
Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA.
Vgradnja azacitidina v DNA povzroči deaktiviranje metiltransferaz DNA, kar vodi do hipometilacije DNA.
• Sleepiness, drowsiness (somnolence).
• zaspanost, dremavost (somnolenca)
There are no human data on the effect of azacitidine on fertility.
Ni podatkov o vplivu azacitidina na plodnost pri ljudeh.
LIST OF EXCIPIENTS Also contains mannitol.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi manitol.
The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
Iz igle pred injiciranjem ne smete iztisniti suspenzije, da zmanjšate pojavnost reakcij na mestu injiciranja.
• if you have advanced liver cancer.
• če imate napredovano obliko raka jeter;
Adult population aged 65 years or older with AML with > 30% marrow blasts
Odrasla populacija, stara 65 let ali več, z AML z > 30 % blastnih celic v kostnem mozgu
Breast-feeding (see section 4.6).
Dojenje (glejte poglavje 4.6).
These may be symptoms of having low levels of platelets in your blood.
To so lahko simptomi nizke ravni krvnih ploščic v vaši krvi.
Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
Manjši citogenetski odziv je bil statistično značilno (p = 0,0015) višji v skupini z azacitidinom (34 %) v primerjavi s kombinirano skupino CCR (10 %).
Infections may be managed with the use of antiinfectives plus growth factor support (e.g. G-CSF) for neutropenia.
Okužbe je mogoče obvladovati z uporabo zdravil, ki preprečujejo okužbe, in s podporo rastnih dejavnikov (npr. G-CSF) za nevtropenijo.
For later use
Za kasnejšo uporabo
The majority of skin and subcutaneous adverse reactions were associated with the injection site.
Večina neželenih učinkov, povezanih s kožo in podkožjem, se je nanašala na mesto injiciranja.
Table 1 below contains adverse reactions associated with azacitidine treatment obtained from the main clinical studies in MDS and AML and post marketing surveillance.
Preglednica 1, spodaj, vključuje neželene učinke, povezane z zdravljenjem z azacitidinom, pridobljene iz glavnih kliničnih študij MDS in AML in iz obdobja spremljanja zdravila na tržišču.
The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration (single 75 mg/m2 doses) was approximately 89% based on area under the curve (AUC).
Absolutna biološka razpoložljivost azacitidina, danega subkutano, v primerjavi z intravensko danim azacitidinom (enkratni odmerki po 75 mg/m2) je bila približno 89 %, na osnovi površine pod krivuljo (AUC - area under the curve).
The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways.
Citotoksični učinki azacitidina morda izvirajo iz več mehanizmov, vključno z zaviranjem sinteze DNA, RNA in beljakovin, vgradnjo v RNA in DNA in aktiviranjem poti poškodovanja DNA.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
Azacitidine can be administered to patients with renal impairment without initial dose adjustment provided these patients are monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney.
Azacitidin lahko bolnikom z okvaro ledvic dajemo brez začetne prilagoditve odmerka pod pogojem, da te bolnike spremljamo zaradi toksičnosti, saj se azacitidin in/ali njegovi presnovki primarno izločajo preko ledvic.
The efficacy and safety of Vidaza was studied in an international, multicentre, controlled, open-label, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Učinkovitost in varnost zdravila Vidaza so proučevali v mednarodni, multicentrični, kontrolirani, odprti študiji 3. faze s paralelnimi skupinami pri bolnikih, starih 65 let ali več, z novo diagnosticirano de novo ali sekundarno AML z >30 % blastnih celic v kostnem mozgu po klasifikaciji SZO, ki niso bili primerni za PKMC.
The effect of known cytidine deaminase polymorphisms on azacitidine metabolism has not been formally investigated.
Farmakogenomika Učinka znanih polimorfizmov citidin deaminaze na presnovo azacitidina niso formalno preučevali.
Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieved.
Po odstranitvi brizge in igle vialo močno pretresite, dokler ne nastane enotna motna suspenzija.
Treatment of male rats resulted in decreased weight of the testes and epididymides, decreased sperm counts, decreased pregnancy rates, an increase in abnormal embryos and increased loss of embryos in mated females (see section 4.4).
Posledica zdravljenja mišjih samcev je bila zmanjšanje teže mod in epididimisov, zmanjšanje števila spermijev, zmanjšana stopnja brejosti podgan, povečanje števila abnormalnih zarodkov in povečana izguba zarodkov pri parjenih samicah (glejte poglavje 4.4).
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščanje serij
However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined.
Če v 14 dneh ne pride do obnovitve, je treba določiti celularnost kostnega mozga.
A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe.
Novo subkutano iglo (priporočena velikost 25 G) čvrsto pritrdite na brizgo.
• White coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums and tonsils (oral fungal infection).
• bele obloge na jeziku, notranji strani lic in včasih na ustnem nebu, dlesnih in mandljih (glivična okužba ust)
5 How to store Vidaza Contents of the pack and other information
5 Shranjevanje zdravila Vidaza Vsebina pakiranja in dodatne informacije
The median age of the subjects was 75.0 years (range: 64 to 91 years), 75.2% were Caucasian and 59.0% were male.
Mediana starosti preskušancev je bila 75,0 let (razpon: 64 do 91 let), 75,2 % je bilo belcev in 59,0 % je bilo moških.
There is no known specific antidote for azacitidine overdose.
Posebnega antidota za prevelik odmerek azacitidina ni.