FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: Storage of the reconstituted product
Slovenian: Shranjevanje rekonstituiranega zdravila
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Slovenian: V vsakem posameznem primeru je treba pretehtati prednosti zdravljenja glede na možna tveganja za plod.
English: To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.
Slovenian: Za ponovno suspendiranje močno kotalite brizgo med dlanmi, da nastane enotna, motna suspenzija.
English: 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.
Slovenian: 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.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: 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.
Slovenian: Če pride do nepojasnjenega zmanjšanja ravni serumskega hidrogenkarbonata na manj kot 20 mmol/l, je treba odmerek v naslednjem ciklu zmanjšati za 50 %.
English: Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA.
Slovenian: Vgradnja azacitidina v DNA povzroči deaktiviranje metiltransferaz DNA, kar vodi do hipometilacije DNA.
English: • Sleepiness, drowsiness (somnolence).
Slovenian: • zaspanost, dremavost (somnolenca)
English: There are no human data on the effect of azacitidine on fertility.
Slovenian: Ni podatkov o vplivu azacitidina na plodnost pri ljudeh.
English: LIST OF EXCIPIENTS Also contains mannitol.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi manitol.
English: The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
Slovenian: Iz igle pred injiciranjem ne smete iztisniti suspenzije, da zmanjšate pojavnost reakcij na mestu injiciranja.
English: • if you have advanced liver cancer.
Slovenian: • če imate napredovano obliko raka jeter;
English: Adult population aged 65 years or older with AML with > 30% marrow blasts
Slovenian: Odrasla populacija, stara 65 let ali več, z AML z > 30 % blastnih celic v kostnem mozgu
English: Breast-feeding (see section 4.6).
Slovenian: Dojenje (glejte poglavje 4.6).
English: These may be symptoms of having low levels of platelets in your blood.
Slovenian: To so lahko simptomi nizke ravni krvnih ploščic v vaši krvi.
English: Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
Slovenian: Manjši citogenetski odziv je bil statistično značilno (p = 0,0015) višji v skupini z azacitidinom (34 %) v primerjavi s kombinirano skupino CCR (10 %).
English: Infections may be managed with the use of antiinfectives plus growth factor support (e.g. G-CSF) for neutropenia.
Slovenian: Okužbe je mogoče obvladovati z uporabo zdravil, ki preprečujejo okužbe, in s podporo rastnih dejavnikov (npr. G-CSF) za nevtropenijo.
English: For later use
Slovenian: Za kasnejšo uporabo
English: The majority of skin and subcutaneous adverse reactions were associated with the injection site.
Slovenian: Večina neželenih učinkov, povezanih s kožo in podkožjem, se je nanašala na mesto injiciranja.
English: Table 1 below contains adverse reactions associated with azacitidine treatment obtained from the main clinical studies in MDS and AML and post marketing surveillance.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The effect of known cytidine deaminase polymorphisms on azacitidine metabolism has not been formally investigated.
Slovenian: Farmakogenomika Učinka znanih polimorfizmov citidin deaminaze na presnovo azacitidina niso formalno preučevali.
English: Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieved.
Slovenian: Po odstranitvi brizge in igle vialo močno pretresite, dokler ne nastane enotna motna suspenzija.
English: 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).
Slovenian: 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).
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined.
Slovenian: Če v 14 dneh ne pride do obnovitve, je treba določiti celularnost kostnega mozga.
English: A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe.
Slovenian: Novo subkutano iglo (priporočena velikost 25 G) čvrsto pritrdite na brizgo.
English: • White coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums and tonsils (oral fungal infection).
Slovenian: • bele obloge na jeziku, notranji strani lic in včasih na ustnem nebu, dlesnih in mandljih (glivična okužba ust)
English: 5 How to store Vidaza Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Vidaza Vsebina pakiranja in dodatne informacije
English: The median age of the subjects was 75.0 years (range: 64 to 91 years), 75.2% were Caucasian and 59.0% were male.
Slovenian: Mediana starosti preskušancev je bila 75,0 let (razpon: 64 do 91 let), 75,2 % je bilo belcev in 59,0 % je bilo moških.
English: There is no known specific antidote for azacitidine overdose.
Slovenian: Posebnega antidota za prevelik odmerek azacitidina ni.
English: Therefore, based on the assessment of all available information for pericarditis, including spontaneous reports identified in the Safety Topic Review, the already listed ADR of pericardial effusion in the Vidaza SmPC and the fact that pericarditis is a listed term for some other products of the same class, the SmPC section 4.8 should be updated by including the term pericarditis under the SOC cardiac disorders with frequency ‘uncommon'.
Slovenian: Zato je treba na podlagi ocene vseh razpoložljivih podatkov o perikarditisu, vključno s spontanimi poročili, zaznanimi v pregledu varnosti, že navedenim neželenim učinkom - perikardnim izlivom - v povzetku glavnih značilnosti zdravila Vidaza in dejstvom, da je perikarditis kot neželeni učinek že naveden pri določenih drugih zdravilih istega razreda, poglavje 4.8 SmPC posodobiti tako, de se pod organski sistem Srčne bolezni vključi neželeni učinek perikarditis s pogostnostjo „občasni“.
English: Colourless type I glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button, containing 100 mg of azacitidine.
Slovenian: Viala iz brezbarvnega stekla tipa I, z zamaškom iz butil elastomera in aluminijasto zaporko s polipropilenskim plastičnim gumbom, ki vsebuje 100 mg azacitidina.
English: As part of the inclusion criteria, patients were required to have an ECOG performance status of 0-2 and intermediate- or poor-risk cytogenetic abnormalities.
Slovenian: Kot del vključitvenih meril so bolniki morali imeti stanje zmogljivosti po ECOG 0-2 in citogenetske abnormalnosti s srednjim ali velikim tveganjem.
English: If recovery is achieved within 14 days, no dose adjustment is necessary.
Slovenian: Če pride do obnovitve v 14 dneh, ni treba prilagajati odmerka.
English: Azacitidine induced tumours of the haematopoietic system in female mice, when administered intraperitoneally 3 times per week for 52 weeks.
Slovenian: Azacitidin je induciral tumorje krvotvornega sistema pri mišjih samicah, če je bil apliciran 52 tednov intraperitonealno trikrat na teden.
English: • Ulcers of your mouth or tongue.
Slovenian: • razjede v ustih ali na jeziku
English: Winthontlaan 6 N 3526 KV Utrecht Netherlands
Slovenian: Winthontlaan 6 N 3526 KV Utrecht Nizozemska
English: Haematological improvement (major or minor) as determined by the IRC was achieved in 49 % of patients receiving azacitidine compared with 29 % of patients treated with combined CCR (p < 0.0001).
Slovenian: Hematološko izboljšanje (bistveno ali manjše), določeno po IRC, je bilo doseženo pri 49 % bolnikov, ki so prejemali azacitidin, v primerjavi z 29 % bolnikov, ki so bili zdravljeni v kombinirani skupini CCR (p < 0,0001).
English: • Bleeding due to a catheter line.
Slovenian: • krvavitev zaradi žilnega katetra
English: These actions are thought to correct problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Slovenian: Domnevno ti učinki popravijo težave pri dozorevanju in rasti mladih krvničk v kostnem mozgu, ki povzročajo mielodisplastične bolezni, in ubijajo rakaste celice pri levkemiji.
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
English: This medicine will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse.
Slovenian: To zdravilo vam bosta zdravnik ali medicinska sestra dala z injekcijo pod kožo (subkutano).
English: The temperature of the suspension at the time of injection should be approximately 20 ºC-25 ºC.
Slovenian: Temperatura suspenzije ob času injiciranja mora biti približno 20 °C - 25 °C.
English: The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates.
Slovenian: Rekonstituirano zdravilo je homogena, motna suspenzija, ki ne vsebuje aglomeratov.
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential and men have to use effective contraception during and up to 3 months after treatment.
Slovenian: Ženske v rodni dobi / Kontracepcija pri moških in ženskah Ženske v rodni dobi in moški morajo uporabljati zanesljivo kontracepcijo med zdravljenjem in do 3 mesece po zdravljenju.
English: Although no clinically relevant differences in the frequency of adverse reactions were noted between subjects with normal renal function compared to those with renal impairment, patients with renal impairment should be closely monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney (see section 4.2).
Slovenian: Čeprav niso opazili klinično pomembnih razlik v pogostnosti neželenih učinkov pri osebah z normalno ledvično funkcijo v primerjavi s tistimi z okvaro ledvic, je treba bolnike z okvaro ledvic skrbno spremljati zaradi toksičnosti, saj se azacitidin in/ali njegovi presnovki primarno izločajo preko ledvic (glejte poglavje 4.2).
English: For unopened vials of this medicine - there are no special storage conditions.
Slovenian: Za neodprte viale tega zdravila - niso potrebna posebna navodila.
English: Men should not father a child while receiving treatment with Vidaza.
Slovenian: Moški naj med zdravljenjem z zdravilom Vidaza ne zaplodijo otroka.
English: If unexplained elevations in serum creatinine or blood urea nitrogen (BUN) to ≥ 2-fold above baseline values and above upper limit of normal (ULN) occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50 % on the next treatment cycle (see section 4.4).
Slovenian: Če pride do nepojasnjenih zvišanj serumskega kreatinina ali dušika sečnine v krvi (DSK) za ≥ 2-krat nad izhodiščnimi vrednostmi in nad zgornjo mejo normalne vrednosti (ZMN), je treba naslednji cikel preložiti, dokler se vrednosti ne vrnejo na normalne ali izhodiščne, odmerek pa je treba v naslednjem ciklu zdravljenja zmanjšati za 50 % (glejte poglavje 4.4).
English: Administration of azacitidine to male mice prior to mating with untreated female mice resulted in decreased fertility and loss of offspring during subsequent embryonic and postnatal development.
Slovenian: Rezultat dajanja azacitidina mišjim samcem pred parjenjem z nezdravljenimi mišjimi samicami je bil zmanjšana plodnost in smrt mladičev med nadaljnjim embrionalnim in postnatalnim razvojem.
English: BSA value of 1.8 m2 Number of vials required
Slovenian: Celotni odmerek na podlagi vrednosti BSA 1,8 m2
English: Special populations Elderly patients
Slovenian: Posebne skupine Starejši ljudje
English: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
Slovenian: Priporočen začetni odmerek za prvi cikel zdravljenja je za vse bolnike, ne glede na izhodiščne hematološke laboratorijske vrednosti, 75 mg/m2 površine telesa, injicirano subkutano enkrat dnevno 7 dni, ki jim sledi 21-dnevno obdobje mirovanja (28-dnevni cikel zdravljenja).
English: Tell your doctor straight away if you become pregnant during treatment.
Slovenian: Takoj obvestite zdravnika, če med zdravljenjem z zdravilom Vidaza zanosite.
English: The efficacy and safety of Vidaza were studied in an international, multicenter, controlled, open-label, randomised, parallel-group, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system.
Slovenian: Učinkovitost in varnost zdravila Vidaza sta bili preučeni v mednarodni, multicentrični, kontrolirani, odprti, randomizirani primerjalni študiji 3. faze z vzporednimi skupinami (AZA PH GL 2003 CL 001) pri odraslih bolnikih z: MDS z vmesno stopnjo 2 in visoko stopnjo tveganja po Mednarodnem prognostičnem sistemu ocenjevanja (IPSS - International Prognostic Scoring System), refraktorno anemijo s presežkom blastov (RAEB - refractory anaemia with excess blasts), refraktorno anemijo s presežkom blastov v transformaciji (RAEB-T - refractory anaemia with excess blastsin transformation) in modificirano kronično mielomonocitno levkemijo (mKMMoL) po francosko-ameriško-britanskem (FAB - French American British) razvrstitvenem sistemu.
English: Absorption Following subcutaneous administration of a single 75 mg/m2 dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first sampling point).
Slovenian: Absorpcija Po subkutanem dajanju enkratnega odmerka 75 mg/m2 se je azacitidin hitro absorbiral z najvišjimi koncentracijami v plazmi 750 ± 403 ng/ml, ki so se pojavile 0,5 ure po injiciranju (prva točka vzorčenja).
English: Vidaza treatment was associated with a median time to death or transformation to AML of 13.0 months versus 7.6 months for those receiving CCR treatment, an improvement of 5.4 months with a stratified log-rank p-value of 0.0025.
Slovenian: Zdravljenje z zdravilom Vidaza je bilo povezano z mediano časa do smrti ali pretvorbo v AML 13,0 mesecev v primerjavi s 7,6 meseci za bolnike, zdravljene s CCR, kar predstavlja izboljšanje za 5,4 mesece s stratificirano log-rank p-vrednostjo 0,0025.
English: • Chest pain or shortness of breath which may be accompanied with a fever.
Slovenian: • Bolečine v prsih ali kratka sapa, ki jo lahko spremlja zvišana telesna temperatura.
English: • Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion, restlessness or fatigue.
Slovenian: • Otekanje spodnjih udov in stopal, bolečina v križu, zmanjšano izločanje urina, zvečana žeja, pospešen srčni utrip, omedlevica in navzea, bruhanje ali zmanjšan tek in občutki zmedenosti, vznemirjenosti ali utrujenosti.
English: • chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,
Slovenian: • kronično mielomonocitno levkemijo (KMMoL) z 10-29 % blastnih celic kostnega mozga brez mieloproliferativne bolezni,
English: Vidaza works by preventing cancer cells from growing.
Slovenian: Zdravilo Vidaza deluje tako, da rakastim celicam preprečuje rast.
English: Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets ≤ 50.0 x 109/l and/or absolute neutrophil count (ANC) ≤ 1 x 109/l.
Slovenian: Hematološka toksičnost je opredeljena kot najnižje število celic v enem ciklu (najnižja točka), če je število trombocitov ≤ 50,0 x 109/l in/ali je absolutno število nevtrofilcev (ANC - Absolute Neutrophil Count) ≤ 1 x 109/l.
English: Patients should be advised to report oliguria and anuria to the health care provider immediately.
Slovenian: Bolnikom je treba svetovati, naj nemudoma obvestijo svojega zdravstvenega delavca o oliguriji in anuriji.
English: Cardiac disorders pericardial effusion pericarditis
Slovenian: Srčne bolezni perikardialni izliv perikarditis
English: The rubber top should be cleaned and a new syringe with needle inserted into the vial.
Slovenian: Gumijasti pokrovček očistite in v vialo vstavite novo brizgo z iglo.
English: If unexplained reductions in serum bicarbonate (< 20 mmol/L) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).
Slovenian: Če pride do nepojasnjenega znižanja serumskega hidrogenkarbonata (< 20 mmol/l) ali zvišanja serumskega kreatinina ali DSK, je treba odmerek zmanjšati ali uporabo preložiti (glejte poglavje 4.2).
English: No formal clinical drug interaction studies with azacitidine have been conducted.
Slovenian: Formalnih kliničnih študij medsebojnega delovanja zdravil z azacitidinom niso izvedli.
English: Men should be advised not to father a child while receiving treatment and must use effective contraception during and up to 3 months after treatment.
Slovenian: Moške je treba opozoriti, da naj v času zdravljenja ne zaplodijo otroka in morajo med zdravljenjem in do 3 mesece po njem uporabljati zanesljivo kontracepcijo.
English: These adverse reactions were managed symptomatically with anti-emetics for nausea and vomiting; anti-diarrhoeals for diarrhoea, and laxatives and/or stool softeners for constipation.
Slovenian: Ti neželeni učinki so bili zdravljeni simptomatsko z antiemetiki za navzeo in bruhanje; z zdravili proti diareji ter z odvajali in/ali mehčali za blato pri obstipaciji.
English: Cardiac events
Slovenian: Srčni dogodki
English: Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro.
Slovenian: Azacitidin inducira mutacije genov in kromosomske aberacije pri celičnih sistemih bakterij in sesalcev in vitro.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
English: This may be due to an infection of the lung called “pneumonia”, and can be life-threatening.
Slovenian: Vzrok je lahko okužba pljuč, imenovana „pljučnica“, ki je lahko smrtno nevarna.
English: Tumour lysis syndrome
Slovenian: Sindrom tumorske lize
English: Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents.
Slovenian: Poročali so o ledvičnih abnormalnostih, ki segajo od zvišanega serumskega kreatinina do ledvične odpovedi in smrti pri bolnikih, zdravljenih z intravenskim azacitidinom v kombinaciji z drugimi kemoterapevtskimi zdravili.