natgillin/translations-raw huggingface dataset:
Vidaza treatment improved peripheral blood counts and led to a reduced need for RBC and platelet transfusions.
Zdravljenje z zdravilom Vidaza je izboljšalo periferno krvno sliko in zmanjšalo potrebo po transfuzijah eritrocitov in trombocitov.
Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin < 30 g/L.
Med zdravljenjem z azacitidinom so poročali o progresivni jetrni komi in smrti bolnikov z razširjeno tumorsko boleznijo zaradi metastatskega obolenja, še zlasti pri bolnikih z izhodiščnim serumskim albuminom < 30 g/l.
• if you have liver disease.
• če imate bolezen ledvic;
After reconstitution each mL of suspension will contain 25 mg of azacitidine (100 mg/4 mL).
Po rekonstituciji bo vsak ml suspenzije vseboval 25 mg azacitidina (100 mg/4 ml).
Studies in mice have shown reproductive toxicity (see section 5.3).
Študije na miših so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• Painless swelling in the finger tips (clubbing).
• neboleča oteklina konic prstov (kladivasti prsti)
Recovery* > 21 days *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Following dose modifications, the cycle duration should return to 28 days.
Obnovitev* > 21 dni *Obnovitev = število ≥ število v najnižji točki + (0,5 x [izhodiščno število - število v najnižji točki]) Po spremembi odmerka mora biti dolžina cikla ponovno 28 dni.
In the ITT analysis of 488 patients (241 Vidaza and 247 CCR), Vidaza treatment was associated with a median survival of 10.4 months versus 6.5 months for those receiving CCR treatment, a difference of 3.8 months, with a stratified log-rank p-value of 0.1009 (two- sided).
V analizi ITT 488 bolnikov (241 zdravilo Vidaza in 247 CCR) je bilo zdravljenje z zdravilom Vidaza povezano z medianim preživetjem 10,4 meseca proti 6,5 meseca pri tistih, ki so prejemali zdravljenje CCR, kar je razlika 3,8 meseca, s stratificirano log-rank vrednostjo p 0,1009 (dvostransko).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children.
subkutana uporaba POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
No accumulation occurs after subcutaneous administration of 75 mg/m2 azacitidine once daily for 7 days.
Po 7-dnevnem subkutanem dajanju 75 mg/m2 azacitidina enkrat na dan ne pride do kopičenja.
• Fluid around the lungs (pleural effusion).
• tekočina okrog pljuč (plevralni izliv)
Overall response rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]) as determined by the IRC was 27.8% in the Vidaza group and 25.1% in the combined CCR group (p = 0.5384).
Stopnja celokupnega odziva (popolna remisija [CR] + popolna remisija z nepopolnim okrevanjem krvne slike [CRi]), ki jo je ugotovil IRC, je bila v skupini z zdravilom Vidaza 27,8 %, v skupini s kombiniranim CCR pa 25,1 % (p = 0,5384).
You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle').
Pred začetkom zdravljenja z zdravilom Vidaza in ob začetku vsakega obdobja zdravljenja (imenovanega ‘cikel') boste opravili preglede krvi.
• An infection of the nose and throat, or sore throat.
• okužba nosu in žrela ali vneto žrelo
The needle of the syringe containing the 4 mL of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
Iglo brizge, ki vsebuje 4 ml vode za injekcije, vstavite skozi gumijast pokrovček viale z azacitidinom in v vialo počasi injicirajte vodo za injekcije.
Overall response (complete remission [CR] + partial remission [PR]) as determined by the investigator was 29 % in the azacitidine group and 12% in the combined CCR group (p = 0.0001).
Celokupni odziv (popolna remisija [CR] + delna remisija [PR]), ki ga je ugotovil raziskovalec, je bil 29 % v skupini z azacitidinom in 12 % v kombinirani skupini CCR (p = 0,0001).
Blood test
Krvne preiskave
Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions.
Zdravilo Vidaza je citotoksično zdravilo, zato je pri rokovanju s suspenzijo azacitidina in njeno pripravo potrebna previdnost, kot pri drugih potencialno toksičnih sestavinah.
Other serious adverse reactions from these 3 studies included infections such as neutropenic sepsis (0.8%) and pneumonia (2.5%) (some with fatal outcome), thrombocytopenia (3.5%), hypersensitivity reactions (0.25%) and haemorrhagic events (e.g. cerebral haemorrhage [0.5%], gastrointestinal haemorrhage [0.8%] and intracranial haemorrhage
Drugi resni neželeni učinki v teh 3 študijah so zajemali okužbe, na primer nevtropenično sepso (0,8 %) in pljučnico (2,5 %) (nekatere s smrtnim izidom), trombocitopenijo (3,5 %), preobčutljivostne reakcije (0,25 %) in hemoragične dogodke (npr. možganska krvavitev [0,5 %], gastrointestinalna krvavitev [0,8 %] in intrakranialna krvavitev [0,5 %]).
Vascular disorders hypotension*, hypertension, orthostatic hypotension, haematoma
Žilne bolezni hipotenzija*, hipertenzija, ortostatska hipotenzija, hematom
INSTRUCTIONS ON USE
Navodilo za uporabo
It is unknown whether azacitidine/metabolites are excreted in human milk.
Ni znano, ali se presnovki azacitidina izločajo v materino mleko.
Reconstitution procedure
Postopek rekonstitucije
Reconstituted suspension For storage conditions after reconstitution of the medicinal product, see section 6.3.
Rekonstituirana suspenzija Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
What Vidaza looks like and contents of the pack Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
Izgled zdravila Vidaza in vsebina pakiranja Zdravilo Vidaza je bel prašek za suspenzijo za injiciranje, ki je na voljo v stekleni viali, ki vsebuje 100 mg azacitidina.
Patients were pre-selected by their physician to 1 of the 3 CCR prior to randomisation.
Bolnike je pred naključno razvrstitvijo vnaprej izbral njihov zdravnik v eno od treh skupin CCR.
Azacitidine undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase.
Azacitidin se spontano hidrolizira in deaminira s citidin deaminazo.
This could be due to an infection as a result of having low levels of white blood cells, which can be life-threatening.
Vzrok bi lahko bila okužba kot posledica nizke ravni levkocitov, ki je lahko smrtno nevarna.
Recent data from a clinical trial in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with azacitidine (see section 4.8).
Novejši podatki iz kliničnih preskušanj pri bolnikih z znano anamnezo kardiovaskularnih ali pljučnih bolezni so pokazali značilno povišano incidenco srčnih dogodkov z azacitidinom (glejte poglavje 4.8).
In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), Vidaza treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001.
V analizi skupine 358 bolnikov ITT (179 azacitidin in 179 CCR), je bilo zdravljenje z zdravilom Vidaza povezano z mediano preživetja 24,46 mesecev v primerjavi s 15,02 meseca v skupini, zdravljeni s CCR, kar predstavlja 9,4 mesecev razlike, s stratificirano log-rank p-vrednostjo 0,0001.
Infections and infestations pneumonia* (including bacterial, viral and fungal), nasopharyngitis sepsis* (including bacterial, viral and fungal), neutropenic sepsis*, respiratory tract infection (includes upper and bronchitis), urinary tract infection, cellulitis, diverticulitis, oral fungal infection, sinusitis, pharyngitis, rhinitis, herpes simplex, skin infection necrotising fasciitis *
Infekcijske in parazitske bolezni pljučnica* (vključno z bakterijsko, virusno in glivično), nazofaringitis sepsa* (vključno z bakterijsko, virusno in glivično), nevtropenična sepsa*, okužbe dihalnih poti (vključujejo zgornja dihala in bronhitis), okužba sečil, celulitis, divertikulitis, glivična okužba ust, sinuzitis, faringitis, rinitis, herpes simpleks, okužba kože nekrotizant ni fasciitis*
Skin and subcutaneous tissue disorders petechiae, pruritus (includes generalized), rash, ecchymosis purpura, alopecia, urticaria, erythema, rash macular acute febrile neutrophilic dermatosis, pyoderma gangrenosum
Bolezni kože in podkožja petehija, pruritus (vključuje generalizirani pruritus), osip, ehimoza purpura, alopecija, urtikarija, eritem, makulozni osip akutna febrilna nevtrofilna dermatoza, gangrenozna pioderma
Patients should be advised to promptly report febrile episodes.
Bolnike je treba opozoriti, da morajo takoj poročati primere zvišane telesne temperature.
It may be given under the skin on your thigh, tummy or upper arm.
Zdravilo se lahko daje pod kožo v stegno, trebuh ali nadlaket.
Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90° angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Rekonstituirano zdravilo Vidaza injicirajte subkutano (iglo vstavite pod kotom 45-90°) z iglo velikosti 25 G v nadlaket, stegno ali trebuh.
In patients who achieved CR or CRi, the median duration of remission was 10.4 months (95% CI = 7.2, 15.2) for the Vidaza subjects and 12.3 months (95% CI = 9.0, 17.0) for the CCR subjects.
Pri bolnikih, ki so dosegli CR ali CRi, je bilo mediano trajanje remisije 10,4 meseca (95 % IZ = 7,2; 15,2) pri preskušancih z zdravilom Vidaza in 12,3 meseca (95 % IZ = 9,0; 17,0) pri preskušancih s CCR.
Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle, see also section 4.8.
Kompletno krvno sliko je treba pridobiti pred začetkom zdravljenja in po potrebi za spremljanje odziva in toksičnosti, najmanj pa pred vsakim ciklom zdravljenja, glejte tudi poglavje 4.8.
Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively,
Po intravenskem in subkutanem dajanju 14C-azacitidina so zaznali 85 % oziroma 50 % radioaktivnosti v urinu in le < 1 % v blatu.
Foetal abnormalities during organogenesis in rats included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly) and others (microphthalmia, micrognathia, gastroschisis, oedema, and rib abnormalities).
Abnormalnosti plodov med organogenezo pri podganah so zajemale: anomalije osrednjega živčnega sistema (eksencefalija/encefalokela), anomalije okončin (mikromelija, čolničasto stopalo, sindaktilija, oligodaktilija) in druge (mikroftalmija, mikrognatija, gastroshiza, edem in abnormalnosti reber).
Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Zdravilo Vidaza je indicirano za zdravljenje odraslih bolnikov, ki niso primerni za presaditev krvotvornih matičnih celic (PKMC) s/z:
Patients received the pre-selected regimen if not randomised to Vidaza.
Bolniki so prejemali vnaprej izbrano shemo zdravljenja, če niso bili naključno razvrščeni na zdravilo Vidaza.
Complete blood counts should be performed as needed to monitor response and toxicity, but at least prior to each treatment cycle.
Kompletno krvno sliko je treba pridobiti po potrebi za spremljanje odziva in toksičnosti, toda vsaj pred vsakim ciklom zdravljenja.
Adult population with MDS, CMML and AML (20-30% marrow blasts)
Odrasla populacija z MDS, CMML in AML (20-30 % blastnih celic v kostnem mozgu)
In all pre- specified subgroups age [(< 75 years & ≥ 75 years), gender, race, ECOG performance status (0 or 1 & 2) , baseline cytogenetic risk (intermediate & poor) , geographic region, WHO classification of AML (including AML with myelodysplasia-related changes), baseline WBC count (≤ 5 x109/L & >5 x 109/L), baseline bone marrow blasts (≤ 50% & > 50%) and prior history of MDS] there was a trend in OS benefit in favour of Vidaza.
V vseh vnaprej določenih podskupinah po starosti[(< 75 let & ≥ 75 let), spolu, rasi, stanju zmogljivosti po ECOG (0 ali 1 & 2), izhodiščnem citogenetskem tveganju (srednje & veliko), zemljepisnem območju, razvrstitvi AML po klasifikaciji SZO (vključno z AML s spremembami, povezanimi z mielodisplazijo), izhodiščnim številom belih krvničk (≤ 5 x109/l & >5 x 109/l), izhodiščnimi blastnimi celicami v kostnem mozgu (≤ 50 % & > 50 %) in prejšnjo anamnezo MDS] se je pokazala tendenca v korist celokupnemu preživetju (OS) v prid zdravila Vidaza.
Storage of the reconstituted product For storage conditions after reconstitution of the medicinal product, see section 6.3.
Shranjevanje rekonstituiranega zdravila Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
Vidaza was administered at a subcutaneous dose of 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle) for a median of 9 cycles (range = 1-39) and a mean of 10.2 cycles.
Bolniki so zdravilo Vidaza prejemali kot subkutani odmerek 75 mg/m2 dnevno 7 dni, ki jim je sledilo 21-dnevno obdobje mirovanja (28-dnevni cikel zdravljenja), z mediano 9 ciklov (razpon = 1-39) in povprečjem 10,2 ciklov.
The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 °C - 25 °C).
Pred uporabo pustite suspenzijo do 30 minut, da se segreje na sobno temperaturo (20 °C - 25 °C).
Renal impairment has no major effect on the pharmacokinetic exposure of azacitidine after single and multiple subcutaneous administrations.
Okvara ledvic po enkratnem in večkratnem subkutanem dajanju nima večjega vpliva na farmakokinetično izpostavljenost azacitidinu.
CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25).
CCR so obsegali samo BSC (n = 105), nizek odmerek citarabina in BSC (n = 49) ali standardno indukcijsko kemoterapijo in BSC (n = 25).
A survival benefit was also demonstrated in patients that had not achieved a complete/partial response following azacitidine treatment.
Tudi pri bolnikih, kjer ni bil dosežen popolni/delni odziv po zdravljenju z azacitidinom, je bilo dokazano izboljšanje preživetja.
Data from a clinical trial allowing enrolment of patients with known history of cardiovascular or pulmonary disease showed a statistically significant increase in cardiac events in patients with newly diagnosed AML treated with azacitidine (see section 4.4).
Podatki iz kliničnega preskušanja, v katerega so se lahko vključili bolniki z znano anamnezo kardiovaskularnih ali pljučnih bolezni, so pokazali statistično značilno zvišanje srčnih dogodkov pri bolnikih z na novo diagnosticirano AML, zdravljenih z azacitidinom (glejte poglavje 4.4).
Bleeding
Krvavitve
Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding inside your head.
Lahko opazite kri v blatu zaradi krvavitev v trebuhu ali prebavilih, možna je tudi krvavitev v glavi.
The survival benefits of Vidaza were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
Izboljšanje preživetja z zdravilom Vidaza je bilo dosledno, ne glede na izbrano skupino CCR (samo BSC, nizek odmerek citarabina plus BSC ali standardna indukcijska kemoterapija plus BSC) v kontrolni skupini.
After reconstitution with 4 mL of water for injections, the reconstituted suspension contains 25 mg/mL azacitidine.
Po rekonstituciji s 4 ml vode za injekcije vsebuje rekonstituirana suspenzija 25 mg/ml azacitidina.
Investigations weight decreased * = rarely fatal cases have been reported
Preiskave zmanjšanje telesne mase *= redko so poročali o smrtnih primerih Opis izbranih neželenih učinkov
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20 °C-25 °C.
Brizgo, napolnjeno z rekonstituirano suspenzijo, lahko pustite do 30 minut pred uporabo, da doseže temperaturo približno 20 °C - 25 °C.
When Vidaza is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25 °C for 45 minutes and at 2 °C to 8 °C for 8 hours.
Pri rekonstituciji zdravila Vidaza z vodo za injekcije, ki ni bila v hladilniku, je rekonstituirano zdravilo kemijsko in fizikalno stabilno 45 minut pri 25 °C in 8 ur pri 2 °C do 8 °C.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• AML with >30% marrow blasts according to the WHO classification.
• AML z >30 % blastnih celic v kostnem mozgu po razvrstitvi SZO.
Other less frequently reported serious adverse reactions in the azacitidine treatment arm included sepsis (5.1%), anaemia (4.2%), neutropenic sepsis (3.0%), urinary tract infection (3.0%), thrombocytopenia (2.5%), neutropenia (2.1%), cellulitis (2.1%), dizziness (2.1%) and dyspnoea (2.1%).
Drugi resni neželeni učinki v skupini zdravljenja z azacitidinom, o katerih so poročali manj pogosto, so vključevali sepso (5,1 %), anemijo (4,2 %), nevtropenično sepso (3,0 %), okužbe sečil (3,0 %), trombocitopenijo (2,5 %), nevtropenijo (2,1 %), celulitis (2,1 %), omotico (2,1 %) in dispnejo (2,1 %).
Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs); interactions related to these metabolizing enzymes in vivo are therefore considered unlikely.
Podatki in vitro kažejo, da presnove azacitidina ne posredujejo izoencimi citokroma P450 (CYPs), glukuronoziltransferaze UDP (UGTs), sulfotransferaze (SULTs) in glutation transferaze (GSTs); zato ni verjetno, da bi prišlo do interakcij, povezanih s temi presnovnimi encimi in vivo.
Immune system disorders hypersensitivity reactions
Bolezni imunskega sistema preobčutljivost ne reakcije
The contents of the dosing syringe must be re-suspended immediately prior to administration.
Vsebino odmerne brizge pred dajanjem zdravila ponovno suspendirajte.
• Pneumonia.
• pljučnica
Serious adverse reactions such as sepsis, including neutropenic sepsis, and pneumonia were reported in patients receiving azacitidine, some with a fatal outcome.
Pri bolnikih, ki so prejemali azacitidin, so poročali o resnih neželenih učinkih, kot sta sepsa, vključno z nevtropenično sepso, in pljučnica, nekateri s smrtnim izidom.
NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection
IME ZDRAVILA Vidaza 25 mg/ml prašek za suspenzijo za injiciranje
A patient was considered RBC or platelet transfusion independent during the treatment period if the subject had no RBC or platelet transfusions during any consecutive 56 days during the reporting period, respectively.
Verjetnost preživetja trombocitov med obdobjem zdravljenja, če ni imel nobene transfuzije eritrocitov oziroma trombocitov v obdobju katerih koli zaporednih 56 dni med obdobjem poročanja.
Vial(s) of azacitidine; vial(s) of water for injections; non-sterile surgical gloves; alcohol wipes; 5 mL injection syringe(s) with needle(s).
Pripraviti je treba naslednje pripomočke: vialo (viale) azacitidina; vialo (viale) vode za injekcije; nesterilne kirurške rokavice; alkoholne robčke; 5 ml injekcijsko brizgo (brizge) z iglo (iglami).
Do not filter the suspension after reconstitution.
Rekonstituirane suspenzije ne filtrirajte.
Nervous system disorders dizziness, headache intracranial haemorrhage*, syncope, somnolence, lethargy
Bolezni živčevja omotica, glavobol intrakranialna krvavitev*, sinkopa, somnolenca, letargija
Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs).
Podatkov in vitro kažejo, da presnove azacitidina ne posredujejo izoencimi citokroma P450 (CYPs), glukuronoziltransferaze UDP (UGTs), sulfotransferaze (SULTs) in glutation transferaze (GSTs).
Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Azacitidin je kontraindiciran pri bolnikih z napredovalo obliko malignih jetrnih tumorjev (glejte poglavje 4.3).
• Being confused.
• zmedenost
In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide.
Poleg tega se je pri 5 osebah s kronično mieloično levkemijo (KML), ki so se zdravile z azacitidinom in etopozidom, razvila ledvična tubularna acidoza, opredeljena kot znižanje serumskega hidrogenkarbonata na < 20 mmol/l v povezavi z alkalnim urinom in hipokaliemijo (serumski kalij < 3 mmol/l).
Respiratory, thoracic and mediastinal disorders dyspnoea, epistaxis pleural effusion, dyspnoea exertional, pharyngolaryngeal pain interstitial lung disease
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa plevralni izliv, dispneja ob naporu, faringolaringeal na bolečina intersticijsk a pljučna bolezen
The syringe with needle should then be removed from the vial and the needle disposed of.
Nato brizgo z iglo izvlecite iz viale in iglo odstranite.
When using later on
Kadar zdravilo uporabite pozneje
CCR consisted of BSC alone (n=45), lowdose cytarabine plus BSC (n=158), or standard intensive chemotherapy with cytarabine and anthracycline plus BSC (n=44).
CCR so sestavljali samo BSC (n=45), citarabin v majhnem odmerku skupaj z BSC (n=158) ali standardna intenzivna kemoterapija s citarabinom in antraciklinom skupaj z BSC (n=44).
Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 45.0 % of these patients became RBC transfusion independent during the treatment period, compared with 11.4 % of the patients in the combined CCR groups (a statistically significant (p < 0.0001) difference of 33.6 % (95 % CI: 22.4, 44.6).
Pri bolnikih v skupini z azacitidinom, ki so bili na izhodišču odvisni od transfuzije eritrocitov, jih je 45,0 % postalo neodvisnih od transfuzije eritrocitov med obdobjem zdravljenja, v primerjavi z 11,4 % bolnikov v kombiniranih skupinah CCR (statistično značilna (p < 0,0001) razlika 33,6 % (95 % IZ: 22,4; 44,6)).
• Nosebleeds (epistaxis).
• krvavitve iz nosu (epistaksa)
Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA.
Predvideva se, da izvirajo antioneoplastični učinki azacitidina iz več mehanizmov, vključno s citotoksičnostjo na nenormalne krvotvorne celice v kostnem mozgu in hipometilacijo DNA.
• Headache.
• glavobol
4 mL of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
V brizgo potegnite 4 ml vode za injekcije in iztisnite vse v brizgi ujete zračne mehurčke.