FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection sites should be rotated.
Slovenian: Mesta injiciranja je treba menjavati.
English: Overall response (CR + PR) as determined by the IRC in AZA PH GL 2003 CL 001 was 7 % (12/179) in the azacitidine group compared with 1 % (2/179) in the combined CCR group (p = 0.0113).
Slovenian: Celokupni odziv (CR + PR), ki ga je ugotovil IRC v študiji AZA PH GL 2003 CL 001, je bil 7 % (12/179) v skupini z azacitidinom v primerjavi z 1 % (2/179) v kombinirani skupini CCR (p = 0,0113).
English: The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p < 0.0001).
Slovenian: Dvoletna stopnja preživetja je bila 50,8 % pri bolnikih, zdravljenih z azacitidinom, v primerjavi s 26,2 % pri bolnikih v skupini CCR (p < 0,0001).
English: A patient was considered RBC or platelet transfusion dependent at baseline if the subject had one or more RBC or platelet transfusions during the 56 days (8 weeks) on or prior to randomization, respectively.
Slovenian: Bolnik je veljal za odvisnega od transfuzij eritrocitov ali trombocitov v izhodišču, če je imel eno ali več transfuzij eritrocitov oziroma trombocitov v 56 dneh (8 tednih) ob randomizaciji ali pred njo.
English: In human liver S9 fractions, formation of metabolites was independent of NADPH implying that azacitidine metabolism was not mediated by cytochrome P450 isoenzymes.
Slovenian: V S9 frakcijah človeških jeter je bilo nastajanje presnovkov neodvisno od NADPH, kar pomeni, da presnova azacitidina ne poteka z izoencimi citokroma P450.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: An increased incidence of tumours in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine administered intraperitoneally for 50 weeks.
Slovenian: Opazili so povečano pojavnost tumorjev v limforetikularnem sistemu, pljučih, mlečnih žlezah in na koži miši, ki so 50 tednov dobivale azacitidin, apliciran intraperitonealno.
English: EXP Read the leaflet for the shelf life of the reconstituted medicine.
Slovenian: EXP Za rok uporabnosti rekonstituiranega zdravila preberite priloženo navodilo.
English: • Dehydration.
Slovenian: • dehidracija
English: The most common serious adverse reactions (≥ 10%) noted from AZA-AML-001 within the azacitidine treatment arm included febrile neutropenia (25.0%), pneumonia (20.3%), and pyrexia (10.6%).
Slovenian: Najpogostejši resni neželeni učinki (≥ 10 %), ki so jih opazili v študiji AZA-AML-001 v skupini zdravljenja z azacitidinom, so vključevali febrilno nevtropenijo (25,0 %), pljučnico (20,3 %) in pireksijo (10,6 %).
English: In rats, azacitidine caused no adverse reactions when given preimplantation, but it was clearly embryotoxic when given during organogenesis.
Slovenian: Pri podganah azacitidin ni povzročil nobenih neželenih reakcij, če je bil dan pred vsaditvijo zarodka, če pa je bil dan med organogenezo, je bil izrazito embriotoksičen.
English: Adult population (MDS, CMML and AML [20-30% marrow blasts])
Slovenian: Odrasla populacija (MDS, CMML in AML [20-30 % blastnih celic v kostnem mozgu])
English: How to use Vidaza
Slovenian: Kako uporabljati zdravilo Vidaza
English: Vidaza is used in adults who are not able to have a stem cell transplantation to treat:
Slovenian: Zdravilo Vidaza se uporablja pri odraslih bolnikih, pri katerih ni možna presaditev matičnih celic, za zdravljenje:
English: Unopened vials This medicinal product does not require any special storage conditions.
Slovenian: Neodprte viale Za shranjevanje zdravila niso potrebna posebna navodila.
English: The vial should then be turned upside down, making sure the needle tip is below the level of the liquid.
Slovenian: Nato vialo obrnite navzdol tako, da je konica igle pod ravnijo tekočine.
English: No formal studies have been conducted in patients with hepatic impairment (see section 4.4).
Slovenian: Formalnih študij pri bolnikih z okvaro jeter niso izvedli (glejte poglavje 4.4).
English: • Difficulty breathing, swelling of the lips, itching or rash.
Slovenian: • Težave z dihanjem, otekanje ustnic, srbenje ali izpuščaj.
English: The hazard ratio for the treatment effect was 0.85 (95% CI= 0.69, 1.03).
Slovenian: Razmerje ogroženosti za učinek zdravljenja je bilo 0,85 (95 % IZ= 0,69; 1,03).
English: If haematological toxicity is observed following Vidaza treatment, the next cycle of the therapy should be delayed until the platelet count and the ANC have recovered.
Slovenian: Če se po zdravljenju z zdravilom Vidaza opazi hematološka toksičnost, je treba naslednji cikel zdravljenja prestaviti do obnovitve števila trombocitov in ANC.
English: Each pack contains one vial of Vidaza.
Slovenian: Ena škatla vsebuje eno vialo zdravila Vidaza.
English: • A viral infection causing cold sores (herpes).
Slovenian: • virusna okužba, ki povzroči izpuščaje (herpes)
English: The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe.
Slovenian: Bat potegnite nazaj, da izvlečete dovolj zdravila za pravilni odmerek, ob tem pa se prepričajte, da v brizgi ni ujetih zračnih mehurčkov.
English: No formal studies have been conducted in patients with hepatic impairment.
Slovenian: Formalnih študij pri bolnikih z okvaro jeter niso izvedli.
English: • Painful skin ulceration (pyoderma gangrenosum).
Slovenian: • boleče kožne razjede (gangrenozna pioderma)
English: In animals, adverse reactions with azacitidine use on male fertility have been documented (see section 5.3).
Slovenian: Pri živalih so dokumentirane neželene reakcije pri uporabi azacitidina na plodnost samcev (glejte poglavje 5.3).
English: Urinary excretion is the primary route of elimination of azacitidine and/or its metabolites.
Slovenian: Glavna pot izločanja azacitidina in/ali njegovih presnovkov je izločanje z urinom.
English: Pregnancy, breast-feeding and fertility
Slovenian: Nosečnost, dojenje in plodnost
English: At baseline 60.7% were classified as AML not otherwise specified, 32.4% AML with myelodysplasia-related changes, 4.1% therapy-related myeloid neoplasms and 2.9% AML with recurrent genetic abnormalities according to the WHO classification.
Slovenian: V izhodišču jih je bilo 60,7 % razvrščenih kot AML, ki ni podrobneje označena, 32,4 % kot AML s spremembami, povezanimi z mielodisplazijo, 4,1 % kot mieloidne neoplazme, povezane z zdravljenjem, in 2,9 % kot AML z recidivnimi genetskimi abnormalnostmi po razvrstitvi SZO.
English: The hazard ratio for the treatment effect was 0.58 (95 % CI: 0.43, 0.77).
Slovenian: Razmerje ogroženosti za ta učinek zdravljenja je bilo 0,58 (95 % IZ: 0,43; 0,77).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than 8 hours at 2 °C to 8 °C when reconstituted using water for injections that has not been refrigerated or not longer than 22 hours when reconstituted using refrigerated (2 °C to 8 °C) water for injections.
Slovenian: Če se zdravilo ne uporabi takoj, so čas in pogoji shranjevanja zdravila pred uporabo odgovornost uporabnika in ne smejo presegati 8 ur pri 2 °C do 8 °C, če je bilo zdravilo rekonstituirano z vodo za injekcije, ki ni bila v hladilniku, ali ne več kot 22 ur, če je bilo zdravilo rekonstituirano z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C).
English: Mannitol (E421)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421)
English: If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered.
Slovenian: Če je zmanjšanje števila levkocitov ali ANC ali trombocitov večje od 50 % od stanja pred zdravljenjem in ni izboljšanja v diferenciaciji celične linije, je treba naslednji cikel zdravljenja z zdravilom Vidaza prestaviti do obnovitve števila trombocitov in ANC.
English: The most commonly reported gastrointestinal adverse reactions associated with azacitidine treatment included constipation, diarrhoea, nausea and vomiting.
Slovenian: Najbolj pogosti neželeni učinki, povezani s prebavili, o katerih so poročali v zvezi z zdravljenjem z azacitidinom, so vključevali obstipacijo, diarejo, navzeo in bruhanje.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for azacitidine, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za azacitidin, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: After administration of the recommended dose for the first cycle, the dose for subsequent cycles should be reduced or its administration delayed based on nadir counts and haematological response (see section 4.2).
Slovenian: Po dajanju priporočenega odmerka zdravila v prvem ciklu je treba odmerek za naslednje cikle zmanjšati ali uporabo prestaviti na podlagi števila krvnih celic v najnižji točki in hematološkega odziva (glejte poglavje 4.2).
English: Subcutaneous adverse reactions such as injection site rash/inflammation/pruritus, rash, erythema and skin lesion may require management with concomitant medicinal products, such as antihistamines, corticosteroids and non-steroidal anti-inflammatory medicinal products (NSAIDs).
Slovenian: Neželeni učinki, povezani s podkožjem, kot so osip/vnetje/srbenje na mestu injiciranja, osip, eritem in lezije kože, je morda treba zdraviti s sočasnim jemanjem zdravil, kot so antihistaminiki, kortikosteroidi in nesteroidna protivnetna zdravila (NSAID).
English: Cardiac and pulmonary disease
Slovenian: Bolezni srca in pljuč
English: Vidaza contains the active substance ‘azacitidine'.
Slovenian: Zdravilo Vidaza vsebuje zdravilno učinkovino 'azacitidin'.
English: Vidaza therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated.
Slovenian: Pri bolnikih, pri katerih se razvije nekrotizantni fasciitis, je treba zdravljenje z zdravilom Vidaza prekiniti in takoj začeti ustrezno zdravljenje.
English: Vidaza was administered at a SC dose of 75mg/m2/day for 7 days, followed by a rest period of 21 days (28 day treatment cycle), for a median of 6 cycles (range: 1 to 28), BSC- only patients for a median of 3 cycles (range: 1 to 20), low-dose cytarabine patients for a median of 4 cycles (range 1 to 25) and standard intensive chemotherapy patients for a median of 2 cycles (range: 1 to 3, induction cycle plus 1 or 2 consolidation cycles).
Slovenian: Zdravilo Vidaza so dajali v s.c. odmerku 75 mg/m2/dan 7 dni, sledilo je obdobje mirovanja, ki je trajalo 21 dni (28-dnevni cikel zdravljenja), mediana števila ciklov je bila 6 (razpon: 1 do 28), pri bolnikih, ki so prejemali samo BSC, je bila mediana števila ciklov 3 (razpon: 1 do 20), pri bolnikih, ki so prejemali citarabin v majhnem odmerku, je bila mediana števila ciklov 4 (razpon 1 do 25), pri bolnikih, ki so prejemali standardno intenzivno kemoterapijo, pa je bila mediana števila ciklov 2 (razpon: 1 do 3, indukcijski cikel plus 1 ali 2 konsolidacijska cikla).
English: dose, mean exposure values (AUC and Cmax) from subjects with mild, moderate and severe renal impairment were increased by 11-21%, 15-27%, and 41-66%, respectively, compared to normal renal function subjects.
Slovenian: Po subkutanem dajanju enkratnega odmerka 75 mg/m2 so se srednje vrednosti izpostavljenosti (AUC in Cmax) oseb z blago, zmerno in hudo okvaro ledvic zvečale za 11-21 %, 15-27 % oziroma 41-66 % v primerjavi z osebami z normalno ledvično funkcijo.
English: Metabolism and nutrition disorders anorexia, decreased appetite, hypokalemia dehydration tumour lysis syndrome
Slovenian: Presnovne in prehranske motnje anoreksija, zmanjšan apetit, hipokaliemija dehidracija sindrom tumorske lize
English: Vidaza treatment improved peripheral blood counts and led to a reduced need for RBC and platelet transfusions.
Slovenian: Zdravljenje z zdravilom Vidaza je izboljšalo periferno krvno sliko in zmanjšalo potrebo po transfuzijah eritrocitov in trombocitov.
English: 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.
Slovenian: 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.
English: • if you have liver disease.
Slovenian: • če imate bolezen ledvic;
English: After reconstitution each mL of suspension will contain 25 mg of azacitidine (100 mg/4 mL).
Slovenian: Po rekonstituciji bo vsak ml suspenzije vseboval 25 mg azacitidina (100 mg/4 ml).
English: Studies in mice have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na miših so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Painless swelling in the finger tips (clubbing).
Slovenian: • neboleča oteklina konic prstov (kladivasti prsti)
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: subkutana uporaba POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: No accumulation occurs after subcutaneous administration of 75 mg/m2 azacitidine once daily for 7 days.
Slovenian: Po 7-dnevnem subkutanem dajanju 75 mg/m2 azacitidina enkrat na dan ne pride do kopičenja.
English: • Fluid around the lungs (pleural effusion).
Slovenian: • tekočina okrog pljuč (plevralni izliv)
English: 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).
Slovenian: 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).
English: You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle').
Slovenian: Pred začetkom zdravljenja z zdravilom Vidaza in ob začetku vsakega obdobja zdravljenja (imenovanega ‘cikel') boste opravili preglede krvi.
English: • An infection of the nose and throat, or sore throat.
Slovenian: • okužba nosu in žrela ali vneto žrelo
English: 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.
Slovenian: Iglo brizge, ki vsebuje 4 ml vode za injekcije, vstavite skozi gumijast pokrovček viale z azacitidinom in v vialo počasi injicirajte vodo za injekcije.
English: 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).
Slovenian: 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).
English: Blood test
Slovenian: Krvne preiskave
English: Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions.
Slovenian: Zdravilo Vidaza je citotoksično zdravilo, zato je pri rokovanju s suspenzijo azacitidina in njeno pripravo potrebna previdnost, kot pri drugih potencialno toksičnih sestavinah.
English: 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
Slovenian: 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 %]).
English: Vascular disorders hypotension*, hypertension, orthostatic hypotension, haematoma
Slovenian: Žilne bolezni hipotenzija*, hipertenzija, ortostatska hipotenzija, hematom
English: INSTRUCTIONS ON USE
Slovenian: Navodilo za uporabo
English: It is unknown whether azacitidine/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se presnovki azacitidina izločajo v materino mleko.
English: Reconstitution procedure
Slovenian: Postopek rekonstitucije
English: Reconstituted suspension For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Rekonstituirana suspenzija Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
English: 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.
Slovenian: 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.
English: Patients were pre-selected by their physician to 1 of the 3 CCR prior to randomisation.
Slovenian: Bolnike je pred naključno razvrstitvijo vnaprej izbral njihov zdravnik v eno od treh skupin CCR.
English: Azacitidine undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase.
Slovenian: Azacitidin se spontano hidrolizira in deaminira s citidin deaminazo.
English: This could be due to an infection as a result of having low levels of white blood cells, which can be life-threatening.
Slovenian: Vzrok bi lahko bila okužba kot posledica nizke ravni levkocitov, ki je lahko smrtno nevarna.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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 *
Slovenian: 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*
English: Skin and subcutaneous tissue disorders petechiae, pruritus (includes generalized), rash, ecchymosis purpura, alopecia, urticaria, erythema, rash macular acute febrile neutrophilic dermatosis, pyoderma gangrenosum
Slovenian: Bolezni kože in podkožja petehija, pruritus (vključuje generalizirani pruritus), osip, ehimoza purpura, alopecija, urtikarija, eritem, makulozni osip akutna febrilna nevtrofilna dermatoza, gangrenozna pioderma
English: Patients should be advised to promptly report febrile episodes.
Slovenian: Bolnike je treba opozoriti, da morajo takoj poročati primere zvišane telesne temperature.
English: It may be given under the skin on your thigh, tummy or upper arm.
Slovenian: Zdravilo se lahko daje pod kožo v stegno, trebuh ali nadlaket.
English: 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.
Slovenian: Rekonstituirano zdravilo Vidaza injicirajte subkutano (iglo vstavite pod kotom 45-90°) z iglo velikosti 25 G v nadlaket, stegno ali trebuh.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively,
Slovenian: Po intravenskem in subkutanem dajanju 14C-azacitidina so zaznali 85 % oziroma 50 % radioaktivnosti v urinu in le < 1 % v blatu.
English: 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).
Slovenian: 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).
English: Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Slovenian: Zdravilo Vidaza je indicirano za zdravljenje odraslih bolnikov, ki niso primerni za presaditev krvotvornih matičnih celic (PKMC) s/z: