FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients received the pre-selected regimen if not randomised to Vidaza.
Slovenian: Bolniki so prejemali vnaprej izbrano shemo zdravljenja, če niso bili naključno razvrščeni na zdravilo Vidaza.
English: Complete blood counts should be performed as needed to monitor response and toxicity, but at least prior to each treatment cycle.
Slovenian: Kompletno krvno sliko je treba pridobiti po potrebi za spremljanje odziva in toksičnosti, toda vsaj pred vsakim ciklom zdravljenja.
English: Adult population with MDS, CMML and AML (20-30% marrow blasts)
Slovenian: Odrasla populacija z MDS, CMML in AML (20-30 % blastnih celic v kostnem mozgu)
English: 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.
Slovenian: 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.
English: Storage of the reconstituted product For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Shranjevanje rekonstituiranega zdravila Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
English: 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.
Slovenian: 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.
English: The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 °C - 25 °C).
Slovenian: Pred uporabo pustite suspenzijo do 30 minut, da se segreje na sobno temperaturo (20 °C - 25 °C).
English: Renal impairment has no major effect on the pharmacokinetic exposure of azacitidine after single and multiple subcutaneous administrations.
Slovenian: Okvara ledvic po enkratnem in večkratnem subkutanem dajanju nima večjega vpliva na farmakokinetično izpostavljenost azacitidinu.
English: CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25).
Slovenian: CCR so obsegali samo BSC (n = 105), nizek odmerek citarabina in BSC (n = 49) ali standardno indukcijsko kemoterapijo in BSC (n = 25).
English: A survival benefit was also demonstrated in patients that had not achieved a complete/partial response following azacitidine treatment.
Slovenian: Tudi pri bolnikih, kjer ni bil dosežen popolni/delni odziv po zdravljenju z azacitidinom, je bilo dokazano izboljšanje preživetja.
English: 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).
Slovenian: 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).
English: Special populations
Slovenian: Posebne skupine
English: Bleeding
Slovenian: Krvavitve
English: Such as blood in the stools due to bleeding in the stomach or gut, or such as bleeding inside your head.
Slovenian: Lahko opazite kri v blatu zaradi krvavitev v trebuhu ali prebavilih, možna je tudi krvavitev v glavi.
English: 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.
Slovenian: 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.
English: After reconstitution with 4 mL of water for injections, the reconstituted suspension contains 25 mg/mL azacitidine.
Slovenian: Po rekonstituciji s 4 ml vode za injekcije vsebuje rekonstituirana suspenzija 25 mg/ml azacitidina.
English: Investigations weight decreased * = rarely fatal cases have been reported
Slovenian: Preiskave zmanjšanje telesne mase *= redko so poročali o smrtnih primerih Opis izbranih neželenih učinkov
English: 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.
Slovenian: Brizgo, napolnjeno z rekonstituirano suspenzijo, lahko pustite do 30 minut pred uporabo, da doseže temperaturo približno 20 °C - 25 °C.
English: 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.
Slovenian: 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.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • AML with >30% marrow blasts according to the WHO classification.
Slovenian: • AML z >30 % blastnih celic v kostnem mozgu po razvrstitvi SZO.
English: 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%).
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: Immune system disorders hypersensitivity reactions
Slovenian: Bolezni imunskega sistema preobčutljivost ne reakcije
English: The contents of the dosing syringe must be re-suspended immediately prior to administration.
Slovenian: Vsebino odmerne brizge pred dajanjem zdravila ponovno suspendirajte.
English: • Pneumonia.
Slovenian: • pljučnica
English: Serious adverse reactions such as sepsis, including neutropenic sepsis, and pneumonia were reported in patients receiving azacitidine, some with a fatal outcome.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection
Slovenian: IME ZDRAVILA Vidaza 25 mg/ml prašek za suspenzijo za injiciranje
English: 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.
Slovenian: Verjetnost preživetja trombocitov med obdobjem zdravljenja, če ni imel nobene transfuzije eritrocitov oziroma trombocitov v obdobju katerih koli zaporednih 56 dni med obdobjem poročanja.
English: Vial(s) of azacitidine; vial(s) of water for injections; non-sterile surgical gloves; alcohol wipes; 5 mL injection syringe(s) with needle(s).
Slovenian: 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).
English: Do not filter the suspension after reconstitution.
Slovenian: Rekonstituirane suspenzije ne filtrirajte.
English: Nervous system disorders dizziness, headache intracranial haemorrhage*, syncope, somnolence, lethargy
Slovenian: Bolezni živčevja omotica, glavobol intrakranialna krvavitev*, sinkopa, somnolenca, letargija
English: 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).
Slovenian: Podatkov in vitro kažejo, da presnove azacitidina ne posredujejo izoencimi citokroma P450 (CYPs), glukuronoziltransferaze UDP (UGTs), sulfotransferaze (SULTs) in glutation transferaze (GSTs).
English: Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Slovenian: Azacitidin je kontraindiciran pri bolnikih z napredovalo obliko malignih jetrnih tumorjev (glejte poglavje 4.3).
English: • Being confused.
Slovenian: • zmedenost
English: 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.
Slovenian: 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).
English: Respiratory, thoracic and mediastinal disorders dyspnoea, epistaxis pleural effusion, dyspnoea exertional, pharyngolaryngeal pain interstitial lung disease
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa plevralni izliv, dispneja ob naporu, faringolaringeal na bolečina intersticijsk a pljučna bolezen
English: The syringe with needle should then be removed from the vial and the needle disposed of.
Slovenian: Nato brizgo z iglo izvlecite iz viale in iglo odstranite.
English: When using later on
Slovenian: Kadar zdravilo uporabite pozneje
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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)).
English: • Nosebleeds (epistaxis).
Slovenian: • krvavitve iz nosu (epistaksa)
English: 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.
Slovenian: Predvideva se, da izvirajo antioneoplastični učinki azacitidina iz več mehanizmov, vključno s citotoksičnostjo na nenormalne krvotvorne celice v kostnem mozgu in hipometilacijo DNA.
English: • Headache.
Slovenian: • glavobol
English: 4 mL of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
Slovenian: V brizgo potegnite 4 ml vode za injekcije in iztisnite vse v brizgi ujete zračne mehurčke.
English: The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events, including constipation (41.9%), nausea (39.8%), and diarrhoea (36.9%), (usually Grade 1-2), general disorders and administration site conditions including pyrexia (37.7%; usually Grade 1-2) and haematological events, including febrile neutropenia (32.2%) and neutropenia (30.1%), (usually Grade 3-4).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali (≥ 30 %) pri zdravljenju z azacitidinom, so bili gastrointestinalni dogodki, vključno z zaprtjem (41,9 %), navzeo (39,8 %) in drisko (36,9 %), (navadno 1.-2. stopnje), splošne težave in spremembe na mestu aplikacije, vključno s pireksijo (37,7 %; navadno 1.-2. stopnje) in hematološki dogodki, vključno s febrilno nevtropenijo (32,2 %) in nevtropenijo (30,1 %), (navadno 3.-4. stopnje).
English: Grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: • A type of anaemia where your red and white blood cells and platelets are reduced.
Slovenian: • vrsta anemije, pri kateri je število eritrocitov, levkocitov in trombocitov zmanjšano
English: The most commonly reported adverse reactions with azacitidine treatment were haematological reactions (71.4 %) including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events (60.6 %) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali v zvezi z zdravljenjem z azacitidinom, so bile hematološke reakcije (71,4 %), vključno s trombocitopenijo, nevtropenijo in levkopenijo (običajno 3.-4. stopnje), prebavni dogodki (60,6 %), vključno z navzeo, bruhanjem (običajno 1.-2. stopnje), ali reakcije na mestu injiciranja (77,1 %; običajno 1.-2. stopnje).
English: If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
Slovenian: Če poteče več kot 45 minut, morate rekonstituirano suspenzijo ustrezno zavreči in pripraviti nov odmerek.
English: Blood and lymphatic system disorders febrile neutropenia*, neutropenia, leukopenia, thrombocytopenia, anaemia pancytopenia*, bone marrow failure
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija*, nevtropenija, levkopenija, trombocitopenij a, anemija pancitopenija*, odpoved kostnega mozga
English: Psychiatric disorders insomnia confusional state, anxiety
Slovenian: Psihiatrične motnje nespečnost stanje zmedenosti, tesnoba
English: What Vidaza is used for
Slovenian: Za kaj zdravilo Vidaza uporabljamo
English: Table 1: ADRs reported in patients with MDS or AML treated with azacitidine (clinical studies and post- marketing)
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali pri bolnikih z MDS ali AML, zdravljenih z azacitidinom (klinične študije in opažanja po prihodu zdravila na trg) Organski sistem Zelo pogosti
English: MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Celgene Europe B.V.
English: Shake the suspension vigorously before administration.
Slovenian: Suspenzijo pred odmerjanjem močno pretresite.
English: • chronic myelomonocytic leukaemia (CMML).
Slovenian: • kronične mielomonocitne levkemije (KMMoL);
English: The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2 °C to 8 °C) water for injections.
Slovenian: Rok uporabnosti rekonstituiranega zdravila se lahko podaljša, če se za rekonstitucijo uporabi voda za injekcije, ki je bila v hladilniku (2 °C do 8 °C).
English: Vidaza 25 mg/mL powder for suspension for injection Azacitidine
Slovenian: Vidaza 25 mg/ml prašek za suspenzijo za injiciranje azacitidin
English: PHARMACEUTICAL FORM Powder for suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Prašek za suspenzijo za injiciranje Bel liofiliziran prašek.
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International
Slovenian: • mielodisplastičnimi sindromi (MDS) z vmesno stopnjo 2 in visoko stopnjo tveganja po
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.
Slovenian: Kompletno krvno sliko je treba pridobiti pred začetkom zdravljenja in po potrebi za spremljanje odziva in toksičnosti, najmanj pa pred vsakim ciklom zdravljenja.
English: Not known (frequency cannot be estimated from the available data) Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
Slovenian: • okužba globljih plasti kože, ki se hitro širi, poškoduje kožo in tkiva in je lahko življenje ogrožajoča (nekrotizantni fasciitis).
English: In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the Vidaza group and 19.2 months in the CCR group.
Slovenian: Pri bolnikih, ki so bili v izhodišču odvisni od transfuzij trombocitov in so ob zdravljenju dosegli neodvisnost od transfuzij, je bilo mediano trajanje neodvisnosti od transfuzij trombocitov v skupini z zdravilom Vidaza 10,8 meseca, v skupini s CCR pa 19,2 meseca.
English: Patients with renal impairment
Slovenian: Bolniki z okvaro ledvic
English: • Lethargy.
Slovenian: • letargija
English: In patients who were RBC transfusion dependent at baseline and became independent, the median duration of RBC transfusion independence was 13 months in the azacitidine group.
Slovenian: Pri bolnikih, ki so bili na izhodišču odvisni od transfuzije eritrocitov in so nato postali od nje neodvisni, je bila mediana trajanja neodvisnosti od transfuzije eritrocitov 13 mesecev v skupini z azacitidinom.
English: • A disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis).
Slovenian: • črevesna bolezen, ki lahko povzroči zvišano telesno temperaturo, bruhanje in bolečine v trebuhu
English: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to
Slovenian: • akutno mieloično levkemijo (AML) z 20-30 % blastnih celic in displazijo več celičnih linij po razvrstitvi Svetovne zdravstvene organizacije (SZO),
English: If it comes into contact with mucous membranes, flush thoroughly with water.
Slovenian: Če pride zdravilo v stik s sluznico, jo temeljito sperite z vodo.
English: • Low levels of potassium in your blood.
Slovenian: • izguba telesne mase • nizka raven kalija v krvi
English: Musculoskeletal and connective tissue disorders arthralgia, musculoskeletal pain (includes back, bone and pain in extremity)
Slovenian: Bolezni mišično-skeletne ga sistema in vezivnega tkiva artralgija, bolečine v mišicah in kosteh (vključuje bolečine v križu, kosteh in udih)
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
Slovenian: Pri bolnikih z razširjeno tumorsko boleznijo zaradi metastatskega obolenja so med zdravljenjem z azacitidinom poročali o odpovedi jeter, progresivni jetrni komi in smrti (glejte poglavje 4.4).
English: Log-Rank p = 0.0001 HR = 0.58 [95% CI: 0.43-0.77]
Slovenian: Log-rank p = 0,0001
English: • Large plum-coloured, raised painful patches on the skin with fever.
Slovenian: • velike izbokle boleče zaplate na koži temno modre barve z zvišano telesno temperaturo
English: Vidaza is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Slovenian: Zdravilo Vidaza je kontraindicirano pri bolnikih z napredovalo obliko malignih jetrnih tumorjev (glejte poglavji 4.3 in 4.4).
English: • Sore or runny nose or sinuses (sinusitis)..
Slovenian: • vnetje nosu, izcedek iz nosu ali sinuzitis
English: Platelets (x 109/l) *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count])
Slovenian: Trombociti (x 109/l) *Obnovitev = število ≥ število v najnižji točki + (0,5 x [izhodiščno število - število v najnižji točki])
English: Deaths: AZA = 82, CCR = 113
Slovenian: RO 0,58 [95 % IZ: 0,43 - 0,77] Smrti: AZA = 82, CCR = 113
English: If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
Slovenian: Če zdravilo shranjujete v hladilniku več kot 8 ur, morate suspenzijo ustrezno zavreči in pripraviti nov odmerek.
English: What Vidaza contains
Slovenian: Kaj vsebuje zdravilo Vidaza
English: Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) ≥ 3.0 x 109/l and ANC ≥ 1.5 x 109/l, and platelets ≥ 75.0 x 109/l) prior to the first treatment
Slovenian: število levkocitov (WBC - White Blood Cells) ≥ 3,0 x 109/l in ANC ≥ 1,5 x 109/l in trombocitov ≥ 75,0 x 109/l)
English: If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Slovenian: Če poteče več kot 30 minut, morate suspenzijo ustrezno zavreči in pripraviti nov odmerek.
English: When using immediately
Slovenian: Kadar zdravilo uporabite takoj
English: Use an effective method of contraception during and up to 3 months after treatment with this medicine.
Slovenian: Med zdravljenjem s tem zdravilom in do 3 mesece po njem uporabljajte zanesljivo kontracepcijsko metodo.
English: • Raised itchy rash on the skin (urticaria).
Slovenian: • izbočen srbeč izpuščaj na koži (koprivnica, urtikarija)
English: Serious adverse reactions such as gastrointestinal haemorrhage and intracranial haemorrhage have been reported.
Slovenian: Poročali so o resnih neželenih učinkih, kot sta krvavitev v prebavila in intrakranialna krvavitev.
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection Azacitidine STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains100 mg azacitidine.
Slovenian: IME ZDRAVILA Vidaza 25 mg/ml prašek za suspenzijo za injiciranje azacitidin NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 100 mg azacitidina.
English: In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the Vidaza group and was not reached in the CCR group.
Slovenian: Pri bolnikih, ki so bili v izhodišču odvisni od transfuzij eritrocitov in so ob zdravljenju dosegli neodvisnost od transfuzij, je bilo mediano trajanje neodvisnosti od transfuzij eritrocitov v skupini z zdravilom Vidaza 13,9 meseca, v skupini s CCR pa neodvisnosti niso dosegli.
English: Skin and subcutaneous tissue adverse reactions
Slovenian: S kožo in podkožjem povezani neželeni učinki