FrancophonIA/ELRC3.0 huggingface dataset:
English: while < 1 % was recovered in faeces.
Maltese: filwaqt li < 1% kienet irkuprata fl-ippurgar.
English: • Rash.
Maltese: • Raxx.
English: Platelets (x 109/l) *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count])
Maltese: Plejtlits (x 109/l) *Irkuprar = għadd ≥ għadd tan-nadir + (0.5 x [għadd fil-linja bażi - għadd tan-nadir])
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).
Maltese: Ibbażat fuq dejta in vitro, ma jidhirx li l-metaboliżmu ta' azacitidine hu medjat mill-isoenzimi ta' ċitokrom P450 (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), u glutathione transferases (GSTs).
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala, treddigħ u fertilità
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 *
Maltese: Infezzjonijiet u infestazzjonijiet pnewmonja* (tinkludi pnewmonja batterjali, virali u fungali), nażofarinġite sepsis* (tinkludi sepsis batterjali, virali u fungali), sepsis newtropenika*, infezzjoni fl-apparat respiratorju (tinkludi infezzjoni fl-apparat respiratorju ta' fuq u bronkite), infezzjoni fl-apparat tal-awrina, ċellulite, divertikulite, infezzjoni fungali orali, sinusite, farinġite, rinite,
English: Following intravenous administration, the mean volume of distribution was 76 ± 26 L, and systemic clearance was 147 ± 47 L/h.
Maltese: Wara l-għoti ġol-vina, il-medja tal-volum tad-distribuzzjoni kienet ta' 76 ± 26 L, u t-tneħħija sistemika kienet ta' 147 ± 47 L/siegħa.
English: Bleeding
Maltese: Treddigħ
English: There is limited safety information available with azacitidine in patients ≥85 years (with 14 [5.9%] patients ≥85 years in AZA-AML-001 study).
Maltese: Hemm informazzjoni limitata disponibbli dwar is-sigurtà b'azacitidine f'pazjenti li għandhom ≥85 sena (b'14-il [5.9%] pazjent li kellhom ≥85 sena fi studju AZA-AML-001).
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.
Maltese: Fis-sottogruppi kollha ta' età speċifikati minn qabel [(< 75 sena u ≥ 75 sena), is-sess tal-persuna, ir-razza, l-istat ta' prestazzjoni ECOG (0 jew 1 u 2), ir-riskju ċitoġenetiku fil-linja bażi (intermedju u batut), ir-reġjun ġeografiku, il-klassifikazzjoni tal-WHO ta' AML (li tinkludi AML b'tibdil relatat ma' majelodisplasija), għadd ta' WBC fil-linja bażi (≤ 5 x109/L u >5 x 109/L), blasts tal-mudullun fil-linja bażi (≤ 50% u > 50%) u storja medika fil-passat ta' MDS], kien hemm tendenza fil-benefiċċju ta' OS favur Vidaza.
English: Pharmacogenomics
Maltese: Pharmakoġenomika
English: • The recommended dose is 75 mg per m2 body surface area.
Maltese: • Id-doża rakkomandata hija 75 mg/m2 ta' erja tas-superfiċje tal-ġisem.
English: The hazard ratio for the treatment effect was 0.58 (95 % CI: 0.43, 0.77).
Maltese: Il-proporzjon tal-periklu għall-effett tal-kura kien ta' 0.58 (95% CI: 0.43; 0.77).
English: Do not use Vidaza
Maltese: Tużax Vidaza
English: • higher-risk myelodysplastic syndromes (MDS).
Maltese: • sindromi majelodisplastiċi (MDS) ta' riskju ogħla.
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).
Maltese: Ir-rispons totali (CR + PR) kif stabbilit mill-IRC fl-istudju AZA PH GL 2003 CL 001 kien ta' 7% (12/179) fil-grupp ta' azacitidine meta mqabbel ma' 1% (2/179) fil-grupp kombinat tas-CCR (p = 0.
English: Log-Rank p = 0.0001 HR = 0.58 [95% CI: 0.43-0.77]
Maltese: Log-Rank p = 0.0001
English: The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vidaza fit-tfal minn età 0 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: • Dehydration.
Maltese: • Deidratazzjoni.
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.
Maltese: It-tossiċità ematoloġika hi definita bħala l-inqas għadd li jintlaħaq f'ċiklu partikulari (nadir) jekk il-plejtlits ≤ 50.0 x 109/l u/jew l-għadd assolut tan-newtrofili (Absolute Neutrophil Count, ANC) ≤ 1 x 109/l.
English: • The other ingredient is mannitol (E421).
Maltese: • Is-sustanza mhux attiva l-oħra hi mannitol (E421).
English: The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 °C - 25 °C).
Maltese: Is-suspensjoni għandha titħalla sa 30 minuta qabel tingħata biex tilħaq it-temperatura tal-kamra (20°C-25°C).
English: Cardiac disorders pericardial effusion pericarditis
Maltese: Disturbi fil-qalb effużjoni perikardijaka perikardite
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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).
Maltese: Mill-pazjenti fil-grupp ta' azacitidine li kienu dipendenti fuq it-trasfużjonijiet tar-RBC fil-linja bażi, 45.0% minn dawn il-pazjenti saru indipendenti mit-trasfużjonijiet tar-RBC matul il-perjodu tal-kura meta mqabbla ma' 11.4% tal-pazjenti fil-gruppi tas-CCR kombinati (differenza statistikament sinifikanti (p < 0.0001) ta' 33.6% (95% CI: 22.4; 44.6)).
English: Uncommon Rare
Maltese: Komuni ħafna
English: After reconstitution each mL of suspension will contain 25 mg of azacitidine (100 mg/4 mL).
Maltese: Wara r-rikostituzzjoni kull millilitru ta' suspensjoni ser ikun fih 25 mg ta' azacitidine (100 mg/4 mL).
English: Gastrointestinal adverse reactions
Maltese: Reazzjonijiet avversi gastro-intestinali
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.
Maltese: F'pazjenti li kisbu CR jew CRi, it-tul medjan ta' tnaqqis fil-mard kien ta' 10.4 xhur (95% CI = 7.2, 15.2) għal individwi fuq Vidaza, u 12.3 xhur (95% CI = 9.0, 17.0) għal individwi fuq CCR.
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).
Maltese: ITT ta' 488 pazjent (241 Vidaza u 247 CCR), il-kura b'Vidaza kienet assoċjata ma' medjan ta' sopravivenza ta' 10.4 xahar kontra 6.5 xhur għal dawk li kienu qed jirċievu l-kura CCR, differenza ta' 3.8 xhur, b'valur p log-rank stratifikat ta' 0.1009 (two-sided).
English: Other medicines and Vidaza
Maltese: Mediċini oħra u Vidaza
English: • Nosebleeds (epistaxis).
Maltese: • Tinfaraġ (epistassi).
English: Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
Maltese: Ir-rispons ċitoġeniku minuri kien ogħla b'mod statistikament sinifikanti (p = 0.0015) fil-grupp ta' azacitidine (34%) meta mqabbel mal-grupp ikkurat b'CCR kombinat (10%).
English: Tumour lysis syndrome
Maltese: Sindromu tal-lisi tat-tumur
English: Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro.
Maltese: Azacitidine jinduċi kemm mutazzjonijiet tal-ġeni kif ukoll aberazzjonijiet kromosomali f'sistemi ta' ċelluli batterjali u mammiferi in vitro.
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.
Maltese: Fil-linja bażi, 60.7% ġew ikklassifikati bħala AML mhux speċifikata mod ieħor, 32.4% b'AML b'tibdil relatat ma' majelodisplasija, 4.1% b'neoplażmi majelojdi relatati mat-terapija, u 2.9% b'AML b'anormalitajiet ġenetiċi rikorrenti skont il-klassifikazzjoni tal-WHO.
English: Advanced malignant hepatic tumours (see section 4.4).
Maltese: Tumuri epatiċi malinni avvanzati (ara sezzjoni 4.4).
English: Skin and subcutaneous tissue disorders petechiae, pruritus (includes generalized), rash, ecchymosis purpura, alopecia, urticaria, erythema, rash macular acute febrile neutrophilic dermatosis, pyoderma gangrenosum
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda tbenġil, ħakk (jinkludi ħakk ġeneralizzat), raxx, ekimożi purpura, alopeċja, urtikarja, eritema, raxx makulari dermatosi newtrofilika akuta bid-deni, pyoderma gangrenosum
English: • Skin infection (cellulitis).
Maltese: • Infezzjoni fil-ġilda(ċellulite).
English: CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25).
Maltese: CCR kienet tikkonsisti f'BSC waħidha (n = 105), cytarabine f'doża baxxa flimkien ma' BSC (n = 49) jew kimoterapija tal-induzzjoni standard flimkien ma' BSC (n = 25).
English: Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively,
Maltese: Wara l-għoti ġol-vina u taħt il-ġilda ta' 14C-azacitidine, 85 u 50% tar-radjuattività mogħtija kienet irkuprata fl-awrina rispettivament,
English: Vidaza 25 mg/mL powder for suspension for injection Azacitidine
Maltese: Vidaza 25 mg/mL trab għal suspensjoni għall-injezzjoni Azacitidine
English: Nervous system disorders dizziness, headache intracranial haemorrhage*, syncope, somnolence, lethargy
Maltese: Disturbi fis-sistema nervuża sturdament, uġigħ ta' ras emorraġija intrakranjali*, sinkope, ngħas, letarġija
English: Reconstitution procedure
Maltese: Suspensjoni rikostitwita
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).
Maltese: L-iktar reazzjonijiet avversi serji komuni osservati mill-istudju ta' importanza kbira (AZA PH GL 2003 CL 001) kienu jinkludu newtropenija bid-deni (8.0%) u anemija (2.3%), li kienu rrappurtati wkoll fl-istudji ta' appoġġ (CALGB 9221 u CALGB 8921).
English: Metabolism and nutrition disorders anorexia, decreased appetite, hypokalemia dehydration tumour lysis syndrome
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni anoreksja, nuqqas ta' aptit, ipokalemja deidratazzjoni sindromu tumour lysis
English: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to
Maltese: • lewkimja majelojde akuta (AML) b'20-30% blasts u displasja multi-lineage, skont il-klassifikazzjoni tal-Organizzazzjoni Dinjija tas-Saħħa (WHO),
English: MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Maltese: Celgene Europe B.V.
English: Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely (see section 5.2).
Maltese: Effetti inibitorji jew induttivi ta' azacitidine fuq l-enzimi ta' ċitokrom P450 li huma klinikament sinifikanti mhumiex mistennija (ara sezzjoni 5.2).
English: Serious adverse reactions such as gastrointestinal haemorrhage and intracranial haemorrhage have been reported.
Maltese: Reazzjonijiet avversi serji bħal emorraġija gastro-intestinali u emorraġija intrakranjali kienu rrappurtati.
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).
Maltese: Dejta riċenti minn prova klinika f'pazjenti bi storja medika magħrufa ta' mard kardjovaskulari jew pulmonari wriet żieda sinifikanti fl-inċidenza ta' avvenimenti kardijaċi b'azacitidine (ara sezzjoni 4.8).
English: However, exposure was within the same general range of exposures observed for subjects with normal renal function.
Maltese: Madankollu, l-esponiment kien fl-istess medda ġenerali ta' esponimenti osservati għal individwi b'funzjoni renali normali.
English: Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
Maltese: (n = 179) kien imqabbel ma' korsijiet ta' kura konvenzjonali (CCR).
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).
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni bil-kura ta' azacitidine kienu reazzjonijiet ematoloġiċi (71.4%) li jinkludu tromboċitopenija, newtropenija u lewkopenija (normalment Grad 3-4), avvenimenti gastrointestinali (60.6%) li jinkludu dardir, rimettar (normalment Grad 1-2) jew reazzjonijiet fis-sit tal-injezzjoni (77.1%; normalment Grad 1-2).
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).
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni (≥ 30%) bil-kura b'azacitidine kienu avvenimenti gastrointestinali, li jinkludu stitikezza (41.9%), dardir (39.8%), u dijarea (36.9%), (normalment Grad 1-2), disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata li jinkludu deni (37.7%; normalment Grad 1-2) u avvenimenti ematoloġiċi, li jinkludu newtropenija bid-deni (32.2%) u newtropenija (30.
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).
Maltese: Ir-rispons totali (tnaqqis sħiħ tal-mard [CR] + tnaqqis parzjali tal-mard [PR]) kif stabbilit mill-investigatur kien ta' 29% fil-grupp ta' azacitidine u 12% fil-grupp kombinat tas-CCR (p = 0.0001).
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna)
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
Maltese: Reazzjonijiet avversi serji oħrajn minn dawn it-3 studji kienu jinkludu infezzjonijiet bħal sepsis newtropenika (0.8%) u pnewmonja (2.5%) (xi wħud b'riżultat fatali), tromboċitopenja (3.5%), reazzjonijiet ta' sensittività eċċessiva (0.25%) u avvenimenti emorraġiċi (eż. emorraġija ċerebrali [0.5%], emorraġija gastrointestinali [0.8%] u emorraġija intrakranjali [0.5%])).
English: In human liver S9 fractions, formation of metabolites was independent of NADPH implying that azacitidine metabolism was not mediated by cytochrome P450 isoenzymes.
Maltese: Fi frazzjonijiet S9 ta' fwied uman, il-formazzjoni tal-metaboliti kienet indipendenti minn NADPH li timplika li l-metaboliżmu ta' azacitidine ma kienx medjat minn isoenzimi ta' ċitokrom P450.
English: Of the patients in the Vidaza group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Maltese: Mill-pazjenti fil-grupp ta' Vidaza li kienu dipendenti fuq trasfużjoni ta' plejtlets fil-linja bażi, 40.6% (95% CI = 30.9, 50.8) minn dawn il-pazjenti saru indipendenti minn trasfużjoni ta' plejtlits matul il-perjodu ta' kura, meta mqabbla ma' 29.3% ta' (95% CI = 19.7, 40.4) pazjenti fil-gruppi ta' CCR kombinat.
English: Non-proliferating cells are relatively insensitive to azacitidine.
Maltese: Iċ-ċelluli li ma jipproliferawx huma relattivament insensittivi għal azacitidine.
English: An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce CYP 1A2, 2C19, or 3A4 or 3A5.
Maltese: Studju in vitro ta' azacitidine b'epatoċiti umani kolturati jindika li f'konċentrazzjonijiet ta' 1.0 µM sa 100 µM (i.e. sa madwar 30 darba ogħla minn konċentrazzjonijiet li jintlaħqu klinikament), azacitidine ma jinduċix CYP 1A2, 2C19, jew 3A4 jew 3A5.
English: RAEB-T patients (21-30 % blasts) are now considered to be AML patients under the current WHO classification system.
Maltese: Pazjenti b'RAEB-T (21-30% blasts) issa huma kkunsidrati li huma pazjenti b'AML taħt is-sistema kurrenti tal-klassifikazzjoni tal-WHO.
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.
Maltese: Ibbażat fuq dejta in vitro, ma jidhirx li l-metaboliżmu ta' azacitidine hu medjat mill-isoenzimi ta' ċitokrom P450 (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), u glutathione transferases (GSTs); l-interazzjonijiet relatati ma' dawn l-enzimi li jimmetabolizzaw in vivo huma għalhekk ikkunsidrati li mhumiex mistennija.
English: • Shaking.
Maltese: • Sturdament.
English: As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Maltese: Bħala parti mill-kriterja tal-inklużjoni, il-pazjenti kienu jeħtieġu li jkollhom stat tal-prestazzjoni Eastern Cooperative Oncology Group (ECOG) ta' 0-2.
English: Patients with renal impairment
Maltese: Pazjenti b'indeboliment renali
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.
Maltese: ITT ta' 358 pazjent (179 azacitidine u 179 CCR), il-kura b'Vidaza kienet assoċjata ma' medjan ta' sopravivenza ta' 24.46 xahar kontra 15.
English: The effect of known cytidine deaminase polymorphisms on azacitidine metabolism has not been formally investigated.
Maltese: L-effett ta' cytidine deaminase polymorphisms magħrufa fuq il-metaboliżmu ta' azacitidine ma kienx investigat formalment.
English: • Fluid around the lungs (pleural effusion).
Maltese: • Fluwidu madwar il-pulmun (effużjoni tal-plewra).
English: Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Maltese: Pazjenti b'għadd imnaqqas taċ-ċelluli tad-demm fil-linja bażi (i.e. WBC < 3.0 x 109/l jew ANC < 1.5 x 109/l jew plejtlits < 75.0 x 109/l) qabel l-ewwel kura
English: Each pack contains one vial of Vidaza.
Maltese: Kull pakkett fih kunjett wieħed ta' Vidaza.
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.
Maltese: Flimkien ma' dan, l-aċidożi tubulari renali, definita bħala tnaqqis fil-livell tal-bicarbonate fis-serum għal < 20 mmol/L flimkien ma' awrina alkalina u ipokalemija (potassium fis-serum < 3 mmol/L) żviluppat f'5 pazjenti b'lewkimja majeloġena kronika (CML) ikkurati b'azacitidine u etoposide.
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).
Maltese: Vidaza flimkien ma' BSC (n=241) ġie pparagunat ma' CCR. CCR kienet tikkonsisti f'BSC waħidha (n=45), cytarabine f'doża baxxa flimkien ma' BSC (n=158) jew kimoterapija intensiva standard ma' cytarabine u anthracycline flimkien ma' BSC (n=44).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Breast-feeding
Maltese: Fl-analiżi
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).
Maltese: Kunjett(i) ta' azacitidine; kunjett(i) ta' ilma għall-injezzjonijiet; ingwanti kirurġiċi mhux sterili; biċċiet tat-tajjar bl-alkoħol; siringa(i) għall-injezzjoni ta' 5 mL bil-labra (labar).
English: The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p < 0.0001).
Maltese: Ir-rati tas-sopravivenza fuq medda ta' sentejn kienu 50.8% f'pazjenti li kienu qed jirċievu azacitidine kontra 26.2% f'pazjenti li kienu qed jirċievu CCR (p < 0.0001).
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.
Maltese: MDS intermedja-2 u ta' riskju għoli skont l-International Prognostic Scoring System (IPSS), anemija refrettarja bi blasts eċċessivi (RAEB), anemija refrettarja bi blasts eċċessivi li qed jinbidlu (RAEB-T) u lewkimja majelomonoċitika kronika modifikata (mCMML) skont is-sistema tal-klassifikazzjoni French American British (FAB).
English: Haematologic and cytogenetic responses were assessed by the investigator and by the IRC with similar results.
Maltese: Ir-risponsi ematoloġiċi u ċitoġenetiċi ġew evalwati mill-investigatur u mill-IRC b'riżultati simili.
English: Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles (see section 4.8).
Maltese: Il-kura b'azacitidine hi assoċjata ma' anemija, newtropenija u tromboċitopenija, speċjalment matul l-ewwel 2 ċikli (ara sezzjoni 4.8).