FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Vidaza is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Maltese: Vidaza hu kontraindikat f'pazjenti b'tumuri epatiċi malinni avvanzati (ara sezzjonijiet 4.3 u 4.4).
English: BSA value of 1.8 m2 Number of vials required
Maltese: Doża totali bbażata fuq il-valur BSA ta' 1.8 m2
English: Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
Maltese: Pazjenti bi storja ta' insuffiċjenza konġestiva severa tal-qalb, mard tal-qalb li jkun klinikament instabbli jew mard pulmonari kienu esklużi mill-istudji ta' reġistrazzjoni ta' importanza kbira (AZA PH GL 2003 CL 001 u AZA-AML-001) u għalhekk is-sigurtà u l-effikaċja ta' azacitidine f'dawn il-pazjenti ma kinux stabbiliti.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: • Constipation, diarrhoea, nausea, vomiting.
Maltese: • Stitikezza dijarea, nawseja, rimettar.
English: PHARMACEUTICAL FORM Powder for suspension for injection.
Maltese: Trab għal suspensjoni għall-injezzjoni.
English: Azacitidine is cleared rapidly from plasma with a mean elimination half-life (t½) after subcutaneous administration of 41 ± 8 minutes.
Maltese: Azacitidine jitneħħa malajr mill-plażma b'half-life medja tal-eliminazzjoni (t½) wara l-għoti taħt il-ġilda ta' 41 ± 8 minuti.
English: Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA.
Maltese: L-inkorporazzjoni ta' azacitidine fid-DNA tirriżulta fl-inattivazzjoni ta' DNA methyltransferases, li twassal għal hypomethylation tad-DNA.
English: • Being confused.
Maltese: • Tħossok konfuż.
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).
Maltese: Vidaza ingħata f'doża SC ta' 75 mg/m2/jum għal 7 ijiem, segwit minn perjodu ta' mistrieħ ta' 21 jum (ċiklu ta' kura ta' 28 jum), għal medjan ta' 6 ċikli (medda: 1 sa 28), pazjenti fuq BSC biss għal medjan ta' 3 ċikli (medda: 1 sa 20), pazjenti fuq cytarabine ta' doża baxxa għal medjan ta' 4 ċikli (medda 1 sa 25) u pazjenti fuq kimoterapija intensiva standard għal medjan ta' 2 ċikli (medda: 1 sa 3, ċiklu ta' induzzjoni flimkien ma' 1 jew 2 ċikli ta' konsolidazzjoni).
English: You may need to read it again.
Maltese: Probabbiltà ta' sopravivenza
English: The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Maltese: Ir-riżultati ppreżentati hawn taħt jirrappreżentaw il-popolazzjoni b'intenzjoni li tiġi kkurata, studjata fi studju AZA-AML-001 (ara sezzjoni 4.1 għall-indikazzjoni approvata).
English: Early embryotoxicity studies in mice revealed a 44 % frequency of intrauterine embryonal death (increased resorption) after a single intraperitoneal injection of azacitidine during organogenesis.
Maltese: Studji dwar l-embrijotossiċità bikrija fil-ġrieden żvelaw frekwenza ta' 44% ta' mewt embrijonali fl-utru (żieda fl-assorbiment) wara injezzjoni waħda mill-peritonew ta' azacitidine matul l-organoġenesi.
English: Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
Maltese: Reazzjonijiet avversi li huma kkunsidrati li huma possibbilment jew probabbilment relatati mal-għoti ta' Vidaza seħħew f'97% tal-pazjenti.
English: • Pneumonia.
Maltese: • Pnewmonja.
English: Adult population aged 65 years or older with AML with > 30% marrow blasts
Maltese: Popolazzjoni adulta li jkollha 65 sena jew aktar b'AML bi > 30% ta' blasts tal-mudullun
English: In a few pre-specified subgroups, the OS HR reached statistical significance including patients with poor cytogenetic risk, patients with AML with myelodysplasia-related changes, patients < 75 years, female patients and white patients.
Maltese: Fi ftit sottogruppi speċifikati minn qabel, l-OS HR laħaq importanza statistika li tinkludi pazjenti b'riskju ċitoġeniku baxx, pazjenti b'AML b'bidliet relatati ma' majelodisplasija, pazjenti li kellhom <75 sena, pazjenti nisa u pazjenti bojod.
English: Blood and lymphatic system disorders febrile neutropenia*, neutropenia, leukopenia, thrombocytopenia, anaemia pancytopenia*, bone marrow failure
Maltese: Disturbi tad-demm u tas-sistema limfatika newtropenija bid-deni*, newtropenija, lewkopenja, tromboċitopenja, anemija panċitopenja*, insuffiċjenza tal-mudullun
English: After reconstitution, each mL suspension contains 25 mg azacitidine.
Maltese: Wara r-rikostituzzjoni, kull mL ta' suspensjoni jkun fih 25 mg azacitidine.
English: • Muscle spasms.
Maltese: • Spażmi fil-muskoli.
English: What Vidaza is
Maltese: X'inhu Vidaza
English: Table 1: ADRs reported in patients with MDS or AML treated with azacitidine (clinical studies and post- marketing)
Maltese: Tabella 1 : ADRs irrappurtati f'pazjenti b'MDS jew AML ikkurati b'azacitidine (studji kliniċi u wara t-tqegħid fis-suq)
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).
Maltese: Dejta minn prova klinika li kienet tippermetti r-reġistrazzjoni ta' pazjenti bi storja medika magħrufa ta' mard kardjovaskulari jew pulmonari wriet żieda statistikament sinifikanti fl-avvenimenti kardijaċi f'pazjenti b'AML li tkun għadha kif ġiet iddijanjostikata, ikkurati b'azacitidine (ara sezzjoni 4.4).
English: Of the patients in the Vidaza group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Maltese: Mill-pazjenti fil-grupp ta' Vidaza li kienu dipendenti fuq trasfużjoni ta' RBC fil-linja bażi, 38.5% (95% CI = 31.1, 46.2) minn dawn il-pazjenti saru indipendenti minn trasfużjoni ta' RBC matul il-perjodu ta' kura, meta mqabbla ma' 27.
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection
Maltese: Vidaza 25 mg/mL trab għal suspensjoni għall-injezzjoni
English: When IPSS cytogenetic subgroups were analysed, similar findings in terms of median overall survival were observed in all groups (good, intermediate, poor cytogenetics, including monosomy 7).
Maltese: Meta s-sotto-gruppi ċitoġeniċi IPSS kienu analizzati, sejbiet simili fir-rigward ta' medjan tas-sopravivenza totali kienu osservati fil-gruppi kollha (ċitoġeniċi tajbin, intermedji, batuti, li jinkludu monosomija 7).
English: • Collection of fluid around the heart (pericardial effusion)..
Maltese: • Akkumulazzjoni ta' fluwidu madwar il-qalb (effużjoni perikardijaka).
English: Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Maltese: Minħabba li pazjenti anzjani huma aktar mistennija li jkollhom tnaqqis fil-funzjoni renali, jista' jkun utli li jsir monitoraġġ tal-funzjoni renali.
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.
Maltese: Meta Vidaza jiġi rikostitwit bl-użu ta' ilma għall-injezzjonijiet li ma jkunx tpoġġa fi friġġ, l-istabbiltà kimika u fiżika waqt l-użu tal-prodott mediċinali rikostitwit intweriet f'temperatura ta' 25°C għal 45 minuta u f'temperatura ta' minn 2°C sa 8°C għal 8 sigħat.
English: Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Maltese: Azacitidine hu kontraindikat f'pazjenti b'tumuri epatiċi malinni avvanzati (ara sezzjoni 4.3).
English: • Indigestion.
Maltese: • Indiġestjoni.
English: PHARMACEUTICAL PARTICULARS
Maltese: FARMAĊEWTIKA
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.
Maltese: Is-siringa mimlija bis-suspensjoni rikostitwita għandha titħalla sa 30 minuta qabel l-għoti biex tilħaq temperatura ta' madwar 20°C-25°C.
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.
Maltese: Vidaza 25 mg/mL trab għal suspensjoni għall-injezzjoni Azacitidine DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: • Muscle aches.
Maltese: • Uġigħ fil-muskoli.
English: After reconstitution with 4 mL of water for injections, the reconstituted suspension contains 25 mg/mL azacitidine.
Maltese: Wara r-rikostituzzjoni b'4 mL ta' ilma għall-injezzjonijiet, is-suspensjoni rikostitwita jkun fiha 25 mg/mL azacitidine.
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).
Maltese: Ir-rata ta' rispons globali (tnaqqis ta' mard komplet [CR] + tnaqqis ta' mard komplet b'irkupru mhux komplet ta' għadd tad-demm [CRI]) kif determinat mill-IRC kienet ta' 27.8% fil-grupp ta' Vidaza u 25.
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.
Maltese: Wara l-għoti taħt il-ġilda ta' doża waħda ta' 75 mg/m2, il-valuri medji tal-esponiment (AUC u Cmax) minn individwi b'indeboliment renali ħafif, moderat u sever żdiedu b'11-21%, 15-27%, u 41-66%, rispettivament, meta mqabbla ma' individwi b'funzjoni renali normali.
English: bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage (at injection site), malaise, chills, catheter site hemorrhage injection site necrosis (at injection site)
Maltese: tbenġil, ematoma, ebusija, raxx, ħakk, infjammazzjoni, tibdil fil-kulur, formazzjoni ta' għoqod u emorraġija (fis-sit tal-injezzjoni), telqa, tertir ta' bard, emorraġija fis-sit tal-kateter nekrożi fis-sit tal-injezzjoni (fis-sit tal-injezzjoni)
English: Cumulatively, the safety database includes 51 cases with 56 events of pericarditis, myocarditis, and/or endocarditis reported with the use of Vidaza.
Maltese: B'mod kumulattiv, il-bażi ta' data tas-sigurtà tinkludi 51 każ b'56 avveniment ta' perikardite, mijokardite, u/jew endokardite rrappurtati bl-użu ta' 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
Maltese: Pazjenti mingħajr għadd imnaqqas taċ-ċelluli tad-demm fil-linja bażi (i.e. Ċelluli Bojod tad-Demm (WBC) ≥ 3.0 x 109/l u ANC ≥ 1.5 x 109/l, u plejtlits ≥ 75.0 x 109/l) qabel l-ewwel kura
English: Vidaza is an anti-cancer agent which belongs to a group of medicines called ‘anti-metabolites'.
Maltese: Vidaza hi sustanza kontra l-kanċer li tappartjeni għal grupp ta' mediċini msejħa ‘antimetaboliti'.
English: For doses requiring more than 1 vial, the dose should be equally divided e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe.
Maltese: Għal dożi li jkunu jeħtieġu iktar minn 1 kunjett, id-doża għandha tinqasam b'mod ugwali eż., doża ta' 150 mg = 6 mL, 2 siringi bi 3 mL f'kull siringa.
English: You will usually receive at least 6 treatment cycles.
Maltese: Normalment inti ser tirċievi mill-inqas 6 ċikli tal-kura.
English: White lyophilised powder.
Maltese: • jekk għandek kanċer avvanzat tal-fwied.
English: Hepatobiliary disorders hepatic failure*, progressive hepatic coma
Maltese: Pazjenti b'indeboliment epatiku
English: Although no clinically relevant differences in the frequency of adverse reactions were noted between subjects with normal renal function compared to those with renal impairment, patients with renal impairment should be closely monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney (see section 4.2).
Maltese: Għalkemm ma ġew innutati l-ebda differenzi klinikament rilevanti fil-frekwenza ta' avvenimenti avversi bejn individwi b'funzjoni renali normali meta mqabbla ma' dawk b'indeboliment renali, pazjenti b'indeboliment renali għandhom ikunu mmonitorjati mill-qrib għat-tossiċità minħabba li azacitidine u/jew il-metaboliti tiegħu jitneħħew primarjament mill-kliewi (ara sezzjoni 4.2).
English: • Dry cough.
Maltese: • jekk qed tredda'.
English: On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years, ≥ 65 years and ≥ 75 years).
Maltese: Meta saret analiżi tas-sotto-gruppi tal-età, żieda fil-medjan tas-sopravivenza totali kienet osservata għall-gruppi kollha (< 65 sena, ≥ 65 sena u ≥ 75 sena).
English: The hazard ratio for the treatment effect was 0.85 (95% CI= 0.69, 1.03).
Maltese: 9), CCR = 46(18.6) HR mhux stratifikat = 0.84 [95%CI: 0.69 - 1.02 ], HR stratifikat = 0.85 [95%CI: 0.69 - 1.03]
English: • Drowsiness, shaking, jaundice, abdominal bloating and easy bruising.
Maltese: • Ngħas, rogħda, suffejra, nefħa addominali u titbenġel faċilment.
English: Doses greater than 4 mL should be injected into two separate sites.
Maltese: Dożi ta' iktar minn 4 mL għandhom ikunu injettati f'żewġ postijiet separati.
English: Soft tissue infections, including cellulitis and necrotising fasciitis in rare cases leading to death, have been reported with azacitidine in the post marketing setting.
Maltese: Infezzjonijiet tat-tessut artab, li jinkludu ċellulite u faxxite nekrotizzanti li f'każijiet rari jwasslu għall-mewt, ġew irrappurtati b'azacitidine fi sfond ta' wara t-tqegħid fis-suq.
English: The most commonly reported (≥ 10%) haematological adverse reactions associated with azacitidine treatment include anaemia, thrombocytopenia, neutropenia, febrile neutropenia and leukopenia, and were usually Grade 3 or 4.
Maltese: L-iktar reazzjonijiet ematoloġiċi avversi li kienu rrappurtati (≥ 10%) b'mod komuni assoċjati mal-kura b'azacitidine jinkludu anemija, tromboċitopenja, newtropenija bid-deni u lewkopenja, u kienu normalment ta' Grad 3 jew 4.
English: Azacitidine can be administered to patients with renal impairment without initial dose adjustment (see section 5.2).
Maltese: Azacitidine jista' jingħata lil pazjenti b'indeboliment renali mingħajr aġġustament tad-doża inizjali (ara sezzjoni 5.2).
English: Therefore, based on the assessment of all available information for pericarditis, including spontaneous reports identified in the Safety Topic Review, the already listed ADR of pericardial effusion in the Vidaza SmPC and the fact that pericarditis is a listed term for some other products of the same class, the SmPC section 4.8 should be updated by including the term pericarditis under the SOC cardiac disorders with frequency ‘uncommon'.
Maltese: Għalhekk, fuq il-bażi tal-valutazzjoni tal-informazzjoni kollha disponibbli għal perikardite, inkluż rapporti spontanji identifikati fir-Reviżjoni tas-Suġġett tas-Sigurtà, l-ADR diġà mniżżla ta' effużjoni perikardijaka fl-SmPC ta' Vidaza u l-fatt li l-perikardite hija terminu mniżżel għal xi prodotti oħrajn tal-istess klassi, is-sezzjoni 4.8 tal-SmPC għandha tiġi aġġornata bl-inklużjoni tat-termini perikardite taħt l-SOC ta' disturbi fil-qalb bi frekwenza “mhux komuni”.
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.
Maltese: F'pazjenti li kienu dipendenti fuq trasfużjoni ta' RBC fil-linja bażi u li kisbu indipendenza mit-trasfużjonijiet waqt li kienu fuq il-kura, it-tul medjan ta' indipendenza minn trasfużjoni ta' RBC kien ta' 13.9 xhur fil-grupp ta' Vidaza, u ma ntlaħaqx fil-grupp ta' CCR.
English: 5 How to store Vidaza Contents of the pack and other information
Maltese: Kif taħżen Vidaza Kontenut tal-pakkett u informazzjoni oħra
English: • Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Maltese: • Sindromu tumour lysis - kumplikazzjonijiet metaboliċi li jistgħu jseħħu waqt il-kura tal kanċer u xi kultant anki mingħajr il-kura.
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.
Maltese: Hu maħsub li azacitidine jeżerċita l-effetti antineoplastiċi tiegħu permezz ta' mekkaniżmi multipli li jinkludu ċitotossiċità fuq ċelluli ematopojetiċi anormali fil-mudullun u hypomethylation tad-DNA.
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.
Maltese: F'pazjenti li kienu dipendenti fuq it-trasfużjonijiet tar-RBC fil-linja bażi u saru indipendenti, it-tul medjan tal-indipendenza mit-trasfużjonijiet tar-RBC kien ta' 13-il xahar fil-grupp ta' azacitidine.
English: Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza.
Maltese: Faxxite nekrotizzanti, li tinkludi każijiet fatali, ġiet irrappurtata f'pazjenti kkurati b'Vidaza.
English: Marketing Authorisation Holder Celgene Europe B.V.
Maltese: Celgene Distribution B.V.
English: HRQoL data could be analysed for a subset of the full trial population.
Maltese: Dejta minn HRQoL setgħet tiġi analizzata għal sottosett tal-popolazzjoni tal-prova sħiħa.
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni)
English: The Vidaza suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Maltese: Is-suspensjoni ta' Vidaza tista' tkun ippreparata immedjatament qabel l-użu u s-suspensjoni rikostitwita għandha tingħata fi żmien 45 minuta.
English: This “treatment cycle” will be repeated every 4 weeks.
Maltese: Dan iċ-“ċiklu tal-kura” ser jiġi ripetut kull 4 ġimgħat.
English: Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tubular acidosis, renal failure and death were reported in patients treated with azacitidine (see section 4.4).
Maltese: Anormalitajiet fil-kliewi, li jvarjaw minn livelli għolja ta' krejatinina fis-serum u ematurja sa aċidożi tubulari tal-kliewi, insuffiċjenza tal-kliewi u mewt kienu rrappurtati f'pazjenti kkurati b'azacitidine (ara sezzjoni 4.4).
English: The temperature of the suspension at the time of injection should be approximately 20 ºC-25 ºC.
Maltese: It-temperatura tas-suspensjoni fil-ħin tal-injezzjoni għandha tkun ta' madwar 20°C-25°C.
English: Haematological improvement (major or minor) as determined by the IRC was achieved in 49 % of patients receiving azacitidine compared with 29 % of patients treated with combined CCR (p < 0.0001).
Maltese: Titjib ematoloġiku (maġġuri jew minuri) kif stabbilit mill-IRC intlaħaq f'49% tal-pazjenti li kienu qed jirċievu azacitidine meta mqabbla ma' 29% tal-pazjenti kkurati b'CCR kombinat (p < 0.0001).
English: As part of the inclusion criteria, patients were required to have an ECOG performance status of 0-2 and intermediate- or poor-risk cytogenetic abnormalities.
Maltese: Bħala parti mill-kriterji ta' inklużjoni, il-pazjenti kienu meħtieġa li jkollhom stat ta' prestazzjoni ECOG ta' 0-2 u anormalitajiet ċitoġenetiċi intermedji jew ta' riskju baxx.
English: • Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion, restlessness or fatigue.
Maltese: • Nefħa tar-riġlejn u tas-saqajn, uġigħ fid-dahar, tnaqqis fl-ammont ta' awrina, żieda fl-għatx, rata mgħaġla tal-polz, sturdament u nawseja, rimettar jew tnaqqis fl-aptit u sensazzjonijiet ta' konfużjoni, nuqqas ta' kwiet jew għeja.
English: OTHER
Maltese: ISEM
English: CLINICAL PARTICULARS
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Low levels of potassium in your blood.
Maltese: • Livelli baxxi ta' potassium fid-demm tiegħek.
English: gastrointestinal haemorrhage* (includes mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
Maltese: emorraġija gastro-intestinali* (jinkludi emorraġija tal-ħalq), emorraġija tal-murliti, stomatite, ħruġ ta' demm tal-ħanek, dispepsja
English: Myelosuppression may lead to neutropenia and an increased risk of infection.
Maltese: Il-majelosoppressjoni tista' twassal għan-newtropenija u għal żieda fir-riskju ta' infezzjoni.
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.
Maltese: Il-benefiċċji tas-sopravivenza ta' Vidaza kienu konsistenti irrispettivament mill-għażla tal-kura CCR (BSC waħidha, doża baxxa ta' cytarabine flimkien ma' BSC jew kimoterapija tal-induzzjoni standard flimkien ma' BSC) użati fil-parti tal-kontroll tal-istudju.
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.
Maltese: Irkuprar* > 21 jum *Irkuprar = għadd ≥ għadd tan-nadir + (0.5 x [għadd fil-linja bażi - għadd tan-nadir]) Wara t-tibdil fid-doża, it-tul taċ-ċiklu għandu jerġa' lura għal 28 jum.
English: The efficacy and safety of Vidaza was studied in an international, multicentre, controlled, open-label, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Maltese: L-effikaċja u s-sigurtà ta' Vidaza ġew studjati fi studju ta' Fażi 3, internazzjonali, multiċentriku, ikkontrollat, open-label, ta' grupp parallel, li twettaq f'pazjenti li kellhom 65 sena jew aktar, b'AML ma għadhom kif ġew dijanjostikati de novo jew AML ddijanjostikata għall-ewwel de novo jew sekondarja bi > 30% blasts tal-mudullun skont il-klassifikazzjoni tal-WHO, li ma kinux eliġibbli għal HSCT.
English: • Bruising.
Maltese: • Tbenġil.
English: Within the Intent to Treat population (ITT), the median age was 69 years (range 38 to 88 years).
Maltese: Fi ħdan il-popolazzjoni b'Intenzjoni li Jigu Kkurati (ITT), l-età medjana kienet ta' 69 sena (medda 38 sa 88 sena).
English: • Shivering (chills).
Maltese: • Irqad, ngħas (sonnolenza).
English: 45 mg
Maltese: INDIVIDWALI 100 mg
English: Subcutaneous use.
Maltese: Jintuża darba biss.