FrancophonIA/ELRC3.0 huggingface dataset:
English: The HCP educational leaflet about Riximyo for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Riximyo treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Riximyo treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any - The need to provide patients with the Patient Alert Card with each infusion
Maltese: - Il-ħtieġa ta' sorveljanza mill-qrib waqt għoti f'ambjent fejn ikunu disponibbli b'mod immedjat faċilitajiet kompluti ta' risussitazzjoni - Il-ħtieġa li qabel kura b'Riximyo wieħed għandu jiċċekkja għal infezzjonijiet, għal immunosoppressjoni, għal medikazzjoni mogħtija qabel/attwalment li taffettwa s-sistema immuni, u storja reċenti ta' tilqim, jew tilqim ippjanat, u storja ta' reazzjoni relatata malinfużjoni - Il-ħtieġa li l-pazjenti għandhom jiġu ssorveljati għal infezzjonijiet, speċjalment PML, matul u wara kura b'Riximyo - Informazzjoni dettaljata dwar ir-riskju ta' PML, il-ħtieġa ta' dijanjosi f'waqtha ta' PML u miżuri xierqa biex tiġi dijanjostikata PML - Il-bżonn li jgħarraf lill-pazjenti dwar ir-riskju ta' infezzjonijiet u PML, inkluż is-sintomi li wieħed għandu jkun konxju minnhom u l-ħtieġa li wieħed għandu jikkuntattja lit-tabib tiegħu minnufih f'każ ta' xi sintomi - Il-ħtieġa li jipprovdi lill-pazjenti b'Kartuna ta' Twissija għall-pazjent ma' kull infużjoni
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Maltese: avalur p huwa minn test eżatt ta' Fisher b'korrezzjoni mid-p b intervall ta' kunfidenza ta' 95% huwa intervall ta' Newcombe kkoreġut
English: In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
Maltese: Limfoma mhux ta' Hodgkin taċ-ċellula B kbira mxerrda Fi prova tat-tip open label magħmula b'għażla każwali, total ta' 399 pazjent anzjani mhux trattati preċedentement (età -minn 60 sa 80 sena) b'limfoma taċ-ċellula B kbira mxerrda ngħataw kimoterapija CHOP standard (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine
English: Rarely Riximyo can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Maltese: B'mod rari Riximyo jista' jikkawża infezzjoni serja fil-moħħ, imsejħa “lewkoenċefalopatija multifokali progressiva” jew PML.
English: Nausea
Maltese: Nazzjonali
English: Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Maltese: Pemphigus vulgaris Riximyo huwa indikat għat-trattament ta' pazjenti b'pemphigus vulgaris (PV) moderat sa sever.
English: Progression-free survival (PFS) 20.6 Overall survival
Maltese: Sopravivenza mingħajr progressjoni (PFS) Sopravivenza globali
English: This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial.
Maltese: Dan ilprodott mediċinali fih 11.5 mmol (263.2 mg) ta' sodium f'kull kunjett ta' 50 mL.
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Maltese: Wara l-użu ta' rituximab għall-kura ta' artrite rewmatika u mard awtoimmuni inkluż Lupus Eritematosus Sistemika (SLE) u vaskulite kienu rrappurtati każijiet rari ħafna ta' lewkoenċefalopatija multifokali progressiva (PML) fatali.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group
Maltese: F'xahar 24, l-estimi ta' sopravivenza globali kienu ta' 68.2% fil- grupp ta' R-CHOP ikkumparati ma' 57.4%
English: In the event of relapse, patients may receive 1000 mg IV.
Maltese: F'każ ta' rkadar, il-pazjenti jistgħu jirċievu 1000 mg IV.
English: Vasculitis (predomin ately cutaneous), leukocytoc lastic vasculitis
Maltese: • ażżma, wisq ftit ossiġnu jilħaq l-organi tal-ġisem
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Riximyo treatment, as appropriate according to local clinical practice guidelines.
Maltese: Profilassi ta' pnewmonja kkawżata minn Pneumocystis jirovecii (PCP - Pneumocystis jirovecii pneumonia) hija rakkomandata għall-pazjenti b'GPA/MPA jew PV matul u wara trattament b'Riximyo, kif xieraq skont il-linji gwida lokali dwar il-prattika klinika.
English: Do not have Riximyo if you have an active infection or a serious problem with your immune system.
Maltese: Tiħux Riximyo jekk ikollok infezzjoni attiva jew problema serja bis-sistema immuni tiegħek.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: • Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Maltese: Għall-indikazzjonijiet għal limfoma mhux ta' Hodgkin (NHL) u Lewkimja limfoċitika kronika
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Maltese: vincristine 1.4 mg/m2 sa massimu ta' 2 mg fl-ewwel jum, u prednisolone 40 mg/m2/jum mill-ewwel sal-ħames jum) kull 3 ġimgħat għal 8 ċikli jew rituximab 375 mg/m2 flimkien ma' CVP (R-CVP).
English: Riximyo should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Maltese: Infezzjonijiet attivi, severi (ara sezzjoni 4.4).
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Maltese: antikorp huwa magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju tal-ħamster Ċiniż) u ppurifikat bi kromatografija tal-affinità u skambju tal-jone, inkluża l-inattivazzjoni virali speċifika u proċeduri tat-tneħħija.
English: Musculoskelet al and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Repeated treatment courses with Riximyo are possible.
Maltese: tal-virus JC u valutazzjonijiet newroloġiċi ripetuti.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Riximyo to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Maltese: Għall pazjenti b'CLL li għandhom għadd ta' limfoċiti ta' > 25 × 109/L huwa rrakkomandat li jingħata 100 mg prednisone/prednisolone ġol-vini eżatt qabel infużjoni b'Riximyo biex titnaqqas ir-rata u sseverità ta' reazzjonijiet akuti għall-infużjoni u/jew is-sindrome tar-reħa taċ-ċitokina.
English: Paraesthesia, migraine, dizziness, sciatica
Maltese: emigranja, sturdament, xjatika
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of Riximyo and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Maltese: Użu konkomitanti/sekwenzjali ta' DMARDs oħra f'artrite rewmatika L-użu konkomitanti ta' Riximyo u terapiji anti-rewmatiċi għajr dawk speċifikati taħt l-indikazzjoni u l pożoloġija għall-artrite rewmatika mhux rakkomandat.
English: Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time
Maltese: Tabella 10a Kura preferita ta' lewkimja limfoċitika kronika Sommarju tar-riżultati tal-effikaċja għal rituximab flimkien ma' FC vs.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Riximyo (the last dose of methylprednisolone may be given on the same day as the first infusion of Riximyo).
Maltese: F'pazjenti bi granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika, methylprednisolone mogħti fil-vini għal 1 sa 3 ijiem b'doża ta' 1000 mg kuljum huwa rrakkomandat qabel l-ewwel infużjoni ta' Riximyo (l-aħħar doża ta' methylprednisolone tista' tingħata fl-istess jum bħall-ewwel infużjoni ta' Riximyo).
English: Table 13 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Maltese: Cyclophosphamide Differenza (CI 95%)
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Maltese: F'pazjenti bi granulomatosi b'polianġite jew polianġite mikroskopika, in-numru ta' ċelluli B fid-demm periferali naqas għal < 10 ċelluli/μL wara infużjonijiet ta' rituximab 375 mg/m2 kull ġimagħtejn u fil-biċca l kbira tal-pazjenti baqa' f'dan il-livell sa 6 xhur.
English: Paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Maltese: stomatite, stitikezza, dispepsja, anoressija, irritazzjoni fil griżmejn
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Maltese: V1 varja mal-erja tas-superfiċje tal-ġisem (BSA) u mat-terapija CHOP. Din il-varjabilità f'V1 (27.1% u 19.0%) ikkontribwita mill-firxa f'BSA (1.53 sa 2.32 m2) u mit-terapija CHOP fl-istess waqt, rispettivament,
English: The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 14).
Maltese: L-istudju wera riżultati statistikament sinifikanti ta' rituximab u doża baxxa ta' prednisone fuq doża standard ta' prednisone fil-kisba ta' CRoff għal ≥ xahrejn f'xahar 24 f'pazjenti b'PV (ara Tabella 14).
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 2).
Maltese: In-numru ta' pazjenti li jirċievu rituximab flimkien ma' doża baxxa ta' prednisone mingħajr terapija bi prednisone jew fuq terapija minima (doża ta' prednisone ta' 10 mg jew inqas kuljum) meta mqabbla ma' pazjenti li jirċievu prednisone b'doża standard matul il-perjodu ta' trattament ta' 24 xahar juri effett ta' rituximab li jnaqqas l-użu ta' sterojdi (Figura 2).
English: Riximyo 100 mg concentrate for solution for infusion Riximyo 500 mg concentrate for solution for infusion rituximab
Maltese: Riximyo 100 mg konċentrat għal soluzzjoni għal infużjoni Riximyo 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: The recommended dosage of Riximyo for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Maltese: Id-dożaġġ rakkomandat ta' Riximyo għat-trattament ta' pemphigus vulgaris huwa ta' 1000 mg mogħti bħala infużjoni IV segwit ġimagħtejn wara mit-tieni infużjoni IV ta' 1000 mg flimkien ma' kors ta' glukokortikojdi li jitnaqqsu għax-xejn.
English: Median PFS: 28.8 Not reached p < 0.0001
Maltese: PFS medjan: 28.8
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Maltese: Fl-esperjenza globali ta' kura ripetuta ta' rituximab fuq medda ta' sena f'artrite rewmatika, il proporzjon ta' pazjenti b'titri ta' antikorpi pożittivi kontra S. pneumoniae, influwenza, ħosba, rubella,
English: Other medicines and Riximyo
Maltese: Kif taħżen Riximyo
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Maltese: Pazjenti b'seroloġija pożittiva għall-epatite B (HBsAg jew HBcAb) għandhom jikkonsultaw esperti tal-mard tal-fwied qabel ma tinbeda l-kura u għandhom jiġu mmonitorjati u mmaniġjati skont standards mediċi lokali biex tiġi evitata attivazzjoni mill-ġdid tal epatite B.
English: Measure blood neutrophils prior to each course of Riximyo, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Maltese: Kejjel in-newtrofili fid-demm qabel kull kors ta' Riximyo, u b'mod regolari għal perjodu sa 6 xhur wara l-waqfien tal-kura, u meta jkun hemm sinjali jew sintomi ta' infezzjoni (ara sezzjoni 4.8).
English: All physicians who are expected to prescribe Riximyo for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Riximyo
Maltese: - Informazzjoni dwar il-prodott - Kartuna ta' twissija tal-HCP (Health care professional - Professjonista tal-kura tas-saħħa) li tindirizza l-użu korretta ta' Riximyo
English: Riximyo maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Maltese: Il-pazjenti kollha fil-grupp ta' cyclophosphamide rċevew terapija ta' manteniment ta' azathioprine waqt ilperjodu li fih ġew segwiti.
English: Bulky disease
Maltese: evalwazzjoni klinika.
English: Riximyo 100 mg concentrate for solution for infusion Riximyo 500 mg concentrate for solution for infusion
Maltese: Riximyo 100 mg konċentrat għal soluzzjoni għal infużjoni Riximyo 500 mg konċentrat għal soluzzjoni għal infużjoni
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with Riximyo.
Maltese: Huwa rrakkomandat li l-livelli ta' immunoglobulina jiġu determinati qabel ma tinbeda l-kura Riximyo.
English: Patient subpopulations - rituximab combination therapy
Maltese: Sottopopolazzjonijiet ta' pazjenti - rituximab bħala terapija kombinata Pazjenti anzjani (≥ 65 sena):
English: Riximyo is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Maltese: Riximyo jintuża għat-trattament ta' pazjenti b'pemphigus vulgaris moderat sa sever.
English: Complete remission at 12 and 18 months
Maltese: Remissjoni kompluta wara 12 u 18-il xahar
English: The reported cases had recognized risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Maltese: Il-każijiet irrappurtati kellhom fatturi ta' riskju rikonoxxuti għal PRES/RPLS, inkluż il-marda tal-pazjent, pressjoni għolja, terapija immunosoppressiva u/jew kimoterapija.
English: < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: sa < 1/1,000) u rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għall-proteini tal-ġrieden, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Malignancy
Maltese: Anzjani
English: Patient subpopulations - rituximab monotherapy
Maltese: tal-pazjenti kkurati b'rituximab bħala monoterapija.
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi
English: Relapsed/Refractory follicular lymphoma
Maltese: Lanaliżi finali kkonfermat li l-kura
English: IgG levels
Maltese: GLSG'00
English: Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Maltese: Tagħrif minn madwar 180 pazjent ikkurati minn qabel b'rituximab wera benefiċċju kliniku (inkluż
English: Figure 1:
Maltese: CI:
English: Chronic lymphocytic leukaemia
Maltese: b) Lewkimja limfoċitika kronika
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of Riximyo.
Maltese: Għandhom ikunu disponibbli għall-użu immedjat prodotti mediċinali għall-kura ta' reazzjonijiet ta' sensittività eċċessiva, eż. epinefrina (adrenalina), antistamini u glukokortikojdi, f'każ li jkun hemm reazzjoni allerġika waqt l-amministrazzjoni ta' Riximyo.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2 mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Maltese: (2 mg/kg/jum) għal 3-6 xhur jew rituximab (375 mg/m2) darba fil-ġimgħa għal 4 ġimgħat.
English: Hypercholestero lemia
Maltese: Kundl L-Awstrija
English: Riximyo 500 mg concentrate for solution for infusion rituximab
Maltese: Riximyo 500 mg konċentrat għal soluzzjoni għall-infużjoni rituximab
English: Grades 3-4
Maltese: Gradi 3-4
English: Cmax (ng/ml) AUCcum (ng.h/ml) t1/2 (min)
Maltese: Cmax (ng/ml) AUCcum (ng.siegħa/ml) t1/2 (min)
English: 100 mg/m2.
Maltese: 2 g/m2.
English: CR EFS
Maltese: CR EFSa
English: Including enterocolitis infectious.
Maltese: Inkluża, enterokolite infettiva.
English: Death (%)
Maltese: Mewt (%)
English: Date of first authorisation: 20 September 2012 Date of latest renewal: 22 May 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 Settembru 2012 Data tal-aħħar tiġdid: 22 Mejju 2017
English: TC (combined group) n = 243
Maltese: TC (grupp flimkien) n = 243
English: Analysis of mature overall survival data (ITT population).
Maltese: Analiżi ta' dejta matura ta' sopravivenza globali (popolazzjoni ITT).
English: Common septic shock* sepsis* sinusitis
Maltese: Komuni xokk settiku* sepsis* sinożite
English: Breast-feeding (see section 4.6)
Maltese: Treddigħ (ara sezzjoni 4.6)
English: Plasma protein binding of decitabine is negligible (< 1%).
Maltese: L-irbit ta' decitabine mal-proteini tal-plażma huwa insinifikanti (< 1%).
English: NA = Not applicable
Maltese: NA = Mhux applikabbli (Not applicable)
English: Dacogen contains potassium and sodium
Maltese: Dacogen fih potassium u sodium
English: CR = complete remission; CRp = complete remission with incomplete platelet recovery, EFS = event-free survival, PFS = progression-free survival, OR = odds ratio, HR = hazard ratio - = Not evaluable
Maltese: CR = (complete remission) kontroll sħiħ tal-marda; CRp = (complete remission with incomplete platelet recovery) kontroll sħiħ tal-marda bi rkuprar mhux sħiħ tal-plejtlits, EFS = (event-free survival) sopravivenza mingħajr effetti, PFS = (progression-free survival) sopravivenza mingħajr avvanz tal-marda, OR = (odds ratio) proporzjon ta' probabbiltà, HR = (hazard ratio) proporzjon ta' periklu - = Ma setax jiġi stmat
English: • Febrile neutropaenia (temperature ≥ 38.5°C and absolute neutrophil count < 1,000/µL)
Maltese: • Newtropenija bid-deni (temperatura ≥ 38.5°C u għadd assolut tan-newtrofils < 1,000/µL)
English: Uncommon pancytopaenia*
Maltese: Mhux komuni panċitopenija*
English: 95% confidence intervals
Maltese: Intervalli ta' kunfidenza 95%
English: HR (95% CI): 0.85 (0.69, 1.04) Logrank p-value: 0.1079
Maltese: HR (95% CI): 0.85 (0.69, 1.04) Logrank valur p: 0.1079
English: In the ITT analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
Maltese: ITT, rata ta' CR ta' 23.6% (95% CI: 13.2,37) ġiet osservata fi 13/55 individwu kkurat b'Dacogen.
English: Do not use Dacogen:
Maltese: Tużax Dacogen:
English: • Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25,000/µL or any central nervous system haemorrhage)
Maltese: • Emorraġija (gastrointestinali, ġenitoawrinarja, pulmonari bi plejtlits < 25,000/µL jew kwalunkwe emorraġija fis-sistema nervuża ċentrali)
English: Table 2: Other efficacy endpoints for Study DACO-016 (ITT population)
Maltese: Tabella 2: Punti aħħarin oħra ta' effikaċja għall-istudju DACO-016 (popolazzjoni ITT)
English: • The active substance is decitabine.
Maltese: • Is-sutanza attiva hija decitabine.
English: Common hypersensitivity including anaphylactic reaction
Maltese: Komuni sensittività eċċessiva inkluża reazzjoni anafilattika
English: Frequency categories are defined as follows: 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 (frequency cannot be estimated from the available data).
Maltese: 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 tal-frekwenza mid-dejta disponibbli).
English: Reported adverse events were consistent with the known safety profile of Dacogen in adults (see section 4.8).
Maltese: Avvenimenti avversi rrappurtati kienu konistenti mal-profil magħruf ta' sigurtà ta' Dacogen fl-adulti (ara sezzjoni 4.8).
English: CL (L/h)
Maltese: CL (L/siegħa)
English: It contains the active substance ‘decitabine'.
Maltese: Huwa fih is-sustanza attiva ‘decitabine'.
English: , e anaemia leukopaenia
Maltese: *, e anemija lewkopenija
English: The median overall survival in the ITT population was 7.6 months (95% CI: 5.7, 11.5).
Maltese: Il-medjan tas-sopravivenza globali fil-poplazzjoni ITT kien ta' 7.6 xhur (95% CI: 5.7, 11.5).
English: The number of patients treated with Dacogen by racial group was White 209 (86.4%) and Asian 33 (13.6%).
Maltese: In-numru ta' pazjenti kkurati b'Dacogen skont ir-razza kienu Bojod 209 (86.4%) u Asjatiċi 33 (13.6%).
English: Uncommon acute febrile neutrophilic dermatosis (Sweet's syndrome)
Maltese: Mhux komuni dermatożi newtrofilika akuta bid-deni (sindromu ta' Sweet)
English: Overall survival (ITT population).
Maltese: Sopravivenza globali (popolazzjoni
English: Including haemorrhage associated with thrombocytopaenia, including fatal cases.
Maltese: Inkluża emorraġija assoċjata ma' tromboċitopenija, inklużi każijiet fatali.
English: The median age for the intent-to-treat (ITT) population was 73 years (range 64 to 91 years).
Maltese: L-età medjana għall-popolazzjoni blintenzjoni li tiġi kkurata (ITT) kienet ta' 73 sena (tvarja minn 64 sa 91 sena).
English: HR (95% CI): 0.82 (0.68, 0.99) Logrank p-value: 0.0373
Maltese: 82 (0.68, 0.99) Logrank valur p: 0.0373
English: • The dose is 20 mg/m2 body surface area.
Maltese: • Id-doża hija ta' 20 mg/m2 ta' erja tas-superfiċje tal-ġisem.
English: 1 vial
Maltese: 1 ISEM
English: Table 1: Adverse drug reactions identified with Dacogen
Maltese: Tabella 1: Reazzjonijiet Avversi għall-Mediċina Identifikati b'Dacogen
English: Dacogen 50 mg powder for infusion decitabine
Maltese: Dacogen 50 mg trab għall-infużjoni decitabine