FrancophonIA/ELRC3.0 huggingface dataset:
English: † Standardised MedDRA Queries (SMQs)
Maltese: Mistoqsijiet Standardizzati MedDRA ((SMQs), Standardised MedDRA Queries)
English: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Germany
Maltese: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224
English: Capsule contents Microcrystalline cellulose Magnesium stearate Talc
Maltese: Kontenut tal-kapsula Microcrystalline cellulose Magnesium stearate Talc
English: The mean absolute oral bioavailability is 58%.
Maltese: Il-bijodisponibbiltà orali assoluta medja hija ta' 58%.
English: The terminal half-life (t1/2) of ixazomib was 9.5 days.
Maltese: Il-half-life terminali (t1/2) ta' ixazomib kienet ta' 9.5 ijiem.
English: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Germany
Maltese: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224
English: Ixazomib did not induce CYP1A2, CYP2B6, and CYP3A4/5 activity or corresponding immunoreactive protein levels.
Maltese: Ixazomib ma induċiex l-attività ta' CYP1A2, CYP2B6 u CYP3A4/5 jew livelli korrispondenti ta' proteini immunoreattivi.
English: Progression-Free Survival Events, n (%)
Maltese: Sopravivenza Ħielsa Minn Progressjoni Avvenimenti, n (%)
English: Nineteen percent had high-risk cytogenetic abnormalities (del[17], t[4;14], t[14;16]) (N=137), 10% had del(17) (N=69) and 34% had 1q amplification (1q21) (N=247).
Maltese: Dsatax fil-mija kellhom anormalitajiet ċitoġenetiċi ta' riskju għoli (del[17], t[4;14], t[14;16]) N = 137), 10% kellhom del(17) (N = 69) u 34% kellhom amplifikazzjoni ta' 1q (1q21) (N = 247).
English: Placebo + Lenalidomide and Dexamethasone (N = 362)
Maltese: Plaċebo + Lenalidomide u Dexamethasone (N = 362)
English: 3 packs of 1 hard capsule.
Maltese: 3 pakketti ta' kapsula iebsa 1.
English: Patients received one to three prior therapies (median of 1) including prior treatment with bortezomib (69%), carfilzomib (<1%), thalidomide (45%), lenalidomide (12%), melphalan (81%).
Maltese: Il-pazjenti rċivew minn terapija waħda sa tlieta preċedenti (medjan ta' 1) inkluż trattament preċedenti b'bortezomib (69%), carfilzomib (< 1%), thalidomide (45%), lenalidomide (12%), u melphalan (81%).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Data tal-ewwel awtorizzazzjoni: 21 ta' Novembru, 2016
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' reazzjonjiet avversi
English: Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Maltese: Is-Cmax ta' ixazomib naqset b'4% u l-AUC naqset bi 11%.
English: PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
Maltese: Folja tal-PVC-Aluminju/Aluminju ssiġillata f'pakkett kartiera b'kapsula waħda.
English: Date of Last Renewal: 16 September 2019
Maltese: Date tal-aħħar tiġdid: 16 ta' Settembru 2019
English: Figure 2: Forest plot of progression-free survival in subgroups
Maltese: Figura 2: Forest-plot ta' sopravivenza mingħajr progressjoni fis-sottogruppi
English: Median (months) p-value*
Maltese: Medjan (xhur) valur p*
English: Ixazomib is not a reversible or a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.
Maltese: Ixazomib mhuwiex inibitur riversibbli, jew dipendenti fuq il-ħin, ta' CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, jew 3A4/5.
English: 1 hard capsule.
Maltese: 1 kapsula iebsa.
English: Takeda Pharmaceuticals Croatia d.o.o.
Maltese: Hrvatska Takeda Pharmaceuticals Croatia d.o.o.
English: Lenalidomide is structurally related to thalidomide.
Maltese: Ixazomib jingħata flimkien ma' lenalidomide. Lenalidomide hu strutturalment relatat ma' thalidomide.
English: Absolute neutrophil count < 500/mm3
Maltese: Għadd totali ta' newtrofili < 500/mm3
English: Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Maltese: Nota: ADRs inklużi bħala termini ppreferuti huma bbażati fuq MedDRA verżjoni 16.0.
English: *Represents a pooling of preferred terms
Maltese: *Jirrappreżenta ġabra ta' termini ppreferuti
English: • In the capsule: microcrystalline cellulose, magnesium stearate and talc.
Maltese: • Fil-kapsula: microcrystalline cellulose, magnesium stearate u talc
English: Figure 1: Kaplan-Meier plot of progression-free survival in the intent-to-treat population
Maltese: Figura 1: Plot ta' Kaplan-Meier tas-sopravivenza bla progressjoni fil-popolazzjoni b'intenzjoni li tiġi kkurata
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Maltese: Takeda Pharma A/S Dybendal Alle 10
English: (95% CI)
Maltese: (95% CI) Rata ta' Rispons Globali‡, n
English: Patients received ixazomib 4 mg or placebo on Days 1, 8, and 15 plus lenalidomide (25 mg) on Days 1 through 21 and dexamethasone (40 mg) on Days 1, 8, 15, and 22 of a 28-day cycle.
Maltese: Pazjenti rċivew ixazomib 4 mg jew plaċebo f'Jiem 1, 8, u 15 flimkien ma' lenalidomide (25 mg) f'Jiem 1 sa 21 u dexamethasone (40 mg) f'Jiem 1, 8, 15, u 22 ta' ċiklu ta' 28 jum.
English: Adverse reactions (all grades)
Maltese: Reazzjonijiet Avversi (il-Gradi Kollha)
English: In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma.
Maltese: In vivo, ixazomib wera attività antitumorali f'diversi mudelli ta' xenografts ta' tumur, inklużi mudelli ta' majeloma multipla.
English: Ixazomib did not prolong the QTc interval at clinically relevant exposures based on the results of a pharmacokinetic-pharmacodynamic analysis of data from 245 patients.
Maltese: Ixazomib ma tawwalx l-intervall tal-QTc f'esponimenti klinikament rilevanti fuq il-bażi tar-riżultati ta' analiżi farmakokinetika-farmakodinamika ta' dejta minn 245 pazjent.
English: Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Maltese: Ixazomib jeħel b'mod preferenzjali u jinibixxi l-attività li tixbah dik ta' chymotrypsin tas-subunità beta 5 tal-proteasome 20S.
English: Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Maltese: L-AUC ta' ixazomib żdiedet b'mod proporzjonali għad-doża fuq medda tad-doża ta' 0.2-10.6 mg.
English: • Swallow the capsule whole with water.
Maltese: • Ibla' l-kapsula sħiħa mal-ilma.
English: The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): 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-konvenzjoni li ġejja tintuża għall-klassifikazzjoni tal-frekwenza ta' reazzjoni avversa għall-mediċina (ADR, adverse drug reaction): 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 tingħata stima mid-data disponibbli).
English: At the final analysis for OS at a median follow up of 19.8 months, OS was improved for patients treated in the ixazomib regimen compared with placebo [p-value=0.0014, HR=0.42, 95% CI: 0.242, 0.726 ]).
Maltese: Fl-analiżi finali għal OS b'follow-up medjan ta' sa 19.8 xhur, l-OS tjieb għal pazjenti ttrattati fil-kors ta' ixazomib meta mqabbel mal-plaċebo [valur p = 0.0014, HR = 0.42, 95% CI: 0.242, 0.726]).
English: Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Maltese: Id-dejta klinika hija limitata iżda dożi ta' sa 12 mg kienu rrappurtati fil-prova klinika kkontrollata.
English: Ixazomib is not an inhibitor of P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, or MATE2-K. Ixazomib is not expected to cause transporter-mediated drug-drug interactions.
Maltese: Ixazomib mhuwiex inibitur ta' P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1 jew MATE2-K.
English: *For additional occurrences, alternate dose modification of lenalidomide and ixazomib †Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03
Maltese: †Gradazzjoni bbażata fuq il-Kriterji ta' Terminoloġija Komuni (CTCAE, Common Terminology Criteria for Adverse Events) tan-National Cancer Institute Verżjoni 4.03
English: The requirements for submission of PSURs for this medicinal product 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 PSURs- 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 kwalunke aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: The primary endpoint was progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central laboratory results.
Maltese: Il-punt aħħari primarju kien sopravivenza mingħajr progressjoni (PFS, progression-free survival) skont il-Kriterji ta' Rispons Uniformi b'Kunsens tal-International Myeloma Working Group (IMWG) 2011 kif evalwat minn kumitat ta' reviżjoni indipendenti (IRC, independent review committee) blinded fuq il-bażi tar-riżultati ta' laboratorju ċentrali.
English: Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhoea (2%).
Maltese: Reazzjonijiet avversi serji rrappurtati f'≥ 2% tal-pazjenti kienu jinkludu tromboċitopenija (2%) u dijarea (2%).
English: The most frequently reported adverse reactions (≥ 20%) across 417 patients treated within the ixazomib regimen and 418 patients within the placebo regimen were diarrhoea (39% vs. 32%), thrombocytopenia (33% vs. 21%), neutropenia (33% vs. 30%), constipation (30% vs. 22%), peripheral neuropathy (25% vs. 20%), nausea (23% vs. 18%), peripheral oedema (23% vs. 17%), vomiting (20% vs. 10%) and upper respiratory tract infection (21% vs. 16%).
Maltese: 30%), stitikezza (30% vs. 22%), newropatija periferali (25% vs. 20%), nawsja (23% vs. 18%), edema periferali (23% vs. 17%), rimettar (20% vs. 10%), u infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju (21% vs. 16%).
English: Nervous system disorders Peripheral neuropathies* Very common
Maltese: Disturbi tas-sistema nervuża Newropatiji periferali* Komuni ħafna
English: Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone.
Maltese: Ixazomib wera ċitotossiċità in vitro kontra ċ-ċelluli tal-majeloma minn pazjenti li rkadew wara diversi terapiji preċedenti, inkluż bortezomib, lenalidomide u dexamethasone.
English: After oral administration of a radiolabeled dose, 70% of total drug-related material in plasma was accounted for by ixazomib.
Maltese: Wara għoti orali ta' doża radjutikkettata, 70% tal-materjal totali relatat mal-mediċina fil-plażma kien attribwibbli għal ixazomib.
English: Infections and infestations Upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni tal-apparat respiratorju ta' fuq
English: Outside of the Phase 3 study, the following serious adverse reactions were rarely reported: acute febrile neutrophilic dermatosis (Sweet's syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumour lysis syndrome and thrombotic thrombocytopenic purpura.
Maltese: Barra mill-istudju ta' Fażi 3, ir-reazzjonijiet avversi serji li ġejjin kienu rrappurtati rarament: dermatożi akuta newtrofilika bid-deni (sindrome ta' Sweet), sindrome ta' Stevens-Johnson, majelite transversali, sindrome ta' enċefalopatija riversibbli posterjuri, sindrome ta' lisi tat-tumur u purpura tromboċitopenika trombotika.
English: A total of 722 patients (intent-to-treat [ITT] population) were randomised in a 1:1 ratio to receive either the combination of ixazomib, lenalidomide, and dexamethasone (N=360; ixazomib regimen) or placebo, lenalidomide and dexamethasone (N=362; placebo regimen) until disease progression or unacceptable toxicity.
Maltese: Għadd totali ta' 722 pazjent (popolazzjoni bl-intenzjoni li tiġi kkurata [ITT - intent to treat]) intgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew il-kombinazzjoni ta' ixazomib, lenalidomide, u dexamethasone (N = 360; kors ta' ixazomib) jew plaċebo, lenalidomide u dexamethasone (N = 362;
English: INSTRUCTIONS ON USE
Maltese: Azzjonijiet rakkomandati
English: Fatigue and dizziness have been observed in clinical trials.
Maltese: Għeja u sturdament kienu osservati fi provi kliniċi.
English: The PK of ixazomib was characterized at a dose of 3 mg in patients with normal renal function (creatinine clearance ≥ 90 mL/min, N=18), severe renal impairment (creatinine clearance < 30 mL/min, N=14), or ESRD requiring dialysis (N=6).
Maltese: Il-PK ta' ixazomib kienet ikkaratterizzata f'doża ta' 3 mg f'pazjenti b'funzjoni normali tal-kliewi (tneħħija tal-krejatinina ta' ≥ 90 mL/min, N = 18), b'indeboliment sever tal-kliewi (tneħħija tal krejatinina ta' < 30 mL/min, N = 14), jew ESRD li teħtieġ dijalisi (N = 6).
English: Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%).
Maltese: Ħafna mill-pazjenti rreġisrati fl-istudju kellhom mard avvanzat ta' Durie-Salmon Stadju III (69%) fid-dijanjosi inizjali, u storja medika ta' trattament li kienu jirċievu mill-inqas 2 terapiji fil-passat (60%) u li kienu refrattorji għal thalidomide (63%).
English: Cardiac arrhythmias in patients > 75 years of age were observed in 10 patients (21%) in the ixazomib regimen and 9 patients (15%) in the placebo regimen.
Maltese: Arritmiji kardijaċi f'pazjenti ta' > 75 sena kienu osservati f'10 pazjenti (21%) fil-kors ta' ixazomib u 9 pazjenti (15%) fil-kors tal-plaċebo.
English:  Daily  Daily  Daily Dexamethasone 
Maltese:  Kuljum  Kuljum  Kuljum Dexamethasone 
English: The steady-state volume of distribution is 543 L.
Maltese: Il-volum fl-istat fiss tad-distribuzzjoni huwa ta' 543 L.
English: The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Maltese: Id-doża rakkomandata tal-bidu ta' dexamethasone hija 40 mg mogħtija oralment f'Jiem 1, 8, 15, u 22 ta' ċiklu ta' trattament ta' 28 jum.
English: Suomi/Finland Takeda Oy
Maltese: België/Belgique/Belgien Takeda Belgium
English: The reduced dose of 3 mg is recommended in patients with moderate (total bilirubin > 1.5-3 x ULN) or severe (total bilirubin > 3 x ULN) hepatic impairment (see section 5.2).
Maltese: Id-doża mnaqqsa ta' 3 mg hija rakkomandata f'pazjenti b'indeboliment moderat (bilirubina totali > 1.5-3 x ULN) jew sever (bilirubina totali > 3 x ULN) tal-fwied (ara t-taqsima 5.2).
English: Grade 4 peripheral neuropathy Discontinue treatment regimen.
Maltese: Newropatija Periferali ta' Grad 4 Waqqaf il-kors ta' trattament.
English: Blood and lymphatic system disorders Thrombocytopenia*
Maltese: Disturbi tad-demm u tas-sistema limfatika Tromboċitopenija*
English: • The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Maltese: • Il-linka tal-istampar fiha: shellac, propylene glycol, potassium hydroxide, u black iron oxide (E172).
English: NINLARO is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine).
Maltese: NINLARO jintuża ma' lenalidomide (mediċina li taffettwa l-mod kif taħdem is-sistema immuni tiegħek) u dexamethasone (mediċina kontra l-infjammazzjoni).
English: How to store NINLARO 6.
Maltese: Kif taħżen NINLARO 6.
English: In vitro, ixazomib affected cell types found in the bone marrow microenvironment including vascular endothelial cells, osteoclasts and osteoblasts.
Maltese: In vitro, ixazomib affettwa t-tipi ta' ċelluli li jinsabu fil-mikroambjent tal-mudullum tal-għadam inklużi ċ-ċelluli endoteljali vaskulari, osteoklasti u osteoblasts.
English: The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Maltese: L-età medjana kienet ta' 66 sena, b'medda minn 38 sa 91 sena; 58% tal-pazjenti kellhom iżjed minn 65 sena.
English: INFORMATION IN BRAILLE NINLARO 2.3 mg
Maltese: INFORMAZZJONI BIL-BRAILLE NINLARO 2.3 mg
English: • Platelet count should be ≥ 75,000/mm3
Maltese: • L-għadd ta' plejtlits għandu jkun ta' ≥ 75,000/mm3
English: Based on a population PK analysis, systemic clearance (CL) was approximately 1.86 L/hr with inter-individual variability of 44%.
Maltese: Fuq il-bażi ta' analiżi tal-PK tal-popolazzjoni, it-tneħħija (CL, clearance) sistematika kienet ta' madwar 1.86 L/siegħa b'varjabilità interindividwali ta' 44%.
English: In the pooled dataset from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled, C16010 China Continuation Study (n=115), the following adverse reactions occurred with a similar rate between the ixazomib and placebo regimens: fatigue (26% vs. 24%),
Maltese: Fis-sett ta' dejta miġbura mill-istudju globali ta' Fażi 3, studju C16010 (n = 720), u mill-Istudju ta' Kontinwazzjoni Ċina C16010, li kien studju double-blind u kkontrollat bil-plaċebo (n = 115), seħħew ir-reazzjonijiet avversi li ġejjin b'rata simili bejn il-korsijiet ta' ixazomib u tal-plaċebo: għeja (26% vs. 24%), nuqqas ta' aptit (12% vs. 9%), pressjoni tad-demm baxxa (4% kull wieħed), insuffiċjenza tal-qalb†
English: Ixazomib + Lenalidomide and Dexamethasone (N = 360)
Maltese: Dexamethasone (N = 360)
English: At the 4 mg dose, mean change from baseline in QTcF was estimated to be 0.07 msec (90% CI; -0.22, 0.36) from the model based analysis.
Maltese: Fid-doża ta' 4 mg. il-bidla medja mil-linja bażi fil-QTcF kienet stmata bħala 0.07 msek (90% CI; -0.22, 0.36) mill-analiżi bbażata fuq il-mudell.
English: The dose should be adjusted for severe (Grade 3-4) symptoms (see section 4.2).
Maltese: Id-doża għandha tkun aġġustata għal sintomi severi (Grad 3-4) (ara sezzjoni 4.2).
English: The most common adverse reactions were blurred vision (5% in the ixazomib regimen and 4% in the placebo regimen), dry eye (4% in the ixazomib regimen and 1% in the placebo regimen), conjunctivitis (5% in the ixazomib regimen and 1% in the placebo regimen) and cataract (4% in the ixazomib regimen and 5% in the placebo regimen).
Maltese: L-aktar reazzjonijiet avversi komuni kienu vista mċajpra (5% fil-kors ta' ixazomib u 4% fil-kors tal-plaċebo), għajnejn xotti (4% fil-kors ta' ixazomib u 1% fil-kors tal-plaċebo), konġuntivite (5% fil-kors ta' ixazomib u 1% fil-kors tal-plaċebo) u katarretti (4% fil-kors ta' ixazomib u 5% fil-kors tal-plaċebo).
English: At clinically relevant ixazomib concentrations, in vitro studies using human cDNA-expressed cytochrome P450 isozymes indicate that no specific CYP isozyme predominantly contributes to ixazomib metabolism and non-CYP proteins contribute to overall metabolism.
Maltese: F'konċentrazzjoni klinikament rilevanti ta' ixazomib, studji in vitro bl-użu ta' isożimi P450 ċitokromiċi espressi mis-cDNA uman jindikaw li l-ebda isożim CYP speċifiku ma jikkontribwixxi b'mod predominanti għall-metaboliżmu ta' ixazomib u li l-proteini mhux CYP jikkontribwixxu għall-metaboliżmu globali.
English: Ixazomib exhibits a multi-exponential disposition profile.
Maltese: Ixazomib jesibixxi profil ta' dispożizzjoni multiesponenzjali.
English: INFORMATION IN BRAILLE NINLARO 4 mg
Maltese: INFORMAZZJONI BIL-BRAILLE NINLARO 4 mg
English: NINLARO 3 mg hard capsule:
Maltese: NINLARO 3 mg kapsula iebsa:
English: • swelling of the legs or feet (peripheral oedema)
Maltese: • nefħa fir-riġlejn jew fis-saqajn (edema periferali)
English: At concentrations exceeding those observed clinically, ixazomib was metabolized by multiple CYP isoforms with estimated relative contributions of 3A4 (42.3%), 1A2 (26.1%), 2B6 (16.0%), 2C8 (6.0%), 2D6 (4.8%), 2C19 (4.8%) and 2C9 (< 1%).
Maltese: 1%), 2B6 (16.0%), 2C8 (6.0%), 2D6 (4.8%), 2C19 (4.8%) u 2C9 (< 1%).
English: Rash has been reported with ixazomib (see section 4.8).
Maltese: Raxx ġie rapportat b'ixazomib (ara sezzjoni 4.8).
English: At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the ixazomib regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60).
Maltese: Fl-analiżi primarja (follow-up medjan ta' sa 8 xhur u medjan ta' 6 ċikli), il-medjan tal-PFS kien ta' 6.7 xhur fil-kors ta' ixazomib meta mqabbel ma' 4 xhur fil-kors tal-plaċebo (valur p = 0.035, HR = 0.60).
English: • low levels of potassium in the blood (hypokalaemia)
Maltese: • livelli baxxi ta' potassju fid-demm (ipokalemija)
English: 2630 Taastrup
Maltese: 2630 Taastrup Id-Danimarka.
English: Peripheral oedema has been reported with ixazomib (see section 4.8).
Maltese: Edema periferali kienet rapportata b'ixazomib (ara sezzjoni 4.8).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX50
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħrajn L381L382
English: Table 3: Adverse reactions in patients treated with ixazomib in combination with lenalidomide and dexamethasone (all grades, grade 3 and grade 4) System organ class /
Maltese: Tabella 3: Reazzjonijiet Avversi f'Pazjenti Ttrattati b'ixazomib Flimkien ma' Lenalidomide u Dexamethasone (il-Gradi Kollha, Grad 3 u Grad 4) Sis te ma tal-Klas sifika tal-Organi/Reazzjoni
English: The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle.
Maltese: Id-doża rakkomandata tal-bidu ta' lenalidomide hija 25 mg mogħtija oralment kuljum f'Jiem 1 sa 21 ta' ċiklu ta' trattament ta' 28 jum.
English: Quality of life as assessed by global health scores (EORTC QLQ-C30 and MY-20) was maintained during treatment and was similar in both treatment regimens in the Phase 3 study (C16010).
Maltese: Il-kwalità tal-ħajja kif evalwata mill-punteġġi tas-saħħa globali (EORTC QLQ-C30 u MY-20) inżammet matul it-trattament u kienet simili fiż-żewġ korsijiet fl-istudju ta' Fażi 3 (C16010).
English: Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Maltese: Refrattorja primarja, definita bħala l-aħjar rispons ta' marda stabbli jew progressjoni ta' marda fuq it-terapiji kollha preċedenti, kienet dokumentata f'6% tal-pazjenti.
English: Ixazomib induced apoptosis of several tumour cell types in vitro.
Maltese: Ixazomib induċa apoptosi ta' diversi tipi ta' ċelluli ta' tumur in vitro.
English: A plasma cell is a blood cell that normally produces proteins to fight infections.
Maltese: Ċellula tal-plażma hija ċellula tad-demm li normalment tipproduċi proteini biex tiġġieled l-infezzjonijiet.
English: Table 2: Dose modifications guidelines for ixazomib in combination with lenalidomide and dexamethasone
Maltese: Tabella 2: Linji gwida għall-modifiki fid-doża għal ixazomib flimkien ma' lenalidomide u dexamethasone
English: The data presented below is the pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).
Maltese: (n = 720), u mill-Istudju ta' Kontinwazzjoni Ċina C16010, li kien studju double-blind u kkontrollat bil-plaċebo (n = 115).
English: Direct contact with the capsule contents should be avoided.
Maltese: Il-kuntatt dirett mal-kontenut tal-kapsula għandu jiġi evitat.
English: Dosing schedule: Ixazomib taken with lenalidomide and dexamethasone 28-day cycle (a 4-week cycle)
Maltese: Skeda tad-Dożaġġ: ixazomib meħud ma' lenalidomide u dexamethasone Ċiklu ta' 28 Jum (ċiklu ta' 4 ġimgħat)
English: See the end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 dwar kif għandek tirraporta effetti sekondarji.