FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of daratumumab on the QTc interval was evaluated in an open-label study for 83 patients (Study GEN501) with relapsed and refractory multiple myeloma following daratumumab infusions (4 to 24 mg/kg).
Maltese: L-effett ta' daratumumab fl-intervall QTc ġie evalwat fi studju bit-tikketta tingħaraf għal 83 pazjent (Studju GEN501) b'majeloma multipla li rkadiet u refrattorja wara infużjonijiet b'daratumumab (4 sa 24 mg/kg).
English: Very Common 19
Maltese: Komuni Ħafna 19
English: Reproductive toxicology
Maltese: Tossiċità tar-riproduzzjoni
English: DARZALEX will be stored at the hospital or clinic.
Maltese: DARZALEX se jinħażen fl-isptar jew klinika.
English: Four individual population PK analyses were performed in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), and included a total of 1404 patients with normal hepatic function (total bilirubin [TB] and aspartate aminotransferase [AST] ≤ upper limit of normal [ULN]), 189 with mild hepatic impairment (TB 1.0 x to 1.5 x ULN or AST >ULN) and 8 patients with moderate (TB > 1.5 x to 3.0 x ULN; n=7), or severe (TB > 3.0 x ULN; n=1) hepatic impairment.
Maltese: Saru erba' analiżi individwali ta' PK ta' popolazzjoni f'pazjenti li kienu qed jirċievu monoterapija b'daratumumab jew diversi terapiji ta' kombinazzjoni (Analiżi 1-4), u kienu jinkludu total ta' 1,404 pazjent b'funzjoni normali tal-fwied (bilirubin totali [TB, total bilirubin] u aspartate aminotransferase [AST] ≤l-ogħla limitu tan-normal [ULN, upper limit of normal]) 189 b'indeboliment ħafif tal-fwied (TB 1.0 x sa 1.5 x ULN jew AST >ULN) u 8 pazjenti b'indeboliment moderat (TB> 1.5 x sa 3.0 x ULN; n=7), jew sever (TB > 3.0 x ULN; n=1) tal-fwied.
English: • medicines to lower swelling and irritation in your lungs (corticosteroids)
Maltese: • mediċini li jniżzlu n-nefħa u jnaqqsu l-irritazzjoni fil-pulmuni tiegħek (kortikosterojdi)
English: Table 6: Adverse reactions in multiple myeloma patients treated with DARZALEX
Maltese: Tabella 6: Reazzjonijiet aversi f'pazjenti b'majeloma multipla ttrattati b'DARZALEX
English: Patients had IgG/IgA/Light chain myeloma in 64%/22%/10% of instances, 19% had ISS Stage I, 42% had ISS Stage II, 38% had ISS Stage III disease and 84% had standard risk cytogenetics.
Maltese: Ilpazjenti kellhom majeloma IgG/IgA/tal-katina ħafifa f'64%/22%/10% tal-każijiet, 19% kellhom marda b'ISS ta' Stadju I, 42% kellhom marda b'ISS ta' Stadju II, 38% kellhom marda b'ISS ta' Stadju III u 84% kellhom ċitoġenetika b'riskju standard.
English: Very Common 10
Maltese: Ħafna 10
English: Part 1 compared induction and consolidation treatment with DARZALEX 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (D-VTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
Maltese: Parti 1 qabblet ittrattament ta' induzzjoni u konsolidazzjoni b'DARZALEX 16-il mg/kg flimkien ma' bortezomib, thalidomide u dexamethasone (D-VTd) ma' trattament b'bortezomib, thalidomide u dexamethasone (VTd) f'pazjenti b'majeloma multipla li tkunu għadha kemm ġiet dijanjostikata eliġibbli għal ASCT.
English: An odds ratio > 1 indicates an advantage for DVd.
Maltese: Proporzjon ta' probabbiltà ta' > 1 tindika vantaġġ għal DVd.
English: Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction between daratumumab and these small molecule medicinal products.
Maltese: Valutazzjonijiet farmakokinetiċi kliniċi ta' daratumumab flimkien ma' lenalidomide, pomalidomide, thalidomide, bortezomib u dexamethasone ma indikaw l-ebda interazzjoni bejn mediċina u oħra li kienet rilevanti b'mod kliniku bejn daratumumab u dawn il-prodotti mediċinali b'molekula żgħira.
English: Efficacy was evaluated by PFS based on IMWG criteria.
Maltese: L-effikaċja ġiet ivvalutata permezz ta' PFS ibbażata fuq il-kriterji IMWG.
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
Maltese: Interferenza ma' Testijiet Indiretti ta' Antiglobulina (Test Indirett ta' Coombs) Daratumumab jintrabat ma' CD38 li jinstab f'livelli baxxi fuq iċ-ċelluli ħomor tad-demm (RBCs - red blood cells) u jista' jwassal għal-test pożittiv indirett ta' Coombs.
English: MRD negativity rate a,c n(%)
Maltese: a,c n(%)
English: • Corticosteroid (long-acting or intermediate-acting) - Monotherapy:
Maltese: • Kortikosterojd (li jaħdem fit-tul jew jaħdem b'mod intermedju) Monoterapija:
English: Table 5: Infusion rates for DARZALEX (16 mg/kg) administration
Maltese: Rati ta' infużjoni għall-għoti ta' DARZALEX (16-il mg/kg)
English: Table 3: DARZALEX dosing schedule in combination with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle dosing regimen)
Maltese: Tabella 3: L-iskeda tal-għoti tad-doża ta' DARZALEX flimkien ma' bortezomib, thalidomide u dexamethasone ([VTd]; reġimen tal-għoti tad-doża f'ċikli ta' 4 ġimgħat)
English: With an overall median follow-up of 13.5 months, the hazard ratio for OS was 0.64 (95% CI: 0.40, 1.01; p=0.0534).
Maltese: B'medjan totali ta' segwitu ta' 13.5 xahar, il-proporzjon ta' periklu għal OS kien 0.64 (95% CI: 0.40, 1.01; p = 0.0534).
English: The mean (standard deviation [SD]) estimated terminal half-life of daratumumab following the first 16 mg/kg dose was 9 (4.3) days.
Maltese: L-istima tal-medja (devjazzjoni standard [SD - standard deviation]) tal-half-life terminali ta' daratumumab wara l-ewwel doża ta' 16-il mg/kg kienet 9 (4.3) ijiem.
English: In this subgroup, median PFS was not reached in the DVMP group and was 17.9 months in the VMP group (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
Maltese: F'dan is-sottogrupp, ilmedjan ta' PFS ma ntlaħaqx fil-grupp ta' D-VMP u kien 17.9 xhur fil-grupp ta' VMP (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used.
Maltese: Intużat stima Mantel-Haenszel għall-proporzjon ta' probabbiltà komuni għal tabelli stratifikati.
English: T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation.
Maltese: Iċċelluli T (CD3+, CD4+, u CD8+) huma magħrufa wkoll li jesprimu CD38 skont l-istadju tal-iżvilupp u l-livell ta' attivazzjoni.
English: Efficacy was evaluated by the stringent Complete Response (sCR) rate at Day 100 post-transplant and Progression free survival (PFS).
Maltese: Sħiħ strett (sCR, stringent Complete Response) f'Jum 100 wara t-trapjant u Sopravivenza mingħajr progressjoni (PFS, Progression free survival).
English: weekly (total of 9 doses)
Maltese: darba fil-ġimgħa (total ta' 9 dożi)
English: Four population PK analyses were performed to describe the PK characteristics of daratumumab and to evaluate the influence of covariates on the disposition of daratumumab in patients with multiple myeloma; Analysis 1 (n=223) in patients receiving DARZALEX monotherapy while Analysis 2 (n=694), Analysis 3 (n=352) and Analysis 4 (n=355) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Maltese: Saru erba' analiżi PK ta' popolazzjoni biex jiddeskrivu l-karatteristiċi PK ta' daratumumab u biex jivvalutaw l-influwenza ta' kovarjati fuq id-dispożizzjoni ta' daratumumab f'pazjenti b'majeloma multipla; Analiżi 1 (n=223) saret f'pazjenti li rċivew monoterapija b'DARZALEX filwaqt li Analiżi 2 (n=694), Analiżi 3 (n=352) u Analiżi 4 (n=355), saru f'pazjenti b'majeloma multipla li kienu rċivew terapiji ta' kombinazzjoni b'daratumumab.
English: The mean estimated terminal half-life associated with linear clearance in combination therapy was approximately 15-23 days.
Maltese: Il-medja tal-half-life terminali stmata assoċjata ma' tneħħija lineari f'terapija ta' kombinazzjoni kienet madwar 15-23 jum.
English: Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
Maltese: Trattament ta' kombinazzjoni b'bortezomib, melphalan u prednisone (VMP) f'pazjenti li ma jkunux eliġibbli għal trapjant awtologu ta' ċelluli stem:
English: The majority were male (59%), 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1 and 10% had an ECOG performance score of 2.
Maltese: Il-biċċa l-kbira kienu rġiel (59%), 48% kellhom punteġġ ta' eżekuzzjoni ta' ECOG ta' 0, 42% kellhom punteġġ ta' eżekuzzjoni ta' ECOG ta' 1 u 10% kellhom punteġġ ta' eżekuzzjoni ta' ECOG ta' 2.
English: Pre-planned interim analysis showed that treatment with daratumumab at 16 mg/kg led to a 36% ORR with 5% CR and 5% VGPR.
Maltese: Analiżi interim ippjanati minn qabel urew li trattament b'daratumumab bid-doża ta' 16-il mg/kg wassal għal ORR ta' 36% b'CR ta' 5% u VGPR ta' 5%.
English: Results of a PFS analysis by censoring patients who were randomized to daratumumab maintenance in the second randomization, at the date of the second randomization showed HR=0.50; 95% CI: 0.34, 0.75; p=0.0005.
Maltese: Riżultati ta' analiżi ta' PFS billi ġew iċċensurati dawk il-pazjenti li intagħżlu b'mod arbitrarju għal manteniment b'daratumumab fit-tieni għażla arbitrarja, fid-data tat-tieni għażla arbitrarja urew HR=0.50; 95% CI: 0.34, 0.75; p=0.0005.
English: • muscle spasms
Maltese: • skumdità fis-sider
English: • medicines for fever (such as paracetamol).
Maltese: • mediċini għad-deni (bħal paracetamol).
English: Four individual population PK analyses were performed based on pre-existing renal function data in patients receiving daratumumab monotherapy, or various combination therapies (Analyses 1-4), and included a total of 441 patients with normal renal function (creatinine clearance [CRCL] ≥90 mL/min), 621 with mild renal impairment (CRCL <90 and ≥60 mL/min), 523 with moderate renal impairment (CRCL <60 and ≥30 mL/min), and 27 with severe renal impairment or end stage renal disease
Maltese: Saru erba' analiżi individwali ta' PK ta' popolazzjoni abbażi ta' dejta li kienet diġà teżisti dwar funzjoni tal-kliewi f'pazjenti li kienu qed jirċievu monoterapija b'daratumumab, jew diversi terapiji ta' kombinazzjoni (Analiżi 1-4) u kienu jinkludu total ta' 441 pazjent b'funzjoni normali tal-kliewi (tneħħija talkreatinina [CRCL - creatinine clearance] ≥90 mL/min), 621 b'indeboliment ħafif tal-kliewi (CRCL <90 u ≥60 mL/min), 523 b'indeboliment moderat tal-kliewi (CRCL <60 u ≥30 mL/min), u 27 b'indeboliment sever tal-kliewi jew mard tal-kliewi fl-aħħar stadju (CRCL <30 mL/min).
English: st
Maltese: Vd
English: Hepatitis B virus reactivation, in some cases fatal, has been reported in patients treated with DARZALEX.
Maltese: Riattivazzjoni tal-virus tal-Epatite B, li f'xi każijiet kien fatali, ġie rrappurtat f'pazjenti ttrattati b'DARZALEX.
English: Eighteen percent (18%) of patients were refractory to a PI only, and 21% were refractory to bortezomib.
Maltese: Tmintax fil-mija (18%) tal-pazjenti ma wiġbux għal PI biss, u 21% ma wiġbux għal bortezomib.
English: Furthermore, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was also consistent with the overall population.
Maltese: Barra minn hekk, l-analiżi tas-sigurtà ta' sottogruppi ta' pazjenti b'punteġġ ta' eżekuzzjoni ta' ECOG ta' 2 (D-VMP: n=89, VMP: n=84), kienet ukoll konsistenti mal-popolazzjoni totali.
English: Prophylaxis for herpes zoster virus reactivation Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Maltese: Profilassi għall-attivazzjoni mill-ġdid tal-virus tal-herpes zoster Għandha titqies profilassi għall-prevenzjoni tal-attivazzjoni mill-ġdid tal-virus tal-herpes zoster.
English: Kaplan-Meier Curve of Primary Analysis of PFS in Study MMY3007
Maltese: Kaplan-Meier għall-Analiżi Primarja ta' PFS fl-Istudju MMY3007
English: Hepatitis B Virus reactivation
Maltese: Influwenza Riattivazzjoni talVirus tal-Epatite B
English: DARZALEX 20 mg/mL concentrate for solution for infusion daratumumab
Maltese: DARZALEX 20 mg/mL konċentrat għal soluzzjoni għall-infużjoni daratumumab
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching (see section 4.4).
Maltese: Interferenza ma' Test Indirett ta' Antiglobulina (Test Indirett ta' Coombs) Daratumumab jintrabat ma' CD38 fuq l-RBCs u jinterferixxi mat-testijiet ta' kompatibiltà, inkluż stħarriġ għal antikorpi u l-kompatibiltà tad-demm tad-donatur u ta' min ikun se jirċevih (ara sezzjoni 4.4).
English: At baseline, 97% of patients were refractory to the last line of treatment, 95% were refractory to both, a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), 77% were refractory to alkylating agents, 63% were refractory to pomalidomide and 48% of patients were refractory to carfilzomib.
Maltese: Fil-linja bażi, 97% tal-pazjenti ma kinux wieġbu għallaħħar għażla ta' trattament, 95% ma kinux wieġbu kemm għal inibitur ta'proteasome (PI) kif ukoll għal sustanza immunomodulatorja (IMiD - immunomodulatory agent), 77% ma kinux wieġbu għal sustanzi alkylating, 63% ma kinux wieġbu għal pomalidomide u 48% tal-pazjenti ma kinux wieġbu għal carfilzomib.
English: weekly (total of 8 doses)
Maltese: darba fil-ġimgħa (total ta' 8 dożi)
English: The pharmacokinetics (PK) of daratumumab following intravenous administration of daratumumab monotherapy were evaluated in patients with relapsed and refractory multiple myeloma at dose levels from 0.1 mg/kg to 24 mg/kg.
Maltese: Il-farmakokinetika (PK - pharmacokinetics) ta' daratumumab wara għoti ta' monoterapija b' daratumumab mill-vini ġiet stmata f'pazjenti b'majeloma multipla li rkadiet jew li ma weġbitx għattrattament b'livelli ta' doża minn 0.1 mg/kg sa 24 mg/kg.
English: Toxicology data have been derived from studies with daratumumab in chimpanzees and with a surrogate anti-CD38 antibody in cynomolgus monkeys.
Maltese: Dejta dwar tossikoloġija nkisbet minn studji b'daratumumab fiċ-ċimpanzis u b'sostituzzjoni talantikorp anti-CD38 f'xadini cynomolgus.
English: A subgroup analysis was performed on patients at least 70 years old, or those 65-69 years old with ECOG performance score of 2, or aged less than 65 years of age with significant comorbidity or ECOG performance score of 2 (D-VMP: n=273, VMP: n=270).
Maltese: Saret analiżi ta' sottogrupp fuq pazjenti li kellhom mill-inqas 70 sena, jew dawk li kellhom bejn 6569 sena b'punteġġ ta' eżekuzzjoni ta' ECOG ta' 2, jew li kellhom anqas minn 65 sena b'komorbidità sinifikanti jew b'punteġġ ta' eżekuzzjoni ta' ECOG ta' 2 (D-VMP: n=273, VMP: n=270).
English: A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Maltese: 350 għall-fergħa ta' D-VMP u 356 għall-fergħa ta' VMP.
English: Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
Maltese: Wara t-tieni infużjoni, id-doża tal-kortikosterojd tista' titnaqqas (methylprednisolone 60 mg mill-ħalq jew millvini).
English: In the Phase III study MMY3007, which compared treatment with D-VMP to treatment with VMP in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was consistent with the overall population (see section 5.1).
Maltese: III MMY3007, li qabbel it-trattament b'D-VMP ma' trattament b'VMP f'pazjenti b'majeloma multipla li tkun għadha kif ġiet dijanjostikata li ma jkunux eliġibbli għal trapjant awtologu ta' ċelluli stem, l-analiżi ta' sigurtà tas-sottogrupp ta' pazjenti b'punteġġ ta' eżekuzzjoni ta' ECOG ta' 2 (D-VMP: n=89, VMP: n=84), kienet konsistenti mal-popolazzjoni globali (ara sezzjoni 5.1).
English: For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Maltese: Għal IRRs ta' kwalunkwe grad/severità, minnufih waqqaf l-infużjoni ta' DARZALEX u ġġestixxi s-sintomi.
English: Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab.
Maltese: Għandhom jingħataw mediċini qabel u wara l-infużjoni biex inaqqsu r-riskju ta' reazzjonijiet marbuta mal-infużjoni (IRRs, infusion related reactions) b'daratumumab.
English: In Study GEN501, 42 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
Maltese: Fl-Istudju GEN501, 42 pazjent b'majeloma multipla li rkadiet jew li ma weġbitx għat-trattament irċivew 16-il mg/kg DARZALEX sakemm kien hemm progressjoni tal-marda.
English: This is equivalent to 1.86% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.86% tat-teħid massimu rrakkomandat kuljum ta' sodium middieta għal adult.
English: Dexamethasone was administered orally at a dose of 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each of the 8 bortezomib cycles (80 mg/week for two out of three weeks of the bortezomib cycle) or a reduced dose of 20 mg/week for patients >75 years, BMI <18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.
Maltese: Dexamethasone ngħata mill-ħalq bid-doża ta' 20 mg fil-Jiem 1, 2, 4, 5, 8, 9, 11, u 12 ta' kull waħda mit-8 ċikli ta' bortezomib (80 mg/fil-ġimgha għall-ġimgħatejn mit-tliet ġimgħat taċ-ċiklu ta' bortezomib) jew doża mnaqqsa ta' 20 mg/ġimgħa għall-pazjenti >75 sena, BMI <18.5, dijabete mellitus li mhijiex ikkontrollata tajjeb jew intolleranza preċedenti għal terpija bl-isterojdi.
English: Patients treated with daratumumab monotherapy (n=199) and combination therapy (n=1051) were evaluated for anti-therapeutic antibody responses to daratumumab at multiple time points during treatment and up to 8 weeks following the end of treatment.
Maltese: Il-pazjenti trattati b'monoterapija (n=199) u bit-terapija ta' kombinazzjoni (n=1051) b'daratumumab ġew stmati għal risponsi ta' antikorpi antiterapewtiċi għal daratumumab f'ħafna punti matul ittrattament u sa 8 ġimgħat wara t-tmiem tat-trattament.
English: On the days of DARZALEX infusion, 20 mg of the dexamethasone dose was administered as a pre-infusion medication.
Maltese: Fil-jiem tal-infużjoni ta' DARZALEX, 20 mg tad-doża ta' dexamethasone ngħatat bħala medikazzjoni qabel l-infużjoni.
English: Based on four individual population PK analyses (1-4) in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), age (range: 31-93 years) had no clinically important effect on the PK of daratumumab, and the exposure of daratumumab was similar between younger (aged <65 years, n=518) and older (aged ≥65 to <75 years n=761; aged ≥75 years, n=334) patients.
Maltese: Abbażi ta' erba' analiżi individwali ta' PK ta' popolazzjoni (1-4) f'pazjenti li kienu qed jirċievu monoterapija b'daratumumab jew diversi terapiji ta' kombinazzjoni (Analiżi 1-4), l-età (firxa: 3193 sena) ma kellha l-ebda effett importanti b'mod kliniku fuq il-PK ta' daratumumab, u l-esponiment għal daratumumab kien jixxiebah bejn pazjenti iżgħar (b'età<65 sena, n=518) u pazjenti akbar (li għandhom ≥65 sa <75 sena n=761; li għandhom ≥75 years, n=334).
English: Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.
Maltese: IgG1κ uman li jintrabat mal-proteina CD38 espressa b'livell għoli fuq is-superfiċje taċ-ċelluli tat-tumur ta' majeloma multipla, kif ukoll tipi oħra ta' ċelluli u tessuti f'diversi livelli.
English: Simulation of daratumumab pharmacokinetics was conducted for all recommended dosing schedules in 1,309 patients with multiple myeloma.
Maltese: Simulazzjoni tal-farmakokinetika ta' daratumumab saret għall-iskedi rrakkomandati kollha ta' għoti tad-doża f'1,309 pazjent b'mijeloma multipla.
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Maltese: Lenalidomide (25 mg darba kuljum mill-ħalq fil-Jiem 1-21 ta' ċikli ripetuti ta' 28 jum [4 ġimgħat]) ingħata mill-ħalq jew mill-vini ma' doża baxxa dexamethasone 40 mg/ġimgħa (jew doża mnaqqsa ta' 20 mg/ġimgħa għal pazjenti >75sena jiew indiċi tal-massa tal-ġisem [BMI, body mass index] <18.5).
English: Pre-infusion medication
Maltese: IL-PRODOTT MEDIĊINALI
English: Dexamethasone 20 mg (or equivalent), administered prior to every DARZALEX infusion.
Maltese: Dexamethasone 20 mg (jew ekwivalenti), mogħti qabel kull infużjoni ta' DARZALEX .
English: In the 1 to 24 mg/kg cohorts, peak serum concentrations (Cmax) after the first dose increased in approximate proportion to dose and volume of distribution was consistent with initial distribution into the plasma compartment.
Maltese: Fil-koorti ta' 1 sa 24 mg/kg, l-ogħla konċentrazzjonijiet fis-serum (Cmax) wara l-ewwel doża żdiedu bejn wieħed u ieħor fi proporzjon mad-doża u l-volum ta' distribuzzjoni kien konsistenti maddistribuzzjoni inizjali ġol-kompartiment tal-plażma.
English: In Study MMY2002, 106 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
Maltese: Fl-Istudju MMY2002, 106 pazjent b'majeloma multipla li rjkadiet jew li ma weġbitx għat-trattament rċivew 16-il mg/kg DARZALEX sakemm kien hemm progressjoni tal-marda.
English: In Part 2, subjects with at least a partial response (PR) by Day 100 post-transplant were re-randomized in a 1:1 ratio to daratumumab maintenance or observation only.
Maltese: F'Parti 2, l-individwi b'mill-inqas rispons parzjali (PR, Partial response) sa Jum 100 intagħżlu mill-ġdid b'mod arbitrarju fi proporzjon ta' 1:1 għal manteniment b'daratumumab jew osservazzjoni biss.
English: In responders, the median time to response was 1.05 months (range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3 months) in the Rd group.
Maltese: F'persuni li rrispondew, il-medjan taż-żmien għar-rispons kien 1.05 xhur (firxa: 0.2 sa 12.1 xhur) filgrupp DRd u 1.05 xhur (firxa: 0.3 sa 15.3 xhur) fil-grupp ta' Rd.
English: Overall response (sCR+CR+VGPR+PR) n(%) p-value
Maltese: Rispons totali (sCR+CR+VGPR+PR) n(%) Valur p
English: This is equivalent to 0.46% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.46% tat-teħid massimu rrakkomandat kuljum ta' sodium middieta għal adult.
English: DARZALEX dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen)
Maltese: Tabella 2: L-iskeda tal-għoti ta' DARZALEX flimkien ma' bortezomib, melphalan u prednisone ([VMP]; reġimen tal-għoti tad-doża f'ċikli ta' 6 ġimgħat)
English: Immune system disorders Anaphylactic reaction b Rare Metabolism and nutrition Decreased appetite Very Common 12
Maltese: Disturbi fis-sistema immuni Reazzjoni anafilattika b Rari
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab (20 mg/mL).
Maltese: Kull kunjett ta' 20 mL ta' konċentrat fih 400 mg ta' daratumumab (20 mg/mL).
English: Stringent complete response (sCR) Complete response (CR)
Maltese: Rispons sħiħ (CR, Complete response)
English: OTHER
Maltese: el
English: CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity.
Maltese: Il-proteina CD38 għandha ħafna funzjonijiet bħal ma huma adeżjoni medjata minn riċettur, għoti ta' sinjali u attività enzimatika.
English: Mantel-Haenszel estimate of the odds ratio for un-stratified tables is used.
Maltese: Intużat stima Mantel-Haenszel għall-proporzjon ta' probabilità komuni għal tabelli stratifikati.
English: DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”.
Maltese: DARZALEX jintuża f'adulti ta' 18-il sena jew aktar, li għandhom tip ta' kanċer msejjaħ “majeloma mutipla”.