FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3-4 infections were noted in 28% and 24.3% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Maltese: Infezzjonijiet ta' Grad 3-4 kienu osservati fi 28% u 24.3% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone u lenalidomide u dexamethasone, rispettivament.
English: d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, herpes virus infection and ophthalmic herpes zoster.
Maltese: d It-terminu herpes zoster huwa ġabra tat-termini li ġejjin: herpes zoster, herpes orali, u infezzjoni tal-virus tal-herpes.
English: Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults.
Maltese: Empliciti jintuża biex jikkura majeloma multipla (kanċer tal-mudullun) fl-adulti.
English: After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes.
Maltese: Wara li s-solidi li baqa' jinħallu kompletament, ħalli s-soluzzjoni rikostitwita wieqfa għal 5 sa 10 minuti.
English: One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone.
Maltese: Pazjent wieħed kien irrapportat b'doża eċċessiva bi 23.3 mg/kg ta' elotuzumab flimkien ma' lenalidomide u dexamethasone.
English: Hypoaesthesia
Maltese: Ipoesteżija
English: Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
Maltese: Pazjenti b'newropatija periferali ta' Grad 2 jew ogħla ġew esklużi millistudji kliniċi b'E-Pd.
English: Empliciti 300 mg powder for concentrate for solution for infusion Each vial contains 300 mg elotuzumab*.
Maltese: U KWANTITATTIVA Empliciti 300 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 300 mg elotuzumab*.
English: PVC infusion sets polyethersulfone and nylon in-line filters with pore sizes of 0.2 μm to 1.2 μm.
Maltese: L-infużjoni ta' Empliciti hija kompatibbli ma': kontenituri tal-PVC u polyolefin; settijiet tal-infużjoni tal-PVC; filtri fil-pajp tal-polyethersulfone u tan-najlon b'daqsijiet tal-pori ta' 0.2 μm sa 1.2 μm.
English: The median age was 66 years (range 37 to 91); 57% of patients were older than 65 years; 60% of patients were male; Whites comprised 84% of the study population, Asians 10%, and blacks 4%.
Maltese: L-età medjana kienet ta' 66 sena (medda ta' 37 sa 91); 57% tal-pazjenti kellhom aktar minn 65 sena; 60% tal-pazjenti kienu rġiel; il-Bojod kienu jikkonsistu minn 84% tal-popolazzjoni ta' studju, l-Asjatiċi 10%, u ssuwed 4%.
English: Empliciti, as a humanised monoclonal antibody, is not expected to be metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of Empliciti.
Maltese: Empliciti, bħala antikorp monoklonali umanizzat, mhuwiex mistenni li jkun metabolizzat minn enzimi ta' ċitokromu P450 (CYP) jew kwalunkwe enzima tal-metaboliżmu ta' mediċina, l-inibizzjoni jew l-induzzjoni ta' dawn l-enzimi permezz ta' prodotti mediċinali mogħtija flimkien mhijiex antiċipata li taffettwa l-farmakokinetika ta' Empliciti.
English: Among, patients treated with aspirin, deep vein thromboses were reported in 4.1% of patients treated with Empliciti combined with lenalidomide and dexamethasone (E-Ld) and 1.4% of patients treated with lenalidomide and dexamethasone (Ld).
Maltese: Fost pazjenti kkurati bl-aspirina, trombożi profondi fil-vini ġew irrapportati f'4.1% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone (E-Ld) u 1.4% tal-pazjenti kkurati b'lenalidomide u dexamethasone (Ld).
English: Cycle 28-Day Cycles 1 and 2
Maltese: Ċikli 1 u 2 ta' 28 Jum
English: Elotuzumab only recognizes human SLAMF7 protein.
Maltese: Elotuzumab jagħraf biss il-proteina SLAMF7 tal-bniedem.
English: Dose 2 and all subsequent doses
Maltese: Doża 2 u d-dożi sussegwenti kollha
English: Before starting treatment with Empliciti, you must also read the package leaflet warnings and precautions of all medicines to be taken in combination with Empliciti for information related to these medicines.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Refractory
Maltese: Ċiklu
English: Solid tumours were reported in 2.5% and 1.9% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Maltese: Tumuri solidi kienu rrapportati fi 2.5% u 1.9% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone u lenalidomide u dexamethasone, rispettivament.
English: CLINICAL PARTICULARS
Maltese: Terapiji preċedenti
English: Infusion reactions Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Maltese: Empliciti ġie assoċjat ma' reazzjonijiet għall-infużjoni (ara sezzjoni 2 “Twissijiet u prekawzjonijiet”).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija essenzjalment ‘mingħajr sodium'.
English: Table 12: Reconstitution instructions Strength
Maltese: Tabella 12: Struzzjonijiet ta' rikostituzzjoni Qawwa
English: Of 390 patients across four clinical studies who were treated with Empliciti and evaluable for the presence of anti-product antibodies, 72 patients (18.5%) tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Maltese: Minn fost 390 pazjent minn madwar erba' studji kliniċi li kienu kkurati b'Empliciti u evalwabbli għall-preżenza ta' antikorpi kontra l-prodott, 72 pazjent (18.5%) ittestjaw pożittiv għall-antikorpi kontra l-prodott ta' kura emerġenti minn assaġġ elettrokemiluminixxenti (electrochemiluminescent, ECL).
English: There is no relevant use of Empliciti in the paediatric population for the indication of multiple myeloma.
Maltese: M'hemm ebda użu rilevanti ta' Empliciti fil-popolazzjoni pedjatrika għall-indikazzjoni ta' majeloma multipla.
English: On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles.
Maltese: Fil-jiem li jingħata Empliciti, dexamethasone għandu jingħata fi 28 mg mill-ħalq darba kuljum bejn 3 u 24 siegħa qabel Empliciti flimkien ma' 8 mg ġol-vina bejn 45 u 90 minuta qabel Empliciti fil-jiem 1, 8, 15, u 22 ta' ċikli ripetuti ta' 28 jum.
English: On days that Empliciti is administered, patients ≤ 75 years old give dexamethasone 28 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti and for patients > 75 years old give dexamethasone 8 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti.
Maltese: Fil-jiem meta jingħata Empliciti, għall-pazjenti ta' ≤ 75 sena, agħti dexamethasone 28 mg millħalq bejn 3 u 24 siegħa qabel Empliciti u 8 mg ġol-vini bejn 45 u 90 minuta qabel Empliciti u għall-pazjenti ta' > 75 sena, agħti dexamethasone 8 mg mill-ħalq bejn 3 u 24 siegħa qabel Empliciti u 8 mg ġol-vini bejn 45 u 90 minuta qabel Empliciti.
English: Prior therapies included stem cell transplant (55%), bortezomib (100%), lenalidomide (99%), cyclophosphamide (66%), melphalan (63%), carfilzomib (21%), ixazomib (6%), and daratumumab (3%).
Maltese: In-numru medjan ta' terapiji preċedenti kien 3. Sebgħa u tmenin fil-mija (87%) tal-pazjenti kienu refrattorji għal lenalidomide, 80 % refrattorji għal PI u 70 % kienu refrattorji kemm għal lenalidomide kif ukoll għal PI. Terapiji preċedenti kienu jinkludu trapjant taċ-ċelloli staminali (55%), bortezomib (100%), lenalidomide (99%), cyclophosphamide (66%), melphalan (63%), carfilzomib (21%), ixazomib (6%), u daratumumab
English: Infusion rate for Empliciti 10 mg/kg
Maltese: Rata ta' infużjoni għal Empliciti 10 mg/kg
English: For men taking Empliciti
Maltese: X'fih Empliciti
English: Nasopharyngitis
Maltese: Rifrattorji
English: Elotuzumab has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe hepatic impairment (TB > 3 × ULN and any AST) (see section 4.2).
Maltese: Elotuzumab ma ġiex studjat f'pazjenti b'indeboliment talfwied moderat (TB > 1.5 sa 3 × ULN u kwalunkwe AST) jew indeboliment tal-fwied sever (TB > 3 × ULN u kwalunkwe AST) (ara sezzjoni 4.2).
English: The following side effects have been reported in clinical trials with elotuzumab:
Maltese: L-effetti sekondarji li ġejjin ġew irrapportati fi provi kliniċi b'elotuzumab:
English: PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
Maltese: PFS (Intenzjoni li tiġi kkurata (intent to treat, ITT)) Proporzjon ta' Periklu [95% CI] Valur p tat-test log-rank stratifikat a
English: No clinically important differences in the pharmacokinetics of elotuzumab were found between patients with severe renal impairment (with and without dialysis) and patients with normal renal function (see section 4.2).
Maltese: Ma nstabux differenzi kliniċi importanti fil-farmakokinetika ta' elotuzumab bejn pazjenti b'indeboliment tal-kliewi sever (bi jew mingħajr dijaliżi) u pazjenti b'funzjoni tal-kliewi normali (ara sezzjoni 4.2).
English: PFS results per the investigator and IRC are summarised in Table 10 (minimum follow-up of 9.1 months).
Maltese: Ir-riżultati tal-PFS skont l-investigatur u l-IRC huma miġbura fil-qosor f'Tabella 10 (segwitu minimu ta' 9.1 xhur).
English: The primary endpoint was investigator assessed PFS by modified International Myeloma Working Group (IMWG) criteria.
Maltese: Il-punt tat-tmiem primarju kien il-PFS ivvalutata mill-investigatur skont kriterji tal-Grupp ta' Ħidma Internazzjonali tal-Majeloma (International Myeloma Working Group, IMWG) modifikati.
English: Table 4: Infusion rate for Empliciti 20 mg/kg
Maltese: Tabella 4: Rata ta' infużjoni għal Empliciti 20 mg/kg
English: HR (95.4% CI): 0.82 (0.68, 1.00) p-value: 0.0408
Maltese: 82 (0.68, 1.00) valur-p: 0.0408
English: Grade 3-4 infections were noted in 13.3% and 21.8% of Empliciti combined with pomalidomide and dexamethasone and pomalidomide and dexamethasone treated patients, respectively.
Maltese: Ġew innutati infezzjonijiet ta' Grad 3-4 fi 13.3 % u 21.8 % ta' pazjenti kkurati b'Empliciti flimkien ma' pomalidomide u dexamethasone u pazjenti kkurati b'pomalidomide u dexamethasone, rispettivament.
English: Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204125, a clinical trial in patients with multiple myeloma comparing Empliciti combined with pomalidomide and dexamethasone treatment (N = 60) to pomalidomide and dexamethasone treatment (N = 55), is shown in Table 7.
Maltese: Ir-rati ta' reazzjonijiet avversi aġġustati għall-espożizzjoni (kollha ta' Gradi u Grad 3/4) f'CA204125, prova klinika f''pazjenti b'majeloma multipla li tqabbel kura b'Empliciti ma' pomalidomide u dexamethasone (N = 60) ma' kura b'pomalidomide u dexamethasone (N = 55), jidhru f'Tabella 7.
English: Elotuzumab 10 mg/kg was administered intravenously each week for the first 2 cycles and 20 mg/kg every 4 weeks thereafter.
Maltese: Elotuzumab 10 mg/kg ngħata ġol-vivna kull ġimgħa għall-ewwel 2 ċikli u 20 mg/kg kull 4 ġimgħat wara dan.
English: European Group for Blood and Marrow Transplantation (EBMT) criteria.
Maltese: Kriterji tal-Grupp Ewropew għat-Trapjant tad-Demm u tal-Mudullun (European Group for Blood and Marrow Transplantation, EBMT).
English: Empliciti has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe (TB > 3 × ULN and any AST) hepatic impairment (see section 5.2).
Maltese: Empliciti ma ġiex studjat f'pazjenti b'indeboliment talfwied moderat (TB > 1.5 sa 3 × ULN u kwalunkwe AST) jew sever (TB > 3 × ULN u kwalunkwe AST) (ara sezzjoni 5.2).
English: a p-value based on the log-rank test stratified by stage of disease at study entry (International Staging System I-II vs III) and number of prior lines of therapy (2-3 vs ≥ 4) at randomization.
Maltese: I-II vs III) u numru ta' linji preċedenti ta' terapija (2-3 vs ≥ 4) mar-randomizzazzjoni.
English: In the clinical trials of patients with multiple myeloma infusion reactions were reported in approximately 10% of premedicated patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3% of premedicated patients treated with Empliciti combined with pomalidomide and dexamethasone (N = 60) (see section 4.4).
Maltese: Fil-provi kliniċi ta' pazjenti b'majeloma multipla, ir-reazzjonijiet għall-infużjoni kienu rrapportati f'bejn wieħed u ieħor 10% tal-pazjenti premedikati b'Empliciti flimkien ma' lenalidomide u dexamethasone (N = 318) u 3 % tal-pazjenti premedikati kkurati b'Empliciti flimkien ma' pomalidomide u dexamethasone (N = 60) (ara sezzjoni 4.4).
English: There were no SPM events reported in patients treated in the Empliciti combined with pomalidomide and dexamethasone study arm (N = 60) and 1 (1.8%) in patients treated in the pomalidomide and dexamethasone arm (N = 55) in study CA204125.
Maltese: Ma kien hemm l-ebda avveniment SPM li ġie rrappurtat f'pazjenti kkurati fil-fergħa tal-istudju ta' Empliciti flimkien ma' pomalidomide u dexamethasone (N = 60) u 1 (1.8%) fil-pazjenti kkurati filfergħa ta' pomalidomide u dexamethasone (N = 55) fl-istudju CA204125.
English: The entire Empliciti infusion should be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (with a pore size of 0.2-1.2 µm) using an automated infusion pump.
Maltese: L-infużjoni kollha ta' Empliciti għandha tingħata b'sett tal-infużjoni u filtru sterili, mhux piroġeniku, li ftit jorbot proteini (b'daqs tal-pori ta' 0.2-1.2 µm) permezz ta' pompa tal-infużjoni awtomatika.
English: Non-melanoma skin cancer was reported in 3.1% and 1.6% of patients treated with Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone, respectively.
Maltese: Il-kanċer tal-ġilda mhux tat-tip melanoma kien irrapportat fi 3.1% u 1.6% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone u lenalidomide u dexamethasone, rispettivament.
English: As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Maltese: IgG, elotuzumab huwa mistenni li jiġi diżintegrat f'peptidi żgħar u aċidi amminiċi permezz tal-passaġġi kataboliċi.
English: The median age was 67 years (range 36 to 81); 62% of patients were older than 65 years; 57% of patients were male; whites comprised 77% of the study population, Asians 21%, and blacks 1%.
Maltese: L-età medjana kienet 67 sena (medda 36 sa 81); 62 % tal-pazjenti kellhom aktar minn 65 sena; 57 % tal-pazjenti kienu rġiel, il-bojod kienu jammontaw għal 77 % tal-popolazzjoni tal-istudju, l-Asjatiċi 21 % u ssuwed 1 %.
English: Deep vein thrombosis
Maltese: Trombożi profonda fil-vini
English: Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).
Maltese: Empliciti huwa indikat flimkien ma' pomalidomide u dexamethasone għall-kura ta' pazjenti adulti b'majeloma multipla rikaduta u refrattarja li rċivew tal-inqas żewġ terapiji preċedenti inkluż lenalidomide u inibitur ta' proteasome u wrew progessjoni tal-marda fuq l-aħħar terapija (ara sezzjonijiet 4.2 u 5.1).
English: The volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection should be adjusted so as to not exceed 5 mL/kg of patient weight at any given dose of Empliciti.
Maltese: Il-volum ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni jew injezzjoni ta' 5% glucose għandu jiġi aġġustat sabiex ma jaqbiżx 5 mL/kg tal-piż tal-pazjent fi kwalunkwe doża mogħtija ta' Empliciti.
English: Empliciti 400 mg powder for concentrate for solution for infusion Each vial contains 400 mg elotuzumab.
Maltese: Empliciti 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 400 mg elotuzumab.
English: If there is no recurrence of the infusion reaction, the escalation can be resumed (see Tables 3 and 4).
Maltese: Jekk ma jkunx hemm rikorrenza tar-reazzjoni għall-infużjoni, l-eskalazzjoni tista' titkompla (ara Tabelli 3 u 4).
English: In the clinical trial of patients with multiple myeloma (CA204004), invasive SPMs have been observed in 6.9% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 4.1% of patients treated with lenalidomide and dexamethasone (N = 317).
Maltese: Fil-prova klinika ta' pazjenti b'majeloma multipla (CA204004), SPMs invażivi kienu osservati f'6.9% talpazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone (N = 318) u 4.1% tal-pazjenti kkurati b'lenalidomide u dexamethasone (N = 317).
English: Table 3: Infusion rate for Empliciti 20 mg/kg
Maltese: Tabella 3: Rata ta' infużjoni għal Empliciti 20 mg/kg
English: Fatal infections were infrequent and were reported in 2.5% of Empliciti combined with lenalidomide and dexamethasone and 2.2% of lenalidomide and dexamethasone treated patients.
Maltese: Infezzjonijiet fatali ma kinux frekwenti u kienu rrapportati fi 2.5% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone u 2.2% ta' lenalidomide u dexamethasone.
English: The geometric mean total clearance of elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state is 0.194 L/day (CV: 62.9%).
Maltese: L-eliminazzjoni totali medja ġeometrika ta' elotuzumab f'10 mg/kg (f'kombinazzjoni ma' lenalidomide u dexamethasone) fi stat fiss hija 0.194
English: Infusion rate for Empliciti 20 mg/kg
Maltese: Rata ta' infużjoni ta' Empliciti 20 mg/kg
English: Pneumoniac
Maltese: Pnewmonja
English: Table 2: Infusion rate for Empliciti 10 mg/kg
Maltese: Tabella 2: Rata ta' infużjoni ta' Empliciti 10 mg/kg
English: Non-clinical safety information primarily consists of limited in vitro human cell/tissue studies where no safety findings were identified.
Maltese: Informazzjoni ta' sigurtà mhux klinika primarjament tikkonsisti minn studji ta' ċelloli/tessuti tal-bniedem in vitro fejn lebda sejba ta' sigurtà ma ġiet identifikata.
English: The rates of deep vein thromboses observed between treatment arms were similar for patients given prophylaxis with low molecular weight heparin (2.2% in both treatment arms), and for patients given vitamin K antagonists the rates were 0% for patients treated with E-Ld and 6.7% for patients treated with Ld.
Maltese: Ir-rati ta' trombożi profondi fil-vini osservati bejn fergħat ta' kura kienu simili għal pazjenti mogħtija profilassi b'eparina ta' piż molekulari baxx (2.2% fiż-żewġ fergħat ta' kura), u għal pazjenti mogħtija antagonisti tal-vitamina K ir-rati kienu 0% għal pazjenti kkurati b'E-Ld u 6.7% għal pazjenti kkurati b'Ld.
English: Prior therapies Lines of prior therapy = 1 Lines of prior therapy = 2 or 3 Prior thalidomide exposure No prior immunomodulatory exposure
Maltese: Linji ta' terapija preċedenti = 2 jew 3
English: Calculate the volume (mL) of diluent (either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection) needed to make up the solution for infusion for the patient.
Maltese: Ikkalkola l-volum (mL) ta' dilwent (jew sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni jew injezzjoni ta' 5% glucose) meħtieġ biex tagħmel is-soluzzjoni għall-infużjoni għall-pazjent.
English: On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients > 75 years old.
Maltese: Fil-jiem meta ma jingħatax Empliciti iżda hija skedata doża ta' dexamethasone (Jiem 8, 15 u 22 ta' ċiklu 3 u kull ċiklu sussegwenti), agħti 40 mg mill-ħalq lill-pazjenti ta' ≤ 75 sena u 20 mg mill-ħalq lill-pazjenti ta' > 75 sena.
English: A pre-specified analysis for 3-year PFS rate was performed based on a minimum follow-up time of 33 months.
Maltese: Analiżi pre-speċifikata għar-rata PFS ta' 3 snin twettqet abbażi ta' żmien ta' segwitu minimu ta' 33 xahar.
English: 400 mg vial
Maltese: kunjett ta' 400 mg
English: Empliciti 300 mg powder for concentrate elotuzumab
Maltese: TAL-PRODOTT MEDIĊINALI Empliciti 300 mg trab għal konċentrat elotuzumab
English: In cycles 3 and beyond, once every 4 weeks on day 1.
Maltese: Fċikli 3 u wara, darba kull 4 ġimgħat f'jum 1.
English: Table 3: Infusion rate for Empliciti 10 mg/kg
Maltese: Tabella 3: Rata ta' infużjoni ta' Empliciti 10 mg/kg
English: c The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
Maltese: c It-terminu pnewmonja huwa ġabra tat-termini li ġejjin: pnewmonja, pnewmonja atipika, bronkopulmonite, pnewmonja lobari, pnewmonja batterjali, pnewmonja fungali, pnewmonja influwenza, u pnewmonja pnewmokokkali.
English: A total of 646 patients were randomised to receive treatment: 321 to Empliciti in combination with lenalidomide and dexamethasone and 325 to lenalidomide and dexamethasone.
Maltese: 321 b'Empliciti flimkien ma' lenalidomide u dexamethasone u 325 b'lenalidomide u dexamethasone.
English: Empliciti at 10 mg/kg dose should be initiated at an infusion rate of 0.5 mL/min.
Maltese: Empliciti b'doża ta' 10 mg/kg għandu jiġi injettat b'rata ta' infużjoni ta' 0.5 mL/min.
English: In a clinical trial of patients with multiple myeloma (CA204004), infections were reported in 81.4% of patients in the Empliciti combined with lenalidomide and dexamethasone arm (N = 318) and 74.4% in lenalidomide and dexamethasone arm (N = 317).
Maltese: Fi studju kliniku ta' pazjenti b'majeloma multipla (CA204004), kienu rrapportati infezzjonijiet f'81.4% tal-pazjenti fil-fergħa ta' Empliciti flimkien ma' lenalidomide u dexamethasone (N = 318) u 74.4% fil-fergħa ta' lenalidomide u dexamethasone (N = 317).
English: In a clinical trial of patients with multiple myeloma (CA204004), deep vein thromboses were reported in 7.2% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3.8% of patients treated with lenalidomide and dexamethasone (N = 317).
Maltese: Fi prova klinika ta' pazjenti b'majeloma multipla (CA204004), trombożi profondi fil-vini ġew irrapportati f'7.2% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone (N = 318) u 3.8% tal-pazjenti kkurati b'lenalidomide u dexamethasone (N = 317).
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg, see section 4.2).
Maltese: Id-doża totali ta' elotuzumab f'mg daqs il-piż totali tal-pazjent f'kg immultiplikat bid-doża ta' elotuzumab (10 jew 20 mg/kg, ara sezzjoni 4.2).
English: Hazard Ratio [97.61% CI]
Maltese: Proporzjon ta' Periklu [97.61% intervall ta' fiduċja (confidence interval, CI)]
English: Empliciti is an IgG1 monoclonal antibody, which is principally cleared by catabolism.
Maltese: IgG1, li jitneħħa prinċipalment permezz tal-kataboliżmu.
English: Response to therapy Relapsed
Maltese: Rispons għat-terapija Rikaduti
English: The effect of hepatic impairment on the clearance of Empliciti was evaluated by population PK analyses in patients with mild hepatic impairment (total bilirubin [TB] ≤ the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST; N = 33).
Maltese: L-ebda aġġustament fid-doża għal Empliciti mhu meħtieġ għal pazjenti b'indeboliment tal-fwied ħafif (bilirubina totali [TB] ≤ il-limitu massimu ta' [upper limit of normal, ULN] normali u AST > ULN jew TB < 1 sa 1.5 × ULN u kwalunkwe AST).