FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8).
Maltese: Tumuri primarji malinni sekondarji (Second primary malignancies, SPMs) Fi prova klinika ta' pazjenti b'majeloma multipla li qabblet Empliciti kkombinat ma' kura b'lenalidomide u dexamethasone ma' kura permezz ta' lenalidomide u dexamethasone (CA204004), linċidenza ta' SPMs, u speċifikament ta' tumuri solidi u kanċer tal-ġilda mhux melanoma, kienet ogħla f'pazjenti kkurati b'Empliciti (ara sezzjoni 4.8).
English: For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Maltese: Għal informazzjoni addizzjonali dwar lenalidomide u dexamethasone, ara s-Sommarju talKaratteristiċi tal-Prodott korrispondenti.
English: Elotuzumab attaches to a target protein called SLAMF7.
Maltese: Elotuzumab jeħel ma' proteina fil-mira msejħa SLAMF7.
English: The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation.
Maltese: Ilbuttuna tas-siġill li tista' tinqala' hija ta' kulur l-avorju għall-preżentazzjoni ta' 300 mg u blu għal preżentazzjoni ta' 400 mg.
English: Withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial.
Maltese: Iġbed il-volum neċessarju għad-doża kkalkolata minn kull kunjett, sa massimu ta' 16 mL minn kunjett ta' 400 mg u 12 mL minn kunjett ta' 300 mg.
English: In study CA204004, the most common symptoms of an infusion reaction included fever, chills, and hypertension.
Maltese: Fl-istudju CA204004, l-aktar sintomi komuni għar-reazzjoni għall-infużjoni kienu jinkludu deni, sirdat, u pressjoni għolja.
English: Upper respiratory tract infection
Maltese: Infezzjoni tan-naħa ta' fuq tal-apparat respiratorju
English: Uncommon a The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection.
Maltese: Mhux komuni a It-terminu herpes zoster huwa ġabra tat-termini li ġejjin: herpes zoster, herpes orali, u infezzjoni tal-virus tal-herpes.
English: Empliciti 400 mg powder for concentrate elotuzumab
Maltese: TAL-PRODOTT MEDIĊINALI Empliciti 400 mg trab għal konċentrat elotuzumab
English: Empliciti 300 mg powder for concentrate for solution for infusion Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Maltese: Empliciti 300 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Empliciti 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni elotuzumab
English: Very severe infusion reactions (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
Maltese: Reazzjonijiet għall-infużjoni severi ħafna (≥ Grad 3) jistgħu jeħtieġu twaqqif permanenti tat-terapija b'Empliciti u kura ta' emerġenza.
English: CA204125 is a randomised, open-label study conducted to evaluate the efficacy and safety of Empliciti in combination with pomalidomide and dexamethasone (E-Pd) in patients with refractory or relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and had disease progression on or within 60 days of their last therapy.
Maltese: Empliciti flimkien ma' pomalidomide u dexamethasone (CA204125) CA204125 huwa studju randomizzat, miftuħ, li sar biex jiġu evalwati l-effikaċja u s-sigurtà ta' Empliciti flimkien ma' pomalidomide u dexamethasone (E-Pd) f'pazjenti b'majeloma multipla rikaduta u refrattarja li rċivew tal-inqas żewġ terapiji preċedenti inkluż lenalidomide u inibitur ta' proteasome (PI) u wrew progessjoni tal-marda fis-60 jum jew fi żmien 60 jum mill-aħħar terapija tagħhom.
English: Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204004, a clinical trial in patients with multiple myeloma comparing Empliciti combined with lenalidomide and dexamethasone treatment (N = 318) to lenalidomide and dexamethasone treatment (N = 317), is shown in Table 6.
Maltese: Ir-rati ta' reazzjonijiet avversi aġġustati għall-espożizzjoni (il-Gradi kollha u Gradi 3/4) f'CA204004, prova klinika f'pazjenti b'majeloma multipla li tqabbel il-kura b'Empliciti flimkien ma' lenalidomide u dexamethasone (N = 318) mal-kura b'lenalidomide u dexamethasone (N = 317), huma murija fitTabella 6.
English: Complete response (CR) + stringent complete response (sCR).
Maltese: valur-pd Rispons Komplut (Complete Response, CR + Rispons Komplut strett (stringent Complete Response, sCR))e n (%)
English: The primary endpoints of this study, progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR) were determined based on assessments made by a blinded Independent Review Committee (IRC).
Maltese: Il-punti tat-tmiem primarji ta' dan l-istudju, il-perjodu ta' sopravivenza mingħajr progressjoni (progression-free survival, PFS), kif ivvalutat mill-proporzjon ta' periklu, u r-rata ta' rispons globali (overall response rate, ORR) kienu determinati abbażi ta' valutazzjonijiet li saru minn Kumitat ta' Reviżjoni Indipendenti (IRC) blinded.
English: When Empliciti is given in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention programme for lenalidomide or pomalidomide respectively (see package leaflet for lenalidomide or pomalidomide).
Maltese: Meta Empliciti jingħata flimkien ma' lenalidomide jew pomalidomide, trid issegwi l-programm ta' prevenzjoni tat-tqala għal lenalidomide jew pomalidomide rispettivament (ara l-fuljett ta' tagħrif għal lenalidomide jew pomalidomide).
English: IRC Assessedf
Maltese: Reazzjoni avversa
English: Hypersensitivity
Maltese: Sensittività eċċessiva Komuni
English: Common cold
Maltese: Il-gradi kollha
English: 20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab.
Maltese: Kunjett tal-ħġieġ ta' Tip I ta' 20 ml, magħluq b'tapp griż tal-butyl u ssiġillat b'siġill irbattut talaluminju b'buttuna tal-polypropylene li tista' tinqala', li fih 300 mg jew 400 mg elotuzumab.
English: On weeks with Empliciti infusion, dexamethasone was administered before Empliciti as a divided dose: subjects  75 years an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects > 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an Empliciti infusion and in the control group, dexamethasone was administered in subjects  75 years as an oral dose of 40 mg and in subjects > 75 years as an oral dose of 20 mg dexamethasone.
Maltese: F'ġimgħat b'infużjoni ta' Empliciti, dexamethasone ngħata qabel Empliciti bħala doża maqsuma: individwi ta' 75 sena doża orali ta' 28 mg u doża ġol-vina ta' 8 mg, u f'individwi ta' > 75 sena doża orali ta' 8 mg u doża ġol-vina ta' 8 mg.
English: Empliciti is available in packs containing 1 vial.
Maltese: Empliciti huwa disponibbli f'pakketti li fihom kunjett wieħed.
English: Adverse reactions reported in 682 patients with multiple myeloma who were treated with elotuzumab in 8 clinical trials are presented in Table 5.
Maltese: Ir-reazzjonijiet avversi rrapportati f'682 pazjent b'majeloma multipla li kienu kkurati b'elotuzumab fi 8 provi kliniċi huma ppreżentati fit-Tabella 5.
English: After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Maltese: Wara r-rikostituzzjoni, kull mL ta' konċentrat fih 25 mg elotuzumab.
English: Medicines given before each infusion You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion reactions: medicine to reduce an allergic reaction (an anti-histamine) medicine to reduce inflammation (dexamethasone) medicine to reduce pain and fever (paracetamol)
Maltese: Mediċini li jingħataw qabel kull infużjoni Għandek tieħu dawn il-mediċini li ġejjin qabel kull infużjoni ta' Empliciti sabiex inaqqsu rreazzjonijiet possibbli minħabba l-infużjoni: mediċina biex titnaqqas reazzjoni allerġika (anti-istamina) mediċina biex tnaqqas infjammazzjoni (dexamethasone) mediċina biex tnaqqas l-uġigħ u d-deni (paracetamol)
English: Fatal infections (i.e. Grade 5 infections) were reported in 5% of Empliciti combined with pomalidomide and dexamethasone and 3.6% of pomalidomide and dexamethasone treated patients.
Maltese: Infezzjonijiet fatali (jiġifieri infezzjonijiet ta' Grad 5) ma kinux frekwenti u kienu rrapportati f'i 5% tal-pazjenti kkurati b'Empliciti flimkien ma' lenalidomide pomalidomide u dexamethasone u fi 3.6% tal-pazjenti kkurati b'ta' lenalidomidepomalidomide u dexamethasone.
English: Each vial contains 300 mg elotuzumab.
Maltese: Kull kunjett fih 300 mg elotuzumab.
English: Each vial contains 400 mg elotuzumab.
Maltese: Kull kunjett fih 400 mg elotuzumab.
English: Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
Maltese: Empliciti huwa indikat flimkien ma' lenalidomide u dexamethasone għall-kura ta' majeloma multipla f'pazjenti adulti li rċevew għallinqas terapija waħda preċedenti (ara sezzjonijiet 4.2 u 5.1).
English: Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg.
Maltese: Elotuzumab juri PK mhux lineari kif ukoll tnaqqis fl-eliminazzjoni hekk kif tiżdied id-doża minn 0.5-20 mg/kg.
English: p-valued Complete Response (CR + sCR)e n (%)
Maltese: Risponsi Kombinati (CR+sCR+VGPR) n (%) Sopravivenza
English: Empliciti contains the active substance elotuzumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Maltese: Empliciti fih is-sustanza attiva elotuzumab, li huwa antikorp monoklonali, tip ta' proteina mfassla biex tagħraf u teħel ma' sustanza fil-mira speċifika fil-ġisem.
English: SPMs are known to be associated with lenalidomide exposure, which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone.
Maltese: SPMs huma magħrufa li huma assoċjati ma' espożizzjoni għal lenalidomide, li kienet estiża għal pazjenti kkurati b'Empliciti kkombinat ma' lenalidomide u dexamethasone vs. lenalidomide u dexamethasone.
English: Posology for administration with lenalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 1 for the dosing schedule.
Maltese: Pożoloġija għall-għoti b'lenalidomide u dexamethasone It-tul ta' kull ċiklu ta' kura huwa 28 jum, ara Tabella 1 għall-iskeda tad-dożi.
English: Eligible patients were randomised in a 1:1 ratio to receive either Empliciti in combination with lenalidomide and dexamethasone or lenalidomide and dexamethasone (Ld).
Maltese: Il-pazjenti eliġibbli kienu randomizzati fi proporzjon 1:1 biex jirċievu jew Empliciti flimkien ma' lenalidomide u dexamethasone jew lenalidomide u dexamethasone (Ld).
English: Posology for administration with pomalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 2 for the dosing schedule.
Maltese: Pożoloġija għall-għoti ma' pomalidomide u dexamethasone It-tul ta' kull ċiklu ta' kura huwa 28 jum, ara Tabella 2 għall-iskeda tad-dożi.
English: EU/1/16/1088/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1088/002
English: A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
Maltese: Total ta' 40 (67%) pazjent kienu ħajjin fil-fergħa ta' E-Pd u 29 (51%) fil-fergħa ta' Pd. L-OS medjana ma ntlaħqitx għall-grupp ta' kura b'E-Pd.
English: EU/1/16/1088/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1088/001
English: Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 12.
Maltese: B'mod asettiku irrikostitwixxi kull kunjett ta' Empliciti b'siringa ta' daqs xieraq u labra ta' 18 gauge jew iżgħar kif muri fit-Tabella 12.
English: Of the 53 patients in CA204125 treated with Empliciti and evaluable for the presence of anti-product antibodies, 19 patients (36%) tested positive, of whom 1 patient tested persistent positive, for treatment-emergent anti-product antibodies by an ECL assay.
Maltese: Mit-53 pazjent f'CA204125 ikkurati b'Empliciti u evalwabbli għall-preżenza ta' antikorpi kontra lprodott, 19-il pazjent (36%) ittestjaw pożittivi, li minnhom pazjent 1 ittestja pożittiv persistenti, għal antikorpi kontra l-prodott li rriżultaw mill-kura permezz ta' assaġġ ECL.
English: For additional information concerning pomalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Maltese: Għal informazzjoni addizzjonali dwar pomalidomide u dexamethasone, ara s-Sommarju talKaratteristiċi tal-Prodott korrispondenti.
English: In clinical trials of patients with multiple myeloma, the incidence of all infections, including pneumonia, were higher in patients treated with Empliciti (see section 4.8).
Maltese: Fi provi kliniċi ta' pazjenti b'majeloma multipla, l-inċidenza tal-infezzjonijiet kollha, inkluż ilpulmonite, kienet ogħla f'pazjenti kkurati b'Empliciti (ara sezzjoni 4.8).
English: Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant.
Maltese: Peress li elotuzumab ma jagħrafx forom mhux tal-bniedem tal-proteina SLAMF7, id-dejta dwar is-sigurtà in vivo minn studji fuq l-annimali hija irrilevanti.
English: Five percent (5%) of patients required interruption of the administration of Empliciti for a median of 25 minutes due to infusion reaction, and 1% of patients discontinued due to infusion reactions.
Maltese: Ħamsa fil-mija (5%) tal-pazjenti kienu jeħtieġu interruzzjoni tal-għoti ta' Empliciti għal medjan ta' 25 minuta minħabba reazzjoni għall-infużjoni, u 1% tal-pazjenti ma komplewx minħabba r-reazzjonijiet għall-infużjoni.
English: b 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: b It-terminu pnewmonja huwa ġabra tat-termini li ġejjin: pnewmonja, pnewmonja atipika, pnewmonja, pnewmonja lobari, pnewmonja batterjali, pnewmonja fungali, pnewmonja influwenza, u pnewmonja pnewmokokkali.
English: The recommended dose of pomalidomide is 4 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Maltese: Id-doża rakkomandata ta' pomalidomide hija ta' 4 mg mill-ħalq darba kuljum fil-jiem 1-21 ta' ċikli ripetuti ta' 28 jum, u tal-inqas sagħtejn wara l-infużjoni ta' Empliciti meta tingħata fl-istess jum.
English: The median number of prior therapies was 3.
Maltese: Linji ta' terapija preċedenti = 1
English: Table 5: Adverse reactions in patients with multiple myeloma treated with Empliciti System Organ Class
Maltese: Reazzjonijiet avversi f'pazjenti b'majeloma multipla kkurati b'Empliciti Sistema tal-Klassifika tal-Organi
English: Upon resolution to ≤ Grade 1, Empliciti should be restarted at 0.5 mL/min and may be gradually increased at a rate of 0.5 mL/min every 30 minutes as tolerated to the rate at which the infusion reaction occurred.
Maltese: Meta jgħaddi għal ≤ Grad 1, Empliciti għandu jerġa' jinbeda b'0.5 mL/min u jista' jiżdied gradwalment b'rata ta' 0.5 mL/min kull 30 minuta kif tollerat għar-rata li biha seħħet ir-reazzjoni għall-infużjoni.
English: This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Maltese: Din l-interferenza jista' jkollha impatt fuq id-determinazzjoni tar-rispons komplut u rikaduta possibbli mir-rispons komplut f'pazjenti bil-proteina tal-majeloma IgG kappa.
English: The recommended dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Maltese: Id-doża rakkomandata ta' lenalidomide hija ta' 25 mg mill-ħalq darba kuljum fil-jiem 1-21 ta' ċikli ripetuti ta' 28 jum, u mill-anqas sagħtejn wara l-infużjoni ta' Empliciti meta mogħtija fl-istess jum.
English: The recommended dose of Empliciti is 10 mg/kg administered intravenously every week on days 1, 8, 15, and 22 of each treatment cycle for the first two cycles and then 20 mg/kg administered on day 1 of each treatment cycle thereafter.
Maltese: Id-doża rakkomandata ta' Empliciti hija 10 mg/kg mogħtija ġol-vina kull ġimgħa fil-jiem 1, 8, 15, u 22 ta' kull ċiklu ta' kura għall-ewwel żewġ ċikli mbagħad 20 mg/kg mogħtija f'jum 1 ta' kull ċiklu ta' kura wara dan.
English: Response Overall Response (ORR)b n (%) [95% CI]
Maltese: Sopravivenza ġenerali (overall survival, OS) medjan f'xhur [95% CI]
English: Uncommon (may affect up to 1 in 100 people) Sudden life-threatening allergic reaction (anaphylactic reaction)
Maltese: Sensittività mnaqqsa, speċjalment fil-ġilda Reazzjonijiet allerġiċi (sensittività eċċessiva)
English: In case of detection of additional peaks on serum immunofixation, the possibility of a biclonal gammopathy should be excluded.
Maltese: Fil-każ ta' kxif ta' quċċati addizzjonali fuq l-immunofissazzjoni tas-serum, il-possibilità ta' gammopatija biklonali għandha tiġi eskluża.
English: Second Primary Malignancies
Maltese: Tumuri Malinni Primarji Sekondarji
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg).
Maltese: Ikkalkola d-doża (mg) u ddetermina n-numru ta' kunjetti meħtieġa għad-doża ta' (10 mg/kg jew 20 mg/kg) abbażi tal-piż tal-pazjent.
English: The maximum infusion rate should not exceed 5 mL/min.
Maltese: Ir-rata tal-infużjoni massima ma għandhiex taqbeż il-5 mL/min.
English: In study CA204125, all of the reported infusion reactions occurred during the first treatment cycle and were ≤ Grade 2.
Maltese: Fl-istudju CA204125, ir-reazzjonijiet tal-infużjoni kollha li ġew irrappurtati seħħew waqt l-ewwel ċiklu ta' kura u kienu ta' ≤ Grad 2.
English: There was no clear causal evidence of altered pharmacokinetic, efficacy, or toxicity profiles with anti-product antibody development based on the population pharmacokinetic and exposure-response analyses.
Maltese: Ma kien hemm l-ebda evidenza kawżali ta' tibdil fil-profili farmakokinetiċi, tal-effikaċja, jew tat-tossiċità bi żvilupp ta' antikorp kontra l--prodott abbażi tal-popolazzjoni farmakokinetika u analizi tar-rispons u l-espożizzjoni.
English: Patients were refractory if they had progressed on or within 60 days of treatment with lenalidomide and a PI and on or within 60 days of their last treatment, or relapsed and refractory if they had achieved at least a partial response to previous treatment with lenalidomide and a PI but progressed within 6 months and had developed progressive disease on or within 60 days after completing their last treatment.
Maltese: Ilpazjenti kienu refrattarji jekk kellhom progressjoni fis-60 jum jew fi żmien 60 jum tal-kura b'lenalidomide u PI fis-60 jum jew fi żmien 60 jum mill-aħħar kura tagħhom, jew rikaduti u refrattarji jekk kienu kisbu mill-inqas rispons parzjali għal kura preċedenti b'lenalidomide u PI iżda kellhom progressjoni fi żmien sitt xhur u żviluppaw progress tal-marda fis-60 jum jew fi żmien 60 jum wara li temmew l-aħħar kura tagħhom.
English: Blood clots in the veins (thrombosis) Painful skin rash with blisters (shingles, zona) Night sweats
Maltese: Emboli tad-demm fil-vini (trombożi) Raxx tal-ġilda bl-infafet u bl-uġigħ (ħruq ta' Sant'Antnin, zona) Għaraq bil-lejl
English: Complete response rates in Empliciti group may be underestimated due to interference of elotuzumab monoclonal antibody with immunofixation assay and serum protein electrophoresis assay.
Maltese: Ir-rati ta' rispons komplut fil-grupp ta' Empliciti jistgħu jiġu sottovalutati minħabba inteferenza tal-antikorp monoklonali elotuzumab mal-assaġġ tal-immunofissazzjoni u l-assaġġ tal-elettroforeżi tal-proteina fis-serum.
English: Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro.
Maltese: Elotuzumab jattiva ċ-ċelloli qattiela naturali direttament kemm permezz tal-passaġġ SLAMF7 kif ukoll tar-riċetturi Fc li jtejbu l-attività kontra l-majeloma in vitro.
English: However, if oral or intravenous dexamethasone is delayed or discontinued, the administration of Empliciti should be based on clinical judgment (e.g. risk of hypersensitivity) (see section 4.4).
Maltese: Madankollu, jekk dexamethasone orali jew ġol-vina huwa pospost jew imwaqqaf, l-għoti ta' Empliciti għandu jkun ibbażat fuq ġudizzju kliniku (eż. riskju ta' sensittività eċċessiva)
English: Mood altered
Maltese: Tqala u treddigħ
English: c p-value based on the Cochran-Mantel-Haenszel chi-square 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: Meta jintuża lenalidomide, hemm bżonn ta' attenzjoni partikolari għal testijiet tat-tqala u r-rekwiżiti tal-prevenzjoni (ara “Tqala u treddigħ” f'din is-sezzjoni).
English: PVC and polyolefin containers
Maltese: 3. GĦAMLA FARMAĊEWTIKA
English: Each vial contains either 300 mg or 400 mg of elotuzumab.
Maltese: Kull kunjett fih jew 300 mg jew 400 mg ta' elotuzumab.
English: Empliciti is used in combination with other medicines for multiple myeloma.
Maltese: Empliciti jintuża flimkien ma' mediċini oħra għal majeloma multipla.
English: c The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased.
Maltese: c It-terminu limfopenja jinkludi t-termini li ġejjin: limpofenja u tnaqqis fl-għadd ta' limfoċiti.
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni jew id-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: b The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased.
Maltese: b It-terminu limfopenja jinkludi t-termini li ġejjin: limpofenja u tnaqqis fl-għadd ta' limfoċita.
English: Table 9: CA204004 Efficacy results for subsets
Maltese: Tabella 9: CA204004
English: Second Primary Malignancies are known to be associated with lenalidomide exposure which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone.
Maltese: It-Tumuri Malinni Primarji Sekondarji huma magħrufa li huma assoċjati ma' espożizzjoni b'lenalidomide li kienet estiża f'pazjenti kkurati b'Empliciti flimkien ma' lenalidomide u dexamethasone vs. lenalidomide u dexamethasone.
English: The lyophilised powder should dissolve in less than 10 minutes.
Maltese: It-trab lijofilizzat għandu jinħall f'inqas minn 10 minuti.
English: You should not be given Empliciti: if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Maltese: Ma għandekx tingħata Empliciti: jekk inti allerġiku għal elotużumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6 “Kontenut tal-pakkett u informazzjoni oħra”).
English: Fatigue
Maltese: Rispons
English: The rate of mild to moderate infusion reactions was > 50% in patients who were not premedicated.
Maltese: Ir-rata ta' reazzjonijiet ħfief għal moderati għall-infużjoni kienet > 50% f'pazjenti li ma kinux premedikati.
English: Treatment was administered in 4-week cycles (28-day cycle) until disease progression or unacceptable toxicity.
Maltese: Il-kura ngħatat f'ċikli ta' 4 ġimgħat (ċiklu ta' 28 jum) sal-progressjoni tal-marda jew tossiċità inaċċettabbli.