FrancophonIA/ELRC3.0 huggingface dataset:
English: Daratumumab as a large protein has a low likelihood of direct ion channel interactions.
Maltese: Daratumumab hija proteina kbira bi probabilità baxxa ta' interazzjonijiet joniċi diretti fil-kanal.
English: No data are available to determine potential effects of daratumumab on fertility in males or females (see section 5.3).
Maltese: Ma hija disponibbli l-ebda dejta biex tiddetermina l-effetti possibbli ta' daratumumab fuq il-fertilità flirgiel jew fin-nisa (ara sezzjoni 5.3).
English: Subsequent (Week 3 onwards, 16 mg/kg) infusions
Maltese: Infużjonijiet sussegwenti (mill-Ġimgħa 3 'l quddiem, 16-il mg/kg)
English: Pre-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) prior to treatment with DARZALEX.
Maltese: Mediċini ta' qabel l-infużjoni għandhom jingħataw biex inaqqsu r-riskju ta' reazzjonijiet relatati mal-infużjoni (IRRs) qabel it-trattament b'DARZALEX.
English: Tel: +386 1 401 18 00
Maltese: Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
English: Based on four individual population PK analyses in patients receiving either daratumumab monotherapy or various combination therapies (Analyses 1-4), the exposure to daratumumab was similar between white (n=1371) and non-white subjects (n=242).
Maltese: Abbażi ta' erba' analiżi individwali ta' PK ta' popolazzjoni f'pazjenti li jew kienu qed jirċievu monoterapija b'daratumumab jew diversi terapiji ta' kombinazzjoni (Analiżi 1-4), l-esponiment għal daratumumab kien simili bejn individwi bojod (n=1,371) u mhux bojod (n=242).
English: Bortezomib was administered by subcutaneous (SC) injection at a dose of 1.3 mg/m2 body surface area twice weekly at
Maltese: Bortezomib ingħata permezz ta' injezzjoni taħt il-ġilda (SC, subcutaneous) bid-doża ta' 1.3 mg/m2 ta'
English: Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
Maltese: Għandhom jintużaw settijiet tal-għoti tal-polyurethane (PU), polybutadiene (PBD), PVC, PP jew PE.
English: DARZALEX is supplied as a carton pack containing 1 glass vial.
Maltese: DARZALEX huwa fornut bħala pakkett tal-kartun li jkun fih kunjett 1 tal-ħġieġ.
English: Adverse reaction Frequency Incidence (%) Any Grade Grade 3-4
Maltese: Reazzjoni avversa Frekwenza Inċidenza (%) Kwalunkwe
English: Sixty-nine percent (69%) of patients had received a prior PI (66% received bortezomib) and 76% of patients received an IMiD (42% received lenalidomide).
Maltese: Disgħa u sittin fil-mija (69%) tal-pazjenti kienu rċivew PI qabel (66% rċivew bortezomib) u 76% tal-pazjenti rċivew IMiD (42% rċivew lenalidomide).
English: In patients who develop reactivation of HBV while on DARZALEX, suspend treatment with DARZALEX and institute appropriate treatment.
Maltese: F'pazjenti li jiżviluppaw riattivazzjoni tal-HBV waqt li jkunu fuq DARZALEX, waqqaf it-trattament b'DARZALEX u ibda trattament xieraq.
English: The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Maltese: Ir-rati ta' meta ċ-ċelluli tattrapjant jibdew jikbru u jagħmlu ċelluli f'saħħithom u tar-rikostituzzjoni ematopoietika kienu jixxiebhu fost l-individwi li ħadu t-trapjant fil-gruppi ta' D-VTd u VTd (D-VTd: 99.8%; VTd: 99.6%; kif imkejjel mill-irkupru tan-newtrofili > 0.5 x 10
English: At baseline, 76% of patients were refractory to the last line of treatment, 64% were refractory to both a PI and IMiD, 60% were refractory to alkylating agents, 36% were refractory to pomalidomide and 17% were refractory to carfilzomib.
Maltese: Fil-linja bażi, 76% tal-pazjenti ma kinux wieġbu għall-aħħar trattament magħżul, 64% ma kinux wieġbu kemm għal PI kif ukoll għal IMiD, 60% ma kinux wieġbu għal sustanzi alkylating, 36% ma kinux wieġbu għal pomalidomide u 17% ma kinux wieġbu għal carfilzomib.
English: The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Maltese: L-inċidenza ta' reazzjonijiet ta' kwalunkwe grad marbuta mal-infużjoni kienet 42%, b'36% tal-pazjenti li kellhom reazzjonijiet marbuta mal-infużjoni f'Jum 1 ta' Ġimgħa 1, 4% f'Jum 2 ta' Ġimgħa 1, u 8% b'infużjonijiet sussegwenti.
English: The mean (SD) predose (trough) serum concentration at the end of weekly dosing was 573 (331.5) micrograms/mL.
Maltese: Il-medja (SD) tal-konċentrazzjoni fis-serum qabel id-doża (l-aktar baxxa) fl-aħħar tal-perjodu ta' għoti ta' dożi kull ġimgħa kienet 573 (331.5) mikrogramma/mL.
English: Additional efficacy results from Study MMY3004 are presented in Table 12 below.
Maltese: Riżultati addizzjonali ta' effikaċja mill-Istudju MMY3004 huma ppreżentati f'Tabella 12.
English: When DARZALEX dosing was interrupted in the setting of ASCT (Study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT.
Maltese: Meta l-għoti tad-doża ta' DARZALEX twaqqaf b'mod temporanju fl-ambjent ta' ASCT (Studju MMY3006) għal medjan ta' 3.75 (firxa: 2.4; 6.9) xhur, mal-bidu mill-ġdid ta' DARZALEX linċidenza ta' IRRs kienet 11% fl-ewwel infuzjoni wara ASCT.
English: Efficacy was evaluated by progression free survival (PFS) based on International Myeloma Working Group (IMWG) criteria.
Maltese: L-effikaċja ġiet evalwata permezz ta' sopravivenza mingħajr progressjoni (PFS, progression free survival) ibbażata fuq il-kriterji tal-Grupp Internazzjonali ta' Ħidma fuq il-Majeloma (IMWG, International Myeloma Working Group).
English: Hyperglycemia
Maltese: Ipogliċemija
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar id-dilwizzjoni tal-prodott mediċinali qabel l-għoti, ara sezzjoni 6.6.
English: 200 mL/hour
Maltese: 200 mL/siegħa
English: This medicine contains 9.3 mg sodium (main component of cooking/table salt) in each 5 mL vial.
Maltese: Din il-mediċina fiha 9.3 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/tal-ikel) f'kull kunjett ta' 5 mL.
English: Twenty-seven percent had International Staging System (ISS) Stage I, 43% had ISS Stage II and 29% had ISS Stage III disease.
Maltese: Sebgħa u għoxrin fil-mija kellhom marda fi Stadju I skont is-Sistema Internazzjonali tal-iStadju (ISS, International Staging System), 43% kellhom marda fi Stadju II u 29% kellhom marda fi Stadju III skont ISS.
English: Study MMY3004 demonstrated an improvement in PFS in the DVd arm as compared to the Vd arm; the median PFS had not been reached in the DVd arm and was 7.2 months in the Vd arm (HR [95% CI]: 0.39 [0.28, 0.53]; p-value<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with DVd versus Vd.
Maltese: L-istudju MMY3004 wera titjib f'PFS fil-fergħa ta' DVd meta mqabbla mal-fergħa ta' Vd; il-medjan ta' PFS ma kienx intlaħaq fil-fergħa ta' DVd u kien ta' 7.2 xhur fil-fergħa ta' Vd (HR [95% CI]: 0.39 [0.28, 0.53]; valur p<0.0001), li jirrapreżenta tnaqqis ta' 61% fir-riskju ta' progressjoni tal-marda jew mewt għall-pazjenti ttrattati b'DVd versus Vd. (ara Figura 4).
English: The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Maltese: Il-medjan tal-età tal-pazjenti kien ta' 64 sena (firxa minn 30 sa 88 sena) u 12% kellhom ≥75 sena.
English: Additional efficacy results from Study MMY3003 are presented in Table 11 below.
Maltese: Riżultati addizzjonali ta' effikaċja mill-Istudju MMY3003 huma ppreżentati f'Tabella 11 taħt.
English: Nervous system disorders Peripheral sensory neuropathy
Maltese: Disturbi fis-sistema nervuża Newropatija tassensazzjoni periferali
English: Additional efficacy results from Study MMY3007 are presented in Table 8 below.
Maltese: Riżultati addizzjonali ta' effikaċja mill-Studju MMY3007 huma ppreżentati f'Tabella 8 taħt.
English: • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient weight.
Maltese: • Ikkalkula d-doża (mg) u l-volum totali (mL) meħtieġa tas-soluzzjoni ta' DARZALEX u nnumru ta' kunjetti ta' DARZALEX meħtieġa abbażi tal-piż tal-pazjent.
English: Median Time to Response [months (range)] Median Duration of Response [months (95% CI)] NE (11.5, NE) MRD negative rate (95% CI)
Maltese: Rispons parzjali (PR, Partial response) [n(%)] Rata ta' negattività MRD (95% CI)
English: In Study MMY1001, patients receiving daratumumab combination treatment (n=97) were administered the first 16 mg/kg daratumumab dose at Week 1 split over two days i.e. 8 mg/kg on Day 1 and Day 2 respectively.
Maltese: Fl-Istudju MMY1001, il-pazjenti li kienu qed jirċievu trattament ta' kombinazzjoni b'daratumumab (n=97) ingħataw l-ewwel doża ta' 16-il mg/kg ta' daratumumab f'Ġimgħa 1 maqsuma fuq jumejn i.e. 8 mg/kg f'Jum 1 u f'Jum 2 rispettivament.
English: It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: DARZALEX jingħata bħala infużjoni fil-vini wara dilwizzjoni b'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%).
English: How to store DARZALEX
Maltese: X'fih DARZALEX
English: Following the start of daratumumab treatment, none of the monotherapy patients and 2 of the 1051 combination therapy patients tested positive for anti-daratumumab antibodies; 1 of the combination therapy patients developed transient neutralising antibodies against daratumumab.
Maltese: Wara l-bidu ta' trattament b'daratumumab, lebda wieħed mill-pazjenti tal-monoterapija ma kellu test pożittiv u 2 mil-1051 pazjent fuq terapija ta' kombinazzjoni kellhom test pożittiv għal antikorpi kontra daratumumab; 1 mill-pazjenti fuq terapija ta' kombinazzjoni żviluppa antikorpi temporanji li jinnewtralizzaw kontra daratumumab.
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab (20 mg/mL).
Maltese: Kull kunjett ta' 5 mL ta' konċentrat fih 100 mg ta' daratumumab (20 mg/mL).
English: An odds ratio > 1 indicates an advantage for D-VMP. p-value from Fisher's exact test.
Maltese: Proporzjon ta' probabbiltà (odds ratio) > 1 jindika vantaġġ għal D-VMP.
English: Table 10: IRC assessed efficacy results for study MMY2002 Efficacy endpoint
Maltese: Riżultati ta' effikaċja vvalutati minn IRC għall-istudju MMY2002 Punt finali ta' effikaċja
English: Table 7: Additional efficacy results from Study MMY3008
Maltese: Riżultati addizzjonali ta' effikaċja mill-Istudju Study MMY3008
English: A total of 737 patients were randomized: 368 to the DRd arm and 369 to the Rd arm.
Maltese: 368 għall-fergħa ta' DRd u 369 għall-fergħa ta' Rd.
English: Chills
Maltese: KUNJETT
English: Recommended concomitant medications
Maltese: TAL-PRODOTT MEDIĊINALI
English: Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Maltese: Il-metodi ta' mitigazzjoni tal-interferenza ta' daratumumab jinkludu t-trattament talRBCs li jirreaġixxu ma' dithiothreitol (DTT) biex ifixkel l-irbit ma' daratumumab jew metodi oħra lokalment validati.
English: DARZALEX will be given to you by a doctor or nurse.
Maltese: DARZALEX se jingħatalek minn tabib jew infermier.
English: Very good partial response (VGPR) Partial response (PR)
Maltese: Rispons parzjali (PR, Partial response) 48 (17.1)
English: Constipation Nausea Vomiting Pancreatitis
Maltese: Stitikezza Nawsja Rimettar Pankreatite
English: Stringent complete response (sCR)
Maltese: Rispons sħiħ strett (sCR, Stringent complete response)
English: This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each 20 mL vial.
Maltese: Din il-mediċina fiha 37.3 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/tal-ikel) f'kull kunjett ta' 20 mL.
English: The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Maltese: Il-medjan tal-età tal-pazjenti kien ta' 65 sena (firxa minn 34 sa 89 sena) u 11%kellhom ≥75 sena.
English: The primary analysis of PFS in Study MMY3007 showed an improvement in the D-VMP arm as compared to the VMP arm; the median PFS had not been reached in the D-VMP arm and was 18.1 months in the VMP arm (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001), representing 50% reduction in the risk of disease progression or death in patients treated with D-VMP.
Maltese: L-analiżi primarja ta' PFS fl-Istudju MMY3007 uriet titjib fil-fergħa ta' D-VMP meta mqabbla malfergħa ta' VMP; il-medjan ta' PFS ma kienx intlaħaq fil-fergħa ta' D-VMP u kien 18.1 xhur fil-fergħa ta' VMP (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001), li jirrapreżenta tnaqqis ta' 50% fir-riskju ta' progressjoni tal-marda jew mewt f'pazjenti ttrattati b'D-VMP.
English: • Grade 4 (life-threatening): Permanently discontinue DARZALEX treatment.
Maltese: Waqqaf b'mod permanenti t-trattament b'DARZALEX
English: Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Maltese: Tabella 1: Skeda għall-għoti tad-dożi ta' DARZALEX flimkien ma' lenalidomide (reġimen ta' ċiklu ta' 4 ġimgħat għall-għoti tad-doża) u għall-monoterapija
English: Odds ratio with 95% CI p-value
Maltese: Proporzjon ta' probabbiltà b'CI ta' 95% Valur p
English: Table 11: Additional efficacy results from Study MMY3003 Response evaluable patient number
Maltese: Tabella 11: Riżultati addizjonali ta' effikaċja mill-Istudju MMY3003 Numru ta' pazjenti b'rispons li seta' jiġi vvalutat
English: Efficacy results of the pre-planned interim analysis based on Independent Review Committee (IRC) assessment are presented in Table 10 below.
Maltese: Riżultati ta' effikaċja ta' analiżi interim ippjanata minn qabel abbażi tal-valutazzjoni tal-Kumitat Indipendenti ta' Rikonsiderazzjoni (IRC - Independent Review Committee) huma ppreżentati f'Tabella 10 hawn taħt.
English: MRD negative rate (95% CI)
Maltese: Rd (95% CI)
English: • Using aseptic technique, remove a volume of 0.9% Sodium Chloride from the infusion bag/container that is equal to the required volume of DARZALEX solution.
Maltese: • Bl-użu tat-teknika asettika, neħħi volum ta' 0.9% Sodium Chloride mill-borża/kontenitur talinfużjoni li huwa daqs il-volum meħtieġ tas-soluzzjoni ta' DARZALEX.
English: Median durations of infusions were 4.2 h for Week 1-Day 1, 4.2 h for Week 1-Day 2, and 3.4 hours for the subsequent infusions.
Maltese: It-tulijiet medjani tal-infużjoni kienu 4.2 sigħat għal Ġimgħa 1Jum 1, 4.2 sigħat għal Ġimgħa 1-Jum 2, u 3.4 sigħat għall-infużjonijiet sussegwenti.
English: Based on population pharmacokinetic (PK) analyses no dosage adjustment is necessary for patients with renal impairment (see section 5.2).
Maltese: Abbażi ta' analiżi ta' farmakokinetika (PK - pharmacokinetic) tal-popolazzjoni ma huwa meħtieġ l-ebda aġġustament fid-doża għall-pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Prior to the launch of DARZALEX (daratumumab) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, aiming at increasing awareness about the Important Identified Risk of “Interference for blood typing (minor antigen) (Positive Indirect Coombs' test)” and providing guidance on how to manage it.
Maltese: Qabel it-tnedija ta' DARZALEX (daratumumab) f'kull Stat Membru (SM) id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorization Holder) għandu jaqbel dwar il-kontenut u l-format tal-materjal edukattiv, bil-għan li jżid l-għarfien dwar ir-Riskju Importanti Identifikat ta' “Interferenza għat-tip tad-demm (antiġen minuri) (Test Pożittiv Indirett ta' Coombs)” u jipprovdi gwida dwar kif għandha tiġi ġestita.
English: 500 mL 50 mL/hour 50 mL/hour every hour
Maltese: 500 mL 50 mL/siegħa 50 mL/siegħa kull siegħa
English: Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
Maltese: Erbgħin fil-mija kellhom marda skont is-Sistema Internazzjonali ta' Attribuzzjoni talIstadji (ISS, International Staging System) ta' Stadju I, 45% kellhom marda b'ISS ta' Stadju II u 15% kellhom marda b'ISS ta' Stadju III.
English: Consider consulting a hepatitis disease expert as clinically indicated.
Maltese: Ikkunsidra konsulta ma' espert fil-marda tal-epatite skont kif ikun indikat b'mod kliniku.
English: Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
Maltese: Rispons sħiħ (CR, Complete response) [n(%)] Rispons parzjali tajjeb ħafna (VGPR, Very good partial response)
English: DARZALEX is a cancer medicine that contains the active substance daratumumab.
Maltese: DARZALEX huwa mediċina tal-kanċer li fih is-sustanza attiva daratumumab.
English: • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing 0.9% Sodium Chloride (see section 4.2).
Maltese: • Iġbed l-ammont meħtieġ ta' soluzzjoni ta' DARZALEX u ddilwixxi għall-volum li suppost billi żżidu ġol-borża/kontenitur tal-infużjoni li fih 0.9% Sodium Chloride (ara sezzjoni 4.2).
English: This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria.
Maltese: IgG kappa ikollhom impatt fl-istima inizjali ta' risponsi kompluti skont il-kriterji tal-International Myeloma Working Group (IMWG).
English: An odds ratio >1 indicates an advantage for DRd.
Maltese: Proporzjon ta' probabbiltà ta' > 1 jindika vantaġġ għal DRd.
English: Response assessment Day 100 posttransplant Stringent Complete Response (sCR) 157 (28.9%) CR or better (sCR+CR) Very Good Partial Response or better (sCR+CR+VGPR) MRD negativity c, d n(%)
Maltese: Rispons parzjali tajjeb ħafna (VGPR, very good partial response) Rispons parzjali (PR, partial response) CR jew aħjar (sCR + CR) Valur p VGPR jew aħjar (sCR + CR + VGPR) Valur p Rata ta' negattività ta' MRD
English: The majority of IRRs occurred at the first infusion and were Grade 1-2 (see section 4.8).
Maltese: Il-maġġoranza tal-IRRs seħħew mal-ewwel infużjoni u kienu ta' Grad 1-2 (ara sezzjoni 4.8).
English: Table 12: Additional efficacy results from Study MMY3004 Response evaluable patient number
Maltese: Tabella 12: Riżultati addizjonali ta' effikaċja mill-Istudju MMY3004
English: Table 4: DARZALEX dosing schedule in combination with bortezomib (3-week cycle dosing regimen)
Maltese: Tabella 4: Skeda għall-għoti tad-dożi ta' DARZALEX flimkien ma' bortezomib (reġimen ta' ċiklu ta' 3 ġimgħat għall-għoti tad-doża)
English: DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval; NE=not estimable.
Maltese: MRD, minimal residual disease=mard residwu minimu; CI, confidence interval=intervall ta' kunfidenza; NE, not estimable=ma jistax jiġi stmat.
English: Study MMY3008 showed an improvement in Progression Free Survival (PFS) in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001), representing 44% reduction in the risk of disease progression or death in patients treated with DRd.
Maltese: L-istudju MMY3008 wera titijib fis-Sopravivenza Mingħajr Progressjoni (PFS) fil-fergħa DRd meta mqabbla mal-fergħa Rd; il-medjan ta' PFS ma kienx intlaħaq fil-fergħa ta' DRd u kien 31.9 xhur fil fergħa ta' Rd (proporzjon ta' periklu [HR, hazard ratio]=0.56; 95% CI: 0.43, 0.73; p<0.0001), lijirrapreżenta tnaqqis ta' 44% fir-riskju ta' progressjoni tal-marda jew mewt f'pazjenti ttrattati b'DRd. Riżultati ta' analiżi aġġornata ta' PFS madwar 9 xhur wara t-tmiem kliniku oriġinali, kompla juri titjib fil-PFS għal pazjenti fil-fergħa DRd meta mqabbla mal-fergħa Rd. Il-PFS medjan ma ntlaħaqx filfergħa ta' DRd u kien 33.8 xhur fil-fergħa ta' Rd (HR=0.56; 95% CI: 0.44, 0.71; p<0.0001).
English: Primary efficacy endpoint (International Myeloma Working Group criteria) CI=confidence interval; NE=not estimable; MR=minimal response
Maltese: L-iskop finali ta' effikaċja (Kriterji tal-Grupp Internazzjonali ta' Ħidma dwar il-Majeloma) CI (confidence interval)=intervall ta' kunfidenza; NE (not estimable)=ma jistax jiġi stmat;
English: Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Maltese: Kull kunjett ta' 20 mL fih 400 mg ta' daratumumab (20 mg daratumumab f'kull mL).
English: At the end of weekly dosing for the recommended monotherapy schedule and dose of 16 mg/kg, the mean (SD) serum Cmax value was 915 (410.3) micrograms/mL, approximately 2.9-fold higher than following the first infusion.
Maltese: Fl-aħħar tal-għoti tad-doża kull ġimgħa għall-iskeda rrakkomandata ta' monoterapija u doża ta' 16-il mg/kg, il-medja (SD) tal-valur tas-Cmax fis-serum kienet 915 (410.3)-il mikrogramma/mL, madwar 2.9 drabi aktar minn wara l-ewwel infużjoni.
English: weekly (total of 6 doses)
Maltese: kull ġimgħa (total ta' 6 dożi)
English: Median OS was not reached for either treatment group.With an overall median follow-up of 7.4 months (95% CI: 0.0, 14.9), the hazard ratio for OS was 0.77 (95% CI: 0.47, 1.26; p=0.2975).
Maltese: B'medjan totali ta' segwitu ta' 7.4 xhur (95% CI: 0.0, 14.9), il-proporzjon ta' periklu għal OS kien 0.
English: nd
Maltese: ni
English: Figure 1: Kaplan-Meier Curve of PFS in Study MMY3008
Maltese: Kaplan-Meier ta' PFS fl-Istudju MMY3008
English: • dizziness or lightheadedness (hypotension)
Maltese: • fwied infjammat (epatite)
English: 500 mL 100 mL/hour 50 mL/hour every hour
Maltese: 500 mL 100 mL/siegħa 50 mL/siegħa kull siegħa
English: No clinically important differences in exposure to daratumumab were observed between patients with renal impairment and those with normal renal function.
Maltese: Ma kienu osservati l-ebda differenzi importanti b'mod kliniku fl-esponiment għal daratumumab bejn pazjenti b'indeboliment talfwied u dawk b'funzjoni normali tal-fwied.
English: • vomiting
Maltese: • influwenza
English: ) NK cells in peripheral whole blood and bone marrow were observed with daratumumab treatment.
Maltese: ) f'demm periferali sħiħ u fil-mudullun talgħadam ġew osservati bi trattament b'daratumumab.
English: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Maltese: Kull kunjett ta' 5 mL fih 100 mg ta' daratumumab (20 mg daratumumab f'kull mL).
English: The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours).
Maltese: Il-ħin medjan għall-bidu tar-reazzjoni kien 1.5 sigħat (firxa: 0 sa 72.8 siegħa).
English: Monitor patients with neutropenia for signs of infection.
Maltese: Immonitorja l-pazjenti b'newtropenija għal sinjali ta' infezzjoni.
English: Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Maltese: Reazzjonijiet avversi oħra marbuta malinfużjoni kienu jinkludu konġestjoni fl-imnieħer, sogħla, tkexkix ta' bard, irritazzjoni fil-gerżuma, rimettar u nawsja (ara sezzjoni 4.4).
English: • sore throat, cough
Maltese: • uġigħ fil-gerżuma, sogħla
English: Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Maltese: Seħħew reazzjonijiet severi, inkluż bronkospażmu, ipoksja, dispnea, pressjoni għolja, edima fil-larinġi u edima fil-pulmuni.
English: For dose and schedule of medicinal products administered with DARZALEX, see section 5.1 and the corresponding Summary of Product Characteristics.
Maltese: Għad-doża u l-iskeda ta' prodotti mediċinali mogħtija flimkien ma' DARZALEX, ara sezzjoni 5.1 u sSommarju tal-Karatteristiċi tal-Prodott tagħhom.
English: Thirty-three percent (33%) of patients were refractory to an IMiD only, and 28% were refractory to lenalidomide.
Maltese: Tlieta u tletin fil-mija (33%) tal-pazjenti ma wiġbux għal IMiD biss, u 28% ma wiġbux għal lenalidomide.