FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommended hydration includes both oral fluids (30 mL/kg/day for 48 hours before day 1 of cycle 1) and intravenous fluids (250 mL to 500 mL of appropriate intravenous fluid before each dose in cycle 1).
Maltese: L-idratazzjoni rakkomandata tinkludi kemm fluwidi orali (30 mL/kg/jum għal 48 siegħa qabel jum 1 ta' ċiklu 1) kif ukoll fluwidi ġol-vini (250 mL sa 500 mL ta' fluwidu ġol-vini xieraq qabel kull doża f'ċiklu 1).
English: • Ringing in the ears (tinnitus)
Maltese: • Żarżir fil-widnejn (tinnitus)
English: Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis.
Maltese: Pressjoni għolja, li tinkludi kriżi ipertensiva u emerġenza ipertensiva, kienet osservata b'Kyprolis.
English: • Serious lung infection (pneumonia)
Maltese: • Infezzjoni serja tal-pulmun (pnewmonja)
English: Kyprolis, lenalidomide, and dexamethasone
Maltese: Kyprolis, lenalidomide, u dexamethasone
English: Similar PFS results were observed in patients who had received prior treatment with bortezomib (HR 0.56, 95% CI: 0.44, 0.73) and patients who had not received prior treatment with bortezomib (HR 0.48, 95% CI: 0.36, 0.66).
Maltese: Riżultati ta' PFS simili kienu osservati f'pazjenti li kienu rċevew trattament minn qabel b'bortezomib (HR 0.56, CI ta' 95%: 0.44, 0.73) u pazjenti li ma kinux irċevew trattament minn qabel b'bortezomib (HR 0.48, CI ta' 95%: 0.36, 0.66).
English: A clinical trial using oral midazolam as a CYP3A probe conducted with carfilzomib at a dose of 27 mg/m2 (2-10 minute infusion) demonstrated that the pharmacokinetics of midazolam were unaffected by concomitant carfilzomib administration, indicating that carfilzomib is not expected to inhibit the metabolism of CYP3A4/5 substrates and is not a CYP3A4 inducer in human subjects.
Maltese: Prova klinika b'midazolam orali bħala sonda tas-CYP3A imwettqa b'carfilzomib b'doża ta' 27 mg/m2 (infużjoni ta' 2-10 minuti) uriet li l-farmakokinetika ta' midazolam ma kinitx affettwata mill-għoti flistess waqt ta' carfilzomib, li juri li carfilzomib mhuwiex mistenni li jinibixxi l-metaboliżmu ta' sottostrati tas-CYP3A4/5 u mhuwiex induttur tas-CYP3A4 f'individwi umani.
English: Kyprolis and dexamethasone
Maltese: Kyprolis u dexamethasone
English: As this medicine is being given by a doctor or nurse, it is unlikely that you will be given too much.
Maltese: Minħabba li din il-mediċina se tingħata minn tabib jew infermier, huwa improbabbli li tingħata doża aktar milli suppost.
English: A statistically significant advantage in OS was observed in patients in the Kd arm compared to patients in the Vd arm (HR = 0.791; 95% CI: 0.65, 0.96; p-value = 0.010) (see figure 4).
Maltese: Kien osservat vantaġġ statistikament sinifikanti fl-OS f'pazjenti fil-grupp ta' Kd meta mqabbel ma' pazjenti fil-grupp ta' Vd (HR = 0.791; CI ta' 95%: 0.65, 0.96; valur p = 0.010) (ara figura 4).
English: Kaplan-Meier curve of overall survival in relapsed multiple myeloma study 2011-003
Maltese: Kaplan-Meier tas-sopravivenza globali fi studju 2011-003 dwar mijeloma multipla li reġgħet tfaċċat
English: When Kyprolis is combined with dexamethasone alone, dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28 day cycles.
Maltese: Meta Kyprolis jiġi kkombinat ma' dexamethasone waħdu, dexamethasone jingħata bħala 20 mg millħalq jew ġol-vini f'jiem 1, 2, 8, 9, 15, 16, 22, u 23 taċ-ċikli ta' 28 jum.
English: The safety and efficacy of Kyprolis were evaluated in a phase 3, randomised, open-label, multicentre study of Kyprolis plus dexamethasone (Kd) versus bortezomib plus dexamethasone (Vd).
Maltese: Is-sigurtà u l-effikaċja ta' Kyprolis kienu evalwati fi studju ta' fażi 3, randomised, open-label, b'aktar minn ċentru wieħed ta' Kyprolis flimkien ma' dexamethasone (Kd) kontra bortezomib flimkien ma' dexamethasone (Vd).
English: Monkeys administered a single bolus intravenous dose of carfilzomib at 3 mg/kg (which corresponds to 36 mg/m2 and is similar to the recommended dose in humans of 27 mg/m2 based on BSA) experienced hypotension, increased heart rate, and increased serum levels of troponin T. The repeated bolus intravenous administration of carfilzomib at ≥ 2 mg/kg/dose in rats and 2 mg/kg/dose in monkeys using dosing schedules similar to those used clinically resulted in mortalities that were due to toxicities occurring in the cardiovascular (cardiac failure, cardiac fibrosis, pericardial fluid accumulation, cardiac haemorrhage/degeneration), gastrointestinal (necrosis/haemorrhage), renal (glomerulonephropathy, tubular necrosis, dysfunction), and pulmonary (haemorrhage/inflammation) systems.
Maltese: Lgħoti ripetut tad-doża bolus ġol-vini ta' carfilzomib ta' ≥ 2 mg/kg/doża fil-firien u ta' 2 mg/kg/doża fix-xadini bl-użu ta' skedi ta' dożaġġ simili għal dawk użati klinikament wassal għal imwiet li kienu dovuti għal tossiċitajiet li seħħew fis-sistemi kardjovaskulari (insuffiċjenza kardijaka, fibrożi kardijaka, akkumulazzjoni ta' fluwidu perikardjali, emorraġija/deġenerazzjoni kardijaka), gastrointestinali (nekrożi/emorraġija), tal-kliewi (glomerulonefropatija, nekrosi tubulari, disfunzjoni), u pulmonari (emorraġija/infjammazzjoni).
English: Kyprolis will be given as an infusion into a vein.
Maltese: Kyprolis se jinħażen fi spiżerija.
English: Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2.
Maltese: Kyprolis jingħata b'doża tal-bidu ta' 20 mg/m2 (doża massima ta' 44 mg) f'ċiklu 1 f'jiem 1 u 2.
English: Lung infection Influenza Herpes zoster* Urinary tract infection Bronchitis Gastroenteritis Viral infection Nasopharyngitis Rhinitis
Maltese: Influwenza Herpes zoster* Infezzjoni fl-apparat tal-awrina
English: Pulmonary embolism Pulmonary oedema Epistaxis
Maltese: Pressjoni pulmonari għolja
English: Scientific conclusions
Maltese: Statistikament sinifikanti
English: Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
Maltese: Carfilzomib huwa metabolizzat primarjament permezz tal-attivitajiet tal-peptidase u l-epoxide hydrolase, u bħala riżultat, huwa improbabbli li l-profil farmakokinetiku ta' carfilzomib ikun affettwat mill-għoti fl-istess waqt ta' inibituri u indutturi taċ-ċitokroma P450.
English: Study eligibility criteria allowed a small subset of patients with myeloma refractory to bortezomib (n = 118) or lenalidomide (n = 57) to be enrolled.
Maltese: Il-kriterji ta' eliġibilità tal-istudju ppermettew sottogrupp żgħir ta' pazjenti b'mijeloma reżistenti għal bortezomib (n = 118) jew lenalidomide (n = 57) biex jiġi rreġistrat.
English: Dyspnoea was reported in approximately 30% of subjects in clinical studies with Kyprolis.
Maltese: Qtugħ ta' nifs kien irrappurtat f'madwar 30% tal-individwi fi studji kliniċi b'Kyprolis.
English: • Difficulty sleeping (insomnia)
Maltese: • Diffikultà biex torqod (insomnja)
English: Kyprolis powder for solution for infusion must not be mixed with sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Kyprolis trab għal soluzzjoni għall-infużjoni m'għandux jitħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Pack size of one vial.
Maltese: Kull pakkett fih kunjett wieħed.
English: At doses between 20 and 56 mg/m2, there was a dose-dependent increase in exposure.
Maltese: B'dożi bejn 20 u 56 mg/m2, kien hemm żieda fl-esponiment dipendenti mid-doża.
English: • Headache
Maltese: • Sirdat
English: Cardiac failure, myocardial infarction and myocardial ischaemia
Maltese: Insuffiċjenza tal-qalb, infart mijokardijaku u iskemija mijokardijaka
English: The 20/56 mg/m2 dose must be administered over 30 minutes.
Maltese: Id-doża ta' 20/56 mg/m2 għandha tingħata fuq firxa ta' 30 minuta.
English: Carfilzomib is a P-glycoprotein (P-gp) but not a BCRP substrate.
Maltese: Carfilzomib huwa glikoproteina P (P-gp - P-glycoprotein) iżda mhuwiex sottostrat ta' BCRP.
English: Cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving carfilzomib who have had prior or concurrent immunosuppressive therapy.
Maltese: Każijiet ta' Lewkoenċefalopatija Multifokali Progressiva (PML) ġew irrappurtati f'pazjenti li qed jirċievu carfilzomib li kellhom terapija immunosoppressiva preċedenti jew fl-istess ħin.
English: Nonetheless, considering the fast elimination of carfilzomib, notably a rapid decline in systemic concentration 5 minutes after the end of infusion, the risk of clinically relevant interactions with substrates of OATP1B1 and UGT1A1 is probably low.
Maltese: Minkejja dan, meta tqis l-eleminazzjoni ta' malajr ta' carfilzomib, b'mod speċjali t-tnaqqis mgħaġġel fil-konċentrazzjoni sistemika 5 minuti wara t-tmiem tal-infużjoni, ir-riskju ta' interazzjonijiet kliniċi relevanti ma' sottostrati ta' OATP1B1 u UGT1A1 aktarx li huwa baxx.
English: PFS months median (95% CI)a
Maltese: Medjan ta' xhur ta' PFS (CI ta' 95%)a
English: Following a 30 minute infusion of the 56 mg/m2 dose, the AUC (948 ng•hr/mL) was approximately 2.5-fold that observed at the 27 mg/m2 level, and Cmax (2,079 ng/mL) was lower compared to that of 27 mg/m2 over the 2 to 10 minute infusion.
Maltese: Wara infużjoni ta' 30 minuta tad-doża ta' 56 mg/m2, l-AUC (948 ng•siegħa/mL) kienet madwar 2.5 darbiet dik osservata fil-livell ta' 27 mg/m2, u Cmax (2,079 ng/mL) kienet aktar baxxa meta mqabbel ma' dik ta' 27 mg/m2 matul l-infużjoni ta' 2 sa 10 minuti.
English: HR (95% CI); 1-sided p-valueb
Maltese: HR (CI ta' 95%); valur p ta' naħa waħdab
English: Evaluate dyspnoea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes.
Maltese: Evalwa l-qtugħ ta' nifs biex teskludi kondizzjonijiet kardjopulmonari li jinkludu insuffiċjenza kardijaka u sindromi pulmonari.
English: For men taking Kyprolis
Maltese: Doża ta' Kyprolis
English: In a randomised, open-label multicentre study in patients receiving Kyprolis 20/56 mg/m2 infused over 30 minutes in combination with dexamethasone (Kd, n = 464) vs bortezomib plus dexamethasone (Vd, n = 465), cases of grade 2 and higher peripheral neuropathy were reported in 7% of patients with relapsed multiple myeloma in the Kd arm, compared with 35% in the Vd arm at the time of the pre-planned OS analysis.
Maltese: Fi studju randomised, open-label, b'aktar minn ċentru wieħed f'pazjenti li kienu qed jirċievu Kyprolis 20/56 mg/m2 infuż fuq firxa ta' 30 minuta flimkien ma' dexamethasone (Kd, n = 464) vs bortezomib flimkien ma' dexamethasone (Vd, n = 465), kienu rrappurtati każijiet ta' newropatija periferali ta' grad 2 u ogħla f'7% tal-pazjenti b'mijeloma multipla li reġgħet tfaċċat fil-grupp ta' Kd, meta mqabbla ma' 35% fil-grupp ta' Vd fil-ħin tal-analiżi ppjanata minn qabel tal-OS.
English: Pharmacokinetic data were collected from patients following administration of a 27 mg/m2 dose as a 30 minute infusion on cycle 1, day 16 and the 56 mg/m2 dose on cycle 2, day 1.
Maltese: Data farmakokinetika nġabret minn pazjenti wara l-għoti ta' doża ta' 27 mg/m2 bħala infużjoni ta' 30 minuta f'ċiklu 1, jum 16 u doża ta' 56 mg/m2 f'ċiklu 2, jum 1.
English: Patients in the Kyprolis, lenalidomide, and dexamethasone (KRd) arm demonstrated improved progression-free survival (PFS) compared with those in the lenalidomide and dexamethasone (Rd) arm, (HR = 0.69, with 1-sided p value < 0.0001) which represents a 45% improvement in PFS or a 31% reduction in the risk of event as determined using standard objective International Myeloma Working Group (IMWG)/European Blood and Marrow Transplantation (EBMT) response criteria by an Independent Review Committee (IRC).
Maltese: Pazjenti fil-grupp tal-istudju b'Kyprolis, lenalidomide u dexamethasone (KRd) urew titjib fissopravivenza mingħajr progressjoni (PFS - progression-free survival) meta mqabbla ma' dawk filgrupp tal-istudju b'lenalidomide u dexamethasone (Rd), (HR = 0.69, b'valur p ta' naħa waħda < 0.0001) li jirrappreżenta titjib ta' 45% fil-PFS jew tnaqqis ta' 31% fir-riskju ta' avveniment kif determinat bl-użu tal-kriterji ta' rispons oġġettiv standard tal-International Myeloma Working Group (IMWG)/European group for Blood and Marrow Transplantation (EBMT) minn Kumitat ta' Analiżi Indipendenti (IRC - Independent Review Committee).
English: Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes.
Maltese: Carfilzomib kien klastoġeniku fit-test tal-aberrazzjoni fil-kromosomi in vitro fil-limfoċiti tad-demm periferali.
English: Kyprolis, as a single agent, was administered intravenously over 30 minutes at 20 mg/m2 on days 1 and 2 and at 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1.
Maltese: Kyprolis, bħala sustanza waħedha, ingħata fil-vini fuq firxa ta' 30 minuta b'doża ta' 20 mg/m2 f'jiem 1 u 2 u b'doża ta' 27 mg/m2 f'jiem 8, 9, 15 u 16 ta' ċiklu 1.
English: Carfilzomib works by blocking the proteasome.
Maltese: Carfilzomib jaħdem billi jimblokka l-proteasome.
English: The PFS benefit of Kd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 143), patients with high risk (n = 210) genetic mutations, and patients with baseline creatinine clearance of 30 - < 50 mL/min (n = 128).
Maltese: Il-benefiċċju ta' PFS ta' Kd kien osservat b'mod konsistenti fis-sottogruppi kollha, inkluż f'pazjenti b'età ta' ≥ 75 (n = 143), pazjenti b'mutazzjonijiet ġenetiċi ta' riskju għoli (n = 210), u pazjenti bi tneħħija tal-krejatinina fil-linja bażi ta' 30 - < 50 mL/min (n = 128).
English: Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion carfilzomib
Maltese: Kyprolis 10 mg trab għal soluzzjoni għall-infużjoni Kyprolis 30 mg trab għal soluzzjoni għall-infużjoni Kyprolis 60 mg trab għal soluzzjoni għall-infużjoni carfilzomib
English: The demographics and baseline characteristics for study 2011-003 were well-balanced between the two arms, including prior treatment with bortezomib (54%), prior treatment with lenalidomide (38%), lenalidomide refractory (25%), age (65 years, range 30-89 years), gender (51% male), ECOG performance status (45% with performance status 1), high risk genetic mutations, consisting of the genetic subtypes t(4;14) or t(14;16) in 10% or more of screened plasma cells, or deletion 17p in ≥ 20%
Maltese: Id-demografiċi u l-karatteristiċi fil-linja bażi għal studju 2011-003 kienu bbilanċjati tajjeb bejn iżżewġ gruppi, inkluż trattament minn qabel b'bortezomib (54%), trattament minn qabel b'lenalidomide (38%), ma rrispondewx għal lenalidomide (25%), età (65 sena, firxa 30-89 sena), sess (51% irġiel), stat ta' prestazzjoni ta' ECOG (45% bi stat ta' prestazzjoni ta' 1), mutazzjonijiet ġenetiċi ta' riskju għoli, li kienu jikkonsistu mis-sottotipi ġenetiċi t(4;14) jew t(14;16) f'10% jew aktar taċ-ċelluli talplażma eżaminati, jew tneħħija ta' 17p f'≥ 20% taċ-ċelluli tal-plażma (23%), mutazzjonijiet ġenetiċi ta' riskju mhux magħruf, li kienu jinkludu individwi b'riżultati mhux miġbura jew mhux analizzati (9%) u marda ta' ISS ta' stadju III fil-linja bażi (24%).
English: Progression/Death, n (%) Median PFS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Maltese: Progressjoni/Mewt, n (%) PFS medjana, mo HR (KRd/Rd) (95% CI) valur p (unidirezzjonali)
English: In clinical studies with Kyprolis, cardiac toxicity and dyspnoea typically occurred early in the course of Kyprolis therapy (see section 4.4).
Maltese: Fi studji kliniċi b'Kyprolis, it-tossiċità kardijaka u lqtugħ ta' nifs tipikament iseħħu kmieni matul it-terapija b'Kyprolis (ara sezzjoni 4.4).
English: In vitro, at concentrations (3 µM) lower than those expected at therapeutic doses, carfilzomib inhibits the efflux transport of digoxin, a P-gp substrate, by 25%.
Maltese: In vitro, f'konċentrazzjonijiet (3 µM) aktar baxxi minn dawk mistennijab'dożi terapewtiċi, carfilzomib jimpedixxi t-trasport tal-effluss ta' digoxin, sottostrat ta' P-gp, b'25%.
English: GRH0219EN v1
Maltese: GRH0298 v1
English: Kaplan-Meier curve of overall survival in relapsed multiple myelomaa
Maltese: Kaplan-Meier tas-sopravivenza globali f'mijeloma multipla li reġgħet feġġeta
English: • Aching muscles
Maltese: • Spażmi fil-muskoli
English: Cases of Hepatitis B Virus (HBV) reactivation have been reported in patients receiving carfilzomib.
Maltese: Każijiet ta' riattivazzjoni tal-Virus tal-Epatite B (HBV) ġew irrappurtati f'pazjenti li qed jirċievu carfilzomib.
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżu u nnutrizzjoni
English: This medicine contains 0.3 mmol sodium (which is 7 mg sodium) per mL of reconstituted solution.
Maltese: Dan il-prodott mediċinali fih 0.3 mmols ta' sodium (li huma 7 mg ta' sodium) f'kull mL ta' soluzzjoni rikostitwita.
English: Carfilzomib was rapidly and extensively metabolised.
Maltese: Carfilzomib kien metabolizzat malajr u b'mod estensiv.
English: Patients enrolled to study PX-171-011 were more heavily pre-treated with lower organ and marrow function as compared to those enrolled in study PX-171-009.
Maltese: Pazjenti rreġistrati għallistudju PX-171-011 kienu rċevew trattamenti aktar b'saħħithom qabel u kellhom funzjoni tal-organi u tal-mudullum aktar baxxa meta mqabbla ma' dawk irreġistrati fl-istudju PX-171-009.
English: Hydration, fluid and electrolyte monitoring
Maltese: Idratazzjoni, monitoraġġ tal-fluwidi u l-elettroliti
English: Number of Subjects at Risk:
Maltese: Numru ta' Individwi f'Riskju:
English: Thus, there are limited data for Kyprolis in combination with lenalidomide and dexamethasone in patients with creatinine clearance (CrCL < 50 mL/min).
Maltese: Għalhekk, hemm data limitata għal Kyprolis flimkien ma' lenalidomide u dexamethasone f'pazjenti bi tneħħija tal-krejatinina (CrCL < 50 mL/min).
English: In study PX-171-009 the incidence of venous thromboembolic events was 15.6% in the KRd arm and 9.0% in the Rd arm. Grade ≥ 3 venous thromboembolic events were reported in 5.6% of patients in the KRd arm and 3.9% of patients in the Rd arm.
Maltese: 6% filgrupp ta' KRd u ta' 9.0% fil-grupp ta' Rd. Avvenimenti tromboemboliċi fil-vini ta' Grad ≥ 3 kienu rrappurtati f'5.6% tal-pazjenti fil-grupp ta' KRd u fi 3.9% tal-pazjenti fil-grupp ta' Rd.
English: These events typically occurred early in the course of Kyprolis therapy (< 5 cycles).
Maltese: Dawn l-avvenimenti seħħew tipikament kmieni matul il-kors ta' terapija b'Kyprolis (< 5 ċikli).
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XX45 Mechanism of action
Maltese: Sustanzi antineoplastiċi, Kodiċi ATC:
English: Kyprolis in combination with dexamethasone for the treatment of patients with relapsed multiple myeloma - study 2011-003 (ENDEAVOR)
Maltese: Kyprolis mogħti flimkien ma' dexamethasone għat-trattament ta' pazjenti b'mijeloma multipla li reġgħet tfaċċat - studju 2011-003 (ENDEAVOR)
English: The pharmacokinetics of Kyprolis has not been evaluated in patients with severe hepatic impairment.
Maltese: Il-farmakokinetika ta' Kyprolis ma ġietx evalwata f'pazjenti b'indeboliment sever tal-fwied.
English: The results of study PX-171-009 are summarised in table 6 and in figure 1 and figure 2.
Maltese: Ir-riżultati tal-istudju PX-171-009 huma mogħtija fil-qosor fit-tabella 6 u fil-figura 1 u l-figura 2.
English: The most common adverse reactions (occurring in > 20% of subjects) were: anaemia, fatigue, thrombocytopenia, nausea, diarrhoea, pyrexia, dyspnoea, respiratory tract infection, cough and neutropenia.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (li jseħħu f'> 20% tal-individwi) kienu: anemija, għeja kbira, tromboċitopenija, dardir, dijarea, deni, qtugħ ta' nifs, infezzjoni fil-passaġġ tan-nifs, sogħla u newtropenija.
English: Kyprolis treatment was administered for a maximum of 18 cycles unless discontinued early for disease progression or unacceptable toxicity.
Maltese: Trattament bi Kyprolis ingħata għal massimu ta' 18-il ċiklu sakemm ma kienx imwaqqaf kmieni minħabba progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL.
Maltese: Is-soluzzjoni rikostitwita fiha carfilzomib f'konċentrazzjoni ta' 2 mg/mL.
English: • Cataract
Maltese: • Kataretti
English: • Infection of the stomach and intestine (gastroenteritis)
Maltese: • Infezzjoni tal-istonku u l-musrana (gastroenterite)
English: The PFS benefit of KRd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 96), patients with high risk (n = 100) or unknown (n = 375) risk genetic mutations, and patients with baseline creatinine clearance of 30 - < 50 mL/min (n = 56).
Maltese: Il-benefiċċju ta' PFS ta' KRd kien osservat b'mod konsistenti fis-sottogruppi kollha, inkluż f'pazjenti ta' ≥ 75 sena (n = 96), pazjenti b'mutazzjonijiet ġenetiċi ta' riskju għoli (n = 100) jew riskju mhux magħruf (n = 375), u pazjenti bi tneħħija tal-krejatinina fil-linja bażi ta' 30 - < 50 mL/min (n = 56).
English: In patients who received prior lenalidomide (38%), median PFS was 12.9 months in the Kd arm versus 7.3 months in the Vd arm (HR = 0.69, 95% CI: 0.52, 0.92), ORR was 70.1% versus 59.3%.
Maltese: F'pazjenti li rċevew lenalidomide minn qabel (38%), PFS medjana kienet ta' 12.9 xhur fil-grupp ta' Kd kontra 7.3 xhur fil-grupp ta' Vd (HR = 0.69, CI ta' 95%: 0.52, 0.92), ORR kienet ta' 70.1% kontra 59.3%.
English: Antiviral prophylaxis should be considered in patients being treated with Kyprolis to decrease the risk of herpes zoster reactivation (see section 4.8).
Maltese: Profilassi antivirali għandha tiġi kkunsidrata għal pazjenti ttrattati b'Kyprolis sabiex jitnaqqas ir-riskju tar-riattivazzjoni tal-herpes zoster (ara sezzjoni 4.8).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kunjett fih 60 mg ta' carfilzomib.
English: After reconstitution, 1 mL of solution contains 2 mg of carfilzomib.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' soluzzjoni fih 2 mg ta' carfilzomib.
English: The upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcF at Cmax was 4.8 msec. With Bazett's correction (QTcB interval), the upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcB at Cmax was 5.9 msec.
Maltese: Bil-korrezzjoni ta' Bazett (intervall QTcB), l-ogħla livell tal-intervall ta' kunfidenza (CI - confidence interval) ta' 95% ta' naħa waħda għall-effett imbassar fuq QTcB f'Cmax kien ta' 5.9 msek.
English: Kyprolis should be discontinued if PRES is suspected.
Maltese: Kyprolis għandu jitwaqqaf jekk hemm suspett ta' PRES.
English: The disease status and other baseline characteristics were well-balanced between the two arms, including age (64 years, range 31-91 years), gender (56% male), ECOG performance status (48% with performance status 1), high-risk genetic mutations, consisting of the genetic subtypes t(4;14), t(14;16), or deletion 17p in ≥ 60% of plasma cells (13%), unknown-risk genetic mutations, which included subjects with results not collected or not analysed (47%), and baseline ISS stage III disease (20%).
Maltese: L-istat tal-marda u karatteristiċi oħrajn tal-linja bażi kienu bbilanċjati sew bejn iż-żewġ gruppi, inkluż l-età (64 sena, firxa ta' 31-91 sena), is-sess (56% kienu rġiel), l-istat ta' prestazzjoni ta' ECOG (48% bi stat ta' prestazzjoni ta' 1), mutazzjonijiet ġenetiċi ta' riskju għoli, li jikkonsistu mis-sottotipi ġenetiċi t(4;14), t(14;16), jew telf ta' 17p f'≥ 60% taċ-ċelluli tal-plażma (13%), mutazzjonijiet ġenetiċi ta' riskju mhux magħruf, li kienu jinkludu individwi b'riżultati mhux miġbura jew mhux analizzati (47%), u marda ta' ISS fil-linja bażi ta' stadju III (20%).
English: The infusion may last up to 30 minutes.
Maltese: L-infużjoni tista' ddum sa 30 minuta.
English: Following intravenous administration of doses ≥ 15 mg/m2, carfilzomib was rapidly cleared from the systemic circulation with a half-life of ≤ 1 hour on day 1 of cycle 1.
Maltese: Wara għoti ġol-vini ta' dożi ta' ≥ 15 mg/m2, carfilzomib kien eliminat b'mod rapidu miċ-ċirkolazzjoni sistemika b'half-life ta' ≤ siegħa waħda f'jum 1 ta' ċiklu 1.