FrancophonIA/ELRC3.0 huggingface dataset:
English: • Bleeding, bruising, weakness, confusion, fever, nausea, vomiting and diarrhoea, and acute kidney failure, which may be signs of a blood condition known as thrombotic microangiopathy
Maltese: • Fsada, tbenġil, dgħufija, konfużjoni, deni, nawsja, rimettar u dijarea, u insuffiċjenza akuta talkliewi, li jistgħu jkunu sinjali ta' kondizzjoni tad-demm magħrufa bħala mikroanġjopatija trombotika
English: The study showed significant improvement in PFS for patients in the Kd arm over those in the Vd arm (HR: 0.53, 95% CI: 0.44, 0.65 [p value < 0.0001]) (see figure 3).
Maltese: L-istudju wera titjib sinifikanti f'PFS għal pazjenti fil-grupp ta' Kd meta mqabbel ma' dawk fil-grupp ta' Vd (HR: 0.53, CI ta' 95%: 0.44, 0.65 [value p < 0.0001]) (ara figura 3).
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval
Maltese: PFS = sopravivenza mingħajr progressjoni (progression-free survival); mo = xhur (months); HR = proporzjon ta' periklu (hazard ratio); CI = intervall ta' kunfidenza (confidence interval)
English: Muscular weakness
Maltese: Uġigħ muskoluskeletriku
English: Study eligibility criteria allowed patients previously treated with carfilzomib (n = 3) or bortezomib (n = 502) to be enrolled as long as patients had at least a partial response (PR) to prior proteasome inhibitor therapy, were not removed from proteasome inhibitor therapy due to toxicity, and had at least a 6-month proteasome inhibitor treatment-free interval from last dose.
Maltese: Il-kriterji ta' eliġibilità tal-istudju ppermettew reġistrazzjoni ta' pazjenti li qabel kienu ttrattati b'carfilzomib (n = 3) jew bortezomib (n = 502) sakemm il-pazjenti kellhom mill-inqas rispons parzjali (PR - partial response) għal terapija b'inibitur ta' proteasome minn qabel, ma kinux imneħħija minn terapija b'inibitur ta' proteasome minħabba tossiċità, u kellhom intervall mingħajr trattament b'inibitur ta' proteasome ta' mill-inqas 6 xhur millaħħar doża.
English: • Low blood pressure (hypotension)
Maltese: • Pressjoni baxxa (ipotensjoni)
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis.
Maltese: Każijiet ta' avvenimenti tromboemboliċi fil-vini, inkluż trombożi fil-vini tal-fond u emboliżmu pulmonari b'riżultati fatali, kienu rrappurtati f'pazjenti li rċevew Kyprolis.
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide, dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; IMWG = International Myeloma Working Group; EBMT = European blood and marrow transplantation; mo = months Note: The response and PD outcomes were determined using standard objective IMWG/EBMT response criteria.
Maltese: IMWG = International Myeloma Working Group; EBMT = European group for blood and marrow transplantation; mo = xhur (months) Nota: Ir-rispons u r-riżultati tal-PD kienu determinati bl-użu tal-kriterji ta' rispons oġġettivi standard talIMWG/EBMT. a.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: L-istudju ma evalwax il-proporzjon ta' benefiċċju/riskju fil-popolazzjoni reżistenti usa'.
English: Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor that selectively and irreversibly binds to the N terminal threonine containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome, and displays little to no activity against other protease classes.
Maltese: Carfilzomib huwa inibitur ta' tetrapeptide epoxyketone proteasome li jorbot b'mod selettiv u irriversibbli mal-N terminal threonine li fih siti attivi tat-20S proteasome, il-partiċella b'qalba proteolitika fit-26S proteasome, u juri ftit li xejn sa xejn affattu attività kontra klassijiet oħra ta' protease. Carfilzomib kellu attivitajiet antiproliferattivi u proapoptotiċi f'mudelli ta' qabel l-użu kliniku f'tumuri ematoloġiċi.
English: Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Maltese: Is-sindrome ta' distress respiratorju akut (ARDS - acute respiratory distress syndrome), insuffiċjenza respiratorja akuta, u mard pulmonari akut mifrux u infiltrattiv bħal pulmonite u mard tal-interstizju talpulmun seħħew f'pazjenti li ngħataw Kyprolis.
English: Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis.
Maltese: Każijiet ta' sindrome tal-lisi tat-tumur (TLS - tumour lysis syndrome), li jinkludu riżultati fatali, kienu rrappurtati f'pazjenti li ngħataw Kyprolis.
English: 15 mg/m2 dose cycle 1, day 1 for mild, moderate, severe renal impairment and chronic dialysis versus normal renal function were 124.36%, 111.07%, 84.73% and 121.72%, respectively.
Maltese: Il-proporzjon tal-medja ġeometrika f'AUCl-aħħar b'doża ta' 15 mg/m2 f'ċiklu 1, jum 1 għal indeboliment tal-kliewi ħafif, moderat u sever u dijalisi kronika kontra funzjoni normali tal-kliewi kien ta' 124.36%, 111.
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis (see section 4.4).
Maltese: F'pazjenti li rċevew Kyprolis kienu rrappurtati każijiet ta' avvenimenti tromboemboliċi fil-vini, inkluż trombożi fil-vini tal-fond u emboliżmu pulmonari b'riżultati fatali (ara sezzjoni 4.4).
English: Cytochrome P450 mediated mechanisms played a minor role in overall carfilzomib metabolism.
Maltese: Il-mekkaniżmi medjati miċ-ċitokroma P450 kellhom rwol żgħir filmetaboliżmu globali ta' carfilzomib.
English: Dose modifications during Kyprolis treatment
Maltese: Tabella 3. Modifiki fid-doża matul it-trattament b'Kyprolis
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion
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
English: In combination with Kyprolis, lenalidomide is administered as 25 mg orally on days 1-21 and dexamethasone is administered as 40 mg orally or intravenously on days 1, 8, 15, and 22 of the 28 day cycles.
Maltese: Flimkien ma' Kyprolis, lenalidomide jingħata bħala 25 mg mill-ħalq fil-jiem 1-21 u dexamethasone jingħata bħala 40 mg mill-ħalq jew ġol-vini fil-jiem 1, 8, 15, u 22 taċ-ċikli ta' 28 jum.
English: As lenalidomide may be used in combination with Kyprolis, particular attention to the lenalidomide pregnancy testing and prevention requirements is needed (see section 4.6).
Maltese: Minħabba li lenalidomide jista' jintuża flimkien ma' Kyprolis, trid tingħata attenzjoni partikolari lir-rekwiżiti tal-ittestjar u l-prevenzjoni tat-tqala ta' lenalidomide (ara sezzjoni 4.6).
English: A number of cases of Hepatitis B reactivation have been identified in relation to carfilzomib treatment.
Maltese: Numru ta' każijiet ta' riattivazzjoni tal-Epatite B ġew identifikati b'rabta mat-trattament b'carfilzomib.
English: • Respiratory tract infection (infection of the airways)
Maltese: • Infezzjoni fl-apparat tal-awrina (infezzjoni fl-istrutturi li jġorru l-awrina)
English: The doses on day 8 and 9 of each cycle will not be given from cycle 13 onwards if you are treated with Kyprolis in combination with lenalidomide and dexamethasone.
Maltese: Id-dożi f'jum 8 u 9 ta' kull ċiklu mhux se jibqgħu jingħataw minn ċiklu 13 'il quddiem jekk qed tiġi ttrattat bi Kyprolis flimkien ma' lenalidomide u dexamethasone.
English: In study 2011 003 the incidence of venous thromboembolic events was 12.5% in the Kd arm and 3.3% in the bortezomib plus dexamethasone (Vd) arm. Grade ≥ 3 venous thromboembolic events were reported in 3.5% of patients in the Kd arm and 1.8% of patients in the Vd arm.
Maltese: Fi studju 2011-003 l-inċidenza ta' avvenimenti tromboemboliċi fil-vini kienet ta' 12.5% fil-grupp ta' Kd u ta' 3.3% fil-grupp ta' bortezomib flimkien ma' dexamethasone (Vd).
English: In patients who received prior bortezomib (54%), median PFS was 15.6 months in the Kd arm versus 8.1 months in the Vd arm (HR = 0.56, 95% CI: 0.44, 0.73), ORR was 71.2% versus 60.3%.
Maltese: F'pazjenti li rċevew bortezomib minn qabel (54%), PFS medjana kienet ta' 15.6 xhur fil-grupp ta' Kd kontra 8.1 xahar fil-grupp ta' Vd (HR = 0.56, CI ta' 95%: 0.44, 0.73), ORR kienet ta' 71.2% kontra
English: Cases of hepatic failure, including fatal cases, have been reported in < 1% of subjects in clinical studies with Kyprolis.
Maltese: Każijiet ta' insuffiċjenza tal-fwied, li jinkludu każijiet fatali, kienu rrappurtati f'< 1% tal-individwi fi studji kliniċi b'Kyprolis.
English: Progression/Death, n (%) Median PFS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Maltese: Progressjoni/Mewt, n (%) PFS Medjana, xhur HR (Kd/Vd) (CI ta' 95%) valur p (ta' naħa waħda)
English: Haemorrhage and thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Baseline hepatic function status had no marked effect on the total systemic exposure (AUClast) of carfilzomib following single or repeat-dose administration (geometric mean ratio in AUClast at the 27 mg/m2 dose in cycle 1, day 16 for mild and moderate impairment versus normal hepatic function were 144.4% and 126.1%, respectively; and at the 56 mg/m2 dose in cycle 2, day 1 were 144.7% and 121.1%).
Maltese: L-istat tal-funzjoni tal-fwied fillinja bażi ma kellu l-ebda effett notevoli fuq l-esponiment sistemiku totali (AUCl-aħħar) għal carfilzomib wara għotja waħda jew għoti ta' dożi ripetuti (il-proporzjon tal-medja ġeometrika f'AUCl-aħħar b'doża ta' 27 mg/m2 f'ċiklu 1, jum 16 għal indeboliment ħafif u moderat kontra funzjoni normali tal-fwied kien ta' 144.4% u 126.
English: Calculate the dose (mg/m2) and number of vials of Kyprolis required using the patient's BSA at baseline.
Maltese: Ikkalkula d-doża (mg/m2) u n-numru ta' kunjetti ta' Kyprolis meħtieġa bl-użu tal-BSA talpazjent fil-linja bażi.
English: Other medicines and Kyprolis
Maltese: Mediċini oħra u Kyprolis
English: Kaplan-Meier curve of progression-free survival in relapsed multiple myelomaa
Maltese: Kaplan-Meier tas-sopravivenza mingħajr progressjoni f'mijeloma multipla li reġgħet feġġeta
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib and dexamethasone; CI = confidence interval; NE = not estimable; HR = Hazard Ratio; ORR = overall response rate; CR = complete response; VGPR = very good partial response a. These endpoints were determined by an Independent Review Committee b. Statistically significant c. Overall response is defined as achieving a best overall response of PR, VGPR, CR, or sCR d. Statistically significant, 1-sided p value = 0.0005 e. Statistically significant, 1-sided p value = 0.0001
Maltese: Vd = bortezomib u dexamethasone; CI = intervall ta' kunfidenza (confidence interval); NE = ma jistax jiġi stmat (not estimable); HR = proporzjon ta' periklu (hazard ratio); ORR = rata ta' rispons globali (overall response rate); CR = rispons sħiħ (complete response); VGPR = rispons parzjali tajjeb ħafna (very good partial response) a.
English: Overall, the subject incidence of certain adverse events (including cardiac arrhythmias, cardiac failure (see section 4.4), dyspnoea, leukopenia and thrombocytopenia) in clinical trials with Kyprolis was higher for patients who were ≥ 75 years of age compared to patients who were < 75 years of age.
Maltese: Globalment, l-inċidenza f'individwi ta' ċerti każijiet avversi (li jinkludu arritmiji tal-qalb, insuffiċjenza kardijaka (ara sezzjoni 4.4), qtugħ ta' nifs, lewkopenija u tromboċitopenija) fi provi kliniċi b'Kyprolis kienet ogħla għal pazjenti li kellhom ≥ 75 sena meta mqabbla ma' pazjenti li kellhom < 75 sena.
English: There are limited efficacy and safety data on patients with baseline creatinine clearance < 30 mL/min.
Maltese: Hemm data limitata dwar leffikaċja u s-sigurtà dwar pazjenti bi tneħħija tal-krejatinina fil-linja bażi ta' < 30 mL/min.
English: Kyprolis, as a single agent, was administered intravenously over 2 to 10 minutes at doses up to 20 mg/m2.
Maltese: Kyprolis, bħala sustanza waħedha, ingħata fil-vini fuq firxa ta' 2 sa 10 minuti b'dożi sa 20 mg/m2.
English: • Stroke
Maltese: • Sturdament
English: Each mL of reconstituted solution contains 7 mg of sodium.
Maltese: Kull mL ta' soluzzjoni rikostitwita fih 7 mg ta' sodium.
English: Clostridium difficile colitis Cytomegalovirus infection Hepatitis B virus reactivation
Maltese: Infezzjoni b'ċitomegalovirus Riattivazzjoni talvirus tal-Epatite B (HBV)
English: Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; OS = overall survival; mo = months; HR = hazard ratio; CI = confidence interval
Maltese: Vd = bortezomib flimkien ma' dexamethasone; OS = sopravivenza globali (overall survival); mo = xhur (months); HR = proporzjon ta' periklu (hazard ratio); CI = intervall ta' kunfidenza (confidence interval)
English: Kyprolis will be given to you by a doctor or nurse.
Maltese: Kyprolis se jingħata lilek minn tabib jew infermier.
English: Thromboprophylaxis should be considered based on an individual benefit/risk assessment.
Maltese: Tromboprofilassi għandha tiġi kkunsidrata abbażi ta' valutazzjoni individwali tal-benefiċċji/riskji.
English: Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2.
Maltese: Pazjenti b'BSA ta' aktar minn 2.2 m2 għandhom jirċievu doża bbażata fuq BSA ta' 2.2 m2.
English: Combination dosing with lenalidomide and dexamethasone did not affect proteasome inhibition.
Maltese: Id-dożaġġ ikkombinat ma' lenalidomide u dexamethasone ma kellu l-ebda effett fuq l-inibizzjoni tal-proteasome.
English: In the first study the M14 metabolite, a peptide fragment and the most abundant circulating metabolite, increased 2- and 3-fold in patients with moderate and severe renal impairment, respectively, and 7-fold in patients requiring dialysis (based on AUClast).
Maltese: Fl-ewwel studju il-metabolit M14, framment ta' peptide u l-aktar metabolit abbundanti fiċ-ċirkolazzjoni, żdied b'darbtejn u bi 3 darbiet f'pazjenti b'indeboliment moderat u sever tal-kliewi, rispettivament, u b'7 darbiet f'pazjenti li jeħtieġu d-dijalisi (abbażi ta' AUCl-aħħar).
English: • Reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
Maltese: • Attivazzjoni mill-ġdid tal-virus tal-ġidri r-riħ (ħruq ta' Sant' Antnin) li jista' jikkawża raxx u uġigħ fil-ġilda (herpes zoster)
English: Thrombocytopenia Neutropenia Anaemia
Maltese: Tromboċitopenija Newtropenija Anemija
English: Proportion Surviving without Progression
Maltese: Sopravivenza mingħajr Progressjoni
English: Vd Arm (N = 465)
Maltese: Grupp ta' Vd (N = 465)
English: From cycle 13, the day 8 and 9 doses of Kyprolis are omitted.
Maltese: Minn ċiklu 13 'il quddiem, id-dożi ta' jum 8 u 9 ta' Kyprolis jitħallew barra.
English: The mean steady-state volume of distribution of a 20 mg/m2 dose of carfilzomib was 28 L. When tested in vitro, the binding of carfilzomib to human plasma proteins averaged 97% over the concentration range of 0.4 to 4 micromolar.
Maltese: Meta ttestjat in vitro, l-irbit ta' carfilzomib mal-proteini tal-plażma tal-bniedem kellu medja ta' 97% fuq firxa ta' konċentrazzjoni ta' 0.4 sa 4 mikromolari.
English: This means that Kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle.
Maltese: Dan ifisser li Kyprolis se jingħata lilek filjiem 1, 2, 8, 9, 15, u 16 ta' kull ċiklu ta' 28 jum.
English: • Muscle spasms
Maltese: • Uġigħ fis-snien
English: • Changes to blood tests (decreased blood levels of sodium, magnesium, protein, calcium or phosphate, increased blood levels of calcium, uric acid, potassium, bilirubin or c-reactive protein)
Maltese: calcium jew phosphate fid-demm, żieda fil-livelli ta' calcium, aċidu uriku, potassium, bilirubina jew proteina reattiva c fid-demm)
English: Myalgia
Maltese: Amgen
English: Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
Maltese: Kyprolis flimkien ma' lenalidomide u dexamethasone jew dexamethasone waħdu huwa indikat għattrattament ta' pazjenti adulti b'mijeloma multipla li rċevew tal-anqas terapija waħda preċedenti (ara sezzjoni 5.1).
English: However, higher subject incidence of hepatic function abnormalities, ≥ grade 3 adverse events and serious adverse events have been reported in patients with mild or moderate baseline hepatic impairment compared with patients with normal hepatic function (see sections 4.4 and 5.2).
Maltese: Madankollu, fl-individwi kienet irrappurtata inċidenza ogħla ta' anormalitajiet fil-funzjoni tal-fwied, avvenimenti avversi ta' ≥ grad 3 u avvenimenti avversi serji f'pazjenti b'indeboliment ħafif jew moderat tal-fwied fil-linja bażi meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Carfilzomib may decrease the efficacy of oral contraceptives (refer to section 4.5).
Maltese: Ma jistax jiġi eskluż li l-effikaċja ta' kontraċettivi orali tista' tonqos matul it-trattament b'carfilzomib (ara sezzjoni 4.5).
English: A pre-planned overall survival (OS) analysis was performed after 246 deaths in the KRd arm and 267 deaths in the Rd arm.
Maltese: Twettqet analiżi ta' sopravivenza globali (OS - overall survival) ippjanata minn qabel wara 246 mewt fil-grupp ta' KRd u 267 mewt fil-grupp ta' Rd.
English: Pruritus Erythema Hyperhidrosis
Maltese: Kriżi ipertensiva Emorraġija
English: Additional clinical experience has been generated with Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma.
Maltese: Esperjenza klinika addizzjonali kienet iġġenerata bil-monoterapija b'Kyprolis f'pazjenti b'mijeloma multipla li reġgħet feġġet u reżistenti.
English: • Hepatitis B infection activated again (viral inflammation of the liver)
Maltese: • Terġa' tiġi attivata l-infezzjoni tal-epatite B (infjammazzjoni virali tal-fwied)
English: Caution should be observed when carfilzomib is combined with medicinal products that are substrates of these enzymes, such as oral contraceptives.
Maltese: Għandu jkun hemm kawtela meta carfilzomib jingħata flimkien ma' prodotti mediċinali li huma sottostrati ta' dawn l-enzimi, bħal kontraċettivi orali.
English: For clinical management of thrombocytopenia during Kyprolis treatment, see section 4.4.
Maltese: Għallimmaniġġjar kliniku tat-tromboċitopenija matul it-trattament b'Kyprolis, ara sezzjoni 4.4.
English: In vitro studies indicated that carfilzomib did not induce human CYP3A4 in cultured human hepatocytes.
Maltese: Studji in vitro indikaw li carfilzomib ma jinduċiex is-CYP3A4 uman f'epatoċiti umani kkultivati.
English: When combined with dexamethasone, Kyprolis is administered intravenously as a 30 minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 2.
Maltese: Meta kkombinat ma' dexamethasone, Kyprolis jingħata ġol-vini bħala infużjoni ta' 30 minuta fuq jumejn konsekuttivi, kull ġimgħa għal tliet ġimgħat (jiem 1, 2, 8, 9, 15, u 16) segwit minn perjodu ta' mistrieħ ta' 12-il jum (jiem 17 sa 28) kif muri f'tabella 2.
English: INSTRUCTIONS ON USE
Maltese: Azzjoni rakkomandata
English: This study evaluated Kyprolis at an initial dose of 20 mg/m2, which was increased to 27 mg/m2 on cycle 1, day 8, administered twice weekly for 3 out of 4 weeks as a 10 minute infusion.
Maltese: Dan l-istudju evalwa Kyprolis b'doża inizjali ta' 20 mg/m2, li ġiet miżjuda għal 27 mg/m2 f'ċiklu 1, jum 8, mogħti darbtejn fil-ġimgħa għal 3 minn 4 ġimgħat bħala infużjoni ta' 10 minuti.
English: The second study was conducted in 23 relapsed multiple myeloma patients with creatinine clearance ≥ 75 mL/min (n = 13) and patients with end stage renal disease (ESRD) requiring dialysis (n = 10).
Maltese: It-tieni studju twettaq fuq 23 pazjent b'majeloma multipla li reġgħet tfaċċat bi tneħħija tal-krejatinina ta' ≥ 75 mL/min (n = 13) u pazjenti b'marda tal-kliewi fl-aħħar stadju (ESRD - end stage renal disease) li jeħtieġu d-dijalisi (n = 10).
English: When combined with lenalidomide and dexamethasone, Kyprolis is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28) as shown in table 1.
Maltese: Meta kkombinat ma' lenalidomide u dexamethasone, Kyprolis jingħata ġol-vini bħala infużjoni ta' 10 minuti, fuq jumejn konsekuttivi, kull ġimgħa għal tliet ġimgħat (jiem 1, 2, 8, 9, 15, u 16), segwit minn perjodu ta' mistrieħ ta' 12-il jum (jiem 17 sa 28) kif muri f'tabella 1.
English: Cataract Blurred vision
Maltese: Kataretti Vista mċajpra
English: Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Maltese: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
English: This study evaluated Kyprolis at an initial dose of 20 mg/m2, which was increased to 56 mg/m2 on cycle 1, day 8, administered twice weekly for 3 out of 4 weeks as a 30 minute infusion until progression or unacceptable toxicity.
Maltese: Dan l-istudju evalwa Kyprolis b'doża inizjali ta' 20 mg/m2, li ġiet miżjuda għal 56 mg/m2 f'ċiklu 1, jum 8, mogħtija darbtejn fil-ġimgħa għal 3 minn 4 ġimgħat bħala infużjoni ta' 30 minuta sa progressjoni jew tossiċità mhux aċċettabbli.
English: Dehydration Hyperkalaemia Hypomagnesaemia Hyponatraemia Hypercalcaemia Hypocalcaemia Hypophosphataemia Hyperuricaemia Hypoalbuminaemia
Maltese: * Il-frekwenza hija kkalkulata abbażi ta' data minn provi kliniċi li fihom il-biċċa l-kbira tal-pazjenti użaw profilassi
English: LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
English: At the higher dose of 56 mg/m2, there was not only a greater inhibition of CT-L subunits (≥ 90%) compared to those at 15 to 20 mg/m2, but also a greater inhibition of other proteasome subunits (LMP7, MECL1, and LMP2).
Maltese: Bid-doża aktar għolja ta' 56 mg/m2, kien hemm mhux biss inibizzjoni akbar ta' sottounitajiet CT-L (≥ 90%) meta mqabbla ma' dawk ta' 15 sa 20 mg/m2, iżda wkoll inibizzjoni akbar ta' sottounitajiet ta' proteasome oħrajn (LMP7, MECL1, u LMP2).
English: Kd Arm (N = 464)
Maltese: Kd (N =464)
English: In vitro, carfilzomib inhibits OATP1B1 with an IC50 = 2.01 µM whereas it is unknown whether carfilzomib may or not inhibit other transporters OATP1B3, OAT1, OAT3, OCT2 and BSEP, at the systemic level.
Maltese: In vitro, carfilzomib jinibixxi OATP1B1 b'IC50 = 2.01 µM filwaqt li mhux magħruf jekk carfilzomib jistax jinibixxi jew le trasportaturi OATP1B3, OAT1, OAT3, OCT2 u BSEP oħrajn, fil-livell sistemiku. Carfilzomib ma jinibixxix UGT2B7 uman iżda jinibixxi UGT1A1 uman b'IC50 ta' 5.5 μM.
English: • Creatinine clearance < 15 mL/min (or creatinine clearance decreases to ≤ 50% of baseline) or need for dialysis (see section 4.4)
Maltese: • It-tneħħija tal-krejatinina hija < 15 mL/min (jew it-tneħħija talkrejatinina tonqos għal ≤ 50% tallinja bażi) jew tkun meħtieġa dijalisi (ara sezzjoni 4.4)
English: Elderly patients
Maltese: Tnemnim Ipoestesija
English: In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see sections 4.4 and 4.8).
Maltese: Barra minn hekk, minħabba ż-żieda fir-riskju ta' avvenimenti tromboemboliċi filvini assoċjata ma' carfilzomib, in-nisa għandhom jevitaw l-użu ta' kontraċettivi ormonali li huma assoċjati ma' riskju ta' trombożi matul it-trattament b'carfilzomib (ara sezzjonijiet 4.4 u 4.8).