FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with KRd reported improved Global Health Status, with higher Global Health Status/Quality of Life (QoL) scores compared with Rd over 18 cycles of treatment (multiplicity unadjusted 1-sided p-value = 0.0001) measured with the EORTC QLQ-C30, an instrument validated in multiple myeloma.
Maltese: Pazjenti trattati b'KRd irrappurtaw titjib fl-Istat ta' Saħħa Globali, b'punteġġi ogħla ta' Stat ta' Saħħa Globali/Kwalità tal-Ħajja (QoL - Quality of Life) meta mqabbla ma' Rd fuq 18-il ċiklu ta' trattament (valur p ta' naħa waħda mhux aġġustat għall-multipliċità = 0.0001) mkejjel bl-EORTC QLQ-C30, strument ivvalidat fil-mijeloma multipla.
English: Kyprolis 30 mg powder for solution for infusion Each vial contains 30 mg of carfilzomib.
Maltese: Kyprolis 30 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 30 mg ta' carfilzomib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1060/002
English: Kyprolis 60 mg powder for solution for infusion Each vial contains 60 mg of carfilzomib.
Maltese: Kyprolis 60 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 60 mg ta' carfilzomib.
English: PFS months median (95% CI) HR (95% CI); 1-sided p-valueb
Maltese: Medjan ta' xhur ta' PFS (CI ta' 95%) HR (CI ta' 95%); valur p ta' naħa waħdab
English: Uric acid lowering medicinal products should be considered in patients at high risk for TLS.
Maltese: Prodotti mediċinali li jbaxxu l-aċidu uriku għandhom jitqiesu għal pazjenti f'riskju għoli ta' TLS.
English: Thromboprophylaxis is recommended in patients being treated with Kyprolis in combination with dexamethasone or with lenalidomide and dexamethasone, and should be based on an assessment of the patient's underlying risks and clinical status.
Maltese: Tromboprofilassi hija rakkomandata għal pazjenti ttrattati b'Kyprolis flimkien ma' dexamethasone jew ma' lenalidomide u dexamethasone, u għandha tkun ibbażata fuq valutazzjoni tar-riskji sottostanti u l-istat kliniku tal-pazjent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of carfilzomib.
Maltese: Kull kunjett fih 10 mg ta' carfilzomib.
English: Carfilzomib is a cytotoxic agent.
Maltese: Evalwa kif meħtieġ.
English: However, given that Kyprolis is administrated intravenously and is extensively metabolised, the pharmacokinetic profile of carfilzomib is unlikely to be affected by P-gp or BCRP inhibitors or inducers.
Maltese: Madankollu, minħabba li Kyprolis jingħata ġol-vini u huwa metabolizzat b'mod estensiv, huwa improbabbli li l-profil farmakokinetiku ta' carfilzomib ikun affettwat minn inibituri jew indutturi talP-gp jew BCRP.
English: Dexamethasone should be administered prior to Kyprolis to reduce the incidence and severity of reactions (see section 4.2).
Maltese: Dexamethasone għandu jingħata qabel Kyprolis sabiex inaqqas l-inċidenza u s-severità tar-reazzjonijiet (ara sezzjoni 4.2).
English: Τηλ.
Maltese: • Tinfaraġ
English: Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma
Maltese: Monoterapija b'Kyprolis f'pazjenti b'mijeloma multipla li reġgħet feġġet u reżistenti
English: Pulmonary haemorrhage Interstitial lung disease
Maltese: Insuffiċjenza respiratorja akuta Emorraġija pulmonari Marda talinterstizju talpulmun
English: OS months median (95% CI) HR (95% CI); 1-sided p-valueb
Maltese: Medjan ta' xhur ta' OS (CI ta' 95%) HR (CI ta' 95%); valur p ta' naħa waħdab
English: Cases of haemorrhage (e.g. gastrointestinal, pulmonary and intracranial haemorrhage) have been reported in patients treated with Kyprolis, often associated with thrombocytopenia.
Maltese: F'pazjenti ttrattati b'Kyprolis kienu rrappurtati każijiet ta' emorraġija (eż. emorraġija gastrointestinali, pulmonari u fil-kranju), spiss assoċjata ma' tromboċitopenija.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 60 mg powder for solution for infusion carfilzomib
Maltese: Kyprolis 60 mg trab għal soluzzjoni għall-infużjoni carfilzomib
English: Vascular disorders
Maltese: Inċident ċerebrovaskulari
English: Serious adverse events related to worsening renal function were more common in subjects with baseline renal dysfunction (see section 4.2).
Maltese: Avvenimenti avversi serji relatati ma' funzjoni tal-kliewi li sejra għall-agħar kienu aktar komuni f'individwi b'disfunzjoni tal-kliewi fil-linja bażi (ara sezzjoni 4.2).
English: Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Maltese: Bidu akut ta' sirdat, pressjoni baxxa, insuffiċjenza tal-kliewi, tromboċitopenija u limfopenija kienu rrappurtati wara doża ta' 200 mg ta' Kyprolis mogħtija bi żvista.
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.4).
Maltese: Il-volum totali tal-fluwidi jista' jiġi aġġustat skont kif indikat klinikament f'pazjenti b'insuffiċjenza kardijaka fil-linja bażi jew li huma f'riskju ta' insuffiċjenza kardijaka (ara sezzjoni 4.4).
English: Oropharyngeal pain Dysphonia Wheezing
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 30 mg powder for solution for infusion carfilzomib
Maltese: Kyprolis 30 mg trab għal soluzzjoni għall-infużjoni carfilzomib
English: A pre-planned second interim OS analysis was performed after 189 deaths in the Kd arm and 209 deaths in the Vd arm. At the time of the analysis, 80% of the targeted events were registered.
Maltese: Twettqet analiżi interim oħra ppjanata minn qabel tal-OS wara 189 mewt fil-grupp ta' Kd u 209 imwiet fil-grupp ta' Vd. Fiż-żmien tal-analiżi, 80% tal-avvenimenti mmirati kienu rreġistrati.
English: The metabolites have no known biologic activity.
Maltese: Dan il-metabolit m'għandux attivitajiet bijoloġiċi magħrufa.
English: Patients in the KRd arm had a 21% reduction in the risk of death compared with those in the Rd arm (HR = 0.79; 95% CI: 0.67, 0.95; p value = 0.0045).
Maltese: Vantaġġ statistikament sinifikanti fl-OS kien osservat f'pazjenti fil-grupp ta' KRd meta mqabbel ma' pazjenti fil-grupp ta' Rd. Pazjenti fil-grupp ta' KRd kellhom tnaqqis ta' 21% fir-riskju ta' mewt meta mqabbla ma' dawk fil-grupp ta' Rd (HR = 0.79; CI ta' 95%: 0.67, 0.95; valur p = 0.0045).
English: Frequency categories were determined from the crude incidence rate reported for each adverse reaction in a dataset of pooled clinical studies (n = 2,944).
Maltese: Għal kull reazzjoni avversa rrapurtata, il-kategoriji tal-frekwenza kienu determinati mir-rata ta' inċidenza kkalkulata minn fuq sett ta' data ta' studji kliniċi miġburin flimkien (n = 2,944).
English: • Blood clots in the veins (deep vein thrombosis)
Maltese: • Emboli tad-demm fil-vini (trombożi fil-vini tal-fond)
English: Carfilzomib administered to pregnant rats during the period of organogenesis was not teratogenic at doses up to 2 mg/kg/day, which is approximately half the recommended dose in humans of 27 mg/m2 based on BSA.
Maltese: Carfilzomib mogħti lill-firien tqal matul il-perjodu ta' organoġenesi ma kienx teratoġeniku b'dożi sa 2 mg/kg/jum, li huma madwar nofs id-doża ta' 27 mg/m2 rakkomandata filbnedmin abbażi l-BSA.
English: Hyperbilirubinaemia
Maltese: • Newtropenija bid-deni
English: The predominant metabolites measured in human plasma and urine, and generated in vitro by human hepatocytes, were peptide fragments and the diol of carfilzomib, suggesting that peptidase cleavage and epoxide hydrolysis were the principal pathways of metabolism.
Maltese: Il-metaboliti predominanti mkejla fil-plażma u l-awrina tal-bniedem, u ġġenerati in vitro miċ-ċelluli tal-fwied tal-bniedem, kienu frammenti ta' peptidi u diol ta' carfilzomib, li jissuġġerixxi li l-qsim tal-peptidase u l-idrolisi tal-epoxide kienu rrotot prinċipali ta' metaboliżmu.
English: NAME OF THE MEDICINAL PRODUCT Kyprolis 10 mg powder for solution for infusion carfilzomib
Maltese: Kyprolis 10 mg trab għal soluzzjoni għall-infużjoni carfilzomib
English: - The other ingredients are betadex sulfobutyl ether sodium, anhydrous citric acid (E330) and sodium hydroxide (see section 2 ‘Kyprolis contains sodium').
Maltese: - Is-sustanzi l-oħra huma betadex sulfobutyl, ether sodium, citric acid anidridu (E330) u sodium hydroxide (ara sezzjoni 2 ‘Kyprolis fih sodium').
English: In clinical studies, hypertension adverse events occurred in approximately 20% of subjects and 7.5% of subjects had grade ≥ 3 hypertension events, but hypertensive crises occurred in < 0.5% of subjects.
Maltese: Fi studji kliniċi, avvenimenti avversi ta' pressjoni għolja seħħew f'madwar 20% tal-individwi u 7.5% tal-individwi kellhom avvenimenti ta' pressjoni għolja ta' grad ≥ 3, iżda kriżijiet ipertensivi seħħew f'< 0.5% tal-individwi.
English: • Shortness of breath with everyday activities or at rest, irregular heartbeat, racing pulse, tiredness, dizziness, and fainting spells, which can be signs of a condition known as pulmonary hypertension
Maltese: • Qtugħ ta' nifs mal-attivitajiet ta' kuljum jew waqt li mistrieħ, taħbit tal-qalb irregolari, polz mgħaġġel, għeja, sturdament, u ħass ħażinijat, li jistgħu jkunu sinjali ta' kondizzjoni magħrufa bħala pressjoni pulmonari għolja
English: Patients with moderate or severe renal impairment were enrolled in Kyprolis-dexamethasone combination studies, but were excluded from Kyprolis-lenalidomide combination studies.
Maltese: Pazjenti b'indeboliment moderat jew sever tal-kliewi ġew irreġistrati fl-istudji ta' Kyprolis flimkien ma' dexamethasone, iżda kienu esklużi mill-istudji ta' Kyprolis flimkien ma' lenalidomide.
English: • Heart failure and heart problems including rapid, strong or irregular heartbeat
Maltese: • Insuffiċjenza kardijaka u problemi tal-qalb li jinkludu taħbit tal-qalb mgħaġġel, b'saħħtu jew irregolari
English: While taking Kyprolis and for 90 days after stopping treatment, you should use a condom even if your partner is pregnant.
Maltese: Waqt li qed tieħu Kyprolis u għal 90 jum wara li twaqqaf it-trattament, għandek tuża kondom, anke jekk is-sieħba tiegħek tkun tqila.
English: Population pharmacokinetic analyses indicate there are no effects of age, gender or race on the pharmacokinetics of carfilzomib.
Maltese: Analiżi farmakokinetiċi tal-popolazzjoni jindikaw li l-età, is-sess jew ir-razza m'għandhom l-ebda effett fuq il-farmakokinetika ta' carfilzomib.
English: Stop Kyprolis for grade 3 and 4 dyspnoea until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see sections 4.2 and 4.8).
Maltese: Waqqaf Kyprolis għal qtugħ ta' nifs ta' grad 3 u 4 sakemm jissolva jew jerġa' lura għallinja bażi u kkunsidra jekk tibdiex Kyprolis mill-ġdid abbażi ta' valutazzjoni tal-benefiċċji u r-riskji (ara sezzjonijiet 4.2 u 4.8).
English: KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; OS = overall survival; HR = hazard ratio; CI = confidence interval; mo = months a. Study PX-171-009
Maltese: KRd = Kyprolis, lenalidomide u dexamethasone; Rd = lenalidomide u dexamethasone; OS = sopravivenza globali;
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1060/001
English: If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg).
Maltese: Jekk tiġi tollerata, id-doża għandha tiġi miżjuda f'jum 8 taċ-ċiklu 1 għal 27 mg/m2 (doża massima ta' 60 mg).
English: In the second study, the exposures for M14 were greater (approximately 4-fold) in subjects with ESRD than in subjects with normal renal function.
Maltese: Fit-tieni studju, l-esponimenti għal M14 kienu akbar (bejn wieħed u ieħor 4 darbiet) f'individwi b'ESRD milli f'individwi b'funzjoni normali tal-kliewi.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for carfilzomib, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal carfilzomib, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: The total volume of fluids may be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac failure (see section 4.2).
Maltese: Il-volum totali tal-fluwidi jista' jiġi aġġustat skont kif indikat klinikament f'pazjenti b'insuffiċjenza kardijaka fil-linja bażi jew li huma f'riskju ta' insuffiċjenza kardijaka (ara sezzjoni 4.2).
English: Lenalidomide is expected to be harmful to the unborn child. As Kyprolis is given in combination with lenalidomide, you must follow the Pregnancy Prevention Programme (see package leaflet for lenalidomide for information on pregnancy prevention and discuss with your doctor, pharmacist or nurse).
Maltese: Minħabba li Kyprolis jingħata flimkien ma' lenalidomide, trid issegwi l-Programm ta' Prevenzjoni tat-Tqala (ara l-fuljett ta' tagħrif għal lenalidomide għal tagħrif dwar il-prevenzjoni tat-tqala u iddiskutih mat-tabib, l-ispiżjar jew l-infermier tiegħek).
English: Kyprolis causes thrombocytopenia with platelet nadirs observed on day 8 or day 15 of each 28-day cycle with recovery to baseline platelet count by the start of the next cycle (see section 4.8).
Maltese: Kyprolis jikkawża tromboċitopenija bl-għadd l-aktar baxx ta' plejtlits osservat f'jum 8 jew jum 15 ta' kull ċiklu ta' 28 jum b'irkupru tal-għadd ta' plejtlits għal dak fil-linja bażi sal-bidu taċ-ċiklu li jmiss (ara sezzjoni 4.8).
English: Death due to cardiac arrest has occurred within a day of Kyprolis administration and fatal outcomes have been reported with cardiac failure and myocardial infarction.
Maltese: Mewt minħabba arrest kardijaku seħħet fi żmien jum mill-għoti ta' Kyprolis u kienu rrappurtati riżultati fatali minħabba insuffiċjenza kardijaka u infart mijokardijaku.
English: Kyprolis in combination with lenalidomide and dexamethasonea
Maltese: Kyprolis flimkien ma' lenalidomide u dexamethasonea
English: However, in patients with mild or moderate baseline hepatic impairment, all of whom had solid tumours, there was a higher subject incidence of hepatic function abnormalities, ≥ grade 3 adverse events and serious adverse events compared with subjects with normal hepatic function (see section 4.2).
Maltese: Madankollu, f'pazjenti b'indeboliment ħafif jew moderat tal-fwied fil-linja bażi, li kollha kellhom tumuri solidi, fl-individwi kien hemm inċidenza ogħla ta' anormalitajiet fil-funzjoni talfwied, avvenimenti avversi ta' ≥ grad 3 u avvenimenti avversi serji meta mqabbla ma' individwi b'funzjoni normali tal-fwied (ara sezzjoni 4.2).
English: In line with the labelling and risk minimisation activities proposed by Segec et al, inclusion of a warning on PML in section 4.4 of the SmPC is warranted.
Maltese: F'konformità mat-tikkettar u l-attivitajiet talminimizzazzjoni tar-riskju proposti minn Segec et al., l-inklużjoni ta' twissija dwar PML fissezzjoni 4.4 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) hija ġġustifikata.
English: Death, n (%) Median OS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Maltese: OS Medjana, xhur HR (Kd/Vd) (CI ta' 95%) valur p (naħa waħda)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 30 mg of carfilzomib.
Maltese: Kull kunjett fih 30 mg ta' carfilzomib.
English: • Stop dose If recovered to ≥ 0.5 x 109/L, continue at same dose level
Maltese: • Waqqaf id-doża Jekk jirkupra għal ≥ 0.5 x 109/L, kompli bl-istess livell ta' doża
English: • Muscle weakness
Maltese: Indeboliment talkliewi
English: Based on the number of relevant cases reported cumulatively, including 16 events with a fatal outcome during the reporting period, the existing warning on cardiac disorders should be updated to recommend that patients should be evaluated for cardiovascular risk factors before treatment with carfilzomib, that a comprehensive cardiological assessment should be considered for patients at high-risk for cardiovascular disease and that hypertension should be controlled during treatment, as a history of hypertension was frequently reported in patients presenting with cardiac disorders.
Maltese: Filwaqt li hija meħtieġa idratazzjoni xierqa qabel id-dożaġġ f'ċiklu 1, il-pazjenti kollha għandhom ikunu mmonitorjati għal evidenza ta' volum eċċessiv, b'mod speċjali pazjenti f'riskju ta' insuffiċjenza kardijaka.
English: Dosing should be modified based on Kyprolis toxicity.
Maltese: Id-dożaġġ għandu jkun modifikat abbażi tat-tossiċità ta' Kyprolis.
English: Patients who had the following were excluded from the trial: creatinine clearance rates < 15 mL/min, NYHA Class III to IV congestive heart failure, myocardial infarction within the last 4 months or those with left ventricular ejection fraction (LVEF) < 40%.
Maltese: III sa IV tal-NYHA, infart mijokardijaku fl-aħħar 4 xhur jew dawk b'porzjon imbuttat 'il barra mill-ventriklu tax-xellug (LVEFleft ventricular ejection fraction) ta' < 40%.
English: • Bone pain, muscle pain, chest pain
Maltese: • Uġigħ fl-għadam, uġigħ fil-muskoli, uġigħ fis-sider
English: Stop Kyprolis for grade 3 or 4 cardiac events until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment (see section 4.2).
Maltese: Waqqaf Kyprolis għal avvenimenti kardijaċi ta' grad 3 jew 4 sakemm jirkupraw u kkunsidra jekk għandekx terġa' tibda Kyprolis bi tnaqqis ta' livell tad-doża wieħed abbażi tal-valutazzjoni talbenefiċċji u r-riskji (ara sezzjoni 4.2).
English: • Multi-organ failure
Maltese: • Insuffiċjenza ta' ħafna organi
English: Months from Randomisation
Maltese: Xhur wara Randomisation
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Maltese: Thalidomide huwa sustanza attiva teratoġenika umana magħrufa li tikkawża difetti tat-twelid severi u ta' periklu għall-ħajja.
English: Death, n (%) Median OS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Maltese: OS Medjana, xhur HR (KRd/Rd) (CI ta' 95%) valur p (naħa waħda)
English: Summary of efficacy analysis in relapsed multiple myeloma study PX-171-009 KRd combination therapy KRd arma (N = 396)
Maltese: Sommarju tal-analiżi tal-effikaċja fl-istudju ta' mijeloma multipla li reġgħet feġġet PX-171-009
English: If a patient is currently using oral contraceptives or a hormonal method of contraception that is associated with a risk of thrombosis, the patient should switch to an alternative method of effective contraception.
Maltese: Jekk pazjenta attwalment qed tuża kontraċettivi orali jew metodu ta' kontraċezzjoni ormonali li huwa assoċjat ma' riskju ta' trombożi, il-pazjenta għandha tibdel għal metodu alternattiv ta' kontraċezzjoni effettiva.
English: Kyprolis will be given to you together with lenalidomide and dexamethasone, or only with dexamethasone.
Maltese: Flimkien ma' Kyprolis inti se tingħata wkoll lenalidomide u dexamethasone, jew dexamethasone waħdu.
English: Use only a 21-gauge or larger gauge needle (0.8 mm or smaller external diameter needle) to aseptically reconstitute each vial by slowly injecting 5 mL (for 10 mg vial), 15 mL (for 30 mg vial) or 29 mL (for 60 mg vial) sterile water for injections through the stopper and directing the solution onto the INSIDE WALL OF THE VIAL to minimise foaming.
Maltese: Uża biss labra b'kejl ta' 21 gauge jew aktar (labra b'dijametru estern ta' 0.8 mm jew iżgħar) biex tirrikostitwixxi b'mod asettiku kull kunjett billi tinjetta bil-mod 5 mL (għall-kunjett at' 10 mg), 15-il mL (għall-kunjett at' 30 mg) jew 29 mL (għall-kunjett at' 60 mg) ta' ilma sterili għall-injezzjonijiet minn ġot-tap u dderiġi s-soluzzjoni għal fuq IL-WIĊĊ INTERN
English: Dyspnoea Cough
Maltese: Kunjett wieħed
English: If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg).
Maltese: Jekk tiġi ttollerata, id-doża għandha tiġi miżjuda f'jum 8 ta' ċiklu 1 għal 56 mg/m2 (doża massima 123 mg).
English: Chemical and physical in-use stability of reconstituted solutions in the vial, syringe or intravenous bag has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at 25°C.
Maltese: Intweriet stabbilità kimika u fiżika waqt l-użu ta' soluzzjonijiet rikostitwiti fil-kunjett, fis-siringa jew f'borża għal għoti ġol-vini għal 24 siegħa f'temperatura ta' 2°C - 8°C jew għal 4 sigħat f'temperatura ta' 25°C.
English: • Constipation
Maltese: • Ansjetà
English: • Pain, swelling, irritation or discomfort where you received the injection into your vein
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: • Women who are breast-feeding (see section 4.6).
Maltese: • Nisa li qed ireddgħu (ara sezzjoni 4.6).
English: In addition and according to the agreed case definition by Mentzer et al., two cases of level 1, one case of level 2 and one case of level 3 were identified.
Maltese: Barra minn hekk u skont id-definizzjoni tal-każ maqbul minn Mentzer et al., ġew identifikati żewġ każijiet tal-1 livell, każ wieħed tat-2 livell u każ wieħed tat-3 livell.
English: Each 28-day period is considered one treatment cycle.
Maltese: Kull perjodu ta' 28 jum huwa ċiklu wieħed ta' trattament.
English: Pulmonary hypertension
Maltese: Infezzjoni filpulmun
English: Proper aseptic technique must be observed.
Maltese: Għandha tiġi segwita teknika asettika xierqa.
English: • Wheezing
Maltese: • Dijarea
English: What Kyprolis is and what it is used for What you need to know before you use Kyprolis How to use Kyprolis
Maltese: Għalhekk, għandu jkun hemm kawtela waqt l-immaniġġjar u lpreparazzjoni ta' Kyprolis.
English: • For subsequent drops to < 0.5 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa
Maltese: • Għal tnaqqis sussegwenti għal < 0.5 x 109/L, segwi l-istess rakkomandazzjonijiet ta' hawn fuq u kkunsidra tnaqqis ta' livell tad-doża wieħed meta terġa' tibda Kyprolisa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1060/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1060/003
English: The pharmacokinetics of carfilzomib was studied in two dedicated renal impairment studies.
Maltese: Il-farmakokinetika ta' carfilzomib ġiet studjata f'żewġ studji dedikati dwar indeboliment tal-kliewi.
English: Kyprolis causes thrombocytopenia through inhibition of platelet budding from megakaryocytes resulting in a classic cyclical thrombocytopenia with platelet nadirs occurring on day 8 or 15 of each 28-day cycle and usually associated with recovery to baseline by the start of the next cycle.
Maltese: Kyprolis jintuża biex jittratta pazjenti adulti b'mijeloma multipla li tal-anqas kellhom trattament wieħed preċedenti għal din il-marda.
English: Kyprolis can make some conditions worse or cause serious side effects, which may be fatal, such as heart problems, lung problems, kidney problems, tumour lysis syndrome (a life-threatening condition that occurs when cancer cells break and release their content to the bloodstream), reactions to the Kyprolis infusion, unusual bruising or bleeding, (including internal bleeding), blood clots in your veins, liver problems, certain blood conditions, or a neurological condition known as PRES. See ‘Conditions you need to look out for' in section 4.
Maltese: Kyprolis jista' jaggrava xi kondizzjonijiet jew jikkawża effetti sekonardji serji, li jistgħu jkunu fatali, bħal problemi tal-qalb, problemi tal-pulmun, problemi talkliewi, sindrome ta' lisi tat-tumur (kondizzjoni ta' theddida għall-ħajja li tiġri meta ċ-ċelluli tal-kanċer jinkisru u jerħu l-kontenut tagħhom fid-demm), reazzjonijiet għall-infużjoni ta' Kyprolis, tbenġil jew fsada mhux normali (inkluża fsada interna), emboli tad-demm fil-vini tiegħek, problemi tal-fwied, ċerti kondizzjonijiet tad-demm, jew kondizzjoni newroloġika magħrufa bħala PRES.
English: Dose level reductions for Kyprolis
Maltese: It-tielet tnaqqis fid-doża ta' Kyprolis
English: Kyprolis 10 mg powder for solution for infusion
Maltese: U KWANTITATTIVA Kyprolis 10 mg trab għal soluzzjoni għall-infużjoni
English: Route of administration
Maltese: Speċi Metodu ta' Amministrazzjoni
English: EU (MA) number
Maltese: Numru tal-EMEA Isem talProdott
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Daqs talIppakkjar
English: Hepatic Effects
Maltese: Effetti Epatiċi
English: • treatment of schizophrenia
Maltese: • kura ta' skizofrenjaskizofrenja