natgillin/translations-raw huggingface dataset:
As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis. 
Ker je zdravilo Kyprolis uporabljeno v kombinaciji z drugimi zdravili, je potrebno pred uvedbo zdravljenja z zdravilom Kyprolis pogledati informacije o teh zdravilih v njihovih povzetkih glavnih značilnosti zdravila.
Serious adverse events related to worsening renal function were more common in subjects with baseline renal dysfunction (see section 4.2). 
Resni neželeni učinki, povezani s poslabšanjem delovanja ledvic, so bili pri bolnikih z izhodiščno motenim delovanjem ledvic pogostejši (glejte poglavje 4.2).
PFS months median (95% CI)a 
Mediana mesecev PFS (95 % IZ)a
• Inflammation of the nose and throat 
• vnetje nosu in žrela,
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). 
Študija je pokazala značilno boljše preživetje brez napredovanja bolezni (PFS) pri bolnikih v skupini Kd kot pri bolnikih v skupini Vd (HR: 0,53, 95 % IZ: 0,44, 0,65 [p-vrednost < 0,0001]) (glejte sliko 3).
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). 
Drugo študijo so izvedli pri 23 bolnikih z recidivom diseminiranega plazmocitoma in očistkom kreatinina ≥ 75 ml/min (n = 13) in bolnikih s končno odpovedjo ledvic, ki so potrebovali dializno zdravljenje (n = 10).
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). 
Rezultati PFS so bili podobni pri bolnikih, ki so predhodno prejemali bortezomib (HR 0,56, 95 % IZ: 0,44, 0,73), in tistih, ki ga predhodno niso prejemali (HR 0,48, 95 % IZ: 0,36, 0,66).
Kyprolis, as a single agent, was administered intravenously over 2 to 10 minutes at doses up to 20 mg/m2. 
Zdravilo Kyprolis so kot monoterapijo uporabili intravensko v 2 do 10 minutah v odmerkih do 20 mg/m2.
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%). 
Izhodiščno stanje delovanja jeter ni izrazito vplivalo na celotno sistemsko izpostavljenost (AUClast) karfilzomibu po enkratnem in po ponavljajočih se odmerkih (geometrična sredina razmerja AUClast ob odmerku 27 mg/m2 16. dan 1. ciklusa v primerjavi z normalnim delovanjem jeter je bila pri blagi okvari jeter 144,4 % in pri zmerni okvari 126,1 %, ob odmerku 56 mg/m2 1. dan 2. ciklusa pa pri blagi okvari 144,7 % in pri zmerni okvari
Patients with moderate or severe hepatic impairment were excluded from Kyprolis studies in combination with either lenalidomide and dexamethasone or dexamethasone alone. 
Bolniki z zmerno ali hudo okvaro jeter niso bili vključeni ne v študije zdravila Kyprolis v kombinaciji z lenalidomidom in deksametazonom ali v kombinaciji s samim deksametazonom.
• For subsequent drops to < 10 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa 
• Pri naslednjih znižanjih na < 10 x 109/l upoštevajte enaka priporočila kot zgoraj, ob ponovnem začetku uporabe zdravila Kyprolis pa razmislite o zmanjšanju odmerka za 1 ravena
Cardiac disorders are known adverse drug reactions of carfilzomib. 
Srčne bolezni so znan neželeni učinek karfilzomiba.
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. 
Vseeno je tveganje za klinično pomembne interakcije s substrati OATP1B1 in UGT1A1 verjetno nizko, če upoštevamo hitro izločanje karfilzomiba, zlasti hitro znižanje sistemske koncentracije 5 minut po koncu infuzije.
Kyprolis is a medicine that contains the active substance carfilzomib. 
Zdravilo Kyprolis vsebuje učinkovino karfilzomib.
If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg). 
Če bolnik ta odmerek ustrezno prenese, je treba 8. dan 1. ciklusa odmerek povečati na 27 mg/m2 (največji odmerek 60 mg).
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. 
Med zdravljenjem z zdravilom Kyprolis so se pojavili sindrom akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome), akutna dihalna odpoved in akutna infiltrativna pljučna bolezen, na primer pnevmonitis in intersticijska bolezen pljuč.
No starting dose adjustment for Kyprolis is recommended in patients with baseline mild, moderate, or severe renal impairment or patients on chronic dialysis based on available pharmacokinetic data (see section 5.2). 
Na podlagi razpoložljivih farmakokinetičnih podatkov ni priporočeno prilagajanje začetnega odmerka zdravila Kyprolis pri bolnikih z izhodiščno blago, zmerno ali hudo okvaro ledvic ter pri bolnikih na kronični dializi (glejte poglavje 5.2).
• Very high blood pressure, severe chest pain, severe headache, confusion, blurred vision, nausea and vomiting, or severe anxiety, which may be signs of a condition known as hypertensive crisis 
• Zelo visok krvni tlak, huda bolečina v prsnem košu, hud glavobol, zmedenost, zamegljen vid, slabost v želodcu in bruhanje ali huda tesnobnost; to so lahko znaki motnje, imenovane hipertenzivna kriza.
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). 
Vendar pa je bila pri bolnikih z izhodiščno blago ali zmerno okvaro jeter (vsi so imeli solidne tumorje) pojavnost motenj delovanja jeter, neželenih učinkov ≥ 3. stopnje in resnih neželenih učinkov večja kot pri bolnikih z normalnim delovanjem jeter (glejte poglavje 4.2).
Symptoms may include fever, chills, arthralgia, myalgia, facial flushing, facial oedema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. 
Med simptomi so lahko zvišana telesna temperatura, mrzlica, artralgija, mialgija, zardevanje obraza, edem obraza, bruhanje, šibkost, kratka sapa, hipotenzija, sinkopa, tiščanje v prsih ali angina pektoris.
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih z infundiranjem povezane reakcije
QUALITATIVE AND QUANTITATIVE COMPOSITION Kyprolis 10 mg powder for solution for infusion Each vial contains 10 mg of carfilzomib. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Kyprolis 10 mg prašek za raztopino za infundiranje Ena viala vsebuje 10 mg karfilzomiba.
This medicine contains 0.3 mmol sodium (which is 7 mg sodium) per mL of reconstituted solution. 
Zdravilo vsebuje 0,3 mmol natrija (7 mg natrija) na mililiter rekonstituirane raztopine.
Carfilzomib may decrease the efficacy of oral contraceptives (refer to section 4.5). 
Karfilzomib lahko zmanjša učinkovitost peroralnih kontraceptivov (glejte poglavje 4.5).
• Lung problems, including a history of shortness of breath at rest or with activity (dyspnoea) 
• Težave s pljuči - če ste kdaj imeli kratko sapo v mirovanju ali med telesno dejavnostjo (dispnejo).
The intravenous administration line should be flushed with normal sodium chloride solution or 5% glucose solution for injection immediately before and after Kyprolis administration. 
Intravensko linijo je treba tik pred dajanjem zdravila Kyprolis in takoj po njegovem dajanju sprati s fiziološko raztopino natrijevega klorida ali 5 % raztopino glukoze za injiciranje.
Together with Kyprolis you will also be given either lenalidomide and dexamethasone, or only dexamethasone. 
Skupaj z zdravilom Kyprolis boste prejemali tudi bodisi lenalidomid in deksametazon bodisi le deksametazon.
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. 
Randomizirana odprta multicentrična študija je primerjala uporabo zdravila Kyprolis 20/56 mg/m2, infundiranega v 30 minutah, v kombinaciji z deksametazonom (Kd, n = 464) in uporabo kombinacije bortezomiba in deksametazona (Vd, n = 465); v tej študiji so ob času predhodno načrtovane analize celokupnega preživetja primere periferne nevropatije 2. stopnje ali več zabeležili pri 7 % bolnikov z recidivom diseminiranega plazmocitoma v skupini Kd in pri 35 % v skupini Vd.
ORR n (%) sCR CR VGPR PR 95% CI of ORR 1-sided p-value KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; OS = overall survival; ORR = overall response rate; sCR = stringent complete response; CR = complete response; VGPR = very good partial response; PR = partial response; IMWG = international myeloma working group; EBMT = European society for blood and marrow transplantation a. As determined by an Independent Review Committee using standard objective IMWG/EBMT response criteria b. Statistically significant 
ORR n (%) sCR CR VGPR PR 95 % IZ za ORR 1-stranska p-vrednost KRd = zdravilo Kyprolis, lenalidomid in deksametazon, Rd = lenalidomid in deksametazon, PFS = preživetje brez napredovanja, HR = razmerje ogroženosti, IZ = interval zaupanja, OS = celokupno preživetje, ORR = celokupni delež odziva, sCR = strogi popolni odziv, CR = popolni odziv, VGPR = zelo dober delni odziv, PR = delni odziv, IMWG = International myeloma working group, EBMT = European society for blood and marrow transplantation.
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). 
Najnižje število trombocitov se pojavi na 8. dan ali na 15. dan vsakega 28-dnevnega ciklusa in se vrne na izhodiščno vrednost do začetka naslednjega ciklusa (glejte poglavje 4.8).
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). 
Koristni vpliv KRd na PFS je bil dosledno opažen v vseh podskupinah, vključno z bolniki, starimi ≥ 75 let (n = 96), bolniki z velikim tveganjem (n = 100) ali mutacijami genov z neznanim tveganjem (n = 375) ter pri bolnikih z izhodiščnim očistkom kreatinina od 30 do < 50 ml/min (n = 56).
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. 
Če je zdravilo Kyprolis uporabljeno le z deksametazonom, je treba uporabiti 20 mg deksametazona peroralno ali intravensko 1., 2., 8., 9., 15., 16., 22. in 23. dan 28-dnevnega ciklusa.
You must look out for certain symptoms while you are taking Kyprolis to reduce the risk of any problems. 
Da boste zmanjšali tveganje za težave, morate biti med uporabo zdravila Kyprolis pozorni na določene simptome.
Non-haematologic toxicity (renal) 
Nehematološki toksični učinki (ledvice)
• Respiratory tract infection (infection of the airways) 
• okužba dihal (okužba dihalnih poti),
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. 
Zdravilo Kyprolis so kot monoterapijo uporabili intravensko v 30 minutah in v odmerku 20 mg/m2 na 1. in 2. dan ter v odmerku 27 mg/m2 na 8., 9., 15. in 16. dan 1. ciklusa.
Appropriate dose reduction for the starting dose of lenalidomide should be considered according to the recommendations in the current lenalidomide summary of product characteristics, for example for patients with baseline renal impairment. 
V skladu z veljavnim povzetkom glavnih značilnosti lenalidomida je treba razmisliti o ustreznem zmanjšanju začetnega odmerka lenalidomida, na primer pri bolnikih z izhodiščno okvaro ledvic.
Kaplan-Meier curve of overall survival in relapsed multiple myelomaa 
Kaplan-Meierjeva krivulja celokupnega preživetja pri recidivnem diseminiranem plazmocitomua
Acute kidney injury Renal failure Renal impairment Decreased creatinine renal clearance 
Bolezni sečil zvišanje kreatinina v krvi akutna poškodba ledvic odpoved ledvic okvara ledvic zmanjšanje očistka kreatinina
Platelet counts should be monitored frequently during treatment with Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis je treba pogosto spremljati število trombocitov.
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. 
Farmakokinetične podatke so zbrali pri bolnikih po uporabi odmerka 27 mg/m2 v 30-minutni infuziji 16. dan 1. ciklusa in po uporabi odmerka 56 mg/m2 1. dan 2. ciklusa.
Rare (≥ 1/10,000 to 
Redki do < 1/1.000)
Kaplan-Meier curve of overall survival in relapsed multiple myeloma study 2011-003 
Kaplan-Meierjeva krivulja celokupnega preživetja v študiji 2011-003 pri recidivnem diseminiranem plazmocitomu
Give an additional 250 mL to 500 mL of intravenous fluids as needed following Kyprolis administration in cycle 1. 
Po uporabi zdravila Kyprolis v 1. ciklusu uporabite še dodatnih 250 ml do 500 ml intravenskih tekočin, kot je potrebno.
• Aching muscles 
• spazmi mišic,
All patients should be monitored for evidence of volume overload and fluid requirements should be tailored to individual patient needs. 
Količino tekočine je treba prilagoditi potrebam posameznega bolnika.
No clinical trial was conducted with a dose of 56 mg/m2. 
Z odmerkom 56 mg/m2 niso izvedli nobenega kliničnega preskušanja.
• Swelling of the hands, feet or ankles 
• oteklost dlani, stopal ali gležnjev,
Carfilzomib is a cytotoxic agent. 
Karfilzomib je tetrapeptiden epoksiketonski zaviralec proteasomov.
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. 
Ta študija je ocenila zdravilo Kyprolis v začetnem odmerku 20 mg/m2, ki so ga 8. dan 1. ciklusa povečali na 27 mg/m2, zdravilo pa so uporabljali v 10-minutni infuziji dvakrat na teden v 3 od
Cases of Hepatitis B Virus (HBV) reactivation have been reported in patients receiving carfilzomib. 
Pri bolnikih, ki so prejemali karfilzomib, so poročali o primerih ponovne aktivacije virusa hepatitisa B (HBV - Hepatitis B Virus).
Hypertensive crises (hypertensive urgency or hypertensive emergency) have occurred following administration of Kyprolis. 
Po uporabi zdravila Kyprolis so se pojavile hipertenzivne krize (hipertenzivna nujna stanja).
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. 
V kliničnem preskušanju karfilzomiba v odmerku 27 mg/m2 (infundiranim 2-10 minut), v katerem je bil kot sonda za CYP3A uporabljen peroralni midazolam, sočasno uporabljeni karfilzomib ni vplival na farmakokinetiko midazolama.
Increased alanine aminotransferase Increased aspartate aminotransferase Gammaglutamyltransferase increased 
Bolezni jeter, žolčnika in žolčevodov zvišanje alaninaminotransferaze zvišanje aspartataminotransferaze zvišanje gamaglutamiltransferaze hiperbilirubinemija odpoved jeter holestaza
• Bleeding in the stomach and bowels 
• krvavitev v želodcu in črevesu,
• Bleeding in the lungs 
• krvavitev v pljučih,
• Kidney problems, including kidney failure 
• težave z ledvicami, vključno z odpovedjo ledvic,
• Unusual bleeding, including easy bruising, bleeding from an injury, such as a cut, that takes longer than expected to stop, or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or bright red blood in your stools; or bleeding in the brain leading to sudden numbness or paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing or difficulty speaking or swallowing. 
• Neobičajne krvavitve, vključno z nagnjenostjo k podplutbam, krvavitvam zaradi poškodbe, kot je vrezna rana, pri kateri ustavitev krvavitve traja dlje kot pričakovano; ali notranje krvavitve, kot je izkašljevanje krvi, kri v izbruhani vsebini, temno, smolasto blato ali svetlo rdeča kri v blatu; ali krvavitev v možgane, ki povzroči nenadno omrtvičenost ali ohromelost na eni strani obraza, eni roki ali eni nogi, nenaden hud glavobol ali težave z vidom ali težave z govorjenjem ali požiranjem.
Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes. 
V preizkusu kromosomskih aberacij v limfocitih periferne krvi in vitro je bil karfilzomib klastogen.
• Unusual bruising or bleeding, such as a cut, that takes longer than usual to stop bleeding; or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or bright red blood in your stools; or bleeding in the brain leading to sudden numbness or paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing or difficulty speaking or swallowing 
• Neobičajne podplutbe ali krvavitve, kot je vrezna rana, pri kateri ustavitev krvavitve traja dlje kot pričakovano; ali notranje krvavitve, kot je izkašljevanje krvi, kri v izbruhani vsebini, temno, smolasto blato ali svetlo rdeča kri v blatu; ali krvavitev v možgane, ki povzroči nenadno omrtvičenost ali ohromelost na eni strani obraza, eni roki ali eni nogi, nenaden hud glavobol ali težave z vidom ali težave z govorjenjem ali požiranjem.
In patients refractory to lenalidomide (25%), median PFS was 8.6 months in the Kd arm versus 6.6 months in the Vd arm (HR = 0.80, 95% CI: 0.57, 1.11), ORR was 61.9% versus 54.9%. 
Pri bolnikih, odpornih na lenalidomid (25 %), je bila mediana PFS 8,6 meseca v skupini Kd in 6,6 meseca v skupini Vd (HR = 0,80, 95 % IZ: 0,57, 1,11), ORR je bil 61,9 % v primerjavi s 54,9 %.
Do not mix Kyprolis with or administer as an infusion with other medicinal products. 
Zdravila Kyprolis se ne sme mešati z drugimi zdravili; prav tako se ga ne sme dajati v infuziji skupaj z drugimi zdravili.
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%. 
Pri bolnikih, ki so predhodno prejemali lenalidomid (38 %), je bila mediana PFS 12,9 mesecev v skupini Kd in 7,3 mesecev v skupini Vd (HR = 0,69, 95 % IZ: 0,52, 0,92), ORR je bil 70,1 % v primerjavi z 59,3 %.
You should talk to your doctor or nurse about suitable methods of contraception. 
O ustreznem načinu kontracepcije se posvetujte z zdravnikom ali medicinsko sestro.
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. 
V študiji PX-171-009 je bila incidenca venskih tromboemboličnih dogodkov v skupini KRd 15,6 % in v skupini Rd 9,0 %.
Do not administer as an intravenous push or bolus. 
Zdravila se ne sme injicirati z intravenskim vbrizganjem ali v bolusu.
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. 
Med 18 ciklusi zdravljenja so prejemniki KRd dosegli izboljšanje celotnega zdravstvenega stanja in višje ocene celotnega zdravstvenega stanja/kakovosti življenja kot prejemniki Rd merjeno z EORTC QLQ-C30, ki je pri diseminiranem plazmocitomu validiran instrument (za večkratna testiranja nekorigirana 1-stranska p-vrednost = 0,0001).
• Infusion reaction 
• infuzijska reakcija,
• Heart attack 
• srčni infarkt,
• 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 
• Krvavitve, podplutbe, šibkost, zmedenost, zvišana telesna temperatura, slabost v želodcu (siljenje na bruhanje), bruhanje in driska ter akutna odpoved ledvic; to so lahko znaki krvne motnje, imenovane trombotična mikroangiopatija.
• 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 
• Kratka sapa pri vsakdanjih dejavnostih ali v mirovanju, neredno bitje srca, hitro bitje srca, utrujenost, omotica in napadi omedlevice; to so lahko znaki motnje, imenovane pljučna hipertenzija.
• Runny nose, nasal congestion or sneezing 
• izcedek iz nosu, zamašen nos ali kihanje,
• Feeling confused 
• zmedenost,
Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma 
Monoterapija z zdravilom Kyprolis pri bolnikih z recidivnim in refraktarnim diseminiranim plazmocitomom
Fatigue, dizziness, fainting, blurred vision, somnolence and/or a drop in blood pressure have been observed in clinical trials. 
V kliničnih preskušanjih so opažali utrujenost, omotico, omedlevico, zamegljen vid, zaspanost in/ali padec krvnega tlaka.
Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis so poročali o infuzijskih reakcijah, vključno z življenjsko ogrožujočimi.
The incidence of hypertension adverse events was similar between those with or without a prior medical history of hypertension. 
Incidenca hipertenzivnih neželenih učinkov je bila pri bolnikih, ki so imeli v anamnezi hipertenzijo, podobna kot pri tistih, ki je niso imeli.
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. 
Posledica je klasična ciklična trombocitopenija, med katero se najnižje število trombocitov pojavi na 8. ali 15. dan vsakega 28-dnevnega ciklusa in se po navadi vrne na izhodiščno vrednost do začetka naslednjega ciklusa.
• A blockage in the flow of bile from the liver (cholestasis), which can cause itchy skin, yellow skin, very dark urine and very pale stools 
• zapora iztekanja žolča iz jeter (holestaza), ki lahko povzroči srbenje kože, porumenelost kože,
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. 
Zdravilo Kyprolis je treba uporabljati v kombinaciji s 25 mg lenalidomida peroralno od 1. do 21. dne ciklusa in 40 mg deksametazona peroralno ali intravensko 1., 8., 15. in 22. dan 28-dnevnega ciklusa.
The reconstituted product should be a clear, colourless to slightly yellow solution and should not be administered if any discolouration or particulate matter is observed. 
Rekonstituirano zdravilo mora biti bistra, brezbarvna do rumenkasta raztopina.