natgillin/translations-raw huggingface dataset:
Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis so poročali o primerih sindroma posteriorne reverzibilne encefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome).
Uric acid lowering medicinal products should be considered in patients at high risk for TLS. 
Pri bolnikih z velikim tveganjem za sindrom lize tumorja je treba razmisliti o uporabo zdravil, ki znižujejo sečno kislino.
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. 
KRd = zdravilo Kyprolis, lenalidomid in deksametazon, Rd = lenalidomid in deksametazon, PFS = preživetje brez napredovanja, HR = razmerje ogroženosti, IZ = interval zaupanja, IMWG = International Myeloma Working Group, EBMT = European blood and marrow transplantation.
Dose modifications during Kyprolis treatment 
Tabela 3: Prilagajanje odmerka med zdravljenjem z zdravilom Kyprolis
First Kyprolis dose reduction 
Prvo zmanjšanje odmerka zdravila Kyprolis
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 
Kyprolis 10 mg prašek za raztopino za infundiranje Kyprolis 30 mg prašek za raztopino za infundiranje Kyprolis 60 mg prašek za raztopino za infundiranje karfilzomib
The majority of dyspnoea adverse reactions were non-serious (< 5% of subjects had grade ≥ 3 events), resolved, rarely resulted in treatment discontinuation, and had an onset early in the course of study (< 3 cycles). 
Ti neželeni učinki so redko povzročili prenehanje zdravljenja in so se pojavili zgodaj med študijo (< 3 ciklusi).
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis so bili opisani primeri hipertenzije, vključno s hipertenzivno krizo in hipertenzivnim nujnim stanjem.
Summary of efficacy analysis in relapsed multiple myeloma study 2011-003 
Tabela 7: Povzetek analize učinkovitosti v študiji 2011-003 pri recidivnen diseminiranem plazmocitomu
Kaplan-Meier curve of progression-free survival in relapsed multiple myelomaa 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni pri recidivnem diseminiranem plazmocitomua
No starting dose adjustment is recommended in patients with mild or moderate hepatic impairment based on available pharmacokinetic data. 
Na podlagi razpoložljivih farmakokinetičnih podatkov bolnikom z blago ali zmerno okvaro jeter začetnega odmerka ni priporočljivo prilagoditi.
• Yellowing of your skin and eyes (jaundice), abdominal pain or swelling, nausea or vomiting, which could be symptoms of liver problems including liver failure. 
• Porumenelost kože in očesnih beločnic (zlatenica), bolečine v trebuhu ali oteklost trebuha, slabost v želodcu ali bruhanje, ki so lahko simptomi težav z jetri, vključno z odpovedjo jeter.
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). 
Pri bolniki, ki so prejemali zdravilo Kyprolis, so poročali o venskih tromboemboličnih dogodkih, vključno z globoko vensko trombozo in pljučno embolijo s smrtnimi izidi (glejte poglavje 4.4).
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%. 
Pri bolnikih, ki so predhodno prejemali bortezomib (54 %), je bila mediana PFS 15,6 mesecev v skupini Kd in 8,1 mesecev v skupini Vd (HR = 0,56, 95 % IZ: 0,44, 0,73), ORR je bil 71,2 % v primerjavi s 60,3 %.
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. 
Ponavljajoče se intravensko dajanje karfilzomiba ≥ 2 mg/kg/odmerek pri podganah in 2 mg/kg/odmerek pri opicah je ob uporabi kliničnim shemam podobnih odmernih shem povzročilo umrljivost zaradi toksičnih učinkov na srce in ožilje (srčno popuščanje, fibroza srca, kopičenje tekočine v perikardu, krvavitev/degeneracija srca), prebavila (nekroza/krvavitev), ledvice (glomerulonefropatija, nekroza tubulov, disfunkcija) in pljuča (krvavitev/vnetje).
• Shortness of breath 
• piskajoče dihanje,
New or worsening cardiac failure (e.g. congestive cardiac failure, pulmonary oedema, decreased ejection fraction), myocardial ischaemia and infarction have occurred following administration of Kyprolis. 
Po uporabi zdravila Kyprolis so se pojavili novonastalo srčno popuščanje ali poslabšanje obstoječega srčnega popuščanja (npr. zastojno srčno popuščanje, pljučni edem, zmanjšan iztisni delež), ishemija miokarda in miokardni infarkt.
Dyspnoea was reported in approximately 30% of subjects in clinical studies with Kyprolis. 
V kliničnih študijah z zdravilom Kyprolis so poročali o dispneji pri približno 30 % bolnikov.
Kyprolis contains sodium 
Zdravilo Kyprolis vsebuje natrij
The dose is calculated using the patient's baseline body surface area (BSA). 
Odmerek je treba določiti glede na bolnikovo izhodiščno telesno površino.
Kyprolis 60 mg powder for solution for infusion Each vial contains 60 mg of carfilzomib. 
Kyprolis 60 mg prašek za raztopino za infundiranje Ena viala vsebuje 60 mg karfilzomiba.
Effective measures to avoid pregnancy should be taken (see section 4.6, and refer also to the current lenalidomide summary of product characteristics), an alternative method of effective contraception should be used if the patient is using oral contraceptives. 
Uporabljati je treba učinkovite načine za preprečevanje nosečnosti (glejte poglavje 4.6, prav tako glejte povzetek glavnih značilnosti lenalidomida).
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). 
Vendar pa je bila pri bolnikih z izhodiščno blago ali zmerno okvaro jeter incidenca motenj delovanja jeter, neželenih učinkov ≥ 3. stopnje in resnih neželenih učinkov večja kot pri bolnikih z normalnim delovanjem jeter (glejte poglavji 4.4 in 5.2).
Therefore, caution should be used during handling and preparation of Kyprolis. 
Karfilzomib je citotoksično zdravilo, zato je pri ravnanju z zdravilom Kyprolis in njegovi pripravi potrebna previdnost.
• Stop dose 
• Prekinite uporabo
Calculate the dose (mg/m2) and number of vials of Kyprolis required using the patient's BSA at baseline. 
Glede na bolnikovo izhodiščno telesno površino izračunajte odmerek (mg/m2) in število potrebnih vial zdravila Kyprolis.
Cases of hepatic failure, including fatal cases, have been reported in < 1% of subjects in clinical studies with Kyprolis. 
V kliničnih študijah zdravila Kyprolis so pri < 1 % bolnikov poročali o primerih odpovedi jeter, vključno s smrtnimi primeri.
Cardiac failure Myocardial infarction Atrial fibrillation Tachycardia Ejection fraction decreased Palpitations 
Srčne bolezni srčno popuščanje miokardni infarkt atrijska fibrilacija tahikardija zmanjšanje iztisnega deleža palpitacije zastoj srca ishemija miokarda perikarditis perikardialni izliv
• Kidney problems, including kidney failure or if you have ever received dialysis 
• Težave z ledvicami - če ste kdaj imeli odpoved ledvic ali ste se zdravili z dializo.
Betadex sulfobutyl ether sodium Anhydrous citric acid (E330) Sodium hydroxide (for pH adjustment) 
6.1 Seznam pomožnih snovi natrijev sulfobutilbetaciklodekstrin brezvodna citronska kislina (E330) natrijev hidroksid (za prilagoditev pH)
Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. 
Zdravilo Kyprolis je treba 1. in 2. dan 1. ciklusa uporabiti v začetnem odmerku 20 mg/m2 (največji odmerek 44 mg).
• Chest pains, shortness of breath, or if there is swelling of your feet, which may be symptoms of heart problems 
• Bolečina v prsnem košu, kratka sapa ali otekanje stopal; to so lahko simptomi težav s srcem.
Kyprolis Dose 
Odmerek zdravila Kyprolis
PFS months median (95% CI) HR (95% CI); 1-sided p-valueb 
Mediana mesecev PFS (95 % IZ) HR (95 % IZ); 1-stranska p-vrednostb
Lung infection Influenza Herpes zoster* Urinary tract infection Bronchitis Gastroenteritis Viral infection Nasopharyngitis Rhinitis 
Infekcijske in parazitske bolezni pljučnica okužba dihal sepsa okužba pljuč gripa herpes zoster* okužba sečil bronhitis gastroenteritis virusna okužba nazofaringitis rinitis kolitis zaradi Clostridium difficile okužba s citomegalovirusom ponovna aktivacija virusa hepatitisa B
Muscular weakness 
• šibkost mišic,
LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide. 
SEZNAM POMOŽNIH SNOVI Natrijev sulfobutilbetaciklodekstrin, brezvodna citronska kislina (E330), natrijev hidroksid.
Kyprolis 30 mg powder for solution for infusion Each vial contains 30 mg of carfilzomib. 
Kyprolis 30 mg prašek za raztopino za infundiranje Ena viala vsebuje 30 mg karfilzomiba.
Similar proteasome inhibition by carfilzomib was achieved with 2 to 10 minute and 30 minute infusions at the 2 dose levels (20 and 36 mg/m2) at which it was tested. 
Z 2- do 10-minutnim in 30-minutnim infundiranjem 2 različnih odmerkov karfilzomiba (20 in 36 mg/m2), s katerima je bilo opravljeno testiranje, so dosegli podobno zavrtje proteasomov.
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. 
V študiji 2011-003 je bila incidenca venskih tromboemboličnih dogodkov 12,5 % v skupini Kd in 3,3 % v skupini z bortezomibom in deksametazonom (Vd).
Kyprolis will be given to you together with lenalidomide and dexamethasone, or only with dexamethasone. 
Zdravilo Kyprolis boste dobili ali skupaj z lenalidomidom in deksametazonom ali skupaj s samim deksametazonom.
Cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving carfilzomib who have had prior or concurrent immunosuppressive therapy. 
Pri bolnikih, ki so prejemali karfilzomib in so predhodno ali istočasno prejemali imunosupresivno zdravljenje, so poročali o primerih progresivne multifokalne levkoencefalopatije (PML - Progressive Multifocal Leukoencephalopathy).
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. 
V primerjavi z bolniki z normalnim delovanjem ledvic je bila geometrična sredina razmerij AUClast ob odmerku 15 mg/m2 1. dan 1. ciklusa v primeru blage okvare ledvic 124,36 %, zmerne 111,07 % in hude 84,73 % ter v primeru kroničnega dializnega zdravljenja 121,72 %.
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 
Kyprolis 10 mg prašek za raztopino za infundiranje Kyprolis 30 mg prašek za raztopino za infundiranje Kyprolis 60 mg prašek za raztopino za infundiranje
Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide. 
Pomožne snovi: natrijev sulfobutilbetaciklodekstrin, brezvodna citronska kislina (E330), natrijev hidroksid.
Each mL of reconstituted solution contains 7 mg of sodium. 
Pomožna snov z znanim učinkom En mililiter rekonstituirane raztopine vsebuje 7 mg natrija.
• Cataract 
• katarakta,
Summary of efficacy analysis in relapsed multiple myeloma study PX-171-009 KRd combination therapy KRd arma (N = 396) 
Tabela 6: Povzetek analize učinkovitosti v študiji PX-171-009 pri recidivnem diseminiranem plazmocitomu
Instructions for reconstitution and preparation of Kyprolis powder for solution for infusion for intravenous administration 
Rekonstitucija in priprava za intravensko uporabo
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). 
Pri bolnikih v skupini s KRd so opazili statistično značilno boljše OS kot pri bolnikih v skupini z Rd. Bolniki v skupini s KRd so imeli 21 % manjše tveganje za smrt kot bolniki v skupini z Rd (HR = 0,79; 95 % IZ: 0,67, 0,95; p-vrednost = 0,0045).
OS months median (95% CI) HR (95% CI); 1-sided p-valueb 
Mediana mesecev OS (95 % IZ) HR (95 % IZ); 1-stranska p-vrednostb
Kyprolis in combination with lenalidomide and dexamethasonea 
Zdravilo Kyprolis v kombinaciji z lenalidomidom in deksametazonom
Cases of haemorrhage (e.g. gastrointestinal, pulmonary and intracranial haemorrhage) have been reported in patients treated with Kyprolis, often associated with thrombocytopenia. 
Pri bolnikih, zdravljenih z zdravilom Kyprolis, so poročali o krvavitvah (npr. krvavitvah v prebavila, pljuča in intrakranialni krvavitvi), pogosto v povezavi s trombocitopenijo.
• Bone pain, muscle pain, chest pain 
• bolečine v kosteh, bolečine v mišicah, bolečine v prsnem košu,
Cases of tumour lysis syndrome (TLS), including with fatal outcome, have been reported in patients who received Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis so poročali o primerih sindroma lize tumorja, vključno s smrtnimi izidi.
25 mg daily Cycles 2-12 
25 mg na dan Od 2.
10 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a light blue plastic flip off cap. 
Kyprolis 10 mg prašek za raztopino za infundiranje 10 ml prozorna viala iz stekla tipa I, zaprta s fluoropolimerno laminiranim elastomernim zamaškom in aluminijasto zaporo s svetlo modro plastično snemno zaporko.
Thromboprophylaxis should be considered based on an individual benefit/risk assessment. 
Na podlagi individualne ocene koristi in tveganja je treba razmisliti o tromboprofilaksi.
Pulmonary hypertension has been reported in patients treated with Kyprolis. 
Med zdravljenjem z zdravilom Kyprolis so poročali o pljučni hipertenziji.
Anxiety Confusional state 
Psihiatrične motnje nespečnost anksioznost stanje zmedenosti
Thrombocytopenia 
Rekonstituirana raztopina
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). 
V primeru dispneje 3. ali 4. stopnje prekinite uporabo zdravila Kyprolis, dokler ne mine ali se ne vrne na izhodiščno raven, na podlagi ocene koristi in tveganja pa razmislite o ponovnem začetku uporabe zdravila Kyprolis (glejte poglavji 4.2 in 4.8).
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. 
Kadar se kombinira z lenalidomidom in deksametazonom, se zdravilo Kyprolis daje intravensko v 10-minutni infuziji dva dni zapored vsak teden 3 tedne zapored (1. in 2., 8. in 9. ter 15. in 16. dan).
Your doctor will check you for signs of this infection before, during and for some time after treatment with this medicine. 
Zdravniku morate povedati, če ste kdaj imeli ali pa imate morda trenutno okužbo s hepatitisom B. Razlog za to je, da lahko to zdravilo povzroči ponovno aktivacijo virusa hepatitisa B. Zdravnik vas bo pregledoval za znake te okužbe pred in med zdravljenjem ter še nekaj časa po zdravljenju s tem zdravilom.
• Fluid in the lungs 
• tekočina v pljučih,
Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis. 
Pri bolnikih, ki so prejemali zdravilo Kyprolis, so poročali o primerih venskih tromboemboličnih dogodkov, vključno z globoko vensko trombozo in pljučno embolijo s smrtnimi izidi.
Third Kyprolis dose reduction 
Tretje zmanjšanje odmerka zdravila Kyprolis
Pruritus Erythema Hyperhidrosis 
Bolezni kože in podkožja izpuščaj srbenje eritem hiperhidroza angioedem
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). 
Bolniki v skupini z zdravilom Kyprolis, lenalidomidom in deksametazonom (KRd) so imeli boljše preživetje brez napredovanja (PFS - Progression Free Survival) kot bolniki v skupini z lenalidomidom in deksametazonom (Rd) (HR = 0,69, 1-stranska p-vrednost < 0,0001).
Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; OS = overall survival; mo = months; HR = hazard ratio; CI = confidence interval 
Kd = zdravilo Kyprolis in deksametazon, Vd = bortezomib in deksametazon, OS = celokupno preživetje, HR = razmerje ogroženosti, IZ = interval zaupanja
Investigations 
Preiskave zvišanje
GRH0219EN v1 
GRH0216SL v1
Talk to your doctor or nurse before using Kyprolis if you have any of the conditions listed below. 
Če imate katero od spodaj navedenih bolezni ali stanj, se posvetujte z zdravnikom ali medicinsko sestro, preden dobite zdravilo Kyprolis.
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. 
Kadar se kombinira z deksametazonom, se zdravilo Kyprolis daje intravensko v 30 minutni infuziji dva dni zapored vsak teden 3 tedne zapored (1. in 2., 8. in 9. ter 15. in 16. dan).
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% 
z lenalidomidom (38 %), odpornostjo na lenalidomid (25 %), starostjo (65 let, razpon od 30 do 89 let), spolom (51 % moških), stanjem zmogljivosti po ECOG (45 % s stanjem zmogljivosti 1), visoko tveganimi genetskimi mutacijami, ki so obsegale genetske podvrste t(4;14) ali t(14;16) pri 10 % ali več presejalno pregledanih plazmatk, ali delecijo 17p pri ≥ 20 % plazmatk (23 %), genetskimi mutacijami z neznanim tveganjem, ki so obsegale bolnike z neodvzetimi ali neanaliziranimi vzorci (9 %) in izhodiščno III. stadijem bolezni po ISS (24 %).
Progression/Death, n (%) Median PFS, mo HR (KRd/Rd) (95% CI) p-value (1-sided) 
Napredovanje/smrt, n (%) Mediana PFS, meseci HR (KRd/Rd) (95 % IZ) p-vrednost (1-stranska)
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). 
Bolnikom z izhodiščnim srčnim popuščanjem ali tveganjem zanj je mogoče celotno količino tekočine prilagoditi, kot je klinično primerno (glejte poglavje 4.4).
Evaluate and stop Kyprolis until resolved and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2). 
Ocenite in prekinite uporabo zdravila Kyprolis, dokler učinek ne mine, na podlagi ocene koristi in tveganja pa razmislite o ponovnem začetku uporabe zdravila Kyprolis (glejte poglavje 4.2).
Progression/Death, n (%) Median PFS, mo HR (Kd/Vd) (95% CI) p-value (1-sided) 
Napredovanje/smrt, n (%) Mediana PFS, meseci HR (Kd/Vd) (95 % IZ) p-vrednost (1-stranska)
Vd Arm (N = 465) 
Skupina Vd (n = 465)
30 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with an orange plastic flip off cap. 
Kyprolis 30 mg prašek za raztopino za infundiranje 30 ml prozorna viala iz stekla tipa I, zaprta s fluoropolimerno laminiranim elastomernim zamaškom in aluminijasto zaporo z oranžno plastično snemno zaporko.
Kd = Kyprolis plus dexamethasone; Vd = bortezomib plus dexamethasone; PFS = progression-free survival; mo = months; HR = hazard ratio; CI = confidence interval 
Kd = zdravilo Kyprolis in deksametazon, Vd = bortezomib in deksametazon, PFS = preživetje brez napredovanja, HR = razmerje ogroženosti, IZ = interval zaupanja
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). 
V skupini Kd so ugotovili statistično značilno boljše celokupno preživetje kot v skupini Vd (HR = 0,791, 95 % IZ: 0,65, 0,96, p-vrednost = 0,010).
Kyprolis, lenalidomide, and dexamethasone 
Zdravilo Kyprolis, lenalidomid in deksametazon
Kd Arm (N = 464) 
Skupina Kd (n = 464)
The pharmacokinetics of carfilzomib has not been studied in patients with severe hepatic impairment (bilirubin > 3 x ULN and any AST). 
Pri bolnikih s hudo okvaro jeter (bilirubin > 3-kratna ZNM in ne glede na AST) farmakokinetika karfilzomiba ni raziskana.
In case of hypertensive crises, stop Kyprolis until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment (see section 4.2). 
V primeru hipertenzivne krize prenehajte uporabljati zdravilo Kyprolis, dokler ne mine ali se ne vrne na izhodiščno raven, na podlagi ocene koristi in tveganja pa razmislite o ponovnem začetku uporabe zdravila Kyprolis (glejte poglavje 4.2).
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). 
Bolnikom z izhodiščnim srčnim popuščanjem ali tveganjem zanj je mogoče celotno količino tekočine prilagoditi, kot je klinično primerno (glejte poglavje 4.2).
For men taking Kyprolis 
Za moške, ki jemljejo zdravilo Kyprolis
50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap. 
Kyprolis 60 mg prašek za raztopino za infundiranje 50 ml prozorna viala iz stekla tipa I, zaprta s fluoropolimerno laminiranim elastomernim zamaškom in aluminijasto zaporo z vijolično plastično snemno zaporko.
• Low platelets, which may cause easy bruising or bleeding (thrombocytopenia) 
• nizko število trombocitov, ki lahko povzroči nagnjenost k podplutbam ali krvavitvam
The geometric mean ratios in AUClast at the 27 mg/m2 dose cycle 1, day 16 and at the 56 mg/m2 dose cycle 2, day 1 for ESRD versus normal renal function were 139.72% and 132.75%, respectively. 
V primerjavi z bolniki z normalnim delovanjem ledvic je bila geometrična sredina razmerij AUClast pri bolnikih s končno odpovedjo ledvic ob odmerku 27 mg/m2 16. dan 1. ciklusa 139,72 % in ob odmerku 56 mg/m2 1. dan 2. ciklusa 132,75 %.
• Lung infection 
• okužba pljuč,
Second Kyprolis dose reduction 
Drugo zmanjšanje odmerka zdravila Kyprolis
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 60 mg of carfilzomib. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 60 mg karfilzomiba.