natgillin/translations-raw huggingface dataset:
PX-171-011 evaluated Kyprolis monotherapy versus a control arm (corticosteroids and cyclophosphamide).
Študija PX-171-011 je ocenila monoterapijo z zdravilom Kyprolis v primerjavi s kontrolno skupino (kortikosteroidi in ciklofosfamid).
• For patients on dialysis receiving Kyprolis, the dose is to be administered after the dialysis procedure
• Bolnikom, ki se zdravijo z dializo in prejemajo zdravilo Kyprolis, je treba odmerek dati po dializi
In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth in models of multiple myeloma.
Pri živalih je karfilzomib zavrl proteasomsko aktivnost v krvi in tkivih ter je zakasnil rast tumorjev v modelih diseminiranega plazmocitoma.
While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for evidence of volume overload, especially patients at risk for cardiac failure.
Ker je pred uporabo v 1. ciklusu je potrebna ustrezna hidracija, je pri vseh bolnikih potrebno spremljati za znake volumske preobremenitve, še posebej bolnike s tveganjem za srčno popuščanje.
Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay.
Karfilzomib ni bil mutagen v preizkusu bakterijskih reverznih mutacij (Amesov test) in vitro, in vivo pa ni bil klastogen v mikrojedrnem preizkusu na kostnem mozgu miši.
Serum potassium levels should be monitored monthly, or more frequently during treatment with Kyprolis as clinically indicated and will depend on the potassium levels measured before the start of treatment, concomitant therapy used (e.g. medicinal products known to increase the risk of hypokalaemia) and associated comorbidities.
Med zdravljenjem z zdravilom Kyprolis je potrebno mesečno ali bolj pogosto, kot je klinično indicirano, spremljati koncentracije kalija v serumu, kar pa bo odvisno od koncentracij kalija, izmerjenih pred začetkom zdravljenja, sočasno uporabljenih zdravil (npr. zdravila, ki povečajo tveganje za hipokaliemijo) in povezanih sočasnih obolenj.
Concomitant medicinal products
Sočasno uporabljana zdravila
What Kyprolis is and what it is used for What you need to know before you use Kyprolis How to use Kyprolis
Kaj je zdravilo Kyprolis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Kyprolis Kako uporabljati zdravilo Kyprolis Možni neželeni učinki
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za infundiranje.
Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2.
Bolniki s telesno površino nad 2,2 m2 morajo dobiti odmerek za telesno površino 2,2 m2.
Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance.
Delovanje ledvic je treba spremljati vsaj mesečno ali v skladu s sprejetimi kliničnimi smernicami, še posebej pri bolnikih z nižjim izhodiščnim očistkom kreatinina.
PX-171-003A1 was a single-arm phase 2 study (N = 266; exposure to ≥ 2 prior therapies required), which met its primary efficacy endpoint of IRC-assessed ORR (22.9%).
Študija PX-171-003A1 je bila študija 2. faze z eno samo skupino (n = 266, zahtevani sta bili ≥ 2 predhodni zdravljenji), ki je dosegla svoj primarni opazovani dogodek učinkovitosti, kar zadeva ORR (22,9 %) po oceni neodvisnega strokovnega odbora.
Cardiac failure, myocardial infarction and myocardial ischaemia
Srčno popuščanje, miokardni infarkt in ishemija miokarda
PRES, formerly termed reversible posterior leukoencephalopathy syndrome (RPLS), is a rare, neurological disorder, which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging.
PRES (v preteklosti imenovan sindrom reverzibilne posteriorne levkoencefalopatije - RPLS) je redka nevrološka motnja, ki se lahko pokaže s konvulzijami, glavobolom, letargijo, zmedenostjo, slepoto, spremenjeno zavestjo ter drugimi vizualnimi in nevrološkimi motnjami, skupaj s hipertenzijo.
If tolerated, patients received 56 mg/m2 starting in cycle 2.
V primeru prenašanja so bolniki dobili odmerek 56 mg/m2 z začetkom v 2. ciklusu.
The study did not meet its primary efficacy endpoint of demonstrating superiority of Kyprolis monotherapy over the active control arm in overall survival (HR = 0.975 [95% CI: 0.760-1.249]).
Študija ni dosegla svojega primarnega opazovanega dogodka učinkovitosti - dokaza superiornosti monoterapije z zdravilom Kyprolis pred skupino, kontrolirano z učinkovino, kar zadeva celokupno preživetje (HR = 0,975 [95 % IZ: 0,760-1,249]).
6.6 Special precautions for disposal and other handling General precautions
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Splošni varnostni ukrepi
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.
Karfilzomib, uporabljen pri brejih podganah med obdobjem organogeneze, ni bil teratogen v odmerkih do 2 mg/kg/dan, kar je približno polovica na podlagi telesne površine priporočenega odmerka pri človeku 27 mg/m2.
• Stop until resolved or returned to baseline
• Prekinite odmerek dokler ne mine ali se ne vrne na izhodiščno vrednost
It cannot be excluded that the efficacy of oral contraceptives may be reduced during carfilzomib treatment (see section 4.5).
Ni mogoče izključiti zmanjšanja učinkovitosti peroralnih kontraceptivov med zdravljenjem s karfilzomibom (glejte poglavje 4.5).
Male patients must use effective contraception measures during and for 3 months following treatment if their partner is pregnant or of childbearing potential and not using effective contraception (refer to section 4.6).
Moški morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 3 mesece po njem, če je njihova partnerica noseča ali je v rodni dobi in ne uporablja učinkovite kontracepcije (glejte poglavje 4.6).
If your partner becomes pregnant whilst you are taking Kyprolis or within 90 days after stopping treatment, notify your doctor or nurse immediately.
Če vaša partnerka med vašim zdravljenjem z zdravilom Kyprolis ali v 90 dneh po koncu zdravljenja zanosi, morate takoj obvestiti zdravnika ali medicinsko sestro.
• Stop dose If recovered to ≥ 0.5 x 109/L, continue at same dose level
• Prekinite uporabo Če se število ponovno poveča na ≥ 0,5 x 109/l, nadaljujte z isto ravnjo odmerka
Kyprolis is for single use only.
Zdravilo Kyprolis je samo za enkratno uporabo.
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.
V kliničnih študijah se je hipertenzija kot neželen učinek pojavila pri približno 20 % preiskovancev; 7,5 % bolnikov je imelo hipertenzivne dogodke ≥ 3. stopnje, toda hipertenzivne krize so se pojavile pri < 0,5 % preiskovancev.
How to use Kyprolis
Kako uporabljati zdravilo Kyprolis
Signs and symptoms of TTP/HUS should be monitored for.
Bolnike je treba spremljati za znake in simptome TTP/HUS.
The PL is updated accordingly.
V skladu s tem se posodobi tudi navodilo za uporabo.
• Heart problems, including a history of chest pain (angina), heart attack, irregular heartbeat, high blood pressure or if you have ever taken a medicine for your heart
• Težave s srcem - če ste kdaj imeli bolečine v prsnem košu (angino pektoris), srčni infarkt, neredno bitje srca, visok krvni tlak ali ste jemali zdravila za srce.
A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended.
Pred začetkom zdravljenja je priporočena temeljita ocena dejavnikov tveganja za razvoj bolezni srca in ožilja.
A pre-planned overall survival (OS) analysis was performed after 246 deaths in the KRd arm and 267 deaths in the Rd arm.
Vnaprej načrtovana analiza celokupnega preživetja (OS) je bila opravljena po 246 smrtih v skupini s KRd in po 267 smrtih v skupini z Rd. Mediani čas spremljanja je bil približno 67 mesecev.
Liver enzymes and bilirubin should be monitored at treatment initiation and monthly during treatment with carfilzomib, regardless of baseline values.
Jetrne encime in bilirubin je treba spremljati ob uvedbi zdravljenja in nato vsak mesec med zdravljenjem s karfilzomibom, ne glede na izhodiščne vrednosti.
Kyprolis is supplied in a glass vial as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use.
Zdravilo Kyprolis je na voljo v steklenih vialah kot bel ali skoraj bel prašek za raztopino za infundiranje, ki ga je treba pred uporabo rekonstituirati (raztopiti).
Thus, there are limited data for Kyprolis in combination with lenalidomide and dexamethasone in patients with creatinine clearance (CrCL < 50 mL/min).
Zato so podatki o uporabi zdravila Kyprolis v kombinaciji z lenalidomidom in deksametazonom pri bolnikih z očistkom kreatinina (CrCl < 50 ml/min) omejeni.
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.
Merila primernosti za študijo so dovoljevala vključitev bolnikov, ki so bili predhodno zdravljeni s karfilzomibom (n = 3) ali bortezomibom (n = 502), če so imeli ti bolniki vsaj delen odziv (PRpartial response) na predhodno zdravljenje z zaviralcem proteasomov, če jim zdravljenja z zaviralcem proteasomov niso ukinili zaradi toksičnosti in če so imeli od zadnjega odmerka zaviralca proteasomov vsaj 6-mesečen interval, med katerim ga niso prejemali.
• Serious lung infection (pneumonia)
• resna okužba pljuč (pljučnica),
• Hepatitis B infection activated again (viral inflammation of the liver)
• ponovno aktivirana okužba s hepatitisom B (virusno vnetje jeter).
• Low blood pressure (hypotension)
• nizek krvni tlak (hipotenzija),
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.
Ker pa se zdravilo Kyprolis daje intravensko in se izdatno presnovi, ni verjetno, da bi zaviralci ali induktorji P-gp ali BCRP vplivali na farmakokinetične značilnosti karfilzomiba.
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).
V prvi študiji se je presnovek M14, fragment peptida in najbolj obilen presnovek v obtoku, pri bolnikih z zmerno okvaro ledvic povečal 2-krat, pri bolnikih s hudo okvaro ledvic 3-krat, ter 7-krat pri bolnikih na dializi (na podlagi AUClast).
A total of 929 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy were enrolled and randomised (464 in the Kd arm; 465 in the Vd arm).
Zajeli in randomizirali so skupno 929 bolnikov z recidivnim ali refraktarnim diseminiranim plazmocitomom, ki so prejeli od 1 do 3 predhodne linije zdravljenja (464 bolnikov v skupini Kd, 465 v skupini Vd).
• A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test results
• Neželen učinek, imenovan sindrom lize tumorja; povzroči ga lahko hitra razgradnja tumorskih celic in njegova posledica so lahko neredno bitje srca, odpoved ledvic ali nenormalni izvidi preiskav krvi.
Following intravenous administration of doses ≥ 15 mg/m2, carfilzomib was rapidly cleared from the systemic circulation with a half-life of ≤ 1 hour on day 1 of cycle 1.
Po intravenski uporabi odmerkov ≥ 15 mg/m2 se je karfilzomib 1. dan 1. ciklusa hitro izločil iz sistemskega obtoka z razpolovnim časom ≤ 1 uro.
• Viral infection
• virusna okužba,
Evaluate dyspnoea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes.
Dispnejo diagnostično opredelite, da boste izključili kardio-pulmonalne bolezni in motnje, vključno s srčnim popuščanjem in pljučnimi sindromi.
Female patients of child bearing potential treated with Kyprolis (and/or their partners) must use effective contraception measures during and for one month following treatment.
Ženske v rodni dobi, ki se zdravijo z zdravilom Kyprolis (in/ali njihovi partnerji), morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še en mesec po njem.
• If absolute neutrophil count returns to baseline grade and fever resolves, resume at the same dose level
• Če se absolutno število nevtrofilcev vrne na izhodiščno raven in zvišana telesna temperatura mine, nadaljujte z enako ravnjo odmerka
What Kyprolis looks like and contents of the pack
Izgled zdravila Kyprolis in vsebina pakiranja
No effects on reproductive tissues were noted during 28-day repeat-dose rat and monkey toxicity studies or in 6-month rat and 9-month monkey chronic toxicity studies.
Med 28-dnevnimi študijami toksičnosti ponavljajočih se odmerkov pri podganah in opicah ter med 6 mesečnimi študijami kronične toksičnosti pri podganah in 9 mesečnimi študijami kronične toksičnosti pri opicah niso ugotovili učinkov na reproduktivna tkiva.
Study eligibility criteria allowed a small subset of patients with myeloma refractory to bortezomib (n = 118) or lenalidomide (n = 57) to be enrolled.
Vključitveni kriteriji študije so dovolili vključitev majhne podskupine bolnikov z desiminiranim plazmocitomom, odpornim proti bortezomibu (n = 118) ali lenalidomidu (n = 57).
If Kyprolis is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Če je zdravilo Kyprolis uporabljeno med nosečnostjo, ali če ženska med jemanjem zdravila Kyprolis zanosi, jo je treba seznaniti z možno ogroženostjo ploda.
It is unknown whether carfilzomib or its metabolites are excreted in human milk.
Ni znano, ali se karfilzomib/njegovi presnovki izločajo v materino mleko.
They should be monitored for clinical and laboratory signs of HBV reactivation during and after the end of treatment.
Med zdravljenjem in po končanem zdravljenju je treba spremljati klinične in laboratorijske znake ponovne aktivacije HBV.
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.
Glavni presnovki, izmerjeni v humani plazmi in urinu, ki in vitro nastajajo v humanih hepatocitih, so bili peptidni fragmenti in diol karfilzomiba.
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
Kd = zdravilo Kyprolis in deksametazon, Vd = bortezomib in deksametazon, IZ = interval zaupanja, NO = ni ocenljivo, HR = razmerje ogroženosti, ORR = celokupni delež odziva, CR = popolni odziv, VGPR = zelo dober delni odziv a. Te opazovane dogodke je ugotavljal neodvisen strokovni odbor (Independent Review Committee) b. Statistično značilno c. Celokupni odziv je opredeljen kot dosežen najboljši celokupni odziv PR, VGPR, CR ali sCR d. Statistično značilno, 1-stranska p-vrednost = 0,0005 e. Statistično značilno, 1-stranska p-vrednost = 0,0001
Since dialysis clearance of Kyprolis concentrations has not been studied, the medicinal product should be administered after the dialysis procedure.
Dializni očistek koncentracij zdravila Kyprolis med dializo ni raziskan, zato je treba to zdravilo uporabiti po koncu dializnega postopka.
Renal function should be assessed at treatment initiation and monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance (CrCL < 30 mL/min).
Delovanje ledvic je treba oceniti na začetku zdravljenja in ga nato spremljati vsaj mesečno ali v skladu s sprejetimi kliničnimi smernicami, še posebej pri bolnikih z nižjim izhodiščnim očistkom kreatinina (CrCl < 30 ml/min).
Do not use Kyprolis after the expiry date printed on the vial and the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je natisnjen na viali in škatli.
Carfilzomib works by blocking the proteasome.
Karfilzomib deluje tako, da zavira proteasom.
For women taking Kyprolis
Za ženske, ki jemljejo zdravilo Kyprolis
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.
Povprečni volumen porazdelitve odmerka 20 mg/m2 karfilzomiba v stanju dinamičnega ravnovesja je bil 28 l. Pri testiranju in vitro je bila vezava karfilzomiba na beljakovine v humani plazmi v razponu koncentracij od 0,4 do 4 mikromole povprečno 97 %.
Based on a number of angioedema cases reported in relation to carfilzomib monotherapy or combination therapy, 5 of which with positive dechallenge, and the plausible mechanism considering possible class effect (bortezomib has angioedema included in section 4.8 of SmPC), as well as presented cases which suggest causal role of carfilzomib, the PRAC considers that the product information (PI) should be updated to include this adverse reaction.
Glede na številne primere angioedema, poročane v povezavi z monoterapijo ali kombinirano terapijo s karfilzomibom, od katerih je bil v 5 primerih poročan pozitiven odziv na prenehanje uporabe, ter verjetni mehanizem, če upoštevamo možnost učinka skupine (angioedem je vključen v poglavje 4.8 povzetka glavnih značilnosti zdravila pri bortezomibu), in glede na predstavljene primere, ki kažejo na vzročno povezavo s karfilzomibom, PRAC meni, da je treba informacije o zdravilu posodobiti tako, da bodo vključevale ta neželeni učinek.
• High blood pressure (hypertension)
• visok krvni tlak (hipertenzija),
DO NOT SHAKE.
NE PRETRESAJTE.
The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
Varnost ponovne uvedbe zdravila Kyprolis pri bolnikih, ki so imeli TTP/HUS, ni znana.
• Difficulty breathing, rapid breathing and/or fingertips and lips looking slightly blue (acute respiratory distress syndrome)
• težko dihanje, hitro dihanje in/ali rahlo modro obarvane konice prstov in ustnice (sindrom akutne dihalne stiske),
These included 1 well-documented serious case of hepatitis B reactivation with a likely association with carfilzomib and no substantial confounders, and 1 case of hepatitis B reactivation suggestive of a causal association which developed with the addition of carfilzomib to an ongoing regimen of lenalidomide plus dexamethasone, as well as 20 other serious cases which had, at minimum, a plausible temporal association with carfilzomib.
V povezavi z zdravljenjem s karfilzomibom so bili prepoznani številni primeri ponovne aktivacije virusa hepatitisa B. Ti so vključevali 1 dobro dokumentiran resen primer ponovne aktivacije virusa hepatitisa B z verjetno povezavo s karfilzomibom in brez motečih dejavnikov, 1 primer ponovne aktivacije virusa hepatitisa B, ki kaže na vzročno povezavo in se je razvil pri dodajanju karfilzomiba v potekajočo shemo lenalidomida in deksametazona, ter 20 drugih resnih primerov, ki so imeli vsaj verjetno začasno povezavo s karfilzomibom.
Increased c-reactive protein
C-reaktivnega proteina zvišanje sečne kisline v krvi
25 mg daily Cycles 13 on
25 mg na dan Od 13. ciklusa naprej
Please refer to the current lenalidomide summary of product characteristics.
Glejte veljavni povzetek glavnih značilnosti lenalidomida.
When administering in an intravenous bag, use only a 21-gauge or larger gauge needle (0.8 mm or smaller external diameter needle) to withdraw the calculated dose from the vial and dilute into a 50 or 100 mL intravenous bag containing 5% glucose solution for injection.
V primeru uporabe v intravenski vrečki uporabite le iglo številka 21 ali večjo (0,8 mm ali manjši zunanji premer igle), da izvlečete izračunani odmerek iz viale in ga razredčite v 50 ali 100 ml intravenski vrečki, ki vsebuje 5 % raztopino glukoze za injiciranje.
Recommended dose modifications
Priporočene prilagoditve odmerka
Adequate hydration is required before dose administration in cycle 1, especially in patients at high risk of tumour lysis syndrome or renal toxicity.
Pred uporabo odmerka v 1. ciklusu je potrebna ustrezna hidracija, zlasti pri bolnikih z velikim tveganjem za sindrom lize tumorja ali za toksične učinke na ledvicah.
Dexamethasone should be administered prior to Kyprolis to reduce the incidence and severity of reactions (see section 4.2).
Pred zdravilom Kyprolis je treba uporabiti deksametazon za zmanjšanje incidence in izrazitosti reakcij (glejte poglavje 4.2).
In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects (5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects (1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects (< 1% of subjects had grade ≥ 3 events).
V kliničnih študijah z zdravilom Kyprolis so poročali o srčnem popuščanju pri približno 7 % bolnikov (pri 5 % bolnikov je bilo ≥ 3. stopnje), miokardnem infarktu pri približno 2 % bolnikov (pri 1,5 % bolnikov je bil ≥ 3. stopnje) in ishemiji miokarda pri približno 1 % bolnikov (pri < 1 % bolnikov je bila ≥ 3. stopnje).
Based on high number of cases, plausible mechanism and seriousness of the risk, hepatitis B reactivation is proposed to be added as an adverse drug reaction in the SmPC and PL. A relevant warning should also be included.
Glede na veliko število primerov, verjetni mehanizem in resnost tveganja je predlagano, da se ponovna aktivacija virusa hepatitisa B doda v povzetek glavnih značilnosti zdravila in v navodilo za uporabo kot neženi učinek zdravila.
However, in phase 3 clinical studies, the incidence of adverse events of acute renal failure was higher in patients with lower baseline creatinine clearance than that among patients with higher baseline creatinine clearance.
Vendar pa je bila v kliničnih študijah 3. faze incidenca neželenih učinkov akutne odpovedi ledvic višja pri bolnikih z nižjim izhodiščnim očistkom kreatinina kot med bolniki z višjim izhodiščnim očistkom kreatinina.
The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.
Varnost ponovne uvedbe zdravila Kyprolis pri bolnikih, ki so imeli PRES, ni znana.
Experts in the treatment of HBV infection should be consulted, as necessary.
Po potrebi se je treba posvetovati s strokovnjaki za zdravljenje okužbe s HBV.
• Cytomegalovirus infection
• okužba s citomegalovirusom,
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).
Zdravilo Kyprolis je v kombinaciji ali z lenalidomidom in deksametazonom ali v kombinaciji s samim deksametazonom indicirano za zdravljenje odraslih bolnikov z diseminiranim plazmocitomom, ki so dobivali že vsaj eno predhodno zdravljenje (glejte poglavje 5.1).
• Platelet count < 10 x 109/L or evidence of bleeding with thrombocytopenia (see section 4.4)
• Število trombocitov < 10 x 109/l ali znaki krvavitve s trombocitopenijo (glejte poglavje 4.4)