natgillin/translations-raw huggingface dataset:
No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl < 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2). 
Pri bolnikih z blago (CrCl = 60 - 89 ml/min), zmerno (CrCl = 30 - 59 ml/min), hudo (CrCl < 30 ml/min) okvaro ledvic ali končno odpovedjo ledvic, ki potrebujejo zdravljenje z dializo, odmerka zdravila Empliciti ni treba prilagajati (glejte poglavje 5.2).
a p-value based on the log-rank test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other). 
a p-vrednost na osnovi testa log-rank, stratificiranega glede na B2 mikroglobuline (< 3,5 mg/l v primerjavi z ≥ 3,5 mg/l), število predhodnih linij zdravljenja (1 v primerjavi z 2 ali 3) in predhodno imunomodulatorno zdravljenje (brez v primerjavi s predhodnim zdravljenjem samo s talidomidom v primerjavi z drugim).
On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles. 
Na dan aplikacije zdravila Empliciti mora bolnik deksametazon prejeti v odmerku 28 mg peroralno enkrat na dan od 3 do 24 ur pred zdravilom Empliciti in 8 mg intravensko od 45 do 90 minut pred aplikacijo zdravila Empliciti na 1., 8., 15. in 22. dan ponavljajočega se 28-dnevnega cikla.
Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg. 
Farmakokinetika elotuzumaba je nelinearna pri čemer se očistek zmanjšuje, odmerek pa povečuje od 0,5-20 mg/kg.
When Empliciti is given in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention programme for lenalidomide or pomalidomide respectively (see package leaflet for lenalidomide or pomalidomide). 
Pri uporabi zdravila Empliciti v kombinaciji z lenalidomidom ali s pomalidomidom morate upoštevati navodila za preprečevanje nosečnosti pri uporabi lenalidomida oziroma pomalidomida (glejte navodila za uporabo lenalidomida oziroma pomalidomida).
The recommended dose of Empliciti is 10 mg/kg administered intravenously every week on days 1, 8, 15, and 22 of each treatment cycle for the first two cycles and then 20 mg/kg administered on day 1 of each treatment cycle thereafter. 
Priporočeni odmerek zdravila Empliciti je 10 mg/kg intravensko vsak teden, na 1., 8., 15. in 22. dan prva dva cikla zdravljenja in nato 20 mg/kg na 1. dan vsakega cikla zdravljenja.
In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8). 
V kliničnem preskušanju, v katerem so pri bolnikih z multiplim mielomom uporabo zdravila Empliciti v kombinaciji z lenalidomidom in deksametazonom primerjali z uporabo lenalidomida in deksametazona (študija CA204004), je bila pojavnost SPN in specifičnih solidnih tumorjev ter nemelanomskega kožnega raka večja pri bolnikih, ki so se zdravili z zdravilom Empliciti (glejte poglavje 4.8).
Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1). 
Zdravilo Empliciti je v kombinaciji s pomalidomidom in deksametazonom indicirano za zdravljenje ponovljenega in neodzivnega multiplega mieloma pri odraslih bolnikih, ki so se predhodno zdravili z vsaj dvema oblikama zdravljenja, vključno z lenalidomidom in zaviralcem proteasoma, bolezen pa je pri zadnjem zdravljenju napredovala (glejte poglavji 4.2 in 5.1).
Sodium citrate Citric acid monohydrate Polysorbate 80 
6.1 Seznam pomožnih snovi saharoza natrijev citrat citronska kislina monohidrat polisorbat 80
Table 1: Recommended dosing schedule of Empliciti in combination with lenalidomide and dexamethasone 
Tabela 1: Priporočena shema odmerjanja zdravila Empliciti v kombinaciji z lenalidomidom in deksametazonom
d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, herpes virus infection and ophthalmic herpes zoster. 
d Izraz herpes zoster je skupina naslednjih izrazov: herpes zoster, oralni herpes, herpesvirusna okužba in očesni herpes zoster.
For women taking Empliciti 
Ženske, ki se zdravijo z zdravilom Empliciti
HR (95.4% CI): 0.82 (0.68, 1.00) p-value: 0.0408 
Razmerje ogroženosti (95,4% IZ): 0,82 (0,68; 1,00) p-vrednost: 0,0408
Powder for concentrate for solution for infusion 1 vial 
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala
Dose 1 
1. odmerek
Conditions for use of medicinal products used with Empliciti Empliciti is used in combination with other medicinal products; therefore, the conditions for use applicable to those medicinal products also apply to the combination therapy. 
Pogoji za uporabo zdravil, ki se uporabljajo skupaj z zdravilom Empliciti Zdravilo Empliciti se uporablja v kombinaciji z drugimi zdravili.
The chromosomal abnormalities as determined by the FISH of del(17p), t(4;14) and t(14;16) were present in 5%, 11% 
S FISH določene kromosomske nepravilnosti del(17p) so bile prisotne pri 5 % bolnikov, t(4;14) pri 11 % bolnikov in t(14;16) pri 7 % bolnikov.
Feeling tired or weak 
Neželen i učinek
d p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other). 
d p-vrednost na osnovi Cochran-Mantel-Haenszelovega hi-kvadrat testa, stratificiranega glede na B2 mikroglobuline (< 3,5 mg/l v primerjavi z ≥ 3,5 mg/l), število predhodnih linij zdravljenja (1 v primerjavi z 2 ali 3) in predhodno imunomodulatorno zdravljenje (brez v primerjavi s predhodnim zdravljenjem samo s talidomidom v primerjavi z drugim).
Below is a list of typical symptoms associated with infusion reactions: Fever Chills High blood pressure 
V nadaljevanju so navedeni značilni simptomi, povezani z infuzijskimi reakcijami:
Empliciti, as a humanised monoclonal antibody, is not expected to be metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of Empliciti. 
Zdravilo Empliciti je humano monoklonsko protitelo, zato presnove s pomočjo encimov citokroma P450 (CYP) ali drugih encimov, ki presnavljajo zdravila, ni pričakovati.
b The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia. 
b Izraz pljučnica je skupina naslednjih izrazov: pljučnica, atipična pljučnica, bronhopnevmonija, lobarna pljučnica, bakterijska pljučnica, glivična pljučnica, virusna pljučnica in pnevmokokna pljučnica.
a p-value based on the log-rank test stratified by stage of disease at study entry (International Staging System I-II vs III) and number of prior lines of therapy (2-3 vs ≥ 4) at randomization. 
a p-vrednost na osnovi testa log rank, stratificiranega glede na stadij bolezni ob vstopu v študijo (mednarodni sistem za razvrščanje v stadije (ISS) I-II v primerjavi s III) in število predhodnih linij zdravljenja (2-3 v primerjavi s 4 ali več) ob randomizaciji.
CA204125 is a randomised, open-label study conducted to evaluate the efficacy and safety of Empliciti in combination with pomalidomide and dexamethasone (E-Pd) in patients with refractory or relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and had disease progression on or within 60 days of their last therapy. 
Zdravilo Empliciti v kombinaciji s pomalidomidom in deksametazonom (študija CA204125) Študija CA204125 je odprta randomizirana študija, izvedena za ovrednotenje učinkovitosti in varnosti zdravila Empliciti v kombinaciji s pomalidomidom in deksametazonom (E-Pd) pri bolnikih z neodzivnim ali ponovljenim in neodzivnim multiplim mielomom, ki so se predhodno zdravili z vsaj dvema oblikama zdravljenja, vključno z lenalidomidom in zaviralcem proteasoma (PI, proteasome inhibitor), bolezen pa je napredovala na oziroma v obdobju 60 dni po zadnjem zdravljenju.
c p-value based on the Cochran-Mantel-Haenszel chi-square test stratified by stage of disease at study entry (International Staging System I-II vs III) and number of prior lines of therapy (2-3 vs ≥ 4) at randomization. 
c p-vrednost na osnovi Cochran-Mantel-Haenszelovega hi-kvadrat testa stratificiranega glede na stadij bolezni ob vstopu v študijo (mednarodni sistem za razvrščanje v stadije (ISS) I-II v primerjavi s III) in število predhodnih linij zdravljenja (2-3 v primerjavi s 4 ali več) ob randomizaciji.
Premedication for prevention of infusion reaction Patients must be administered with the following premedications 45-90 minutes prior to Empliciti infusion (see section 4.4): Dexamethasone 8 mg intravenous H1 blocker: diphenhydramine (25-50 mg orally or intravenous) or equivalent H1 blocker. 
Premedikacija za preprečevanje infuzijske reakcije Bolniki morajo od 45 do 90 minut pred infundiranjem zdravila Empliciti prejeti premedikacijo z naslednjimi zdravili (glejte poglavje 4.4): Deksametazon 8 mg intravensko.
Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro. 
Elotuzumab z delovanjem na SLAMF7 in receptorje Fc neposredno aktivira naravne celice ubijalke in tako okrepi protimielomsko aktivnost in vitro.
Stopping your treatment with Empliciti may stop the effect of the medicine. 
Če ste prenehali uporabljati zdravilo Empliciti Če zdravljenje z zdravilom Empliciti prekinete, bodo učinki zdravila izzveneli.
c The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia. 
c Izraz pljučnica je skupina naslednjih izrazov: pljučnica, atipična pljučnica, bronhopnevmonija, lobarna pljučnica, bakterijska pljučnica, glivična pljučnica, virusna pljučnica in pnevmokokna pljučnica.
The rate of mild to moderate infusion reactions was > 50% in patients who were not premedicated. 
Pri bolnikih, ki niso prejeli premedikacije, je bil delež blagih do zmernih infuzijskih reakcij > 50 %.
Second Primary Malignancies 
Sekundarne primarne novotvorbe
Elotuzumab will be given in combination with lenalidomide or pomalidomide and breast-feeding should be stopped because of the use of lenalidomide or pomalidomide. 
Elotuzumab se uporablja v kombinaciji z lenalidomidom ali pomalidomidom, zato je zaradi uporabe lenalidomida ali pomalidomida treba prenehati z dojenjem.
Empliciti 400 mg powder for concentrate for solution for infusion Each vial contains 400 mg elotuzumab. 
Empliciti 400 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 400 mg elotuzumaba.
Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204125, a clinical trial in patients with multiple myeloma comparing Empliciti combined with pomalidomide and dexamethasone treatment (N = 60) to pomalidomide and dexamethasone treatment (N = 55), is shown in Table 7. 
Deleži neželenih učinkov, prilagojeni glede na izpostavljenost (vse stopnje in stopnje 3/4) v kliničnem preskušanju CA204125, izvedenem pri bolnikih z multiplim mielomom, v katerem so zdravljenje z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom (N = 60) primerjali z zdravljenjem s pomalidomidom in deksametazonom (N = 55), so prikazani v tabeli 7.
There was no clear causal evidence of altered pharmacokinetic, efficacy, or toxicity profiles with anti-product antibody development based on the population pharmacokinetic and exposure-response analyses. 
Na osnovi analize populacijske farmakokinetike in analize izpostavljenost-odziv niso odkrili jasne vzročne povezave med razvojem protiteles proti zdravilu in spremembo farmakokinetike, učinkovitosti ali profila neželenih učinkov.
Elotuzumab will be given in combination with lenalidomide, which is contraindicated during pregnancy. 
Izkušenj z uporabo elotuzumaba med nosečnostjo pri človeku ni. Elotuzumab se uporablja v kombinaciji z lenalidomidom, katerega uporaba med nosečnostjo je kontraindicirana.
Uncommon a The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection. 
Izraz herpes zoster je skupina naslednjih izrazov: herpes zoster, oralni herpes in herpesvirusna okužba.
Table 7: CA204125 Exposure-adjusted rates for adverse reactions for Empliciti-treated patients versus pomalidomide and dexamethasone-treated patients [includes multiple occurrences in all treated patients] 
Tabela 7: Študija CA204125: Deleži neželenih učinkov, prilagojeni glede na izpostavljenost, pri bolnikih, ki so se zdravili z zdravilom Empliciti, v primerjavi z bolniki, ki so se zdravili s pomalidomidom in deksametazonom [vključno z večkratno pojavnostjo pri vseh zdravljenih bolnikih]
Table 6: CA204004 Exposure-adjusted rates for adverse reactions for Empliciti-treated patients versus lenalidomide and dexamethasone-treated patients [includes multiple occurrences in all treated patients] 
Tabela 6: Študija CA204004: Deleži neželenih učinkov, prilagojeni glede na izpostavljenost, pri bolnikih, ki so se zdravili z zdravilom Empliciti, v primerjavi z bolniki, ki so se zdravili z lenalidomidom in deksametazonom [vključno z večkratno pojavnostjo pri vseh zdravljenih bolnikih]
Very severe infusion reactions may require permanent discontinuation of Empliciti therapy and emergency treatment. 
V primeru pojava zelo hudih infuzijskih reakcij bo zdravljenje z zdravilom Empliciti morda treba trajno ukiniti in uvesti ustrezno nujno zdravljenje.
On days that Empliciti is administered, patients ≤ 75 years old give dexamethasone 28 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti and for patients > 75 years old give dexamethasone 8 mg orally between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti. 
Na dan aplikacije zdravila Empliciti morajo bolniki, stari 75 let ali mlajši, deksametazon prejeti v odmerku 28 mg peroralno od 3 do 24 ur pred zdravilom Empliciti in 8 mg intravensko od 45 do 90 minut pred aplikacijo zdravila Empliciti, bolniki, starejši od 75 let, pa morajo deksametazon prejeti v odmerku 8 mg peroralno od 3 do 24 ur pred zdravilom Empliciti in 8 mg intravensko od 45 do 90 minut pred aplikacijo zdravila Empliciti.
Elotuzumab is not expected to be excreted into human milk. 
Izločanje elotuzumaba v materino mleko se ne predvideva.
Eligible patients were randomised in a 1:1 ratio to receive either Empliciti in combination with lenalidomide and dexamethasone or lenalidomide and dexamethasone (Ld). 
Primerni bolniki so bili v razmerju 1:1 randomizirani na zdravljenje z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (Ld) ali zdravljenje z lenalidomidom in deksametazonom.
b The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased. 
b Izraz limfopenija vključuje naslednje izraze: limfopenija in zmanjšanje števila limfocitov.
The Summary of Product Characteristics for all medicinal products used in combination with Empliciti must be consulted before starting therapy. 
Pred začetkom zdravljenja je treba prebrati povzetke glavnih značilnosti vseh zdravil, ki se uporabljajo v kombinaciji z zdravilom Empliciti.
This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein. 
Ta interferenca lahko pri bolnikih z IgG kapa mielomskim proteinom vpliva na določitev popolnega odziva, po možnosti pa tudi na določitev ponovitve po polnem odzivu.
In a clinical trial of patients with multiple myeloma (CA204125), infections were reported in 65% of patients in the Empliciti combined with pomalidomide and dexamethasone arm (N = 60) and 65.5% in the pomalidomide and dexamethasone arm (N = 55). 
V kliničnem preskušanju, izvedenem pri bolnikih z multiplim mielomom (študija CA204125), so o okužbah poročali pri 65 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom (N = 60), in pri 65,5 % bolnikov, ki so se zdravili s pomalidomidom in deksametazonom (N = 55).
In the clinical trials of patients with multiple myeloma infusion reactions were reported in approximately 10% of premedicated patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3% of premedicated patients treated with Empliciti combined with pomalidomide and dexamethasone (N = 60) (see section 4.4). 
V kliničnih preskušanjih, izvedenih pri bolnikih z multiplim mielomom, so o infuzijskih reakcijah poročali pri približno 10 % premediciranih bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (N = 318) in 3 % premediciranih bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom (N = 60) (glejte poglavje 4.4).
Posology for administration with pomalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 2 for the dosing schedule. 
Odmerjanje pri uporabi s pomalidomidom in deksametazonom Dolžina vsakega cikla zdravljenja je 28 dni.
Posology for administration with lenalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 1 for the dosing schedule. 
Odmerjanje pri uporabi z lenalidomidom in deksametazonom Dolžina vsakega cikla zdravljenja je 28 dni.
The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation. 
Dvižna zaporka 300 mg oblike zdravila je barve slonovine, dvižna zaporka 400 mg oblike zdravila pa modre barve.
Among, patients treated with aspirin, deep vein thromboses were reported in 4.1% of patients treated with Empliciti combined with lenalidomide and dexamethasone (E-Ld) and 1.4% of patients treated with lenalidomide and dexamethasone (Ld). 
Pri bolnikih, ki so se zdravili z acetilsalicilno kislino, so o globoki venski trombozi poročali pri 4,1 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (E-Ld), in 1,4 % bolnikov, ki so se zdravili z lenalidomidom in deksametazonom (Ld).
If you become pregnant while using Empliciti, tell your doctor. 
Če med zdravljenjem z zdravilom Empliciti zanosite, o tem obvestite zdravnika.
On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients ≤ 75 years old and 20 mg orally to patients > 75 years old. 
Na dan brez uporabe zdravila Empliciti, ko je predvidena uporaba deksametazona (8., 15. in 22. dan 3. cikla in vsi nadaljnji cikli), morajo bolniki, stari 75 let ali mlajši, deksametazon prejeti v odmerku 40 mg peroralno, bolniki, starejši od 75 let, pa v odmerku 20 mg peroralno.
Your doctor may consider slowing the Empliciti infusion or interrupting it to manage these symptoms. 
Zdravnik lahko za ublažitev teh simptomov zmanjša hitrost infundiranja zdravila Empliciti ali pa infundiranje zdravila prekine.
Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) Overall Survivalg Hazard Ratio [95.4% CI] Stratified log-rank test p-value 
Zelo dober delni odziv (VGPR) n (%) Delni odziv (RR/PR) n (%) Kombinirani odzivi (CR+sCR+VGPR) n (%) Celokupno preživetje (OS)g
Grade 3-4 infections were noted in 13.3% and 21.8% of Empliciti combined with pomalidomide and dexamethasone and pomalidomide and dexamethasone treated patients, respectively. 
O okužbah stopnje 3-4 so poročali pri 13,3 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom, in pri 21,8 % bolnikov, ki so se zdravili s pomalidomidom in deksametazonom.
Patients who have escalated to 5 mL/min at 10 mg/kg dose must decrease the rate to 3 mL/min at the first infusion at 20 mg/kg. 
Pri bolnikih, pri katerih je hitrost infundiranja pri uporabi odmerka 10 mg/kg dosegla hitrost 5 ml/min, je pri prvem infundiranju zdravila v odmerku 20 mg/kg treba hitrost infundiranja zmanjšati na 3 ml/min.
SPMs are known to be associated with lenalidomide exposure, which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone. 
Za SPN je znano, da so povezane z izpostavljenostjo lenalidomidu, ki pa je bila pri bolnikih, ki so se zdravili z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom daljša kot pri bolniki, ki so se zdravili z lenalidomidom in deksametazonom.
CA204004 is a randomised, open-label study was conducted to evaluate the efficacy and safety of Empliciti in combination with lenalidomide and dexamethasone (E-Ld) in patients with multiple myeloma who have received one to three prior therapies. 
Zdravilo Empliciti v kombinaciji z lenalidomidom in deksametazonom (študija CA204004) Študija CA204004 je odprta randomizirana študija, izvedena za ovrednotenje učinkovitosti in varnosti zdravila Empliciti v kombinaciji z lenalidomidom in deksametazonom (E-Ld) pri bolnikih z multiplim mielomom, ki so se predhodno zdravili z eno do tremi oblikami zdravljenja.
Stratified log-rank test p-valuea 1-Year PFS rate (%) [95% CI] 2-Year PFS rate (%) [95% CI] 3-Year PFS rateb(%) [95% CI] Median PFS in months [95% CI] 
Delež 3-letnega PFSb (%) [95 % IZ] Mediana PFS v mesecih [95 % IZ]
Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204004, a clinical trial in patients with multiple myeloma comparing Empliciti combined with lenalidomide and dexamethasone treatment (N = 318) to lenalidomide and dexamethasone treatment (N = 317), is shown in Table 6. 
Deleži neželenih učinkov, prilagojeni glede na izpostavljenost (vse stopnje in stopnje 3/4) v kliničnem preskušanju CA204004, izvedenem pri bolnikih z multiplim mielomom, v katerem so zdravljenje z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom (N = 318) primerjali z zdravljenjem z lenalidomidom in deksametazonom (N = 317), so prikazani v tabeli 6.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema limfopenijac zelo pogosti pogosti levkopenija pogosti pogosti
Herpes zostera 
Okvara ledvic
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies. 
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC: L01XC23
When Empliciti is used with lenalidomide or pomalidomide there is a risk of foetal harm, including severe life-threatening human birth defects associated with these agents and the need to follow requirements regarding pregnancy avoidance, including testing and contraception. 
Pri uporabi zdravila Empliciti skupaj z lenalidomidom ali pomalidomidom obstaja tveganje za poškodbo ploda, vključno s hudimi, smrtno nevarnimi prirojenimi okvarami, povezanimi z uporabo teh zdravil.
Empliciti 300 mg powder for concentrate for solution for infusion Each vial contains 300 mg elotuzumab*. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Empliciti 300 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 300 mg elotuzumaba*.
See Method of administration below for instruction on infusion rates. 
Za navodila glede hitrosti infundiranja glejte Način uporabe v nadaljevanju.