FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution and dilution The reconstituted solution should be transferred from the vial into the infusion bag immediately.
Slovenian: Po rekonstituciji in redčenju Rekonstituirano raztopino je treba iz viale takoj prenesti v infuzijsko vrečko.
English: You should use a condom while taking Empliciti and for 180 days after stopping treatment to ensure your partner does not become pregnant.
Slovenian: Med zdravljenjem in še 180 dni po koncu zdravljenja z zdravilom Empliciti morate uporabljati kondom za zagotovilo, da partnerica ne zanosi.
English: As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Slovenian: Za elotuzumab se kot za IgG monoklonsko protitelo predvideva, da preko katabolnih poti razpade do manjših peptidov in aminokislin.
English: Treatment should continue until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje je treba nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Empliciti powder for concentrate for solution for infusion (powder for concentrate) is a white to off white whole or fragmented cake provided in a glass vial.
Slovenian: Empliciti prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) je bel do sivobel prašek v obliki celega ali razdrobljenega skupka v stekleni viali.
English: 20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab.
Slovenian: 20-ml viala iz stekla tipa I, zaprta s sivim zamaškom iz butilne gume, aluminijastim obročkom in polipropilensko dvižno zaporko, ki vsebuje 300 mg ali 400 mg elotuzumaba.
English: Lenalidomide 25 mg was taken orally once daily for the first 3 weeks of each cycle.
Slovenian: Bolniki so lenalidomid jemali peroralno v odmerku 25 mg enkrat na dan prve 3 tedne vsakega cikla.
English: The metabolic pathway of elotuzumab has not been characterized.
Slovenian: Presnovna pot elotuzumaba ni bila opisana.
English: SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities.
Slovenian: SLAMF7 je močno izražen na celicah multiplega mieloma, neodvisno od citogenetskih nepravilnosti.
English: The median age was 67 years (range 36 to 81); 62% of patients were older than 65 years; 57% of patients were male; whites comprised 77% of the study population, Asians 21%, and blacks 1%.
Slovenian: Mediana starost je bila 67 let (razpon: od 36 do 81), 62 % bolnikov je bilo starejših od 65 let, 57 % bolnikov je bilo moškega spola, 77 % raziskovane populacije je bilo belcev, 21 % Azijcev in 1 % bolnikov črne
English: Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8).
Slovenian: Infuzijska reakcija Pri bolnikih, ki so prejemali elotuzumab, so poročali o pojavu infuzijskih reakcij (glejte poglavje 4.8).
English: Improvements observed in PFS were consistent across subsets regardless of age (< 65 versus ≥ 65), risk status, presence or absence of cytogenetic categories del17p or t(4;14), ISS stage, number of prior therapies, prior immunomodulatory exposure, prior bortezomib exposure, relapsed or refractory status or renal function as shown in Table 9.
Slovenian: Opaženo izboljšanje preživetja brez napredovanja bolezni je bilo konsistentno po podskupinah ne glede na starost (< 65 v primerjavi z ≥ 65), status ogroženosti, prisotnost ali odsotnost citogenetskih kategorij del17p ali t(4;14), ISS stadij, število predhodnih zdravljenj, predhodno izpostavljenost imunomodulatorjem, predhodno izpostavljenost bortezomibu, status ponovitve ali neodzivnosti ali delovanje ledvic, kot je prikazano v tabeli 9.
English: More than one vial of Empliciti may be needed to give the total dose for the patient.
Slovenian: Za aplikacijo celotnega odmerka boste morda potrebovali več kot eno vialo zdravila Empliciti.
English: How to store Empliciti 6.
Slovenian: Shranjevanje zdravila Empliciti 6.
English: Treatment was administered in 4-week cycles (28-day cycle) until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje je potekalo v 4-tedenskih ciklih (28-dnevni cikel) do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Demographics and baseline characteristics were balanced between treatment arms.
Slovenian: Demografske in izhodiščne lastnosti so bile med obema skupinama zdravljenja uravnotežene.
English: There is no relevant use of Empliciti in the paediatric population for the indication of multiple myeloma.
Slovenian: Pediatrična populacija Pri pediatrični populaciji uporaba zdravila Empliciti za indikacijo multipli mielom ni relevantna.
English: The median number of treatment cycles was 19 for the Empliciti arm and 14 for the comparator arm.
Slovenian: V skupini z zdravilom Empliciti je mediano število ciklov zdravljenja znašalo 19, v primerjalni skupini pa 14.
English: Empliciti contains the active substance elotuzumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Slovenian: Učinkovina zdravila Empliciti je elotuzumab, monoklonsko protitelo, vrsta beljakovine, ki prepozna in se pritrdi na posebno ciljno mesto v telesu.
English: When elotuzumab binds to SLAMF7 on the multiple myeloma or natural killer cells, it stimulates your immune system to attack and destroy the multiple myeloma cells.
Slovenian: Elotuzumab z vezavo na SLAMF7 na celicah multiplega mieloma ali naravnih celicah ubijalkah spodbudi imunski sistem, da napade in uniči celice multiplega mieloma.
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for the treatment groups.
Slovenian: Ne glede na ovrednoteno podskupino je bilo preživetje brez napredovanja bolezni v splošnem konsistentno s tistim, opaženim v populaciji vseh vključenih bolnikov za zdravljene skupine.
English: In clinical trials of patients with multiple myeloma, the incidence of all infections, including pneumonia, were higher in patients treated with Empliciti (see section 4.8).
Slovenian: V kliničnih preskušanjih, izvedenih pri bolnikih z multiplim mielomom, je bila pojavnost vseh okužb, vključno s pljučnico, večja pri bolnikih, ki so se zdravili z zdravilom Empliciti (glejte poglavje 4.8).
English: Prior therapies included: stem cell transplant (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), and lenalidomide (6%).
Slovenian: Predhodna zdravljenja so vključevala: presaditev krvotvornih matičnih celic (55 %), bortezomib (70 %), melfalan (65 %), talidomid (48 %) in lenalidomid (6 %).
English: PFS ITT assessment per investigator was evaluated in several subgroups including age (< 65 versus ≥ 65), race, ISS stage, prior therapies, transplant, risk category, ECOG status, creatinine clearance, and cytogenic abnormalities.
Slovenian: Vrednotenje PFS vseh vključenih bolnikov (ITT) po oceni raziskovalca je bilo izvedeno v več podskupinah, vključno glede na starost (< 65 v primerjavi z ≥ 65), spol, ISS stadij, predhodna zdravljenja, presaditev, kategorijo tveganja, stanje telesne zmogljivosti po lestvici ECOG, očistek kreatinina in citogenetske nepravilnosti.
English: If the dose of one medicine in the regimen is delayed, interrupted, or discontinued, the treatment with the other medicinal products may continue as scheduled.
Slovenian: Odložitev odmerka, prekinitev ali ukinitev zdravljenja Če se odmerek enega zdravila v režimu odloži, zdravljenje z zdravilom prekine ali ukine, se zdravljenje z drugimi zdravili lahko nadaljuje po predvideni shemi.
English: Complete response rates in Empliciti group may be underestimated due to interference of elotuzumab monoclonal antibody with immunofixation assay and serum protein electrophoresis assay.
Slovenian: Deleži popolnega odziva bi v skupini z zdravilom Empliciti lahko bili podcenjeni zaradi vpliva elotuzumaba, monoklonskega protitelesa, na test imunofiksacije in test serumske proteinske elektroforeze.
English: Overall Response (ORR)c n (%)
Slovenian: Celokupni odziv (ORR)c n (%)
English: The median age was 66 years (range 37 to 91); 57% of patients were older than 65 years; 60% of patients were male; Whites comprised 84% of the study population, Asians 10%, and blacks 4%.
Slovenian: Mediana starost je bila 66 let (razpon: od 37 do 91), 57 % bolnikov je bilo starejših od 65 let, 60 % bolnikov je bilo moškega spola, 84 % raziskovane populacije je bilo belcev, 10 % Azijcev in 4 % bolnikov črne rase.
English: The median number of treatment cycles was 9 for the E-Pd arm and 5 for the Pd arm.
Slovenian: V skupini zdravljenja E-Pd je mediano število ciklov zdravljenja znašalo 9, v skupini zdravljenja Pd pa 5.
English: Chemical and physical in use stability of the reconstituted and diluted solution has been demonstrated for 24 hours at 2°C - 8°C and protected from light.
Slovenian: Dokazano je bilo, da je raztopina po rekonstituciji in redčenju kemijsko in fizikalno stabilna 24 ur, če se jo shranjuje pri temperaturi od 2 °C do 8 °C in zaščiteno pred svetlobo.
English: Five percent (5%) of patients required interruption of the administration of Empliciti for a median of 25 minutes due to infusion reaction, and 1% of patients discontinued due to infusion reactions.
Slovenian: Zaradi infuzijske reakcije je bilo treba infundiranje zdravila Empliciti prekiniti pri 5 % bolnikov za mediano 25 minut, pri 1 % bolnikov pa je bilo treba zdravljenje zaradi infuzijske reakcije ukiniti.
English: The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.
Slovenian: Druge sestavine (pomožne snovi) zdravila so saharoza, natrijev citrat (glejte poglavje 2 “Zdravilo Empliciti vsebuje natrij”), citronska kislina monohidrat in polisorbat 80.
English: The most common adverse reactions (occurring in > 10% of patients) with elotuzumab treatment were infusion related reactions, diarrhoea, herpes zoster, nasopharyngitis, cough, pneumonia, upper respiratory tract infection, lymphopenia and weight decreased.
Slovenian: Najpogostejši neželeni učinki (ki so se pojavili pri > 10 % bolnikov) pri zdravljenju z elotuzumabom so bili reakcije, povezane z infundiranjem, driska, herpes zoster, nazofaringitis, kašelj, pljučnica, okužba zgornjih dihal, limfopenija in zmanjšanje telesne mase.
English: The primary endpoint was investigator assessed PFS by modified International Myeloma Working Group (IMWG) criteria.
Slovenian: Primarni opazovani dogodek je bil preživetje brez napredovanja bolezni (PFS, progression free survival), ki ga je ocenil raziskovalec v skladu z modificiranimi kriteriji mednarodne delovne skupine za mielom (IMWG, International Myeloma Working Group).
English: Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Slovenian: Delovanje ledvic Izhodiščni CrCl < 60 ml/min Izhodiščni CrCl ≥ 60 ml/min
English: The high risk cytogenetic categories of del17p and t(4;14) were present in 32% and 9% of patients, respectively.
Slovenian: Visoko rizična citogenetska kategorija del17p je bila prisotna pri 32 % bolnikov, t(4;14) pa pri 9 % bolnikov.
English: A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
Slovenian: V skupini zdravljenja E-Pd je bilo živih 40 bolnikov (67 %), v skupini zdravljenja Pd pa 29 bolnikov (51 %).
English: Of the 53 patients in CA204125 treated with Empliciti and evaluable for the presence of anti-product antibodies, 19 patients (36%) tested positive, of whom 1 patient tested persistent positive, for treatment-emergent anti-product antibodies by an ECL assay.
Slovenian: Od 53 bolnikov v študiji CA204125, ki so se zdravili z zdravilom Empliciti, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 19 bolnikov (36 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu, od teh pa je bil 1 bolnik trajno pozitiven.
English: How to use Empliciti
Slovenian: Kako uporabljati zdravilo Empliciti
English: Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults.
Slovenian: Zdravilo Empliciti uporabljamo za zdravljenje multiplega mieloma (rak kostnega mozga) pri odraslih.
English: In cycles 3 and beyond, once every 2 weeks on days 1 and 15.
Slovenian: Pri 3. in kasnejših ciklih enkrat na vsaka 2 tedna na 1. in 15. dan.
English: The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl > 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl <30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl < 30 mL/min; N = 9).
Slovenian: Vpliv okvare ledvic na farmakokinetiko elotuzumaba so ovrednotili pri bolnikih z normalnim delovanjem ledvic (CrCl > 90 ml/min; N = 8), bolnikih s hudo okvaro ledvic, ki niso potrebovali zdravljenja z dializo (CrCl < 30 ml/min; N = 9) in bolnikih s končno odpovedjo ledvic, ki so potrebovali zdravljenje z dializo (CrCl < 30 ml/min; N = 9).
English: Empliciti will be given to you together with lenalidomide and dexamethasone or together with pomalidomide and dexamethasone.
Slovenian: Zdravilo Empliciti boste prejemali skupaj z lenalidomidom in deksametazonom ali skupaj s pomalidomidom in deksametazonom.
English: Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and macrophage-mediated antibody-dependant cellular phagocytosis (ADCP).
Slovenian: Elotuzumab z delovanjem na SLAMF7 na mielomskih celicah in preko interakcij z receptorji Fc na specifičnih imunskih celicah tudi pomaga spodbuditi uničenje mielomskih celic preko z naravnimi celicami ubijalkami posredovane od protiteles odvisne celične citotoksičnosti (ADCC, antibody-dependent cellular cytotoxicity) in z makrofagi posredovane od protiteles odvisne celične fagocitoze (ADCP, antibody dependant cellular phagocytosis).
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg).
Slovenian: Celotni odmerek elotuzumaba v mg je enako telesna masa bolnika v kg pomnoženo z odmerkom elotuzumaba (10 ali 20 mg/kg).
English: Of 390 patients across four clinical studies who were treated with Empliciti and evaluable for the presence of anti-product antibodies, 72 patients (18.5%) tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Slovenian: Od 390 bolnikov iz štirih kliničnih študij, ki so se zdravili z zdravilom Empliciti, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 72 bolnikov (18,5 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu.
English: One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone.
Slovenian: Pri enem bolniku so poročali o prevelikem odmerjanju elotuzumaba v odmerku 23,3 mg/kg v kombinaciji z lenalidomidom in deksametazonom.
English: The Empliciti infusion should be used immediately.
Slovenian: Empliciti raztopino za infundiranje je treba uporabiti takoj.
English: Population PK analysis suggested that the following factors had no clinically important effect on the clearance of elotuzumab: age, gender, race, baseline LDH, albumin, renal impairment, mild hepatic impairment, and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.
Slovenian: Analiza populacijske farmakokinetike kaže, da naslednji dejavniki nimajo klinično pomembnega vpliva na očistek elotuzumaba: starost, spol, rasa, izhodiščna vrednost LDH, albumin, okvara ledvic, blaga okvara jeter in sočasna uporaba lenalidomida/deksametazona ali pomalidomida/deksametazona.
English: Once the reaction has resolved (symptoms ≤ Grade 1), Empliciti can be restarted at the initial infusion rate of 0.5 mL/min.
Slovenian: Ko reakcija izzveni (simptomi ≤ stopnje 1), se infundiranje zdravila Empliciti lahko nadaljuje z začetno hitrostjo infundiranja 0,5 ml/min.
English: If a ≥ Grade 2 infusion reaction occurs during Empliciti administration, the infusion must be interrupted.
Slovenian: Če se med aplikacijo zdravila Empliciti pojavi infuzijska reakcija ≥ stopnje 2, je treba infundiranje zdravila prekiniti.
English: The administration of dexamethasone is as follows:
Slovenian: Deksametazon je treba uporabljati na naslednji način:
English: If you miss a dose of Empliciti
Slovenian: Če niste prejeli odmerka zdravila Empliciti
English: Table 5: Adverse reactions in patients with multiple myeloma treated with Empliciti System Organ Class
Slovenian: Tabela 5: Neželeni učinki pri bolnikih z multiplim mielomom, ki so se zdravili z zdravilom Empliciti
English: The incidence of SPMs was higher with Empliciti treatment than with control (see section 4.4).
Slovenian: Pojavnost SPN je bila pri zdravljenju z zdravilom Empliciti večja kot v kontrolni skupini (glejte poglavje 4.4).
English: 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22
Slovenian: 3. in nadaljnji cikli 28-dnevnega cikla Dan cikla 1 8 15 22 1 8 15 22
English: In the unlikely case of an overdose, your doctor will monitor you for side effects.
Slovenian: V primeru prevelikega odmerka boste pod zdravniškim nadzorom zaradi neželenih učinkov.
English: Empliciti is for single use only.
Slovenian: Zdravilo Empliciti je namenjeno samo za enkratno uporabo.
English: Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle.
Slovenian: Bolniki so deksametazon prejeli na: 1., 8., 15. in 22. dan vsakega cikla.
English: The entire Empliciti infusion should be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (with a pore size of 0.2-1.2 µm) using an automated infusion pump.
Slovenian: Celotno količino zdravila Empliciti morate infundirati s pomočjo infuzijskega seta in sterilnega nepirogenega filtra, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm) ter avtomatske infuzijske črpalke.
English: The incidence of infections, including pneumonia, was higher with Empliciti treatment than with control (see section 4.4).
Slovenian: Pojavnost okužb, vključno s pljučnico, je bila pri zdravljenju z zdravilom Empliciti večja kot v kontrolni skupini (glejte poglavje 4.4).
English: In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
Slovenian: V nekliničnih modelih elotuzumab v kombinaciji z lenalidomidom, s pomalidomidom ali z bortezomibom deluje sinergistično.
English: Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje je potekalo v 4-tedenskih ciklih do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag immediately.
Slovenian: Po rekonstituciji je treba rekonstituirano raztopino iz viale takoj prenesti v infuzijsko vrečko.
English: Reconstitution of vials
Slovenian: Rekonstitucija vial
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg, see section 4.2).
Slovenian: Celotni odmerek elotuzumaba v mg je enako telesna masa bolnika v kg pomnoženo z odmerkom elotuzumaba (10 ali 20 mg/kg, glejte poglavje 4.2).
English: If well tolerated, the infusion rate may be increased stepwise as described in Tables 3 and 4 (see section 4.2 Method of administration).
Slovenian: Če bolnik to hitrost dobro prenaša, lahko hitrost infundiranja postopoma povečujete, kot je prikazano tabeli 3 in tabeli 4 (glejte poglavje 4.2 Način uporabe).
English: The active substance is elotuzumab.
Slovenian: Učinkovina je elotuzumab.
English: No animal data are present regarding the effect on reproductive toxicity because of the lack of an adequate animal model.
Slovenian: Zaradi pomanjkanja ustreznega živalskega modela ni podatkov o vplivu na sposobnost razmnoževanja pri živalih.
English: Empliciti is used in combination with other medicines for multiple myeloma.
Slovenian: Zdravilo Empliciti se uporablja v kombinaciji z drugimi zdravili za zdravljenje multiplega mieloma.
English: The International Staging System (ISS) Stage was I in 50%, II in 38% and III in 12% of patients.
Slovenian: Po mednarodnem sistemu za razvrščanje v stadije (ISS; International Staging System) je ISS stadij I imelo 50 %, ISS stadij II 38 % in ISS stadij III 12 % bolnikov.
English: The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma.
Slovenian: Farmakokinetiko elotuzumaba so raziskali pri bolnikih z multiplim mielomom.
English: For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o uporabi lenalidomida in deksametazona glejte ustrezen povzetek glavnih značilnosti zdravila.
English: Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 12.
Slovenian: Aseptično rekonstituirajte vsako vialo z zdravilom Empliciti s pomočjo injekcijske brizge ustrezne velikosti in injekcijske igle debeline 18G ali tanjše kot je prikazano v tabeli 12.
English: When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur.
Slovenian: Ko simptomi izzvenijo ali se izboljšajo, se infundiranje zdravila lahko nadaljuje z manjšo hitrostjo.
English: The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients), bortezomib and dexamethasone (103 patients) or pomalidomide and dexamethasone (128 patients) pooled across 8 clinical trials.
Slovenian: Varnost elotuzumaba so ovrednotili na osnovi združenih podatkov iz 8 kliničnih preskušanj pri skupno 682 bolnikih z multiplim mielomom, ki so se zdravili z elotuzumabom v kombinaciji z lenalidomidom in deksametazonom (451 bolnikov), bortezomibom in deksametazonom (103 bolniki) ali pomalidomidom in deksametazonom (128 bolnikov).
English: The International Staging System (ISS) Stage was I in 43%, II in 32% and III in 21% of patients.
Slovenian: Po mednarodnem sistemu za razvrščanje v stadije (ISS; International Staging System) je ISS stadij I imelo 43 %, ISS stadij II 32 % in ISS stadij III 21 % bolnikov.
English: PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
Slovenian: PFS (vsi vključeni bolniki) Razmerje ogroženosti [95% IZ] stratificirani test log rank, p-vrednosta Mediana PFS v mesecih [95 % IZ]
English: For additional information concerning pomalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o uporabi pomalidomida in deksametazona glejte ustrezen povzetek glavnih značilnosti zdravila.
English: Cycle 1, Dose 2
Slovenian: 1. cikel, 2. odmerek
English: Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80.
Slovenian: Pomožne snovi: saharoza, natrijev citrat, citronska kislina monohidrat in polisorbat 80.
English: No clinically important differences in the clearance of Empliciti were found between patients with mild hepatic impairment and patients with normal hepatic function.
Slovenian: Pri bolnikih z blago okvaro jeter niso ugotovili klinično pomembnih razlik v očistku zdravila Empliciti v primerjavi z bolniki z normalnim delovanjem jeter.
English: The incidence of pneumonia was higher in the Empliciti combined with lenalidomide and dexamethasone arm compared to lenalidomide and dexamethasone arm reported at 15.1% vs. 11.7% with a fatal outcome at 0.6% vs. 0%, respectively.
Slovenian: Pojavnost pljučnice je bila večja v skupini z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom v primerjavi s skupino z lenalidomidom in deksametazonom (15,1 % v primerjavi z 11,7 %, s smrtnim izidom pa 0,6 % v primerjavi z 0 %).