FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Učinak oštećenja funkcije bubrega na farmakokinetiku elotuzumaba ocjenjivao se u bolesnika s normalnom funkcijom bubrega (CrCl > 90 ml/min; N = 8), teškim oštećenjem funkcije bubrega koje nije zahtijevalo dijalizu (CrCl < 30 ml/min; N = 9) ili onih u terminalnoj fazi bubrežne bolesti kojima je bila potrebna dijaliza (CrCl < 30 ml/min; N = 9).
English: The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.
Croatian: Drugi sastojci (pomoćne tvari) su saharoza, natrijev citrat (pogledajte odlomak "Empliciti sadrži natrij" u dijelu 2.), citratna kiselina hidrat i polisorbat 80.
English: The rate of mild to moderate infusion reactions was > 50% in patients who were not premedicated.
Croatian: Stopa blagih do umjerenih reakcija na infuziju u bolesnika koji nisu primili premedikaciju bila je > 50%.
English: Prior therapies included stem cell transplant (55%), bortezomib (100%), lenalidomide (99%), cyclophosphamide (66%), melphalan (63%), carfilzomib (21%), ixazomib (6%), and daratumumab (3%).
Croatian: Prethodne terapije uključivale su presađivanje matičnih stanica (55%), bortezomib (100%), lenalidomid (99%), ciklofosfamid (66%), melfalan (63%), karfilzomib (21%), iksazomib (6%) i daratumumab (3%).
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.
Croatian: Najčešće nuspojave (koje su se javile u > 10% bolesnika) kod liječenja elotuzumabom bile su reakcije na infuziju, proljev, herpes zoster, nazofaringitis, kašalj, pneumonija, infekcija gornjih dišnih putova, limfopenija i smanjenje tjelesne težine.
English: Treatment was administered in 4-week cycles (28-day cycle) until disease progression or unacceptable toxicity.
Croatian: Liječenje se primjenjivalo u 4-tjednim ciklusima (28-dnevni ciklusi) do progresije bolesti ili pojave neprihvatljive toksičnosti.
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).
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s multiplim mijelomom, incidencija svih infekcija, uključujući pneumoniju, bila je viša u bolesnika liječenih lijekom Empliciti (vidjeti dio 4.8).
English: The rate of haematologic malignancies was the same between the two treatment arms.
Croatian: Stopa hematoloških zloćudnih bolesti bila je jednaka u obje liječene skupine.
English: The median number of treatment cycles was 9 for the E-Pd arm and 5 for the Pd arm.
Croatian: Medijan broja ciklusa liječenja iznosio je 9 u skupini koja je primala E-Pd te 5 u onoj koja je primala Pd.
English: Empliciti may be detected in the serum protein electrophoresis (SPEP) and serum immunofixation assays of myeloma patients and could interfere with correct response classification.
Croatian: Testovi elektroforeze serumskih proteina (engl. serum protein electrophoresis, SPEP) i imunofiksacije u serumu mogu u bolesnika s mijelomom detektirati lijek Empliciti, što može utjecati na točnu klasifikaciju odgovora.
English: For women taking Empliciti
Croatian: Za žene koje primaju Empliciti
English: Overall Response (ORR)c n (%)
Croatian: Ukupan odgovor (ORR)c n (%)
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Croatian: Natrijev citrat Citratna kiselina hidrat Polisorbat 80
English: Empliciti will be given to you together with lenalidomide and dexamethasone or together with pomalidomide and dexamethasone.
Croatian: Empliciti ćete primati zajedno s lenalidomidom i deksametazonom ili zajedno s pomalidomidom i deksametazonom.
English: After reconstitution and dilution The reconstituted solution should be transferred from the vial into the infusion bag immediately.
Croatian: Nakon rekonstitucije i razrjeđivanja Rekonstituiranu otopinu treba odmah prenijeti iz bočice u infuzijsku vrećicu.
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%.
Croatian: Medijan dobi iznosio je 66 godina (raspon: 37 - 91); 57% bolesnika bilo je starije od 65 godina; 60% bolesnika bili su muškarci; bijelci su činili 84% ispitivane populacije, Azijati 10%, a crnci 4%.
English: Upon resolution to ≤ Grade 1, Empliciti should be restarted at 0.5 mL/min and may be gradually increased at a rate of 0.5 mL/min every 30 minutes as tolerated to the rate at which the infusion reaction occurred.
Croatian: Nakon što se reakcija ublaži do ≤ 1. stupnja, primjenu lijeka Empliciti treba ponovno započeti brzinom od 0,5 ml/min, koja se može postupno povećavati za 0,5 ml/min svakih 30 minuta sukladno podnošljivosti do brzine pri kojoj se pojavila reakcija na infuziju.
English: Table 10: CA204125 Efficacy results
Croatian: Tablica 10: Rezultati za djelotvornost u ispitivanju CA204125
English: When given in combination with pomalidomide and dexamethasone, Empliciti is given as follows:
Croatian: Kada se daje u kombinaciji s pomalidomidom i deksametazonom, Empliciti se primjenjuje na sljedeći način:
English: 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22
Croatian: Dan ciklusa 1 8 15 22 1 8 15 22
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji iza oznake "Rok valjanosti".
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.
Croatian: Populacijska farmakokinetička analiza ukazala je na to da sljedeći faktori nemaju klinički značajnog učinka na klirens elotuzumaba: dob, spol, rasa, početni LDH, albumin, oštećenje funkcije bubrega, blago oštećenje funkcije jetre i istodobna primjena lenalidomida/deksametazona ili pomalidomida/deksametazona.
English: The administration of dexamethasone is as follows:
Croatian: Deksametazon se primjenjuje na sljedeći način:
English: Dexamethasone (mg) orally Day of Cycle 1
Croatian: Deksametazon (mg) peroralno Dan ciklusa 1.
English: For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Croatian: Za više informacija o lenalidomidu i deksametazonu pročitajte odgovarajuće sažetke opisa svojstava lijeka.
English: In study CA204004, the most common symptoms of an infusion reaction included fever, chills, and hypertension.
Croatian: Najčešći simptomi reakcije na infuziju u ispitivanju CA204004 uključivali su vrućicu, zimicu i hipertenziju.
English: The geometric mean total clearance of elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state is 0.194 L/day (CV: 62.9%).
Croatian: Geometrijska srednja vrijednost ukupnog klirensa elotuzumaba pri dozi od 10 mg/kg (u kombinaciji s lenalidomidom i deksametazonom) u stanju dinamičke ravnoteže iznosi 0,194 L/danu (CV 62,9%)..
English: Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg.
Croatian: Elotuzumab pokazuje nelinearnu farmakokinetiku sa smanjenjem klirensa kod povećanja doze od 0,5 do 20 mg/kg.
English: Posology for administration with lenalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 1 for the dosing schedule.
Croatian: Doziranje kod primjene s lenalidomidom i deksametazonom Svaki ciklus liječenja traje 28 dana; vidjeti Tablicu 1 za raspored doziranja.
English: The incidence of infections, including pneumonia, was higher with Empliciti treatment than with control (see section 4.4).
Croatian: Incidencija infekcija, uključujući pneumoniju, bila je viša u bolesnika liječenih lijekom Empliciti nego u kontrolnoj skupini (vidjeti dio 4.4).
English: Prior therapies included: stem cell transplant (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), and lenalidomide (6%).
Croatian: Prethodne terapije uključivale su: presađivanje matičnih stanica (55%), bortezomib (70%), melfalan (65%), talidomid (48%) i lenalidomid (6%).
English: 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]
Croatian: 1-godišnja stopa PFS-a (%) [95% CI] 2-godišnja stopa PFS-a (%) [95% CI] 3-godišnja stopa PFS-ab
English: The rates of deep vein thromboses observed between treatment arms were similar for patients given prophylaxis with low molecular weight heparin (2.2% in both treatment arms), and for patients given vitamin K antagonists the rates were 0% for patients treated with E-Ld and 6.7% for patients treated with Ld.
Croatian: Stope duboke venske tromboze primijećene u liječenim skupinama bile su slične u bolesnika koji su primali profilaksu heparinom niske molekularne težine (2,2% u obje liječene skupine), dok je među bolesnicima koji su primali antagonistie vitamina K iznosila 0% u bolesnika koji su liječeni E-Ld-om te 6,7% u onih koji su liječeni Ld-om.
English: Posology for administration with pomalidomide and dexamethasone The length of each treatment cycle is 28 days, see Table 2 for the dosing schedule.
Croatian: Doziranje kod primjene s pomalidomidom i deksametazonom Svaki ciklus liječenja traje 28 dana; vidjeti Tablicu 2 za raspored doziranja.
English: The median number of treatment cycles was 19 for the Empliciti arm and 14 for the comparator arm.
Croatian: Medijan broja ciklusa liječenja iznosio je 19 u skupini koja je primala Empliciti te 14 u usporednoj skupini.
English: No clinically important differences in the pharmacokinetics of elotuzumab were found between patients with severe renal impairment (with and without dialysis) and patients with normal renal function (see section 4.2).
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici elotuzumaba između bolesnika s teškim oštećenjem funkcije bubrega (neovisno o dijalizi) i onih s normalnom funkcijom bubrega (vidjeti dio 4.2).
English: In cycles 3 and beyond, once every 2 weeks on days 1 and 15.
Croatian: U 3. i svim sljedećim ciklusima jedanput svaka 2 tjedna, 1. i 15. dana.
English: The International Staging System (ISS) Stage was I in 43%, II in 32% and III in 21% of patients.
Croatian: International Staging System, ISS) bio je I u 43% bolesnika, II u 32% bolesnika te III u 21% bolesnika.
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.
Croatian: Od 390 bolesnika iz četiri klinička ispitivanja koji su liječeni lijekom Empliciti i u kojih se mogla odrediti prisutnost protutijela na lijek, 72 bolesnika (18,5%) imala su pozitivan nalaz elektrokemiluminiscencijskog testa na protutijela na lijek nastala tijekom liječenja.
English: One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone.
Croatian: U jednog je bolesnika prijavljeno predoziranje dozom elotuzumaba od 23,3 mg/kg u kombinaciji s lenalidomidom i deksametazonom.
English: After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Croatian: Nakon rekonstitucije, jedan ml koncentrata sadrži 25 mg elotuzumaba.
English: If a ≥ Grade 2 infusion reaction occurs during Empliciti administration, the infusion must be interrupted.
Croatian: Ako se tijekom primjene lijeka Empliciti pojavi reakcija na infuziju ≥ 2. stupnja, infuzija se mora privremeno prekinuti.
English: Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity.
Croatian: Liječenje se primjenjivalo u 4-tjednim ciklusima do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
Croatian: Empliciti je indiciran u kombinaciji s lenalidomidom i deksametazonom za liječenje multiplog mijeloma u odraslih bolesnika koji su prethodno primili najmanje jednu terapiju (vidjeti dijelove 4.2 i 5.1).
English: On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), dexamethasone should be given 40 mg orally.
Croatian: Onih dana kada se Empliciti ne primjenjuje, a predviđena je primjena doze deksametazona (8. i 22. dan 3. i svih sljedećih ciklusa), deksametazon treba davati peroralno u dozi od 40 mg.
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.
Croatian: Ocijenjeni su objedinjeni podaci o sigurnosti elotuzumaba prikupljeni u ukupno 682 bolesnika s multiplim mijelomom liječena elotuzumabom u kombinaciji s lenalidomidom i deksametazonom (451 bolesnik), bortezomibom i deksametazonom (103 bolesnika) ili pomalidomidom i deksametazonom (128 bolesnika) u 8 kliničkih ispitivanja.
English: PVC infusion sets polyethersulfone and nylon in-line filters with pore sizes of 0.2 μm to 1.2 μm.
Croatian: Infuzija lijeka Empliciti kompatibilna je sa: spremnicima od PVC-a i poliolefina infuzijskim setovima od PVC-a polietersulfonskim i najlonskim in-line filtrima s veličinom pora od 0,2 µm do 1,2 µm.
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).
Croatian: Elotuzumab također ciljano djeluje na SLAMF7 na stanicama mijeloma te interakcijama s Fc receptorima na specifičnim imunosnim stanicama pridonosi uništavanju stanica mijeloma putem stanične citotoksičnosti ovisne o protutijelima (engl. antibody-dependent cellular cytotoxicity, ADCC) posredovane NK stanicama i stanične fagocitoze ovisne o protutijelima (engl. antibody-dependent cellular phagocytosis, ADCP) posredovane makrofagima.
English: When given in combination with lenalidomide and dexamethasone, Empliciti is given as follows:
Croatian: Kada se daje u kombinaciji s lenalidomidom i deksametazonom, Empliciti se primjenjuje na sljedeći način:
English: 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.
Croatian: Budući da je Empliciti humanizirano monoklonsko protutijelo, ne očekuje se da će ga metabolizirati enzimi citokroma P450 (CYP) niti drugi enzimi koji metaboliziraju lijekove.
English: A total of 117 patients were randomised in a 1:1 ratio to receive treatment: 60 to elotuzumab in combination with pomalidomide and dexamethasone (E-Pd) and 57 to pomalidomide and dexamethasone (Pd).
Croatian: Ukupno je 117 bolesnika bilo randomizirano za liječenje (u omjeru 1:1): 60 za primanje elotuzumaba u kombinaciji s pomalidomidom i deksametazonom (E-Pd) i 57 za primanje pomalidomida i deksametazona (Pd).
English: HR (95% CI): 0.54 (0.34, 0.86) p-value: 0.0078
Croatian: HR (95% CI): 0,54 (0,34; 0,86) p-vrijednost: 0,0078
English: SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells).
Croatian: SLAMF7 se u velikim količinama nalazi na površini stanica multiplog mijeloma te na određenim stanicama imunosnog sustava (NK stanicama).
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).
Croatian: Ukupna doza elotuzumaba u mg jednaka je bolesnikovoj tjelesnoj težini u kg pomnoženoj s dozom elotuzumaba (10 ili 20 mg/kg, vidjeti dio 4.2).
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.
Croatian: Od 53 bolesnika iz ispitivanja CA204125 koja su bila liječena lijekom Empliciti i u kojih se mogla odrediti prisutnost protutijela na lijek, 19 bolesnika (36%) imalo je pozitivan nalaz elektrokemiluminiscencijskog testa na protutijela na lijek nastala tijekom liječenja, a 1 od njih imao je perzistentno pozitivan nalaz.
English: 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).
Croatian: Kada se Empliciti daje u kombinaciji s lenalidomidom ili pomalidomidom, morate se pridržavati programa za sprječavanje trudnoće kod primjene lenalidomida odnosno pomalidomida (pogledajte uputu o lijeku za lenalinomid ili pomalidomid).
English: Cycle 1, Dose 1
Croatian: 1. ciklus, 1. doza
English: Before starting treatment with Empliciti, you must also read the package leaflet warnings and precautions of all medicines to be taken in combination with Empliciti for information related to these medicines.
Croatian: Prije početka liječenja lijekom Empliciti morate pročitati i upozorenja i mjere opreza navedene u uputi o lijeku svakog lijeka koji će se primjenjivati u kombinaciji s lijekom Empliciti, kako biste saznali podatke vezane uz te lijekove.
English: The International Staging System (ISS) Stage was I in 50%, II in 38% and III in 12% of patients.
Croatian: Stadij prema Međunarodnoj klasifikaciji za stupnjevanje bolesti (ISS) bio je I u 50% bolesnika, II u 38% bolesnika te III u 12% bolesnika.
English: IRC Assessedf
Croatian: Ocjena IRC-af
English: Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro.
Croatian: Elotuzumab izravno aktivira NK stanice i kroz signalni put proteina SLAMF7 i kroz Fc receptore, čime pojačava aktivnost protiv mijeloma in vitro.
English: The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg).
Croatian: Ukupna doza elotuzumaba u mg jednaka je bolesnikovoj tjelesnoj težini u kg pomnoženoj s dozom elotuzumaba (10 ili 20 mg/kg).
English: Cycle 28-Day Cycles 1 and 2
Croatian: 1. i 2. 28-dnevni ciklus
English: Median PFS (months) [95% CI]
Croatian: Medijan PFS-a (mjeseci) [95% CI]
English: Tell your doctor or nurse straight away if you get any of the infusion reactions listed at the top of section 4.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od reakcija na infuziju navedenih na početku dijela 4. Te se nuspojave najčešće javljaju tijekom ili nakon infuzije prve doze.
English: No animal data are present regarding the effect on reproductive toxicity because of the lack of an adequate animal model.
Croatian: Zbog nedostatka odgovarajućeg životinjskog modela nema podataka o reproduktivnoj toksičnosti u životinja.
English: 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).
Croatian: Nije potrebno prilagođavati dozu lijeka Empliciti u bolesnika s blagim (CrCl = 60 - 89 ml/min), umjerenim (CrCl = 30 - 59 ml/min) ili teškim (CrCl < 30 ml/min) oštećenjem funkcije bubrega, kao ni u bolesnika u terminalnoj fazi bubrežne bolesti kojima je potrebna dijaliza (vidjeti dio 5.2).
English: The recommended dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Croatian: Preporučena doza lenalidomida je 25 mg peroralno jedanput na dan od 1. do 21. dana u ponavljajućim 28-dnevnim ciklusima, a primjenjuje se najmanje 2 sata nakon infuzije lijeka Empliciti kada se ona daje isti dan.
English: E-Pd 60 48 43 37 32 25 7 1 1 1 1
Croatian: E-Pd 60 48 43 37 32 25 7 1 1 1 1 Pd 57 42 31 22 16 10 6 2 1
English: Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Croatian: Funkcija bubrega Početni CrCl < 60 ml/min Početni CrCl ≥ 60 ml/min
English: The geometric mean volume of distribution of elotuzumab at the recommended dosing regimen in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone at steady state is 5.7 L (CV: 23%) and 5.6 L (CV: 21%) respectively.
Croatian: Geometrijska srednja vrijednost volumena distribucije elotuzumaba u stanju dinamičke ravnoteže pri preporučenom režimu doziranja u kombinaciji s lenalidomidom/deksametazonom ili pomalidomidom/deksametazonom iznosi 5,7 l (CV: 23%) odnosno 5,6 l (CV: 21%).
English: An open-label study (CA204007) evaluated the pharmacokinetics of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma with varying degrees of renal impairment (classified using the CrCl values).
Croatian: U jednom otvorenom ispitivanju (CA204007) ocjenjivala se farmakokinetika elotuzumaba u kombinaciji s lenalidomidom i deksametazonom u bolesnika s multiplim mijelomom i različitim stupnjevima oštećenja funkcije bubrega (koje se klasificiralo na temelju vrijednosti CrCl).
English: HR (97.61% CI): 0.68 (0.55, 0.85) p-value: 0.0001
Croatian: HR (97,61% CI): 0,68 (0,55; 0,85) p-vrijednost: 0,0001
English: The Empliciti infusion should be used immediately.
Croatian: Infuziju lijeka Empliciti treba odmah primijeniti.
English: Lenalidomide and Dexamethasone N = 317
Croatian: Lenalidomid i deksametazon N = 317
English: The recommended dose of pomalidomide is 4 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Croatian: Preporučena doza pomalidomida je 4 mg peroralno jedanput na dan od 1. do 21. dana u ponavljajućim 28-dnevnim ciklusima, a primjenjuje se najmanje 2 sata nakon infuzije lijeka Empliciti kada se ona daje isti dan.
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).
Croatian: Ako bolesnik dobro podnosi infuziju, njezina se brzina može postupno povećavati na način opisan u Tablicama 3 i 4 (vidjeti odlomak "Način primjene" u dijelu 4.2).
English: No clinically important differences in the clearance of Empliciti were found between patients with mild hepatic impairment and patients with normal hepatic function.
Croatian: Nisu primijećene klinički značajne razlike u klirensu lijeka Empliciti između bolesnika s blagim oštećenjem funkcije jetre i onih s normalnom funkcijom jetre.
English: Pomalidomide and Dexamethasone N = 55
Croatian: Pomalidomid i deksametazon N = 55
English: Each vial contains either 300 mg or 400 mg of elotuzumab.
Croatian: Jedna bočica sadrži ili 300 mg ili 400 mg elotuzumaba.
English: Patients receiving Empliciti in combination with lenalidomide or pomalidomide should adhere to the pregnancy prevention programme of lenalidomide or pomalidomide respectively.
Croatian: Bolesnici koji primaju Empliciti u kombinaciji s lenalidomidom ili pomalidomidom moraju se pridržavati programa za sprječavanje trudnoće kod primjene lenalidomida odnosno pomalidomida.
English: [5.59, NE]
Croatian: [5,59; NO]