FrancophonIA/ELRC3.0 huggingface dataset:
English: In study CA204125, all of the reported infusion reactions occurred during the first treatment cycle and were ≤ Grade 2.
Croatian: Sve reakcije na infuziju prijavljene u ispitivanju CA204125 nastupile su tijekom prvog ciklusa liječenja i bile su ≤ 2. stupnja težine.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja, bolesnike je potrebno pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te treba uvesti odgovarajuće simptomatsko liječenje.
English: If any of the symptoms of infusion reaction reach Grade ≥ 2, Empliciti infusion must be interrupted and appropriate medical and supportive measures instituted.
Croatian: Ako bilo koji simptom reakcije na infuziju dosegne stupanj ≥ 2, infuzija lijeka Empliciti mora se privremeno prekinuti te se moraju uvesti odgovarajuće medicinske i potporne mjere.
English: In the majority of patients, immunogenicity occurred early in treatment and was transient resolving by 2 to 4 months.
Croatian: U većine je bolesnika imunogenost nastupila u ranoj fazi liječenja, no bila je prolazna i povukla se nakon 2 - 4 mjeseca.
English: If you stop using Empliciti
Croatian: Ako prestanete primati Empliciti
English: Days 1-21
Croatian: 1. - 21. dan
English: Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on patient weight.
Croatian: Izračunajte dozu (mg) i odredite broj bočica potrebnih za dozu (10 mg/kg ili 20 mg/kg) na temelju bolesnikove tjelesne težine.
English: If symptoms do not recur, the infusion rate may be gradually escalated every 30 minutes to a maximum of 5 mL/min (see section 4.2 Method of administration).
Croatian: Ako se simptomi ne povrate, brzina infuzije može se postupno povećavati svakih 30 minuta do najviše 5 ml/min (vidjeti odlomak "Način primjene" u dijelu 4.2).
English: The 1-, 2-, 3-, 4- and 5-year rates of overall survival for Empliciti in combination with lenalidomide and dexamethasone treatment were 91%, 73%, 60%, 50% and 40% respectively, compared with 83%, 69%, 53%, 43% and 33% respectively, for lenalidomide and dexamethasone treatment (See Figure 2).
Croatian: 1-godišnja, 2-godišnja,3-godišnja, 4-godišnja i 5-godišnja stopa ukupnog preživljenja uz liječenje lijekom Empliciti u kombinaciji s lenalidomidom i deksametazonom iznosile su 91%, 73% ,60%, 50% odnosno 40% u usporedbi s 83%, 69%, 53%, 43% odnosno 33% uz liječenje lenalidomidom i deksametazonom (vidjeti Sliku 2).
English: In patients who experience an infusion reaction, vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Croatian: U bolesnika u kojih se razvije reakcija na infuziju potrebno je kontrolirati vitalne znakove svakih 30 minuta tijekom 2 sata nakon završetka infuzije lijeka Empliciti.
English: The hazard ratio and 95% CI were 0.54 (0.30, 0.96).
Croatian: Omjer hazarda i 95% CI iznosili su 0,54 (0,30; 0,96).
English: Medicines given before each infusion You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion reactions: medicine to reduce an allergic reaction (an anti-histamine) medicine to reduce inflammation (dexamethasone) medicine to reduce pain and fever (paracetamol)
Croatian: Lijekovi koje ćete primiti prije svake infuzije Prije svake infuzije lijeka Empliciti morate primiti sljedeće lijekove, koji će pomoći smanjiti vjerojatnost razvoja reakcija na infuziju: lijek koji ublažava alergijsku reakciju (antihistaminik) lijek koji ublažava upalu (kortikosteroid) lijek za ublažavanje boli i snižavanje vrućice (paracetamol)
English: Subset description
Croatian: Opis podskupine
English: 21.4 [16.6, NE]
Croatian: 21,4 [16,6; NO]
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.
Croatian: Ako se primjena doze jednog lijeka u sklopu režima odgodi, privremeno prekine ili trajno obustavi, liječenje drugim lijekovima može se nastaviti sukladno rasporedu.
English: For instructions on reconstitution and dilution of Empliciti before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka Empliciti prije primjene vidjeti dio 6.6.
English: Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy).
Croatian: Medijan broja prethodnih terapija iznosio je 2. Trideset i pet posto (35%) bolesnika bilo je refraktorno (progresija tijekom ili unutar 60 dana od posljednje terapije), a 65% bolesnika doživjelo je relaps (progresija nakon 60 dana od posljednje terapije).
English: 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.
Croatian: Kada se Empliciti koristi s lenalidomidom ili pomalidomidom, postoji rizik od oštećenja ploda, uključujući teške i po život opasne prirođene mane u ljudi povezane s primjenom tih lijekova. te je potrebno pridržavati se zahtjeva za sprječavanje trudnoće, koji uključuju testiranje na trudnoću i kontracepciju.
English: Your doctor may consider slowing the Empliciti infusion or interrupting it to manage these symptoms.
Croatian: Liječnik će možda razmotriti smanjenje brzine ili privremeni prekid infuzije lijeka Empliciti kako bi zbrinuo te simptome.
English: The high risk cytogenetic categories of del17p and t(4;14) were present in 32% and 9% of patients, respectively.
Croatian: Visokorizične citogenetske kategorije del17p i t(4;14) bile su prisutne u 32% odnosno 9% bolesnika.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Progression free survival (Months)
Croatian: Preživljenje bez progresije bolesti (mjeseci)
English: Final volume of reconstituted Empliciti in the vial
Croatian: Konačan volumen rekonstituiranog lijeka Empliciti u bočici
English: The reconstituted solution is colourless to slightly yellow and clear to very opalescent.
Croatian: Rekonstituirana otopina je bezbojna do blijedo žuta te bistra do vrlo opalescentna.
English: Empliciti is an IgG1 monoclonal antibody, which is principally cleared by catabolism.
Croatian: Empliciti je IgG1 monoklonsko protutijelo koje se prvenstveno izlučuje katabolizmom.
English: Adverse reactions reported in 682 patients with multiple myeloma who were treated with elotuzumab in 8 clinical trials are presented in Table 5.
Croatian: Nuspojave prijavljene u 682 bolesnika s multiplim mijelomom liječena elotuzumabom u 8 kliničkih ispitivanja prikazane su u Tablici 5.
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.
Croatian: Empliciti sadrži djelatnu tvar elotuzumab, koja je monoklonsko protutijelo, tj. jedna vrsta proteina oblikovana tako da prepozna specifičnu ciljnu tvar u tijelu i pričvrsti se za nju.
English: A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
Croatian: Ukupno je bilo živo 40 (67%) bolesnika u skupini koja je primala E-Pd i 29 (51%) bolesnika u skupini koja je primala Pd.
English: These cells divide out of control and collect in the bone marrow.
Croatian: Te se stanice nekontrolirano dijele i nakupljaju u koštanoj srži.
English: In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
Croatian: U nekliničkim je modelima elotuzumab ostvario sinergističko djelovanje u kombinaciji s lenalidomidom, pomalidomidom ili bortezomibom.
English: Treatment should continue until disease progression or unacceptable toxicity.
Croatian: Liječenje treba nastaviti do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: Upon discontinuation of elotuzumab in combination with lenalidomide and dexamethasone or in combination with pomalidomide and dexamethasone, concentrations of elotuzumab will decrease to approximately 3% (approximately 97% washout as estimated by 5 half-lives) of the population predicted steady-state maximal serum concentration by 3 months.
Croatian: Nakon prekida primjene elotuzumaba u kombinaciji s lenalidomidom i deksametazonom ili u kombinaciji s pomalidomidom i deksametazonom, koncentracije elotuzumaba će se unutar 3 mjeseca smanjiti na približno 3% (ispiranje od približno 97%, procijenjeno na temelju 5 poluvjekova) maksimalne serumske koncentracije u stanju dinamičke ravnoteže predviđene za populaciju.
English: 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.
Croatian: Uvjeti za primjenu lijekova koji se koriste s lijekom Empliciti Budući da se Empliciti koristi u kombinaciji s drugim lijekovima, uvjeti koji se odnose na primjenu tih lijekova vrijede i za kombiniranu terapiju.
English: Once the reaction has resolved (symptoms ≤ Grade 1), Empliciti can be restarted at the initial infusion rate of 0.5 mL/min.
Croatian: Nakon što se reakcija povuče (simptomi ≤ 1. stupnja), primjena lijeka Empliciti može se ponovno započeti početnom brzinom infuzije od 0,5 ml/min.
English: Empliciti is used in combination with other medicines for multiple myeloma.
Croatian: Empliciti se koristi u kombinaciji s drugim lijekovima za liječenje multiplog mijeloma.
English: Table 5: Adverse reactions in patients with multiple myeloma treated with Empliciti System Organ Class
Croatian: Tablica 5: Nuspojave u bolesnika s multiplim mijelomom liječenih lijekom Empliciti Organski sustav
English: In the control group and on weeks without Empliciti, dexamethasone 40 mg was administered as a single oral dose weekly.
Croatian: U kontrolnoj skupini i u tjednima kada se nije primjenjivao Empliciti, deksametazon se davao u jednoj peroralnoj dozi od 40 mg na tjedan.
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.
Croatian: Stope potpunog odgovora u skupini liječenoj lijekom Empliciti mogu biti podcijenjene zbog interferencije monoklonskog protutijela elotuzumaba s testom imunofiksacije i testom elektroforeze serumskih proteina.
English: Lenalidomide (25 mg) orally
Croatian: Lenalidomid (25 mg) peroralno
English: The median PFS per ITT was 10.25 months (95% CI: 5.59, NE) in the E-Pd arm and 4.67 months (95% CI: 2.83, 7.16) in the Pd arm. PFS and ORR were also assessed by the IRC.
Croatian: Medijan PFS-a u ITT populaciji iznosio je 10,25 mjeseci (95% CI: 5,59; NO) u skupini koja je primala E-Pd te 4,67 mjeseci (95% CI: 2,83; 7,16) u onoj koja je primala Pd. PFS i ORR ocjenjivao je i IRC.
English: Patients were refractory if they had progressed on or within 60 days of treatment with lenalidomide and a PI and on or within 60 days of their last treatment, or relapsed and refractory if they had achieved at least a partial response to previous treatment with lenalidomide and a PI but progressed within 6 months and had developed progressive disease on or within 60 days after completing their last treatment.
Croatian: Bolesnici su imali refraktornu bolest ako je kod njih došlo do progresije na ili unutar 60 dana od terapije lenalidomidom i s PI, i na ili unutar 60 dana od posljednje terapije ili su imali relapsirajuću i refraktornu bolest ako su postigli najmanje djelomični odgovor na prethodno liječenje lenalidomidom i s PI, ali su progredirali unutar 6 mjeseci i razvili progresivnu bolest na ili unutar 60 dana nakon završetka posljednje terapije.
English: Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilised cake.
Croatian: Držeći bočicu uspravno, lagano promiješajte otopinu okretanjem bočice kako bi se liofilizirani kolačić rastopio.
English: Based on a population PK analysis using data from 440 patients, the clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.
Croatian: Prema populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 440 bolesnika, klirens elotuzumaba povećavao se s povećanjem tjelesne težine, što podupire doziranje na temelju tjelesne težine.
English: Patients with mild or moderate infusion reactions may receive Empliciti with a reduced infusion rate and close monitoring (see section 4.2 Method of administration).
Croatian: Bolesnici s blagim ili umjerenim reakcijama na infuziju mogu primati Empliciti smanjenom brzinom infuzije i uz strogi nadzor (vidjeti odlomak "Način primjene" u dijelu 4.2).
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.
Croatian: U 5% bolesnika je zbog reakcije na infuziju bilo potrebno privremeno prekinuti primjenu lijeka Empliciti tijekom medijana od 25 minuta, dok je u 1% bolesnika primjena trajno obustavljena zbog reakcija na infuziju.
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.
Croatian: Kada se elotuzumab veže za SLAMF7 na stanicama multiplog mijeloma ili NK stanicama, on potiče imunosni sustav da napadne i uništiti stanice multiplog mijeloma.
English: Thus, hepatic functional impairment is not likely to alter its clearance.
Croatian: Stoga nije vjerojatno da će oštećenje funkcije jetre izmijeniti njegov klirens.
English: In cycles 3 and beyond, once every 4 weeks on day 1.
Croatian: U 3. i svim sljedećim ciklusima jedanput svaka 4 tjedna, 1. dana.
English: In the unlikely case of an overdose, your doctor will monitor you for side effects.
Croatian: Ako u malo vjerojatnom slučaju do predoziranja ipak dođe, liječnik će Vas nadzirati kako bi uočio moguće nuspojave.
English: On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines.
Croatian: S obzirom na prijavljene nuspojave, ne očekuje se da će Empliciti utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Cycle 1, Dose 2
Croatian: 1. ciklus, 2. doza
English: You should use a condom while taking Empliciti and for 180 days after stopping treatment to ensure your partner does not become pregnant.
Croatian: Tijekom liječenja lijekom Empliciti i još 180 dana po njegovu završetku morate koristiti prezervativ kako biste bili sigurni da Vam partnerica neće zatrudnjeti.
English: The primary endpoints of this study, progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR) were determined based on assessments made by a blinded Independent Review Committee (IRC).
Croatian: Primarne mjere ishoda u ovom ispitivanju - preživljenje bez progresije bolesti (engl. progression-free survival, PFS) ocijenjeno prema omjeru hazarda te stopa ukupnog odgovora (engl. overall response rate, ORR) - određivale su se na temelju ocjena zaslijepljenog Neovisnog ocjenjivačkog povjerenstva
English: As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Croatian: Budući da je elotuzumab IgG monoklonsko protutijelo, očekuje se da će se kataboličkim putovima razgraditi na male peptide i aminokiseline.
English: Upper respiratory tract infection
Croatian: Infekcija gornjih dišnih putova
English: SLAMF7 is also expressed on natural killer cells (NK), normal plasma cells, and other immune cells including some T cell subsets, monocytes, B cells, macrophages, and pDCs (plasmacytoid dendritic cells), but is not detected on normal solid tissues or haematopoietic stem cells.
Croatian: SLAMF7 se također eksprimira i na prirodnoubilačkim (engl. natural killer, NK) stanicama, normalnim plazmatskim stanicama te drugim stanicama imunološkog sustava, uključujući neke podskupine T-stanica, monocite, B-stanice, makrofage i plazmacitoidne dendritične stanice (engl. plasmacytoid dendritic cell, pDC), ali nije prisutan na normalnim solidnim tkivima ni hematopoetskim matičnim stanicama.
English: Before each infusion of Empliciti, you will be given medicines to reduce infusion reaction (see section 3 “How to use Empliciti, Medicines given before each infusion”).
Croatian: Prije svake infuzije lijeka Empliciti dobit ćete lijekove kako bi se ublažila reakcija na infuziju (pogledajte odlomak "Lijekovi koje ćete primiti prije svake infuzije" u dijelu 3.
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.
Croatian: Cijelu infuziju lijeka Empliciti treba primijeniti infuzijskim setom i sterilnim, nepirogenim filtrom male sposobnosti vezanja proteina (veličina pora: 0,2 - 1,2 μm) uz pomoć automatizirane infuzijske pumpe.
English: Infusion reactions Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Croatian: Empliciti se povezuje s reakcijama na infuziju (pogledajte odlomak "Upozorenja i mjere opreza" u dijelu 2.).
English: Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults.
Croatian: Empliciti se koristi za liječenje multiplog mijeloma (raka koštane srži) u odraslih osoba.
English: Median OS was not reached for E-Pd treatment group.
Croatian: Nije dosegnut medijan OS-a u skupini koja je primala E-Pd.
English: Lenalidomide 25 mg was taken orally once daily for the first 3 weeks of each cycle.
Croatian: Lenalidomid se primjenjivao u peroralnoj dozi od 25 mg jedanput na dan tijekom prva 3 tjedna svakog ciklusa.
English: Prior to Empliciti infusion, dexamethasone was administered as a divided dose: an oral dose of 28 mg and an intravenous dose of 8 mg.
Croatian: Prije infuzije lijeka Empliciti, deksametazon se primjenjivao podijeljen u dvije doze: peroralnu dozu od 28 mg i intravensku dozu od 8 mg.
English: Grade 3/4
Croatian: Učestalost 3./4. stupnja
English: 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.
Croatian: Premedikacija u svrhu prevencije reakcija na infuziju Bolesnicima se 45 - 90 minuta prije infuzije lijeka Empliciti mora primijeniti sljedeća premedikacija (vidjeti dio 4.4): Deksametazon 8 mg intravenski Blokator H1 receptora: difenhidramin (25 - 50 mg peroralno ili intravenski) ili ekvivalentni blokator H1 receptora.
English: Very severe infusion reactions (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
Croatian: Vrlo teške reakcije na infuziju (≥ 3. stupnja) mogu zahtijevati trajnu obustavu terapije lijekom Empliciti i hitno liječenje.
English: Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8).
Croatian: U bolesnika liječenih elotuzumabom prijavljene su reakcije na infuziju (vidjeti dio 4.8).
English: Below is a list of typical symptoms associated with infusion reactions: Fever Chills High blood pressure
Croatian: U nastavku slijedi popis tipičnih simptoma povezanih s reakcijama na infuziju:
English: Patients who were refractory to lenalidomide were excluded and 6% of patients had prior lenalidomide treatment.
Croatian: U ispitivanje nisu bili uključeni bolesnici refraktorni na lenalidomid, a 6% bolesnika je prethodno bilo liječeno lenalidomidom.
English: Very severe infusion reactions may require permanent discontinuation of Empliciti therapy and emergency treatment.
Croatian: Vrlo teške reakcije na infuziju mogu zahtijevati trajan prekid terapije lijekom Empliciti i hitno liječenje.
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.
Croatian: Ispitivač je ocjenjivao PFS u ITT populaciji u nekoliko podskupina, uključuju podskupine prema dobi (< 65 naspram ≥ 65 godina), rasi, stadiju prema ISS klasifikaciji, prethodnim terapijama, presađivanju, kategoriji rizika, ECOG statusu, klirensu kreatinina i citogenetskim abnormalnostima.
English: Elotuzumab is not expected to be excreted into human milk.
Croatian: Ne očekuje se izlučivanje elotuzumaba u majčino mlijeko.
English: Withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial.
Croatian: Iz svake bočice izvucite potreban volumen za izračunatu dozu - najviše 16 ml iz bočice od 400 mg odnosno najviše 12 ml iz bočice od 300 mg.
English: The following side effects have been reported in clinical trials with elotuzumab:
Croatian: U kliničkim ispitivanjima elotuzumaba prijavljene su sljedeće nuspojave:
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.
Croatian: Primijećena poboljšanja PFS-a bila su dosljedna u svim podskupinama, neovisno o dobi (< 65 naspram ≥ 65 godina), rizičnom statusu, prisutnosti ili odsutnosti citogenetskih kategorija del17p ili t(4;14), stadiju prema ISS klasifikaciji, broju prethodnih terapija, prethodnoj izloženosti imunomodulatorima, prethodnoj izloženosti bortezomibu, relapsnom ili refraktornom statusu ili funkciji bubrega, kao što je prikazano u Tablici 9.
English: If you miss a dose of Empliciti
Croatian: Ako ste propustili dozu lijeka Empliciti
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%.
Croatian: Medijan dobi iznosio je 67 godina (raspon: 36 - 81); 62% bolesnika bilo je starije od 65 godina; 57% bolesnika bili su muškarci; bijelci su činili 77% ispitivane populacije, Azijci 21%, a crnci 1%.
English: Refer to the Summary of Product Characteristics for requirements regarding contraception due to presence and transmission in sperm and for additional detail.
Croatian: Pročitajte sažetak opisa svojstava lijeka za više informacija o zahtjevima koji se odnose na kontracepciju zbog prisutnosti lijeka u spermi i prijenosa spermom.
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.
Croatian: Staklena bočica (staklo tipa I) od 20 ml, zatvorena sivim butilnim čepom i zapečaćena aluminijskim zaštitnim prstenom s polipropilenskom "flip off" kapicom, koja sadrži 300 mg ili 400 mg elotuzumaba.
English: From a microbiological point of view, the solution for infusion should be used immediately.
Croatian: S mikrobiološkog stanovišta, otopinu za infuziju treba odmah primijeniti.