FrancophonIA/ELRC3.0 huggingface dataset:
English: DARZALEX treatment was continued until disease progression or unacceptable toxicity.
Croatian: Liječenje lijekom DARZALEX nastavilo se do progresije bolesti ili neprihvatljive toksičnosti.
English: The median duration of response was not reached (95% CI: 5.6 months, not estimable).
Croatian: Medijan trajanja odgovora nije dosegnut (95% CI: 5,6 mjeseci; ne može se procijeniti).
English: In patients with persistent very good partial response, where daratumumab interference is suspected, consider using a validated daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient's serum, to facilitate determination of a complete response.
Croatian: U bolesnika s trajnim vrlo dobrim djelomičnim odgovorom, kada se sumnja na interferenciju daratumumabom, u obzir uzmite korištenje validiranih IFE analiza specifičnih na daratumumab, kako biste razlikovali daratumumab od bilo kojeg endogenog M proteina preostalog u bolesnikovom serumu, kako bi se omogućilo određivanje potpunog odgovora.
English: Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
Croatian: Daratumumab je inducirao apoptozu in vitro nakon križnog povezivanja posredstvom
English: However, fatigue has been reported in patients taking daratumumab and this should be taken into account when driving or using machines.
Croatian: Međutim, u bolesnika koji uzimaju daratumumab zabilježen je umor i to se mora uzeti u obzir prilikom upravljanja vozilima i rada sa strojevima.
English: If a planned dose of DARZALEX is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Croatian: Ako bolesnik propusti planiranu dozu lijeka DARZALEX, ona se mora primijeniti što je prije moguće, a raspored primjene potrebno je sukladno tome prilagoditi kako bi se održao potreban razmak između doza.
English: Thirty-three percent (33%) of patients were refractory to an IMiD only, and 28% were refractory to lenalidomide.
Croatian: Trideset i tri posto (33%) bolesnika bilo je refrakterno samo na imunomodulator, a 28% bilo je refrakterno na lenalidomid.
English: It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Lijek se primjenjuje kao intravenska infuzija nakon razrjeđivanja otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%).
English: • Since DARZALEX does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature (15°C-25°C) and in room light.
Croatian: • Budući da DARZALEX ne sadrži konzervans, razrijeđenu otopinu treba primijeniti unutar 15 sati (što uključuje i vrijeme primjene infuzije) ako se čuva na sobnoj temperaturi (15°C-25°C) i sobnoj svjetlosti.
English: Daratumumab concentration-time profiles were similar following the monotherapy and combination therapies.
Croatian: Profili koncentracija-vrijeme za daratumumab bili su slični nakon monoterapije, odnosno kombiniranih terapija.
English: See below “Recommended concomitant medications”, “Management of infusion-related reactions” and section 4.4.
Croatian: Vidjeti odlomke „Preporučeni lijekovi za istodobnu primjenu” i „Zbrinjavanje reakcija na infuziju” u nastavku te dio 4.4.
English: 6/kg) and among those who completed mobilization, more patients in the D-VTd group received plerixafor compared to those in the VTd arm (D-VTd: 21.7%; VTd: 7.9%).
Croatian: 6/kg), a među bolesnicima kod kojih je mobilizacija dovršena broj onih koji su primali pleriksafor bio je veći u skupini liječenoj kombinacijom D-VTd nego u onoj koja je primala VTd (D-VTd: 21,7%; VTd: 7,9%).
English: Tell your doctor or nurse straight away if you get any of the infusion-related reactions listed at the top of section 4.
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako primijetite bilo koju od reakcija na infuziju navedenih na početku dijela 4.
English: • medicines to help the airways in your lungs stay open (bronchodilators)
Croatian: • lijekove koji pomažu održati dišne putove u plućima otvorenima (bronhodilatatore)
English: This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Croatian: Ova interferencija može utjecati na određivanje potpunog odgovora i progresiju bolesti u nekih bolesnika s IgG kapa mijeloma proteinom.
English: Women of child-bearing potential should use effective contraception during, and for 3 months after cessation of daratumumab treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i još 3 mjeseca nakon prestanka liječenja daratumumabom.
English: Median OS was not reached for either treatment group.
Croatian: Medijan ukupnog preživljenja nije bio dostignut ni za jednu od liječenih skupina.
English: Simulation of daratumumab pharmacokinetics was conducted for all recommended dosing schedules in 1,309 patients with multiple myeloma.
Croatian: Simulacija farmakokinetike daratumumaba bila je provedena za sve preporučene rasporede doziranja u 1309 bolesnika s multiplim mijelomom.
English: • Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
Croatian: • Antihistaminik (25 do 50 mg difenhidramina ili ekvivalent peroralno ili intravenski).
English: Manage patients according to current clinical guidelines.
Croatian: Bolesnike je potrebno zbrinuti sukladno trenutno važećim kliničkim smjernicama.
English: If you forget your appointment to have DARZALEX It is very important to go to all your appointments to make sure your treatment works.
Croatian: Ako ste zaboravili doći na termin za primjenu lijeka DARZALEX Vrlo je važno da dolazite na sve dogovorene termine kako biste bili sigurni da je liječenje djelotvorno.
English: Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
Croatian: Na temelju četiri populacijske farmakokinetičke analize (1.-4. analiza), tjelesna težina identificirana je kao statistički značajna kovarijata za klirens daratumumaba.
English: Maternal IgG is excreted in human milk, but does not enter the neonatal and infant circulations in substantial amounts as they are degraded in the gastrointestinal tract and not absorbed.
Croatian: U ljudi se majčin IgG izlučuje u mlijeko, ali ne ulazi u krvotok novorođenčeta i dojenčeta u znatnijoj količini jer se razgrađuje u probavnom sustavu i ne apsorbira.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcija na infuziju
English: Weeks 7 to 54
Croatian: 7. - 54. tjedan
English: No data are available to determine potential effects of daratumumab on fertility in males or females (see section 5.3).
Croatian: Nema dostupnih podataka na temelju kojih bi se odredili mogući učinci daratumumaba na plodnost muškaraca ili žena (vidjeti dio 5.3).
English: • medicines for inflammation (corticosteroids)
Croatian: • lijekove za upalu (kortikosteroide)
English: If you get infusion-related reactions, you may need other medicines, or the infusion may need to be slowed down or stopped.
Croatian: Ako razvijete reakcije na infuziju, možda će Vam biti potrebni drugi lijekovi ili će se možda morati smanjiti brzina infuzije ili prekinuti njezina primjena.
English: Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Croatian: Odmah obavijestite liječnika ako se pojave znakovi umora koji se pogoršava, ili Vam požute koža ili bjeloočnice.
English: Other common symptoms (affecting up to 1 in 10 people) are:
Croatian: Drugi česti simptomi (javljaju se u do 1 na 10 osoba) su:
English: Resumption of DARZALEX treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV.
Croatian: O nastavku liječenja lijekom DARZALEX u bolesnika kod kojih je reaktivacija HBV-a dovoljno dobro kontrolirana treba razgovarati s liječnicima specijaliziranima za liječenje HBV-a.
English: CARTON (100 mg/400 mg) (WITH BLUE BOX)
Croatian: KUTIJA (100 mg/400 mg) (S PLAVIM OKVIROM)
English: In clinical trials IRRs were reported in approximately half of all patients treated with DARZALEX.
Croatian: U kliničkim ispitivanjima reakcije na infuziju prijavljene su u približno polovice svih bolesnika liječenih lijekom DARZALEX.
English: The data reflects exposure to DARZALEX (16 mg/kg) in 2066 patients with multiple myeloma including 1910 patients who received DARZALEX in combination with background regimens and 156 patients who received DARZALEX as monotherapy.
Croatian: Podaci prikazuju izloženost lijeku DARZALEX (pri dozi od 16 mg/kg) u 2066 bolesnika s multiplim mijelomom, uključujući 1910 bolesnika koji su primali DARZALEX u kombinaciji s osnovnim režimima i 156 bolesnika koji su primali DARZALEX u monoterapiji.
English: If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 5).
Croatian: Ako se kod bolesnika ne pojave dodatni simptomi, brzina infuzije može se ponovo povećavati u prikladnim koracima i intervalima (Tablica 5).
English: Eighteen percent (18%) of patients were refractory to a PI only, and 21% were refractory to bortezomib.
Croatian: Osamnaest posto (18%) bolesnika bilo je refrakterno samo na inhibitore proteasoma, a 21% bilo je refrakterno na bortezomib.
English: Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Croatian: Temeljeno na populaciji predviđenoj za liječenje p-vrijednost iz Cochran Mantel-Haenszelovog hi-kvadrat testa.
English: Methylprednisolone 100 mg, or equivalent, administered intravenously.
Croatian: Metilprednizolon 100 mg ili ekvivalent, primijenjen intravenski.
English: Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies.
Croatian: Tijekom liječenja periodično kontrolirajte kompletnu krvnu sliku prema uputama proizvođača lijekova za osnovnu terapiju.
English: • Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.
Croatian: • DARZALEX se ne smije infundirati istodobno s drugim lijekovima u istoj intravenskoj liniji.
English: For patients with evidence of positive HBV serology, monitor for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of DARZALEX treatment.
Croatian: Bolesnike s pozitivnim nalazom serološkog testiranja na HBV treba nadzirati zbog moguće pojave kliničkih i laboratorijskih znakova reaktivacije HBV-a tijekom liječenja lijekom DARZALEX i još najmanje 6 mjeseci po njegovu završetku.
English: In addition, T-cell receptor DNA sequencing verified that T-cell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.
Croatian: Uz to, sekvenciranje DNK za receptor T-stanica potvrdilo je da se kod liječenja daratumumabom povećava klonalnost T-stanica, što ukazuje na imunomodulacijske učinke koji bi mogli pridonijeti kliničkom odgovoru.
English: Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction between daratumumab and these small molecule medicinal products.
Croatian: Kliničke farmakokinetičke procjene daratumumaba u kombinaciji s lenalidomidom, pomalidomida, talidomida, bortezomiba i deksametazona nisu pokazale klinički značajnu reakciju lijek-lijek između daratumumaba i ovih malomolekulskih lijekova.
English: CARTON FOR INITIATION PACK COMPRISING 11 PACKS (WITH BLUE BOX)
Croatian: LIJEČENJA KOJE SE SASTOJI OD 11 PAKIRANJA (S PLAVIM OKVIROM)
English: Three additional population PK analyses (Analysis 2, Analysis 3 and Analysis 4) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Croatian: Tri dodatne populacijske farmakokinetičke analize (2. analiza, 3. analiza i 4. analiza) provedene su u bolesnika s multiplim mijelomom koji su primili kombinirane terapije daratumumaba.
English: If the patient does not experience any further IRR symptoms, infusion rate escalation may be resumed at increments and intervals as clinically appropriate up to the maximum rate of 200 mL/hour (Table 5).
Croatian: Ako se kod bolesnika ne pojave daljnji simptomi reakcije na infuziju, njezina se brzina može ponovo povećavati u koracima i intervalima koji su klinički prikladni, sve do najveće brzine od 200 ml/sat (Tablica 5).
English: What DARZALEX is and what it is used for
Croatian: Što je DARZALEX i za što se koristi
English: • build up of fluid in the lungs making you short of breath
Croatian: • nakupljanje tekućine u plućima radi kojeg imate nedostatak zraka
English: There are no human or animal data to assess the risk of daratumumab use during pregnancy.
Croatian: Nema podataka prikupljenih u ljudi ili životinja na temelju kojih bi se mogao ocijeniti rizik od primjene daratumumaba tijekom trudnoće.
English: The median duration of response had not been reached in the D-VMP group and was 21.3 months (range: 18.4, not estimable) in the VMP group.
Croatian: Medijan trajanja odgovora nije bio postignut u D-VMP skupini i bio je 21,3 mjeseca (raspon: 18,4, nije se moglo procijeniti) u VMP skupini.
English: • Grade 3 (severe): Once reaction symptoms resolve, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred.
Croatian: • Reakcija 3. stupnja (teška): Nakon nestanka simptoma reakcije, može se razmotriti ponovno uvođenje infuzije, brzinom koja mora biti najmanje upola manja od one pri kojoj je nastupila reakcija.
English: Following the last weekly infusion, Cmax increased in a greater than dose-proportional manner, consistent with target mediated drug disposition.
Croatian: Nakon posljednje infuzije kod primjene jednom na tjedan, Cmax se povećao više nego proporcionalno dozi, što je u skladu s dispozicijom lijeka ovisnom o vezivanju za ciljno mjesto.
English: • Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre).
Croatian: • Primijenite razrijeđenu otopinu intravenskom infuzijom uz pomoć infuzijskog seta opremljenog regulatorom protoka i ugrađenim (in-line) sterilnim, apirogenim polietersulfonskim (PES) filtrom male sposobnosti vezanja proteina (veličina pora: 0,22 ili 0,2 mikrometra).
English: This medicine contains 9.3 mg sodium (main component of cooking/table salt) in each 5 mL vial.
Croatian: Ovaj lijek sadrži 9,3 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 5 ml.
English: Key: D=daratumumab; Vd=bortezomib-dexamethasone; Rd=lenalidomide-dexamethasone; Pd=pomalidomidedexamethasone; VMP=bortezomib-melphalan-prednisone; VTd=bortezomib-thalidomide-dexamethasone.
Croatian: Kratice: D=daratumumab; Vd=bortezomib-deksametazon; Rd=lenalidomid-deksametazon; Pd=pomalidomid-deksametazon; VMP=bortezomib-melfalan-prednizon; VTd=bortezomib-talidomid-deksametazon.
English: Newly diagnosed multiple myeloma
Croatian: Novodijagnosticirani multipli mijelom
English: Less than 1% of patients had a Grade 3/4 infusion-related reaction with the Week 2 or subsequent infusions.
Croatian: Manje od 1% bolesnika imalo je reakciju na infuziju 3./4. stupnja kod infuzije u 2. tjednu ili sljedećih infuzija.
English: This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each 20 mL vial.
Croatian: Ovaj lijek sadrži 37,3 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 20 ml.
English: The MAH shall ensure that in each MS where DARZALEX (daratumumab) is marketed, all HCPs and patients who are expected to prescribe, dispense and receive this product have access to/are provided with the below.
Croatian: Nositelj odobrenja treba osigurati da u svakoj zemlji članici u kojoj se lijek DARZALEX (daratumumab) nalazi na tržištu, svi zdravstveni radnici i bolesnici za koje se očekuje da će propisivati, izdavati i primati ovaj lijek imaju pristup odnosno dobiju sve ispod navedeno.
English: Stringent complete response (sCR) Complete response (CR)
Croatian: Striktan potpuni odgovor (sCR) Potpuni odgovor (CR)
English: Table 5: Infusion rates for DARZALEX (16 mg/kg) administration
Croatian: Tablica 5: Brzina infuzije lijeka DARZALEX (16 mg/kg)
English: If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.
Croatian: Ako zatrudnite tijekom liječenja ovim lijekom, odmah se obratite svom liječniku ili medicinskoj sestri.
English: At the end of weekly dosing for the recommended monotherapy schedule and dose of 16 mg/kg, the mean (SD) serum Cmax value was 915 (410.3) micrograms/mL, approximately 2.9-fold higher than following the first infusion.
Croatian: Na kraju razdoblja primjene doze od 16 mg/kg jedanput na tjedan prema preporučenom rasporedu za monoterapiju, srednja vrijednost (SD) Cmax u serumu iznosila je 915 (410,3) µg/ml, što je približno 2,9 puta više od vrijednosti zabilježene nakon prve infuzije.
English: The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Croatian: Incidencija reakcija povezanih s infuzijom bilo kojeg stupnja bila je 42%, s time da je 36% bolesnika doživjelo reakcije povezane s infuzijom 1. dan 1. tjedna, 4% 2. dan 1. tjedna te 8% tijekom sljedećih infuzija.
English: The Guide for HCP and Blood Banks shall contain the following key elements:
Croatian: Vodič za zdravstvene radnike i banke krvi treba sadržavati sljedeće ključne elemente:
English: Paraesthesia Headache
Croatian: parestezija glavobolja
English: Melphalan at 9 mg/m2, and prednisone at 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9).
Croatian: Melfalan u dozi od 9 mg/m2 i prednizon u dozi od 60 mg/m2 primijenjeni su peroralno od 1. do 4. dana u devet 6-tjednih ciklusa (1.-9. ciklus).
English: The determination of a patient's ABO and Rh blood type are not impacted.
Croatian: Nema utjecaja na određivanje bolesnikove krvne grupe (ABO) ni Rh faktora.
English: DARZALEX is a cancer medicine that contains the active substance daratumumab.
Croatian: DARZALEX je lijek za rak koji sadrži djelatnu tvar daratumumab.
English: Week 1 Day 2 (8 mg/kg)
Croatian: 1. tjedan, 2. dan (8 mg/kg)
English: Adverse reaction Frequency Incidence (%) Any Grade Grade 3-4
Croatian: Incidencija (%) Svi stupnjevi
English: • low level of calcium in the blood
Croatian: • niske razine kalcija u krvi
English: • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient weight.
Croatian: • Izračunajte dozu (mg), ukupan volumen (ml) otopine lijeka DARZALEX koji je potreban i potreban broj bočica lijeka DARZALEX na temelju bolesnikove tjelesne težine.
English: • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Croatian: • kao monoterapija za liječenje odraslih bolesnika s relapsnim i refrakternim multiplim mijelomom čija je prethodna terapija uključivala inhibitor proteasoma i imunomodulator i kojima je bolest progredirala tijekom posljednje terapije.
English: • bronchitis
Croatian: • bronhitis
English: Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Croatian: Metode za ublažavanje interferencije daratumumaba uključuju tretiranje reagentnih eritrocita ditiotreitolom (DTT-om) kako bi se prekinulo vezanje daratumumaba ili druge lokalno validirane metode.
English: The HCPs and Blood Banks educational materials, shall contain the following key elements:
Croatian: Edukacijski materijali za zdravstvene radnike i banke krvi, trebaju sadržavati sljedeće ključne elemente:
English: Dexamethasone 20 mg (or equivalent), administered prior to every DARZALEX infusion.
Croatian: Deksametazon 20 mg (ili ekvivalent), primijenjen prije svake infuzije lijeka DARZALEX.
English: In clinical trials (monotherapy and combination treatments; N=2066) the incidence of any grade infusion-related reactions was 37% with the first (16 mg/kg, Week 1) infusion of DARZALEX, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions.
Croatian: U kliničkim ispitivanjima (monoterapija i kombinirana liječenja; N=2066) incidencija reakcija na infuziju bilo kojeg stupnja bila je 37% uz prvu (16 mg/kg, 1. tjedan) infuziju lijeka DARZALEX, 2% uz infuziju u 2. tjednu i kumulativno 6% sa sljedećim infuzijama.
English: Constipation Nausea Vomiting Pancreatitis
Croatian: konstipacija mučnina povraćanje pankreatitis
English: • The other ingredients are glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride and water for injections (see “DARZALEX contains sodium” in section 2).
Croatian: • Ostali sastojci su ledena acetatna kiselina, manitol (E421), polisorbat 20, natrijev acetat trihidrat, natrijev klorid i voda za injekcije (pogledajte odlomak „DARZALEX sadrži natrij” u dijelu 2.).
English: For information on the VMP dose and dosing schedule when administered with DARZALEX, see section 5.1.
Croatian: Za informacije o VMP dozi i rasporedu doziranja kada se primjenjuje s lijekom DARZALEX, vidjeti dio 5.1.
English: DARZALEX can cause serious infusion related reactions (IRRs), including anaphylactic reactions (see section 4.8).
Croatian: DARZALEX može uzrokovati ozbiljne reakcije na infuziju (engl. infusion related reactions, IRRs), uključujući anafilaktičke reakcije (vidjeti dio 4.8).
English: All patients were ≤ 65 years: 43% were in the age group ≥ 60-65 years, 41% were in the age group ≥ 50-60 years and 16% below age of 50 years.
Croatian: Svi bolesnici imali su ≤ 65 godina: njih 43% bilo je u dobnoj skupini od ≥ 60 do 65 godina, njih 41% u dobnoj skupini od ≥ 50 do 60 godina, a njih 16% bilo je mlađe od 50 godina.
English: A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Croatian: Ukupno 706 bolesnika bilo je randomizirano: 350 u D-VMP skupinu i 356 u VMP skupinu.
English: Gender did not affect exposure of daratumumab to a clinically relevant degree in the population PK analyses.
Croatian: Spol nije utjecao na izloženost daratumumabu u klinički značajnoj mjeri ni u jednoj farmakokinetičkoj analizi.
English: Interference with Serum Protein Electrophoresis and Immunofixation Tests Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein).
Croatian: Interferencija s testovima elektroforeze serumskih proteina i imunofiksacije Daratumumab se može otkriti testovima elektroforeze serumskih proteina (SPE) i imunofiksacije (IFE) koji se koriste za praćenje bolesti putem monoklonskih imunoglobulina (M proteina).
English: This is equivalent to 1.86% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,86% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis.
Croatian: Podskupina supresorskih stanica mijeloidnog porijekla (CD38+MDSCs), regulatornih T stanica (CD38+Tregs) i B stanica (CD38+Bregs) smanjile su se za daratumumabom posredovanu lizu stanica.
English: Four percent of all patients had an IRR at more than one infusion.
Croatian: Četiri posto (4%) svih bolesnika doživjelo je reakciju na infuziju tijekom više od jedne infuzije.