FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will check you for signs of this infection before, during and for some time after treatment with DARZALEX.
Croatian: Liječnik će provjeravati postoje li znakovi ove infekcije prije, tijekom i neko vrijeme nakon liječenja lijekom DARZALEX.
English: Missed dose (s)
Croatian: Propuštena(e) doza(e)
English: The incidence of infusion interruptions due to reactions was 30%.
Croatian: Incidencija prekidanja infuzija zbog reakcija bila je 30%.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC24
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela, ATK oznaka: L01XC24
English: DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood.
Croatian: DARZALEX može sniziti broj bijelih krvnih stanica koje pomažu u borbi protiv infekcija i krvnih stanica koje se zovu krvne pločice koje pomažu pri zgrušavanju krvi.
English: DARZALEX has no or negligible influence on the ability to drive and use machines.
Croatian: DARZALEX ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Prophylaxis for herpes zoster virus reactivation Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Croatian: Profilaksa reaktivacije herpes zoster virusa Potrebno je razmotriti antivirusnu profilaksu radi sprječavanja reaktivacije herpes zoster virusa.
English: When given alone, DARZALEX is given as follows:
Croatian: Kada se primjenjuje sam, DARZALEX se primjenjuje na sljedeći način:
English: leukopenia)
Croatian: leukopenija)
English: Warnings and precautions Talk to your doctor or nurse before you are given DARZALEX:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije nego primite DARZALEX:
English: CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity.
Croatian: Protein CD38 ima više funkcija, kao što su receptorom posredovana adhezija, signalizacija i enzimska aktivnost.
English: When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.
Croatian: Kada se DARZALEX primjenjuje zajedno s drugim lijekovima liječnik Vam može promijeniti vremenski razmak između doza, kao i broj doza koje ćete primiti.
English: DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available.
Croatian: DARZALEX mora primijeniti zdravstveni radnik u okruženju u kojem je dostupna oprema za reanimaciju.
English: This is because DARZALEX could cause hepatitis B virus to become active again.
Croatian: To je zato što DARZALEX može uzrokovati ponovnu aktivaciju virusa hepatitisa B.
English: Hepatitis B virus (HBV) Reactivation
Croatian: Reaktivacija virusa hepatitisa B (HBV)
English: T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation.
Croatian: Poznato je da T-stanice (CD3+, CD4+ i CD8+) također eksprimiraju CD38 ovisno o stupnju razvoja i razini aktivacije.
English: The Patient Alert Card, shall contain the following key elements:
Croatian: Kartica s upozorenjima za bolesnika, treba sadržavati sljedeće ključne elemente:
English: • nerve damage that may cause tingling, numbness, or pain
Croatian: • oštećenje živca koje može uzrokovati trnce, utrnulost ili bol
English: • Corticosteroid (long-acting or intermediate-acting) - Monotherapy:
Croatian: • Kortikosteroid (dugodjelujući ili srednje dugog djelovanja) Monoterapija:
English: In the event of a planned transfusion blood transfusion centres should be notified of this interference with indirect antiglobulin tests (see section 4.5).
Croatian: U slučaju planirane transfuzije, potrebno je obavijestiti centre za transfuziju krvi o toj interferenciji s nalazima indirektnog antiglobulinskog testa (vidjeti dio 4.5).
English: Women of child-bearing potential/Contraception
Croatian: Žene reproduktivne dobi/Kontracepcija
English: Increases in AUC were more than dose-proportional and clearance (CL) decreased with increasing dose.
Croatian: Povećanja AUC-a bila su veća nego proporcionalna dozi, dok se klirens (CL) smanjivao s povećanjem doze.
English: If you are not sure, talk to your doctor or nurse before you are given DARZALEX.
Croatian: Ako niste sigurni, obratite se svom liječniku ili medicinskoj sestri prije nego primite DARZALEX.
English: IgG1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy.
Croatian: Poznato je da IgG1 monoklonska protutijela prolaze kroz posteljicu nakon prvog tromjesečja trudnoće.
English: Efficacy results of the pre-planned interim analysis based on Independent Review Committee (IRC) assessment are presented in Table 10 below.
Croatian: Rezultati za djelotvornost iz unaprijed planirane interim analize na temelju ocjene neovisnog ocjenjivačkog povjerenstva prikazani su u Tablici 10 u nastavku.
English: Indicates grouping of terms
Croatian: Ukazuje na grupiranje termina
English: The majority of IRRs occurred at the first infusion and were Grade 1-2 (see section 4.8).
Croatian: Većina reakcija na infuziju nastupila je tijekom prve infuzije i bile su 1. do 2. stupnja (vidjeti dio 4.8).
English: Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, gdje je svrsishodno, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: • Check that the DARZALEX solution is colourless to yellow.
Croatian: • Provjerite je li otopina lijeka DARZALEX bezbojna do žuta.
English: Consider consulting a hepatitis disease expert as clinically indicated.
Croatian: Razmotrite potrebu za konzultiranjem sa specijalistom za liječenje hepatitisa prema kliničkim indikacijama.
English: DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”.
Croatian: DARZALEX se koristi u odraslih osoba u dobi od 18 ili više godina koji imaju vrstu raka koja se zove „multipli mijelom”.To je rak koštane srži.
English: If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems:
Croatian: Ako imate dišnih tegoba, poput astme ili kronične opstruktivne plućne bolesti (KOPB), primit ćete lijekove za udisanje koji će pomoći ublažiti Vaše dišne tegobe:
English: Based on Intent-to-treat population and threshold of 10
Croatian: Na temelju populacije predviđene za liječenje i praga od 10
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka moraju se jasno evidentirati.
English: Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).
Croatian: Infuzijske vrećice/spremnici moraju biti načinjeni od polivinilklorida (PVC), polipropilena (PP), polietilena (PE) ili poliolefinske mješavine (PP+PE).
English: Infections and infestations Pneumonia
Croatian: Infekcije i infestacije pneumonija
English: Relapsed/Refractory multiple myeloma
Croatian: Relapsni/refraktorni multipli mijelom
English: Patients refractory to lenalidomide were excluded from the study.
Croatian: Bolesnici refrakterni na lenalidomid bili su isključeni iz ispitivanja.
English: The usual starting dose of DARZALEX is 16 mg per kg of body weight.
Croatian: Uobičajena početna doza lijeka DARZALEX je 16 mg po kilogramu tjelesne težine.
English: In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.
Croatian: U malo vjerojatnom slučaju da primite previše lijeka (predoziranje), liječnik će Vas nadzirati kako bi uočio moguće nuspojave.
English: The safety results of this subgroup were consistent with the overall population.
Croatian: Rezultati iz sigurnosti primjene u ovoj podskupini bili su u skladu s onima u ukupnoj populaciji.
English: Clearance also decreased with multiple doses, which may be related to tumour burden decreases.
Croatian: Klirens se smanjio i kod primjene višestrukih doza, što bi moglo biti povezano sa smanjenjem tumorskog opterećenja.
English: Daratumumab as a large protein has a low likelihood of direct ion channel interactions.
Croatian: Kao velik protein, daratumumab ima nisku vjerojatnost direktne interakcije s ionskim kanalima.
English: The effect of daratumumab on newborns/infants is unknown.
Croatian: Učinak daratumumaba na novorođenčad/dojenčad nije poznat.
English: Fatal infections were primarily due to pneumonia and sepsis.
Croatian: Infekcije sa smrtnim ishodom prvenstveno su bile posljedica pneumonije i sepse.
English: Decreased blood cell counts
Croatian: Snižen broj krvnih stanica
English: If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus.
Croatian: Ako bolesnica zatrudni dok uzima ovaj lijek, mora je se upozoriti na mogući rizik za plod.
English: • low number of white blood cells which help fight infections (neutropenia, lymphopenia,
Croatian: • nizak broj bijelih krvnih stanica koje pomažu u borbi protiv infekcija (neutropenija, limfopenija,
English: DARZALEX will be given to you by a doctor or nurse.
Croatian: DARZALEX će Vam dati liječnik ili medicinska sestra.
English: There is no known specific antidote for daratumumab overdose.
Croatian: Nema poznatog specifičnog protulijeka za predoziranje daratumumabom.
English: • If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions (2°C-8°C) and protected from light.
Croatian: • Ako se ne primijeni odmah, razrijeđena otopina može se prije primjene čuvati do 24 sata u hladnjaku (2ºC-8ºC), zaštićena od svjetlosti.
English: The mean (SD) central volume of distribution is 56.98 (18.07) mL/kg.
Croatian: Srednja vrijednost (SD) volumena distribucije u središnjem odjeljku iznosi 56,98 (18,07) ml/kg.
English: However, the employed assay has limitations in detecting anti-daratumumab antibodies in the presence of high concentrations of daratumumab.
Croatian: Međutim, primijenjeni test ima ograničenja u otkrivanju protutijela na daratumumab u prisutnosti visokih koncentracija daratumumaba.
English: 95% CI (%) Odds ratio with 95% CI MRD negativity in combination with CR or better c n(%)
Croatian: 95% CI (%) Omjer izgleda uz 95% CI Negativan nalaz na MRD u kombinaciji s CR ili boljim odgovorom c n(%)
English: Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Croatian: Žene koje primaju DARZALEX moraju koristiti učinkovitu kontracepciju tijekom liječenja i još 3 mjeseca nakon njega.
English: Pre-planned interim analysis showed that treatment with daratumumab at 16 mg/kg led to a 36% ORR with 5% CR and 5% VGPR.
Croatian: Unaprijed planirana interim analiza pokazala je da je liječenje daratumumabom u dozi od 16 mg/kg dovelo do ORR-a od 36%, uz CR od 5% i VGPR od 5%.
English: • Grade 4 (life-threatening): Permanently discontinue DARZALEX treatment.
Croatian: • Reakcija 4. stupnja (opasna po život): Trajno obustaviti liječenje lijekom DARZALEX.
English: Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
Croatian: Nakon druge infuzije, doza kortikosteroida može biti snižena (60 mg metilprednizolona peroralno ili intravenski).
English: Treatment was continued in both arms until disease progression or unacceptable toxicity.
Croatian: Liječenje se nastavilo u obje skupine do progresije bolesti ili neprihvatljive toksičnosti.
English: In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Croatian: Uz to, daratumumab je modulirao enzimsku aktivnost proteina CD38 inhibirajući aktivnost enzima ciklaze i stimulirajući aktivnost hidrolaze.
English: You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.
Croatian: Vi i Vaš liječnik odlučit ćete je li korist liječenja ovim lijekom veća od rizika za Vaše dijete.
English: MRD negativity rate (95% CI)
Croatian: MRD negativna stopa (95% CI)
English: Pneumonia was the most commonly reported severe (Grade 3 or 4) infection across studies.
Croatian: U ispitivanjima je pneumonija bila najčešće prijavljena teška infekcija (stupanj 3. ili 4.).
English: Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
Croatian: Moraju se koristiti poliuretanski (PU), polibutadienski (PBD), PVC, PP ili PE setovi za primjenu.
English: Efficacy was evaluated by the stringent Complete Response (sCR) rate at Day 100 post-transplant and Progression free survival (PFS).
Croatian: Djelotvornost se ocjenjivala na temelju stope striktnog potpunog odgovora (engl. stringent complete response, sCR) 100. dana nakon transplantacije i poboljšanja preživljenja bez progresije bolesti (PFS).
English: • swollen hands, ankles or feet
Croatian: • oticanje šaka, zglobova ili stopala
English: The European Medicines Agency has waived the obligation to submit the results of studies with DARZALEX in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka DARZALEX u svim podskupinama pedijatrijske populacije za multipli mijelom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Monitor patients with neutropenia for signs of infection.
Croatian: Pratite bolesnike s neutropenijom zbog moguće pojave znakova infekcije.
English: This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria.
Croatian: Ovo može dovesti do lažno pozitivnih rezultata testova SPE i IFE u bolesnika s IgG kapa mijeloma proteinom koji utječu na početnu procjenu potpunog odgovora prema kriterijima Međunarodne radne skupine za mijelom.
English: Primary efficacy endpoint (International Myeloma Working Group criteria) CI=confidence interval; NE=not estimable; MR=minimal response
Croatian: Primarna mjera ishoda za djelotvornost (kriteriji Međunarodne radne skupine za mijelom) CI (engl. confidence interval)=interval pouzdanosti; NP=ne može se procijeniti; MR (engl. minimal response)=minimalan odgovor
English: o The guide for HCPs and Blood Banks, to advice about the risk of interference for blood typing and how to minimise it; o The Patient Alert Card.
Croatian: o Vodič za zdravstvene radnike i banke krvi, s ciljem savjetovanja o riziku od interferencije kod tipiziranja krvi i kako ga smanjiti; o Karticu s upozorenjima za bolesnika.
English: A modified initial rate (100 mL/hour) for subsequent infusions (i.e. Week 3 onwards) should only be used only if there were no IRRs during the previous infusion.
Croatian: Promijenjenu početnu brzinu (100 ml/sat) za sljedeće infuzije (tj. 3. tjedan i ostale nakon nje) treba koristiti samo ako nije bilo reakcija povezanih s infuzijom tijekom prethodne infuzije.
English: Furthermore, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was also consistent with the overall population.
Croatian: Nadalje, sigurnosna analiza podskupine bolesnika s ECOG funkcionalnim statusom 2 (D-VMP: n=89, VMP: n=84), također je bila u skladu s onom u ukupnoj populaciji.
English: If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given per local blood bank practices.
Croatian: Ako je potrebna hitna transfuzija, mogu se primijeniti ABO/RhD-kompatibilni eritrociti za koje nije provedena križna proba, u skladu s praksom lokalne banke krvi.
English: The overall response rate was 90% in the D-VMP group and 74% in theVMP group (VGPR rate:29% in D-VMP group and 26% in VMP group; CR: 22% in D-VMP group and 18% in VMP group; sCR rate: 20% in D-VMP group and 7% in VMP group).
Croatian: Stopa ukupnog odgovora bila je 90% u D-VMP skupini i 74% uVMP skupini (VGPR stopa: 29% u D-VMP skupini i 26% u VMP skupini; CR: 22% u D-VMP skupini i 18% u VMP skupini; sCR stopa: 20% u D-VMP skupini i 7% u VMP skupini).
English: A dilution volume of 500 mL for the 16 mg/kg dose should be used only if there were no IRRs the previous week.
Croatian: Volumen razrijeđene otopine od 500 ml za dozu od 16 mg/kg treba koristiti samo ako prethodni tjedan nije bilo reakcija povezanih s infuzijom.
English: Thalidomide was administered orally at 100 mg daily during the six bortezomib cycles.
Croatian: Talidomid se primjenjivao peroralno u dozi od 100 mg na dan tijekom šest ciklusa primjene bortezomiba.
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during or in the 3 days after the infusion.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koji od sljedećih znakova reakcije na infuziju tijekom infuzije ili unutar 3 dana nakon nje.
English: Prepare the solution for infusion using aseptic technique as follows:
Croatian: Pripremite otopinu za infuziju koristeći tehniku aspetičke izrade kako slijedi:
English: DARZALEX is supplied as a carton pack containing 1 glass vial.
Croatian: DARZALEX dolazi u kartonskoj kutiji koja sadrži 1 staklenu bočicu.
English: In the 1 to 24 mg/kg cohorts, peak serum concentrations (Cmax) after the first dose increased in approximate proportion to dose and volume of distribution was consistent with initial distribution into the plasma compartment.
Croatian: U kohortama koje su primale doze od 1 do 24 mg/kg, vršne serumske koncentracije (Cmax) nakon prve doze povećavale su se približno proporcionalno dozi, a volumen distribucije bio je u skladu s početnom distribucijom u plazmatski odjeljak.
English: A subgroup analysis was performed on patients at least 70 years old, or those 65-69 years old with ECOG performance score of 2, or aged less than 65 years of age with significant comorbidity or ECOG performance score of 2 (D-VMP: n=273, VMP: n=270).
Croatian: Analiza podskupina bila je provedena na bolesnicima u dobi od najmanje 70 godina, na onima u dobi od 65-69 godina s ECOG funkcionalnim statusom 2, i na onima mlađima od 65 godina sa značajnim komorbiditetom ili ECOG funkcionalnim statusom 2 (D-VMP: n=273, VMP: n=270).
English: Study MMY3006 is a 2 Part, open-label, randomized, active-controlled Phase 3 study.
Croatian: Ispitivanje MMY3006 bilo je dvodijelno, otvoreno, randomizirano, aktivnim lijekom kontrolirano ispitivanje faze 3.
English: Patients refractory to bortezomib were excluded from the study.
Croatian: Bolesnici refrakterni na bortezomib bili su isključeni iz ispitivanja.
English: Linear mixed PK-PD analyses indicated no large increase in mean QTcF interval (i.e. greater than 20 ms) at daratumumab Cmax.
Croatian: Linearna miješana PK-PD analiza nije pokazala veliko povećanje srednjeg QTc intervala (tj. veće od 20 ms) kod Cmax daratumumaba.
English: Recommended concomitant medications
Croatian: Preporučeni lijekovi za istodobnu primjenu
English: In the active controlled studies, discontinuations from treatment due to infections (1-4%) and fatal infections were generally infrequent and balanced between the DARZALEX containing regimens and active control arms.
Croatian: U ispitivanjima kontroliranima aktivnim lijekom prekidi liječenja zbog infekcija (1-4%) i infekcija sa smrtnim ishodom uglavnom nisu bili česti i bili su uravnoteženi između skupina koje su primale režime s lijekom DARZALEX i skupina s aktivnom kontrolom.
English: • Gently invert the bag/container to mix the solution.
Croatian: • Nježno okrenite vrećicu/spremnik da biste promiješali otopinu.
English: In patients receiving DARZALEX combination therapy, Grade 3 or 4 infections were reported as follows:
Croatian: U bolesnika koji primaju kombiniranu terapiju lijekom DARZALEX, infekcije stupnja 3. i 4. bile su prijavljene kako slijedi:
English: D-VMP (n=350) VMP (n=356) Overall response (sCR+CR+VGPR+PR) [n(%)] 318 (90.9) p-value
Croatian: D-VMP (n=350) VMP (n=356) Ukupni odgovor (sCR+CR+VGPR+PR) [n(%)] 318 (90,9) p-vrijednost
English: • low number of red blood cells which carry oxygen in the blood (anaemia)
Croatian: • nizak broj crvenih krvnih stanica koje prenose kisik krvlju (anemija)
English: Median durations of infusions were 4.2 h for Week 1-Day 1, 4.2 h for Week 1-Day 2, and 3.4 hours for the subsequent infusions.
Croatian: Medijan trajanja infuzija bio je 4,2 h za 1. tjedan-1. dan, 4,2 sata za 1. tjedan-2. dan i 3,4 sata za sljedeće infuzije.
English: The simulation results confirmed that the split and single dosing for the first dose provide similar PK, with the exception of the PK profile in the first day of the treatment.
Croatian: Rezultati simulacije potvrdili su da podijeljeno doziranje i jednostruko doziranje prve doze imaju sličnu farmakokinetiku, s iznimkom farmakokinetičkog profila u prvom danu liječenja.
English: It is not known whether daratumumab is excreted into human or animal milk.
Croatian: Nije poznato izlučuje li se daratumumab u mlijeko ljudi ili životinja.
English: Overall response rate (ORR) in MMY2002 was similar regardless of type of prior anti-myeloma therapy.
Croatian: Stopa ukupnog odgovora (engl. overall response rate, ORR) u ispitivanju MMY2002 bila je slična neovisno o vrsti prethodne terapije za mijelom.
English: What you need to know before you are given DARZALEX
Croatian: Što morate znati prije nego počnete primati DARZALEX
English: Prior to the launch of DARZALEX (daratumumab) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, aiming at increasing awareness about the Important Identified Risk of “Interference for blood typing (minor antigen) (Positive Indirect Coombs' test)” and providing guidance on how to manage it.
Croatian: Prije stavljanja lijeka DARZALEX (daratumumab) u promet u svim zemljama članicama, nositelj odobrenja mora dogovoriti sadržaj i format edukacijskih materijala, s ciljem povećanja svijesti o važnom identificiranom riziku „Interferencije kod tipiziranja krvi (manje značajan antigen) (Pozitivan indirektan Coombsov test)” i osiguranja smjernica kako njime upravljati.
English: You may need other medicines, or the infusion may need to be slowed down or stopped.
Croatian: Možda će Vam biti potrebni drugi lijekovi ili će se možda morati smanjiti brzina infuzije ili prekinuti njezina primjena.
English: To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively, see Table 5 below.
Croatian: Kako bi se olakšala primjena, prva propisana doza od 16 mg/kg u 1. tjednu može se podijeliti kroz dva uzastopna dana, tj. 8 mg/kg 1. dan odnosno 2. dan, pogledati tablicu 5 niže.
English: As such, variations in drug-metabolising enzymes are not expected to affect the elimination of daratumumab.
Croatian: Stoga se ne očekuje da će varijacije enzima koji metaboliziraju lijekove utjecati na eliminaciju daratumumaba.
English: Changes in hepatic function are unlikely to have any effect on the elimination of daratumumab since IgG1 molecules such as daratumumab are not metabolised through hepatic pathways.
Croatian: Nije vjerojatno da će promjene jetrene funkcije imati učinka na eliminaciju daratumumaba jer se IgG1 molekule poput daratumumaba ne metaboliziraju jetrenim putovima.
English: What DARZALEX is and what it is used for What you need to know before you are given DARZALEX How DARZALEX is given
Croatian: Što je DARZALEX i za što se koristi Što morate znati prije nego počnete primati DARZALEX Kako primjenjivati DARZALEX Moguće nuspojave
English: Combination treatment with lenalidomide:
Croatian: Kombinirano liječenje s lenalidomidom: