FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on in vitro studies, daratumumab may utilise multiple effector functions, resulting in immune mediated tumour cell death.
Croatian: Ispitivanja in vitro pokazala su da daratumumab može koristiti veći broj izvršnih (efektorskih) funkcija, što dovodi do imunosno posredovane smrti tumorske stanice.
English: Relapsed/refractory patient studies: DVd: 21%, Vd: 19%; DRd: 27%, Rd: 23%; DPd: 28% Newly diagnosed patient studies: D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
Croatian: Ispitivanja u bolesnika s novodijagnosticiranom bolešću: D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
English: Combination therapy:
Croatian: Kombinirana terapija:
English: DARZALEX 20 mg/mL concentrate for solution for infusion daratumumab
Croatian: DARZALEX 20 mg/ml koncentrat za otopinu za infuziju daratumumab
English: DARZALEX delay may be required to allow recovery of blood cell counts.
Croatian: Možda će biti potrebno odgoditi primjenu lijeka DARZALEX radi oporavka broja krvnih stanica.
English: Additionally the use of post-infusion medications (e.g. inhaled corticosteroids, short and long acting bronchodilators) should be considered for patients with a history of chronic obstructive pulmonary disease to manage respiratory complications should they occur (see section 4.2).
Croatian: Osim toga, u bolesnika s kroničnom opstruktivnom plućnom bolesti u anamnezi potrebno je razmotriti postinfuzijsku primjenu lijekova (npr. inhalacijskih kortikosteroida, kratkodjelujućih i dugodjelujućih bronhodilatatora) za zbrinjavanje respiratornih komplikacija, ako se pojave (vidjeti dio 4.2).
English: Dose adjustments for lenalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Croatian: Doze lenalidomida i deksametazona prilagođavale su se u skladu s proizvođačevim informacijama o lijeku.
English: Interference with determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein (see section 4.5).
Croatian: Interferencija s određivanjem potpunog odgovora Daratumumab je humano IgG kapa monoklonsko protutijelo koje se može otkriti i testom elektroforeze serumskih proteina (SPE) i testom imunofiksacije (IFE), koji se koriste za kliničko praćenje endogenih M proteina (vidjeti dio 4.5).
English: CARTON (100 mg/400 mg) FOR 1 VIAL COMPONENT AS INTERMEDIATE PACK/COMPONENT OF AN INITIATION PACK (WITHOUT BLUE BOX)
Croatian: KUTIJA (100 mg/400 mg) ZA 1 BOČICU KAO UNUTARNJE PAKIRANJE/SASTAVNICA PAKIRANJA ZA POČETAK
English: Combination treatment with bortezomib:
Croatian: Kombinirano liječenje s bortezomibom:
English: Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-infusion medications including short and long acting bronchodilators, and inhaled corticosteroids should be considered.
Croatian: Osim toga, u bolesnika s kroničnom opstruktivnom plućnom bolesti u anamnezi potrebno je razmotriti postinfuzijsku primjenu kratkodjelujućih i dugodjelujućih bronhodilatatora te inhalacijskih kortikosteroida.
English: The median time to onset of a reaction was 1.8 hours (range: 0.1 to 5.4 hours).
Croatian: Medijan vremena do nastupanja reakcije bio je 1,8 sati (raspon: 0,1 do 5,4 sata).
English: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
Croatian: Jedna bočica lijeka DARZALEX od 5 ml sadrži 0,4 mmol (9,3 mg) natrija, a jedna bočica od 20 ml sadrži 1,6 mmol (37,3 mg) natrija.
English: o All patients should be typed and screened prior to start treatment with daratumumab; alternatively, phenotyping may also be considered; o Daratumumab-mediated positive indirect Coombs test (interfering with cross-matching of blood) may persist for up to 6 months after the last product's infusion, therefore, the HCP should advise the patient to carry the Patient Alert Card until 6 months after the treatment has ended; o Daratumumab bound to Red Blood Cells (RBCs) may mask the detection of antibodies to minor antigens in the patient's serum; o The determination of a patient's ABO and Rh blood type are not impacted; o The interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Croatian: o Prije početka liječenja daratumumabom svi bolesnici trebaju biti tipizirani i probrani, a kao alternativa u obzir se može uzeti fenotipizacija; o Daratumumabom posredovan pozitivan indirektan Coombsov test (interferira s križnim probama krvi) može potrajati do 6 mjeseci nakon posljednje infuzije lijeka, stoga zdravstveni radnik treba savjetovati bolesnika da sa sobom nosi Karticu s upozorenjima za bolesnika do 6 mjeseci nakon završetka liječenja; o Daratumumab vezan za eritrocite može otežati detekciju protutijela na manje značajne antigene u bolesnikovu serumu; o Nema utjecaja na određivanje bolesnikove krvne grupe (ABO) ni Rh faktora; o Metode za ublažavanje interferencije daratumumaba uključuju tretiranje reagentnih eritrocita ditiotreitolom (DTT-om) kako bi se prekinulo vezanje daratumumaba ili druge lokalno validirane metode.
English: These reactions are very common (may affect more than 1 in 10 people):
Croatian: Te su reakcije vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: Very Common 40
Croatian: Vrlo često 40
English: The mean (SD) predose (trough) serum concentration at the end of weekly dosing was 573 (331.5) micrograms/mL.
Croatian: Srednja vrijednost (SD) serumske koncentracije prije primjene lijeka (najniža koncentracija) na kraju razdoblja primjene jedanput na tjedan iznosila je 573 (331,5) mikrograma/ml.
English: 9/L, leukocytes > 1.0 x 10
Croatian: 9/l, broja leukocita na vrijednost > 1,0 x 10 9/l i broja trombocita na vrijednost > 50 x 10
English: For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Croatian: Informacije o lijekovima koji se daju u kombinaciji s lijekom DARZALEX, pogledajte u odgovarajućem sažetku opisa svojstava lijeka.
English: The pharmacokinetics (PK) of daratumumab following intravenous administration of daratumumab monotherapy were evaluated in patients with relapsed and refractory multiple myeloma at dose levels from 0.1 mg/kg to 24 mg/kg.
Croatian: Farmakokinetika daratumumaba nakon intravenske primjene monoterapije daratumumabom ocjenjivala se u bolesnika s relapsnim i refrakternim multiplim mijelomom pri razinama doza od 0,1 mg/kg do 24 mg/kg.
English: Since the Kell Blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs.
Croatian: Budući da je Kell sustav krvnih grupa također osjetljiv na tretiranje DTT-om, nakon isključivanja ili identificiranja aloprotutijela uz pomoć eritrocita tretiranih DTT-om potrebno je uvesti Kell-negativne jedinice.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCEAND MANUFACTURE RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: MRD negativity rate a,c n(%)
Croatian: MRD negativna stopa a, c
English: Very Common 32
Croatian: Vrlo često 32
English: Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Croatian: Manje česti simptomi bili su piskanje u plućima, alergijski rinitis, pireksija, nelagoda u prsnom košu, pruritus i hipotenzija (vidjeti dio 4.8).
English: Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumour cells.
Croatian: Pokazalo se da daratumumab in vivo snažno inhibira rast tumorskih stanica koje eksprimiraju CD38.
English: • Grade 1-2 (mild to moderate): Once reaction symptoms resolve, the infusion should be resumed at no more than half the rate at which the IRR occurred.
Croatian: • Reakcija 1. ili 2. stupnja (blaga do umjerena): Nakon nestanka simptoma reakcije, infuziju treba nastaviti brzinom koja je najmanje upola manja od one pri kojoj je nastupila reakcija na infuziju.
English: Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Croatian: Ostale nuspojave povezane s infuzijom uključile su kongestiju nosa, kašalj, zimicu, nadraženost grla, povraćanje i mučninu (vidjeti dio 4.4).
English: Results of an updated PFS analysis approximately 4 months after the original clinical cutoff, continued to show an improvement in PFS for patients in the D-VMP arm compared with the VMP arm.
Croatian: Rezultati ažurirane PFS analize otprilike 4 mjeseca nakon izvornog prekida prikupljanja kliničkih podataka (engl. cutoff), nastavili su pokazivati poboljšanje PFS-a za bolesnike u D-VMP skupini u usporedbi s VMP skupinom.
English: Elderly No dose adjustments are considered necessary (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: Maximum rate
Croatian: Najveća brzina
English: Weeks 9 to 16
Croatian: 9. - 16. tjedan
English: Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity (see section 4.4).
Croatian: U slučaju hematološke toksičnosti može biti potrebna odgoda primjene radi oporavka broja krvnih stanica (vidjeti dio 4.4).
English: The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein.
Croatian: Budući da je daratumumab protein, u razrijeđenoj otopini mogu nastati vrlo male, prozirne do bijele proteinske čestice.
English: For intravenous use after dilution
Croatian: Za intravensku primjenu nakon razrjeđivanja
English: Following the first four infusions, if the patient experiences no major IRRs, these inhaled post-infusion medications may be discontinued at the discretion of the physician.
Croatian: Ako bolesnik ne doživi veću reakciju na infuziju nakon prve četiri infuzije, liječnik može odlučiti prekinuti primjenu tih inhalacijskih lijekova nakon infuzije.
English: Carcinogenicity and mutagenicity No animal studies have been performed to establish the carcinogenic potential of daratumumab.
Croatian: Nisu provedena ispitivanja na životinjama u svrhu utvrđivanja kancerogenog potencijala daratumumaba.
English: Weeks 10 to 24
Croatian: 10. - 24. tjedan
English: Monotherapy:
Croatian: Monoterapija:
English: At a survival update with a median duration of follow-up of 14.7 months, median Overall Survival (OS) was 17.5 months (95% CI:13.7, not estimable).
Croatian: U trenutku ažuriranja podataka o preživljenju nakon medijana praćenja od 14,7 mjeseci, medijan ukupnog preživljenja (engl. overall survival, OS) iznosio je 17,5 mjeseci (95% CI: 13,7; ne može se procijeniti).
English: Concentrate for solution for infusion Initiation pack: 11 vials (6 x 5 mL vials + 5 x 20 mL vials)
Croatian: koncentrat za otopinu za infuziju Pakiranje za početak liječenja: 11 bočica (6 x bočice od 5 ml + 5 x bočice od 20 ml)
English: Dexamethasone was administered orally at a dose of 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each of the 8 bortezomib cycles (80 mg/week for two out of three weeks of the bortezomib cycle) or a reduced dose of 20 mg/week for patients >75 years, BMI <18.5, poorly controlled diabetes mellitus or prior intolerance to steroid therapy.
Croatian: Deksametazon je bio primijenjen peroralno u dozi od 20 mg 1., 2., 4., 5., 8., 9., 11. i 12. dan svakog od 8 ciklusa bortezomiba (80 mg/tjedan tijekom dva od tri tjedna ciklusa bortezomiba) li sniženom dozom od 20 mg/tjedan za bolesnike >75 godina, ITM <18,5, slabo kontroliranom šećernom bolešću ili prethodnim nepodnošenjem steroidnog terapije.
English: At baseline, 97% of patients were refractory to the last line of treatment, 95% were refractory to both, a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), 77% were refractory to alkylating agents, 63% were refractory to pomalidomide and 48% of patients were refractory to carfilzomib.
Croatian: Na početku ispitivanja, 97% bolesnika bilo je refrakterno na posljednju liniju liječenja, njih 95% bilo je refrakterno i na inhibitor proteasoma i na imunomodulator, 77% ih je bilo refrakterno na alkilirajuće lijekove, 63% na pomalidomid, a 48% na karfilzomib.
English: The median duration of response had not been reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable) in the Rd group.
Croatian: Medijan trajanja odgovora nije bio dosegnut u DRd skupini, dok je u Rd skupini iznosio 34,7 mjeseci (95% CI: 30,8; nije se moglo procijeniti).
English: For dose and schedule of medicinal products administered with DARZALEX, see section 5.1 and the corresponding Summary of Product Characteristics.
Croatian: Za dozu i raspored primjene lijekova primijenjenih s lijekom DARZALEX, pogledajte dio 5.1 i odgovarajući sažetak opisa svojstava lijeka.
English: Week 55 onwards until disease progression b every four weeks
Croatian: 55. tjedan i nadalje do progresije bolesti
English: Based on four individual population PK analyses in patients receiving either daratumumab monotherapy or various combination therapies (Analyses 1-4), the exposure to daratumumab was similar between white (n=1371) and non-white subjects (n=242).
Croatian: Na temelju četiri zasebne populacijske farmakokinetičke analize u bolesnika koji primaju bilo daratumumab u monoterapiji ili u različitim kombiniranim terapijama (1.-4. analiza), izloženost daratumumabu je bila slična u bijelaca (n=1371) i ispitanika drugih rasa (n=242).
English: Dosing schedule in combination with bortezomib (3-week cycle regimen):
Croatian: Raspored primjene kod kombinacije s bortezomibom (režim 3-tjednog ciklusa):
English: In Study MMY1001, patients receiving daratumumab combination treatment (n=97) were administered the first 16 mg/kg daratumumab dose at Week 1 split over two days i.e. 8 mg/kg on Day 1 and Day 2 respectively.
Croatian: U ispitivanju MMY1001, bolesnicima koji su primali kombinirano liječenje daratumumabom (n=97) prva doza daratumumaba od 16 mg/kg primijenjena je u 1. tjednu podijeljena kroz dva dana, tj.
English: Response assessment Day 100 posttransplant Stringent Complete Response (sCR) 157 (28.9%) CR or better (sCR+CR) Very Good Partial Response or better (sCR+CR+VGPR) MRD negativity c, d n(%)
Croatian: Ocjena odgovora 100. dana nakon transplantacije Striktan potpuni odgovor (sCR) CR ili bolji odgovor (sCR+CR) Vrlo dobar djelomični ili bolji odgovor (sCR+CR+VGPR) Negativan nalaz na MRD
English: Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
Croatian: Možete osjetiti umor nakon uzimanja lijeka DARZALEX, što može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: In Part 2, subjects with at least a partial response (PR) by Day 100 post-transplant were re-randomized in a 1:1 ratio to daratumumab maintenance or observation only.
Croatian: U drugom dijelu ispitivanja, ispitanici s najmanje djelomičnim odgovorom (engl. partial response, PR) do 100. dana nakon transplantacije bili su ponovo randomizirani u omjeru 1:1 na skupinu koja je primala terapiju održavanja daratumumabom ili skupinu koja nije primala lijek.
English: Four population PK analyses were performed to describe the PK characteristics of daratumumab and to evaluate the influence of covariates on the disposition of daratumumab in patients with multiple myeloma; Analysis 1 (n=223) in patients receiving DARZALEX monotherapy while Analysis 2 (n=694), Analysis 3 (n=352) and Analysis 4 (n=355) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Croatian: Četiri populacijske farmakokinetičke analize provedene su kako bi se opisala farmakokinetička svojstva daratumumaba i kako bi se procijenio utjecaj kovarijati na dispoziciju daratumumaba u bolesnika s multiplim mijelomom; 1. analiza (n=223) u bolesnika koji primaju lijek DARZALEX u monoterapiji dok su 2. analiza (n=694), 3. analiza (n=352) i 4. analiza (n=355) bile provedene u bolesnika s multiplim mijelomom koji su primili kombinirane terapije s daratumumabom.
English: Median OS was not reached for either treatment group.With an overall median follow-up of 7.4 months (95% CI: 0.0, 14.9), the hazard ratio for OS was 0.77 (95% CI: 0.47, 1.26; p=0.2975).
Croatian: Medijan ukupnog preživljenja nije bio dostignut ni za jednu od liječenih skupina.S ukupnim medijanom praćenja od 7,4 mjeseci (95% CI: 0,0; 14,9), omjer hazarda za ukupno preživljenje bio je 0,77 (95% CI: 0,47; 1,26; p=0,2975).
English: Based on population PK analyses, no dosage adjustments are necessary for patients with hepatic impairment (see section 5.2).
Croatian: S obzirom na rezultate populacijskih farmakokinetičkih analiza, nije potrebno prilagođavati dozu u bolesnika s oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL 1 vial, 400 mg/20 mL
Croatian: Koncentrat za otopinu za infuziju 1 bočica, 100 mg/5 ml 1 bočica, 400 mg/20 ml
English: As an IgG1қ monoclonal antibody, renal excretion and hepatic enzyme-mediated metabolism of intact daratumumab are unlikely to represent major elimination routes.
Croatian: IgG1қ monoklonsko protutijelo, nije vjerojatno da će izlučivanje daratumumaba u neizmijenjenu obliku putem bubrega i njegov metabolizam posredovan jetrenim enzimima činiti važne putove eliminacije.
English: Dexamethasone is given intravenously prior to the first DARZALEX infusion and oral administration may be considered prior to subsequent infusions.
Croatian: Deksametazon se daje intravenski prije prve infuzije lijeka DARZALEX te se može razmotriti peroralna primjena deksametazona prije sljedećih infuzija.
English: Weeks 1 to 9
Croatian: 1. - 9. tjedan
English: Very Common 16
Croatian: Vrlo često 16
English: What DARZALEX is
Croatian: Što je DARZALEX
English: In patients who develop reactivation of HBV while on DARZALEX, suspend treatment with DARZALEX and institute appropriate treatment.
Croatian: U bolesnika kod kojih je došlo do reaktivacije HBV-a tijekom liječenja lijekom DARZALEX treba prekinuti liječenje lijekom DARZALEX i započeti odgovarajuću terapiju.
English: 1 vial, 400 mg/20 mL
Croatian: 1 bočica, 400 mg/20 mL
English: 5 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of daratumumab.
Croatian: 5 ml koncentrata u staklenoj bočici (staklo tipa 1) zatvorenoj elastomernim čepom i aluminijskim zaštitnim zatvaračem s flip-off kapicom, koja sadrži 100 mg daratumumaba.
English: At baseline, 76% of patients were refractory to the last line of treatment, 64% were refractory to both a PI and IMiD, 60% were refractory to alkylating agents, 36% were refractory to pomalidomide and 17% were refractory to carfilzomib.
Croatian: Na početku ispitivanja, 76% bolesnika bilo je refrakterno na posljednju liniju liječenja, njih 64% bilo je refrakterno i na inhibitor proteasoma i na imunomodulator, 60% ih je bilo refrakterno na alkilirajuće lijekove, 36% na pomalidomid, a 17% na karfilzomib.
English: DARZALEX may increase neutropenia and thrombocytopenia induced by background therapy (see section 4.8).
Croatian: DARZALEX može pogoršati neutropeniju i trombocitopeniju induciranu osnovnim liječenjem (vidjeti dio 4.8).
English: In responders, the median time to response was 0.79 months (range: 0.4 to 15.5 months) in the D-VMP group and 0.82 months (range: 0.7 to 12.6 months) in the VMP group.
Croatian: Kod bolesnika koji su odgovorili na liječenje, medijan vremena do odgovora bio je 0,79 mjeseci (raspon: 0,4 do 15,5 mjeseci) u D-VMP skupini i 0,82 mjeseca (raspon: 0,7 do 12,6 mjeseci) u VMP skupini.
English: Very Common 26
Croatian: Vrlo često 26
English: Hyperglycemia
Croatian: hiperglikemija
English: In Study GEN501, 42 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
Croatian: U ispitivanju GEN501, 42 bolesnika s relapsnim i refrakternim multiplim mijelomom primala su DARZALEX u dozi od 16 mg/kg do progresije bolesti.
English: Before each infusion of DARZALEX you will be given medicines which help to lower the chance of infusion-related reactions.
Croatian: Prije svake infuzije lijeka DARZALEX primit ćete lijekove koji će pomoći smanjiti vjerojatnost razvoja reakcija na infuziju.
English: 20 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of daratumumab.
Croatian: 20 ml koncentrata u staklenoj bočici (staklo tipa 1) zatvorenoj elastomernim čepom i aluminijskim zaštitnim zatvaračem s flip-off kapicom, koja sadrži 400 mg daratumumaba.
English: Very Common 25
Croatian: Vrlo često 25
English: Dosing schedule in combination with lenalidomide (4-week cycle regimen) and for monotherapy: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1.
Croatian: Raspored primjene u kombinaciji s lenalidomidom (režim 4-tjednog ciklusa) i u monoterapiji: Preporučena doza lijeka DARZALEX je 16 mg/kg tjelesne težine, a primjenjuje se kao intravenska infuzija prema sljedećem rasporedu primjene navedenom u Tablici 1.
English: Very Common 10
Croatian: Vrlo često 10
English: For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Croatian: U slučaju reakcije na infuziju bilo kojeg stupnja/težine, infuzija lijeka DARZALEX mora se odmah prekinuti, a simptomi zbrinuti.
English: Management of IRRs may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX as outlined below (see section 4.4).
Croatian: Zbrinjavanje reakcija na infuziju može zahtijevati smanjenje brzine infuzije ili obustavu liječenja lijekom DARZALEX na način opisan u nastavku (vidjeti dio 4.4).
English: DARZALEX contains sodium
Croatian: DARZALEX sadrži natrij
English: 95% CI (%) Odds ratio with 95% CI
Croatian: 95% CI (%) Omjer izgleda uz 95% CI
English: Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table 5 below.
Croatian: Nakon razrjeđivanja, infuziju lijeka DARZALEX treba primijeniti intravenski uz početnu brzinu navedenu u Tablici 5 u nastavku.
English: Red blood cell genotyping is not impacted by daratumumab and may be performed at any time.
Croatian: Daratumumab ne utječe na genotipizaciju eritrocita, te se ona može provesti u svakom trenutku.
English: Medicines given during treatment with DARZALEX You may be given medicines to lower the chance of getting shingles.
Croatian: Lijekovi koji se primjenjuju tijekom liječenja lijekom DARZALEX Možda ćete primiti lijekove koji smanjuju vjerojatnost razvoja herpes zostera.
English: • Using aseptic technique, remove a volume of 0.9% Sodium Chloride from the infusion bag/container that is equal to the required volume of DARZALEX solution.
Croatian: • Koristeći aseptičnu tehniku, iz infuzijske vrećice/spremnika izvucite volumen 0,9 %-tne otopine natrijeva klorida za injekciju jednak potrebnom volumenu otopine lijeka DARZALEX koji će se dodati.
English: Neutropenia/Thrombocytopenia
Croatian: Neutropenija/trombocitopenija
English: Dose adjustments for bortezomib, thalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Croatian: Doze bortezomiba, talidomida i deksametazona prilagođavale su se u skladu s proizvođačevim informacijama o lijeku.
English: Weeks 9 to 24
Croatian: 9. - 24. tjedan
English: Hepatitis B Virus reactivation
Croatian: Često gripa reaktivacija virusa hepatitisa B
English: The median time to response was 1 (range: 0.5 to 3.2) month.
Croatian: Medijan vremena do odgovora iznosio je 1 mjesec (raspon: 0,5 - 3,2 mjeseca).