natgillin/translations-raw huggingface dataset:
Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Daptomicin je prirodni ciklički lipopeptid koji djeluje samo na Gram-pozitivne bakterije.
Daptomycin is eliminated primarily by the kidney.
Daptomicin se prvenstveno eliminira bubrezima.
Daptomycin is excreted primarily by the kidneys.
Daptomicin se izlučuje prvenstveno putem bubrega.
Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes (see sections 4.2 and 5.2).
Daptomicin se može primijeniti intravenski kao infuzija tijekom 30 ili 60 minuta ili kao injekcija tijekom 2 minute (vidjeti dijelove 4.2 i 5.2).
Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes.
Daptomicin se može primijeniti intravenski kao infuzija tijekom 30 ili 60 minuta ili kao injekcija tijekom 2 minute.
Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy volunteers.
Farmakokinetika daptomicina općenito je linearna i neovisna o vremenu pri dozama od 4 do 12 mg/kg koje su primijenjene kao jednokratne dnevne doze putem 30-minutne intravenske infuzije zdravim dobrovoljcima do 14 dana.
Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test.
Daratumumab se veže za CD38, koji se u malim količinama nalazi na crvenim krvnim stanicama (eritrocitima) te može dovesti do pozitivnog nalaza indirektnog Coombsova testa.
Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching (see section 4.4).
Daratumumab se veže za CD38 na eritrocitima i utječe na testove kompatibilnosti, uključujući probir na protutijela i križne probe (vidjeti dio 4.4).
Daratumumab bound to Red Blood Cells (RBCs) may mask the detection of antibodies to minor antigens in the patient’s serum;
Daratumumab vezan za eritrocite može otežati detekciju protutijela na manje značajne antigene u bolesnikovu serumu;
Daratumumab has not been studied in patients with moderate (TB > 1.5 x to 3 x ULN and any AST) or severe (TB > 3 x ULN and any AST) hepatic impairment.
Daratumumab se nije ispitivao u bolesnika s umjerenim (ukupni bilirubin > 1,5 – 3 x GGN i bilo koja vrijednost AST-a) ni teškim (ukupni bilirubin > 3 x GGN i bilo koja vrijednost AST-a) oštećenjem jetrene funkcije.
Daratumumab has not been studied in patients with moderate to severe hepatic impairment (TB > 1.5 x ULN and any AST), therefore no dose recommendations can be made in these patient populations (see section 5.2).
Daratumumab se nije ispitivao u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije (ukupni bilirubin > 1,5 x GGN i bilo koja vrijednost AST-a), pa se ne mogu dati preporuke za doziranje u tim populacijama bolesnika (vidjeti dio 5.2).
Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
Daratumumab je inducirao apoptozu in vitro nakon križnog povezivanja posredstvom Fc receptora.
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).
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).
Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein).
Daratumumab se može otkriti testovima elektroforeze serumskih proteina (SPE) i imunofiksacije (IFE) koji se koriste za praćenje bolesti putem monoklonskih imunoglobulina (M proteina).
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;
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;
Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
Pozitivan nalaz indirektnog Coombsova testa uzrokovan djelovanjem daratumumaba može potrajati do 6 mjeseci nakon posljednje infuzije daratumumaba.
Darbepoetin alfa, the active substance in Aranesp, acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure.
Darbepoetin alfa, djelatna tvar lijeka Aranesp, djeluje na potpuno isti način kao prirodni eritropoetin koji se stvara u tijelu i potiče proizvodnju crvenih krvnih stanica, ali se blago razlikuje u strukturi.
Darifenacin AUC24 and Cmax from 30 mg once-daily dosing in subjects who are extensive metabolisers were 95% and 128% higher when erythromycin (moderate CYP3A4 inhibitor) was co-administered with darifenacin than when darifenacin was taken alone.
U osoba koje darifenacin opsežno metaboliziraju, AUC24 i Cmax darifenacina pri dozi od 30 mg jednom na dan bili su za 95%, odnosno za 128% veći kada se uz darifenacin primjenjivao i eritromicin (umjereno jaki inhibitor CYP3A4), nego kada se darifenacin primjenjivao sam.
Darifenacin is a lipophilic base and is 98% bound to plasma proteins (primarily to alpha-1-acid- glycoprotein).
Darifenacin je lipofilna baza i 98% je vezan na proteine plazme (prvenstveno na alfa-1-kiseli glikoprotein).
Darifenacin is extensively metabolised by the liver following oral administration.
Darifenacin se nakon oralne primjene opsežno metabolizira u jetri.
Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4.
U metabolizmu darifenacina prvenstveno posreduju enzimi citokroma P450 CYP2D6 i CYP3A4.
Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Tamnobež, filmom obložene tablete, u obliku trokuta, s oznakom „20“ utisnutom na jednoj strani i „L“ na drugoj..
Dark blue
tamnoplava
Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body.
Kapsule tamnoplave boje, veličine 1, duga oko 19 mm, s otisnutim „OPC 50” na kapici i „Bial” na tijelu kapsule.
Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width:
Tamnosmećkasto ljubičaste, ovalne, bikonveksne filmom obložene tablete s oznakom „S12“ i logom Boehringer Ingelheim utisnutima na jednoj te oznakom „1000“ na drugoj strani (duljina tablete:
Dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200’ on one side.
Tamno smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 200" na jednoj strani.
Dark coloured urine
tamno obojenu mokraću
dark or bloody stools, intense abdominal pain
tamne ili krvave stolice, jaka bol u trbuhu,
dark or bloody stools, intense abdominal pain,
tamne ili krvave stolice, jaka bol u trbuhu,
Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Želatinozna kapsula tvrde ovojnice s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
želatinozna kapsula s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
želatinozna kapsula tvrde ovojnice s tamnoružičastom neprozirnom kapicom i tamnoružičastim neprozirnim tijelom napunjena bjeličastim prahom.
Dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Želatinozna kapsula tvrde ovojnice s tamnoružičastom neprozirnom kapicom i bijelim neprozirnim tijelom napunjena bjeličastim prahom.
Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Tamno ružičasta, bikonveksna filmom obložena tableta ovalnog oblika, veličine 12,6 mm x 7 mm i s ugraviranom oznakom „M20” na jednoj strani.
Dark red oval shaped tablet of 20.0 mm, debossed with “800” on one side and “T” on the other side.
Tamnocrvena, ovalna tableta od 20,0 mm, s utisnutim“800” na jednoj strani i “T” na drugoj strani.
dark urine
tamna mokraća
dark urine
tamnu mokraću
dark urine confusion and/or disorientation.
tamnu boju mokraće smetenost i/ili dezorijentaciju
Dark urine, blood in urine, difficulty urinating Dehydration
tamna mokraća, krv u mokraći, poteškoće s mokrenjem dehidracija
Dark urine, urinary incontinence
tamna mokraća, urinarna inkontinencija
Dark yellow and white, printed with “3805”.
Tamnožuta i bijela, s otisnutom oznakom "3805".
Dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Tamnožute do smećkasto narančaste duguljaste filmom obložene tablete s razdjelnom crtom na jednoj strani.
Dark yellow to brownish orange round film-coated tablets with a score line on one side.
Tamnožute do smećkasto narančaste okrugle filmom obložene tablete s razdjelnom crtom na jednoj strani.
Dark yellow, capsule-shaped, debossed with “225” on one side.
Tamnožuta, u obliku kapsule, s utisnutom oznakom "225" na jednoj strani.
Dark yellow, oval film-coated tablets debossed with ‘SP’ on one side and ‘100’ on the other side.
Tamnožute, ovalne filmom obložene tablete s utisnutim 'SP' na jednoj strani i '100' na drugoj strani.
dark, cloudy or abnormally coloured urine,
tamnu, zamućenu ili neuobičajeno obojenu mokraću,
dark-coloured urine
tamno obojanu mokraću
dark-coloured urine
tamno obojenu mokraću
dark-coloured urine itching of your skin
tamnu mokraću svrbež na koži
dark-coloured urine itching of your skin.
tamnu boju urina svrbež kože.
dark/black blood in the stools
tamna/crna krv u stolici
darkening of an area of skin (hyperpigmentation);
tamnjenje dijela kože (hiperpigmentacija);
Darkening of the eyelashes, darkening of the iris colour, increased blinking, bleeding in the back of the eye (retinal bleeding), inflammation within the eye
Tamnjenje trepavica, tamnjenje šarenice, pojačano treptanje, krvarenje u stražnjem dijelu oka (mrežnično krvarenje), upala u unutrašnjosti oka
Darkening of your skin
tamna boja kože
darkening skin colour
tamnija boja kože
Darker eyelashes
Tamnije trepavice
Darker eyelid colour
Tamnija boja vjeđa
Darker iris colour
Tamnija boja šarenice
Darker skin colour around the eye
Tamnija boja kože oko oka
Darunavir
bilirubina, pogotovo u
Darunavir
C24 11,64 (7,96; 17,02)
Darunavir (600 mg twice daily)
Darunavir (600 mg dvaput na dan)
darunavir 600 mg and ritonavir 100 mg twice daily
darunavir 600 mg i ritonavir 100 mg dvaput na dan
Darunavir 600 mg twice daily with ritonavir 100 mg twice daily in antiretroviral treatment. (ART) experienced patients.
Darunavir 600 mg dva puta na dan s ritonavirom 100 mg dva puta na dan u bolesnika koji su već primali antiretrovirusnu terapiju (ART).
Darunavir 600, single 100 q12h Darunavir ↑ 14 fold
Darunavir 600, jednokratno 100 svakih 12h Darunavir ↑ 14 puta
Darunavir 800 mg once daily
darunavir 800 mg jednom dnevno
Darunavir 800 mg once daily with ritonavir 100 mg once daily in ART-naïve patients.
Darunavir 800 mg jedanput na dan s ritonavirom 100 mg jedanput na dan bolesnicima koji još nisu primali ART
Darunavir 800 mg once daily with ritonavir 100 mg once daily may be used in some ART experienced patients.
Darunavir 800 mg jedanput na dan s ritonavirom 100 mg jedanput na dan može se primjenjivati kod nekih bolesnika koji su prethodno primali
Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
darunavir800 mg/ritonavir 100 mg jedanput na dan (daklatazvir 30 mg jedanput na dan)
darunavir and ritonavir
darunavir i ritonavir
Darunavir and ritonavir are metabolised by CYP3A.
Darunavir i ritonavir se metaboliziraju putem CYP3A.
darunavir and ritonavir fosamprenavir and ritonavir
darunavirom i ritonavirom fosamprenavirom i ritonavirom
Darunavir and Viramune can be co- administered without dose adjustments.
Darunavir i Viramune mogu se istodobno primjenjivati bez prilagodbe doze.
darunavir associated
ako nema izražene
darunavir AUC 1.18 (1.11-1.25) ↑ darunavir Cmax 1.04 (0.99-1.10) ↔ darunavir Cmin 1.31 (1.13-1.52) ↑ ritonavir AUC 1.32 (1.25-1.40) ↑ ritonavir Cmax 1.23 (1.14-1.32) ↑ ritonavir Cmin 1.44 (1.30-1.61) ↑ simeprevir AUC 2.59 (2.15-3.11) ↑* simeprevir Cmax 1.79 (1.55-2.06) ↑* simeprevir Cmin 4.58 (3.54-5.92) ↑*
darunavir AUC 1,18 (1,11-1,25)  darunavir Cmax 1,04 (0,99-1,10) ↔ darunavir Cmin 1,31 (1,13-1,52)  ritonavir AUC 1,32 (1,25-1,40)  ritonavir Cmax 1,23 (1,14-1,32)  ritonavir Cmin 1,44 (1,30-1,61)  simeprevir AUC 2,59 (2,15-3,11) * simeprevir Cmax 1,79 (1,55-2,06) * simeprevir Cmin 4,58 (3,54-5,92) 
Darunavir AUC ↑ 1.24 (0.97-1.57)
Darunavir AUC  1,24 (0,97-1,57)
darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79% (inhibition of CYP3A enzymes)
darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirin AUC ↑ 130% rilpivirin Cmin ↑ 178% rilpivirin Cmax ↑ 79% (inhibicija enzima CYP3A)
Darunavir AUC  1.24 (0.97-1.57)
Darunavir AUC  1,24 (0,97-1,57)
Darunavir AUC12: ↓ 0.86
Darunavir AUC12  0,86
Darunavir boosted with cobicistat is more sensitive for CYP3A induction than darunavir boosted with ritonavir.
Darunavir pojačan s kobicistatom osjetljiviji je na CYP3A indukciju, nego darunavir pojačan s ritonavirom.
Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3), and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
Darunavir pojačan s kobicistatom osjetljiviji je na CYP3A indukciju: stoga je kontraindicirana istodobna primjena darunavira/kobicistata i snažnih induktora CYP3A (vidjeti dio 4.3), te se ne preporučuje istodobna primjena sa slabim do umjerenim induktorima CYP3A (vidjeti dio 4.5).
Darunavir boosted with ritonavirf (800/100 mg once daily)
Darunavir pojačan ritonaviromf (800/100 mg jedanput na dan)
Darunavir C12: ↓ 0.77
Darunavir C12  0,77
Darunavir Cmax ↑ 1.40 (1.14-1.73)
Darunavir Cmax  1,40 (1,14-1,73)
darunavir Cmax ↔
darunavir AUC ↔
darunavir Cmax ↔
darunavir Cmin ↔
darunavir Cmax ↔
lijekove.
Darunavir Cmax  1.40 (1.14-1.73)
Darunavir Cmax  1,40 (1,14-1,73)
Darunavir Cmax: ↔ 0.96
Darunavir Cmax  0,96
darunavir Cmin 17%
darunavir Cmin 17% darunavir Cmax ↔
darunavir Cmin 17% darunavir Cmax ↔
darunavir Cmin 17
darunavir Cmin ↔
#darunavir Cmin ↑ 24
Darunavir Cmin ↔ 1.02 (0.79-1.32)
Darunavir Cmin  1,02 (0,79-1,32)
darunavir Cmin ↔ darunavir Cmax ↔
darunavir Cmin ↔
Darunavir Cmin  1.02 (0.79-1.32)
Darunavir Cmin  1,02 (0,79-1,32)
Darunavir combined with
Darunavir u kombinaciji s
Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to ng/ml).
Darunavir pokazuje aktivnost protiv laboratorijskih sojeva i kliničkih izolata HIV-1 te laboratorijskih sojeva HIV-2 u akutno inficiranim linijama T-stanica, humanim mononuklearnim stanicama iz periferne krvi i humanim monocitima/makrofagima s medijanom vrijednosti EC50 u rasponu od 1,2 do 8,5 nM (0,7 do 5,0 ng/ml).
Darunavir exposure (and also ritonavir exposure) may increase on stopping St John’s wort.
Po prestanku uzimanja gospine trave može doći do povećane izloženosti darunaviru (kao i izloženosti ritonaviru).
Darunavir exposures in treatment-naïve adolescents 12 to 17 years weighing at least 40 kg receiving PREZISTA 800 mg once daily have been determined and were found to be within the therapeutic range as has been established in adults receiving PREZISTA 800 mg once daily.
Određene izloženosti darunaviru u adolescenata u dobi od 12 do 17 godina težine najmanje 40 kg koji nisu prethodno liječeni i primaju lijek PREZISTA od 800 mg jedanput na dan, bile su unutar terapijskog raspona koji je ustanovljen u odraslih koji primaju lijek PREZISTA od 800 mg jedanput na dan.
Darunavir exposures in treatment-naïve adolescents 12 to 17 years weighing at least 40 kg receiving PREZISTA/ritonavir 800/100 mg once daily have been determined and were found to be within the therapeutic range as has been established in adults receiving PREZISTA/ritonavir 800/100 mg once daily.
Određene izloženosti darunaviru u adolescenata u dobi od 12 do 17 godina, težine najmanje 40 kg koji nisu prethodno liječeni i primaju lijek PREZISTA/ritonavir od 800/100 mg jedanput na dan, bile su unutar terapijskog raspona koji je ustanovljen u odraslih koji primaju lijek PREZISTA/ritonavir od 800/100 mg jedanput na dan.
Darunavir has different interaction profiles depending on whether the compound is boosted with ritonavir or cobicistat:
Profil interakcija darunavira različit je i ovisan o tome je li pojačan s ritonavirom ili s kobicistatom:
Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 x 10-12M).
Darunavir je inhibitor dimerizacije i katalitičke aktivnosti HIV-1 proteaze (KD od 4.5 x 10-12M).
Darunavir may increase plasma concentrations of prednisone. (CYP3A inhibition)
Darunavir može povećati koncentracije prednizona u plazmi. (CYP3A inhibicija)
Darunavir may therefore have different recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat.
Stoga su moguće različite preporuke za uzimanje darunavira s istodobno primijenjenim lijekovima, ovisno o tome je li pojačan s ritonavirom ili s kobicistatom.
Darunavir  Ritonavir  (induction of UGT1A1
darunavir  ritonavir  (indukcija enzima UGT1A1 i CYP3A)
Darunavir  Ritonavir  Etravirine 
darunavir  ritonavir  etravirin 
Darunavir+ritonavir+etravirine/ Dolutegravir
darunavir+ritonavir+etravirin/ dolutegravir
Darunavir, cobicistat and emtricitabine/tenofovir disoproxil fumarate (n = 50)
Darunavir, kobicistat i emtricitabin/tenofovirdi zoproksilfumarat (n = 50)
darunavir, ritonavir concentrations were
koncentracije darunavira, ritonavira bile
darunavir, the dose of Vitekta
darunavirom, doza lijeka Vitekta
Darunavir/
Darunavir
Darunavir/cobicistat
darunavir/kobicistat
Darunavir/ritonavir
dnevno)
Darunavir/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 34 pregnant women (17 in each arm) during the second and third trimesters, and postpartum.
U kliničkom ispitivanju s 34 trudnice (po 17 u svakoj skupini), procijenjena je terapija darunavir/ritonavir (600/100 mg dva puta na dan ili 800/100 mg jedanput dnevno) u kombinaciji s osnovnim režimom liječenja tijekom drugog i trećeg trimestra, te postpartalno.
Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabine/Tenofovir disoproxil fumarate (200 mg/300 mg q.d.)1
(800 mg q.d./100 mg q.d.) + emtricitabin/tenofovirdizoproksil- fumarat (200 mg/300 mg q.d.)1
Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabine/Tenofovir disoproxil fumarate (200 mg/300 mg q.d.)1
Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabin/Tenofovirdizoproksilfum arat (200 mg/300 mg q.d.)1
Darunavir/ritonavir + etravirine
darunavir/ritonavir + etravirin
Darunavir/ritonavir 400/100 mg BID
400/100 mg 2x/dan
darunavir/ritonavir 400/100 mg twice daily
darunavir/ritonavir 400/100 mg dva puta
darunavir/ritonavir 600/100 mg twice daily regimen should be used.
600/100 mg dvaput na dan.
darunavir/ritonavir 800/100 mg
darunavirom/ritonavirom u dozi
darunavir/ritonavir and telaprevir (see
darunavir/ritonavir s telaprevirom (vidjeti
darunavir/ritonavir can be
darunavir/ritonavir mogu se
Darunavir/ritonavir should be used with caution in combination with Atripla.
Preporuka za istovremenu primjenu s Atriplom
darunavir/ritonavir, atazanavir/ritonavir, rilpivirine
darunavir/ritonavir, atazanavir/ritonavir, rilpivirin
Darunavir/ritonavir/emtricitabine
Darunavir/ritonavir/emtricitabin
Darunavir/ritonavir/Tenofovir disoproxil fumarate (300 mg b.i.d.*/100 mg b.i.d./300 mg q.d.)
fumarat (300 mg b.i.d.*/100 mg b.i.d./300 mg q.d.)
Darunavir: comparison of
Darunavir: usporedba
DARZALEX as monotherapy is indicated 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.
DARZALEX je kao monoterapija indiciran za liječenje odraslih bolesnika s relapsnim i refraktornim multiplim mijelomom čija je prethodna terapija uključivala inhibitor proteasoma i imunomodulator i kojima je bolest progredirala tijekom posljednje terapije.
DARZALEX can affect the results of this blood test.
DARZALEX može utjecati na nalaze te krvne pretrage.
Darzalex can only be obtained with a prescription and should be given by a healthcare professional in a place where facilities for resuscitating patients are readily available.
Darzalex se izdaje se samo na liječnički recept, a treba ga dati zdravstveni djelatnik u ustanovi gdje je oprema za reanimaciju bolesnika odmah dostupna.
Darzalex contains the active substance daratumumab.
Darzalex sadrži djelatnu tvar daratumumab.
Darzalex has been given ‘conditional approval’.
Za lijek Darzalex izdano je „uvjetno odobrenje”.
Darzalex has been investigated in two main studies involving a total of 196 multiple myeloma patients whose disease came back after, or did not respond to, at least two previous treatments including a proteasome inhibitor and an immunomodulatory agent.
Darzalex je ispitivan u okviru dvaju glavnih ispitivanja koja su uključivala ukupno 196 bolesnika s multiplim mijelomom kod kojih se bolest vratila ili nije reagirala na najmanje dvije prethodne terapije, koje su uključivale inhibitor je proteasoma i imunomodulatorni agens.
Darzalex has been shown to be effective at treating multiple myeloma in patients whose disease had progressed despite at least two previous treatments.
Darzalex se pokazao učinkovitim u liječenju bolesnika koji boluju od multiplog mijeloma kod kojih je bolest uznapredovala unatoč barem dvama prethodnim oblicima liječenja.
DARZALEX infusion should be interrupted for IRRs of any severity.
Infuziju lijeka DARZALEX potrebno je privremeno prekinuti u slučaju nastupa reakcije na infuziju bilo koje težine.
Darzalex is a cancer medicine used on its own to treat adults with multiple myeloma (a cancer of the bone marrow).
Darzalex je lijek za liječenje raka koji se koristi kao monoterapija za liječenje odraslih osoba s multiplim mijelomom (rak koštane srži).
DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
DARZALEX je koncentrat za otopinu za infuziju te bezbojna do žuta tekućina.
Darzalex is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Darzalex je dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
DARZALEX is used if your cancer has not responded to, or has come back after certain treatments.
DARZALEX se koristi ako rak nije reagirao ili se vratio nakon određenih terapija.
DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”.
DARZALEX se koristi u odraslih osoba u dobi od 18 ili više godina koji imaju vrstu raka koja se zove "multipli mijelom".