FrancophonIA/ELRC3.0 huggingface dataset:
English: Red blood cell genotyping is not impacted by daratumumab and may be performed at any time.
Slovenian: Zdravljenje z daratumumabom ne vpliva na genotipizacijo eritrocitov, zato jo je mogoče opraviti tudi med zdravljenjem.
English: weekly (total of 6 doses)
Slovenian: 1. do 6. teden enkrat tedensko (skupno 6 odmerkov)
English: Read the package leaflet before use.
Slovenian: intravenska uporaba po razredčenju Pred uporabo preberite priloženo navodilo!
English: Constipation Nausea Vomiting Pancreatitis
Slovenian: Bolezni prebavil driska zelo pogosti obstipacija navzea bruhanje pankreatitis pogosti
English: Study MMY3008 showed an improvement in Progression Free Survival (PFS) in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001), representing 44% reduction in the risk of disease progression or death in patients treated with DRd.
Slovenian: Študija MMY3008 je pokazala izboljšanje preživetja brez napredovanja bolezni (PFS) v skupini DRd v primerjavi s skupino Rd; mediana PFS v skupini DRd ni bila dosežena, v skupini Rd pa je bila 31,9 meseca (razmerje ogroženosti, [hazard ratio, HR]=0,56; 95-odstotni IZ: 0,43, 0,73; p<0,0001), kar predstavlja 44-odstotno zmanjšanje tveganja za napredovanje bolezni ali smrt pri bolnikih, zdravljenih z DRd.
English: • low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)
Slovenian: • zmanjšano število krvnih ploščic (trombocitov), ki sodelujejo pri strjevanju krvi
English: Figure 1: Kaplan-Meier Curve of PFS in Study MMY3008
Slovenian: Slika 1: Kaplan-Meierjeva krivulja PFS v študiji MMY3008
English: Table 3: DARZALEX dosing schedule in combination with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle dosing regimen)
Slovenian: Razpored odmerjanja zdravila DARZALEX v kombinaciji z bortezomibom, talidomidom in deksametazonom ([VTd]; režim odmerjanja s 4-tedenskim krogom)
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab-mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion.
Slovenian: Vpliv na rezultat indirektnega antiglobulinskega testa (indirektnega Coombsovega testa) Daratumumab se veže na protein CD38, ki je v majhni koncentraciji prisoten na eritrocitih, in lahko povzroči, da so rezultati indirektnega Coombsovega testa pozitivni.
English: Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumour cells.
Slovenian: Dokazano je, da daratumumab in vivo močno zavira razmnoževanje tumorskih celic, na katerih je prisoten protein CD38.
English: What DARZALEX is
Slovenian: Kaj je zdravilo DARZALEX
English: Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
Slovenian: Celokupna stopnja odziva (sCR+CR+VGPR+PR) [n(%)] vrednost p strog popolni odziv (sCR) [n(%)] popolni odziv (CR) [n(%)] zelo dober delni odziv (VGPR) [n(%)] delni odziv (PR) [n(%)] Stopnja odsotne MRD (95-odstotni IZ)
English: DARZALEX is a cancer medicine that contains the active substance daratumumab.
Slovenian: o Kontaktne podatke zdravnika, ki je predpisal zdravljenje z zdravilom DARZALEX (daratumumabom).
English: DARZALEX delay may be required to allow recovery of blood cell counts.
Slovenian: V nekaterih primerih je treba odmerjanje zdravila DARZALEX odložiti do izboljšanja krvne slike.
English: - Keep this leaflet.
Slovenian: Raztopine ne zamrzujte.
English: • low number of white blood cells which help fight infections (neutropenia, lymphopenia,
Slovenian: • zmanjšano število belih krvnih celic, ki sodelujejo pri obrambi telesa pred okužbami
English: The solution is colourless to yellow.
Slovenian: koncentrat za raztopino za infundiranje Raztopina je brezbarvna do rumena.
English: Permanently discontinue DARZALEX upon the third occurrence of a Grade 3 or greater infusion reaction.
Slovenian: Pri tretji ponovitvi infuzijske reakcije stopnje 3 ali več je treba zdravilo DARZALEX dokončno ukiniti.
English: Additional efficacy results from Study MMY3004 are presented in Table 12 below.
Slovenian: Drugi rezultati učinkovitosti iz študije MMY3004 so prikazani spodaj v preglednici 12.
English: Infusion-related reaction includes terms determined by investigators to be related to infusion, see below
Slovenian: * med njimi ni bilo nobenega primera 4. stopnje označuje združevanje terminov neželeni učinki v obdobju trženja zdravila infuzijska reakcija vključuje neželene učinke, ki so po oceni raziskovalcev povezani z infuzijo, glejte spodaj
English: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 3.
Slovenian: Priporočeni odmerek zdravila DARZALEX je 16 mg/kg telesne mase z odmerjanjem v obliki intravenske infuzije po naslednjem razporedu v preglednici 3.
English: However, the employed assay has limitations in detecting anti-daratumumab antibodies in the presence of high concentrations of daratumumab.
Slovenian: Vendar pa je ob prisotnosti velikih koncentracij daratumumaba sposobnost določanja protiteles proti daratumumabu z izbranim testom omejena.
English: every three weeks (total of 5 doses)
Slovenian: 10. do 24. teden vsak tretji teden (skupno 5 odmerkov)
English: On DARZALEX infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
Slovenian: V dneh, ko so bolniki prejemali infuzijo zdravila DARZALEX, so deksametazon prejemali kot premedikacijo pred infuzijo, preostanek odmerka pa so prejeli dan po infuziji.
English: How to store DARZALEX
Slovenian: Kako prejemate zdravilo DARZALEX
English: Week 2 (16 mg/kg)infusion
Slovenian: Infuzija v 2 tednu (16 mg/kg)
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: One mL of concentrate contains 20 mg daratumumab.
Slovenian: En mililiter koncentrata vsebuje 20 mg daratumumaba.
English: Oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate-acting or long-acting corticosteroid in accordance with local standards) should be administered on each of the two days following all infusions (beginning the day after the infusion).
Slovenian: Bolnikom je treba prvi in drugi dan po vsaki infuziji dati peroralni kortikosteroid (20 mg metilprednizolona ali enakovreden odmerek drugega srednje dolgo delujočega ali dolgo delujočega kortikosteroida v skladu z lokalnimi standardi).
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab (20 mg/mL).
Slovenian: Ena viala s 5 ml koncentrata vsebuje 100 mg daratumumaba (20 mg/ml).
English: Study MMY3003 demonstrated an improvement in PFS in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 18.4 months in the Rd arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing 63% reduction in the risk of disease progression or death in patients treated with DRd (see Figure 3).
Slovenian: Rezultati študije MMY3003 so pokazali izboljšano preživetje brez napredovanja bolezni v skupini DRd v primerjavi s skupino Rd. Mediana PFS v skupini DRd ni bila dosežena, v skupini Rd pa je znašala 18,4 mesece (razmerje ogroženosti=0,37; 95-odstotni IZ: 0,27; 0,52; vrednost-p<0,0001), kar predstavlja 63% zmanjšanje tveganja za napredovanje bolezni ali za smrt pri bolnikih, zdravljenih z DRd (glejte sliko 3).
English: NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
Slovenian: Število naravnih celic ubijalk (celic NK, natural killer) in limfocitov T Znano je, da celice NK izražajo velike količine proteina CD38 in so dovzetne z daratumumabom posredovano citolizo.
English: DARZALEX dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen)
Slovenian: Preglednica 2: Razpored odmerjanja zdravila DARZALEX v kombinaciji z bortezomibom, melfalanom in prednizonom ([VMP]; režim odmerjanja s 6-tedenskim krogom)
English: Immune system disorders Anaphylactic reaction b Rare Metabolism and nutrition Decreased appetite Very Common 12
Slovenian: Presnovne in prehranske motnje zmanjšan apetit zelo pogosti hiperglikemija pogosti hipoglikemija dehidracija
English: No formal studies of daratumumab in patients with renal impairment have been conducted.
Slovenian: Formalnih študij uporabe daratumumaba pri bolnikih z okvaro ledvic niso izvajali.
English: Study MMY3007, an open-label, randomised, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib, melphalan and prednisone (D-VMP), to treatment with VMP in patients with newly diagnosed multiple myeloma.
Slovenian: V študiji MMY3007, odprti, randomizirani, aktivno nadzorovani študiji faze III, so primerjali zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z bortezomibom, melfalanom in prednizonom (D-VMP) z zdravljenjem z VMP pri bolnikih z novo odkritim diseminiranim plazmocitomom.
English: HBV screening should be performed in all patients before initiation of treatment with DARZALEX.
Slovenian: Pred uvedbo zdravljenja z zdravilom DARZALEX, je treba pri vseh bolnikih preveriti prisotnost virusa HBV.
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab.
Slovenian: Ena viala s 5 ml koncentrata vsebuje 100 mg daratumumaba.
English: Talk to your doctor or nurse before you are given DARZALEX if you are pregnant, think you might be pregnant or are planning to have a baby.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo DARZALEX.
English: Additional efficacy results from Study MMY3008 are presented in Table 7 below.
Slovenian: Dodatni rezultati učinkovitosti iz študije MMY3008 so prikazani v preglednici 7.
English: On the days of DARZALEX infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication.
Slovenian: V dneh, ko so bolniki prejemali infuzijo zdravila DARZALEX, so deksametazon prejemali kot premedikacijo pred infuzijo.
English: every two weeks (total of 8 doses)
Slovenian: 9. do 24. teden vsak drugi teden (skupno 8 odmerkov)
English: What DARZALEX contains
Slovenian: Kaj vsebuje zdravilo DARZALEX
English: Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.
Slovenian: Veže se na protein CD38, ki je v veliki meri prisoten na površini tumorskih celic diseminiranega plazmocitoma, v različnih merah pa tudi na drugih vrstah celic in tkiv.
English: Weeks 1 to 8
Slovenian: 1. do 8. teden enkrat tedensko (skupno 8 odmerkov)
English: Bortezomib was administered by SC injection or IV infusion at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11)
Slovenian: Bortezomib so prejemali s subkutanimi injekcijami ali z intravenskimi infuzijami v odmerku 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v več 21-dnevnih (3-tedenskih) krogih, skupno 8 krogov zdravljenja.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija zelo pogosti trombocitopenija anemija limfopenija levkopenija
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.
Slovenian: In 12. dan vsakega od 8 krogov z bortezomibom (80 mg/teden v dveh od treh tednov kroga z boretzomibom) ali zmanjšan odmerek 20 mg/teden pri bolnikih, ki so bili stari več kot 75 let, so imeli indeks telesne mase [ITM] <18,5, slabo urejeno sladkorno bolezen ali predhodno niso prenašali zdravljenja s kortikosteroidi.
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab (20 mg/mL).
Slovenian: Ena viala z 20 ml koncentrata vsebuje 400 mg daratumumaba (20 mg/ml).
English: What DARZALEX looks like and contents of the pack
Slovenian: Shranjevanje zdravila DARZALEX Vsebina pakiranja in dodatne informacije
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab.
Slovenian: Ena viala z 20 ml koncentrata vsebuje 400 mg daratumumaba.
English: Additional efficacy results from Study MMY3003 are presented in Table 11 below.
Slovenian: Drugi rezultati učinkovitosti iz študije MMY3003 so prikazani spodaj v preglednici 11.
English: Seventy-four percent of patients had received prior ASCT.
Slovenian: Štiriinsedemdesetim odstotkom bolnikov so predhodno opravili avtologno presaditev krvotvornih matičnih celic.
English: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Slovenian: Ena 5-mililitrska viala vsebuje 100 mg daratumumaba (20 mg daratumumaba na mililiter).
English: Additional efficacy results from Study MMY3007 are presented in Table 8 below.
Slovenian: Drugi rezultati učinkovitosti iz študije MMY3007 so prikazani spodaj v preglednici 8.
English: No formal studies of daratumumab in patients with hepatic impairment have been conducted.
Slovenian: Formalnih študij uporabe daratumumaba pri bolnikih z okvaro jeter niso izvajali.
English: Patients should be pre-medicated with antihistamines, antipyretics and corticosteroids to reduce the risk of IRRs prior to treatment with DARZALEX.
Slovenian: Za zmanjševanje tveganja za infuzijske reakcije morajo bolniki pred odmerjanjem zdravila DARZALEX prejeti premedikacijo z antihistaminiki, antipiretiki in kortikosteroidi.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu zelo pogosti mišični krči
English: Study MMY3008, an open-label, randomized, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with newly diagnosed multiple myeloma.
Slovenian: V študiji MMY3008, odprti, randomizirani, aktivno nadzorovani študiji faze III, so primerjali zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z lenalidomidom in majhnimi odmerki deksametazona (DRd) z zdravljenjem z lenalidomidom in majhnimi odmerki deksametazona (Rd) pri bolnikih z novo odkritim diseminiranim plazmocitomom.
English: Atrial fibrillation Common
Slovenian: Srčne bolezni atrijska fibrilacija pogosti
English: Pre-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) prior to treatment with DARZALEX.
Slovenian: Za zmanjšanje tveganja za infuzijske reakcije je treba bolnikom pred infundiranjem zdravila DARZALEX aplicirati premedikacijska zdravila.
English: Table 6: Adverse reactions in multiple myeloma patients treated with DARZALEX
Slovenian: Preglednica 6: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z zdravilom DARZALEX 16 mg/kg
English: Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Slovenian: Ena 20-mililitrska viala vsebuje 400 mg daratumumaba (20 mg daratumumaba na mililiter).
English: Table 11: Additional efficacy results from Study MMY3003 Response evaluable patient number
Slovenian: Preglednica 11: Drugi rezultati učinkovitosti iz študije MMY3003 Število bolnikov z ocenljivim odzivom DRd (n=281)
English: • itchy, runny or blocked nose
Slovenian: • srbenje ali izcedek iz nosu ali zamašen nos
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.
Slovenian: Zato čas shranjevanja (vključno s časom infundiranja) razredčene raztopine pri sobni temperaturi (od 20 °C do 25 °C) in sobni osvetlitvi ne sme presegati 15 ur.
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.
Slovenian: Pri bolnikih z diseminirnim plazmocitomom, ki so prejemali daratumumab v kombinacijah z drugimi zdravili, so izvedli tri dodatne analize populacijske farmakokinetike (2., 3. in 4. analizo).
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-4-week dosing schedule is given at Week 25
Slovenian: od 25. tedna dalje do napredovanja bolezni b vsak četrti teden prvi odmerek po razporedu enkrat na 2 tedna prejme bolnik v 9. tednu prvi odmerek po razporedu enkrat na 4 tedne prejme bolnik v 25. tednu
English: First dose of the every-3-week dosing schedule is given at Week 10 First dose of the every-4-week dosing schedule is given at Week 25
Slovenian: od 25. tedna dalje do napredovanja bolezni b vsak četrti teden prvi odmerek po razporedu enkrat na 3 tedne prejme bolnik v 10. tednu prvi odmerek po razporedu enkrat na 4 tedne prejme bolnik v 25. tednu
English: Figure 3: Kaplan-Meier Curve of PFS in Study MMY3003
Slovenian: Slika 2: Kaplan-Meierjeva krivulja PFS v študiji MMY3007
English: Odds ratio with 95% CI
Slovenian: b razmerje obetov s 95-odstotnim IZ vrednost-p
English: Study MMY3003, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Slovenian: V študiji MMY3003, odprti, randomizirani, aktivno nadzorovani študiji faze III, so primerjali zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z lenalidomidom in majhnimi odmerki deksametazona (DRd) z zdravljenjem z lenalidomidom in majhnimi odmerki deksametazona (Rd) pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno predhodno zdravljenje.
English: Study MMY3004 demonstrated an improvement in PFS in the DVd arm as compared to the Vd arm; the median PFS had not been reached in the DVd arm and was 7.2 months in the Vd arm (HR [95% CI]: 0.39 [0.28, 0.53]; p-value<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with DVd versus Vd.
Slovenian: Mediana PFS v skupini DVd ni bila dosežena, v skupini Vd pa je znašala 7,2 meseca (razmerje ogroženosti [95-odstotni IZ]: 0,39 [0,28; 0,53]; vrednostp<0,0001), kar predstavlja 61% zmanjšanje tveganja za napredovanje bolezni ali za smrt pri bolnikih, zdravljenih z DVd v primerjavi z Vd (glejte sliko 4).
English: Concentrate for solution for infusion.
Slovenian: Razmislite lahko tudi o uporabi genotipizacije.
English: Weeks 1, 2, 4 and 5 for the first 6-week cycle (Cycle 1; 8 doses), followed by once weekly administrations at Weeks 1, 2, 4 and 5 for eight more 6-week cycles (Cycles 2-9; 4 doses per cycle).
Slovenian: Bortezomib so prejemali s subkutanimi injekcijami v odmerku 1,3 mg/m2 telesne površine dvakrat na teden v 1., 2., 4. in 5. tednu prvega 6-tedenskega kroga zdravljenja (1. krog; 8 odmerkov), nato pa so ga prejemali enkrat na teden v 1., 2., 4. in 5. tednu nadaljnjih osem 6-tedenskih krogov zdravljenja (2. do 9. krog; 4 odmerki na krog).
English: No clinically important differences in the exposure to daratumumab were observed between patients with hepatic impairment and those with normal hepatic function.
Slovenian: Med bolniki z okvaro jeter in tistimi z normalno jetrno funkcijo niso opažali klinično pomembnih razlik v izpostavljenosti daratumumabu.
English: • inflamed pancreas
Slovenian: • okužba sečil
English: First dose of the every-3-week dosing schedule is given at Week 7 First dose of the every-4-week dosing schedule is given at Week 55
Slovenian: od 55. tedna dalje do napredovanja bolezni b vsak četrti teden prvi odmerek po razporedu enkrat na 3 tedne prejme bolnik v 7. tednu prvi odmerek po razporedu enkrat na 4 tedne prejme bolnik v 55. tednu
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.
Slovenian: Rezultati študije MMY3004 so pokazali izboljšano preživetje brez napredovanja bolezni (PFS) v skupini DVd v primerjavi s skupino Vd.
English: Patients should be typed and screened prior to starting daratumumab treatment.
Slovenian: Pred začetkom zdravljenja z daratumumabom je treba opraviti tipizacijo in presejanje krvi.
English: Study MMY3004, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib and dexamethasone (DVd), to treatment with bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Slovenian: V študiji MMY3004, odprti, randomizirani, z učinkovino nadzorovani študiji faze III, so primerjali zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z bortezomibom in deksametazonom (DVd) z zdravljenjem z bortezomibom in deksametazonom (Vd) pri bolnikih, ki so imeli diseminirani plazmocitom in so že prejeli najmanj eno predhodno zdravljenje.
English: Dyspnoea Pulmonary oedema
Slovenian: • vnetje trebušne slinavke
English: Gastrointestinal disorders Diarrhoea
Slovenian: Profilaksa reaktivacije virusa herpes zoster
English: Maximum rate
Slovenian: Celokupna stopnja odziva
English: Do not use if opaque particles, discolouration or other foreign particles are present.
Slovenian: Če je barva raztopine spremenjena ali vsebuje neprozorne ali tuje delce, je ne smete uporabiti.
English: Odds ratio with 95% CI p-value
Slovenian: b razmerje obetov (OR) s 95-odstotnim IZ Vrednost-p
English: Your doctor may decide not to use DARZALEX if you have a strong infusion reaction.
Slovenian: Če doživite hudo infuzijsko reakcijo, se vaš zdravnik lahko odloči, da vam ne bo več dajal zdravila DARZALEX.
English: Glacial acetic acid Mannitol (E421) Polysorbate 20
Slovenian: 6.1 Seznam pomožnih snovi koncentrirana ocetna kislina manitol (E421) polisorbat 20 natrijev acetat trihidrat natrijev klorid voda za injekcije
English: Less than 1% of patients had a Grade 3/4 infusion-related reaction with the Week 2 or subsequent infusions.
Slovenian: Pri infuziji v 2. tednu ali nadaljnjih infuzijah se je infuzijska reakcija 3./4.
English: DARZALEX infusion should be interrupted for IRRs of any severity and medical management/supportive treatment for IRRs should be instituted as needed.
Slovenian: Ob pojavu infuzijske reakcije je treba ne glede na njeno intenzivnost prekiniti infundiranje zdravila DARZALEX in po potrebi uvesti ustrezno podporno zdravljenje.
English: Dilution volume
Slovenian: • zvišana telesna temperatura
English: DARZALEX therapy should be discontinued immediately and permanently (see sections 4.2 and 4.3).
Slovenian: Zdravljenje z zdravilom DARZALEX je treba takoj in trajno ukiniti.