FrancophonIA/ELRC3.0 huggingface dataset:
English: For dose and schedule of medicinal products administered with DARZALEX, see section 5.1 and the corresponding Summary of Product Characteristics.
Slovenian: Za odmerke in razpored odmerjanja zdravil, ki jih bolnik prejema skupaj z zdravilom DARZALEX, glejte poglavje 5.1 in ustrezen Povzetek glavnih značilnosti zdravila.
English: Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
Slovenian: In vitro je daratumumab sprožil apoptozo po navzkrižnem povezovanju, ki ga posreduje Fc fragment.
English: In responders, the median time to response was 1.05 months (range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3 months) in the Rd group.
Slovenian: Med bolniki z odzivom je bil mediani čas do odziva v skupini DRd 1,05 meseca (od 0,2 do 12,1 meseca) in v skupini Rd 1,05 meseca (od 0,3 do 15,3 meseca).
English: At baseline, 32% of patients were refractory to the last line of treatment.
Slovenian: Ob izhodišču je bilo 32% bolnikov neodzivnih na zadnjo linijo zdravljenja.
English: The mean (SD) central volume of distribution is 56.98 (18.07) mL/kg.
Slovenian: Povprečna vrednost centralnega volumna porazdelitve je 56,98 ml/kg (s standardnim odklonom 18,07 ml/kg.
English: Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
Slovenian: 2. možnost (infuzija z deljenim odmerkom) 1. teden 1. dan (8 mg/kg)
English: The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, dyspnoea, cough, neutropenia, thrombocytopenia, anaemia, oedema peripheral, asthenia, peripheral sensory neuropathy and upper respiratory tract infection.
Slovenian: Najpogostejši neželeni učinki (≥ 20%) so bile infuzijske reakcije, utrujenost, navzea, driska, obstipacija, zvišana telesna temperatura, dispneja, kašelj, nevtropenija, trombocitopenija, anemija, periferni edemi, astenija, periferna senzorična nevropatija in okužba zgornjih dihal.
English: Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
Slovenian: Uporabiti je treba komplet za apliciranje iz poliuretana (PU), polibutadiena (PBD), polivinilklorida (PVC), polipropilena (PP) ali polietilena (PE).
English: Following the last weekly infusion, Cmax increased in a greater than dose-proportional manner, consistent with target mediated drug disposition.
Slovenian: Cmax po zadnjem od odmerkov, ki so jih prejemali enkrat tedensko, je naraščala bolj kot sorazmerno z velikostjo odmerka, kar je v skladu s tarčno posredovanim razporejanjem zdravila.
English: • build up of fluid in the lungs making you short of breath
Slovenian: • zastajanje tekočine v pljučih, zaradi česar ste lahko zadihani
English: In the Phase III study MMY3007, which compared treatment with D-VMP to treatment with VMP in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was consistent with the overall population (see section 5.1).
Slovenian: V študiji faze III z oznako MMY3007, v kateri so primerjali zdravljenje z D-VMP z zdravljenjem z VMP pri bolnikih z novo odkritim diseminiranim plazmocitomom, ki niso bili primerni za avtologno presaditev matičnih celic, je bila analiza varnosti podskupine bolnikov z oceno ECOG 2 (D-VMP: n=89, VMP: n=84) podobna oceni v celokupni populaciji (glejte poglavje 5.1).
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.
Slovenian: Če po prvih štirih infuzijah ne pride do hudih infuzijskih reakcij, je po zdravnikovi presoji mogoče prenehati z odmerjanjem navedenih inhalacijskih zdravil.
English: Twenty-seven percent had International Staging System (ISS) Stage I, 43% had ISS Stage II and 29% had ISS Stage III disease.
Slovenian: Sedemindvajset odstotkov jih je imelo stadij I po mednarodnem sistemu razvrščanja v stadije bolezni (ISS), 43% jih je imelo ISS stadij II in 29% ISS stadij III.
English: DARZALEX can cause serious infusion related reactions (IRRs), including anaphylactic reactions (see section 4.8).
Slovenian: Zdravilo DARZALEX lahko povzroči hude infuzijske reakcije, vključno z anafilaktičnimi reakcijami (glejte poglavje 4.8).
English: Excipients: glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride, water for injections.
Slovenian: Pomožne snovi: koncentrirana ocetna kislina, manitol (E421), polisorbat 20, natrijev acetat trihidrat, natrijev klorid, voda za injekcije.
English: The effect of daratumumab on the QTc interval was evaluated in an open-label study for 83 patients (Study GEN501) with relapsed and refractory multiple myeloma following daratumumab infusions (4 to 24 mg/kg).
Slovenian: Učinek daratumumaba na interval QTc so ocenjevali v odprti študiji (študija GEN501) pri 83 bolnikih s ponovljenim in neodzivnim diseminiranim plazmocitomom po infundiranju daratumumaba (v odmerku 4-24 mg/kg).
English: • The other ingredients are glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride and water for injections (see “DARZALEX contains sodium” in section 2).
Slovenian: • Druge sestavine zdravila so koncentrirana ocetna kislina, manitol (E421), polisorbat 20, natrijev acetat trihidrat, natrijev klorid in voda za injekcije (glejte odstavek “Zdravilo DARZALEX vsebuje natrij” v poglavju 2).
English: A total of 498 patients were randomised; 251 to the DVd arm and 247 to the Vd arm.
Slovenian: Skupno so randomizirali 498 bolnikov: 251 v skupino DVd in 247 v skupino Vd.
English: Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Slovenian: Raztopine ne uporabljajte, če vsebuje vidne neprozorne ali tuje delce ali če je spremenjene barve.
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.
Slovenian: Rezultati načrtovane vmesne analize so pokazali, da je zdravljenje z daratumumabom v odmerku 16 mg/kg omogočilo ORR 36%, pri čemer je bila stopnja popolnega odziva (CR) 5%, stopnja zelo dobrega delnega odziva (VPGR) pa 5%.
English: Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
Slovenian: Po mednarodnem sistemu razvrščanja v stadije bolezni (ISS) jih je imelo štirideset odstotkov stadij I, 45% jih je imelo ISS stadij II in 15% ISS stadij III.
English: The clinical efficacy and safety of DARZALEX monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had demonstrated disease progression on the last therapy, was demonstrated in two open-label studies.
Slovenian: Klinično učinkovitost in varnost zdravila DARZALEX v monoterapiji pri zdravljenju odraslih bolnikov s ponovljenim in neodzivnim diseminiranim plazmocitomom, pri katerih je predhodno zdravljenje vključevalo zaviralec proteasoma in imunomodulatorno zdravilo in pri katerih je bolezen po zadnji terapiji napredovala, so dokazali v dveh odprtih študijah.
English: No dose reduction of DARZALEX is recommended.
Slovenian: Zmanjševanje odmerka zdravila DARZALEX ni priporočljivo.
English: Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
Slovenian: O postopnem povečevanju hitrosti infundiranja lahko razmislite le, če bolnik ni imel nobene infuzijske reakcije.
English: For information on the VMP dose and dosing schedule when administered with DARZALEX, see section 5.1.
Slovenian: Za podatke o odmerkih zdravljenja z VMP in o razporedu odmerjanja sočasno z zdravilom DARZALEX glejte poglavje 5.1.
English: The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours).
Slovenian: Mediani čas do nastopa reakcije je bil 1,5 ure (od 0 do 72,8 ure).
English: Sixty-nine percent (69%) of patients had received a prior PI (66% received bortezomib) and 76% of patients received an IMiD (42% received lenalidomide).
Slovenian: Devetinšestdeset odstotkov (69%) bolnikov je predhodno prejemalo zaviralec proteasoma (66% jih je prejemalo bortezomib) in 76% bolnikov je prejemalo imunomodulirajoče zdravilo (42% jih je prejemalo lenalidomid).
English: Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Slovenian: Druge neželene infuzijske reakcije so vključevale kongestijo nosne sluznice, kašelj, mrazenje, draženje žrela, bruhanje in navzeo (glejte poglavje 4.4).
English: Primary efficacy endpoint (International Myeloma Working Group criteria) CI=confidence interval; NE=not estimable; MR=minimal response
Slovenian: IZ=interval zaupanja; NMO=vrednosti ni mogoče oceniti; MR=minimalni odziv (minimal response)
English: Results of a PFS analysis by censoring patients who were randomized to daratumumab maintenance in the second randomization, at the date of the second randomization showed HR=0.50; 95% CI: 0.34, 0.75; p=0.0005.
Slovenian: Rezultati PFS analize s krnenjem bolnikov, ki so bili randomizirani na vzdrževanje z daratumumabom v drugi randomizaciji, je na dan druge randomizacije pokazala razmerje ogroženosti=0,50; 95-odstotni IZ: 0,34, 0,75; p=0,0005.
English: Hrvatska Johnson & Johnson S.E.
Slovenian: Johnson & Johnson S.E.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila za redčenje zdravila pred apliciranjem glejte poglavje 6.6.
English: There is no known specific antidote for daratumumab overdose.
Slovenian: Specifični antidot za daratumumab ni znan.
English: Week 1 Day 2 (8 mg/kg)
Slovenian: 1. teden 2. dan (8 mg/kg)
English: Dexamethasone 20 mg (or equivalent), administered prior to every DARZALEX infusion.
Slovenian: 20 mg deksametazona (ali drugega enakovrednega zdravila) pred vsako infuzijo zdravila DARZALEX.
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.
Slovenian: Mediana trajanja odziva v skupini DRd ni bila dosežena, v skupini Rd pa je bila 34,7 meseca (95-odstotni IZ: 30,8, zgornje meje ni bilo mogoče oceniti).
English: If you forget your appointment to have DARZALEX It is very important to go to all your appointments to make sure your treatment works.
Slovenian: Če pozabite priti na infuzijo zdravila DARZALEX Za uspešno zdravljene je zelo pomembno, da pridete na vsak dogovorjeni obisk.
English: With an overall median follow-up of 13.5 months, the hazard ratio for OS was 0.64 (95% CI: 0.40, 1.01; p=0.0534).
Slovenian: S skupnim medianim trajanjem spremljanja 13,5 meseca je bilo razmerje ogroženosti za celokupno preživetje 0,64 (95-odstotni IZ: 0,40, 1,01; p=0,0534).
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%.
Slovenian: Študije pri novo odkritih bolnikih D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
English: Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Slovenian: Bortezomib se daje dvakrat na teden v 1., 2., 4. in 5. tednu v prvem 6-tedenskem krogu, nato pa enkrat na teden v 1., 2., 4. in 5. tednu naslednjih osem 6-tedenskih krogov.
English: • Grade 3 (severe): Once reaction symptoms resolve, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred.
Slovenian: • Reakcija stopnje 3 (huda): Ko simptomi reakcije izzvenijo, se lahko razmisli o ponovnem začetku infundiranja s hitrostjo, ki ne presega polovične vrednosti hitrosti infundiranja, pri kateri je do infuzijske reakcije prišlo.
English: If the patient does not experience any further IRR symptoms, infusion rate escalation may be resumed at increments and intervals as clinically appropriate up to the maximum rate of 200 mL/hour (Table 5).
Slovenian: Če bolnik nima več nobenih novih simptomov infuzijske reakcije, se lahko v klinično primernih korakih in intervalih hitrost infundiranja spet poveča do največje hitrosti 200 ml/h (preglednica 5).
English: If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 5).
Slovenian: Če bolnik nima več nobenih novih simptomov infuzijske reakcije, lahko v primernih korakih in intervalih hitrost infundiranja spet povečate (preglednica 5).
English: A total of 737 patients were randomized: 368 to the DRd arm and 369 to the Rd arm.
Slovenian: Skupno so randomizirali 737 bolnikov: 368 v skupino DRd in 369 v skupino Rd.
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.
Slovenian: V študiji MMY1001 so bolnikom, ki so prejemali kombinirano zdravljenje z daratumumabom (n=97), dajali prvi odmerek 16 mg/kg daratumumaba v 1. tednu razdeljeno v dveh dneh, kar pomeni, da so 1. dan prejeli odmerek 8 mg/kg in 2. dan prav tako odmerek 8 mg/kg.
English: Interference with Serum Protein Electrophoresis and Immunofixation Tests Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein).
Slovenian: Vpliv na elektroforezo serumskih proteinov in imunofiksacijo Daratumumab lahko zaznamo z elektroforezo serumskih proteinov in imunofiksacijo, ki se uporabljata za spremljanje monoklonskega imunoglobulina pri diseminiranem plazmocitomu (M-protein).
English: At a survival update with a median duration of follow-up of 15.2 months, median OS was not reached (95% CI: 19.9 months, not estimable), with 74% of subjects still alive.
Slovenian: Pri posodobitvi podatkov za oceno preživetja bolnikov po medianem trajanju sledenja bolnikom 15,2 meseca mediana trajanja celokupnega preživetja ni bila dosežena (95-odstotni IZ: 19,9 meseca, zgornje meje ni bilo mogoče oceniti), pri čemer je bilo 74% preiskovancev še živih.
English: A total of 569 patients were randomised; 286 to the DRd arm and 283 to the Rd arm.
Slovenian: Skupno so randomizirali 569 bolnikov: 286 v skupino DRd in 283 v skupino Rd.
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL
Slovenian: koncentrat za raztopino za infundiranje 1 viala, 100 mg/5 ml
English: • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient weight.
Slovenian: • Izračunajte, kolikšen odmerek zdravila (v mg), kolikšen volumen DARZALEX koncentrata za raztopino za infundiranje (v ml) in koliko vial zdravila DARZALEX potrebujete glede na bolnikovo telesno maso.
English: Dexamethasone (oral or intravenous) was administered at 40 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23 of Cycles 1 and 2, and at 40 mg on Days 1-2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16) of Cycles 3-4.
Slovenian: Deksametazon (peroralni ali intravenski) so prejemali v odmerku 40 mg na 1., 2., 8., 9., 15., 16., 22. in 23. dan 1. in 2. kroga ter v odmerku 40 mg na 1. in 2. dan in 20 mg na naslednje dni odmerjanja (na 8., 9., 15. in 16. dan) 3. in 4. kroga.
English: Table 5: Infusion rates for DARZALEX (16 mg/kg) administration
Slovenian: Preglednica 5: Hitrosti infundiranja pri odmerjanju zdravila DARZALEX (16 mg/kg)
English: Prepare the solution for infusion using aseptic technique as follows:
Slovenian: Raztopino za infundiranje pripravite v aseptičnih pogojih po naslednjih navodilih:
English: In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Slovenian: V nekaterih primerih lahko pride do hude infuzijske reakcije, ki lahko vključuje otekanje obraza, ustnic, ust, jezika ali grla, težko požiranje ali dihanje ali srbeč izpuščaj (koprivnica).
English: Gender did not affect exposure of daratumumab to a clinically relevant degree in the population PK analyses.
Slovenian: Spol ni v klinično pomembni meri vplival na izpostavljenost daratumumabu pri nobeni od analiz populacijske farmakokinetike.
English: Women of child-bearing potential should use effective contraception during, and for 3 months after cessation of daratumumab treatment.
Slovenian: Ženske v rodni dobi morajo v času zdravljenja z daratumumabom in še 3 mesece po prekinitvi zdravljenja z njim uporabljati učinkovito kontracepcijo.
English: Table 7: Additional efficacy results from Study MMY3008
Slovenian: Preglednica 7: Dodatni rezultati učinkovitosti iz študije MMY3008
English: Option 1 (Single dose infusion)
Slovenian: Infuzija v 1. tednu 1. možnost (enkratna infuzija z )
English: • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Slovenian: • kot monoterapija za zdravljenje odraslih bolnikov s ponovljenim in neodzivnim diseminiranim plazmocitomom, pri katerih je predhodno zdravljenje vključevalo zaviralec proteasoma in imunomodulatorno zdravilo in ob katerih je prišlo do napredovanja bolezni ob prejemanju zadnjega zdravljenja.
English: The majority were white (92%), male (52%), 34% had an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 49.5% had an ECOG performance score of 1 and 17% had an ECOG performance score of ≥2.
Slovenian: Večina bolnikov je bila belcev (92%), moškega spola (52%), 34% bolnikov je imelo oceno stanja zmogljivosti ECOG (Eastern Cooperative Oncology Group) 0, 49,5% jih je imelo oceno ECOG 1 in 17% jih je imelo oceno ECOG ≥2.
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.
Slovenian: To pri bolnikih z IgGκ lahko povzroči lažno pozitiven izvid elektroforeze serumskih proteinov in imunofiksacije, kar lahko vpliva na začetno oceno popolnega odziva po IMWG kriterijih.
English: These studies suggest that daratumumab can induce tumour cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis in malignancies expressing CD38.
Slovenian: Kot kažejo te študije, lahko daratumumab sproži lizo tumorskih celic z od komplementa odvisno citotoksičnostjo, od protiteles odvisno celično posredovano citotoksičnostjo in od protiteles odvisno celično fagocitozo pri malignih boleznih z izraženim proteinom CD38.
English: Before each infusion of DARZALEX you will be given medicines which help to lower the chance of infusion-related reactions.
Slovenian: Pred vsako infuzijo zdravila DARZALEX boste prejeli zdravila, ki zmanjšajo možnost pojava infuzijskih reakcij.
English: The median time to onset of a reaction was 1.8 hours (range: 0.1 to 5.4 hours).
Slovenian: Mediani čas do nastopa reakcije je bil 1,8 ure (od 0,1 do 5,4 ure).
English: When DARZALEX dosing was interrupted in the setting of ASCT (Study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT.
Slovenian: Ko so odmerjanje zdravila DARZALEX prekinili zaradi avtologne presaditve matičnih celic (v študiji MMY3006) za mediano 3,75 meseca (od 2,4 do 6,9 meseca), je bila ob prvi infuziji pri ponovni uvedbi zdravila DARZALEX po avtologni presaditvi matičnih celic pojavnost infuzijskih reakcij 11%.
English: If you miss an appointment, make another one as soon as possible.
Slovenian: Če pozabite ali ne morete priti na infuzijo zdravila, se čimprej dogovorite za drug datum.
English: DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
Slovenian: Zdravilo DARZALEX lahko prejemate kot samostojno zdravilo ali skupaj z drugimi zdravili, ki jih uporabljamo za zdravljenje diseminiranega plazmocitoma.
English: For patients with Grade 1, 2, or 3 IRRs, the infusion rate should be reduced when re-starting the infusion.
Slovenian: Pri ponovni uvedbi infuzije bolnikom z infuzijskimi reakcijami 1., 2. ali 3. stopnje je treba infuzijo začeti z zmanjšano hitrostjo infundiranja.
English: Toxicology data have been derived from studies with daratumumab in chimpanzees and with a surrogate anti-CD38 antibody in cynomolgus monkeys.
Slovenian: Toksikološki podatki so pridobljeni z raziskavami daratumumaba pri šimpanzih in z uporabo nadomestnih protiteles proti proteinu CD38 pri opicah cinomolgus.
English: In patients who develop reactivation of HBV while on DARZALEX, suspend treatment with DARZALEX and institute appropriate treatment.
Slovenian: Bolnikom, pri katerih pride do reaktivacije HBV med zdravljenjem z zdravilom DARZALEX, je treba zdravljenje z zdravilom DARZALEX prekiniti in uvesti ustrezno zdravljenje.
English: The median duration of response had not been reached in the D-VMP group and was 21.3 months (range: 18.4, not estimable) in the VMP group.
Slovenian: Mediana trajanja odziva v skupini D-VMP ni bila dosežena, v skupini VMP pa je bila 21,3 meseca (od 18,4, zgornje meje ni bilo mogoče oceniti).
English: It should be recognised that daratumumab bound to RBCs may mask detection of antibodies to minor antigens in the patient's serum.
Slovenian: Treba je vedeti, da na eritrocite vezani daratumumab lahko moti določanje protiteles proti manjšim antigenom v bolnikovem serumu.
English: DARZALEX is also supplied as an initiation pack containing 11 vials: (6 x 5 mL vials + 5 x 20 mL vials).
Slovenian: Zdravilo DARZALEX je na voljo tudi v pakiranju za uvedbo zdravljenja in vsebuje 11 vial (6 x 5 ml vial + 5 x 20 ml vial).
English: For patients with evidence of positive HBV serology, monitor for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of DARZALEX treatment.
Slovenian: Bolnike s pozitivnim izvidom serološke preiskave na HBV je treba spremljati glede kliničnih in laboratorijskih znakov HBV med zdravljenjem in še najmanj šest mesecev po zaključku zdravljenja z zdravilom DARZALEX in jih zdraviti skladno s trenutno veljavnimi kliničnimi smernicami.
English: Warnings and precautions Talk to your doctor or nurse before you are given DARZALEX:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom prejemanja zdravila DARZALEX se posvetujte z zdravnikom ali medicinsko sestro:
English: Dose adjustments for lenalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Slovenian: Pri prilagajanju odmerka lenalidomida in deksametazona so upoštevali proizvajalčeve informacije za predpisovanje zdravila.
English: These reactions are very common (may affect more than 1 in 10 people):
Slovenian: Te reakcije so zelo pogoste (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Stringent complete response (sCR)
Slovenian: vrednost p strog popolni odziv (sCR)
English: The median age was 58 (range: 22 to 65) years.
Slovenian: Mediana starost bolnikov je bila 58 let (od 22 do 65 let).
English: Phenotyping may be considered prior to starting daratumumab treatment as per local practice.
Slovenian: V skladu z lokalno prakso se lahko pred začetkom zdravljenja z daratumumabom razmisli o fenotipizaciji.
English: • Severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives).
Slovenian: • huda alergijska reakcija, ki jo lahko spremlja otekanje obraza, ustnic, ust, jezika ali grla, težko požiranje ali dihanje ali srbeč izpuščaj (koprivnica)
English: The majority were white (85%), female (54%), 25% had an ECOG performance score of 0, 50% had an ECOG performance score of 1 and 25% had an ECOG performance score of 2.
Slovenian: Večina je bila belcev (85%), žensk je bilo 54%, 25% bolnikov je imelo oceno stanja zmogljivosti ECOG 0, 50% jih je imelo oceno ECOG 1 in 25% jih je imelo oceno ECOG 2.