natgillin/translations-raw huggingface dataset:
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.
Pri bolnikih z anamnezo kronične obstruktivne pljučne bolezni je treba razmisliti tudi o uporabi dodatnih zdravil po infuziji, med drugim kratko in dolgo delujočih bronhodilatatorjev in inhalacijskih kortikosteroidov.
Eighteen percent (18%) of patients were refractory to a PI only, and 21% were refractory to bortezomib.
Osemnajst odstotkov (18%) bolnikov je bilo neodzivnih samo na zaviralec proteasoma, 21% pa jih je bilo neodzivnih na bortezomib.
The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Stopnji vsaditve in hematopoetske rekonstitucije po presaditvi sta bili podobni pri bolnikih v skupinah D-VTd in VTd (v skupini D-VTd: 99,8%; v skupini VTd: 99,6% glede na izmerjeno obnovitev števila nevtrofilcev na > 0,5 x 10
Discard any unused portion left in the vial.
Neporabljen preostanek zdravila v viali zavrzite.
All patients were ≤ 65 years: 43% were in the age group ≥ 60-65 years, 41% were in the age group ≥ 50-60 years and 16% below age of 50 years.
Vsi bolniki so bili stari ≤ 65 let: 43% jih je bilo v starostni skupini ≥ 60-65 let, 41% jih je bilo v starostni skupini ≥ 50-60 let, 16% bolnikov pa je bilo starih manj kot 50 let.
Thalidomide was administered orally at 100 mg daily during the six bortezomib cycles.
Talidomid so prejemali peroralno v odmerku 100 mg enkrat na dan v šestih krogih z bortezomibom.
Other common symptoms (affecting up to 1 in 10 people) are:
Drugi pogosti simptomi (pojavijo se pri največ 1 od 10 bolnikov) so:
• dizziness or lightheadedness (hypotension)
• omotičnost ali občutek slabosti pred omedlevico (hipotenzija)
Patients had IgG/IgA/Light chain myeloma in 64%/22%/10% of instances, 19% had ISS Stage I, 42% had ISS Stage II, 38% had ISS Stage III disease and 84% had standard risk cytogenetics.
Bolniki so imeli plazmocitom z IgG/IgA/lahkimi verigami v 64%/22%/10% primerov, po mednarodnem sistemu razvrščanja v stadije bolezni (ISS) jih je imelo 19% stadij I, 42% stadij II in 38% stadij III, 84% pa je imelo prisotne standardne neugodne citogenetske spremembe.
In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Poleg tega je daratumumab vplival tudi na encimsko aktivnost proteina CD38, in sicer je zaviral ciklazno encimsko aktivnost in stimuliral hidrolazno aktivnost.
Adverse reaction Frequency Incidence (%) Any Grade Grade 3-4
Pojavnost (%) vse stopnje stopnja
1 vial, 400 mg/20 mL
1 viala, 400 mg/20 ml
• medicines for inflammation (corticosteroids)
• zdravila proti vnetju (kortikosteroide),
Combination treatment with bortezomib:
Kombinirano zdravljenje z bortezomibom:
From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če metoda odpiranja oziroma redčenja izključuje tveganje za kontaminacijo z mikrobi.
This is equivalent to 1.86% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 1,86% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3).
Pred vsako infuzijo zdravila DARZALEX in po njej boste prejeli zdravila, ki lahko zmanjšajo možnost infuzijske reakcije (glejte odstavek “Zdravila, ki jih boste prejemali med zdravljenjem z zdravilom DARZALEX” v poglavju 3).
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca odgovornega za sproščanje serij
Prior therapies included bortezomib (99%), lenalidomide (99%), pomalidomide (63%) and carfilzomib (50%).
Predhodno zdravljenje je vključevalo bortezomib (99%), lenalidomid (99%), pomalidomid (63%) in karfilzomib (50%).
Melphalan at 9 mg/m2, and prednisone at 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9).
Melfalan v odmerku 9 mg/m2 in prednizon v odmerku 60 mg/m2 so bolniki prejemali peroralno na 1. do 4. dan devetih 6-tedenskih krogov zdravljenja (1.-9. krog).
Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of DARZALEX as follows:
Za zmanjševanje tveganja za infuzijske reakcije je treba vsem bolnikom 1-3 ure pred vsako infuzijo zdravila DARZALEX aplicirati:
Changes in hepatic function are unlikely to have any effect on the elimination of daratumumab since IgG1 molecules such as daratumumab are not metabolised through hepatic pathways.
Po vsej verjetnosti razlike v delovanju jeter ne vplivajo na izločanje daratumumaba, saj se molekule IgG1, kot je daratumumab, ne presnavljajo s procesi v jetrih.
A dilution volume of 500 mL for the 16 mg/kg dose should be used only if there were no IRRs the previous week.
Zdravilo je mogoče uporabiti z volumnom razredčitve 500 ml za odmerek 16 mg/kg samo v primeru, da v prvem tednu pri bolniku ni prišlo do infuzijske reakcije.
• Do not store any unused portion of the infusion solution for reuse.
• Neporabljeni preostanek infuzijske raztopine morate zavreči.
Figure 2:
Preglednica 3:
Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56
Pri zdravljenju z daratumumabom so opažali zmanjšanje tako absolutnega števila kot odstotkov vseh celic NK (CD16+CD56+) in aktiviranih celic NK (CD16+CD56
To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively, see Table 5 below.
Za lažje odmerjanje se lahko prvi predpisani odmerek 16 mg/kg v 1. tednu razdeli na dva zaporedna dneva, 8 mg/kg na prvi dan in 8 mg/kg na drugi dan zdravljenja, glejte spodaj preglednico 5.
At baseline, 27% of patients were refractory to the last line of treatment.
Ob izhodišču je bilo 27% bolnikov neodzivnih na zadnjo linijo zdravljenja.
A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Skupno so randomizirali 706 bolnikov: 350 v skupino D-VMP in 356 v skupino VMP.
This is equivalent to 0.46% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 0,46% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Schedule
Razpored
In clinical trials (monotherapy and combination treatments; N=2066) the incidence of any grade infusion-related reactions was 37% with the first (16 mg/kg, Week 1) infusion of DARZALEX, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions.
V kliničnih študijah (monoterapije in kombiniranega zdravljenja; N=2066) je bila pojavnost infuzijskih reakcij katere koli stopnje ob prvi infuziji zdravila DARZALEX (16 mg/kg, 1. teden) 37%, pri infuziji v 2. tednu 2%, in pri nadaljnjih infuzijah kumulativno 6%.
In patients with persistent very good partial response, where daratumumab interference is suspected, consider using a validated daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient's serum, to facilitate determination of a complete response.
Kadar obstaja sum vpliva daratumumaba je treba pri bolnikih z dolgotrajnim zelo dobrim delnim odzivom, razmisliti o uporabi validiranih analiz imunofiksacije, specifičnih za daratumumab, da bi lahko razlikovali daratumumab od katerega koli drugega endogenega M-proteina v bolnikovem serumu in s tem omogočili določanje popolnega odziva
DARZALEX is supplied as a carton pack containing 1 glass vial.
Zdravilo DARZALEX je pakirano v škatli, v kateri je 1 steklena viala.
The Guide for HCP and Blood Banks shall contain the following key elements:
Vodnik za za zdravstvene delavce in krvno banko mora vsebovati naslednje ključne elemente:
The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Pojavnost infuzijskih reakcij katere koli stopnje je bila 42%, pri čemer je na 1. dan 1. tedna prišlo do infuzijske reakcije pri 36% bolnikov, na 2. dan 1. tedna pri 4% bolnikov, pri nadaljnjih infuzijah pa pri 8% bolnikov.
A total of 1085 patients were randomized: 543 to the D-VTd arm and 542 to the VTd arm.
Skupno so randomizirali 1085 bolnikov: 543 v skupino D-VTd in 542 v skupino VTd.
Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom DARZALEX boste morda utrujeni, kar lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
If not used immediately, in-use storage times and conditions are the responsibility of the user and should be no more than 24 hours at refrigerated conditions (2°C-8°C) protected from light, followed by 15 hours (including infusion time) at room temperature (15°C-25°C) and room light.
Če uporabnik zdravila ne uporabi takoj, je za čas in pogoje shranjevanja pripravljenega zdravila odgovoren sam. Čas shranjevanja v hladilniku (2°C-8°C) in zaščiteno pred svetlobo ne sme presegati 24 ur, zatem pa sme biti zdravilo 15 ur (vključno s časom infundiranja) pri sobni temperaturi (15°C-25°C) in sobni osvetlitvi.
Eighty percent of patients had received prior autologous stem cell transplantation (ASCT).
Osemdesetim odstotkom bolnikov so predhodno opravili avtologno presaditev krvotvornih matičnih celic.
Prophylaxis for herpes zoster virus reactivation Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Za preprečevanje reaktivacije virusa herpes zoster je treba razmisliti o profilaktični uporabi protivirusnih zdravil.
Terminal half-life increases with increasing dose and with repeated dosing.
Končni razpolovni čas izločanja se podaljšuje z velikostjo odmerka in s ponavljanjem odmerjanja.
The HCPs and Blood Banks educational materials, shall contain the following key elements:
Izobraževalna gradiva za zdravstvene delavce in krvno banko, ki vsebujejo naslednje ključne elemente:
For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Za podatke o zdravilih, ki jih bolnik prejema v kombinaciji z zdravilom DARZALEX, glejte ustrezen Povzetek glavnih značilnosti zdravila.
Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%).
Predhodno zdravljenje je vključevalo bortezomib (100%), lenalidomid (95%), pomalidomid (36%) in karfilzomib (19%).
For dose and schedule of medicinal products administered with DARZALEX, see section 5.1 and the corresponding Summary of Product Characteristics.
Za odmerke in razpored odmerjanja zdravil, ki jih bolnik prejema skupaj z zdravilom DARZALEX, glejte poglavje 5.1 in ustrezen Povzetek glavnih značilnosti zdravila.
Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
In vitro je daratumumab sprožil apoptozo po navzkrižnem povezovanju, ki ga posreduje Fc fragment.
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.
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).
At baseline, 32% of patients were refractory to the last line of treatment.
Ob izhodišču je bilo 32% bolnikov neodzivnih na zadnjo linijo zdravljenja.
The mean (SD) central volume of distribution is 56.98 (18.07) mL/kg.
Povprečna vrednost centralnega volumna porazdelitve je 56,98 ml/kg (s standardnim odklonom 18,07 ml/kg.
Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
2. možnost (infuzija z deljenim odmerkom) 1. teden 1. dan (8 mg/kg)
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.
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.
Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
Uporabiti je treba komplet za apliciranje iz poliuretana (PU), polibutadiena (PBD), polivinilklorida (PVC), polipropilena (PP) ali polietilena (PE).
Following the last weekly infusion, Cmax increased in a greater than dose-proportional manner, consistent with target mediated drug disposition.
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.
• build up of fluid in the lungs making you short of breath
• zastajanje tekočine v pljučih, zaradi česar ste lahko zadihani
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).
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).
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.
Če po prvih štirih infuzijah ne pride do hudih infuzijskih reakcij, je po zdravnikovi presoji mogoče prenehati z odmerjanjem navedenih inhalacijskih zdravil.
Twenty-seven percent had International Staging System (ISS) Stage I, 43% had ISS Stage II and 29% had ISS Stage III disease.
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.
DARZALEX can cause serious infusion related reactions (IRRs), including anaphylactic reactions (see section 4.8).
Zdravilo DARZALEX lahko povzroči hude infuzijske reakcije, vključno z anafilaktičnimi reakcijami (glejte poglavje 4.8).
Excipients: glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride, water for injections.
Pomožne snovi: koncentrirana ocetna kislina, manitol (E421), polisorbat 20, natrijev acetat trihidrat, natrijev klorid, voda za injekcije.
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).
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).
• 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).
• 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).
A total of 498 patients were randomised; 251 to the DVd arm and 247 to the Vd arm.
Skupno so randomizirali 498 bolnikov: 251 v skupino DVd in 247 v skupino Vd.
Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Raztopine ne uporabljajte, če vsebuje vidne neprozorne ali tuje delce ali če je spremenjene barve.
Pre-planned interim analysis showed that treatment with daratumumab at 16 mg/kg led to a 36% ORR with 5% CR and 5% VGPR.
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%.
Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
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.
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.
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.
No dose reduction of DARZALEX is recommended.
Zmanjševanje odmerka zdravila DARZALEX ni priporočljivo.
Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
O postopnem povečevanju hitrosti infundiranja lahko razmislite le, če bolnik ni imel nobene infuzijske reakcije.
For information on the VMP dose and dosing schedule when administered with DARZALEX, see section 5.1.
Za podatke o odmerkih zdravljenja z VMP in o razporedu odmerjanja sočasno z zdravilom DARZALEX glejte poglavje 5.1.
The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours).
Mediani čas do nastopa reakcije je bil 1,5 ure (od 0 do 72,8 ure).
Sixty-nine percent (69%) of patients had received a prior PI (66% received bortezomib) and 76% of patients received an IMiD (42% received lenalidomide).
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).
Other adverse infusion-related reactions included nasal congestion, cough, chills, throat irritation, vomiting and nausea (see section 4.4).
Druge neželene infuzijske reakcije so vključevale kongestijo nosne sluznice, kašelj, mrazenje, draženje žrela, bruhanje in navzeo (glejte poglavje 4.4).
Primary efficacy endpoint (International Myeloma Working Group criteria) CI=confidence interval; NE=not estimable; MR=minimal response
IZ=interval zaupanja; NMO=vrednosti ni mogoče oceniti; MR=minimalni odziv (minimal response)
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.
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.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Za navodila za redčenje zdravila pred apliciranjem glejte poglavje 6.6.
There is no known specific antidote for daratumumab overdose.
Specifični antidot za daratumumab ni znan.
Week 1 Day 2 (8 mg/kg)
1. teden 2. dan (8 mg/kg)
Dexamethasone 20 mg (or equivalent), administered prior to every DARZALEX infusion.
20 mg deksametazona (ali drugega enakovrednega zdravila) pred vsako infuzijo zdravila DARZALEX.
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.
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).
If you forget your appointment to have DARZALEX It is very important to go to all your appointments to make sure your treatment works.
Če pozabite priti na infuzijo zdravila DARZALEX Za uspešno zdravljene je zelo pomembno, da pridete na vsak dogovorjeni obisk.
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).
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).
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%.
Študije pri novo odkritih bolnikih D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
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.
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.
• 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.
• 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.
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).
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).
If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 5).
Če bolnik nima več nobenih novih simptomov infuzijske reakcije, lahko v primernih korakih in intervalih hitrost infundiranja spet povečate (preglednica 5).
A total of 737 patients were randomized: 368 to the DRd arm and 369 to the Rd arm.
Skupno so randomizirali 737 bolnikov: 368 v skupino DRd in 369 v skupino Rd.
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.
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.
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).
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).