natgillin/translations-raw huggingface dataset:
A decision should be made whether to discontinue breast-feeding or to discontinue DARZALEX therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba, ali prekiniti dojenje ali zdravljene z zdravilom DARZALEX, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za bolnico.
If an anaphylactic reaction or life-threatening (Grade 4) infusion reaction occurs, appropriate emergency resuscitation should be initiated immediately.
V primeru anafilaktične reakcije ali življenjsko nevarne infuzijske reakcije (4. stopnje) je treba takoj začeti s postopki oživljanja.
DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”.
Zdravilo DARZALEX uporabljamo za zdravljenje odraslih, starih 18 let ali več, ki imajo vrsto raka, ki ga imenujemo “diseminirani plazmocitom”.
• infections of the airways - such as nose, sinuses or throat
• okužbe dihalnih poti - kot so okužbe nosu, obnosnih votlin (sinusov) ali grla oziroma žrela
Alternatively, phenotyping or genotyping may also be considered (see section 4.4).
Razmislite lahko tudi o uporabi fenotipizacije ali genotipizacije (glejte poglavje 4.4).
Patients in the study had received a median of 4 prior lines of therapy.
Bolniki v študiji so predhodno prejeli mediano 4 linije zdravljenja.
The effect of daratumumab on newborns/infants is unknown.
Učinek daratumumaba na novorojenčke oziroma dojenčke ni znan.
Decreased blood cell counts
Zmanjšanje števila krvnih celic
Efficacy was evaluated by progression free survival (PFS) based on International Myeloma Working Group (IMWG) criteria.
Učinkovitost so vrednotili s trajanjem preživetja brez napredovanja bolezni (PFS - Progression Free Survival) po kriterijih mednarodne delovne skupine za plazmocitom (IMWG - International Myeloma Working Group).
What you need to know before you are given DARZALEX
Kaj morate vedeti, preden boste prejeli zdravilo DARZALEX
Combination treatment with lenalidomide:
Kombinirano zdravljenje z lenalidomidom:
Table 9: Efficacy results from Study MMY3006 D-VTd (n=543) VTd (n=542)
Preglednica 9: Rezultati učinkovitosti iz študije MMY3006 D-VTd (n=543) VTd (n=542)
Four percent of all patients had an IRR at more than one infusion.
Pri štirih odstotkih bolnikov se je infuzijska reakcija pojavila pri več kot eni infuziji zdravila.
Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Ženske, ki prejemajo zdravilo DARZALEX, morajo uporabljati učinkovito kontracepcijo med in še 3 mesece po zdravljenju.
Other medicines and DARZALEX
Druga zdravila in zdravilo DARZALEX
The usual starting dose of DARZALEX is 16 mg per kg of body weight.
Običajni začetni odmerek zdravila DARZALEX je 16 mg na kilogram telesne mase.
There are no human or animal data to assess the risk of daratumumab use during pregnancy.
Za oceno tveganja pri uporabi daratumumaba med nosečnostjo ni podatkov iz raziskav pri ljudeh ali živalih.
In patients receiving DARZALEX combination therapy, Grade 3 or 4 infections were reported as follows:
Pri bolnikih, ki so prejemali zdravilo DARZALEX v okviru kombiniranega zdravljenja, so o okužbah 3. ali 4. stopnje poročali, kot sledi:
Furthermore, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was also consistent with the overall population.
Poleg tega pa je bila tudi analiza varnosti v podskupini bolnikov z oceno stanja zmogljivosti ECOG 2 (D-VMP: n=89, VMP: n=84) podobna kot v celotni populaciji.
If you are given more DARZALEX than you should This medicine will be given by your doctor or nurse.
Če prejmete več zdravila DARZALEX, kot bi smeli To zdravilo vam bosta odmerjala zdravnik ali medicinska sestra.
It is not known whether daratumumab is excreted into human or animal milk.
Ni znano, ali se daratumumab pri ljudeh ali živalih izloča v materino mleko.
CARTON (100 mg/400 mg) FOR 1 VIAL COMPONENT AS INTERMEDIATE PACK/COMPONENT OF AN INITIATION PACK (WITHOUT BLUE BOX)
ŠKATLA (100 mg/400 mg) ZA 1 VIALO KOT VMESNO PAKIRANJE/DEL KOMPLETA ZA UVEDBO ZDRAVLJENJA (BREZ MODREGA OKENCA)
• Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
• antihistaminiki (25 do 50 mg difenhidramina peroralno ali intravensko ali drugo enakovredno zdravilo).
6/kg) and among those who completed mobilization, more patients in the D-VTd group received plerixafor compared to those in the VTd arm (D-VTd: 21.7%; VTd: 7.9%).
6/kg), med bolniki, pri katerih so dosegli zadostno mobilizacijo, je v skupini D-VTd prejemalo pleriksafor več bolnikov kot v skupini VTd (v skupini D-VTd: 21,7%; v skupini VTd: 7,9%).
This is a cancer of your bone marrow.
To je rak kostnega mozga.
Prior to the launch of DARZALEX (daratumumab) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, aiming at increasing awareness about the Important Identified Risk of “Interference for blood typing (minor antigen) (Positive Indirect Coombs' test)” and providing guidance on how to manage it.
Pred prihodom zdravila DARZALEX (daratumumab) na trg se mora imetnik dovoljenja za promet (imetnik) v vsaki državi članici dogovoriti glede vsebine in oblike izobraževalnih gradiv, katerih cilj je povečanje ozaveščenosti o pomembnem znanem tveganju vpliva na tipizacijo krvi (majhen antigen) (pozitiven indirektni Coombsov test) in zagotavljanje smernic za obvladovanje tega tveganja.
• Check that the DARZALEX solution is colourless to yellow.
• Preverite, da je raztopina z zdravilom DARZALEX brezbarvna do rumene barve.
Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells.
Daratumumab je zasnovan tako, da se v telesu veže na določene rakave celice zato, da jih vaš imunski sistem lahko uniči.
In Part 2, subjects with at least a partial response (PR) by Day 100 post-transplant were re-randomized in a 1:1 ratio to daratumumab maintenance or observation only.
V 2. delu so preiskovance z najmanj delnim odzivom (PR - Partial Response) do 100. dneva po transplantaciji randomizirali 1:1 na vzdrževanje z daratumumabom ali samo na opazovanje.
The European Medicines Agency has waived the obligation to submit the results of studies with DARZALEX in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom DARZALEX za vse podskupine pediatrične populacije za indikacijo diseminirani plazmocitom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.
Skupaj z zdravnikom bosta ocenila, ali so koristi zdravljenja s tem zdravilom večje od tveganja za vašega otroka.
Patients refractory to lenalidomide were excluded from the study.
Bolnikov, ki so bili neodzivni na lenalidomid, niso vključevali v študijo.
When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.
Kadar boste zdravilo DARZALEX prejemali skupaj z drugimi zdravili, bo zdravnik morda spremenil časovne presledke med odmerki in število krogov zdravljenja, ki jih morate prejeti.
Study MMY3006 is a 2 Part, open-label, randomized, active-controlled Phase 3 study.
Študija MMY3006, odprta randomizirana, aktivno nadzorovana študija faze 3 je bila sestavljena iz 2 delov.
The significance of these in vitro effects in a clinical setting, and the implications on tumour growth, are not well-understood.
Pomen teh in vitro mehanizmov za klinično uporabo in njihov vpliv na razmnoževanje tumorskih celic nista povsem pojasnjena.
There has been no experience of overdosage in clinical studies.
V kliničnih študijah ni bilo primerov prevelikega odmerjanja.
The procedure above should be repeated in the event of recurrence of Grade 3 symptoms.
Če se simptomi stopnje 3 ponovijo, je treba ponoviti zgoraj opisani postopek.
You and your doctor will decide if the benefit of breastfeeding is greater than the risk to your baby.
Skupaj z zdravnikom se bosta odločila ali je korist dojenja za vašega dojenčka večja od tveganja.
The data reflects exposure to DARZALEX (16 mg/kg) in 2066 patients with multiple myeloma including 1910 patients who received DARZALEX in combination with background regimens and 156 patients who received DARZALEX as monotherapy.
Podatki zajemajo izpostavljenost zdravilu DARZALEX (16 mg/kg) pri 2066 bolnikih z diseminiranim plazmocitomom, vključno s 1910 bolniki, ki so prejemali zdravilo DARZALEX v kombinaciji z osnovnimi shemami zdravljenja, in 156 bolnikov, ki so prejemali zdravilo DARZALEX kot monoterapijo.
Daratumumab concentration-time profiles were similar following the monotherapy and combination therapies.
Profili časovnega poteka koncentracij daratumumaba so bili pri zdravljenju v monoterapiji in kombiniranem zdravljenju podobni.
• Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.
• Zdravila DARZALEX ne smete infundirati sočasno z drugimi zdravili po isti intravenski liniji.
Daratumumab as a large protein has a low likelihood of direct ion channel interactions.
Ker je daratumumab velik protein, je verjetnost za neposredne interakcije z ionskimi kanalčki majhna.
• irregular heart beat (atrial fibrillation)
• motnje srčnega ritma (atrijska fibrilacija)
The simulation results confirmed that the split and single dosing for the first dose provide similar PK, with the exception of the PK profile in the first day of the treatment.
Rezultati teh simulacij potrjujejo, da odmerjanje prvega odmerka v dveh deljenih odmerkih zagotavlja podobno farmakokinetiko kot enkratno odmerjanje z izjemo farmakokinetičnega profila na prvi dan zdravljenja.
In addition, T-cell receptor DNA sequencing verified that T-cell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.
Poleg tega so s sekvencioniranjem DNK za T-celični receptor potrdili, da zdravljenje z daratumumabom poveča klonalnost limfocitov T, kar kaže na imunomodulatorno delovanje, ki lahko prispeva k doseganju kliničnega odziva.
Patients had received a median of 5 prior lines of therapy.
Bolniki so predhodno prejeli mediano 5 linij zdravljenja.
The baseline demographic and disease characteristics were similar between the DARZALEX and the control arm.
Izhodiščne demografske karakteristike in karakteristike bolezni so bile podobne v skupini z zdravilom DARZALEX in v kontrolni skupini.
In the active controlled studies, discontinuations from treatment due to infections (1-4%) and fatal infections were generally infrequent and balanced between the DARZALEX containing regimens and active control arms.
V aktivno nadzorovanih študijah prekinitve zdravljenja zaradi okužbe (1-4%) in okužbe s smrtnim izidom večinoma niso bile pogoste, njihova pogostnost je bila med skupinami, ki so prejemale zdravilo DARZALEX, in skupinami z aktivno kontrolo večinoma izenačena.
In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.
Če bi se zgodilo, da bi prejeli preveč zdravila (da bi prišlo do prevelikega odmerjanja), kar je sicer malo verjetno, vas bo zdravnik pregledal glede pojava neželenih učinkov.
The safety results of this subgroup were consistent with the overall population.
Tudi rezultati za oceno varnosti v tej skupini so bili podobni kot v celotni populaciji.
DARZALEX will be given to you by a doctor or nurse.
Zdravilo DARZALEX vam bosta dajala zdravnik ali medicinska sestra.
In clinical trials IRRs were reported in approximately half of all patients treated with DARZALEX.
V kliničnih študijah so o infuzijskih reakcijah so poročali pri približno polovici bolnikov, ki so prejemali zdravilo DARZALEX.
Efficacy results of the pre-planned interim analysis based on Independent Review Committee (IRC) assessment are presented in Table 10 below.
V Preglednici 10 so prikazani rezultati učinkovitosti v načrtovani vmesni analizi na osnovi ocene neodvisnega odbora (Independent Review Committee - IRC).
Simulation of daratumumab pharmacokinetics was conducted for all recommended dosing schedules in 1,309 patients with multiple myeloma.
Simulacija farmakokinetike daratumumaba je bila izvedena za vse priporočene razporede odmerjanja pri 1.309 bolnikih z diseminiranim plazmocitomom.
Elderly No dose adjustments are considered necessary (see section 5.2).
Starejši Prilagajanje odmerjanja pri starejših ni potrebno (glejte poglavje 5.2).
Thirty-three percent (33%) of patients were refractory to an IMiD only, and 28% were refractory to lenalidomide.
Triintrideset odstotkov (33%) bolnikov je bilo neodzivnih samo na imunomodulirajoče zdravilo, 28% jih je bilo neodzivnih na lenalidomid.
o The guide for HCPs and Blood Banks, to advice about the risk of interference for blood typing and how to minimise it; o The Patient Alert Card.
o Vodnik za za zdravstvene delavce in krvno banko s podatki o tveganju glede vpliva na tipizacijo krvi in navodili, kako zmanjšati to tveganje; o Opozorilno kartico za bolnika.
This medicine contains 9.3 mg sodium (main component of cooking/table salt) in each 5 mL vial.
To zdravilo vsebuje 9,3 mg natrija (glavne sestavine kuhinjske soli) v eni 5-mililitrski viali.
After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
Po vsaki infuziji zdravila DARZALEX boste prejeli zdravila (kot so kortikosteroidi) za zmanjševanje možnosti za infuzijske reakcije.
If you get infusion-related reactions, you may need other medicines, or the infusion may need to be slowed down or stopped.
Če pride do infuzijskih reakcij, boste morda potrebovali dodatna zdravila ali pa bo treba upočasniti ali povsem prekiniti infundiranje zdravila.
• then once every 2 weeks for 16 weeks
• naslednjih 16 tednov ga boste prejemali enkrat na 2 tedna,
Fertility No animal studies have been performed to determine potential effects on fertility in males or females.
Plodnost Na živalih niso izvajali študij za oceno morebitnega vpliva zdravila na plodnost samcev ali samic.
The MAH shall ensure that in each MS where DARZALEX (daratumumab) is marketed, all HCPs and patients who are expected to prescribe, dispense and receive this product have access to/are provided with the below.
Imetnik mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo DARZALEX (daratumumab) na trgu, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali prejeli to zdravilo, imeli dostop oziroma prejeli:
CARTON (100 mg/400 mg) (WITH BLUE BOX)
ŠKATLA (100 mg/400 mg) (Z MODRIM OKENCEM)
This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Ta motnja lahko vpliva na določanje popolnega odgovora na zdravljenje in napredovanja bolezni pri nekaterih bolnikih z IgG1 kapa proteini diseminiranega plazmocitoma.
Fatal infections were primarily due to pneumonia and sepsis.
Do smrtnega izida zaradi okužbe je prišlo predvsem zaradi pljučnice in sepse.
• low number of red blood cells which carry oxygen in the blood (anaemia)
• zmanjšano število rdečih krvničk, ki prenašajo kisik po krvi (anemija ali slabokrvnost)
Key: D=daratumumab; Vd=bortezomib-dexamethasone; Rd=lenalidomide-dexamethasone; Pd=pomalidomidedexamethasone; VMP=bortezomib-melphalan-prednisone; VTd=bortezomib-thalidomide-dexamethasone.
Razlaga kratic: D=daratumumab; Vd=bortezomib-deksametazon; Rd=lenalidomid-deksametazon; Pd=pomalidomiddeksametazon; VMP=bortezomib-melfalan-prednizon; VTd=bortezomib-talidomid-deksametazon
This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each 20 mL vial.
To zdravilo vsebuje 37,3 mg natrija (glavne sestavine kuhinjske soli) v eni 20-mililitrski viali.
DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood.
Zdravilo DARZALEX lahko zmanjša število belih krvnih celic (levkocitov), ki sodelujejo pri obrambi telesa pred okužbami, in število krvnih ploščic, ki jih imenujemo trombociti in omogočajo strjevanje krvi.
In the 1 to 24 mg/kg cohorts, peak serum concentrations (Cmax) after the first dose increased in approximate proportion to dose and volume of distribution was consistent with initial distribution into the plasma compartment.
V kohorti bolnikov, ki so prejemali odmerke od 1 do 24 mg/kg, je vrednost najvišje koncentracije v serumu (Cmax) po prvem odmerku naraščala približno sorazmerno z velikostjo odmerka, volumen porazdelitve pa je bil skladen z začetno porazdelitvijo v predelek plazme.
How much is given
Koliko zdravila prejemate
In the event of a planned transfusion blood transfusion centres should be notified of this interference with indirect antiglobulin tests (see section 4.5).
V primeru načrtovane transfuzije je treba transfuzijski center obvestiti o možnosti opisanega vpliva na rezultate indirektnih antiglobulinskih testov (glejte poglavje 4.5).
• Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre).
• Razredčeno raztopino injicirajte z intravensko infuzijo z uporabo infuzijskega kompleta z regulatorjem pretoka in linijskim sterilnim apirogenim polietersulfonskim (PES) filtrom, ki minimalno veže proteine (z velikostjo por 0,22 ali 0,2 mikrometra).
• swollen hands, ankles or feet
• otekanje rok, gležnjev ali stopal
In Study MMY3006, the number of CD34+ cell yield was numerically lower in the D-VTd arm compared with the VTd arm (Median: D-VTd: 6.3 x 10
V študiji MMY3006 je bilo absolutno število zbranih celic CD34+ (cell yield) v skupini D-VTd manjše kot v skupini VTd (mediana: v skupini D-VTd 6,3 x 10
Median durations of infusions were 4.2 h for Week 1-Day 1, 4.2 h for Week 1-Day 2, and 3.4 hours for the subsequent infusions.
Mediano trajanje infuzij na 1. dan 1. tedna je bilo 4,2 ure, na 2. dan 1.tedna 4,2 ure, pri nadaljnjih infuzijah pa 3,4 ure.
DARZALEX is for intravenous use.
Zdravilo DARZALEX je namenjeno intravenski uporabi.
For patients that experience any Grade IRRs, continue monitoring post-infusion until symptoms resolve.
Bolnike, pri katerih pride do infuzijske reakcije katere koli stopnje, je treba spremljati tudi v obdobju po infuziji vse dokler simptomi ne izzvenijo.
A subgroup analysis was performed on patients at least 70 years old, or those 65-69 years old with ECOG performance score of 2, or aged less than 65 years of age with significant comorbidity or ECOG performance score of 2 (D-VMP: n=273, VMP: n=270).
Analizo podatkov podskupine bolnikov so izvedli pri bolnikih, ki so bili stari najmanj 70 let in pri tistih, ki so bili stari 65-69 let in so imeli oceno ECOG 2, ter pri bolnikih, ki so bili stari manj kot 65 let in so imeli pomembno sočasno bolezen ali oceno stanja zmogljivosti ECOG 2 (D-VMP: n=273, VMP: n=270).
The dose of DARZALEX will depend on your body weight.
Odmerek zdravila DARZALEX je odvisen od vaše telesne mase.
Pneumonia was the most commonly reported severe (Grade 3 or 4) infection across studies.
V vseh študijah so med hudimi okužbami (3. ali 4. stopnje) najpogosteje poročali o pljučnici.
These observations suggest CD38 may become saturated at higher doses, after which the impact of target binding clearance is minimised and the clearance of daratumumab approximates the linear clearance of endogenous IgG1.
Ta opažanja kažejo, da pri večjih odmerkih morda pride do zasičenosti proteina CD38 in da je po tej točki pomen odstranjevanja po vezavi na tarčo (target binding clearance) majhen, očistek daratumumaba pa se približa linearnemu očistku endogenih IgG1.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi tega zdravila, se obrnite na zdravnika ali medicinsko sestro.
Management of infusion-related reactions
Obvladovanje infuzijskih reakcij
The median duration of response was not reached (95% CI: 5.6 months, not estimable).
Mediana trajanja odziva ni bila dosežena (95-odstotni IZ: 5,6 meseca, zgornje meje ni mogoče oceniti).
What DARZALEX is and what it is used for What you need to know before you are given DARZALEX How DARZALEX is given
Kaj je zdravilo DARZALEX in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo DARZALEX Kako se uporablja zdravilo DARZALEX Možni neželeni učinki
If a planned dose of DARZALEX is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Če bolnik ne prejme načrtovanega odmerka zdravila DARZALEX, ga mora prejeti čimprej, nadaljnji razpored odmerjanja pa je treba prilagoditi tako, da se interval med odmerki ne spremeni.
The overall response rate was 90% in the D-VMP group and 74% in theVMP group (VGPR rate:29% in D-VMP group and 26% in VMP group; CR: 22% in D-VMP group and 18% in VMP group; sCR rate: 20% in D-VMP group and 7% in VMP group).
Celokupna stopnja odziva je bila v skupini D-VMP 90%, v skupini VMP pa 74% (stopnja zelo dobrega delnega odziva (VGPR) je bila v skupini D-VMP 29%, v skupini VMP pa 26%; stopnja popolnega odziva (CR): 22% v skupini D-VMP in 18% v skupini VMP; stopnja strogega popolnega odziva (sCR): 20% v skupini D-VMP in 7% v skupini VMP).
Resumption of DARZALEX treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV.
O nadaljevanju zdravljenja z zdravilom DARZALEX pri bolnikih, pri katerih je reaktivacija HBV ustrezno nadzorovana, se je treba posvetovati s specialistom za zdravljenje HBV.
At the end of weekly dosing for the recommended monotherapy schedule and dose of 16 mg/kg, the mean (SD) serum Cmax value was 915 (410.3) micrograms/mL, approximately 2.9-fold higher than following the first infusion.
Ob koncu priporočenenega razporeda odmerjanja enkrat tedensko v monoterapiji in odmerku 16 mg/kg je bila povprečna vrednost Cmax v serumu 915 mikrogramov/ml (s standardnim odklonom 410,3 mikrogramov/ml), kar je približno 2,9-krat več kot po prvi infuziji.
It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection.
Apliciramo ga z intravensko infuzijo po redčenju z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za iniciranje.
95% CI (%) Odds ratio with 95% CI MRD negativity in combination with CR or better c n(%)
c,d n (%) 95-odstotni IZ (%) razmerje obetov s 95-odstotnim IZ Stopnja odsotne MRD v kombinaciji s CR ali še boljšim odzivom c n(%)
The majority of patients (86%) received a prior PI, 55% of patients had received a prior IMiD, including 18% of patients who had received prior lenalidomide; and 44% of patients had received both a prior PI and IMiD.
Večina bolnikov (86%) je predhodno prejemala zaviralec proteasoma, 55% bolnikov je predhodno prejemalo imunomodulirajoče zdravilo, vključno z 18% bolnikov, ki so predhodno prejemali lenalidomid, 44% bolnikov pa je predhodno prejemalo tako zaviralec proteasoma kot imunomodulirajoče zdravilo.
What DARZALEX is and what it is used for
Kaj je zdravilo DARZALEX in za kaj ga uporabljamo
Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction between daratumumab and these small molecule medicinal products.
Ocena klinične farmakokinetike daratumumaba v kombinaciji z lenalidomidom, pomalidomidom, talidomidom, bortezomibom in deksametazonom ni pokazala klinično pomembnih interakcij med daratumumabom in navedenimi učinkovinami iz skupine malih molekul.