natgillin/translations-raw huggingface dataset:
This medicinal product is for single-use only. 
Zdravilo je samo za enkratno uporabo.
Your healthcare professional will throw away any medicines that are no longer being used. 
Zdravstveni delavci bodo ustrezno zavrgli zdravilo, ki ga ne rabijo več.
The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established. 
Varnost in učinkovitost zdravila DARZALEX pri otrocih, starih manj kot 18 let, nista bili dokazani.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). 
Pogostnosti neželenih učinkov so opredeljene kot zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
Women of child-bearing potential/Contraception 
Ženske v rodni dobi/kontracepcija
Median Time to Response [months (range)] 
mediani čas do odziva [meseci (okvirne vrednosti ranga)]
6/kg; VTd 8.9 x 10 
6/kg; v skupini VTd 8,9 x 10
See below “Recommended concomitant medications”, “Management of infusion-related reactions” and section 4.4. 
Glejte spodnja odstavka “Priporočena sočasna zdravila” in “Obvladovanje infuzijskih reakcij” ter poglavje 4.4.
You must not be given DARZALEX - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6). 
Zdravila DARZALEX ne smete prejeti - če ste alergični na daratumumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
When these reactions go away, or get better, the infusion can be started again. 
Ko navedene reakcije minejo ali se izboljšajo, je mogoče ponovno začeti z infundiranjem.
• feeling short of breath or other breathing problems. 
• občutek zadihanosti ali druge težave z dihanjem
If you have had an infusion-related reaction once it is less likely to happen again. 
Če ste infuzijsko reakcijo že imeli, je verjetnost, da ponovno pride do reakcije, manjša.
Complete response (CR) 
popolni odziv (CR)
The mean estimated terminal half-life associated with linear clearance in combination therapy was approximately 15-23 days. 
Povprečni ocenjeni končni razpolovni čas pri linearnem izločanju zdravila je bil pri kombiniranem zdravljenju približno 15-23 dni.
Efficacy was evaluated by the stringent Complete Response (sCR) rate at Day 100 post-transplant and Progression free survival (PFS). 
Učinkovitost so vrednotili s stopnjo strogega popolnega odziva (sCR) na 100. dan po presaditvi in s preživetjem brez napredovanja bolezni (PFS).
The incidence of infusion modifications due to reactions was 36%. 
Pojavnost prilagoditev infundiranja zaradi reakcije je bila 36%.
The majority of IRRs occurred at the first infusion and were Grade 1-2 (see section 4.8). 
Večina infuzijskih reakcij se je pojavila ob prvi infuziji in je bila 1. ali 2. stopnje (glejte poglavje 4.8).
The consolidation phase of treatment began a minimum of 30 days post-ASCT, when the patient had recovered sufficiently, and engraftment was complete. 
S konsolidacijsko fazo zdravljenja so začeli najmanj 30 dni po avtologni presaditvi matičnih celic, ko je bolnik v zadostni meri okreval in je bil proces vsaditve zaključen.
Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness. 
V razvrstitvah pogostnosti so, kjer je to relevantno, neželeni učinki navedeni po padajoči resnosti.
The baseline demographic and disease characteristics were similar between the two treatment groups. 
Izhodiščne demografske karakteristike in karakteristike bolezni so bile podobne v obeh zdravljenih skupinah.
• high level of sugar in the blood 
• zvišana vrednost sladkorja v krvi
If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems: 
Če imate težave z dihanjem, na primer astmo ali kronično obstruktivno pljučno bolezen (KOPB), boste prejeli zdravila za inhaliranje, ki vam bodo olajšala težave z dihanjem:
The incidence of infusion interruptions due to reactions was 30%. 
Pojavnost prekinitev infundiranja zaradi reakcije je bila 30%.
The estimated terminal half-life of daratumumab following the last 16 mg/kg dose increased, but there are insufficient data for a reliable estimation. 
Ocenjeni končni razpolovni čas izločanja daratumumaba se je po zadnjem odmerku 16 mg/kg povečal, vendar za zanesljivo oceno ni dovolj podatkov.
9/L, leukocytes > 1.0 x 10 
9/l, levkocitov na > 1,0 x 10
• medicines for an allergic reaction (anti-histamines) 
• zdravila za zdravljenje alergijskih reakcij (antihistaminike),
IgG1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy. 
Znano je, da monoklonska protitelesa IgG1 prehajajo skozi placento po prvem trimesečju nosečnosti.
T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation. 
Tudi za limfocite T (CD3+, CD4+ in CD8+) je znano, da izražajo protein CD38 v odvisnosti od stopnje razvoja in ravni aktivacije.
DARZALEX has no or negligible influence on the ability to drive and use machines. 
Zdravilo DARZALEX nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
CARTON FOR INITIATION PACK COMPRISING 11 PACKS (WITH BLUE BOX) 
ŠKATLA ZA UVEDBO ZDRAVLJENJA, KI VSEBUJE 11 PAKIRANJ (Z MODRIM OKENCEM)
200 mL/hour 
200 ml/uro
Uncommon (may affect up to 1 in 100 people) • inflamed liver (hepatitis) 
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • vnetje jeter (hepatitis)
CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity. 
Protein CD38 ima več funkcij, kot so receptorsko posredovana adhezija, signaliziranje in encimska aktivnost.
Treatment phase 
Faza zdravljenja
You may need other medicines, or the infusion may need to be slowed down or stopped. 
Morda boste potrebovali še druga zdravila ali pa vam bo zdravnik moral upočasniti ali prekiniti infuzijo.
• Antipyretics (oral paracetamol 650 to 1,000 mg) 
• antipiretiki (650 do 1.000 mg paracetamola peroralno)
Otherwise, use a dilution volume of 1,000 mL. 
V nasprotnem primeru je treba zdravilo razredčiti do volumna 1.000 ml.
Overall response rate (ORR) in MMY2002 was similar regardless of type of prior anti-myeloma therapy. 
Celokupna stopnja odziva (ORR) v študiji MMY2002 je bila približno enaka ne glede na vrsto predhodnega zdravljenja diseminiranega plazmocitoma.
In the first week your doctor may give you the DARZALEX dose split over two consecutive days. 
V prvem tednu zdravljenja vam bo zdravnik morda dal zdravilo DARZALEX v dveh deljenih odmerkih v dveh zaporednih dneh.
No data are available to determine potential effects of daratumumab on fertility in males or females (see section 5.3). 
Ni podatkov za ugotavljanje morebitnega vpliva daratumumaba na plodnost pri moških in ženskah (glejte poglavje 5.3).
• nerve damage that may cause tingling, numbness, or pain 
• poškodba živcev, ki lahko povzroča mravljinčenje, odrevenelost ali bolečine
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC24 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC24
If you are not sure, talk to your doctor or nurse before you are given DARZALEX. 
Če niste prepričani, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo DARZALEX.
• medicines to help the airways in your lungs stay open (bronchodilators) 
• zdravila, ki pomagajo ohranjati odprte dihalne poti v pljučih (bronhodilatatorji)
• low level of calcium in the blood 
• znižana vrednost kalcija v krvi
The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. 
V razredčeni raztopini se lahko oblikujejo zelo majhni prosojni do beli proteinski delci, saj je daratumumab protein.
Monitor patients with neutropenia for signs of infection. 
Bolnike z nevtropenijo je treba spremljati glede znakov okužbe.
However, fatigue has been reported in patients taking daratumumab and this should be taken into account when driving or using machines. 
Pri bolnikih, ki so prejemali daratumumab, so poročali o utrujenosti, kar je treba upoštevati pri vožnji in upravljanju strojev.
• Corticosteroid (long-acting or intermediate-acting) - Monotherapy: 
• kortikosteroid (dolgo delujoči ali srednje dolgo delujoči) Monoterapija:
If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus. 
Če bolnica zanosi med zdravljenjem s tem zdravilom, jo je treba obvestiti o možnem tveganju za plod.
Treatment was continued in both arms until disease progression or unacceptable toxicity. 
V obeh skupinah so bolniki z zdravljenjem nadaljevali do napredovanja bolezni ali nesprejemljive toksičnosti.
• Grade 4 (life-threatening): Permanently discontinue DARZALEX treatment. 
• Reakcija stopnje 4 (življenjsko nevarna): dokončno ukinite zdravilo DARZALEX.
DARZALEX treatment was continued until disease progression or unacceptable toxicity. 
Zdravljenje z zdravilom DARZALEX je trajalo do napredovanja bolezni ali nesprejemljive toksičnosti.
Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE). 
Infuzijske vrečke/vsebniki morajo biti iz polivinilklorida (PVC), polipropilena (PP), polietilena (PE) ali mešanice poliolefinov (PP+PE).
No animal studies have been performed to evaluate the potential effects of daratumumab on reproduction or development. 
Na živalih niso izvajali študij za oceno morebitnega vpliva daratumumaba na sposobnost razmnoževanja ali razvoj.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
• medicines for fever (such as paracetamol). 
• zdravila za zniževanje zvišane telesne temperature (kot je paracetamol).
How the medicine is given 
Kako boste prejemali zdravilo
Increases in AUC were more than dose-proportional and clearance (CL) decreased with increasing dose. 
Povečevanje AUC je bilo večje od sorazmernega z velikostjo odmerka, očistek zdravila pa se je z velikostjo odmerka zmanjševal.
Maternal IgG is excreted in human milk, but does not enter the neonatal and infant circulations in substantial amounts as they are degraded in the gastrointestinal tract and not absorbed. 
Pri človeku se materina protitelesa IgG izločajo v mleko, vendar ne prehajajo v večji količini v krvni obtok novorojenčka oziroma dojenčka, ker se v gastrointestinalnem traktu razgradijo in se ne absorbirajo.
DARZALEX will be stored at the hospital or clinic. 
Zdravilo DARZALEX bo shranjeno v bolnišnici oziroma zdravniški ordinaciji.
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.