natgillin/translations-raw huggingface dataset:
After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes.
Ko se vsa trdna snov popolnoma raztopi, pustite rekonstituirano raztopino stati od 5 do 10 minut.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom preden prejmete to zdravilo.
What Empliciti is and what it is used for 2.
Kaj je zdravilo Empliciti in za kaj ga uporabljamo 2.
In these 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of Empliciti treatment.
Pri teh 19 bolnikih so se protitelesa proti zdravilu pojavila v prvih 2 mesecih po uvedbi zdravljenja z zdravilom Empliciti.
Women of childbearing potential should use effective contraception.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
The lyophilised powder should dissolve in less than 10 minutes.
Liofiliziran prašek se mora raztopiti prej kot v 10 minutah.
It is not known, whether elotuzumab passes into breast milk or if there is any risk to the breast-fed infant.
Ni znano, če se elotuzumab izloča v materino mleko, ali če obstaja kakršno koli tveganje za dojenega otroka.
European Group for Blood and Marrow Transplantation (EBMT) criteria.
Kriteriji Evropske skupine za presajanje kostnega mozga in krvotvornih matičnih celic (EBMT).
Dose 2 and all subsequent doses
2. odmerek in vsi kasnejši odmerki
Lenalidomide and pomalidomide are expected to be harmful for an unborn baby.
Za lenalidomid in pomalidomid se pričakuje, da bosta škodovala nerojenemu otroku.
Number of subjects at risk
Število ogroženih oseb
Then invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper.
Nato vialo nekajkrat obrnite, da se raztopi tudi ves prašek, ki bi lahko bil prisoten na vrhu viale ali zamašku.
Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
Nevtralizirajoča protitelesa so odkrili pri 19 od 299 bolnikov v študiji CA204004.
The most serious adverse reaction that may occur during elotuzumab treatment is pneumonia.
Najbolj resen neželeni učinek, ki se lahko pojavi med zdravljenjem z elotuzumabom, je pljučnica.
After dilution, the infusion must be completed within 24 hours of preparation.
Po redčenju je treba infundiranje dokončati v 24 urah po pripravi.
Patients with Grade 2 or higher peripheral neuropathy were excluded from the clinical studies with E-Pd.
Bolnike s periferno nevropatijo stopnje 2 ali višjo, so iz kliničnih študij E-Pd izključili.
In the majority of patients, immunogenicity occurred early in treatment and was transient resolving by 2 to 4 months.
Pri večini bolnikov se je imunogenost pojavljala na začetku zdravljenja in je bila prehodna ter izzvenela v 2 do 4 mesecih.
Multiple myeloma is a cancer of a type of white blood cell called plasma cells.
Multipli mielom je rak vrste belih krvnih celic, imenovanih plazmatke.
[95% CI]
[95 % IZ]
Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
Kaplan-Meierjeva krivulja preživetja PFS po oceni raziskovalca je prikazana na sliki 3.
The reconstituted solution is colourless to slightly yellow and clear to very opalescent.
Rekonstituirana raztopina je brezbarvna do rahlo rumena in bistra do zelo opalescentna.
The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in treatment of multiple myeloma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za vse podskupine pediatrične populacije pri zdravljenju multiplega mieloma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Grade 3/4
vse stopnje stopnja 3/4
In case of detection of additional peaks on serum immunofixation, the possibility of a biclonal gammopathy should be excluded.
V primeru odkritja dodatnih vrhov pri imunofiksaciji seruma je treba izključiti možnost biklonske gamopatije.
Thus, the effect of elotuzumab on male and female fertility is unknown.
Učinek elotuzumaba na plodnost pri moških in ženskah ni znan.
Anti-product antibodies resolved by 2 to 3 months in 18 (95%) of these 19 patients.
Protitelesa proti zdravilu so izzvenela v 2 do 3 mesecih pri 18 (95 %) od 19 bolnikov.
Grade 3 infusion reactions occurred in 1% of patients.
Infuzijske reakcije stopnje 3 so se pojavile pri 1 % bolnikov.
Neutralizing antibodies were detected in 2 of 53 patients.
Nevtralizirajoča protitelesa so odkrili pri 2 od 53 bolnikov.
How to use Empliciti 4.
Kako uporabljati zdravilo Empliciti 4.
All patients had documented progression following their most recent therapy.
Pri vseh bolnikih je bilo dokumentirano napredovanje bolezni po zadnjem zdravljenju.
Vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Vitalne znake je treba nadzirati vsakih 30 minut 2 uri po koncu infundiranja zdravila Empliciti.
Absorption Elotuzumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Absorpcija Elotuzumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant.
Ker elotuzumab ne prepozna nečloveških oblik proteina SLAMF7, in vivo pridobljeni podatki o varnosti pri živalih niso relevantni.
As with all therapeutic proteins, there is a potential for immunogenicity to Empliciti.
Kot pri drugih terapevtskih beljakovinah tudi pri uporabi zdravila Empliciti obstaja možnost pojava imunogenosti.
The patient had no symptoms, did not require any treatment for the overdose, and was able to continue on elotuzumab therapy.
Bolnik ni imel nobenih simptomov, zdravljenje zaradi prevelikega odmerjanja ni bilo potrebno, zdravljenje z elotuzumabom pa se je lahko nadaljevalo.
The presence of elotuzumab in patient's serum may cause a small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation.
Elotuzumab v serumu bolnika lahko povzroči majhen vrh v začetni regiji gama pri SPEP, ki je IgGƙ pri imunofiksaciji seruma.
If there is no recurrence of the infusion reaction, the escalation can be resumed (see Tables 3 and 4).
Če se infuzijska reakcija ne ponovi, se s povečevanjem hitrosti lahko nadaljuje (glejte tabeli 3 in 4).
You will receive Empliciti under the supervision of an experienced healthcare professional.
Zdravilo Empliciti boste prejeli pod nadzorom zdravstvenega delavca z ustreznimi izkušnjami.
In study CA204125, all of the reported infusion reactions occurred during the first treatment cycle and were ≤ Grade 2.
V študiji CA204125 so se vse infuzijske reakcije, o katerih so poročali, pojavile pri prvem ciklu zdravljenja in so bile ≤ stopnje 2.
The OS data from the exploratory analysis were not mature at the data cut-off (29 November 2018) with a minimum follow up of 18.3 months.
Podatki o celokupnem preživetju iz eksploratorne analize ob pridobitvi podatkov (29. november 2018) še niso bili zreli, najmanjše obdobje spremljanja pa je bilo 18,3 meseca.
Patients with cardiac amyloidosis or plasma cell leukemia were excluded from this study.
Bolnike s srčno amiloidozo ali plazmocitno levkemijo so izključili iz študije.
If you have any further questions, ask your doctor, or pharmacist or nurse.
Če imate dodatna vprašanja, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
Patients should be monitored and infections should be managed with standard treatment.
Bolnike je treba nadzirati, v primeru okužb pa uvesti standardno zdravljenje.
The maximum infusion rate should not exceed 5 mL/min.
Največja hitrost infundiranja ne sme preseči 5 ml/min.
Investigator Assessed
Ocena raziskovalca
Studies to evaluate the effect of elotuzumab on fertility have not been performed.
Študij, ki bi ovrednotile vpliv elotuzumaba na plodnost, niso izvedli.
A pre-specified analysis for 3-year PFS rate was performed based on a minimum follow-up time of 33 months.
Vnaprej določena analiza deleža 3-letnega preživetja brez napredovanja bolezni (PFS) je bila izvedena na osnovi minimalnega časa spremljanja 33 mesecev.
Non-clinical safety information primarily consists of limited in vitro human cell/tissue studies where no safety findings were identified.
Nekliničnih podatkov o varnosti je malo, v glavnem pa so bili pridobljeni z in vitro študijami na človeških celicah/tkivih, kjer pa niso ugotovili vpliva na varnost.
The pre-planned final OS analysis was performed after 212 deaths in the E-Ld arm and 225 deaths in the Ld arm.
Vnaprej načrtovana končna analiza celokupnega preživetja je bila izvedena po 212 smrtnih primerih v skupini E-Ld in 225 smrtnih primerih v skupini Ld.
These cells divide out of control and collect in the bone marrow.
Te celice se nenadzorovano delijo in kopičijo v kostnem mozgu.
Cycle 1, Dose 3 and 4 and all subsequent Cycles
1. cikel, 3. in 4. odmerek in vsi kasnejši cikli
Final volume of reconstituted Empliciti in the vial
Končni volumen rekonstituiranega zdravila Empliciti v viali
Depending on the seriousness of the infusion reactions, you may require additional treatment to prevent complications and reduce your symptoms, or your infusion of Empliciti may be interrupted.
Odvisno od resnosti infuzijskih reakcij boste morda potrebovali dodatno zdravljenje za preprečitev zapletov ali ublažitev simptomov, infundiranje zdravila Empliciti pa bo morda treba prekiniti.
Do not stop treatment unless you have discussed this with your doctor.
Zdravljenja ne prekinjajte, ne da bi se o tem prej posvetovali z zdravnikom.
Children and adolescents Empliciti is not recommended for use in children and adolescents aged under 18 years.
Otroci in mladostniki Pri otrocih in mladostnikih, mlajših od 18 let, uporaba zdravila Empliciti ni priporočljiva.
Absence of del17p Presence of t(4;14) Absence of t(4;14) ISS Stage I
Odsotnost del17p Prisotnost t(4;14) Odsotnost t(4;14)
Median OS was not reached for E-Pd treatment group.
Mediana celokupnega preživetja za skupino zdravljenja E-Pd ni bila dosežena.
What Empliciti is and what it is used for
Kaj je zdravilo Empliciti in za kaj ga uporabljamo
Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy).
Petintrideset odstotkov (35 %) bolnikov je bilo neodzivnih (napredovanje med ali v 60 dneh po zadnjem zdravljenju), pri 65 % bolnikov pa se je bolezen ponovila (napredovanje po 60 dneh po zadnjem zdravljenju).
Thus, hepatic functional impairment is not likely to alter its clearance.
Okvara delovanja jeter tako najverjetneje ne spremeni njegovega očistka.
Before each infusion of Empliciti, you will be given medicines to reduce infusion reaction (see section 3 “How to use Empliciti, Medicines given before each infusion”).
Pred vsakim infundiranjem zdravila Empliciti boste prejeli zdravila za zmanjšanje infuzijske reakcije (glejte poglavje 3 “Kako uporabljati zdravilo Empliciti, Zdravila, ki jih boste prejeli pred vsakim infundiranjem”).
Withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial.
Potreben volumen glede na izračunani odmerek izvlecite iz vsake viale, do največ 16 ml iz 400 mg viale in 12 ml iz 300 mg viale.
Table 1: Reconstitution instructions
Tabela 1: Navodila za rekonstitucijo
IRC Assessedf
Ocena IRCf
Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Bolnikom, pri katerih se pojavi infuzijska reakcija, je treba svetovati, da ne smejo voziti vozil ali upravljati s stroji, dokler simptomi ne izzvenijo.
Complete response (CR) + stringent complete response (sCR).
Popolni odziv (CR) + strikten popolni odziv (sCR).
Uncommon (may affect up to 1 in 100 people) Sudden life-threatening allergic reaction (anaphylactic reaction)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) nenadna, življenje ogrožajoča alergijska reakcija (anafilaktična reakcija)
The rate of haematologic malignancies were the same between the two treatment arms (1.6%).
Delež hematoloških malignomov je bil enak v obeh skupinah zdravljenja (1,6 %).
Based on a population PK analysis using data from 440 patients, the clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.
Na osnovi analize populacijske farmakokinetike z uporabo podatkov, pridobljenih pri 440 bolnikih, se očistek elotuzumaba povečuje s povečanjem telesne mase, kar podpira odmerjanje na osnovi telesne mase.
When lenalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see “Pregnancy and breast-feeding” in this section).
Pri uporabi lenalidomida morate biti še posebej pozorni na test nosečnosti in potrebne ukrepe za preprečevanje nosečnosti (glejte “Nosečnost in dojenje” v tem poglavju).
Empliciti should not be used during pregnancy unless the clinical condition of the woman requires treatment with elotuzumab.
Zdravila Empliciti se ne sme uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z elotuzumabom.
Overall survival (OS) was a secondary endpoint with the pre-planned final OS analysis to occur after at least 427 deaths.
Celokupno preživetje (OS, overall survival) je bilo sekundarni opazovani dogodek v vnaprej načrtovani končni analizi celokupnega preživetja po najmanj 427 smrtnih primerih.
How much Empliciti is given The amount of Empliciti you will be given will be calculated based on your body weight.
Odmerek zdravila Empliciti Količina zdravila Empliciti, ki jo boste prejeli, se izračuna na osnovi telesne mase.
If not used immediately, the solution for infusion may be stored in the refrigerator (2 °C - 8 °C) for up to 24 hours.
Če se zdravila ne uporabi takoj, se raztopino za infundiranje lahko shrani v hladilniku (od 2 °C do 8 °C) za do 24 ur.
A pre-specified final analysis for OS was performed based on at least 427 deaths with a minimum follow-up time of 70.6 months.
Vnaprej načrtovana končna analiza celokupnega preživetja (OS) je bila izvedena na osnovi najmanj 427 smrtnih primerov in z minimalnim časom spremljanja 70,6 mesecev.
Male patients must use effective contraception measures during and for 180 days following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.
Moški bolniki morajo med zdravljenjem in še 180 dni po koncu zdravljenja uporabljati učinkovite metode za preprečevanje neželene nosečnosti, če je njihova partnerica noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije.
If any of the symptoms of infusion reaction reach Grade ≥ 2, Empliciti infusion must be interrupted and appropriate medical and supportive measures instituted.
Če kateri koli simptom infuzijske reakcije doseže stopnjo ≥ 2, je treba infundiranje zdravila Empliciti prekiniti in uvesti ustrezne medicinske in podporne ukrepe.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
V primeru prevelikega odmerjanja je treba bolnike skrbno nadzirati glede znakov in simptomov neželenih učinkov in po potrebi uvesti ustrezno simptomatsko zdravljenje.
Post-reconstitution concentration
Koncentracija po rekonstituciji
In study CA204004, the most common symptoms of an infusion reaction included fever, chills, and hypertension.
V študiji CA204004 so najpogostejši simptomi infuzijske reakcije vključevali zvišano telesno temperaturo, mrzlico in hipertenzijo.
The median OS in the E-Ld arm was 48.30 months compared with 39.62 months in the Ld arm.
Mediana celokupnega preživetja v skupini E-Ld je bila 48,30 mesecev, v skupini Ld pa 39,62 mesecev.
Final volume of reconstituted Empliciti in the vial (including volume displaced by the solid cake)
Končni volumen rekonstituiranega zdravila Empliciti v viali (vključno z volumnom zaradi izpodrinjenega trdnega skupka)
Premedication Empliciti (mg/kg) intravenously Pomalidomide (4 mg) orally
Premedikacija Empliciti (mg/kg) intravensko Pomalidomid (4 mg) peroralno
Infusion reactions Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Uporaba zdravila Empliciti je bila povezana z infuzijskimi reakcijami (glejte poglavje 2 “Opozorila in previdnostni ukrepi”).
If symptoms do not recur, the infusion rate may be gradually escalated every 30 minutes to a maximum of 5 mL/min (see section 4.2 Method of administration).
Če se simptomi ne ponovijo, se lahko hitrost infundiranja postopoma povečuje vsakih 30 minut do največje hitrosti 5 ml/min (glejte poglavje 4.2 Način uporabe).
The median number of prior therapies was 3.
Mediano število predhodnih zdravljenj je bilo 3.
Target-mediated clearance of elotuzumab increased with higher serum M-protein concentrations.
Ciljni očistek elotuzumaba je z višanjem koncentracij M proteina v serumu naraščal.
Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein.
Elotuzumab je imunostimulatorno humano monoklonsko protitelo IgG1, ki je posebej usmerjeno proti proteinu SLAMF7 (signaling lymphocyte activation molecule family member 7).
Do not freeze the reconstituted or diluted solution.
Rekonstituirane ali razredčene raztopine ne zamrzujte.
Transfer the withdrawn volumes of all vials needed according to the calculated dose for this patient into one single infusion bag made of polyvinyl chloride or polyolefin containing the calculated volume of diluent.
Izvlečen volumen iz vseh vial, potreben glede na izračun pri posameznem bolniku, prenesite v eno samo infuzijsko vrečko iz polivinilklorida ali poliolefina, ki vsebuje izračunan volumen sredstva za redčenje.
The product should be used immediately.
Zdravilo je treba uporabiti takoj.
The median number of prior therapies was 2.
Mediano število predhodnih zdravljenj je bilo 2.
Other medicines and Empliciti Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
What Empliciti looks like and contents of the pack
Izgled zdravila Empliciti in vsebina pakiranja
Empliciti is taken in treatment cycles that are 28 days (4 weeks) long in combination with other medicines used to treat multiple myeloma.
Zdravljenje z zdravilom Empliciti poteka v ciklih, ki so dolgi 28 dni (4 tedne), v kombinaciji z drugimi zdravili za zdravljenje multiplega mieloma.
No dose adjustment is required for Empliciti in patients over 65 years of age (see section 5.2).
Pri bolnikih, starejših od 65 let, odmerka zdravila Empliciti ni treba prilagajati (glejte poglavje 5.2).
Of the patients who experienced an infusion reaction, 70% (23/33) had the reaction during the first dose.
Pri bolnikih z infuzijsko reakcijo se je infuzijska reakcija pri 70 % bolnikov (23/33) pojavila pri prvem odmerku.
Adverse reactions reported in 682 patients with multiple myeloma who were treated with elotuzumab in 8 clinical trials are presented in Table 5.
Neželeni učinki, o katerih so poročali pri 682 bolnikih z multiplim mielomom, ki so se zdravili z elotuzumabom v 8 kliničnih preskušanjih so predstavljeni v tabeli 5.
The primary endpoints of this study, progression-free survival (PFS), as assessed by hazard ratio, and overall response rate (ORR) were determined based on assessments made by a blinded Independent Review Committee (IRC).
Primarna opazovana dogodka te študije sta bila preživetje brez napredovanja bolezni (PFS, progression-free survival), ovrednoteno z razmerjem ogroženosti, in delež celokupnega odziva (ORR, overall response rate) na osnovi vrednotenja, ki ga je izvedel neodvisen odbor za pregled (IRC, Independent Review Committee).
In patients who experience an infusion reaction, vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Pri bolnikih, pri katerih se je pojavila infuzijska reakcija, je treba še 2 uri po koncu infundiranja zdravila Empliciti nadzirati vitalne znake na vsakih 30 minut.
Each vial contains a slight overfill to ensure sufficient extractable volume.
Vsaka viala vsebuje rahel pribitek za zagotovitev zadostnega volumna, ki se ga lahko izvleče.
SLAMF7 is also expressed on natural killer cells (NK), normal plasma cells, and other immune cells including some T cell subsets, monocytes, B cells, macrophages, and pDCs (plasmacytoid dendritic cells), but is not detected on normal solid tissues or haematopoietic stem cells.
SLAMF7 je izražen tudi na naravnih celicah ubijalkah (NK), normalnih plazmatkah in drugih imunskih celicah, vključno s podskupino nekaterih celic T, monociti, celicami B, makrofagi in plazmacitoidnimi dentritičnimi celicami (pDC), niso pa ga odkrili na normalnih solidnih tkivih ali hematopoetskih zarodnih celicah.
In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
Pri 1. in 2. ciklu enkrat na teden na 1., 8., 15. in 22. dan.
The rate of haematologic malignancies was the same between the two treatment arms.
Delež hematoloških malignomov je bil enak v obeh skupinah zdravljenja.
Patients with mild or moderate infusion reactions may receive Empliciti with a reduced infusion rate and close monitoring (see section 4.2 Method of administration).
Bolniki z blagimi ali zmernimi infuzijskimi reakcijami lahko prejemajo zdravilo Empliciti z zmanjšano hitrostjo infundiranja in ob skrbnem nadziranju (glejte poglavje 4.2 Način uporabe).
* Elotuzumab is produced in NS0 cells by recombinant DNA technology.
* Elotuzumab je pridobljen s tehnologijo rekombinantne DNA na celicah NS0.
Progression free survival (Months)
Preživetje brez napredovanja bolezni (meseci)
Method of administration Empliciti is for intravenous use only.
Način uporabe Zdravilo Empliciti je namenjeno samo za intravensko uporabo.
Table 12: Reconstitution instructions Strength
Tabela 12: Navodila za rekonstitucijo Jakost
Empliciti may be detected in the serum protein electrophoresis (SPEP) and serum immunofixation assays of myeloma patients and could interfere with correct response classification.
Zdravilo Empliciti se lahko odkrije s serumsko proteinsko elektroforezo (SPEP) in serumsko imunofiksacijo pri bolnikih z mielomom in lahko vpliva na pravilno klasifikacijo odziva.
Woman of childbearing potential/Contraception in the males and females Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with elotuzumab.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Zdravila Empliciti se ne sme uporabljati pri ženskah v rodni dobi, razen če klinično stanje ženske zahteva zdravljenje z elotuzumabom.
In cycles 3 and beyond, once every 4 weeks on day 1.
Pri 3. in kasnejših ciklih enkrat na vsake 4 tedne na 1. dan.
Patients were refractory if they had progressed on or within 60 days of treatment with lenalidomide and a PI and on or within 60 days of their last treatment, or relapsed and refractory if they had achieved at least a partial response to previous treatment with lenalidomide and a PI but progressed within 6 months and had developed progressive disease on or within 60 days after completing their last treatment.
Bolniki so bili neodzivni, če je prišlo do napredovanja bolezni na ali v obdobju 60 dni zdravljenja z lenalidomidom in PI in na ali v obdobju 60 dni po zadnjem zdravljenju, oziroma neodzivni s ponovljeno boleznijo, če je bil dosežen vsaj delni odziv na predhodno zdravljenje z lenalidomidom in PI, vendar je prišlo do napredovanja bolezni v obdobju 6 mesecev in so razvili napredovalo bolezen na oziroma v obdobju 60 dni po zaključenem zadnjem zdravljenju.
Empliciti is an IgG1 monoclonal antibody, which is principally cleared by catabolism.
Zdravilo Empliciti je monoklonsko protitelo IgG1, ki se v glavnem očisti s katabolizmom.