FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, hepatic functional impairment is not likely to alter its clearance.
Slovenian: Okvara delovanja jeter tako najverjetneje ne spremeni njegovega očistka.
English: Time interval
Slovenian: Časovni interval
English: 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”).
Slovenian: 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”).
English: 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.
Slovenian: 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.
English: Table 1: Reconstitution instructions
Slovenian: Tabela 1: Navodila za rekonstitucijo
English: IRC Assessedf
Slovenian: Ocena IRCf
English: Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Slovenian: Bolnikom, pri katerih se pojavi infuzijska reakcija, je treba svetovati, da ne smejo voziti vozil ali upravljati s stroji, dokler simptomi ne izzvenijo.
English: Complete response (CR) + stringent complete response (sCR).
Slovenian: Popolni odziv (CR) + strikten popolni odziv (sCR).
English: Uncommon (may affect up to 1 in 100 people) Sudden life-threatening allergic reaction (anaphylactic reaction)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) nenadna, življenje ogrožajoča alergijska reakcija (anafilaktična reakcija)
English: The rate of haematologic malignancies were the same between the two treatment arms (1.6%).
Slovenian: Delež hematoloških malignomov je bil enak v obeh skupinah zdravljenja (1,6 %).
English: 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.
Slovenian: 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.
English: When lenalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see “Pregnancy and breast-feeding” in this section).
Slovenian: Pri uporabi lenalidomida morate biti še posebej pozorni na test nosečnosti in potrebne ukrepe za preprečevanje nosečnosti (glejte “Nosečnost in dojenje” v tem poglavju).
English: Empliciti should not be used during pregnancy unless the clinical condition of the woman requires treatment with elotuzumab.
Slovenian: Zdravila Empliciti se ne sme uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z elotuzumabom.
English: Overall survival (OS) was a secondary endpoint with the pre-planned final OS analysis to occur after at least 427 deaths.
Slovenian: Celokupno preživetje (OS, overall survival) je bilo sekundarni opazovani dogodek v vnaprej načrtovani končni analizi celokupnega preživetja po najmanj 427 smrtnih primerih.
English: How much Empliciti is given The amount of Empliciti you will be given will be calculated based on your body weight.
Slovenian: Odmerek zdravila Empliciti Količina zdravila Empliciti, ki jo boste prejeli, se izračuna na osnovi telesne mase.
English: If not used immediately, the solution for infusion may be stored in the refrigerator (2 °C - 8 °C) for up to 24 hours.
Slovenian: Če se zdravila ne uporabi takoj, se raztopino za infundiranje lahko shrani v hladilniku (od 2 °C do 8 °C) za do 24 ur.
English: 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.
Slovenian: Vnaprej načrtovana končna analiza celokupnega preživetja (OS) je bila izvedena na osnovi najmanj 427 smrtnih primerov in z minimalnim časom spremljanja 70,6 mesecev.
English: 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.
Slovenian: 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.
English: If any of the symptoms of infusion reaction reach Grade ≥ 2, Empliciti infusion must be interrupted and appropriate medical and supportive measures instituted.
Slovenian: Če kateri koli simptom infuzijske reakcije doseže stopnjo ≥ 2, je treba infundiranje zdravila Empliciti prekiniti in uvesti ustrezne medicinske in podporne ukrepe.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je treba bolnike skrbno nadzirati glede znakov in simptomov neželenih učinkov in po potrebi uvesti ustrezno simptomatsko zdravljenje.
English: Post-reconstitution concentration
Slovenian: Koncentracija po rekonstituciji
English: In study CA204004, the most common symptoms of an infusion reaction included fever, chills, and hypertension.
Slovenian: V študiji CA204004 so najpogostejši simptomi infuzijske reakcije vključevali zvišano telesno temperaturo, mrzlico in hipertenzijo.
English: The median OS in the E-Ld arm was 48.30 months compared with 39.62 months in the Ld arm.
Slovenian: Mediana celokupnega preživetja v skupini E-Ld je bila 48,30 mesecev, v skupini Ld pa 39,62 mesecev.
English: Final volume of reconstituted Empliciti in the vial (including volume displaced by the solid cake)
Slovenian: Končni volumen rekonstituiranega zdravila Empliciti v viali (vključno z volumnom zaradi izpodrinjenega trdnega skupka)
English: Premedication Empliciti (mg/kg) intravenously Pomalidomide (4 mg) orally
Slovenian: Premedikacija Empliciti (mg/kg) intravensko Pomalidomid (4 mg) peroralno
English: Infusion reactions Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Slovenian: Uporaba zdravila Empliciti je bila povezana z infuzijskimi reakcijami (glejte poglavje 2 “Opozorila in previdnostni ukrepi”).
English: 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).
Slovenian: 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).
English: The median number of prior therapies was 3.
Slovenian: Mediano število predhodnih zdravljenj je bilo 3.
English: Target-mediated clearance of elotuzumab increased with higher serum M-protein concentrations.
Slovenian: Ciljni očistek elotuzumaba je z višanjem koncentracij M proteina v serumu naraščal.
English: Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein.
Slovenian: Elotuzumab je imunostimulatorno humano monoklonsko protitelo IgG1, ki je posebej usmerjeno proti proteinu SLAMF7 (signaling lymphocyte activation molecule family member 7).
English: Do not freeze the reconstituted or diluted solution.
Slovenian: Rekonstituirane ali razredčene raztopine ne zamrzujte.
English: 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.
Slovenian: 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.
English: The product should be used immediately.
Slovenian: Zdravilo je treba uporabiti takoj.
English: The median number of prior therapies was 2.
Slovenian: Mediano število predhodnih zdravljenj je bilo 2.
English: Other medicines and Empliciti Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: What Empliciti looks like and contents of the pack
Slovenian: Izgled zdravila Empliciti in vsebina pakiranja
English: Empliciti is taken in treatment cycles that are 28 days (4 weeks) long in combination with other medicines used to treat multiple myeloma.
Slovenian: Zdravljenje z zdravilom Empliciti poteka v ciklih, ki so dolgi 28 dni (4 tedne), v kombinaciji z drugimi zdravili za zdravljenje multiplega mieloma.
English: No dose adjustment is required for Empliciti in patients over 65 years of age (see section 5.2).
Slovenian: Pri bolnikih, starejših od 65 let, odmerka zdravila Empliciti ni treba prilagajati (glejte poglavje 5.2).
English: Of the patients who experienced an infusion reaction, 70% (23/33) had the reaction during the first dose.
Slovenian: Pri bolnikih z infuzijsko reakcijo se je infuzijska reakcija pri 70 % bolnikov (23/33) pojavila pri prvem odmerku.
English: Adverse reactions reported in 682 patients with multiple myeloma who were treated with elotuzumab in 8 clinical trials are presented in Table 5.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Each vial contains a slight overfill to ensure sufficient extractable volume.
Slovenian: Vsaka viala vsebuje rahel pribitek za zagotovitev zadostnega volumna, ki se ga lahko izvleče.
English: 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.
Slovenian: 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.
English: In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
Slovenian: Pri 1. in 2. ciklu enkrat na teden na 1., 8., 15. in 22. dan.
English: The rate of haematologic malignancies was the same between the two treatment arms.
Slovenian: Delež hematoloških malignomov je bil enak v obeh skupinah zdravljenja.
English: 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).
Slovenian: 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).
English: * Elotuzumab is produced in NS0 cells by recombinant DNA technology.
Slovenian: * Elotuzumab je pridobljen s tehnologijo rekombinantne DNA na celicah NS0.
English: Progression free survival (Months)
Slovenian: Preživetje brez napredovanja bolezni (meseci)
English: Method of administration Empliciti is for intravenous use only.
Slovenian: Način uporabe Zdravilo Empliciti je namenjeno samo za intravensko uporabo.
English: Table 12: Reconstitution instructions Strength
Slovenian: Tabela 12: Navodila za rekonstitucijo Jakost
English: Empliciti may be detected in the serum protein electrophoresis (SPEP) and serum immunofixation assays of myeloma patients and could interfere with correct response classification.
Slovenian: Zdravilo Empliciti se lahko odkrije s serumsko proteinsko elektroforezo (SPEP) in serumsko imunofiksacijo pri bolnikih z mielomom in lahko vpliva na pravilno klasifikacijo odziva.
English: 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.
Slovenian: 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.
English: In cycles 3 and beyond, once every 4 weeks on day 1.
Slovenian: Pri 3. in kasnejših ciklih enkrat na vsake 4 tedne na 1. dan.
English: 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.
Slovenian: 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.
English: Empliciti is an IgG1 monoclonal antibody, which is principally cleared by catabolism.
Slovenian: Zdravilo Empliciti je monoklonsko protitelo IgG1, ki se v glavnem očisti s katabolizmom.
English: Patients had to recover after transplant for a minimum of 12 weeks from autologous stem cell transplant (SCT), and 16 weeks from allogeneic SCT.
Slovenian: Bolniki so morali po avtologni presaditvi krvotvornih matičnih celic okrevati najmanj 12 tednov, po alogenični presaditvi krvotvornih matičnih celic pa 16 tednov.
English: Patients who were refractory to lenalidomide were excluded and 6% of patients had prior lenalidomide treatment.
Slovenian: Bolniki, ki so bili neodzivni na zdravljenje z lenalidomidom, so bili izključeni, predhodno pa se je z lenalidomidom zdravilo 6 % bolnikov.
English: Subset description
Slovenian: Opis podskupine
English: 400 mg vial
Slovenian: 400 mg viala
English: If any medicine in the treatment is delayed, interrupted, or discontinued, your doctor will decide how your treatment should be continued.
Slovenian: V primeru, da se zdravljenje s katerim koli zdravilom odloži, prekine ali ukine, bo o nadaljnjem poteku zdravljenja odločil zdravnik.
English: You should not be given Empliciti: if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Empliciti Zdravila Empliciti ne smete prejeti: če ste alergični na elotuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 “Vsebina pakiranja in dodatne informacije”).
English: Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.
Slovenian: Zdravnik bo zdravljenje z zdravilom Empliciti nadaljeval vse dokler se bo bolezen izboljševala ali bila stabilna, neželeni učinki pa bodo sprejemljivi.
English: Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
Slovenian: Zdravljenje z elotuzumabom mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju multiplega mieloma.
English: Lenalidomide (25 mg) orally
Slovenian: Lenalidomid (25 mg) peroralno
English: Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on patient weight.
Slovenian: Izračunajte odmerek (mg) in določite število potrebnih vial za odmerek (10 mg/kg ali 20 mg/kg) na osnovi telesne mase bolnika.
English: Prior bortezomib exposure No prior bortezomib exposure
Slovenian: Brez predhodne izpostavljenosti bortezomibu
English: Second primary malignancies (SPMs)
Slovenian: Sekundarne primarne novotvorbe (SPN)
English: Medicines given before each infusion You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion reactions: medicine to reduce an allergic reaction (an anti-histamine) medicine to reduce inflammation (dexamethasone) medicine to reduce pain and fever (paracetamol)
Slovenian: Zdravila, ki jih boste prejeli pred vsakim infundiranjem Pred vsakim infundiranjem zdravila Empliciti morate prejeti naslednja zdravila, da se zmanjša tveganje za pojav infuzijskih reakcij: zdravilo za zmanjševanje alergijske reakcije (antihistaminik) zdravilo za zmanjševanje vnetja (deksametazon) zdravilo za zmanjševanje bolečine in zvišane telesne temperature (paracetamol)
English: It will be given into a vein (intravenously) as a drip (infusion) over several hours.
Slovenian: Zdravilo boste prejeli v obliki kapljične infuzije v veno (intravensko), ki bo trajala več ur.
English: Elotuzumab only recognizes human SLAMF7 protein.
Slovenian: Elotuzumab prepozna le humani protein SLAMF7.
English: Patients in the E-Ld arm had an 18% reduction in the risk of death compared with those in the Ld arm (HR = 0.82; 95.4% CI: 0.68, 1.00; p-value = 0.0408).
Slovenian: Bolniki v skupini E-Ld so imeli 18 % manjše tveganje za smrt v primerjavi z bolniki iz skupine Ld (razmerje ogroženosti = 0,82; 95,4 % IZ: 0,68, 1,00; p-vrednost = 0,0408).
English: SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells).
Slovenian: SLAMF7 se v velikih količinah nahaja na površini celic multiplega mieloma in na nekaterih celicah imunskega sistema (naravne celice ubijalke).
English: Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Slovenian: Zdravilo Empliciti uporabljamo pri bolnikih, ki se na nekatera druga zdravljenja niso odzvali ali pa se je rak po zdravljenju z njimi ponovil.
English: Elotuzumab attaches to a target protein called SLAMF7.
Slovenian: Elotuzumab se pritrdi na ciljno beljakovino, imenovano SLAMF7.
English: For instructions on reconstitution and dilution of Empliciti before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila Empliciti pred dajanjem glejte poglavje 6.6.
English: If the infusion reaction recurs, the Empliciti infusion must be stopped and not restarted on that day (see section 4.4).
Slovenian: Če se infuzijska reakcija ponovi, je treba infundiranje zdravila Empliciti prekiniti, bolnik pa na ta dan zdravila ne sme več prejeti (glejte poglavje 4.4).
English: The solution for infusion may be stored for a maximum of 8 hours of the total 24 hours at 20°C − 25°C and room light.
Slovenian: Raztopina za infundiranje je od celotnih 24 ur lahko največ 8 ur pri sobni temperaturi od 20 °C do 25 °C in sobni svetlobi.
English: Upon discontinuation of elotuzumab in combination with lenalidomide and dexamethasone or in combination with pomalidomide and dexamethasone, concentrations of elotuzumab will decrease to approximately 3% (approximately 97% washout as estimated by 5 half-lives) of the population predicted steady-state maximal serum concentration by 3 months.
Slovenian: Po ukinitvi zdravljenja z elotuzumabom v kombinaciji z lenalidomidom in deksametazonom ali v kombinaciji s pomalidomidom in deksametazonom se koncentracije elotuzumaba v 3 mesecih zmanjšajo do približno 3 % (približno 97 % izpiranje na osnovi ocene 5 razpolovnih časov) populacijsko predvidene največje serumske koncentracije v stanju dinamičnega ravnovesja.
English: Median PFS (months) [95% CI]
Slovenian: Mediana PFS (meseci) [95 % IZ]
English: However, if oral or intravenous dexamethasone is delayed or discontinued, the administration of Empliciti should be based on clinical judgment (e.g. risk of hypersensitivity) (see section 4.4).
Slovenian: Če se peroralni ali intravenski odmerek deksametazona odloži ali zdravljenje z njim ukine, je treba zdravilo Empliciti uporabljati na osnovi klinične presoje (npr. tveganje za preobčutljivost) (glejte poglavje 4.4).
English: Data on the efficacy and safety of Empliciti in patients ≥ 85 years of age are very limited.
Slovenian: Pri bolnikih, starih ≥ 85 let, je na voljo zelo malo podatkov o varnosti in učinkovitosti zdravila Empliciti.
English: 300 mg vial
Slovenian: 300 mg viala
English: On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines.
Slovenian: Na podlagi sporočenih neželenih učinkov se ne predvideva, da bi zdravilo Empliciti vplivalo na sposobnost vožnje in upravljanja strojev.
English: Before starting treatment with Empliciti, you must also read the package leaflet warnings and precautions of all medicines to be taken in combination with Empliciti for information related to these medicines.
Slovenian: Pred začetkom zdravljenja z zdravilom Empliciti morate prebrati tudi opozorila in previdnostne ukrepe v navodilih za uporabo vseh zdravil, ki se jih uporablja v kombinaciji z zdravilom Empliciti.
English: Cycle 28-Day Cycles 1 and 2
Slovenian: Cikel 1. in 2. cikel 28-dnevnega cikla
English: In the same line, no carcinogenicity data are available for elotuzumab in animals, nor were fertility and embryo-foetal toxicity studies performed.
Slovenian: Prav tako ni podatkov o kancerogenosti elotuzumaba pri živalih, študije vplivov na plodnost in škodljivih vplivov na razvoj zarodka/plodu pa niso bile izvedene.
English: Demographics and baseline characteristics were well balanced between treatment arms.
Slovenian: Demografske in izhodiščne lastnosti so bile med obema skupinama zdravljenja dobro uravnotežene.
English: A slight back pressure may be experienced during administration of the water for injections, which is considered normal.
Slovenian: Med dodajanjem vode za injekcije se lahko pojavi blag povratni pritisk, kar je normalno.
English: Table 10: CA204125 Efficacy results
Slovenian: Tabela 10: Študija CA204125: Rezultati učinkovitosti
English: As Empliciti will be given to you by a healthcare professional, it is unlikely you will be given too much.
Slovenian: Če ste prejeli prevelik odmerek zdravila Empliciti Zdravilo Empliciti vam bo dal zdravstveni delavec, zato je malo verjetno, da boste prejeli prevelik odmerek.
English: After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Slovenian: Po rekonstituciji en ml koncentrata vsebuje 25 mg elotuzumaba.
English: Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilised cake.
Slovenian: Vialo držite pokonci in z vrtenjem viale vrtinčite raztopino, da se liofiliziran skupek raztopi.
English: The geometric mean total clearance of elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state is 0.194 L/day (CV: 62.9%).
Slovenian: Geometrijski srednji skupni očistek elotuzumaba pri 10 mg/kg (v kombinaciji z lenalidomidom in deksametazonom) v stanju dinamičnega ravnovesja znaša 0,194 l/dan (KV: 62,9%).
English: Probability progression free (%)
Slovenian: Verjetnost preživetja brez napredovanja bolezni (%)
English: Preparation and administration of Empliciti
Slovenian: Priprava in aplikacija zdravila Empliciti