natgillin/translations-raw huggingface dataset:
Patients had to recover after transplant for a minimum of 12 weeks from autologous stem cell transplant (SCT), and 16 weeks from allogeneic SCT.
Bolniki so morali po avtologni presaditvi krvotvornih matičnih celic okrevati najmanj 12 tednov, po alogenični presaditvi krvotvornih matičnih celic pa 16 tednov.
Patients who were refractory to lenalidomide were excluded and 6% of patients had prior lenalidomide treatment.
Bolniki, ki so bili neodzivni na zdravljenje z lenalidomidom, so bili izključeni, predhodno pa se je z lenalidomidom zdravilo 6 % bolnikov.
400 mg vial
400 mg viala
If any medicine in the treatment is delayed, interrupted, or discontinued, your doctor will decide how your treatment should be continued.
V primeru, da se zdravljenje s katerim koli zdravilom odloži, prekine ali ukine, bo o nadaljnjem poteku zdravljenja odločil zdravnik.
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”).
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”).
Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.
Zdravnik bo zdravljenje z zdravilom Empliciti nadaljeval vse dokler se bo bolezen izboljševala ali bila stabilna, neželeni učinki pa bodo sprejemljivi.
Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
Zdravljenje z elotuzumabom mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju multiplega mieloma.
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.
Izračunajte odmerek (mg) in določite število potrebnih vial za odmerek (10 mg/kg ali 20 mg/kg) na osnovi telesne mase bolnika.
Prior bortezomib exposure No prior bortezomib exposure
Brez predhodne izpostavljenosti bortezomibu
Second primary malignancies (SPMs)
Sekundarne primarne novotvorbe (SPN)
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)
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)
It will be given into a vein (intravenously) as a drip (infusion) over several hours.
Zdravilo boste prejeli v obliki kapljične infuzije v veno (intravensko), ki bo trajala več ur.
Elotuzumab only recognizes human SLAMF7 protein.
Elotuzumab prepozna le humani protein SLAMF7.
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).
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).
SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells).
SLAMF7 se v velikih količinah nahaja na površini celic multiplega mieloma in na nekaterih celicah imunskega sistema (naravne celice ubijalke).
Empliciti is used if your cancer has not responded to, or has come back after certain treatments.
Zdravilo Empliciti uporabljamo pri bolnikih, ki se na nekatera druga zdravljenja niso odzvali ali pa se je rak po zdravljenju z njimi ponovil.
Elotuzumab attaches to a target protein called SLAMF7.
Elotuzumab se pritrdi na ciljno beljakovino, imenovano SLAMF7.
For instructions on reconstitution and dilution of Empliciti before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila Empliciti pred dajanjem glejte poglavje 6.6.
If the infusion reaction recurs, the Empliciti infusion must be stopped and not restarted on that day (see section 4.4).
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).
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.
Raztopina za infundiranje je od celotnih 24 ur lahko največ 8 ur pri sobni temperaturi od 20 °C do 25 °C in sobni svetlobi.
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.
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.
Median PFS (months) [95% CI]
Mediana PFS (meseci) [95 % IZ]
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).
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).
Data on the efficacy and safety of Empliciti in patients ≥ 85 years of age are very limited.
Pri bolnikih, starih ≥ 85 let, je na voljo zelo malo podatkov o varnosti in učinkovitosti zdravila Empliciti.
300 mg vial
300 mg viala
On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines.
Na podlagi sporočenih neželenih učinkov se ne predvideva, da bi zdravilo Empliciti vplivalo na sposobnost vožnje in upravljanja strojev.
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.
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.
Cycle 28-Day Cycles 1 and 2
Cikel 1. in 2. cikel 28-dnevnega cikla
In the same line, no carcinogenicity data are available for elotuzumab in animals, nor were fertility and embryo-foetal toxicity studies performed.
Prav tako ni podatkov o kancerogenosti elotuzumaba pri živalih, študije vplivov na plodnost in škodljivih vplivov na razvoj zarodka/plodu pa niso bile izvedene.
Demographics and baseline characteristics were well balanced between treatment arms.
Demografske in izhodiščne lastnosti so bile med obema skupinama zdravljenja dobro uravnotežene.
A slight back pressure may be experienced during administration of the water for injections, which is considered normal.
Med dodajanjem vode za injekcije se lahko pojavi blag povratni pritisk, kar je normalno.
Table 10: CA204125 Efficacy results
Tabela 10: Študija CA204125: Rezultati učinkovitosti
As Empliciti will be given to you by a healthcare professional, it is unlikely you will be given too much.
Če ste prejeli prevelik odmerek zdravila Empliciti Zdravilo Empliciti vam bo dal zdravstveni delavec, zato je malo verjetno, da boste prejeli prevelik odmerek.
After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Po rekonstituciji en ml koncentrata vsebuje 25 mg elotuzumaba.
Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilised cake.
Vialo držite pokonci in z vrtenjem viale vrtinčite raztopino, da se liofiliziran skupek raztopi.
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%).
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%).
Probability progression free (%)
Verjetnost preživetja brez napredovanja bolezni (%)
Preparation and administration of Empliciti
Priprava in aplikacija zdravila Empliciti
After reconstitution and dilution The reconstituted solution should be transferred from the vial into the infusion bag immediately.
Po rekonstituciji in redčenju Rekonstituirano raztopino je treba iz viale takoj prenesti v infuzijsko vrečko.
You should use a condom while taking Empliciti and for 180 days after stopping treatment to ensure your partner does not become pregnant.
Med zdravljenjem in še 180 dni po koncu zdravljenja z zdravilom Empliciti morate uporabljati kondom za zagotovilo, da partnerica ne zanosi.
As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Za elotuzumab se kot za IgG monoklonsko protitelo predvideva, da preko katabolnih poti razpade do manjših peptidov in aminokislin.
Treatment should continue until disease progression or unacceptable toxicity.
Zdravljenje je treba nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Empliciti powder for concentrate for solution for infusion (powder for concentrate) is a white to off white whole or fragmented cake provided in a glass vial.
Empliciti prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) je bel do sivobel prašek v obliki celega ali razdrobljenega skupka v stekleni viali.
20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab.
20-ml viala iz stekla tipa I, zaprta s sivim zamaškom iz butilne gume, aluminijastim obročkom in polipropilensko dvižno zaporko, ki vsebuje 300 mg ali 400 mg elotuzumaba.
Lenalidomide 25 mg was taken orally once daily for the first 3 weeks of each cycle.
Bolniki so lenalidomid jemali peroralno v odmerku 25 mg enkrat na dan prve 3 tedne vsakega cikla.
The metabolic pathway of elotuzumab has not been characterized.
Presnovna pot elotuzumaba ni bila opisana.
SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities.
SLAMF7 je močno izražen na celicah multiplega mieloma, neodvisno od citogenetskih nepravilnosti.
The median age was 67 years (range 36 to 81); 62% of patients were older than 65 years; 57% of patients were male; whites comprised 77% of the study population, Asians 21%, and blacks 1%.
Mediana starost je bila 67 let (razpon: od 36 do 81), 62 % bolnikov je bilo starejših od 65 let, 57 % bolnikov je bilo moškega spola, 77 % raziskovane populacije je bilo belcev, 21 % Azijcev in 1 % bolnikov črne
Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8).
Infuzijska reakcija Pri bolnikih, ki so prejemali elotuzumab, so poročali o pojavu infuzijskih reakcij (glejte poglavje 4.8).
Improvements observed in PFS were consistent across subsets regardless of age (< 65 versus ≥ 65), risk status, presence or absence of cytogenetic categories del17p or t(4;14), ISS stage, number of prior therapies, prior immunomodulatory exposure, prior bortezomib exposure, relapsed or refractory status or renal function as shown in Table 9.
Opaženo izboljšanje preživetja brez napredovanja bolezni je bilo konsistentno po podskupinah ne glede na starost (< 65 v primerjavi z ≥ 65), status ogroženosti, prisotnost ali odsotnost citogenetskih kategorij del17p ali t(4;14), ISS stadij, število predhodnih zdravljenj, predhodno izpostavljenost imunomodulatorjem, predhodno izpostavljenost bortezomibu, status ponovitve ali neodzivnosti ali delovanje ledvic, kot je prikazano v tabeli 9.
More than one vial of Empliciti may be needed to give the total dose for the patient.
Za aplikacijo celotnega odmerka boste morda potrebovali več kot eno vialo zdravila Empliciti.
How to store Empliciti 6.
Shranjevanje zdravila Empliciti 6.
Treatment was administered in 4-week cycles (28-day cycle) until disease progression or unacceptable toxicity.
Zdravljenje je potekalo v 4-tedenskih ciklih (28-dnevni cikel) do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Demographics and baseline characteristics were balanced between treatment arms.
Demografske in izhodiščne lastnosti so bile med obema skupinama zdravljenja uravnotežene.
There is no relevant use of Empliciti in the paediatric population for the indication of multiple myeloma.
Pediatrična populacija Pri pediatrični populaciji uporaba zdravila Empliciti za indikacijo multipli mielom ni relevantna.
The median number of treatment cycles was 19 for the Empliciti arm and 14 for the comparator arm.
V skupini z zdravilom Empliciti je mediano število ciklov zdravljenja znašalo 19, v primerjalni skupini pa 14.
Empliciti contains the active substance elotuzumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Učinkovina zdravila Empliciti je elotuzumab, monoklonsko protitelo, vrsta beljakovine, ki prepozna in se pritrdi na posebno ciljno mesto v telesu.
When elotuzumab binds to SLAMF7 on the multiple myeloma or natural killer cells, it stimulates your immune system to attack and destroy the multiple myeloma cells.
Elotuzumab z vezavo na SLAMF7 na celicah multiplega mieloma ali naravnih celicah ubijalkah spodbudi imunski sistem, da napade in uniči celice multiplega mieloma.
Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for the treatment groups.
Ne glede na ovrednoteno podskupino je bilo preživetje brez napredovanja bolezni v splošnem konsistentno s tistim, opaženim v populaciji vseh vključenih bolnikov za zdravljene skupine.
In clinical trials of patients with multiple myeloma, the incidence of all infections, including pneumonia, were higher in patients treated with Empliciti (see section 4.8).
V kliničnih preskušanjih, izvedenih pri bolnikih z multiplim mielomom, je bila pojavnost vseh okužb, vključno s pljučnico, večja pri bolnikih, ki so se zdravili z zdravilom Empliciti (glejte poglavje 4.8).
Prior therapies included: stem cell transplant (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), and lenalidomide (6%).
Predhodna zdravljenja so vključevala: presaditev krvotvornih matičnih celic (55 %), bortezomib (70 %), melfalan (65 %), talidomid (48 %) in lenalidomid (6 %).
PFS ITT assessment per investigator was evaluated in several subgroups including age (< 65 versus ≥ 65), race, ISS stage, prior therapies, transplant, risk category, ECOG status, creatinine clearance, and cytogenic abnormalities.
Vrednotenje PFS vseh vključenih bolnikov (ITT) po oceni raziskovalca je bilo izvedeno v več podskupinah, vključno glede na starost (< 65 v primerjavi z ≥ 65), spol, ISS stadij, predhodna zdravljenja, presaditev, kategorijo tveganja, stanje telesne zmogljivosti po lestvici ECOG, očistek kreatinina in citogenetske nepravilnosti.
If the dose of one medicine in the regimen is delayed, interrupted, or discontinued, the treatment with the other medicinal products may continue as scheduled.
Odložitev odmerka, prekinitev ali ukinitev zdravljenja Če se odmerek enega zdravila v režimu odloži, zdravljenje z zdravilom prekine ali ukine, se zdravljenje z drugimi zdravili lahko nadaljuje po predvideni shemi.
Complete response rates in Empliciti group may be underestimated due to interference of elotuzumab monoclonal antibody with immunofixation assay and serum protein electrophoresis assay.
Deleži popolnega odziva bi v skupini z zdravilom Empliciti lahko bili podcenjeni zaradi vpliva elotuzumaba, monoklonskega protitelesa, na test imunofiksacije in test serumske proteinske elektroforeze.
Overall Response (ORR)c n (%)
Celokupni odziv (ORR)c n (%)
The median age was 66 years (range 37 to 91); 57% of patients were older than 65 years; 60% of patients were male; Whites comprised 84% of the study population, Asians 10%, and blacks 4%.
Mediana starost je bila 66 let (razpon: od 37 do 91), 57 % bolnikov je bilo starejših od 65 let, 60 % bolnikov je bilo moškega spola, 84 % raziskovane populacije je bilo belcev, 10 % Azijcev in 4 % bolnikov črne rase.
The median number of treatment cycles was 9 for the E-Pd arm and 5 for the Pd arm.
V skupini zdravljenja E-Pd je mediano število ciklov zdravljenja znašalo 9, v skupini zdravljenja Pd pa 5.
Chemical and physical in use stability of the reconstituted and diluted solution has been demonstrated for 24 hours at 2°C - 8°C and protected from light.
Dokazano je bilo, da je raztopina po rekonstituciji in redčenju kemijsko in fizikalno stabilna 24 ur, če se jo shranjuje pri temperaturi od 2 °C do 8 °C in zaščiteno pred svetlobo.
Five percent (5%) of patients required interruption of the administration of Empliciti for a median of 25 minutes due to infusion reaction, and 1% of patients discontinued due to infusion reactions.
Zaradi infuzijske reakcije je bilo treba infundiranje zdravila Empliciti prekiniti pri 5 % bolnikov za mediano 25 minut, pri 1 % bolnikov pa je bilo treba zdravljenje zaradi infuzijske reakcije ukiniti.
The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.
Druge sestavine (pomožne snovi) zdravila so saharoza, natrijev citrat (glejte poglavje 2 “Zdravilo Empliciti vsebuje natrij”), citronska kislina monohidrat in polisorbat 80.
The most common adverse reactions (occurring in > 10% of patients) with elotuzumab treatment were infusion related reactions, diarrhoea, herpes zoster, nasopharyngitis, cough, pneumonia, upper respiratory tract infection, lymphopenia and weight decreased.
Najpogostejši neželeni učinki (ki so se pojavili pri > 10 % bolnikov) pri zdravljenju z elotuzumabom so bili reakcije, povezane z infundiranjem, driska, herpes zoster, nazofaringitis, kašelj, pljučnica, okužba zgornjih dihal, limfopenija in zmanjšanje telesne mase.
The primary endpoint was investigator assessed PFS by modified International Myeloma Working Group (IMWG) criteria.
Primarni opazovani dogodek je bil preživetje brez napredovanja bolezni (PFS, progression free survival), ki ga je ocenil raziskovalec v skladu z modificiranimi kriteriji mednarodne delovne skupine za mielom (IMWG, International Myeloma Working Group).
Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Delovanje ledvic Izhodiščni CrCl < 60 ml/min Izhodiščni CrCl ≥ 60 ml/min
The high risk cytogenetic categories of del17p and t(4;14) were present in 32% and 9% of patients, respectively.
Visoko rizična citogenetska kategorija del17p je bila prisotna pri 32 % bolnikov, t(4;14) pa pri 9 % bolnikov.
A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
V skupini zdravljenja E-Pd je bilo živih 40 bolnikov (67 %), v skupini zdravljenja Pd pa 29 bolnikov (51 %).
Of the 53 patients in CA204125 treated with Empliciti and evaluable for the presence of anti-product antibodies, 19 patients (36%) tested positive, of whom 1 patient tested persistent positive, for treatment-emergent anti-product antibodies by an ECL assay.
Od 53 bolnikov v študiji CA204125, ki so se zdravili z zdravilom Empliciti, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 19 bolnikov (36 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu, od teh pa je bil 1 bolnik trajno pozitiven.
How to use Empliciti
Kako uporabljati zdravilo Empliciti
Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults.
Zdravilo Empliciti uporabljamo za zdravljenje multiplega mieloma (rak kostnega mozga) pri odraslih.
In cycles 3 and beyond, once every 2 weeks on days 1 and 15.
Pri 3. in kasnejših ciklih enkrat na vsaka 2 tedna na 1. in 15. dan.
The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl > 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl <30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl < 30 mL/min; N = 9).
Vpliv okvare ledvic na farmakokinetiko elotuzumaba so ovrednotili pri bolnikih z normalnim delovanjem ledvic (CrCl > 90 ml/min; N = 8), bolnikih s hudo okvaro ledvic, ki niso potrebovali zdravljenja z dializo (CrCl < 30 ml/min; N = 9) in bolnikih s končno odpovedjo ledvic, ki so potrebovali zdravljenje z dializo (CrCl < 30 ml/min; N = 9).
Empliciti will be given to you together with lenalidomide and dexamethasone or together with pomalidomide and dexamethasone.
Zdravilo Empliciti boste prejemali skupaj z lenalidomidom in deksametazonom ali skupaj s pomalidomidom in deksametazonom.
Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and macrophage-mediated antibody-dependant cellular phagocytosis (ADCP).
Elotuzumab z delovanjem na SLAMF7 na mielomskih celicah in preko interakcij z receptorji Fc na specifičnih imunskih celicah tudi pomaga spodbuditi uničenje mielomskih celic preko z naravnimi celicami ubijalkami posredovane od protiteles odvisne celične citotoksičnosti (ADCC, antibody-dependent cellular cytotoxicity) in z makrofagi posredovane od protiteles odvisne celične fagocitoze (ADCP, antibody dependant cellular phagocytosis).
The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg).
Celotni odmerek elotuzumaba v mg je enako telesna masa bolnika v kg pomnoženo z odmerkom elotuzumaba (10 ali 20 mg/kg).
Of 390 patients across four clinical studies who were treated with Empliciti and evaluable for the presence of anti-product antibodies, 72 patients (18.5%) tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Od 390 bolnikov iz štirih kliničnih študij, ki so se zdravili z zdravilom Empliciti, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 72 bolnikov (18,5 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu.
One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone.
Pri enem bolniku so poročali o prevelikem odmerjanju elotuzumaba v odmerku 23,3 mg/kg v kombinaciji z lenalidomidom in deksametazonom.
The Empliciti infusion should be used immediately.
Empliciti raztopino za infundiranje je treba uporabiti takoj.
Population PK analysis suggested that the following factors had no clinically important effect on the clearance of elotuzumab: age, gender, race, baseline LDH, albumin, renal impairment, mild hepatic impairment, and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.
Analiza populacijske farmakokinetike kaže, da naslednji dejavniki nimajo klinično pomembnega vpliva na očistek elotuzumaba: starost, spol, rasa, izhodiščna vrednost LDH, albumin, okvara ledvic, blaga okvara jeter in sočasna uporaba lenalidomida/deksametazona ali pomalidomida/deksametazona.
Once the reaction has resolved (symptoms ≤ Grade 1), Empliciti can be restarted at the initial infusion rate of 0.5 mL/min.
Ko reakcija izzveni (simptomi ≤ stopnje 1), se infundiranje zdravila Empliciti lahko nadaljuje z začetno hitrostjo infundiranja 0,5 ml/min.
If a ≥ Grade 2 infusion reaction occurs during Empliciti administration, the infusion must be interrupted.
Če se med aplikacijo zdravila Empliciti pojavi infuzijska reakcija ≥ stopnje 2, je treba infundiranje zdravila prekiniti.