natgillin/translations-raw huggingface dataset:
The administration of dexamethasone is as follows:
Deksametazon je treba uporabljati na naslednji način:
If you miss a dose of Empliciti
Če niste prejeli odmerka zdravila Empliciti
Table 5: Adverse reactions in patients with multiple myeloma treated with Empliciti System Organ Class
Tabela 5: Neželeni učinki pri bolnikih z multiplim mielomom, ki so se zdravili z zdravilom Empliciti
The incidence of SPMs was higher with Empliciti treatment than with control (see section 4.4).
Pojavnost SPN je bila pri zdravljenju z zdravilom Empliciti večja kot v kontrolni skupini (glejte poglavje 4.4).
28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22
3. in nadaljnji cikli 28-dnevnega cikla Dan cikla 1 8 15 22 1 8 15 22
In the unlikely case of an overdose, your doctor will monitor you for side effects.
V primeru prevelikega odmerka boste pod zdravniškim nadzorom zaradi neželenih učinkov.
Empliciti is for single use only.
Zdravilo Empliciti je namenjeno samo za enkratno uporabo.
Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle.
Bolniki so deksametazon prejeli na: 1., 8., 15. in 22. dan vsakega cikla.
The entire Empliciti infusion should be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (with a pore size of 0.2-1.2 µm) using an automated infusion pump.
Celotno količino zdravila Empliciti morate infundirati s pomočjo infuzijskega seta in sterilnega nepirogenega filtra, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm) ter avtomatske infuzijske črpalke.
The incidence of infections, including pneumonia, was higher with Empliciti treatment than with control (see section 4.4).
Pojavnost okužb, vključno s pljučnico, je bila pri zdravljenju z zdravilom Empliciti večja kot v kontrolni skupini (glejte poglavje 4.4).
In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
V nekliničnih modelih elotuzumab v kombinaciji z lenalidomidom, s pomalidomidom ali z bortezomibom deluje sinergistično.
Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity.
Zdravljenje je potekalo v 4-tedenskih ciklih do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag immediately.
Po rekonstituciji je treba rekonstituirano raztopino iz viale takoj prenesti v infuzijsko vrečko.
Reconstitution of vials
Rekonstitucija vial
The total elotuzumab dose in mg equals the patient's weight in kg multiplied by the elotuzumab dose (10 or 20 mg/kg, see section 4.2).
Celotni odmerek elotuzumaba v mg je enako telesna masa bolnika v kg pomnoženo z odmerkom elotuzumaba (10 ali 20 mg/kg, glejte poglavje 4.2).
If well tolerated, the infusion rate may be increased stepwise as described in Tables 3 and 4 (see section 4.2 Method of administration).
Če bolnik to hitrost dobro prenaša, lahko hitrost infundiranja postopoma povečujete, kot je prikazano tabeli 3 in tabeli 4 (glejte poglavje 4.2 Način uporabe).
The active substance is elotuzumab.
Učinkovina je elotuzumab.
No animal data are present regarding the effect on reproductive toxicity because of the lack of an adequate animal model.
Zaradi pomanjkanja ustreznega živalskega modela ni podatkov o vplivu na sposobnost razmnoževanja pri živalih.
Empliciti is used in combination with other medicines for multiple myeloma.
Zdravilo Empliciti se uporablja v kombinaciji z drugimi zdravili za zdravljenje multiplega mieloma.
The International Staging System (ISS) Stage was I in 50%, II in 38% and III in 12% of patients.
Po mednarodnem sistemu za razvrščanje v stadije (ISS; International Staging System) je ISS stadij I imelo 50 %, ISS stadij II 38 % in ISS stadij III 12 % bolnikov.
The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma.
Farmakokinetiko elotuzumaba so raziskali pri bolnikih z multiplim mielomom.
For additional information concerning lenalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o uporabi lenalidomida in deksametazona glejte ustrezen povzetek glavnih značilnosti zdravila.
Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 12.
Aseptično rekonstituirajte vsako vialo z zdravilom Empliciti s pomočjo injekcijske brizge ustrezne velikosti in injekcijske igle debeline 18G ali tanjše kot je prikazano v tabeli 12.
When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur.
Ko simptomi izzvenijo ali se izboljšajo, se infundiranje zdravila lahko nadaljuje z manjšo hitrostjo.
The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients), bortezomib and dexamethasone (103 patients) or pomalidomide and dexamethasone (128 patients) pooled across 8 clinical trials.
Varnost elotuzumaba so ovrednotili na osnovi združenih podatkov iz 8 kliničnih preskušanj pri skupno 682 bolnikih z multiplim mielomom, ki so se zdravili z elotuzumabom v kombinaciji z lenalidomidom in deksametazonom (451 bolnikov), bortezomibom in deksametazonom (103 bolniki) ali pomalidomidom in deksametazonom (128 bolnikov).
The International Staging System (ISS) Stage was I in 43%, II in 32% and III in 21% of patients.
Po mednarodnem sistemu za razvrščanje v stadije (ISS; International Staging System) je ISS stadij I imelo 43 %, ISS stadij II 32 % in ISS stadij III 21 % bolnikov.
PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
PFS (vsi vključeni bolniki) Razmerje ogroženosti [95% IZ] stratificirani test log rank, p-vrednosta Mediana PFS v mesecih [95 % IZ]
For additional information concerning pomalidomide and dexamethasone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o uporabi pomalidomida in deksametazona glejte ustrezen povzetek glavnih značilnosti zdravila.
Cycle 1, Dose 2
1. cikel, 2. odmerek
Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80.
Pomožne snovi: saharoza, natrijev citrat, citronska kislina monohidrat in polisorbat 80.
No clinically important differences in the clearance of Empliciti were found between patients with mild hepatic impairment and patients with normal hepatic function.
Pri bolnikih z blago okvaro jeter niso ugotovili klinično pomembnih razlik v očistku zdravila Empliciti v primerjavi z bolniki z normalnim delovanjem jeter.
The incidence of pneumonia was higher in the Empliciti combined with lenalidomide and dexamethasone arm compared to lenalidomide and dexamethasone arm reported at 15.1% vs. 11.7% with a fatal outcome at 0.6% vs. 0%, respectively.
Pojavnost pljučnice je bila večja v skupini z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom v primerjavi s skupino z lenalidomidom in deksametazonom (15,1 % v primerjavi z 11,7 %, s smrtnim izidom pa 0,6 % v primerjavi z 0 %).
You should not use Empliciti if you are pregnant, unless your doctor specifically recommends it.
Med nosečnostjo zdravila Empliciti ne smete uporabljati, razen na izrecno priporočilo zdravnika.
Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 1.
Aseptično rekonstituirajte vsako vialo z zdravilom Empliciti s pomočjo injekcijske brizge ustrezne velikosti in injekcijske igle debeline 18G ali tanjše kot je prikazano v tabeli 1.
The median PFS per ITT was 10.25 months (95% CI: 5.59, NE) in the E-Pd arm and 4.67 months (95% CI: 2.83, 7.16) in the Pd arm. PFS and ORR were also assessed by the IRC.
Mediana PFS vseh vključenih bolnikov (ITT) je v skupini E-Pd znašala 10,25 meseca (95 % IZ: 5,59; NE), v skupini zdravljenja Pd pa 4,67 meseca (95 % IZ: 2,83; 7,16).
Median OS in months [95% CI]
Mediana OS v mesecih [95 % IZ]
The following side effects have been reported in clinical trials with elotuzumab:
V kliničnih preskušanjih, izvedenih z elotuzumabom, so poročali o naslednjih neželenih učinkih:
HR (95% CI): 0.54 (0.34, 0.86) p-value: 0.0078
Razmerje ogroženosti (95 % IZ): 0,54 (0,34; 0,86) p-vrednost: 0,0078
The rates of deep vein thromboses observed between treatment arms were similar for patients given prophylaxis with low molecular weight heparin (2.2% in both treatment arms), and for patients given vitamin K antagonists the rates were 0% for patients treated with E-Ld and 6.7% for patients treated with Ld.
Pri bolnikih, ki so prejemali profilakso z nizkomolekularnim heparinom, je bil delež globoke venske tromboze med obema skupinami zdravljenja podoben (2,2 % v obeh skupinah zdravljenja), pri bolnikih, ki so prejemali antagoniste vitamina K, pa je pri bolnikih, ki so se zdravili z E-Ld znašal 0 %, pri bolnikih, ki so se zdravili z Ld, pa 6,7 %.
Figure 3: CA204125 Progression free survival per investigator
Študija CA204125: Preživetje brez napredovanja bolezni po oceni raziskovalca
PVC infusion sets polyethersulfone and nylon in-line filters with pore sizes of 0.2 μm to 1.2 μm.
Empliciti raztopina za infundiranje je kompatibilna: z vsebniki iz PVC-ja in poliolefina z infuzijskimi seti iz PVC-ja z linijskimi filtri iz polietersulfona in najlona z velikostjo por od 0,2 µm do 1,2 µm.
The recommended dose of Empliciti is 10 mg/kg administered intravenously every week, on days 1, 8, 15, and 22 for the first two treatment cycles and every 2 weeks thereafter on days 1 and 15.
Priporočeni odmerek zdravila Empliciti je 10 mg/kg intravensko vsak teden, na 1., 8., 15. in 22. dan prva dva cikla zdravljenja in nato na vsaka 2 tedna na 1. in 15. dan.
H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or equivalent H2 blocker.
Antagonist histaminskih receptorjev H2: ranitidin (50 mg intravensko ali 150 mg peroralno) ali enakovreden antagonist histaminskih receptorjev H2.
You must use effective contraception while you are being treated with Empliciti, if there is any chance you could become pregnant.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Empliciti uporabljati učinkovito obliko kontracepcije, če obstaja kakršna koli možnost zanositve.
Table 2: Recommended dosing schedule of Empliciti in combination with pomalidomide and dexamethasone
Tabela 2: Priporočena shema odmerjanja zdravila Empliciti v kombinaciji s pomalidomidom in deksametazonom
a The term cough includes the following terms: cough, productive cough, and upper airway cough syndrome.
Izraz kašelj vključuje naslednje izraze: kašelj, produktivni kašelj in sidrom kašlja zgornjih dihalnih poti.
Figure 2: CA204004 Overall survival
Študija CA204004: Celokupno preživetje
The effect of hepatic impairment on the clearance of Empliciti was evaluated by population PK analyses in patients with mild hepatic impairment (total bilirubin [TB] ≤ the upper limit of normal [ULN] and AST > ULN or TB < 1 to 1.5 × ULN and any AST; N = 33).
Učinek okvare jeter na očistek zdravila Empliciti so raziskali z analizo populacijske farmakokinetike pri bolnikih z blago okvaro jeter (vrednost skupnega bilirubina [SB] ≤ od zgornje meje normalne [ZMN] vrednosti in vrednost AST > od ZMN vrednosti ali vrednost SB < od 1 do 1,5 × ZMN vrednosti in katera koli vrednost AST; N = 33).
Very severe infusion reactions (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
V primeru zelo hudih infuzijskih reakcij (≥ stopnja 3), bo zdravljenje z zdravilom Empliciti morda treba trajno ukiniti in uvesti ustrezno nujno zdravljenje.
On days that Empliciti is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), dexamethasone should be given 40 mg orally.
Na dan brez uporabe zdravila Empliciti, ko je predvidena uporaba deksametazona (8. in 22. dan 3. cikla in vsi nadaljnji cikli), mora bolnik deksametazon prejeti v odmerku 40 mg peroralno.
Discard any unused portion left in the vial.
Neporabljeno zdravilo, ki ostane v viali, zavrzite.
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
Zdravilo Empliciti je v kombinaciji z lenalidomidom in deksametazonom indicirano za zdravljenje multiplega mieloma pri odraslih bolnikih, ki so se predhodno zdravili z vsaj eno obliko zdravljenja (glejte poglavji 4.2 in 5.1).
A total of 117 patients were randomised in a 1:1 ratio to receive treatment: 60 to elotuzumab in combination with pomalidomide and dexamethasone (E-Pd) and 57 to pomalidomide and dexamethasone (Pd).
Na zdravljenje so vsega skupaj randomizirali 117 bolnikov v razmerju 1:1. 60 bolnikov je prejelo zdravljenje z elotuzumabom v kombinaciji s pomalidomidom in deksametazonom (E-Pd), 57 bolnikov pa zdravljenje s pomalidomidom in deksametazonom (Pd).
Patients receiving Empliciti in combination with lenalidomide or pomalidomide should adhere to the pregnancy prevention programme of lenalidomide or pomalidomide respectively.
Bolniki, ki prejemajo zdravilo Empliciti v kombinaciji z lenalidomidom ali pomalidomidom, se morajo držati programa za preprečevanje nosečnosti, ki je predviden pri uporabi lenalidomida oziroma pomalidomida.
The recommended dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Priporočeni odmerek lenalidomida je 25 mg peroralno enkrat na dan od 1. do 21. dneva ponavljajočega se 28-dnevnega cikla in najmanj 2 uri po infundiranju zdravila Empliciti, če se zdravili uporabi na isti dan.
Lenalidomide and Dexamethasone N = 317
lenalidomid in deksametazon N = 317
Table 9: CA204004 Efficacy results for subsets
Tabela 9: Študija CA204004: Rezultati učinkovitosti po podskupinah
A statistically significant advantage in OS was observed in patients in the E-Ld arm compared to patients in the Ld arm.
V primerjavi z bolniki v skupini Ld so pri bolnikih v skupini E-Ld opazili statistično značilno prednost pri celokupnem preživetju.
HR (97.61% CI): 0.68 (0.55, 0.85) p-value: 0.0001
Razmerje ogroženosti (97,61 % IZ): 0,68 (0,55; 0,85) p-vrednost: 0,0001
You will be monitored for signs of such effects during and after the infusion.
Med in po infundiranju zdravila vas bodo nadzirali glede pojava znakov teh neželenih učinkov.
Fatal infections (i.e. Grade 5 infections) were reported in 5% of Empliciti combined with pomalidomide and dexamethasone and 3.6% of pomalidomide and dexamethasone treated patients.
O okužbah s smrtnim izidom (na primer okužbah stopnje 5) so poročali pri 5 % bolnikov, ki so se zdravili z zdravilom Empliciti v kombinaciji s pomalidomidom in deksametazonom, in pri 3,6 % bolnikov, ki so se zdravili s pomalidomidom in deksametazonom.
Calculate the volume (mL) of diluent (either sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection) needed to make up the solution for infusion for the patient.
Izračunajte potreben volumen (ml) sredstva za redčenje (bodisi 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje ali 5-odstotne raztopine glukoze za injiciranje) za pripravo raztopine za infundiranje bolniku.
What Empliciti contains
Kaj vsebuje zdravilo Empliciti
p-valued Complete Response (CR + sCR)e n (%)
Popolni odziv (CR + sCR)e n (%)
Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) 12 (20.0)
Zelo dober delni odziv (VGPR) n (%) Delni odziv (RR/PR) n (%) Kombinirani odzivi (CR+sCR+VGPR) n (%)
When given in combination with pomalidomide and dexamethasone, Empliciti is given as follows:
Pri uporabi v kombinaciji s pomalidomidom in z deksametazonom se zdravilo Empliciti uporablja:
Lenalidomide and pomalidomide are present in the blood and sperm of patients receiving the medicine.
Pri bolnikih, ki se zdravijo z lenalidomidom in pomalidomidom, sta le-ta prisotna v krvi in spermi.
Empliciti + Pomalidomide and Dexamethasone N = 60
Empliciti + pomalidomid in deksametazon N = 60
No clinically important differences in the pharmacokinetics of elotuzumab were found between patients with severe renal impairment (with and without dialysis) and patients with normal renal function (see section 4.2).
Pri bolnikih s hudo okvaro ledvic (pri zdravljenju z dializo in brez nje) niso ugotovili klinično pomembnih razlik v farmakokinetiki elotuzumaba v primerjavi z bolniki z normalnim delovanjem ledvic (glejte poglavje 4.2).
The reconstituted solution should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection to obtain a final infusion concentration range between 1 mg/mL and 6 mg/mL.
Po rekonstituciji morate raztopino razredčiti z 9 mg/ml (0,9%) raztopino natrijevega klorida za injiciranje ali s 5-odstotno raztopino glukoze za injiciranje, da se končna koncentracija raztopine za infundiranje giblje v razponu med 1 mg/ml in 6 mg/ml.
A total of 646 patients were randomised to receive treatment: 321 to Empliciti in combination with lenalidomide and dexamethasone and 325 to lenalidomide and dexamethasone.
Na zdravljenje je bilo vsega skupaj randomiziranih 646 bolnikov: 321 bolnikov na zdravljenje z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, 325 bolnikov pa na zdravljenje z lenalidomidom in deksametazonom.
The rate of infusion reactions was much higher in patients who were not premedicated.
Pri bolnikih, ki niso prejeli premedikacije, je bil delež infuzijskih reakcij precej večji.
The recommended dose of pomalidomide is 4 mg orally once daily on days 1-21 of repeated 28-day cycles, and at least 2 hours after Empliciti infusion when administered on the same day.
Priporočeni odmerek pomalidomida je 4 mg peroralno enkrat na dan od 1. do 21. dneva ponavljajočega se 28 dnevnega cikla in najmanj 2 uri po infundiranju zdravila Empliciti, če se zdravili uporabi na isti dan.
Cycle 1, Dose 1
1. cikel, 1. odmerek
The volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection should be adjusted so as to not exceed 5 mL/kg of patient weight at any given dose of Empliciti.
Volumen 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje ali 5-odstotne raztopine glukoze za injiciranje morate prilagoditi tako, da pri katerem koli apliciranem odmerku zdravila Empliciti ne presega 5 ml/kg telesne mase bolnika.
Table 8: CA204004 Efficacy results
Tabela 8: Študija CA204004: Rezultati učinkovitosti
The 1-, 2-, 3-, 4- and 5-year rates of overall survival for Empliciti in combination with lenalidomide and dexamethasone treatment were 91%, 73%, 60%, 50% and 40% respectively, compared with 83%, 69%, 53%, 43% and 33% respectively, for lenalidomide and dexamethasone treatment (See Figure 2).
Pri zdravljenju z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom je delež 1-letnega celokupnega preživetja znašal 91 %, delež 2-letnega celokupnega preživetja 73 %, delež 3-letnega celokupnega preživetja 60 %, delež 4-letnega celokupnega preživetja 50 %, delež 5-letnega celokupnega preživetja pa 40 % v primerjavi z zdravljenjem z lenalidomidom in deksametazonom, kjer je delež 1-letnega celokupnega preživetja znašal 83 %, delež 2-letnega celokupnega preživetja 69 %, delež 3-letnega celokupnega preživetja 53 %, delež 4-letnega celokupnega preživetja 43 %, delež 5-letnega celokupnega preživetja pa 33 % (glejte sliko 2).
Empliciti + Lenalidomide and Dexamethasone N = 318
Empliciti + lenalidomid in deksametazon N = 318
Each vial contains either 300 mg or 400 mg of elotuzumab.
Ena viala vsebuje 300 mg ali 400 mg elotuzumaba.
When given in combination with lenalidomide and dexamethasone, Empliciti is given as follows:
Pri uporabi v kombinaciji z lenalidomidom in deksametazonom se zdravilo Empliciti uporablja:
Pomalidomide and Dexamethasone N = 55
pomalidomid in deksametazon N = 55
No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl < 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2).
Pri bolnikih z blago (CrCl = 60 - 89 ml/min), zmerno (CrCl = 30 - 59 ml/min), hudo (CrCl < 30 ml/min) okvaro ledvic ali končno odpovedjo ledvic, ki potrebujejo zdravljenje z dializo, odmerka zdravila Empliciti ni treba prilagajati (glejte poglavje 5.2).
a p-value based on the log-rank test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
a p-vrednost na osnovi testa log-rank, stratificiranega glede na B2 mikroglobuline (< 3,5 mg/l v primerjavi z ≥ 3,5 mg/l), število predhodnih linij zdravljenja (1 v primerjavi z 2 ali 3) in predhodno imunomodulatorno zdravljenje (brez v primerjavi s predhodnim zdravljenjem samo s talidomidom v primerjavi z drugim).
On days that Empliciti is administered, dexamethasone should be given as 28 mg orally once daily between 3 and 24 hours before Empliciti plus 8 mg intravenously between 45 and 90 minutes before Empliciti on days 1, 8, 15, and 22 of repeated 28-day cycles.
Na dan aplikacije zdravila Empliciti mora bolnik deksametazon prejeti v odmerku 28 mg peroralno enkrat na dan od 3 do 24 ur pred zdravilom Empliciti in 8 mg intravensko od 45 do 90 minut pred aplikacijo zdravila Empliciti na 1., 8., 15. in 22. dan ponavljajočega se 28-dnevnega cikla.
Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg.
Farmakokinetika elotuzumaba je nelinearna pri čemer se očistek zmanjšuje, odmerek pa povečuje od 0,5-20 mg/kg.
When Empliciti is given in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention programme for lenalidomide or pomalidomide respectively (see package leaflet for lenalidomide or pomalidomide).
Pri uporabi zdravila Empliciti v kombinaciji z lenalidomidom ali s pomalidomidom morate upoštevati navodila za preprečevanje nosečnosti pri uporabi lenalidomida oziroma pomalidomida (glejte navodila za uporabo lenalidomida oziroma pomalidomida).
The recommended dose of Empliciti is 10 mg/kg administered intravenously every week on days 1, 8, 15, and 22 of each treatment cycle for the first two cycles and then 20 mg/kg administered on day 1 of each treatment cycle thereafter.
Priporočeni odmerek zdravila Empliciti je 10 mg/kg intravensko vsak teden, na 1., 8., 15. in 22. dan prva dva cikla zdravljenja in nato 20 mg/kg na 1. dan vsakega cikla zdravljenja.
In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8).
V kliničnem preskušanju, v katerem so pri bolnikih z multiplim mielomom uporabo zdravila Empliciti v kombinaciji z lenalidomidom in deksametazonom primerjali z uporabo lenalidomida in deksametazona (študija CA204004), je bila pojavnost SPN in specifičnih solidnih tumorjev ter nemelanomskega kožnega raka večja pri bolnikih, ki so se zdravili z zdravilom Empliciti (glejte poglavje 4.8).
Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).
Zdravilo Empliciti je v kombinaciji s pomalidomidom in deksametazonom indicirano za zdravljenje ponovljenega in neodzivnega multiplega mieloma pri odraslih bolnikih, ki so se predhodno zdravili z vsaj dvema oblikama zdravljenja, vključno z lenalidomidom in zaviralcem proteasoma, bolezen pa je pri zadnjem zdravljenju napredovala (glejte poglavji 4.2 in 5.1).
Sodium citrate Citric acid monohydrate Polysorbate 80
6.1 Seznam pomožnih snovi saharoza natrijev citrat citronska kislina monohidrat polisorbat 80