FrancophonIA/ELRC3.0 huggingface dataset:
English: The data presented below is the pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).
Slovenian: Spodaj predstavljeni podatki so združeni podatki o varnosti iz ključne globalne študije C16010 (n = 720) tretje faze in dvojno slepe, s placebom nadzorovane študije C16010 Kitajske nadaljevalne študije (n = 115).
English: Ixazomib caused embryo-foetal toxicity in pregnant rats and rabbits only at maternally toxic doses and at exposures that were slightly higher than those observed in patients receiving the recommended dose.
Slovenian: Iksazomib je pri brejih podganah in kunčicah imel toksične učinke za zarodke/plodove le pri odmerkih, ki so bili toksični za matere, in pri izpostavljenostih, ki so bile nekoliko večje od izpostavljenosti, opažene pri bolnikih pri uporabi priporočenega odmerka.
English: Ninety three percent of patients had an ECOG performance status of 0-1 and 12% had baseline ISS stage III disease (N=90).
Slovenian: 93 % bolnikov je imelo stanje telesne zmogljivosti po lestvici ECOG 0-1 in 12 % bolnikov izhodiščni ISS stadij III (N = 90).
English: Ixazomib is given in combination with lenalidomide.
Slovenian: Iksazomib se daje v kombinaciji z lenalidomidom.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX50
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX50
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Takeda Pharma A/S
English: The mean AUC was 35% higher in Asian patients; however, there was overlap in the AUC of ixazomib across White and Asian patients.
Slovenian: Pri bolnikih azijskega porekla je bila povprečna vrednost AUC za 35 % večja, vendar pa so se vrednosti AUC iksazomiba pri bolnikih bele rase in azijskega porekla prekrivale.
English: Day 8 Days 9 to 14
Slovenian: 8. dan 9. do 14. dan dan
English: Ixazomib is not a substrate of BCRP, MRP2 or hepatic OATPs.
Slovenian: Iksazomib ni substrat za BCRP, MRP2 ali jetrne OATP.
English: Each blister contains one capsule).
Slovenian: V vsakem pretisnem omotu je ena kapsula.
English: What NINLARO is and what it is used for
Slovenian: Kaj je zdravilo NINLARO in za kaj ga uporabljamo
English: Thrombocytopenia did not result in an increase in haemorrhagic events or platelet transfusions.
Slovenian: Trombocitopenija ni bila povezana s povečanjem števila hemoragičnih dogodkov ali transfuzijami trombocitov.
English: People with multiple myeloma have cancerous plasma cells, also called myeloma cells, which can damage the bones.
Slovenian: Bolniki z diseminiranim plazmocitomom imajo rakavo spremenjene plazmatke, imenovane tudi mielomske celice, ki lahko poškodujejo kosti.
English: Hazard Ratio†
Slovenian: Razmerje ogroženosti†
English: Less than 1% of patients in both regimens had a platelet count ≤ 5,000/mm3 during treatment.
Slovenian: Med zdravljenjem je manj kot 1 % bolnikov v obeh režimih zdravljenja imel število trombocitov ≤ 5.000/mm3.
English: NINLARO is used with lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine).
Slovenian: Zdravilo NINLARO uporabljamo skupaj z lenalidomidom (zdravilo, ki vpliva na delovanje imunskega sistema) in deksametazonom (protivnetno zdravilo).
English: NINLARO is not recommended during pregnancy as it may harm your unborn baby.
Slovenian: Zdravila NINLARO ne uporabljajte med nosečnostjo, saj lahko škoduje nerojenemu otroku.
English: Patients experiencing new or worsening peripheral neuropathy may require dose modification (see section 4.2).
Slovenian: Pri bolnikih, ki imajo periferno nevropatijo na novo ali se jim stanje poslabša, je lahko potrebna sprememba odmerka (glejte poglavje 4.2).
English: • Absolute neutrophil count should be ≥ 1,000/mm3
Slovenian: • mora biti absolutno število nevtrofilcev ≥ 1.000/mm3.
English: Each pack contains 3 hard capsules (three single cartons, each containing a blister sealed inside a wallet.
Slovenian: Eno pakiranje vsebuje 3 trde kapsule, tri posamezne škatle, v katerih je pretisni omot pakiran v obliki listnice.
English: If you have liver or kidney problems, your doctor may prescribe NINLARO capsules containing 3 mg.
Slovenian: Bolnikom, ki imajo težave z jetri ali ledvicami, lahko zdravnik predpiše zdravljenje s 3 mg kapsulami zdravila NINLARO.
English: Concomitant medicinal products, such as antiemetic, antiviral, and antihistamine medicinal products were given to patients at the physician's discretion as prophylaxis and/or management of symptoms.
Slovenian: Bolniki so po presoji zdravnika sočasno prejemali zdravila, kot so antiemetiki, protivirusna zdravila in antihistaminiki, in sicer zaradi profilakse in/ali zdravljenja simptomov.
English: Approximately 2-fold accumulation in AUC was observed with weekly oral dosing on Day 15.
Slovenian: Pri tedenskem odmerjanju na 15. dan so pri vrednosti AUC opazili približno 2-kratno kopičenje.
English: The efficacy and safety of ixazomib in combination with lenalidomide and dexamethasone was evaluated in an international randomised, double-blind, placebo-controlled, multicenter Phase 3 superiority study (C16010) in patients with relapsed and/or refractory multiple myeloma who had received at least one prior therapy.
Slovenian: Učinkovitost in varnost iksazomiba v kombinaciji z lenalidomidom in deksametazonom so vrednotili v mednarodni, randomizirani, dvojno slepi, s placebom nadzorovani, multicentrični študiji superiornosti 3. faze (C16010) pri bolnikih s ponovitvijo in/ali z neodzivnim diseminiranim plazmocitomom, ki so se predhodno zdravili z vsaj eno obliko zdravljenja.
English: The recommended dose of dexamethasone is 40 mg taken once a week on the same day for all 4 weeks of the cycle.
Slovenian: Priporočeni odmerke deksametazona je 40 mg enkrat na teden na isti dan v tednu vse 4 tedne vsakega cikla zdravljenja.
English: If contact occurs, wash thoroughly with soap and water.
Slovenian: V primeru stika kožo temeljito umijte z milom in vodo.
English: Patients should be advised not to drive or operate machines if they experience any of these symptoms.
Slovenian: Bolniku je treba pojasniti, da v primeru pojava katerega koli od teh simptomov, ne sme voziti vozil ali upravljati strojev.
English: At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the ixazomib regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60).
Slovenian: Pri primarni analizi (mediana spremljanja 8 mesecev in mediana 6 ciklov) je bila mediana PFS pri režimu zdravljenja z iksazomibom 6,7 meseca primerjavi s 4 meseci pri režimu zdravljenja s placebom (p-vrednost = 0,035, HR = 0,60).
English: Do not use this medicine after the expiry date which is stated on the blister, wallet and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnih omotih, ovojnini v obliki listnice in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Therefore, co-administration of strong CYP3A inducers with ixazomib is not recommended (see section 4.4).
Slovenian: Sočasna uporaba močnih induktorjev CYP3A in iksazomiba ni priporočljiva (glejte poglavje 4.4).
English: Adverse reactions (all grades)
Slovenian: Neželeni učinki (vse s topnje )
English: NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Slovenian: Zdravilo NINLARO je v kombinaciji z lenalidomidom in deksametazonom indicirano za zdravljenje diseminiranega plazmocitoma pri odraslih bolnikih, ki so se predhodno zdravili z vsaj eno obliko zdravljenja.
English: Consider adding G-CSF as per clinical guidelines.
Slovenian: Razmislite o dodatku granulocitne kolonije stimulirajočega faktorja (G-CSF) v skladu s kliničnimi smernicami.
English: 1 hard capsule
Slovenian: 1 trda kapsula
English: After oral administration of a radiolabeled dose, 70% of total drug-related material in plasma was accounted for by ixazomib.
Slovenian: Po peroralni uporabi z radioaktivnim izotopom označenega odmerka je 70 % celotnega z zdravilom povezanega materiala v plazmi bilo posledica iksazomiba.
English: Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Slovenian: Iksazomib se prednostno veže in zavira kimotripsinu podobno aktivnost beta 5 podenote 20S proteasoma.
English: A total of 722 patients (intent-to-treat [ITT] population) were randomised in a 1:1 ratio to receive either the combination of ixazomib, lenalidomide, and dexamethasone (N=360; ixazomib regimen) or placebo, lenalidomide and dexamethasone (N=362; placebo regimen) until disease progression or unacceptable toxicity.
Slovenian: Skupaj je bilo 722 bolnikov (populacija vseh vključenih bolnikov [ITT]) randomiziranih v razmerju 1 : 1 na zdravljenje s kombinacijo iksazomib, lenalidomid in deksametazon (N = 360; režim zdravljenja z iksazomibom) ali zdravljenje s kombinacijo placebo, lenalidomid in deksametazon (N = 362; režim zdravljenja s placebom) do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Ixazomib was not mutagenic in a bacterial reverse mutation assay (Ames assay) or clastogenic in a bone marrow micronucleus assay in mice.
Slovenian: Iksazomib ni deloval mutageno pri bakterijskem testu povratnih mutacij (Amesov test) ali klastogeno pri mikronukleusnemu testu na kostnem mozgu miši.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Slovenian: Neželeni učinki so znotraj organskega sistema navedeni po pogostnosti, pri čemer je najprej naveden najpogostejši neželeni učinek.
English: Post-authorisation efficacy study (PAES) C16010: To provide an interim report of overall survival at the time of the 3rd interim analysis and to provide a final report for the final analysis of OS from the phase 3, randomized, double-blind study C16010 in adult patients with relapsed and/or refractory multiple myeloma.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES) C16010: Vmesno poročilo celokupnega preživetja v času 3. vmesne analize in zagotavljanje končnega poročila za končno analizo splošnega preživetja iz 3. faze, randomizirane, dvojno slepe študije C16010 pri odraslih pri odraslih bolnikih s ponovitvijo in/ali z neodzivnim diseminiranim plazmocitomom.
English: If a dose is missed or delayed, you should take the dose as long as the next scheduled dose is more than 3 days or 72 hours away.
Slovenian: Če ste pozabili vzeti odmerek zdravila ali ste odmerek odložili, pozabljeni odmerek vzemite, če je do naslednjega predvidenega odmerka še več kot 3 dni oziroma 72 ur.
English: For other concomitant medicinal products that may be required, refer to the current lenalidomide and dexamethasone SmPC.
Slovenian: Za druga sočasno uporabljena zdravila, ki bi lahko bila potrebna, glejte zadnji odobreni SmPC za lenalidomid in deksametazon.
English: See the package leaflets for lenalidomide and dexamethasone for additional information on pregnancy and breast-feeding
Slovenian: Glejte navodili za uporabo lenalidomida in deksametazona za dodatne informacije o nosečnosti in dojenju.
English: At clinically relevant ixazomib concentrations, in vitro studies using human cDNA-expressed cytochrome P450 isozymes indicate that no specific CYP isozyme predominantly contributes to ixazomib metabolism and non-CYP proteins contribute to overall metabolism.
Slovenian: In vitro študije z uporabo humanih cDNA-izraženih izoencimov citokroma P450 kažejo, da pri klinično pomembnih koncentracijah iksazomiba pri presnovi iksazomiba v glavnem sodelujejo nespecifični izoencimi CYP, ne-CYP proteini pa pri celokupni presnovi.
English: Co-administration of ixazomib with rifampicin decreased ixazomib Cmax by 54% and AUC by 74%.
Slovenian: Pri sočasni uporabi iksazomiba in rifampicina se je vrednost Cmax iksazomiba zmanjšala za 54 %, vrednost AUC pa za 74 %.
English: There was no clinically meaningful effect of age (23-91 years), sex, body surface area (1.2-2.7 m2), or race on the clearance of ixazomib based on the results of a population PK analysis.
Slovenian: Na osnovi rezultatov analize populacijske farmakokinetike starost (23-91 let), spol, telesna površina (1,2-2,7 m2) ali rasa nimajo klinično pomembnega vpliva na očistek iksazomiba.
English: CYP inducers
Slovenian: Induktorji CYP
English: Patients received ixazomib 4 mg or placebo on Days 1, 8, and 15 plus lenalidomide (25 mg) on Days 1 through 21 and dexamethasone (40 mg) on Days 1, 8, 15, and 22 of a 28-day cycle.
Slovenian: Bolniki so prejemali iksazomib v odmerku 4 mg ali placebo na 1., 8. in 15. dan, lenalidomid (25 mg) od 1. do 21. dne ter deksametazon (40 mg) na 1., 8., 15. in 22. dan 28-dnevnega cikla zdravljenja.
English: NINLARO, lenalidomide and dexamethasone are taken in 4-week treatment cycles.
Slovenian: Zdravljenje z zdravilom NINLARO, lenalidomidom in deksametazonom poteka v 4-tedenskih ciklih.
English: The most frequently reported adverse reactions (≥ 20%) across 417 patients treated within the ixazomib regimen and 418 patients within the placebo regimen were diarrhoea (39% vs. 32%), thrombocytopenia (33% vs. 21%), neutropenia (33% vs. 30%), constipation (30% vs. 22%), peripheral neuropathy (25% vs. 20%), nausea (23% vs. 18%), peripheral oedema (23% vs. 17%), vomiting (20% vs. 10%) and upper respiratory tract infection (21% vs. 16%).
Slovenian: Neželeni učinki, o katerih so pri režimu zdravljenja z iksazomibom pri 417 bolnikih in pri režimu zdravljenja s placebom pri 418 bolnikih poročali najpogosteje (≥ 20 %), so: driska (39 % v primerjavi z 32 %), trombocitopenija (33 % v primerjavi z 21 %), nevtropenija (33 % v primerjavi s 30 %), zaprtost (30 % v primerjavi z 22 %), periferna nevropatija (25 % v primerjavi z 20 %), navzea (23 % v primerjavi z 18 %), periferni edem (23 % v primerjavi s 17 %), bruhanje (20 % v primerjavi z 10 %), okužba zgornjih dihalnih poti (21 % v primerjavi s 16 %).
English: The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines.
Slovenian: Kombinacija iksazomiba in lenalidomida ima sinergistične citotoksične učinke na celičnih linijah diseminiranega plazmocitoma.
English: If ixazomib is used during pregnancy or if the patient becomes pregnant while taking ixazomib, the patient should be apprised of the potential hazard to the foetus.
Slovenian: Če se iksazomib uporablja med nosečnostjo ali bolnica med zdravljenjem z iksazomibom zanosi, ji je treba pojasniti možno tveganje za plod.
English: In vitro, ixazomib affected cell types found in the bone marrow microenvironment including vascular endothelial cells, osteoclasts and osteoblasts.
Slovenian: Iksazomib in vitro prizadene celične tipe v mikrookolju kostnega mozga, vključno z vaskularnimi endotelijskimi celicami, osteoklasti in osteoblasti.
English: Antiviral prophylaxis should be considered in patients being treated with ixazomib to decrease the risk of herpes zoster reactivation.
Slovenian: Pri bolnikih, ki se zdravijo z iksazomibom, je treba razmisliti o protivirusni profilaksi za zmanjšanje tveganja za reaktivacijo herpesa zostra.
English: Ixazomib will be given in combination with lenalidomide and breast-feeding should be stopped because of the use of lenalidomide.
Slovenian: Iksazomib se daje v kombinaciji z lenalidomidom, zato je treba dojenje zaradi uporabe lenalidomida prekiniti.
English: In case of capsule breakage, avoid raising dust during clean-up.
Slovenian: Če se kapsula zdrobi, med čiščenjem ne smete dvigati prahu.
English: • If Grade 2 or 3 rash occurs again, withhold ixazomib and lenalidomide until rash recovers to ≤ Grade 1.
Slovenian: • Če se izpuščaj stopnje 2 ali 3 ponovi, zdravljenje z iksazomibom in lenalidomidom zadržite, dokler se izpuščaj ne ublaži do ≤ stopnje 1.
English: More frequent monitoring should be considered during the first three cycles as per the lenalidomide SmPC.
Slovenian: Med prvimi tremi cikli zdravljenja je v skladu s SmPC-jem za lenalidomid treba razmisliti o pogostejšem preverjanju.
English: The most common adverse reactions were blurred vision (5% in the ixazomib regimen and 4% in the placebo regimen), dry eye (4% in the ixazomib regimen and 1% in the placebo regimen), conjunctivitis (5% in the ixazomib regimen and 1% in the placebo regimen) and cataract (4% in the ixazomib regimen and 5% in the placebo regimen).
Slovenian: Najpogostejši neželeni učinki so bili zamegljen vid (5 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi s 4 % pri režimu zdravljenja s placebom), suho oko (4 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi z 1 % pri režimu zdravljenja s placebom), konjunktivitis (5 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi z 1 % pri režimu zdravljenja s placebom) in katarakto (4 % pri pri režimu zdravljenja z iksazomibom v primerjavi s 5 % pri režimu zdravljenja s placebom).
English: Blood and lymphatic system disorders Thrombocytopenia*
Slovenian: Bolezni krvi in limfatičnega sistema Trombocitopenija*
English: In the event that a ixazomib dose is delayed or missed, the dose should be taken only if the next scheduled dose is ≥ 72 hours away.
Slovenian: Odloženi ali izpuščeni odmerek iksazomiba lahko bolnik vzame le, če je do naslednjega predvidenega odmerka ≥ 72 ur.
English: Grade 2 peripheral neuropathy with pain or Grade 3 peripheral
Slovenian: Periferna nevropatija stopnje 2 z bolečino ali periferna nevropatija stopnje 3
English: These medicines should be avoided as they may reduce the effectiveness of NINLARO.
Slovenian: Ta zdravila lahko zmanjšajo učinkovitost zdravila NINLARO, zato se je treba uporabi teh zdravil izogibati.
English: Patients included in studies with ixazomib who received antiviral prophylaxis had a lower incidence of herpes zoster infection compared to patients who did not receive prophylaxis.
Slovenian: Pri bolnikih, ki so v študijah z zdravilom NINLARO prejemali protivirusno profilakso, je bila pojavnost herpesa zostra manjša, kot pri bolnikih, ki profilakse niso prejemali.
English: Musculoskeletal and connective tissue disorders Back pain
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Bolečina v hrbtu zelo pogosto občasno
English: • In the capsule: microcrystalline cellulose, magnesium stearate and talc.
Slovenian: • Vsebina kapsule: mikrokristalna celuloza, magnezijev stearat in smukec.
English: No dose adjustment of ixazomib is required for patients over 65 years of age.
Slovenian: Pri bolnikih, starejših od 65 let, odmerka iksazomiba ni treba prilagajati.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, ki jih lahko dobite brez recepta, kot so vitamini ali zdravila rastlinskega izvora.
English: Grade 3 adverse reactions were reported in 2% of patients in both regimens.
Slovenian: O neželenih učinkih stopnje 3 so poročali pri 2 % bolnikov pri obeh režimih zdravljenja.
English: Rash should be managed with supportive care or with dose modification if Grade 2 or higher (see section 4.2).
Slovenian: Izpuščaj je treba zdraviti s podpornim zdravljenjem ali spremembo odmerka, če je stopnje 2 ali višje (glejte poglavje 4.2).
English: The frequency of severe (Grade 3-4) events of hypokalaemia was higher in the ixazomib regimen (5%) than the placebo regimen (<1%).
Slovenian: Pogostnost hude (stopnja 3-4) hipokaliemije je bila večja pri režimu zdravljenja z iksazomibom (5 %) kot pri režimu zdravljenja s placebom (< 1 %).
English: Table 2: Dose modifications guidelines for ixazomib in combination with lenalidomide and dexamethasone
Slovenian: Tabela 2: Smernice za prilagoditev odmerka iksazomiba v kombinaciji z lenalidomidom in deksametazonom
English: You should read the Package Leaflets of these other medicines for further information on their use and effects.
Slovenian: Za nadaljnje informacije o uporabi in učinkih drugih zdravil preberite tudi ustrezno navodilo za uporabo, ki je priloženo tem zdravilom.
English: The capsule should not be removed until just prior to dosing.
Slovenian: Kapsulo lahko iz ovojnine vzamete šele neposredno pred uporabo.
English: Thromboprophylaxis is recommended in patients being treated with ixazomib in combination with lenalidomide and dexamethasone, and should be based on an assessment of the patient's underlying risks and clinical status.
Slovenian: Pri bolnikih, ki se zdravijo z iksazomibom v kombinaciji z lenalidomidom in deksametazonom, je priporočljiva tromboprofilaksa, ki mora temeljiti na oceni bolnikovega osnovnega tveganja in kliničnega stanja.
English: Administration with a high-fat meal decreased ixazomib AUC by 28% compared with administration after an overnight fast (see section 4.2).
Slovenian: Pri uporabi skupaj z obrokom z veliko vsebnostjo maščob se je vrednost AUC iksazomiba zmanjšala za 28 % v primerjavi z uporabo odmerka zjutraj na tešče (glejte poglavje 4.2).
English: Grade 3 adverse reactions of peripheral neuropathy were reported in 2% of patients in both regimens.
Slovenian: O neželenih učinkih periferne nevropatije stopnje 3 so poročali pri 2 % bolnikov pri obeh režimih zdravljenja.
English: Reproductive and embryo-foetal development
Slovenian: Razmnoževanje in razvoj zarodkov/plodov
English: C16019: In order to further investigate the efficacy the MAH should provide additional OS/PFS2 data when approximately 200 death events have occurred from the Phase 3, randomized, placebo-controlled, double-blind study of ixazomib in maintenance therapy in patients with multiple myeloma following SCT.
Slovenian: C16019: Da bi še dodatno raziskali učinkovitost mora imetnik dovoljenja za promet zagotoviti dodatne podatke OS/PFS2, ko pride do približno 200 primerov smrti, v 3. fazi randomizirane, dvojno slepe, s placebom kontrolirane študije iksazomiba pri podpornem zdravljenju pri bolnikih z diseminiranim plazmocitomom po SCT.
English: Dosing schedule: Ixazomib taken with lenalidomide and dexamethasone 28-day cycle (a 4-week cycle)
Slovenian: Shema odmerjanja: Jemanje iksazomiba skupaj z lenalidomidom in deksametazonom 28-dnevni cikel (4-tedenski cikel)
English: Following oral administration, a tissue distribution study in rats revealed that the brain and spinal cord were amongst the tissues with the lowest levels, suggesting that the penetration of ixazomib through the blood-brain barrier appears to be limited.
Slovenian: Študija porazdelitve po tkivih po peroralni uporabi pri podganah je pokazala, da so možgani in hrbtenjača med tkivi z najmanjšimi vrednostmi, kar kaže, da je prehajanje iksazomiba skozi krvno-možgansko pregrado omejeno, vendar pa pomen tega za človeka ni znan.
English: There was no discernible relationship between ixazomib concentration and the RR interval suggesting no clinically meaningful effect of ixazomib on heart rate.
Slovenian: Povezava med koncentracijo iksazomiba in intervalom RR ni bila zaznana, kar kaže, da iksazomib nima klinično pomembnega učinka na srčno frekvenco.
English: The majority of target organ findings demonstrated partial to full recovery following discontinuation of treatment, with the exception of neuronal findings in the lumbar dorsal root ganglion and dorsal column.
Slovenian: Večina sprememb na ciljnih organih je po prekinitvi uporabe zdravila deloma ali popolno izzvenela, z izjemo sprememb na spinalnih ganglijih in dorzalni hrbtenjači.
English: Because myeloma cells produce a lot of proteins, blocking the action of proteasomes can kill the cancerous cells.
Slovenian: Ker mielomske celice (tumorske celica) proizvajajo veliko beljakovin, lahko iksazomib z zavrtjem delovanja proteasomov uniči rakave celice.