FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central laboratory results.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS; “progression-free survival”) po poenotenih kriterijih odziva iz leta 2011, ki jih je pripravila mednarodna delovna skupina za mielom (IMWG; “International Myeloma Working Group”), kar je ovrednotil zaslepljeni neodvisni odbor za presojo odziva (IRC; “independent review committee”) na osnovi centralnih laboratorijskih rezultatov.
English: Studies of fertility and early embryonic development and pre- and post-natal toxicology were not conducted with ixazomib, but evaluation of reproductive tissues was conducted in the general toxicity studies.
Slovenian: Študije vplivov iksazomiba na plodnost in zgodnji embrionalni razvoj ter študije prenatalne in postnatalne toksičnosti niso bile izvedene, so pa vrednotenje vplivov na reproduktivna tkiva izvedli v študijah splošne toksičnosti.
English: If you vomit after taking a dose, do not take an extra dose.
Slovenian: Če potem, ko ste vzeli odmerek zdravila bruhate, ne smete vzeti dodatnega odmerka.
English: Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.
Slovenian: Ne uporabljajte tega zdravila, če opazite kakršno koli poškodbo ali druge znake, da je bila ovojnina zdravila že odprta.
English: NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
Slovenian: Zdravilo NINLARO se jemlje enkrat na teden (na isti dan v tednu) prve 3 tedne vsakega cikla zdravljenja.
English: Figure 2: Forest plot of progression-free survival in subgroups
Slovenian: Slika 2: Drevesni diagram (“forest plot”) preživetja brez napredovanja bolezni v podskupinah
English: Of the 5 patients in the placebo regimen, 2 had a confirmed very good partial response.
Slovenian: Od 5 bolnikov pri režimu zdravljenja s placebom sta 2 bolnika imela potrjen zelo dober delni odziv.
English: Take each NINLARO capsule whole with water at the same time each week, at least one hour before or no sooner than two hours after any food.
Slovenian: Kapsulo zdravila NINLARO pogoltnite celo skupaj z vodo vsak teden ob istem času, vsaj eno uro pred ali vsaj dve uri po kakršni koli hrani.
English: In the event of an overdose, monitor the patient for adverse reactions (section 4.8) and provide appropriate supportive care.
Slovenian: V primeru prevelikega odmerjanja je bolnika treba nadzirati glede pojava neželenih učinkov (glejte poglavje 4.8) in zagotoviti ustrezno podporno zdravljenje.
English: As NINLARO is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unborn child.
Slovenian: Ker se zdravilo NINLARO uporablja v kombinaciji z lenalidomidom, se morate držati programa za preprečevanje nosečnosti, ki velja za lenalidomid, saj lahko lenalidomid škoduje nerojenemu otroku.
English: Ixazomib is 99% bound to plasma proteins and distributes into red blood cells with a blood-to-plasma AUC ratio of 10.
Slovenian: Iksazomib se v 99 % veže na proteine v plazmi in porazdeli v rdeče krvne celice pri čemer razmerje AUC kri-plazma znaša 10.
English: Seventy seven percent of patients relapsed after prior therapies and 11% were refractory to prior therapies.
Slovenian: Pri 77 % bolnikov je prišlo do ponovitve po predhodnih terapijah, 11 % bolnikov pa je bilo neodzivnih na predhodne terapije.
English: Day 1 Days 2 to 7
Slovenian: 1. dan 2. do 7. dan
English: Table 1: Ixazomib dose reduction steps Recommended starting dose* First reduction to
Slovenian: Tabela 1: Koraki za zmanjšanje odmerka iksazomiba Priporočeni začetni odmerek* Prvo zmanjšanje do Drugo zmanjšanje do
English: Absolute neutrophil count < 500/mm3
Slovenian: Absolutno število nevtrofilcev < 500/mm3
English: Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Slovenian: Poročila o periferni motorični nevropatiji niso bila pogosta pri nobenem režimu (< 1 %).
English: * Neutropenia (absolute neutrophil count)
Slovenian: * Nevtropenija (absolutno število nevtrofilcev)
English: Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Slovenian: Vrednost Cmax iksazomiba se je zmanjšala za 4 %, vrednost AUC pa povečala za 11 %.
English: If you forget to take NINLARO
Slovenian: Če ste pozabili vzeti zdravilo NINLARO
English: A plasma cell is a blood cell that normally produces proteins to fight infections.
Slovenian: Plazmatke so krvne celice, ki normalno proizvajajo beljakovine, ki se borijo proti okužbam.
English: PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, altered consciousness, and visual disturbances.
Slovenian: PRES je redko reverzibilno nevrološko obolenje, ki se lahko kaže z epileptičnimi napadi, hipertenzijo, glavobolom, motnjami zavesti in motnjami vida.
English: Placebo + Lenalidomide and Dexamethasone (N = 362)
Slovenian: Placebo + lenalidomid in deksametazon (N = 362)
English: PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
Slovenian: PVC-aluminij/aluminij pretisni omot z eno kapsulo, ki je zaprt v pakiranju v obliki listnice.
English: If the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water.
Slovenian: Če prašek po nesreči pride v stik s kožo, kožo temeljito umijte z milom in vodo.
English: Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Slovenian: Kliničnih podatkov je sicer malo, vendar pa so v randomiziranem nadzorovanem preskušanju poročali o uporabi odmerkov do 12 mg.
English: How and when to take NINLARO
Slovenian: Kako in kdaj vzeti zdravilo NINLARO
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Slovenian: Ženske, ki uporabljajo hormonske kontraceptive, morajo dodatno uporabljati še mehansko obliko kontracepcije.
English: The capsule should be swallowed whole with water.
Slovenian: Kapsulo je treba pogoltniti celo skupaj z vodo.
English: A randomised, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria.
Slovenian: Na Kitajskem je bila izvedena randomizirana, dvojno slepa, s placebom nadzorovana študija tretje faze (N = 115) s podobno zasnovo in merili primernosti.
English: It is unknown whether ixazomib or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se iksazomib ali njegovi presnovki izločajo v materino mleko.
English: This is because other medicines can affect the way NINLARO works.
Slovenian: Druga zdravila lahko vplivajo na delovanje zdravila NINLARO.
English: However, ixazomib was negative in an in vivo comet assay in mice, in which percent tail DNA was assessed in the stomach and liver.
Slovenian: Vendar pa je bil iksazomib negativen pri in vivo testu komet pri miših, pri katerem je bil odstotek repne DNA ovrednoten v želodcu in jetrih.
English: Ixazomib is a low affinity substrate of P-gp.
Slovenian: Iksazomib je nizko afinitetni substrat za P-gp.
English: Therefore, women using oral hormonal contraceptives should additionally use a barrier method of contraception.
Slovenian: Zato morajo ženske, ki uporabljajo hormonske kontraceptive, dodatno uporabljati še mehansko obliko kontracepcije.
English: • Swallow the capsule whole with water.
Slovenian: • Kapsulo pogoltnite celo skupaj z vodo.
English: Twenty three percent of patients had light chain disease and 12% of patients had measurable disease by free light chain assay only.
Slovenian: 23 % bolnikov je imelo bolezen lahkih verig, 12 % bolnikov pa je imelo bolezen merljivo le s testom prostih lahkih verig.
English: Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Slovenian: Iksazomib je peroralni, zelo selektivni in reverzibilni zaviralec proteasoma.
English: In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: carbamazepine, phenytoin, rifampicin and St. John's wort (Hypericum perforatum).
Slovenian: Bodite še posebej pozorni, da boste zdravnika, farmacevta ali medicinsko sestro obvestili, če jemljete katero koli od naslednjih zdravil: karbamazepin, fenitoin, rifampicin ali šentjanževko (Hypericum perforatum).
English: Treatment should be continued until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje se mora nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Strong inducers may reduce the efficacy of ixazomib, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see sections 4.5 and 5.2).
Slovenian: Močni induktorji lahko zmanjšajo učinkovitost iksazomiba, zato se je sočasni uporabi močnih induktorjev CYP3A, kot so karbamazepin, fenitoin, rifampicin in šentjanževka (Hypericum perforatum), treba izogibati (glejte poglavji 4.5 in 5.2).
English: Days 23 to 28
Slovenian: 23. do 28. dan
English: Therefore, the weight of evidence indicates that ixazomib is not considered to present a genotoxic risk.
Slovenian: Na osnovi dokazov lahko torej sklepamo, da iksazomib ne predstavlja genotoksičnega tveganja.
English: The recommended dose is one 4 mg capsule taken by mouth.
Slovenian: Priporočeni odmerek je ena 4 mg kapsula peroralno (skozi usta).
English: Fifty seven percent of patients were male.
Slovenian: 57 % bolnikov je bilo moškega spola.
English: Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.
Slovenian: Iksazomibijev citrat je predzdravilo, ki se v fizioloških pogojih hitro hidrolizira do biološke aktivne oblike iksazomiba.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ixazomib in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z iksazomibom za vse podskupine pediatrične populacije pri zdravljenju diseminiranega plazmocitoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Other medicines and NINLARO
Slovenian: Druga zdravila in zdravilo NINLARO
English: Ixazomib was positive in an in vitro clastogenicity test in human peripheral blood lymphocytes.
Slovenian: Iksazomib je bil pozitiven pri in vitro testu klastogenosti na humanih limfocitih iz periferne krvi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično
English: If the capsule breaks, clean up the powder, taking care that it does not cause dust in the air.
Slovenian: Če se kapsula zdrobi, prašek previdno očistite brez dviganja prahu v zrak.
English: After administration of a single oral dose of 14C-ixazomib to 5 patients with advanced cancer, 62% of the administered radioactivity was excreted in urine and 22% in the faeces.
Slovenian: Po uporabi enkratnega peroralnega odmerka 14C iksazomiba pri 5 bolnikih z napredovalim rakom, se je 62 % uporabljene radioaktivnosti izločilo z urinom, 22 % pa z blatom.
English: Thrombocytopenia can be managed with dose modifications (see section 4.2) and platelet transfusions as per standard medical guidelines.
Slovenian: Trombocitopenijo se lahko obvladuje s spremembami odmerka (glejte poglavje 4.2) in s transfuzijami trombocitov v skladu s standardnimi smernicami.
English: Treatment for multiple myeloma involves killing myeloma cells and reducing the symptoms of the disease.
Slovenian: Zdravljenje diseminiranega plazmocitoma vključuje uničenje mielomskih celic in zmanjšanje simptomov bolezni.
English: NSMM-5001: The MAH should conduct a global, prospective, non-interventional, observational study in multiple myeloma patients and provide a report of descriptive data on 1,000 patients including 200 RRMM patients treated with ixazomib.
Slovenian: NSMM-5001: Imetnik dovoljenja za promet mora opraviti globalno, perspektivno, ne-intervencijsko, opazovalno študijo pri bolnikih z diseminiranim plazmocitomom, ter pripraviti poročilo opisnih podatkov na 1000 bolnikov, vključno z 200 bolniki RRMM, ki se zdravijo z iksazomibom.
English: Treatment continued until disease progression or unacceptable toxicities.
Slovenian: Zdravljenje se je nadaljevalo do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%).
Slovenian: Veliko bolnikov, vključenih v študijo, je imelo pri začetni diagnozi III stadij bolezni glede na stopnjo razširjenosti bolezni po Durie-Salmonu (69 %) in zgodovino zdravljenja, kjer so prejeli vsaj 2 predhodni zdravljenji (60 %) ter so bili neodzivni na talidomid (63 %).
English: In the 9-month study (10 cycles) in dogs orally administered with a dosing schedule mimicking the clinical regimen (28-day cycle), microscopic neuronal effects were generally minimal in nature and only observed at 0.2 mg/kg (4 mg/m2).
Slovenian: Pri 9-mesečni študiji (10 ciklov) pri psih, ki so zdravilo prejemali peroralno po shemi odmerjanja, ki je posnemala režim klinične uporabe (28-dnevni cikel), so bili mikroskopski učinki na nevrone na splošno minimalni, opazili pa so jih le pri odmerku 0,2 mg/kg (4 mg/m2).
English: Non-clinical safety pharmacology studies both in vitro (on hERG channels) and in vivo (in telemetered dogs following single oral administration) demonstrated no effects of ixazomib on cardiovascular or respiratory functions at AUC more than 8-fold higher than the clinical value.
Slovenian: Neklinične študije farmakološke varnosti tako in vitro (hERG kanalčki) kot in vivo (telemetrično spremljanje psov po enkratnem peroralnem odmerku) niso pokazale nobenega učinka iksazomiba na delovanje kardiovaskularnega ali respiratornega sistema pri vrednostih AUC, ki so bile več kot 8-krat večje od klinične vrednosti.
English: Very common
Slovenian: zelo pogosto pogosto
English: As multiple myeloma is a heterogeneous disease, benefit may vary across subgroups in the Phase 3 study (C16010) (see Figure 2).
Slovenian: Ker je diseminirani plazmocitom heterogena bolezen, je korist zdravljenja po podskupinah v 3. fazi študije (C16010) bolnikov lahko različna (glejte sliko 2).
English: Based on a population PK analysis, systemic clearance (CL) was approximately 1.86 L/hr with inter-individual variability of 44%.
Slovenian: Na osnovi analize populacijske farmakokinetike sistemski očistek znaša približno 1,86 l/uro z variabilnostjo med bolniki 44 %.
English: Ixazomib has minor influence on the ability to drive or use machines.
Slovenian: Iksazomib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Women of childbearing potential must use highly effective contraception while taking ixazomib and for 90 days after stopping treatment (see sections 4.5 and 4.6).
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z iksazomibom in še 90 dni po koncu zdravljenja uporabljati učinkovito kontracepcijo (glejte poglavji 4.5 in 4.6).
English: Nineteen percent had high-risk cytogenetic abnormalities (del[17], t[4;14], t[14;16]) (N=137), 10% had del(17) (N=69) and 34% had 1q amplification (1q21) (N=247).
Slovenian: 19 % bolnikov je imelo visoko citogenetsko tveganje del[17], t[4;14], t[14;16]) (N = 137), 10 % del(17) (N = 69) in 34 % 1q ampflikacijo (1q21) (N = 247).
English: Fifty seven percent of patients had undergone prior stem cell transplantation.
Slovenian: Pri 57 % bolnikov je bila predhodno opravljena presaditev krvotvornih matičnih celic.
English: Treatment with ixazomib in combination with lenalidomide and dexamethasone for longer than 24 cycles should be based on an individual benefit risk assessment, as the data on the tolerability and toxicity beyond 24 cycles are limited (see section 5.1).
Slovenian: Zdravljenje z iksazomibom v kombinaciji z lenalidomidom in deksametazonom dlje kot 24 ciklov mora temeljiti na vrednotenju koristi in tveganj pri posameznem bolniku, saj je na voljo le malo podatkov o prenašanju zdravila in toksičnih učinkih pri zdravljenju nad 24 ciklov (glejte poglavje 5.1).
English: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Germany
Slovenian: Takeda GmbH Production Site Singen Robert Bosch Strasse 8 78224 Singen Nemčija
English: • Platelet count should be ≥ 75,000/mm3
Slovenian: • mora biti število trombocitov ≥ 75.000/mm3.
English: When ixazomib is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of oral contraceptives needs to be considered.
Slovenian: Če se iksazomib uporablja skupaj z deksametazonom, ki je znan šibek do zmeren induktor CYP3A4, pa tudi drugih encimov in prenašalcev, je treba upoštevati tveganje za zmanjšanje učinkovitosti peroralnih kontraceptivov.
English: Patients received one to three prior therapies (median of 1) including prior treatment with bortezomib (69%), carfilzomib (<1%), thalidomide (45%), lenalidomide (12%), melphalan (81%).
Slovenian: Bolniki so se predhodno zdravili z eno do treh terapij (mediano 1), vključno z bortezomibom (69 %), karfilzomibom (< 1 %), talidomidom (45 %), lenalidomidom (12 %) in melfalanom (81 %).
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Slovenian: Talidomid je za človeka znana teratogena zdravilna učinkovina, ki povzroča hude smrtno nevarne okvare ploda.
English: Grade 4 peripheral neuropathy Discontinue treatment regimen.
Slovenian: Periferna nevropatija stopnje 4 Režim zdravljenja ukinite.
English: A hazard ratio less than 1 indicates an advantage for the ixazomib regimen.
Slovenian: Razmerje ogroženosti manjše od 1 kaže prednost režima zdravljenja z iksazomibom.
English: Ixazomib is not a reversible or a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.
Slovenian: Iksazomib ni reverzibilni ali časovno odvisni zaviralec CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ali 3A4/5.
English: Do not take NINLARO if you are allergic to ixazomib or to any of the other any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na iksazomib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: As data are limited in these patients, a careful risk-benefit assessment is recommended before initiating the ixazomib regimen.
Slovenian: Ker je pri teh bolnikih na voljo malo podatkov, je pred uvedbo režima zdravljenja z iksazomibom priporočljivo skrbno ovrednotiti koristi in tveganja.
English: • Withhold ixazomib until peripheral neuropathy recovers to ≤ Grade 1 without pain or patient's baseline.
Slovenian: • Zdravljenje z iksazomibom zadržite dokler se periferna nevropatija ne ublaži do ≤ stopnje 1 brez bolečine ali bolnikovega izhodiščnega stanja.
English: Ixazomib did not induce CYP1A2, CYP2B6, and CYP3A4/5 activity or corresponding immunoreactive protein levels.
Slovenian: Iksazomib ne inducira aktivnosti CYP1A2, CYP2B6 in CYP3A4/5 ali nivoja ustreznih imunoreaktivnih proteinov.
English: Children and adolescents NINLARO is not recommended for use in children and adolescents aged under 18 years.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih, mlajših od 18 let, uporaba zdravila NINLARO ni priporočljiva.
English: 3 packs of 1 hard capsule.
Slovenian: 3 pakiranja z 1 trdo kapsulo
English: If a patient vomits after taking a dose, the patient should not repeat the dose but should resume dosing at the time of the next scheduled dose.
Slovenian: Če bolnik potem, ko je vzel odmerek zdravila bruha, odmerka ne sme vzeti ponovno, temveč lahko vzame le naslednji predvideni odmerek ob predvidenem času.
English: PFS results are summarised in Table 4 and Figure 1.
Slovenian: Rezultati preživetja brez napredovanja bolezni so povzeti v tabeli 4 in prikazani na sliki 1.
English: The ixazomib dose reduction steps are presented in Table 1 and the dose modification guidelines are provided in Table 2.
Slovenian: Koraki za zmanjšanje odmerka iksazomiba so prikazani v Tabela 1, smernice za prilagoditev odmerka pa v Error!
English: Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhoea (2%).
Slovenian: Resni neželeni učinki, o katerih so poročali pri ≥ 2 % bolnikov, vključujejo trombocitopenijo (2 %) in drisko (2 %).
English: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Germany
Slovenian: Takeda GmbH Takeda (Werk Singen) Robert Bosch Straße 8 78224 Singen Nemčija
English: Protein produced by myeloma cells can damage the kidneys.
Slovenian: Beljakovine, ki jih proizvajajo mielomske celice, lahko poškodujejo ledvice.
English: At concentrations exceeding those observed clinically, ixazomib was metabolized by multiple CYP isoforms with estimated relative contributions of 3A4 (42.3%), 1A2 (26.1%), 2B6 (16.0%), 2C8 (6.0%), 2D6 (4.8%), 2C19 (4.8%) and 2C9 (< 1%).
Slovenian: Pri koncentracijah, ki so bile večje od koncentracij pri klinični uporabi, se je iksazomib presnavljal z multiplimi izooblikami CYP, pri čemer so bili ocenjeni relativni prispevki naslednji: 3A4 (42,3 %), 1A2 (26,1 %), 2B6 (16,0 %), 2C8 (6,0 %), 2D6 (4,8 %), 2C19 (4,8 %) in 2C9 (< 1 %).
English: In multi-cycle repeated-dose toxicity studies conducted in rats and dogs, the principal target organs included the gastrointestinal tract, lymphoid tissues, and the nervous system.
Slovenian: V študijah ponavljajočih se odmerkov v več ciklih, izvedenih pri podganah in psih, so glavni ciljni organi vključevali prebavila, limfoidno tkivo in živčevje.
English: Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Slovenian: Opomba: Neželeni učinki so navedeni kot prednostni izrazi na osnovi različice 16.0 MedDRA. *Predstavlja združitev prednostnih izrazov
English: Male and female patients who are able to have children must use effective contraceptive measures during and for 90 days following treatment.
Slovenian: Moški in ženske, ki lahko zanosijo, morajo med zdravljenjem in še 90 dni po koncu zdravljenja uporabljati učinkovito kontracepcijo.
English: Other possible side effects Tell your doctor or pharmacist if any of the side effects below become severe.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če katerikoli od spodaj navedenih neželenih učinkov postane resen.
English: Ixazomib is not an inhibitor of P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1, or MATE2-K. Ixazomib is not expected to cause transporter-mediated drug-drug interactions.
Slovenian: Iksazomib ni zaviralec P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1 ali MATE2-K. Za iksazomib ne pričakujemo, da bi povzročal interakcije z drugimi zdravili, ki bi bile posledica vpliva na prenašalce.
English: Outside of the Phase 3 study, the following serious adverse reactions were rarely reported: acute febrile neutrophilic dermatosis (Sweet's syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumour lysis syndrome and thrombotic thrombocytopenic purpura.
Slovenian: Resni neželeni učinki, o katerih so izven študije 3. faze poročali redko so: akutna febrilna nevtrofilna dermatoza (Sweetov sindrom), Stevens-Johnsonov sindrom, transverzalni mielitis, sindrom posteriorne reverzibilne encefalopatije, sindrom tumorske lize in trombotična trombocitopenična purpura.
English: Herpes zoster
Slovenian: Herpes zoster pogosto pogosto
English: Nervous system disorders Peripheral neuropathies* Very common
Slovenian: Bolezni živčevja Periferna nevropatija* zelo pogosto pogosto