FrancophonIA/ELRC3.0 huggingface dataset:
English: • Withhold lenalidomide until rash recovers to ≤ Grade 1.
Slovenian: • Zdravljenje z lenalidomidom zadržite dokler se izpuščaj ne ublaži do ≤ stopnje 1.
English: Figure 1: Kaplan-Meier plot of progression-free survival in the intent-to-treat population
Slovenian: Slika 1: Kaplan Meierjeva krivulja preživetja brez napredovanja bolezni po primarni analizi (indicirana populacija)
English: If you take more NINLARO than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila NINLARO, kot bi smeli Če ste vzeli večji odmerek zdravila NINLARO, kot bi smeli, se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru.
English: The dose of dexamethasone should be adjusted per its prescribing information or ixazomib for Grade 3 or 4 symptoms (see section 4.2).
Slovenian: Odmerek deksametazona je treba prilagoditi glede na navodila o predpisovanju deksametazona ali iksazomiba za stopnje simptomov 3 ali 4 (glejte poglavje 4.2).
English: NINLARO must be prescribed to you by a doctor with experience of treating multiple myeloma.
Slovenian: Zdravljenje z zdravilom NINLARO mora predpisati zdravnik z izkušnjami pri zdravljenju diseminiranega plazmocitoma.
English: Pre- and post-dialyzer concentrations of ixazomib measured during the haemodialysis session were similar, suggesting that ixazomib is not dialyzable (see section 4.2).
Slovenian: Med hemodializo izmerjene koncentracije iksazomiba so bile pred in po dializi podobne, kar kaže, da se iksazomib ne izloča z dializo (glejte poglavje 4.2).
English: After oral administration, peak plasma concentrations of ixazomib were achieved at approximately one hour after dosing.
Slovenian: Največje koncentracije iksazomiba v plazmi so dosežene približno eno uro po peroralni uporabi odmerka.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Takeda
English: Unbound dose-normalized AUC was 27% higher in patients with moderate or severe hepatic impairment as compared to patients with normal hepatic function (see section 4.2).
Slovenian: Pri bolnikih z zmerno ali s hudo okvaro jeter je bil nevezan odmerek, normaliziran na vrednost AUC, večji za 27 % kot pri bolnikih z normalnim delovanjem jeter (glejte poglavje 4.2).
English: Animal toxicology and/or pharmacology
Slovenian: Toksični in/ali farmakološki učinki pri živalih
English: Thromboprophylaxis was recommended for all patients in both treatment groups according to the lenalidomide SmPC.
Slovenian: Tromboprofilaksa je bila priporočljiva pri vseh bolnikih v obeh skupinah zdravljenja v skladu s povzetkom glavnih značilnosti zdravila za lenalidomid.
English: Capsule contents Microcrystalline cellulose Magnesium stearate Talc
Slovenian: Vsebina kapsule mikrokristalna celuloza magnezijev stearat smukec
English: In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma.
Slovenian: In vivo iksazomib kaže protitumorsko aktivnost pri različnih heterolognih tumorskih modelih, vključno z modeli diseminiranega plazmocitoma.
English: Infections and infestations Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni Okužba zgornjih dihal zelo pogosto občasno
English: A double dose should not be taken to make up for a missed dose.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka, če je pozabil vzeti prejšnji odmerek.
English: In patients developing PRES, discontinue ixazomib.
Slovenian: Pri bolnikih, pri katerih se razvije PRES, je treba zdravljenje z iksazomibom ukiniti.
English: Ixazomib is not recommended in women of childbearing potential not using contraception.
Slovenian: Iksazomib ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Table 3: Adverse reactions in patients treated with ixazomib in combination with lenalidomide and dexamethasone (all grades, grade 3 and grade 4) System organ class /
Slovenian: Tabela 3: Neželeni učinki pri bolnikih, ki so se zdravili z iksazomibom v kombinaciji z lenalidomidom in deksametazonom (vse stopnje, stopnja 3 in stopnja 4) Organski sistem / neželeni učinek
English: Ixazomib induced apoptosis of several tumour cell types in vitro.
Slovenian: Iksazomib in vitro inducira apoptozo več vrst tumorskih celic.
English: Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju diseminiranega plazmocitoma.
English: Fatigue and dizziness have been observed in clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o utrujenosti in omotici.
English: Ixazomib is not expected to produce drug-drug interactions via CYP inhibition or induction.
Slovenian: Za iksazomib ne pričakujemo, da bi z zaviranjem ali indukcijo CYP povzročal interakcije z drugimi zdravili.
English: C16014: In order to further investigate the efficacy the MAH should conduct a phase 3, randomized, double-blind, multicenter study comparing ixazomib plus lenalidomide and dexamethasone versus placebo plus lenalidomide and dexamethasone in adult patients with newly diagnosed multiple myeloma not eligible for stem cell transplantation (SCT) and provide the final report for primary endpoint PFS.
Slovenian: C16014: Da bi še dodatno raziskali učinkovitost mora imetnik dovoljenja za promet opraviti 3. fazo, randomizirane, dvojno slepe, multicentrične študije s primerjavo iksazomiba z lenalidomidom in deksametazona v primerjavi s placebom z lenalidomidom in deksametazonom pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom, ki niso primerni za transplantacijo matičnih celic (SCT), in pripraviti končno poročilo za primarni cilj preživetja brez napredovanja bolezni.
English: If you have side effects, your doctor may prescribe NINLARO capsules containing 3 mg or 2.3 mg.
Slovenian: V primeru pojava neželenih učinkov lahko zdravnik predpiše zdravljenje s 3 mg ali 2,3 mg kapsulami zdravila NINLARO.
English: Peripheral neuropathy Grade 1 peripheral neuropathy with pain or Grade 2 peripheral neuropathy
Slovenian: Periferna nevropatija Periferna nevropatija stopnje 1 z bolečino ali periferna nevropatija stopnje 2
English: Patients enrolled in the trial had multiple myeloma that was refractory, including primary refractory, had relapsed after prior therapy, or had relapsed and was refractory to any prior therapy.
Slovenian: Bolniki, vključeni v preskušanje, so imeli neodzivni diseminirani plazmocitom, vključno s primarno neodzivnostjo, ponovitev diseminiranega plazmocitoma po predhodnem zdravljenju ali ponovitev in neodzivnost na katero koli predhodno zdravljenje.
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC.
Slovenian: • Po okrevanju nadaljujte zdravljenje z lenalidomidom z naslednjim manjšim odmerkom v skladu z njegovim SmPC-jem.
English: Ixazomib is not recommended during pregnancy as it can cause foetal harm when administered to a pregnant woman.
Slovenian: Iksazomib ne uporabljajte med nosečnostjo, saj lahko škoduje plodu, če ga uporablja nosečnica.
English: What you need to know before you take NINLARO 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo NINLARO Ne jemljite zdravila NINLARO
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO 2.3 mg hard capsules
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA NINLARO 2,3 mg trde kapsule
English: Other Grade 3 or 4 non-haematological toxicities
Slovenian: Drugi nehematološki toksični učinki stopnje 3 ali 4
English: Skin and subcutaneous tissue disorders Rash*
Slovenian: Bolezni kože in podkožja Izpuščaj*
English: EU/1/16/1094/002
Slovenian: EU/1/16/1094/001 EU/1/16/1094/002 EU/1/16/1094/003
English: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate) For the full list of excipients, see section 6.1.
Slovenian: Ena kapsula vsebuje 4 mg iksazomiba (v obliki 5,7 mg iksazomibijevega citrata) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (see section 4.2).
Slovenian: Potrebno je redno spremljanje jetrnih encimov, odmerek pa je treba prilagoditi glede na simptome stopnje 3 ali 4 stopnje (glejte poglavje 4.2).
English: The improvement in PFS in the ixazomib regimen was supported by improvements in overall response rate.
Slovenian: Izboljšanje preživetja brez napredovanja bolezni pri režimu odmerjanja iksazomiba podpira izboljšanje skupne odzivne stopnje.
English: There is no known specific antidote for ixazomib overdose.
Slovenian: V primeru prevelikega odmerjanja iksazomiba specifični antidot ni znan.
English: You may feel tired and dizzy while taking NINLARO.
Slovenian: Med jemanjem zdravila NINLARO lahko začutite utrujenost in omotico.
English: Fertility studies have not been conducted with ixazomib (see section 5.3).
Slovenian: Študij vplivov iksazomiba na plodnost niso izvedli (glejte poglavje 5.3).
English: Talk to your doctor, pharmacist or nurse before taking NINLARO if: you have a history of bleeding you have persistent nausea, vomiting or diarrhoea you have a history of nerve problems, to include tingling and numbness you have a history of swelling you have a persistent rash you have or have had liver or kidney problems as your dose may have to be adjusted.
Slovenian: če imate ali ste kdaj imeli težave s krvavitvami; če imate dolgotrajne težave s siljenjem na bruhanje, z bruhanjem ali drisko; ste kdaj imeli težave z živci, vključno z mravljinčenjem in omrtvelostjo; če ste otekali; imate že dlje časa izpuščaj; če imate ali ste kdaj imeli kakršne koli težave z jetri ali ledvicami.
English: Co-administration of ixazomib with clarithromycin, a strong CYP3A inhibitor, did not result in a clinically meaningful change in the systemic exposure of ixazomib.
Slovenian: Pri sočasni uporabi iksazomiba in klaritromicina, močnega zaviralca CYP3A, se sistemska izpostavljenost iksazomibu ni klinično pomembneje spremenila.
English: The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle.
Slovenian: Priporočeni začetni odmerek lenalidomida je 25 mg enkrat na dan od 1. do 21. dneva 28-dnevnega cikla zdravljenja.
English: Days 16 to 21
Slovenian: 16. do 21. dan dan
English: Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 24% in patients in the ixazomib regimen and 15% of patients in the placebo regimen.
Slovenian: O očesnih boleznih so poročali pri različnih prednostnih pogojih, vendar združeno, pogostost je bila 24 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi s 15 % pri režimu zdravljenja s placebom.
English: Ixazomib is for oral use.
Slovenian: Iksazomib je namenjen za peroralno uporabo.
English: If you are uncertain whether the condition above applies to you, talk to your doctor, pharmacist or nurse before taking NINLARO.
Slovenian: Če ste glede gornje navedbe kakor koli negotovi, se pred začetkom jemanja zdravila NINLARO posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Refer to the lenalidomide SmPC, section 4.2 for the dose reduction steps for these toxicities.
Slovenian: Za korake zmanjšanja odmerka v primeru teh toksičnih učinkov glejte poglavje 4.2 SmPC-ja za lenalidomid.
English: Ixazomib exhibits a multi-exponential disposition profile.
Slovenian: Profil dispozicije iksazomiba je multieksponenten.
English: At this analysis, estimated median PFS was 20 months in the ixazomib regimen and 15.9 months in the placebo regimen (HR=0.82 [95% CI (0.67, 1.0)]) in the ITT population.
Slovenian: Pri tej analizi je ocenjena mediana preživetja brez napredovanja bolezni pri režimu zdravljenja z iksazomibom znašala 20 mesecev, pri režimu zdravljenja s placebom pa 15,9 meseca (RO = 0,82 [95 % IZ (0,67, 1,0)]) pri populaciji vseh vključenih bolnikov.
English: Rash Grade† 2 or 3
Slovenian: Stopnja† 2 ali 3
English: Dose modifications
Slovenian: Prilagoditve odmerka
English: The PK of ixazomib was characterized at a dose of 3 mg in patients with normal renal function (creatinine clearance ≥ 90 mL/min, N=18), severe renal impairment (creatinine clearance < 30 mL/min, N=14), or ESRD requiring dialysis (N=6).
Slovenian: Farmakokinetiko iksazomiba so ovrednotili pri odmerku 3 mg pri bolnikih z normalnim delovanjem ledvic (kreatininski očistek ≥ 90 ml/min, N = 18), s hudo okvaro ledvic (kreatininski očistek < 30 ml/min, N = 14), ali bolnikih s končno odpovedjo ledvic, ki so potrebovali zdravljenje z dializo (N = 6).
English: NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma.
Slovenian: Zdravilo NINLARO boste uporabljali skupaj z lenalidomidom in deksametazonom, dvema drugima zdraviloma, ki ju uporabljamo za zdravljenje diseminiranega plazmocitoma.
English: Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone.
Slovenian: Iksazomib in vitro deluje citotoksično proti mielomskim celicam bolnikov s ponovitvijo bolezni po večkratnih predhodnih zdravljenjih, vključno z bortezomibom, lenalidomidom in deksametazonom.
English: Breast-feeding should be stopped when taking NINLARO.
Slovenian: Med uporabo zdravila NINLARO je treba prekiniti dojenje.
English: The PK of ixazomib was characterized in patients with normal hepatic function at 4 mg (N=12), moderate hepatic impairment at 2.3 mg (total bilirubin > 1.5-3 x ULN, N=13) or severe hepatic impairment at 1.5 mg (total bilirubin > 3 x ULN, N=18).
Slovenian: Farmakokinetiko iksazomiba so ovrednotili pri bolnikih z normalnim delovanjem jeter pri odmerku 4 mg (N = 12), zmerno okvaro jeter pri odmerku 2,3 mg (vrednost skupnega bilirubina > 1,5-3 x ZMN vrednosti, N = 13) ali s hudo okvaro jeter pri odmerku 1,5 mg (vrednost skupnega bilirubina > 3 x ZMN vrednosti, N = 18).
English: The recommended dose of lenalidomide is 25 mg taken every day for the first 3 weeks of the cycle.
Slovenian: Priporočeni odmerek lenalidomida je 25 mg enkrat na dan prve 3 tedne vsakega cikla zdravljenja.
English: Cardiac arrhythmias in patients > 75 years of age were observed in 10 patients (21%) in the ixazomib regimen and 9 patients (15%) in the placebo regimen.
Slovenian: Pri bolnikih, starih > 75 let, so srčne aritmije pri režimu zdravljenja z iksazomibom opazili pri 10 bolnikih (21 %), pri režimu zdravljenja s placebom pa pri 9 bolnikih (15 %).
English: The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Slovenian: Priporočeni začetni odmerek deksametazona je 40 mg na 1., 8., 15. in 22. dan 28-dnevnega cikla zdravljenja.
English: Platelet counts should be monitored at least monthly during ixazomib treatment.
Slovenian: Med zdravljenjem z iksazomibom je treba število trombocitov preveriti vsaj enkrat na mesec.
English: Multiple myeloma is a cancer of the blood which affects a type of cell, called the plasma cell.
Slovenian: Diseminirani plazmocitom je krvni rak, ki prizadene celice, imenovane plazmatke.
English: Discontinuations in patients > 75 years of age were reported in 13 patients (28%) in the ixazomib regimen and 10 patients (16%) in the placebo regimen.
Slovenian: Pri bolnikih, starih > 75 let, so o prekinitvah zdravljenja pri režimu zdravljenja z iksazomibom poročali pri 13 bolnikih (28 %), pri režimu zdravljenja s placebom pa pri 10 bolnikih (16 %).
English: At the final analysis for OS at a median follow up of 19.8 months, OS was improved for patients treated in the ixazomib regimen compared with placebo [p-value=0.0014, HR=0.42, 95% CI: 0.242, 0.726 ]).
Slovenian: Pri končni analizi celokupnega preživetja po mediani 19,8 meseca se je stopnja celokupnega preživetja pri režimu zdravljenja z iksazomibom v primerjavi z režimom zdravljenja s placebom izboljšala [p-vrednost = 0,0014, RO = 0,42, 95 % IZ
English: Peripheral neuropathy occurred in 25% of patients in the ixazomib regimen compared to 20% of patients in the placebo regimen.
Slovenian: Periferna nevropatija se je pojavila pri 25 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi z 20 % bolnikov pri režimu zdravljenja s placebom.
English: Discontinuations
Slovenian: Ukinitev
English: The dose should be adjusted for severe (Grade 3-4) symptoms (see section 4.2).
Slovenian: V primeru hudih simptomov (stopnja 3-4) je treba odmerek prilagoditi (glejte poglavje 4.2).
English: Haematological toxicities
Slovenian: Hematološki toksični učinki
English: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with ixazomib (see section 4.8).
Slovenian: Pri uporabi iksazomiba so občasno poročali o poškodbi jeter, povezani z zdravilom, poškodbi jetrnih celic, jetrni steatozi, holeostatskem hepatitisu in hepatotoksičnosti (glejte poglavje 4.8).
English: • Non-haematologic toxicities should, at the physician's discretion, generally be recovered to patient's baseline condition or ≤ Grade 1
Slovenian: • nehematološki toksični učinki se morajo po presoji zdravnika povrniti do izhodiščnega stanja ali ≤ stopnje 1.
English: Patients with renal impairment received a starting dose of lenalidomide according to its SmPC.
Slovenian: Bolniki z okvaro ledvic so začetni odmerek lenalidomida prejeli v skladu z ustreznim povzetkom glavnih značilnosti zdravila.
English: How to take NINLARO
Slovenian: Kako jemati zdravilo NINLARO
English: • If platelet count falls to < 30,000/mm3 again, withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Slovenian: • Če se število trombocitov zopet zmanjša < 30.000/mm3, zdravljenje z iksazomibom in lenalidomidom zadržite, dokler število trombocitov ne doseže ≥ 30.000/mm3.
English: The most commonly reported reaction was peripheral sensory neuropathy (16% and 12% in the ixazomib and placebo regimen, respectively).
Slovenian: Najpogosteje so poročali o periferni senzorični nevropatiji (16 % pri režimu zdravljenja z iksazomibom in 12 % pri režimu zdravljenja s placebom).
English: For additional information regarding lenalidomide and dexamethasone, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
Slovenian: Za dodatne informacije o uporabi lenalidomida in deksametazona glejte ustrezen povzetek glavnih značilnosti zdravila (SmPC).
English: Brain imaging, preferably Magnetic Resonance Imaging, is used to confirm the diagnosis.
Slovenian: Diagnozo potrdimo s slikovnim pregledom možganov - z magnetno resonanco.
English: The recommended starting dose of ixazomib is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.
Slovenian: Priporočeni začetni odmerek iksazomiba je 4 mg peroralno enkrat na teden na 1., 8. in 15. dan 28-dnevnega cikla zdravljenja.
English: Thrombocytopenia (platelet count) Platelet count < 30,000/mm3
Slovenian: Trombocitopenija (število trombocitov) Število trombocitov < 30.000/mm3
English: At the primary analysis (median follow up of 14.7 months and a median of 13 cycles), PFS was statistically significantly different between the treatment arms.
Slovenian: Pri primarni analizi (mediano spremljanje 14,7 meseca in mediani cikli 13).
English: • Withhold ixazomib and lenalidomide until absolute neutrophil count is ≥ 500/mm3.
Slovenian: • Zdravljenje z iksazomibom in lenalidomidom zadržite dokler absolutno število nevtrofilcev ne doseže ≥ 500/mm3.
English: The capsules should not be opened or crushed.
Slovenian: Kapsul ne smete odpirati ali drobiti.
English: Metabolism by multiple CYP enzymes and non-CYP proteins is expected to be the major clearance mechanism for ixazomib.
Slovenian: Po pričakovanjih je glavni mehanizem očistka iksazomiba presnova z multiplimi encimi CYP in ne-CYP proteini.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measure:
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji ukrep: Opis
English: Take the next dose, as normal, when it is due.
Slovenian: Vzemite le naslednji predvideni odmerek ob predvidenem času.
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional information on fertility, pregnancy and lactation.
Slovenian: Ker se iksazomib uporablja v kombinaciji z lenalidomidom in deksametazonom, za dodatne informacije o plodnosti, nosečnosti in dojenju glejte tudi SmPC-ja teh dveh zdravil.
English: Other non-haematological toxicities
Slovenian: Drugi nehematološki toksični učinki
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR WALLET
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: *For additional occurrences, alternate dose modification of lenalidomide and ixazomib †Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03
Slovenian: †Stopnje v skladu z verzijo 4.03 terminološko poenotenih kriterijev ameriškega Nacionalnega onkološkega inštituta (CTCAE).
English: NINLARO is used to treat a cancer of the bone marrow called multiple myeloma.
Slovenian: Zdravilo NINLARO uporabljamo za zdravljenje raka kostnega mozga, imenovanega diseminirani plazmocitom.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules
Slovenian: IME ZDRAVILA NINLARO 2,3 mg trde kapsule NINLARO 3 mg trde kapsule NINLARO 4 mg trde kapsule
English: Rash occurred in 18% of patients in the ixazomib regimen compared to 10% of patients in the placebo regimen.
Slovenian: Izpuščaj se je pojavil pri 18 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi z 10 % bolnikov pri režimu zdravljenja s placebom.
English: Grade 3 rash was reported in 2% of patients in the ixazomib regimen compared to 1% of patients in the placebo regimen.
Slovenian: O izpuščaju stopnje 3 so poročali pri 2 % bolnikov pri režimu zdravljenja z iksazomibom v primerjavi z 1 % bolnikov pri režimu zdravljenja s placebom.
English: CYP inhibitors
Slovenian: Zaviralci CYP
English: Women should avoid becoming pregnant while being treated with ixazomib.
Slovenian: Zato ženske, med zdravljenjem z iksazomibom, ne smejo zanositi.
English: NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules ixazomib
Slovenian: NINLARO 2,3 mg trde kapsule NINLARO 3 mg trde kapsule NINLARO 4 mg trde kapsule iksazomib
English: Table 4: Progression free survival and response Results in multiple myeloma patients treated with ixazomib or placebo in combination with lenalidomide and dexamethasone (intent-to-treat population)
Slovenian: Tabela 4:Preživetje brez napredovanja bolezni in rezultati odziva pri bolnikih z neodzivnim diseminiranim plazmocitomom, ki so se zdravili z iksazomibom ali s placebom v kombinaciji z lenalidomidom in deksametazonom (populacija vseh vključenih bolnikov) Iksazomib + lenalidomid in deksametazon (N = 360)
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC and resume ixazomib at its most recent dose.
Slovenian: • Po okrevanju nadaljujte zdravljenje z lenalidomidom z naslednjim manjšim odmerkom v skladu z njegovim SmPC-jem, zdravljenje z iksazomibom pa z zadnjim uporabljenim odmerkom.
English: Do not crush, chew or open the capsule.
Slovenian: Kapsule ne smete drobiti, žvečiti ali odpirati.
English: At the 4 mg dose, mean change from baseline in QTcF was estimated to be 0.07 msec (90% CI; -0.22, 0.36) from the model based analysis.
Slovenian: Analiza na osnovi modela kaže, da je pri 4 mg odmerku ocenjena srednja sprememba vrednosti QTcF od izhodišča znašala 0,07 ms (90 %
English: INFORMATION IN BRAILLE NINLARO 4 mg
Slovenian: PODATKI V BRAILLOVI PISAVI NINLARO 4 mg