FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: AUC nevezane frakcije lijeka normaliziran za dozu bio je 27% viši u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre u usporedbi s bolesnicima s normalnom funkcijom jetre (vidjeti dio 4.2).
English: Ixazomib is not dialyzable and, therefore, can be administered without regard to the timing of dialysis (see section 5.2).
Croatian: Iksazomib se ne uklanja dijalizom te se stoga može primijeniti bez obzira na vrijeme dijalize (vidjeti dio 5.2).
English: Refer to the lenalidomide SmPC, section 4.2 for the dose reduction steps for these toxicities.
Croatian: Proučite dio 4.2 sažetka opisa svojstava lijeka za lenalidomid za korake smanjenja doze za te toksičnosti.
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%).
Croatian: Najčešće zabilježene nuspojave (≥ 20%) među 417 bolesnika koji su primali iksazomib i 418 bolesnika koji su primali placebo bile su dijareja (39% naspram 32%), trombocitopenija (33% naspram 21%), neutropenija (33% naspram 30%), konstipacija (30% naspram 22%), periferna neuropatija (25% naspram 20%), mučnina (23% naspram 18%), periferni edem (23% naspram 17%), povraćanje (20% naspram 10%) i infekcija gornjeg dišnog trakta (21% naspram 16%).
English: Ixazomib was not mutagenic in a bacterial reverse mutation assay (Ames assay) or clastogenic in a bone marrow micronucleus assay in mice.
Croatian: Iksazomib nije bio mutagen u testu reverzne mutacije na bakterijama (Amesov test) ili klastogen u mikronukleusnom testu koštane srži u miševa.
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.
Croatian: NINLARO je u kombinaciji s lenalidomidom i deksametazonom indiciran za liječenje odraslih bolesnika s multiplim mijelomom koji su primili barem jednu prethodnu terapiju.
English: • Withhold lenalidomide until rash recovers to ≤ Grade 1.
Croatian: • Odgodite primjenu lenalidomida dok se osip ne vrati na ≤ 1. stupanj.
English: Breast-feeding should be stopped when taking NINLARO.
Croatian: Dojenje treba prekinuti tijekom uzimanja lijeka NINLARO.
English: Ixazomib is given in combination with lenalidomide.
Croatian: Iksazomib se daje u kombinaciji s lenalidomidom.
English: NINLARO will be given to you together with lenalidomide and dexamethasone, which are other medicines used to treat multiple myeloma.
Croatian: NINLARO ćete primati zajedno s lenalidomidom i deksametazonom, drugim lijekovima koji se koriste za liječenje multiplog mijeloma.
English: Day 1 Days 2 to 7
Croatian: 4. tje dan dan 2. do 7. dan dan
English: In vitro, ixazomib affected cell types found in the bone marrow microenvironment including vascular endothelial cells, osteoclasts and osteoblasts.
Croatian: In vitro je iksazomib utjecao na vrste stanica nađene u mikrookolini koštane srži uključujući stanice vaskularnog endotela, osteoklaste i osteoblaste.
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).
Croatian: U primarnoj analizi (medijan praćenja od 8 mjeseci i medijan od 6 ciklusa) medijan PFS-a iznosio je 6,7 mjeseci u režimu s iksazomibom, u usporedbi s 4 mjeseca u režimu s placebom (p-vrijednost = 0,035, HR = 0,60).
English: Ixazomib is not expected to produce drug-drug interactions via CYP inhibition or induction.
Croatian: Ne očekuje se da će iksazomib uzrokovati interakcije lijekova putem inhibicije ili indukcije CYP enzima.
English: There was no discernible relationship between ixazomib concentration and the RR interval suggesting no clinically meaningful effect of ixazomib on heart rate.
Croatian: Nije bilo primjetne povezanosti između koncentracije iksazomiba i RR intervala, što ukazuje da iksazomib nema klinički značajan utjecaj na srčani ritam.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S
English: A planned interim analysis for overall survival (OS) at a median follow up of 23 months was conducted with 35% of the required number of deaths for final OS analysis in the ITT population; there were 81 deaths in the ixazomib regimen and 90 deaths in the placebo regimen.
Croatian: Planirana interim analiza ukupnog preživljenja pri medijanu praćenja od 23 mjeseca provedena je s 35% smrtnih slučajeva potrebnih za konačnu analizu ukupnog preživljenja u populaciji s namjerom liječenja; zabilježen je 81 smrtni slučaj u skupini koja je primala režim s iksazomibom i 90 smrtnih slučajeva u skupini koja je primala terapijski režim s placebom.
English: Avoid becoming pregnant or breast-feeding while being treated with NINLARO.
Croatian: Izbjegavajte trudnoću ili dojenje dok se liječite lijekom NINLARO.
English: = intake of medicinal product
Croatian: = Primjena lijeka
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.
Croatian: Djelotvornost i sigurnost iksazomiba u kombinaciji s lenalidomidom i deksametazonom procijenjene su u međunarodnom randomiziranom dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju superiornosti faze 3 (C16010) u bolesnika s recidivirajućim i/ili refraktornim multiplim mijelomom koji su primili barem jednu prethodnu terapiju.
English: In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma.
Croatian: In vivo je iksazomib pokazao antitumorsku aktivnost u različitim tumorskim modelima ksenografta uključujući modele multiplog mijeloma.
English: Thrombocytopenia has been reported with ixazomib (see section 4.8) with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle and recovery to baseline by the start of the next cycle (see section 4.8).
Croatian: Trombocitopenija je zabilježena pri primjeni iksazomiba (vidjeti dio 4.8) s najnižim vrijednostima trombocita koje su se u pravilu javljale između 14. i 21. dana svakog 28-dnevnog ciklusa i oporavljale na početno stanje do početka sljedećeg ciklusa (vidjeti dio 4.8).
English: Ixazomib is not a reversible or a time-dependent inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4/5.
Croatian: Iksazomib nije reverzibilni ili o vremenu ovisan inhibitor enzima CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6 ili 3A4/5.
English: • low platelet counts (thrombocytopenia) which may increase the risk of nose bleeds and you may easily bruise
Croatian: • nizak broj trombocita (trombocitopenija) koji može povećati rizik od krvarenja iz nosa i lakog stvaranja modrica
English: NINLARO is used to treat a cancer of the bone marrow called multiple myeloma.
Croatian: NINLARO se koristi za liječenje raka koštane srži zvanog multipli mijelom.
English: NINLARO must be prescribed to you by a doctor with experience of treating multiple myeloma.
Croatian: NINLARO Vam mora propisati liječnik iskusan u liječenju multiplog mijeloma.
English: Patients with renal impairment received a starting dose of lenalidomide according to its SmPC.
Croatian: Bolesnici s oštećenjem bubrega primali su početnu dozu lenalidomida u skladu s njegovim sažetkom opisa svojstava lijeka.
English: In patients developing PRES, discontinue ixazomib.
Croatian: U bolesnika u kojih se razvije PRES, liječenje iksazomibom treba prekinuti.
English: • low levels of potassium in the blood (hypokalaemia)
Croatian: • niske razine kalija u krvi (hipokalemija)
English: Three percent of patients in the ixazomib regimen and 1% of patients in the placebo regimen had a platelet count ≤ 10,000/mm3 during treatment.
Croatian: Tri posto bolesnika koji su uzimali iksazomib i 1% bolesnika koji su uzimali placebo imali su tijekom terapije broj trombocita ≤ 10 000/mm3.
English: • muscle weakness, loss of feelings of the toes and feet or loss of leg movement (transverse myelitis)
Croatian: • slabost u mišićima, gubitak osjeta u nožnim prstima i stopalima ili gubitak pokreta u nogama (transverzalni mijelitis)
English: • swelling of the legs or feet (peripheral oedema)
Croatian: • oticanje nogu ili stopala (periferni edem)
English: • rare blood condition resulting from blood clots that may cause fatigue, fever, bruising, nose bleeds, decreased urination (thrombotic thrombocytopenic purpura)
Croatian: • rijetko stanje krvi koje proizlazi iz krvnih ugrušaka što može uzrokovati umor, vrućicu, stvaranje modrica, krvarenje iz nosa, smanjeno mokrenje (trombotička trombocitopenična purpura)
English: For other concomitant medicinal products that may be required, refer to the current lenalidomide and dexamethasone SmPC.
Croatian: Za druge istodobno primijenjene lijekove koji mogu biti potrebni proučite trenutno odobreni Sažetak opisa svojstava lijeka za lenalidomid i deksametazon.
English: Thromboprophylaxis was recommended for all patients in both treatment groups according to the lenalidomide SmPC.
Croatian: Tromboprofilaksa je bila preporučena za sve bolesnike u obje terapijske skupine u skladu sa sažetkom opisa svojstava lijeka za lenalidomid.
English: See the package leaflets for lenalidomide and dexamethasone for additional information on pregnancy and breast-feeding
Croatian: Pogledajte upute o lijeku za lenalidomid i deksametazon za dodatne informacije o trudnoći i dojenju.
English: The recommended dose of lenalidomide is 25 mg taken every day for the first 3 weeks of the cycle.
Croatian: Preporučena doza lenalidomida je 25 mg svaki dan tijekom prva 3 tjedna ciklusa.
English: Peripheral neuropathy Grade 1 peripheral neuropathy with pain or Grade 2 peripheral neuropathy
Croatian: Periferna neuropatija Periferna neuropatija 1. stupnja s boli ili periferna neuropatija 2. stupnja
English: Ixazomib is not a substrate of BCRP, MRP2 or hepatic OATPs.
Croatian: Iksazomib nije supstrat za BCRP, MRP2 ili jetrene OATP-ove.
English: Skin and subcutaneous tissue disorders Rash*
Croatian: Poremećaji kože i potkožnog tkiva Osip*
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.
Croatian: Pri dozi od 4 mg, srednja promjena od početnog QTcF-a procijenjena je iz analize temeljene na modelu na 0,07 msec (90% CI; -0,22, 0,36).
English: Capsule contents Microcrystalline cellulose Magnesium stearate Talc
Croatian: Sadržaj kapsule Mikrokristalična celuloza Magnezijev stearat Talk
English: Blood and lymphatic system disorders Thrombocytopenia*
Croatian: Poremećaji krvi i limfnog sustava Trombocitopenija*
English: Ixazomib will be given in combination with lenalidomide and breast-feeding should be stopped because of the use of lenalidomide.
Croatian: Iksazomib će se davati u kombinaciji s lenalidomidom i dojenje treba prekinuti zbog primjene lenalidomida.
English: • If Grade 2 or 3 rash occurs again, withhold ixazomib and lenalidomide until rash recovers to ≤ Grade 1.
Croatian: • Ako se osip 2. ili 3. stupnja ponovno pojavi, odgodite primjenu iksazomiba i lenalidomida dok se osip ne vrati na ≤ 1. stupanj.
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.
Croatian: NSMM-5001: nositelj odobrenja za stavljanje lijeka u promet mora provesti globalno, prospektivno, neintervencijsko opservacijsko ispitivanje u bolesnika s multiplim mijelomom i izraditi izvješće s opisnim podacima za 1000 bolesnika, uključujući 200 bolesnika s relapsnim i/ili refraktornim multiplim mijelomom koji su liječeni iksazomibom.
English: Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
Croatian: Iksazomib se preferencijalno veže i inhibira kimotripsinu nalik aktivnost beta 5 podjedinice proteasoma 20S.
English: Days 16 to 21
Croatian: 16. do 21. dan 22. dan
English: What NINLARO is used for
Croatian: Za što se NINLARO koristi
English: Takeda Pharmaceuticals Croatia d.o.o.
Croatian: Hrvatska Takeda Pharmaceuticals Croatia d.o.o.
English: Ixazomib has minor influence on the ability to drive or use machines.
Croatian: Iksazomib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • numbness, tingling or burning of the hands or feet (peripheral neuropathy)
Croatian: • obamrlost, osjećaj trnaca ili žarenja šaka ili stopala (periferna neuropatija)
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.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES) C16010: izraditi interim izvješće o ukupnom preživljenju u vrijeme 3. interim analize i izraditi završno izvješće za završnu analizu OS-a iz dvostruko slijepog randomiziranog ispitivanja faze 3 C16010 u odraslih bolesnika s relapsnim i/ili refraktornim multiplim mijelomom.
English: Rash Grade† 2 or 3
Croatian: Osip 2. ili 3. stupanj†
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measure:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedenu mjeru: Opis
English: Brain imaging, preferably Magnetic Resonance Imaging, is used to confirm the diagnosis.
Croatian: Za potvrdu dijagnoze koriste se slikovne pretrage mozga, po mogućnosti magnetska rezonanca.
English: Co-administration of ixazomib with strong CYP1A2 inhibitors did not result in a clinically meaningful change in the systemic exposure of ixazomib based on the results of a population pharmacokinetic (PK) analysis.
Croatian: Istodobna primjena iksazomiba s jakim inhibitorima CYP1A2 nije uzrokovala klinički značajnu promjenu u sistemskoj izloženosti iksazomibu na temelju rezultata analize populacijske farmakokinetike.
English: NINLARO is used to treat adults with multiple myeloma.
Croatian: NINLARO se koristi za liječenje odraslih bolesnika s multiplim mijelomom.
English: Grade 3 adverse reactions of peripheral neuropathy were reported in 2% of patients in both regimens.
Croatian: Nuspojave periferne neuropatije 3. stupnja zabilježene su u 2% bolesnika na oba režima.
English: Table 2: Dose modifications guidelines for ixazomib in combination with lenalidomide and dexamethasone
Croatian: Tablica 2: Smjernice za prilagodbu doze za iksazomib u kombinaciji s lenalidomidom i deksametazonom
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 /
Croatian: Tablica 3: Nuspojave u bolesnika liječenih iksazomibom u kombinaciji s lenalidomidom i deksametazonom (svi stupnjevi, 3. stupanj i 4. stupanj) Klasifikacija organskih sustava / Nuspojava
English: Antiviral prophylaxis should be considered in patients being treated with ixazomib to decrease the risk of herpes zoster reactivation.
Croatian: U bolesnika koji se liječe iksazomibom treba razmotriti antivirusnu profilaksu kako bi se smanjio rizik od reaktivacije herpes zostera.
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.
Croatian: Iksazomib nije inhibitor prijenosnika P-gp, BCRP, MRP2, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1 ili MATE2-K.
English: • Non-haematologic toxicities should, at the physician's discretion, generally be recovered to patient's baseline condition or ≤ Grade 1
Croatian: • Nehematološke toksičnosti se trebaju, prema liječnikovoj procjeni, uglavnom vratiti na bolesnikovo početno stanje ili na ≤ 1. stupnja
English: Therefore, no dose modification is required for ixazomib with co-administration of strong CYP1A2 inhibitors.
Croatian: Stoga nije potrebna prilagodba doze iksazomiba uz istodobnu primjenu jakih CYP1A2 inhibitora.
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).
Croatian: Koncentracije iksazomiba prije ulaska i nakon izlaska krvi iz dijalizatora, izmjerene tijekom postupka hemodijalize bile su slične, ukazujući na to da se iksazomib ne može dijalizirati (vidjeti dio 4.2).
English: Dosing schedule: Ixazomib taken with lenalidomide and dexamethasone 28-day cycle (a 4-week cycle)
Croatian: Raspored doziranja: iksazomib u kombinaciji s lenalidomidom i deksametazonom 28-dnevni ciklus (4-tjedni ciklus)
English: Administration with a high-fat meal decreased ixazomib AUC by 28% compared with administration after an overnight fast (see section 4.2).
Croatian: Primjena uz obrok s visokim sadržajem masti smanjilo je AUC iksazomiba za 28% u usporedbi s primjenom lijeka ujutro natašte (vidjeti dio 4.2).
English: Toxicities should, at the physician's discretion, generally recover to patient's baseline condition or at most Grade 1 prior to resuming ixazomib.
Croatian: Toksičnosti se, prema liječnikovoj procjeni, trebaju općenito oporaviti na bolesnikovo početno stanje ili barem na 1. stupanj prije nastavka terapije iksazomibom.
English: Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone.
Croatian: Iksazomib je in vitro iskazao citotoksičnost protiv stanica mijeloma bolesnika s relapsom nakon višestrukih prethodnih terapija, uključujući bortezomib, lenalidomid i deksametazon.
English: Diarrhoea, constipation, nausea and vomiting have been reported with ixazomib, occasionally requiring use of antiemetic and antidiarrhoeal medicinal products and supportive care (see section 4.8).
Croatian: Dijareja, konstipacija, mučnina i povraćanje koji povremeno zahtijevaju primjenu antiemetika i lijekova protiv dijareje te potpornu skrb zabilježeni su pri primjeni iksazomiba (vidjeti dio 4.8).
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.
Croatian: Poremećaji oka prijavljivani su korištenjem brojnih različitih preporučenih pojmova, no učestalost je ukupno iznosila 24% u bolesnika na režimu s iksazomibom i 15% u bolesnika na režimu s placebom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO 2.3 mg hard capsules
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV NINLARO 2,3 mg tvrde kapsule
English: How to take NINLARO
Croatian: Kako uzimati NINLARO
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.
Croatian: C16019: radi daljnjeg ispitivanja djelotvornosti, nositelj odobrenja za stavljanje lijeka u promet treba nakon pojave približno 200 smrtnih događaja prikazati dodatne OS/PFS2 podatke iz randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja faze 3 iksazomiba kao terapije održavanja u bolesnika s multiplim mijelomom nakon SCT-a.
English: Grade 3 adverse reactions were reported in 2% of patients in both regimens.
Croatian: Nuspojave 3. stupnja prijavljene su za 2% bolesnika u oba režima.
English: 1 hard capsule
Croatian: 1 tvrda kapsula
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.
Croatian: Prekidi liječenja u bolesnika starijih od 75 godina prijavljeni su za 13 bolesnika (28%) na terapijskom režimu iksazomibom i za 10 bolesnika (16%) na režimu placebom.
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.
Croatian: Istodobna primjena iksazomiba s klaritromicinom, jakim inhibitorom CYP3A enzima, nije uzrokovala klinički značajnu promjenu u sistemskoj izloženosti iksazomibu.
English: Absolute neutrophil count < 500/mm3
Croatian: Neutropenija (apsolutni broj neutrofila) Apsolutni broj neutrofila < 500/mm3
English: Therefore, no dose modification is required for ixazomib with co-administration of strong CYP3A inhibitors.
Croatian: Stoga nije potrebna prilagodba doze iksazomiba uz istodobnu primjenu jakih CYP3A inhibitora.
English: Unbound AUC was 38% higher in patients with severe renal impairment or ESRD requiring dialysis as compared to patients with normal renal function.
Croatian: AUC nevezane frakcije lijeka bio je 38% viši u bolesnika s teškim oštećenjem funkcije bubrega ili završnim stadijem bubrežne bolesti koja zahtjeva dijalizu u usporedbi s bolesnicima s normalnom funkcijom bubrega.
English: • feeling tired or weak (fatigue)
Croatian: • osjećaj umora ili slabosti (umor)
English: Grade 2 peripheral neuropathy with pain or Grade 3 peripheral
Croatian: Periferna neuropatija 2. stupnja s boli ili periferna neuropatija 3. stupnja
English: In case of capsule breakage, avoid raising dust during clean-up.
Croatian: U slučaju loma kapsule, pri čišćenju treba paziti da se ne podiže prašina.
English: Table 1: Ixazomib dose reduction steps Recommended starting dose* First reduction to
Croatian: Preporučena početna doza* Prvo smanjenje na
English: The frequency of severe (Grade 3-4) events of hypokalaemia was higher in the ixazomib regimen (5%) than the placebo regimen (<1%).
Croatian: Učestalost događaja teške hipokalemije (3.-4. stupnja) bila je veća kod bolesnika koji su uzimali iksazomib (5%) nego kod bolesnika koji su uzimali placebo (< 1%).
English: Thrombocytopenia (platelet count) Platelet count < 30,000/mm3
Croatian: Trombocitope nija (broj trombocita) Broj trombocita < 30 000/mm3
English: Common side effects may affect up to 1 in 10 people:
Croatian: Česte nuspojave koje se mogu javiti u manje od 1 na 10 osoba:
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.
Croatian: Srčane aritmije u bolesnika starijih od 75 godina prijavljene su za 10 bolesnika (21%) na terapijskom režimu iksazomibom i za 9 bolesnika (15%) na režimu placebom.
English: Rash resulted in discontinuation of one or more of the three medicinal products in < 1% of patients in both regimens.
Croatian: Osip je rezultirao prekidom jednog ili više od predmetnih triju lijekova u < 1% bolesnika u oba režima.
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.
Croatian: U bolesnika koji se liječe iksazomibom u kombinaciji s lenalidomidom i deksametazonom preporučuje se tromboprofilaksa, koja se treba temeljiti na procjeni bolesnikovih podležećih rizika i kliničkog statusa.
English: Hepatic enzymes should be monitored regularly and the dose should be adjusted for Grade 3 or 4 symptoms (see section 4.2).
Croatian: Potrebno je redovito nadzirati jetrene enzime i prilagoditi dozu za simptome 3. ili 4. stupnja (vidjeti dio 4.2).