FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of ixazomib is required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min).
Croatian: Nije potrebna prilagodba doze iksazomiba u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (klirens kreatinina ≥ 30 ml/min).
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.
Croatian: Jedna kapsula sadrži 4 mg iksazomiba (u obliku 5,7 mg iksazomibcitrata) Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: • vision conditions including blurred vision, dry eye and pink eye (conjunctivitis)
Croatian: • poremećaji vida uključujući zamućenje vida, suhoću oka i crveno oko (konjunktivitis)
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.
Croatian: C16014: radi daljnjeg ispitivanja djelotvornosti, nositelj odobrenja za stavljanje lijeka u promet mora provesti randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 za usporedbu iksazomiba uz lenalidomid i deksametazon naspram placeba uz lenalidomid i deksametazon u odraslih bolesnika s novodijagnosticiranim multiplim mijelomom koji nije pogodan za transplantaciju matičnih stanica (SCT) i izraditi završno izvješće za primarnu mjeru ishoda PFS-a.
English: The dose of dexamethasone should be adjusted per its prescribing information or ixazomib for Grade 3 or 4 symptoms (see section 4.2).
Croatian: Potrebno je prilagoditi dozu deksametazona u skladu s njegovim sažetkom opisa svojstava lijeka ili iksazomiba u skladu s uputama za simptome 3. ili 4. stupnja (vidjeti dio 4.2).
English: Ixazomib is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se primjena NINLARA u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Ixazomib induced apoptosis of several tumour cell types in vitro.
Croatian: Iksazomib je in vitro inducirao apoptozu nekoliko tipova tumorskih stanica.
English: For additional information regarding lenalidomide and dexamethasone, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
Croatian: Za dodatne informacije o lenalidomidu i deksametazonu proučite Sažetak opisa svojstava lijeka (SmPC) za te lijekove.
English: No dose adjustment of ixazomib is required for patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin > 1-1.5 x ULN and any AST).
Croatian: Nije potrebna prilagodba doze iksazomiba za bolesnike s blagim oštećenjem funkcije jetre (ukupni bilirubin ≤ gornje granice normale (GGN) i aspartat aminotransferaza (AST) > GGN ili ukupni bilirubin > 1−1,5 x GGN uz bilo koju vrijednost AST).
English: Rash should be managed with supportive care or with dose modification if Grade 2 or higher (see section 4.2).
Croatian: Osip treba liječiti potpornom skrbi ili prilagodbom doze ako se radi o osipu 2. ili višeg stupnja (vidjeti dio 4.2).
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.
Croatian: U toj analizi procijenjeni medijan PFS-a iznosio je 20 mjeseci u skupini koja je bila na terapijskom režimu s iksazomibom te 15,9 mjeseci u skupini na terapijskom režimu s placebom) (HR = 0,82 [95% CI (0,67; 1,0)]) u populaciji s namjerom liječenja.
English: Ixazomib is a low affinity substrate of P-gp.
Croatian: Iksazomib je supstrat niskog afiniteta za P-glikoprotein.
English: 1 hard capsule.
Croatian: 1 tvrda kapsula.
English: The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle.
Croatian: Preporučena početna doza deksametazona je 40 mg, primijenjena na 1., 8., 15. i 22. dan 28-dnevnog ciklusa liječenja.
English: The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28-day treatment cycle.
Croatian: Preporučena početna doza lenalidomida je 25 mg, primijenjena jedanput dnevno od 1. do 21. dana 28-dnevnog ciklusa liječenja.
English: CYP inducers
Croatian: Induktori CYP enzima
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.
Croatian: Preporučena početna doza iksazomiba je 4 mg, primijenjena peroralno jedanput tjedno na 1., 8. i 15. dan 28-dnevnog ciklusa liječenja.
English: Week 1
Croatian: 1. tje dan
English: The capsule should not be removed until just prior to dosing.
Croatian: Kapsula se ne smije vaditi iz pakiranja sve do same primjene.
English: CYP inhibitors
Croatian: Inhibitori CYP enzima
English: For each adverse reaction, one or more of the three medicinal products was discontinued in ≤ 1% of patients in the ixazomib regimen.
Croatian: Za svaku nuspojavu prekinuta je primjena jednog ili više od predmetnih triju lijekova u ≤ 1% bolesnika na režimu iksazomibom.
English: Fertility studies have not been conducted with ixazomib (see section 5.3).
Croatian: Nisu provedena ispitivanja utjecaja iksazomiba na plodnost (vidjeti dio 5.3).
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 ]).
Croatian: U konačnoj analizi ukupnog preživljenja (OS) pri medijanu praćenja od 19,8 mjeseci, OS se poboljšao u bolesnika liječenih u režimu s iksazomibom u usporedbi s režimom placeba (p-vrijednost = 0,0014, HR = 0,42 [95% CI: 0,242; 0,726]).
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).
Croatian: Farmakokinetika iksazomiba okarakterizirana je u bolesnika s normalnom funkcijom jetre pri dozi od 4 mg (N = 12), u bolesnika s umjerenim oštećenjem funkcije jetre pri dozi od 2,3 mg (ukupni bilirubin > 1,5-3 x GGN, N = 13) ili teškim oštećenjem funkcije jetre pri dozi od 1,5 mg (ukupni bilirubin > 3 x GGN, N = 18).
English: Transporter-based interactions
Croatian: Interakcije posredovane prijenosnicima
English: The PK of ixazomib is similar in patients with normal renal function and in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min) based on the results of a population PK analysis.
Croatian: Farmakokinetika iksazomiba slična je u bolesnika s normalnom funkcijom bubrega i u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega (klirens kreatinina ≥ 30 ml/min) na temelju rezultata analize populacijske farmakokinetike.
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).
Croatian: Farmakokinetika iksazomiba okarakterizirana je pri dozi od 3 mg u bolesnika s normalnom funkcijom bubrega (klirens kreatinina ≥ 90 ml/min, N = 18), u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min, N = 14) ili u bolesnika sa završnim stadijem bubrežne bolesti koja zahtijeva dijalizu (N = 6).
English: • If platelet count falls to < 30,000/mm3 again, withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Croatian: • Ako broj trombocita opet padne na < 30 000/mm3, odgodite primjenu iksazomiba i lenalidomida dok broj trombocita ne bude ≥ 30 000/mm3.
English: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have been uncommonly reported with ixazomib (see section 4.8).
Croatian: Pri primjeni iksazomiba manje često zabilježeni su oštećenje jetre uzrokovano lijekom, hepatocelularno oštećenje, hepatička steatoza, kolestatski hepatitis i hepatotoksičnost (vidjeti dio 4.8).
English: Day 8 Days 9 to 14
Croatian: 9. do 14. dan 15. dan
English: Peripheral neuropathy occurred in 25% of patients in the ixazomib regimen compared to 20% of patients in the placebo regimen.
Croatian: Periferna neuropatija pojavila se u 25% bolesnika koji su uzimali iksazomib u usporedbi sa 20% bolesnika koji su uzimali placebo.
English: Refer to the lenalidomide SmPC for dosing recommendations in patients with renal impairment.
Croatian: Proučite Sažetak opisa svojstava lijeka za lenalidomid za preporuke o doziranju u bolesnika s oštećenjem bubrega.
English: • shortness of breath or persistent coughing or wheezing (heart failure)
Croatian: • nedostatak zraka ili kašalj koji ne prestaje ili piskanje u plućima (zatajenje srca)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING WALLET UNIT PACKS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S POJEDINAČNIM PAKIRANJAMA OVITAKA
English: • Withhold ixazomib and lenalidomide until absolute neutrophil count is ≥ 500/mm3.
Croatian: • Odgodite primjenu iksazomiba i lenalidomida dok apsolutni broj neutrofila ne bude ≥ 500/mm3.
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).
Croatian: C16010 (n = 720) i dvostruko slijepog, placebom kontroliranog nastavka ispitivanja C16010 u Kini (n = 115).
English: Elderly
Croatian: NINLARO 
English: Platelet counts should be monitored at least monthly during ixazomib treatment.
Croatian: Tijekom liječenja iksazomibom potrebno je nadzirati broj trombocita barem jedanput na mjesec.
English: The active substance is ixazomib.
Croatian: • Djelatna tvar je iksazomib.
English: Gastrointestinal disorders Diarrhoea
Croatian: Poremećaji probavnog sustava Dijareja
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: The PK of ixazomib is similar in patients with normal hepatic function and in patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin > 1-1.5 x ULN and any AST) based on the results of a population PK analysis.
Croatian: Farmakokinetika iksazomiba slična je u bolesnika s normalnom funkcijom jetre i u bolesnika s blagim oštećenjem funkcije jetre (ukupni bilirubin ≤ GGN i AST > GGN ili ukupni bilirubin > 1-1,5 x GGN te bilo koja vrijednost AST) na temelju rezultata analize populacijske farmakokinetike.
English: • If attributable to ixazomib, resume ixazomib at the next lower dose following recovery.
Croatian: • Ako se toksičnosti mogu pripisati iksazomibu, nastavite terapiju iksazomibom pri sljedećoj nižoj dozi nakon oporavka.
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.
Croatian: Kako se iksazomib primjenjuje u kombinaciji s lenalidomidom i deksametazonom, proučite Sažetak opisa svojstava lijeka za te lijekove za dodatne informacije o plodnosti, trudnoći i dojenju.
English: Fatigue and dizziness have been observed in clinical trials.
Croatian: U kliničkim ispitivanjima uočeni su umor i omaglica.
English: Do not take a missed dose if it is within 3 days or 72 hours of your next scheduled dose.
Croatian: Nemojte uzeti propuštenu dozu ako je do sljedeće redovite doze preostalo manje od 3 dana ili 72 sata.
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)
Croatian: Tablica 4: Rezultati za preživljenje bez napredovanja bolesti (PFS) i odgovor u bolesnika s multiplim mijelomom liječenih iksazomibom ili placebom u kombinaciji s lenalidomidom i deksametazonom (populacija bolesnika s namjerom liječenja) iksazomib + lenalidomid i deksametazon (N = 360)
English: INFORMATION IN BRAILLE NINLARO 2.3 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU NINLARO 2.3 mg
English: Week 2
Croatian: 2. tje dan
English: NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules ixazomib
Croatian: NINLARO 2,3 mg tvrde kapsule NINLARO 3 mg tvrde kapsule NINLARO 4 mg tvrde kapsule iksazomib
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules NINLARO 3 mg hard capsules NINLARO 4 mg hard capsules
Croatian: NAZIV LIJEKA NINLARO 2,3 mg tvrde kapsule NINLARO 3 mg tvrde kapsule NINLARO 4 mg tvrde kapsule
English: Ixazomib is for oral use.
Croatian: Iksazomib se primjenjuje peroralno.
English: Rash occurred in 18% of patients in the ixazomib regimen compared to 10% of patients in the placebo regimen.
Croatian: Osip se pojavio u 18% bolesnika koji su uzimali iksazomib u usporedbi s 10% bolesnika koji su uzimali placebo.
English: *Recommended reduced dose of 3 mg in the presence of moderate or severe hepatic impairment, severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
Croatian: * U prisutnosti umjerenog ili teškog oštećenja jetre, teškog oštećenja bubrega ili završnog stadija bolesti bubrega koja zahtijeva dijalizu preporučena je smanjena doza od 3 mg.
English: Peripheral neuropathy has been reported with ixazomib (see section 4.8).
Croatian: Periferna neuropatija zabilježena je pri primjeni iksazomiba (vidjeti dio 4.8).
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Croatian: Propilenglikol Kalijev hidroksid Crni željezov oksid (E172)
English: Peripheral neuropathy resulted in discontinuation of one or more of the three medicinal products in 1% of patients in the ixazomib regimen compared to <1% of patients in the placebo regimen.
Croatian: Periferna neuropatija rezultirala je prekidom jednog ili više od predmetnih triju lijekova u 1% bolesnika koji su primali iksazomib, u usporedbi s < 1% bolesnika koji su primali placebo.
English: There were no effects due to ixazomib treatment on male or female reproductive organs in studies up to 6-months duration in rats and up to 9-months duration in dogs.
Croatian: U ispitivanjima u trajanju do 6 mjeseci na štakorima i do 9 mjeseci na psima primjena iksazomiba nije utjecala na muške ili ženske reproduktivne organe.
English: The reduced dose of 3 mg is recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease (ESRD) requiring dialysis.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) ili završnim stadijem bubrežne bolesti koja zahtijeva dijalizu preporučuje se smanjena doza od 3 mg.
English: • Following recovery, resume ixazomib at the next lower dose.
Croatian: • Nakon oporavka nastavite terapiju iksazomibom pri sljedećoj nižoj dozi.
English: The reduced dose of 3 mg is recommended in patients with moderate (total bilirubin > 1.5-3 x ULN) or severe (total bilirubin > 3 x ULN) hepatic impairment (see section 5.2).
Croatian: Kod bolesnika s umjerenim (ukupni bilirubin > 1,5−3 x GGN) ili teškim (ukupni bilirubin > 3 x GGN) oštećenjem funkcije jetre preporučuje se smanjena doza od 3 mg (vidjeti dio 5.2).
English: Grade 3 rash was reported in 2% of patients in the ixazomib regimen compared to 1% of patients in the placebo regimen.
Croatian: Osip 3. stupnja pojavio se u 2% bolesnika koji su uzimali iksazomib u usporedbi s 1% bolesnika koji su uzimali placebo.
English: How to store NINLARO
Croatian: Kako čuvati NINLARO
English: INFORMATION IN BRAILLE NINLARO 4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU NINLARO 4 mg
English: Titanium dioxide (E171) Black iron oxide (E172)
Croatian: Titanijev dioksid (E171) Crni željezov oksid (E172)
English: Ixazomib is cytotoxic.
Croatian: Iksazomib je citotoksičan.
English: • Withhold ixazomib and lenalidomide until platelet count ≥ 30,000/mm3.
Croatian: • Odgodite primjenu iksazomiba i lenalidomida dok broj trombocita ne bude ≥ 30 000/mm3.
English: Dose modifications
Croatian: Prilagodba doze
English: • The capsule shell contains: gelatin, titanium dioxide (E171) and black iron oxide (E172)
Croatian: • Ovojnica kapsule sadrži: želatinu, titanijev dioksid (E171) i crni željezov oksid (E172).
English: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate) NINLARO 4 mg hard capsules
Croatian: Jedna kapsula sadrži 3 mg iksazomiba (u obliku 4,3 mg iksazomibcitrata) NINLARO 4 mg tvrde kapsule
English: An alternating dose modification approach is recommended for ixazomib and lenalidomide for overlapping toxicities of thrombocytopenia, neutropenia and rash.
Croatian: Kod preklapanja toksičnosti trombocitopenije, neutropenije i osipa preporučuje se pristup naizmjenične prilagodbe doze za iksazomib i lenalidomid.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Croatian: Titanijev dioksid (E171) Žuti željezov oksid (E172) Crveni željezov oksid (E172)
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional special warnings and precautions for use.
Croatian: Budući da se iksazomib primjenjuje u kombinaciji s lenalidomidom i deksametazonom, proučite Sažetak opisa svojstava lijeka za te lijekove za dodatna posebna upozorenja i mjere opreza pri uporabi.
English: Do not remove the capsule until you need to take a dose.
Croatian: Nemojte vaditi kapsulu iz pakiranja sve do same primjene.
English: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Croatian: Jedna kapsula sadrži 4 mg iksazomiba (u obliku 5,7 mg iksazomibcitrata).
English: In the pooled dataset from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled, C16010 China Continuation Study (n=115), the following adverse reactions occurred with a similar rate between the ixazomib and placebo regimens: fatigue (26% vs. 24%),
Croatian: Prema objedinjenim podacima iz globalnog pivotalnog ispitivanja faze 3 C16010 (n = 720) i dvostruko slijepog placebom kontroliranog nastavka ispitivanja C16010 u Kini (n = 115), stopa pojavnosti sljedećih nuspojava bila je slična kod bolesnika koji su uzimali iksazomib i bolesnika koji su uzimali placebo: umor (26% naspram 24%), smanjen apetit (12% naspram 9%), hipotenzija (4% oba režima), zatajenje srca† (3% oba režima), aritmija† (12% naspram 11%) i oštećenje jetre uključujući promjene u razinama enzima† (8% naspram 6%).
English: Rash has been reported with ixazomib (see section 4.8).
Croatian: Osip je zabilježen pri primjeni iksazomiba (vidjeti dio 4.8).
English: Overall Response Rate‡, n (%) 282 (78.3) Response Category, n (%) Complete Response
Croatian: Stopa ukupnog odgovora‡, n (%) (ORR) Kategorija odgovora, n (%) Potpuni odgovor (CR) Vrlo dobar djelomični odgovor (VGPR) Djelomični odgovor (PR) Vrijeme do odgovora, mjeseci Medijan Trajanje odgovora§, mjeseci Medijan
English: • Following recovery, resume lenalidomide at the next lower dose according to its SmPC.
Croatian: • Nakon oporavka nastavite terapiju lenalidomidom pri sljedećoj nižoj dozi u skladu s njegovim sažetkom opisa svojstava lijeka.
English: INFORMATION IN BRAILLE NINLARO 3 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU NINLARO 3 mg
English: Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients given the ixazomib, lenalidomide and dexamethasone combination.
Croatian: U bolesnika koji su primali kombinaciju iksazomiba, lenalidomida i deksametazona rijetko su zabilježene gljivična i virusna pneumonija koje su rezultirale smrtnim ishodom.
English: Titanium dioxide (E171) Red iron oxide (E172)
Croatian: Titanijev dioksid (E171) Crveni željezov oksid (E172)
English: NINLARO 2.3 mg hard capsules
Croatian: NINLARO 2,3 mg tvrde kapsule
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate) NINLARO 3 mg hard capsules
Croatian: Jedna kapsula sadrži 2,3 mg iksazomiba (u obliku 3,3 mg iksazomibcitrata) NINLARO 3 mg tvrde kapsule
English: Peripheral oedema has been reported with ixazomib (see section 4.8).
Croatian: Periferni edem zabilježen je pri primjeni iksazomiba (vidjeti dio 4.8).
English: Printing ink Shellac
Croatian: Tinta za označavanje Šelak
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.
Croatian: 62% primijenjene radioaktivnosti izlučilo se u urinu, a 22% u fecesu.
English: Thrombocytopenia resulted in discontinuation of one or more of the three medicinal products in < 1% of patients in the ixazomib regimen and 1% of patients in the placebo regimen.
Croatian: Trombocitopenija je bila uzrok prekida jednog ili više od predmetnih triju lijekova u < 1% bolesnika koji su uzimali iksazomib i 1% bolesnika koji su uzimali placebo.
English: *For additional occurrences, alternate dose modification of lenalidomide and ixazomib †Grading based on National Cancer Institute Common Terminology Criteria (CTCAE) Version 4.03
Croatian: Stupnjevanje prema Zajedničkim terminološkim kriterijima Nacionalnog instituta za rak (engl.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 4 mg iksazomiba (u obliku 5,7 mg iksazomibcitrata)
English: Diarrhoea resulted in discontinuation of one or more of the three medicinal products in 1% of patients in the ixazomib regimen and < 1% of patients in the placebo regimen.
Croatian: Dijareja je bila uzrokom prekida jednog ili više od predmetnih triju lijekova u 1% bolesnika koji su uzimali iksazomib i < 1% bolesnika koji su uzimali placebo.
English: NINLARO 4 mg hard capsule:
Croatian: NINLARO 4 mg tvrde kapsule:
English: NINLARO 3 mg hard capsule:
Croatian: NINLARO 3 mg tvrde kapsule:
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg ixazomib
Croatian: NAZIV LIJEKA NINLARO 2,3 mg iksazomib
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg ixazomib
Croatian: NAZIV LIJEKA NINLARO 4 mg iksazomib
English: NAME OF THE MEDICINAL PRODUCT NINLARO 2.3 mg hard capsules ixazomib
Croatian: NAZIV LIJEKA NINLARO 2,3 mg tvrde kapsule iksazomib
English: • Following recovery, resume ixazomib at the next lower dose and resume lenalidomide at its most recent dose.
Croatian: • Nakon oporavka, nastavite terapiju iksazomibom pri sljedećoj nižoj dozi te s lenalidomidom pri njegovoj posljednjoj dozi.*
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate)
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 2,3 mg iksazomiba (u obliku 3,3 mg iksazomibcitrata)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1094/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1094/001
English: • The printing ink contains: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Croatian: • Tinta za označavanje sadrži: šelak, propilenglikol, kalijev hidroksid i crni željezov oksid
English: As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these medicinal products for additional contraindications.
Croatian: Budući da se iksazomib primjenjuje u kombinaciji s lenalidomidom i deksametazonom, proučite Sažetak opisa svojstava lijeka za te lijekove za dodatne kontraindikacije.
English: NAME OF THE MEDICINAL PRODUCT NINLARO 4 mg hard capsules ixazomib
Croatian: NAZIV LIJEKA NINLARO 4 mg tvrde kapsule iksazomib
English: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
Croatian: Jedna kapsula sadrži 2,3 mg iksazomiba (u obliku 3,3 mg iksazomibcitrata).
English: NAME OF THE MEDICINAL PRODUCT NINLARO 3 mg ixazomib
Croatian: NAZIV LIJEKA NINLARO 3 mg iksazomib
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING CARTON CONTAINING WALLET UNIT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S POJEDINAČNIM PAKIRANJIMA OVITAKA