FrancophonIA/ELRC3.0 huggingface dataset:
English: If you vomit after taking a dose, do not take an extra dose.
Croatian: Ako povraćate nakon primjene lijeka, ne smijete uzeti dodatnu dozu.
English: Of the 5 patients in the ixazomib regimen, one patient had a confirmed partial response and 3 confirmed stable disease (however 2 were unconfirmed partial response and 1 was an unconfirmed very good partial response).
Croatian: Od 5 bolesnika na režimu s iksazomibom, jedan je bolesnik imao potvrđen djelomični odgovor, a njih 3 potvrđenu stabilnu bolest (međutim, 2 su bili nepotvrđeni djelomični odgovori i 1 je bio nepotvrđen vrlo dobar djelomični odgovor).
English: Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Croatian: Napomena: Nuspojave uključene kao preporučeni pojmovi temelje se na verziji 16.0 MedDRA-e.
English: Therefore, the weight of evidence indicates that ixazomib is not considered to present a genotoxic risk.
Croatian: Stoga, težina dokaza ukazuje da se ne smatra da iksazomib predstavlja genotoksični rizik.
English: This is because other medicines can affect the way NINLARO works.
Croatian: To je stoga jer drugi lijekovi mogu utjecati na način djelovanja lijeka NINLARO.
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).
Croatian: Nemojte uzimati NINLARO ako ste alergični na iksazomib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Neutropenia*
Croatian: Neutropenija*
English: Approximately 2-fold accumulation in AUC was observed with weekly oral dosing on Day 15.
Croatian: Približno dvostruka akumulacija u AUC uočena je s tjednim peroralnim doziranjem na 15. dan.
English: The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Sljedeća konvencija je korištena za klasifikaciju učestalosti nuspojava: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Effect of ixazomib on other medicinal products
Croatian: Učinak iksazomiba na druge lijekove
English: These medicines should be avoided as they may reduce the effectiveness of NINLARO.
Croatian: Te lijekove treba izbjegavati jer mogu smanjiti učinkovitost lijeka NINLARO.
English: Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Croatian: Periferna motorička neuropatija nije često zabilježena ni u jednom režimu (< 1%).
English: If you take more NINLARO than you should
Croatian: Ako uzmete više lijeka NINLARO nego što ste trebali
English: *Represents a pooling of preferred terms
Croatian: *Prikazuje grupiranje preporučenih pojmova
English: Hazard Ratio†
Croatian: Omjer hazarda†
English: This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
Croatian: To uključuje i bilo koje druge lijekove bez recepta, poput vitamina ili biljnih pripravaka.
English: A double dose should not be taken to make up for a missed dose.
Croatian: Ne smije se uzeti dvostruka doza kako bi se nadoknadila propuštena.
English: Your doctor will examine you and you will be monitored closely during treatment.
Croatian: Tijekom terapije liječnik će Vas pregledati i pažljivo nadzirati.
English: In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
Croatian: U slučaju teških gastrointestinalnih događaja, preporučuje se praćenje razine serumskog kalija.
English: For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of lenalidomide or a proteasome inhibitor.
Croatian: Za svrhu ovog ispitivanja refraktorna bolest bila je definirana kao napredovanje bolesti tijekom liječenja ili napredovanje unutar 60 dana od zadnje doze lenalidomida ili inhibitora proteasoma.
English: The capsule should be swallowed whole with water.
Croatian: Kapsulu treba progutati cijelu s vodom.
English: What multiple myeloma is
Croatian: Što je multipli mijelom
English: Other possible side effects Tell your doctor or pharmacist if any of the side effects below become severe.
Croatian: Ostale moguće nuspojave Obavijestite liječnika ili ljekarnika ako bilo koja od dolje navedenih nuspojava postane ozbiljna.
English: In the event of an overdose, monitor the patient for adverse reactions (section 4.8) and provide appropriate supportive care.
Croatian: U slučaju predoziranja nadzirite bolesnika na pojavu nuspojava (dio 4.8) i osigurajte odgovarajuću potpornu skrb.
English: Of the 5 patients in the placebo regimen, 2 had a confirmed very good partial response.
Croatian: Od 5 bolesnika na režimu s placebom 2 su imala potvrđen vrlo dobar djelomični odgovor.
English: Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Croatian: Iksazomib je oralni, visoko selektivni i reverzibilni inhibitor proteasoma.
English: The steady-state volume of distribution is 543 L.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže iznosi 543 l.
English: December
Croatian: Prosinac
English: • Swallow the capsule whole with water.
Croatian: • Progutajte kapsulu cijelu s vodom.
English: The terminal half-life (t1/2) of ixazomib was 9.5 days.
Croatian: Terminalni poluvijek (t1/2) iksazomiba iznosio je 9,5 dana.
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.
Croatian: Progutajte NINLARO kapsulu cijelu s vodom u isto vrijeme svaki tjedan, barem jedan sat prije ili najmanje dva sata nakon jela.
English: • not feeling like eating (decreased appetite)
Croatian: • nezainteresiranost za hranu (smanjen apetit)
English: Each pack contains 3 hard capsules (three single cartons, each containing a blister sealed inside a wallet.
Croatian: Svako pakiranje sadrži 3 tvrde kapsule (tri zasebne kutije, od kojih svaka sadrži blister zatvoren u ovitku.
English: Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite ikakvo oštećenje ili znakove neovlaštenog otvaranja pakiranja lijeka.
English: Based on a population PK analysis, systemic clearance (CL) was approximately 1.86 L/hr with inter-individual variability of 44%.
Croatian: Na temelju analize populacijske farmakokinetike, sistemski klirens (CL) iznosio je približno 1,86 l/h s interindividualnom varijabilnosti od 44%.
English: Because myeloma cells produce a lot of proteins, blocking the action of proteasomes can kill the cancerous cells.
Croatian: Budući da stanice mijeloma stvaraju mnogo proteina, blokiranje djelovanja proteasoma može ubiti stanice raka.
English: No dose adjustment of ixazomib is required for patients over 65 years of age.
Croatian: Nije potrebna prilagodba doze iksazomiba za bolesnike starije od 65 godina.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30 °C.
English: If the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water.
Croatian: Ako prašak slučajno dođe u dodir s kožom, temeljito ga isperite sapunom i vodom.
English: Twenty five percent of patients had a creatinine clearance of < 60 mL/min.
Croatian: Dvadeset i pet posto bolesnika imalo je klirens kreatinina < 60 ml/min.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX50
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici, ATK oznaka: L01XX50
English: For these toxicities, the first dose modification step is to withhold/reduce lenalidomide.
Croatian: Za te toksičnosti prvi korak u prilagodbi doze je odgoditi primjenu/smanjiti dozu lenalidomida.
English: NINLARO is not recommended during pregnancy as it may harm your unborn baby.
Croatian: NINLARO se ne preporučuje tijekom trudnoće jer može naštetiti Vašem nerođenom djetetu.
English: Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Croatian: AUC iksazomiba raste proporcionalno s dozom u rasponu doza od 0,2 do 10,6 mg.
English: A plasma cell is a blood cell that normally produces proteins to fight infections.
Croatian: Plazma stanica je krvna stanica koja inače stvara proteine za borbu protiv infekcija.
English: The mean absolute oral bioavailability is 58%.
Croatian: Prosječna apsolutna bioraspoloživost kod peroralne primjene je 58%.
English: As multiple myeloma is a heterogeneous disease, benefit may vary across subgroups in the Phase 3 study (C16010) (see Figure 2).
Croatian: Kako je multipli mijelom heterogena bolest, korist liječenja može se razlikovati među podskupinama u ispitivanju faze 3 (C16010) (vidjeti Sliku 2).
English: Seventy seven percent of patients relapsed after prior therapies and 11% were refractory to prior therapies.
Croatian: Sedamdeset i sedam posto bolesnika recidiviralo je nakon prethodnih terapija, a 11% njih bilo je refraktorno na prethodne terapije.
English: • lowered blood pressure (hypotension)
Croatian: • snižen krvni tlak (hipotenzija)
English: † Standardised MedDRA Queries (SMQs)
Croatian: † Standardizirani MedDRA upiti (SMQ-i)
English: Additionally, tell a doctor immediately if you notice any of these following rare side effects which may affect up to 1 in 1,000 people:
Croatian: Također, odmah obavijestite liječnika ako primijetite bilo koju od sljedećih rijetkih nuspojava koje se mogu javiti u manje od 1 na 1000 osoba:
English: In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
Croatian: U ispitivanju faze 3 (C16010), 10 bolesnika (5 u svakom režimu liječenja) na početku je imalo teško oštećenje funkcije bubrega.
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.
Croatian: S obzirom da se NINLARO daje u kombinaciji s lenalidomidom, morate se pridržavati programa za sprječavanje trudnoće za lenalidomid jer lenalidomid može biti štetan za nerođeno dijete.
English: • changes in vision, changes in mental status, or seizures (posterior reversible encephalopathy syndrome)
Croatian: • promjene u vidu, promjene u mentalnom statusu ili napadaji (sindrom posteriorne reverzibilne encefalopatije)
English: Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Croatian: Cmax iksazomiba smanjen je za 4%, a AUC se povećao za 11%.
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.
Croatian: Bolesnici uključeni u ispitivanje imali su multipli mijelom koji je bio refraktoran, uključujući i primarno refraktoran, bio u relapsu nakon prethodne terapije ili je bio u relapsu i refraktoran na bilo koju prethodnu terapiju.
English: Treatment should be continued until disease progression or unacceptable toxicity.
Croatian: Liječenje treba nastaviti do napredovanja bolesti ili do neprihvatljive toksičnosti.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene slijedom smanjenja ozbiljnosti.
English: Quality of life as assessed by global health scores (EORTC QLQ-C30 and MY-20) was maintained during treatment and was similar in both treatment regimens in the Phase 3 study (C16010).
Croatian: Kvaliteta života prema procjeni ljestvica za ocjenu općeg zdravstvenog stanja (EORTC QLQ-C30 i MY-20) održana je tijekom terapije i bila je slična u oba režima liječenja u ispitivanju faze 3 (C16010).
English: People with multiple myeloma have cancerous plasma cells, also called myeloma cells, which can damage the bones.
Croatian: Osobe s multiplim mijelomom imaju kancerozne plazma stanice koje se također nazivaju mijelomskim stanicama, koje mogu oštetiti kosti.
English: • lowered white blood cells called neutrophils (neutropenia) that may increase the risk of infection
Croatian: • sniženi broj bijelih krvnih stanica zvanih neutrofili (neutropenija), što može povećati rizik od infekcije
English: Infections and infestations Upper respiratory tract infection
Croatian: Infekcije i infestacije Infekcija gornjeg dišnog trakta
English: The majority of target organ findings demonstrated partial to full recovery following discontinuation of treatment, with the exception of neuronal findings in the lumbar dorsal root ganglion and dorsal column.
Croatian: Većina nalaza na ciljnim organima pokazala je djelomični do puni oporavak nakon prekida terapije uz iznimku nalaza na neuronima u lumbalnom dorzalnom spinalnom gangliju i dorzalnoj kolumni.
English: There is no known specific antidote for ixazomib overdose.
Croatian: Nema poznatog specifičnog antidota za predoziranje iksazomibom.
English: Tell your doctor or pharmacist straight away if you notice any of these following very common serious side effects which may affect more than 1 in 10 people:
Croatian: Odmah obavijestite liječnika ili ljekarnika ako primijetite jednu od sljedećih vrlo čestih ozbiljnih nuspojava koje se mogu javiti u više od 1 na 10 osoba:
English: Adverse reactions (all grades)
Croatian: Nuspojave (svi stupnjevi)
English: Ixazomib should be taken at approximately the same time on days 1, 8, and 15 of each treatment cycle at least 1 hour before or at least 2 hours after food (see section 5.2).
Croatian: Iksazomib treba uzimati u približno isto vrijeme na 1., 8. i 15. dan svakog ciklusa liječenja te barem sat vremena prije ili barem 2 sata nakon obroka (vidjeti dio 5.2).
English: • yellow discoloration of eyes and skin (jaundice which could be a symptom of liver impairment)
Croatian: • žutilo očiju i kože (žutica koja bi mogla biti simptom oštećenja jetre)
English: Figure 2: Forest plot of progression-free survival in subgroups
Croatian: Slika 2: Forestova krivulja preživljenja bez napredovanja bolesti u podskupinama
English: Treatment for multiple myeloma involves killing myeloma cells and reducing the symptoms of the disease.
Croatian: Liječenje multiplog mijeloma uključuje uništavanje mijelomskih stanica i smanjenje simptoma bolesti.
English: The capsules should not be opened or crushed.
Croatian: Kapsule se ne smiju otvarati niti lomiti.
English: More frequent monitoring should be considered during the first three cycles as per the lenalidomide SmPC.
Croatian: Češće praćenje treba razmotriti tijekom prva tri ciklusa kako je navedeno u Sažetku opisa svojstava lenalidomida.
English: As data are limited in these patients, a careful risk-benefit assessment is recommended before initiating the ixazomib regimen.
Croatian: S obzirom da su podaci za ove bolesnike ograničeni, preporučuje se pažljiva procjena odnosa rizika i koristi prije početka terapije iksazomibom.
English: There was no clinically meaningful effect of age (23-91 years), sex, body surface area (1.2-2.7 m2), or race on the clearance of ixazomib based on the results of a population PK analysis.
Croatian: Nije bilo klinički značajnog učinka dobi (23-91 godina), spola, površine tijela (1,2-2,7 m2) ili rase na klirens iksazomiba na temelju rezultata analize populacijske farmakokinetike.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja iksazomiba u svim podskupinama pedijatrijske populacije za multipli mijelom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Croatian: Ispitivanje faze 3 isključilo je bolesnike koji su bili refraktorni na lenalidomid ili inhibitore proteasoma, te bolesnike koji su primili više od tri prethodne terapije.
English: NINLARO may affect your ability to drive or use machines.
Croatian: NINLARO može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: If you are a woman of childbearing potential or a man who can father a child, you must use effective contraception during and for 90 days after treatment.
Croatian: Ako ste žena koja može zanijeti ili muškarac koji može začeti dijete morate koristiti djelotvorne mjere kontracepcije tijekom i barem 90 dana nakon terapije.
English: Placebo + Lenalidomide and Dexamethasone (N = 362)
Croatian: placebo + lenalidomid i deksametazon (N = 362)
English: The mean AUC was 35% higher in Asian patients; however, there was overlap in the AUC of ixazomib across White and Asian patients.
Croatian: Srednja vrijednost AUC-a bila je za 35% viša u azijskih bolesnika; međutim, postojalo je preklapanje u AUC iksazomiba u bolesnika bijele i azijske rase.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svake klase organskih sustava, nuspojave su poredane po učestalosti, pri čemu su najčešće navedene na prvom mjestu.
English: What NINLARO is NINLARO is a cancer medicine that contains ixazomib, a ‘proteasome inhibitor'.
Croatian: Što je NINLARO NINLARO je lijek protiv raka koji sadrži iksazomib, „inhibitor proteasoma“.
English: A randomised, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria.
Croatian: Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 provedeno je u Kini (N = 115), sa sličnim dizajnom i uključnim kriterijima.
English: Tell doctor right away if you or your partner becomes pregnant while receiving NINLARO.
Croatian: Odmah obavijestite svog liječnika ako zatrudnite, ili ako Vaša partnerica zatrudni, dok primate NINLARO.
English: Nervous system disorders Peripheral neuropathies* Very common
Croatian: Poremećaji živčanog sustava Periferne neuropatije* Vrlo često
English: Do not drive or operate machines if you have these side effects.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako imate te nuspojave.
English: Concomitant medicinal products, such as antiemetic, antiviral, and antihistamine medicinal products were given to patients at the physician's discretion as prophylaxis and/or management of symptoms.
Croatian: Konkomitantni lijekovi poput antiemetika, antivirusnih lijekova i antihistaminika davani su bolesnicima prema odluci liječnika kao profilaksa i/ili simptomatska terapija.
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.
Croatian: Na primarnoj analizi (medijan praćenja do 14,7 mjeseci, a medijan broja ciklusa 13), PFS rezultati bili su statistički značajno različiti između liječenih skupina.
English: Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.
Croatian: Iksazomibcitrat je predlijek koji se u fiziološkim uvjetima brzo hidrolizira u svoj biološki aktivni oblik, iksazomib.
English: Twenty three percent of patients had light chain disease and 12% of patients had measurable disease by free light chain assay only.
Croatian: Dvadeset i tri posto bolesnika imalo je bolest lakih lanaca, a 12% bolesnika imalo je bolest koja se mogla dokazati samo mjerenjem slobodnih lakih lanaca.
English: Unchanged ixazomib accounted for < 3.5% of the administered dose recovered in urine.
Croatian: Nepromijenjeni iksazomib sačinjavao je < 3,5% primijenjene doze pronađene u mokraći.
English: What you need to know before you take NINLARO
Croatian: Što morate znati prije nego počnete uzimati NINLARO
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.
Croatian: U više ciklusa ispitivanja toksičnosti ponovljene doze provedenih na štakorima i psima, glavni ciljni organi uključivali su gastrointestinalni trakt, limfoidna tkiva i živčani sustav.
English: Ixazomib caused embryo-foetal toxicity in pregnant rats and rabbits only at maternally toxic doses and at exposures that were slightly higher than those observed in patients receiving the recommended dose.
Croatian: Iksazomib je uzrokovao embriofetalnu toksičnost u gravidnih ženki štakora i kunića samo pri maternalno toksičnim dozama i pri izloženostima koje su bile nešto više od onih uočenih u bolesnika koji su primali preporučenu dozu.
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.
Croatian: Ispitivanja plodnosti i ranog embrionalnog razvoja kao i pre- i postnatalna toksikologija nisu provedena s iksazomibom, ali je procjena reproduktivnih tkiva provedena u ispitivanjima opće toksičnosti.
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.
Croatian: Kada se iksazomib primjenjuje zajedno s deksametazonom, za koji je poznato da je slabi do umjereno jaki induktor CYP3A4 kao i drugih enzima i prijenosnika, potrebno je uzeti u obzir rizik od smanjene djelotvornosti oralnih kontraceptiva.
English: Ixazomib exhibits a multi-exponential disposition profile.
Croatian: Iksazomib iskazuje multieksponencijalni profil dispozicije.
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).
Croatian: Devetnaest posto imalo je citogenetičke abnormalnosti visokog rizika (del[17], t[4;14], t[14;16]) N = 137), 10% del(17) (N = 69), a 34% amplifikaciju lq (1q21) (N = 247).
English: Patients experiencing new or worsening peripheral neuropathy may require dose modification (see section 4.2).
Croatian: U bolesnika u kojih se pojavi nova ili se pogorša postojeća periferna neuropatija može biti potrebna prilagodba doze (vidjeti dio 4.2).
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Croatian: Žene koje koriste hormonske kontraceptive trebaju dodatno koristiti mehaničku metodu kontracepcije.
English: After oral administration, peak plasma concentrations of ixazomib were achieved at approximately one hour after dosing.
Croatian: Nakon peroralne primjene vršne koncentracije iksazomiba u plazmi postignute su približno sat vremena nakon doziranja.
English: Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Croatian: Klinički podaci su ograničeni, ali su u randomiziranom kontroliranom kliničkom ispitivanju zabilježene doze do 12 mg.
English: Male and female patients who are able to have children must use effective contraceptive measures during and for 90 days following treatment.
Croatian: Muški i ženski bolesnici reproduktivne dobi moraju koristiti djelotvorne kontracepcijske mjere tijekom i 90 dana nakon liječenja.
English: Metabolism by multiple CYP enzymes and non-CYP proteins is expected to be the major clearance mechanism for ixazomib.
Croatian: Očekuje se da će metabolizam putem više CYP enzima i ne-CYP proteina biti glavni mehanizam eliminacije za iksazomib.
English: Less than 1% of patients in both regimens had a platelet count ≤ 5,000/mm3 during treatment.
Croatian: Manje od 1% bolesnika u oba režima imalo je tijekom liječenja broj trombocita ≤ 5000/mm3.