FrancophonIA/ELRC3.0 huggingface dataset:
English: If PML is suspected, further administration must be suspended until PML has been excluded by a specialist with appropriate diagnostic testing.
Croatian: Ako se sumnja na PML, daljnja primjena mora se obustaviti dok specijalist ne isključi PML odgovarajućim dijagnostičkim ispitivanjem.
English: Dose adjustments do not need to be made for weight changes of less than or equal to 20%.
Croatian: Nisu potrebne prilagodbe doze za promjene tjelesne težine koje su manje ili jednake 20%.
English: In vitro studies indicated that carfilzomib did not induce human CYP3A4 in cultured human hepatocytes.
Croatian: In vitro ispitivanja upućuju na to da karfilzomib nije inducirao humani CYP3A4 u kulturi humanih hepatocita.
English: Multiple myeloma is a cancer of plasma cells (a type of white blood cell).
Croatian: Multipli mijelom je rak plazma stanica (vrsta bijelih krvnih stanica).
English: The safety and efficacy of Kyprolis in paediatric patients have not been established.
Croatian: Sigurnost i djelotvornost lijeka Kyprolis u pedijatrijskih bolesnika nisu ustanovljene.
English: What Kyprolis contains
Croatian: Što Kyprolis sadrži
English: The marketing authorisation holder shall submit the first PSUR for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: Nonetheless, considering the fast elimination of carfilzomib, notably a rapid decline in systemic concentration 5 minutes after the end of infusion, the risk of clinically relevant interactions with substrates of OATP1B1 and UGT1A1 is probably low.
Croatian: Ipak, uzimajući u obzir brzu eliminaciju karfilzomiba, posebno brz pad sistemske koncentracije 5 minuta nakon završetka infuzije, rizik od klinički relevantnih interakcija sa supstratima OATP1B1 i UGT1A1 vjerojatno je nizak.
English: Carfilzomib does not inhibit human UGT2B7 but inhibits human UGT1A1 with an IC50 of 5.5 µM.
Croatian: Karfilzomib ne inhibira humani UGT2B7, ali inhibira humani UGT1A1 uz IC50 vrijednosti od 5,5 µM.
English: The effect of carfilzomib on cardiac repolarisation using the QT interval with Fridericia's correction (QTcF interval) and the analysis of concentration-QTc relationships show no clear signal of any dose-related effect.
Croatian: Učinak karfilzomiba na repolarizaciju srca, koristeći QT interval s Fridericia korekcijom (QTcF interval) i analiza povezanosti koncentracije i QTc intervala ne pokazuje jasan signal bilo kojeg učinka povezanog s dozom.
English: • Low white blood cell count, which may decrease your ability to fight infection and may be associated with fever
Croatian: • Niska razina bijelih krvnih stanica, što može smanjiti Vašu sposobnost da se obranite od infekcija i može biti povezano s vrućicom
English: • Serious infection including infection in the blood (sepsis)
Croatian: • Ozbiljna infekcija, uključujući infekciju krvi (sepsa)
English: For potential dose-related effects, see section 4.8.
Croatian: Za moguće učinke povezane s dozom, vidjeti dio 4.8.
English: For patients with positive HBV serology, prophylaxis with antivirals should be considered.
Croatian: Za bolesnike s pozitivnom serologijom na HBV treba razmotriti profilaktičko liječenje antiviroticima.
English: a. Study PX-171-009
Croatian: Ispitivanje PX-171-009
English: Other medicines and Kyprolis
Croatian: Drugi lijekovi i Kyprolis
English: If you have ever had hepatitis B infection, treatment with this medicine may cause the hepatitis B infection to become active again.
Croatian: Ako ste ikada bili zaraženi hepatitisom B, liječenje ovim lijekom može uzrokovati ponovno aktiviranje infekcije hepatitisom B.
English: From cycle 13, the day 8 and 9 doses of Kyprolis are omitted.
Croatian: Od 13. ciklusa se izostavljaju doze lijeka Kyprolis 8. i 9. dana.
English: Oral and/or intravenous hydration should be continued, as needed, in subsequent cycles.
Croatian: Prema potrebi treba nastaviti s peroralnom i/ili intravenskom hidracijom u sljedećim ciklusima.
English: A pre-planned overall survival (OS) analysis was performed after 246 deaths in the KRd arm and 267 deaths in the Rd arm.
Croatian: Prethodno planirana analiza ukupnog preživljenja (engl. overall survival, OS) je bila provedena nakon 246 smrti u skupini KRd i 267 smrti u skupini Rd.
English: Results from both studies show that renal function status had no marked effect on the exposure of carfilzomib following single or repeat-dose administration.
Croatian: Rezultati iz oba ispitivanja pokazuju da status funkcije bubrega nije imao znatan utjecaj na izloženost karfilzomiba nakon jednokratne ili opetovane primjene.
English: Treatment may be continued until disease progression or until unacceptable toxicity occurs.
Croatian: Liječenje se može nastaviti do progresije bolesti ili neprihvatljive toksičnosti.
English: The results of study PX-171-009 are summarised in table 6 and in figure 1 and figure 2.
Croatian: Rezultati ispitivanja PX-171-009 sažeti su u tablici 6 i na slici 1 i slici 2.
English: If a patient is currently using oral contraceptives or a hormonal method of contraception that is associated with a risk of thrombosis, the patient should switch to an alternative method of effective contraception.
Croatian: Ako bolesnica trenutno primjenjuje oralne kontraceptive ili hormonsku metodu kontracepcije povezanu s rizikom od tromboze, bolesnica bi trebala prijeći na alternativne učinkovite metode kontracepcije.
English: Kyprolis treatment was administered for a maximum of 18 cycles unless discontinued early for disease progression or unacceptable toxicity.
Croatian: Kyprolis je primjenjivan maksimalno 18 ciklusa, osim ako primjena nije prekinuta ranije zbog progresije bolesti ili neprihvatljive toksičnosti.
English: The incidence of hypertension adverse events was similar between those with or without a prior medical history of hypertension.
Croatian: Incidencija hipertenzivnih štetnih događaja bila je slična u bolesnika sa ili bez prethodne anamneze hipertenzije.
English: However, if you are given too much Kyprolis your doctor will monitor you for side effects.
Croatian: Međutim, ako primite previše lijeka Kyprolis, Vaš liječnik će Vas pratiti zbog nuspojava.
English: Proteasome inhibition was maintained for ≥ 48 hours following the first dose of carfilzomib for each week of dosing.
Croatian: Inhibicija proteasoma održala se tijekom ≥ 48 sati nakon prve doze karfilzomiba u svakom tjednu doziranja.
English: The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have child bearing potential.
Croatian: Uvjeti Programa prevencije trudnoće za lenalidomid moraju se ispuniti za sve bolesnice, osim za one za koje postoje pouzdani dokazi da nemaju reproduktivnog potencijala.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Croatian: Bolesnike i liječnike se upućuje da obrate pozornost na znakove i simptome tromboembolije.
English: Lenalidomide and dexamethasone are other medicines used to treat multiple myeloma.
Croatian: Lenalidomid i deksametazon su drugi lijekovi koji se koriste u liječenju multiplog mijeloma.
English: Caution should be observed when carfilzomib is combined with medicinal products that are substrates of these enzymes, such as oral contraceptives.
Croatian: Potreban je oprez kada se karfilzomib primjenjuje u kombinaciji s lijekovima koji su supstrati ovih enzima, kao što su oralni kontraceptivi.
English: Carfilzomib works by blocking the proteasome.
Croatian: Karfilzomib djeluje blokiranjem proteasoma.
English: Store refrigerated (2°C to 8°C).
Croatian: Čuvati u hladnjaku (2°C do 8°C).
English: The risk of cardiac failure is increased in elderly patients (≥ 75 years).
Croatian: Rizik zatajenja srca veći je u starijih bolesnika (≥ 75 godina).
English: Carfilzomib was rapidly and extensively metabolised.
Croatian: Karfilzomib se brzo i opsežno metabolizirao.
English: Kyprolis is for single use only.
Croatian: Kyprolis je isključivo za jednokratnu primjenu.
English: The risk of cardiac failure is also increased in Asian patients.
Croatian: Rizik zatajenja srca također je povećan u bolesnika azijatskog podrijetla.
English: The safety of resuming carfilzomib, after HBV reactivation is adequately controlled, is not known.
Croatian: Sigurnost nastavka liječenja karfilzomibom nakon postizanja odgovarajuće kontrole reaktivacije HBV-a nije poznata.
English: In vitro, at concentrations (3 µM) lower than those expected at therapeutic doses, carfilzomib inhibits the efflux transport of digoxin, a P-gp substrate, by 25%.
Croatian: In vitro, pri koncentracijama (3 µM) koje su niže od onih očekivanih za terapijske doze, karfilzomib je inhibirao efluksni transport digoksina, supstrata P-gp-a, za 25%.
English: Patients with a BSA greater than 2.2 m2 should receive a dose based upon a BSA of 2.2 m2.
Croatian: U bolesnika s BSA većom od 2,2 m2 treba se primijeniti doza koja odgovara BSA od 2,2 m2.
English: In vitro, carfilzomib was found to have minimal neurotoxicity and minimal reaction to non-proteasomal proteases.
Croatian: In vitro, pokazalo se da je karfilzomib minimalno neurotoksičan i da ima minimalnu reakciju na ne-proteasomske proteaze.
English: Lenalidomide and dexamethasone administration could continue until progression or unacceptable toxicity.
Croatian: Primjena lenalidomida i deksametazona mogla se nastaviti do progresije ili neprihvatljive toksičnosti.
English: All patients should be routinely evaluated for hypertension while on Kyprolis and treated as needed.
Croatian: Sve bolesnike potrebno je rutinski procijeniti za hipertenziju dok se liječe lijekom Kyprolis i prema potrebi ih liječiti.
English: Dose level reductions are presented in table 4.
Croatian: Smanjenja razine doze prikazana su u tablici 4.
English: Reduce or stop dose as appropriate (see section 4.2).
Croatian: Prema potrebi smanjite dozu ili prekinite primjenu (vidjeti dio 4.2).
English: Based on its mechanism of action and findings in animals, Kyprolis can cause foetal harm when administered to a pregnant woman.
Croatian: Na temelju mehanizma djelovanja i rezultata iz ispitivanja na životinjama, Kyprolis može naštetiti fetusu kada se primjenjuje u trudnica.
English: In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see sections 4.4 and 4.8).
Croatian: Dodatno, zbog povećanog rizika od venskih tromboemboličkih događaja povezanih s primjenom karfilzomiba, žene bi trebale izbjegavati primjenu hormonskih kontraceptiva povezanih s rizikom od tromboze tijekom liječenja karfilzomibom (vidjeti dijelove 4.4 i 4.8).
English: • Flu-like symptoms (influenza)
Croatian: • Simptomi nalik gripi (influenca)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for carfilzomib, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za karfilzomib, znanstveni zaključci CHMP-a su sljedeći:
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XX45 Mechanism of action
Croatian: Farmakoterapijska skupina: Antineoplastični lijekovi, ATK oznaka: L01XX45
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kyprolis 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 lijeka Kyprolis u svim podskupinama pedijatrijske populacije u multiplom mijelomu (vidjeti dio 4.2 za informacije o primjeni lijeka u pedijatrijskoj populaciji).
English: • Absolute neutrophil count < 0.5 x 109/L and an oral temperature > 38.5°C or two consecutive readings of > 38.0°C for 2 hours
Croatian: • Apsolutni broj neutrofila < 0,5 x 109/l i oralna temperatura > 38,5°C ili u dva uzastopna mjerenja kroz 2 sata > 38,0°C
English: Kyprolis is used to treat adult patients with multiple myeloma who have had at least one previous treatment for this disease.
Croatian: Kyprolis se koristi za liječenje odraslih bolesnika s multiplim mijelomom koji su prethodno primili najmanje jednu terapiju za ovu bolest.
English: Kyprolis can cause elevations of serum transaminases (see section 4.8).
Croatian: Kyprolis može uzrokovati povišenje vrijednosti serumskih transaminaza (vidjeti dio 4.8).
English: Chemical and physical in-use stability of reconstituted solutions in the vial, syringe or intravenous bag has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at 25°C.
Croatian: Kemijska i fizikalna stabilnost rekonstituiranih otopina za primjenu u bočici, štrcaljki ili vrećici za infuziju dokazana je tijekom 24 sata na temperaturi od 2°C - 8°C ili tijekom 4 sata na temperaturi od 25°C.
English: In the second study, the exposures for M14 were greater (approximately 4-fold) in subjects with ESRD than in subjects with normal renal function.
Croatian: U drugom ispitivanju, izloženost za M14 je bila veća (otprilike četiri puta više) u ispitanika sa ZSBB-om nego u ispitanika s normalnom funkcijom bubrega.
English: • For patients on dialysis receiving Kyprolis, the dose is to be administered after the dialysis procedure
Croatian: • Za bolesnike na dijalizi koji primaju Kyprolis, doza se treba primijeniti nakon postupka dijalize
English: This may impair your ability to drive or operate machines.
Croatian: To može umanjiti Vašu sposobnost upravljanja vozilima i strojevima.
English: • All other grade 3 or 4 non-haematologic toxicities (see section 4.4)
Croatian: • Sve druge nehematološke toksičnosti 3. ili 4. stupnja (vidjeti dio 4.4)
English: In vitro, carfilzomib inhibits OATP1B1 with an IC50 = 2.01 µM whereas it is unknown whether carfilzomib may or not inhibit other transporters OATP1B3, OAT1, OAT3, OCT2 and BSEP, at the systemic level.
Croatian: In vitro, karfilzomib inhibira OATP1B1 uz IC50 = 2,01 µM, dok nije poznato može li ili ne karfilzomib na sustavnom nivou inhibirati i druge transportere OATP1B3, OAT1, OAT3, OCT2 i BSEP.
English: At doses between 20 and 56 mg/m2, there was a dose-dependent increase in exposure.
Croatian: Pri dozama između 20 i 56 mg/m2 došlo je do povećanja izloženosti ovisnog o dozi.
English: Lymphopenia Leukopenia
Croatian: Limfopenija Leukopenija
English: White to off-white lyophilised powder.
Croatian: Bijeli do prljavo bijeli liofilizirani prašak.
English: Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Croatian: Liječenje lijekom Kyprolis treba nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Based on the number of relevant cases reported cumulatively, including 16 events with a fatal outcome during the reporting period, the existing warning on cardiac disorders should be updated to recommend that patients should be evaluated for cardiovascular risk factors before treatment with carfilzomib, that a comprehensive cardiological assessment should be considered for patients at high-risk for cardiovascular disease and that hypertension should be controlled during treatment, as a history of hypertension was frequently reported in patients presenting with cardiac disorders.
Croatian: Na temelju broja relevantnih slučajeva prijavljenih kumulativno, uključujući 16 događaja sa smrtnim ishodom tijekom izvještajnog razdoblja, potrebno je ažurirati postojeće upozorenje o srčanim poremećajima kako bi se preporučilo da se bolesnici prije liječenja karfilzomibom procijene na čimbenike kardiovaskularnog rizika, da je u bolesnika s visokim rizikom od kardiovaskularne bolesti potrebno uzeti u obzir sveobuhvatnu kardiološku procjenu i da hipertenziju treba kontrolirati tijekom liječenja jer je anamneza hipertenzije često prijavljena u bolesnika sa srčanim poremećajima.
English: • Heart failure and heart problems including rapid, strong or irregular heartbeat
Croatian: • Zatajenje srca i problemi sa srcem uključujući ubrzane, snažne i nepravilne otkucaje srca
English: Pruritus Erythema Hyperhidrosis
Croatian: Pruritus Eritem Hiperhidroza
English: Anxiety Confusional state
Croatian: Anksioznost Konfuzno stanje
English: Kyprolis has minor influence on the ability to drive and use machines.
Croatian: Kyprolis malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If the diagnosis is suspected, stop Kyprolis and evaluate patients for possible TTP/HUS.
Croatian: Ako se sumnja na tu dijagnozu, prekinite primjenu lijeka Kyprolis i procijenite bolesnika za mogući TTP/HUS.
English: The doses on day 8 and 9 of each cycle will not be given from cycle 13 onwards if you are treated with Kyprolis in combination with lenalidomide and dexamethasone.
Croatian: Doze koje se primjenjuju 8. i 9. dana u svakom ciklusu neće se primjenjivati od 13. ciklusa nadalje ako se liječite lijekom Kyprolis u kombinaciji s lenalidomidom i deksametazonom.
English: • Pain, swelling, irritation or discomfort where you received the injection into your vein
Croatian: • Bol, oticanje, iritacija ili nelagoda na mjestu gdje ste primili injekciju u venu
English: Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake klasifikacije organskog sustava i kategorije učestalosti, nuspojave su navedene slijedom smanjenja ozbiljnosti.
English: An evaluation of possible effects of carfilzomib on cardiac function was performed by analysing, via central blind reading, triplicate ECG in 154 subjects with advanced malignancies, including multiple myeloma.
Croatian: Procjena mogućih učinaka karfilzomiba na funkciju srca provedena je analizom centralnog slijepog očitanja trostrukog EKG-a u 154 ispitanika s uznapredovalom malignom bolesti, uključujući multipli mijelom.
English: Carfilzomib does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19 and 2D6 in vitro and is therefore not expected to influence exposure of medicinal products that are substrates of these enzymes as a result of inhibition.
Croatian: Karfilzomib ne inhibira CYP1A2, 2B6, 2C8, 2C9, 2C19 i 2D6 in vitro te se prema tome ne očekuje da će, kao posljedica inhibicije, utjecati na izloženost lijekovima koji su supstrati ovih enzima.
English: This is because this medicine could cause hepatitis B virus to become active again.
Croatian: To je zato što bi ovaj lijek mogao izazvati ponovno aktiviranje virusa hepatitisa B.
English: • Blood clots in the veins (deep vein thrombosis)
Croatian: • Krvni ugrušci u venama (duboka venska tromboza)
English: • Changes to blood tests (decreased blood levels of potassium, increased blood levels of sugar and/or creatinine)
Croatian: • Promjene krvnih pretraga (smanjene razine kalija, povišene razine šećera i/ili kreatinina u krvi)
English: There are no data from the use of carfilzomib in pregnant women.
Croatian: Nema podataka o primjeni karfilzomiba u trudnica.
English: There is no known specific antidote for carfilzomib overdose.
Croatian: Ne postoji poznati specifični antidot za predoziranje karfilzomibom.
English: All patients should be monitored for evidence of volume overload and fluid requirements should be tailored to individual patient needs.
Croatian: Sve bolesnike treba pratiti zbog utvrđivanja volumnog preopterećenja, a zahtjeve za tekućinom potrebno je prilagoditi potrebama pojedinog bolesnika.
English: No fertility studies have been performed in animals (see section 5.3).
Croatian: Nisu provedena ispitivanja plodnosti u životinja (vidjeti dio 5.3).
English: • Heart problems, including a history of chest pain (angina), heart attack, irregular heartbeat, high blood pressure or if you have ever taken a medicine for your heart
Croatian: • Problemi sa srcem, uključujući i povijest bolova u prsnom košu (angina), srčanog udara, nepravilnog srčanog ritma, visok krvni tlak ili ako ste ikada uzimali lijekove za srce
English: The dose is calculated using the patient's baseline body surface area (BSA).
Croatian: Doza se računa prema površini tijela bolesnika (BSA, od engl. body surface area).
English: In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth in models of multiple myeloma.
Croatian: U životinja, karfilzomib je inhibirao aktivnost proteasoma u krvi i tkivima i odgodio rast tumora u modelima multiplog mijeloma.
English: If Kyprolis is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Croatian: Ako se Kyprolis primjenjuje tijekom trudnoće ili ako bolesnica postane trudna tijekom primjene ovog lijeka, bolesnicu treba upoznati s potencijalnim opasnostima za fetus.
English: Subjects had received 1 to 3 prior lines of therapy (median of 2), including prior treatment with bortezomib (66%), thalidomide (44%) and lenalidomide (20%).
Croatian: Ispitanici su primili 1 do 3 prethodne linije liječenja (medijan 2), uključujući prethodno liječenje bortezomibom (66%), talidomidom (44%) i lenalidomidom (20%).
English: Increased alanine aminotransferase Increased aspartate aminotransferase Gammaglutamyltransferase increased
Croatian: Povišena vrijednost alanin aminotransferaze Povišena vrijednost aspartat aminotransferaze Povišena vrijednost gama-glutamil transferaze Hiperbilirubinemija
English: All patients should be screened for HBV before initiation of treatment with carfilzomib.
Croatian: Svi bolesnici moraju se testirati na HBV prije početka liječenja karfilzomibom.
English: The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL.
Croatian: Rekonstituirana otopina sadrži karfilzomib u koncentraciji od 2 mg/ml.
English: • Liver problems, including a history of hepatitis, fatty liver, or if you have ever been told your liver is not working properly
Croatian: • Problemi s jetrom, uključujući povijest hepatitisa i masne jetre ili ako Vam je ikada bilo rečeno da Vaša jetra ne radi pravilno
English: Kyprolis powder for solution for infusion must not be mixed with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Kyprolis prašak za otopinu za infuziju se ne smije miješati s 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekcije.
English: If PML is confirmed, carfilzomib must be discontinued.
Croatian: Ako se PML potvrdi, liječenje karfilzomibom se mora trajno prekinuti.
English: • Creatinine clearance < 15 mL/min (or creatinine clearance decreases to ≤ 50% of baseline) or need for dialysis (see section 4.4)
Croatian: • Klirens kreatinina < 15 ml/min (ili klirens kreatinina smanjen na ≤ 50% od početne vrijednosti) ili potreba za dijalizom (vidjeti dio 4.4)
English: Study PX-171-011 was an open-label randomised phase 3 study (N = 315; exposure to ≥ 3 prior therapies required).
Croatian: Ispitivanje PX-171-011 je bilo otvoreno randomizirano ispitivanje faze 3 (N = 315; potrebna izloženost do ≥ 3 prethodna liječenja).
English: Therefore, caution should be used during handling and preparation of Kyprolis.
Croatian: Stoga je potreban oprez tijekom rukovanja i pripreme lijeka Kyprolis.
English: • If absolute neutrophil count returns to baseline grade and fever resolves, resume at the same dose level
Croatian: • Ako se apsolutni broj neutrofila vrati na početnu vrijednost i vrućica se povuče, nastavite liječenje jednakom dozom
English: Pack size of one vial.
Croatian: Veličina pakiranja od jedne bočice.