FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Croatian: Stoga bolesnici moraju biti oprezni kad upravljaju vozilima ili rade sa strojevima i potrebno im je savjetovati da ne voze i ne upravljaju strojevima ako dožive te simptome (vidjeti dio 4.8).
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Croatian: Konačna analiza za ukupno preživljenje (OS) napravljena nakon medijana praćenja u trajanju od 8,6 godina, nije pokazala značajnu razliku u OS između dviju liječenih skupina.
English: Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
Croatian: Bortezomib se brže eliminira nakon prve doze u usporedbi sa sljedećim dozama.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 22 July 2016
Croatian: Datum prvog odobrenja: 22. srpnja 2016.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Croatian: Medijan preživljenja svih uključenih bolesnika bio je 17 mjeseci (raspon < 1 do 36+ mjeseci).
English: Mediana response duration
Croatian: Medijana trajanja odgovora
English: Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Croatian: Vaš liječnik može promijeniti dozu i ukupni broj ciklusa liječenja ovisno o Vašem odgovoru na liječenje, pojavi određenih nuspojava i drugim prisutnim stanjima (npr. problemi s jetrom).
English: However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Croatian: Međutim, prijavljeni su slučajevi teške motorne neuropatije sa ili bez senzorne periferne neuropatije.
English: Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Croatian: Moguću korist od liječenja treba pažljivo ocijeniti u odnosu na rizik, osobito u slučaju umjerene do teške trombocitopenije i čimbenika rizika za krvarenje.
English: 2132JH HOOFDDORP NETHERLANDS
Croatian: 2132 JH HOOFDDORP NIZOZEMSKA
English: No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver).
Croatian: Nisu bili primijećeni novi sigurnosni pokazatelji tijekom ispitivanja, a konkretno bortezomib nije pogoršao oštećenja ciljnih organa (srce, bubreg i jetra).
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Croatian: Za neklinička ispitivanja kardiovaskularne sigurnosne farmakologije vidjeti dio 5.3.
English: Special handling instructions
Croatian: Posebne upute za rukovanje
English: Cycles 1 to 4
Croatian: 1. do 4. ciklus
English: Surgical and medical procedures
Croatian: Operativni i medicinski postupci
English: For these dose cohorts, the combined 1-year survival rate was 88.1%.
Croatian: U ovim kohortama prema dozi, kombinirana stopa jednogodišnjeg preživljavanja iznosila je 88,1 %.
English: Posterior Reversible Encephalopathy Syndrome (PRES)
Croatian: Posterior Reversible Encephalopathy Syndrome)
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Croatian: Tablica 14: Sažetak ishoda bolesti u ispitivanjima faze III (APEX) i faze II Faza III
English: Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Croatian: Zbog ovog ranog prelaska na drugi lijek, medijan trajanja praćenja preživjelih bolesnika bio je 8,3 mjeseca.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Croatian: Temelj za izradu Tablice 7 bila je verzija 14.1 MedDRA-e.
English: Table 8 has been generated using Version 16 of the MedDRA.
Croatian: Temelj za izradu Tablice 8 bila je verzija 16 MedDRAe.
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Croatian: Venska injekcija daje se brzo tijekom 3 do 5 sekundi.
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Croatian: 1. stupanj (asimptomatski; gubitak dubokih tetivnih refleksa ili parestezija) bez bolova ili gubitka funkcije
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Croatian: Bolesnici koji postignu odgovor ili stabilnu bolest nakon 4 ciklusa tijekom ovog kombiniranog liječenja mogu nastaviti primati istu kombinaciju tijekom maksimalno 4 dodatna ciklusa.
English: A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
Croatian: Skupina bolesnika na dijalizi koji su primali dozu nakon dijalize također je bila uključena u ispitivanje (n=8).
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Croatian: Faktori stimulacije kolonija granulocita mogu se primijeniti za hematološku toksičnost sukladno lokalnoj standardnoj praksi.
English: Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Croatian: Zadržavanje tekućine može biti predisponirajući čimbenik za pojavu znakova i simptoma zatajenja srca.
English: The teratogenic potential of bortezomib has not been fully investigated.
Croatian: Teratogeni potencijal bortezomiba nije u potpunosti istražen.
English: Day -- -- Day
Croatian: Dan -- -- Dan
English: The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Croatian: Rekonstituirana otopina je bistra i bezbojna, s konačnim pH od 4 do 7.
English: Bortezomib SUN should not be used in children and adolescents because it is not known how the medicine will affect them.
Croatian: Bortezomib SUN se ne smije primjenjivati kod djece i adolescenata jer nije poznato kako će lijek utjecati na njih.
English: This minimises the effects of observed confounders when estimating treatment effects using non-randomised data.
Croatian: Ovo umanjuje učinke uočenih zbunjujućih čimbenika kada se procjenjuje učinak liječenja koristeći nerandomizirane podatke.
English: If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Croatian: Ako ste u prošlosti imali infekciju hepatitisom B, liječnik će Vas pažljivo pregledati na znakove aktivnog hepatitisa B.
English: Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Croatian: Nisu provedena ispitivanja utjecaja na plodnost, ali napravljena je procjena reproduktivnih tkiva u ispitivanjima opće toksičnosti.
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Croatian: Preporučeno je da bolesnici s najmanje parcijalnim odgovorom prime 2 dodatna ciklusa.
English: Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Croatian: Budući da bolesnici s neutropenijom imaju povećan rizik od infekcija, oni se moraju nadzirati na znakove i simptome infekcije, te što prije liječiti.
English: In this case, the duration of a treatment cycle is 42 days (6 weeks).
Croatian: U ovom slučaju, trajanje jednog ciklusa liječenja je 42 dana (6 tjedana).
English: Neuropathy has been managed with supportive care and other therapies.
Croatian: Neuropatiju se liječilo potpornim mjerama i drugim terapijama.
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Croatian: Izloženost bortezomibu (prema dozi normalizirani AUC i Cmax) bila je usporediva unutar svih skupina (vidjeti dio 4.2).
English: Hyde Park, Hayes 3
Croatian: Millington Road 11 Hyde Park, Hayes 3
English: Antiviral prophylaxis should be considered.
Croatian: Mora se uzeti u obzir antivirusna profilaksa.
English: Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area).
Croatian: Vaš će liječnik izračunati dozu Bortezomib SUN-a prema vašoj visini i težini (površini tijela).
English: From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Croatian: S mikrobiološkog gledišta, rekonstituirana otopina se mora primijeniti odmah nakon pripreme.
English: Similar proportions of patients had creatinine clearance ≤30 ml/min (3% in each arm).
Croatian: Slični udjeli bolesnika imali su klirens kreatinina ≤ 30 ml/min (3 % u svakoj skupini).
English: The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Croatian: Primarna mjera ishoda bio je najbolje potvrđen odgovor na liječenje procijenjen prema EBMT kriterijima.
English: The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
Croatian: 26S proteasom je veliki proteinski kompleks koji razgrađuje ubikvitinirane proteine.
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Croatian: Kratice: SGOT = serumska glutamat oksaloacetat transaminaza;
English: The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Croatian: Medijan trajanja liječenja bio je 24,0 tjedna, i medijan broja primljenih ciklusa liječenja bio je 6,0, te je bio dosljedan unutar liječenih skupina.
English: The reported efficacy data are considered inconclusive (see section 4.2).
Croatian: Prijavljeni podaci o djelotvornosti smatraju se neuvjerljivima (vidjeti dio 4.2).
English: Table 11: Efficacy results following the final survival update to VISTA study
Croatian: Tablica 11: Rezultati djelotvornosti nakon finalnog ažuriranja podataka o preživljenju u ispitivanju VISTA
English: Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Croatian: Sveukupno, bortezomib je primijenjen za liječenje multiplog mijeloma u 3974 bolesnika.
English: The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Croatian: Cmax nakon supkutane primjene (20,4 ng/ml) bila je niža nego kod intravenske primjene (223 ng/ml).
English: This 21-day period (3 weeks) corresponds to one treatment cycle.
Croatian: Ovo razdoblje od 21 dana (3 tjedna) odgovara jednom ciklusu liječenja.
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Croatian: Učinkovito ponovno uvođenje režima kemoterapije s više lijekova bilo je primijenjeno u 3 bloka.
English: Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Croatian: Takve promjene mogu biti reverzibilne nakon prekida liječenja bortezomibom (vidjeti dio 4.8).
English: Decreased appetite
Croatian: Vrlo često Smanjeni apetit
English: Congenital, familial and genetic disorders
Croatian: Prirođeni, obiteljski i genetski poremećaji
English: Time related events
Croatian: Odnos događaja i vremena
English: and 32.
Croatian: Dan 22
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib SUN must be considered unless the benefit of treatment clearly outweighs the risk.
Croatian: Ako se toksičnost ne povuče ili se ponovno pojavi pri najnižoj dozi, mora se razmotriti prestanak primjene Bortezomib SUN-a, osim ako je korist od liječenja neupitno veća od rizika.
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Croatian: U šestomjesečnom ispitivanju na štakorima primijećeni su degenerativni učinci na testise i jajnike.
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Croatian: Dodatno, ishodi djelotvornosti povezani sa sekundarnim odgovorom i vremenom do događaja pokazali su dosljedne rezultate za supkutanu i intravensku primjenu (Tablica 15).
English: The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Croatian: Ukupno vrijeme čuvanja rekonstituiranog lijeka prije primjene ne smije prijeći 8 sati.
English: NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Croatian: NF-kB je transkripcijski čimbenik čija je aktivacija potrebna za mnoge aspekte tumorigeneze, uključujući rast i preživljenje stanica, angiogenezu, interakcije između stanica i metastaze.
English: Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Croatian: Na temelju ispitivanja na životinjama čini se da je prolazak bortezomiba kroz krvno-moždanu barijeru ograničen, ako uopće postoji, a važnost tog nalaza za ljude nije poznata.
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Croatian: Finalno ažuriranje podataka o preživljenju napravilo se uz medijan praćenja od 60,1 mjeseci.
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Croatian: Demografske karakteristike bolesnika, te osnovne karakteristike bolesti bile su slične među liječenim skupinama.
English: Acute diffuse infiltrative pulmonary and pericardial disease.
Croatian: Akutna difuzna infiltrativna plućna i perikardijalna bolest.
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Croatian: Bolesnici koji su prethodno primili 2 do 3 terapijske sheme imali su stopu odgovora od 32 % (10/32), a bolesnici koji su prethodno primili više od 7 terapijskih shema imali su stopu odgovora od 31 % (21/67).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX32.
Croatian: Farmakoterapijska skupina: Antineoplastični lijekovi, ostali antineoplastici, ATK oznaka: L01XX32.
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Croatian: Međutim, srednje vrijednosti AUC normalizirane prema dozi bile su povećane za približno 60 % u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
English: Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Croatian: Inhibicijom 26S proteasoma sprječava se ova ciljana proteoliza i utječe na višestruku kaskadu signala unutar stanica, što naposljetku rezultira smrću stanica raka.
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant Group.
Croatian: U populaciji s refraktornom bolešću u ispitivanju faze II, odgovore na liječenje je utvrdilo neovisno ocjenjivačko povjerenstvo, a odgovor se procjenjivao prema kriterijima Europske skupine za presađivanje koštane srži.
English: A minority of patients with orthostatic hypotension experienced syncopal events.
Croatian: Manjina bolesnika s ortostatskom hipotenzijom doživjela je sinkope.
English: Phase III
Croatian: Faza III
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Croatian: Većina slučajeva PML-a bila je dijagnosticirana unutar 12 mjeseci od primjene prve doze bortezomiba.
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Croatian: Incidencija smrti od „Progresije bolesti” bila je 18 % u supkutanoj skupini i 9 % u intravenskoj skupini.
English: Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Croatian: Bolesnici čije razine paraproteina nastave padati nakon 8 ciklusa, također mogu nastaviti liječenje sve dok ga podnose i dok imaju odgovor.
English: Posology modification or delay
Croatian: Prilagodba ili odgađanje doziranja
English: There was no evidence of cumulative thrombocytopenia.
Croatian: Nije bilo dokaza kumulativne trombocitopenije.
English: Macrophage activation
Croatian: Aktivacija makrofaga
English: Bortezomib SUN dose.
Croatian: Bortezomib SUN-a.
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Croatian: U slučaju pojave novih ili pogoršanja postojećih plućnih simptoma (npr. kašalj, dispneja), bolesnicima se mora napraviti brza dijagnostička obrada, te ih je potrebno liječiti na odgovarajući način.
English: One hundred and twenty seven matched pairs of patients were identified.
Croatian: Identificirano je 127 odgovarajućih parova.
English: The duration of a treatment cycle is 21 days (3 weeks).
Croatian: Trajanje ciklusa liječenja je 21 dan (3 tjedna).
English: Response parameters as well as TTP remained significantly better for bortezomib independently of age.
Croatian: Parametri odgovora kao i TTP ostali su značajno bolji u skupini koja je primala bortezomib neovisno o dobi.
English: BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Croatian: BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onom zabilježenom u odraslih.
English: Bortezomib SUN must be reconstituted by a healthcare professional (see section 6.6).
Croatian: Bortezomib SUN mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
English: Electrocardiogram investigations
Croatian: Elektrokardiogramske pretrage
English: By interfering with their function, bortezomib can kill cancer cells.
Croatian: Utječući na njihove funkcije, bortezomib može uništiti stanice raka.
English: If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
Croatian: Ako se sumnja na PML, bolesnika je potrebno uputiti na specijalistički pregled, te započeti odgovarajuće dijagnostičke postupke za PML.
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below.
Croatian: Nuspojave identificirane poput onih s incidencijom ≥ 1 %, slične ili veće incidencije u BzmbR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BzmbRCAP navedene su u Tablici 8 ispod.
English: Overall, the literature results are suggestive of a possible causal association between bortezomib (and other proteasome inhibitors) and TMA.
Croatian: Sveukupno, literaturni rezultati upućuju na moguću uzročnu povezanost između bortezomiba (i drugih inhibitora proteasoma) i TMA.
English: • need to handling the medicinal product in sterile setting
Croatian: • neophodnost rukovanja lijekom u sterilnim uvjetima
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Croatian: Bolesnike je potrebno redovito pratiti radi mogućnosti pojave novih ili pogoršanja postojećih neuroloških simptoma ili znakova koji mogu upućivati na PML, kao dio diferencijalne dijagnoze problema SŽS-a.
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Croatian: Liječenje ortostatske/posturalne hipotenzije može uključivati prilagodbu antihipertenzivnih lijekova, rehidraciju ili primjenu mineralokortikoida i/ili simpatomimetika.
English: Treatment with Bortezomib SUN can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Croatian: Liječenje Bortezomib SUN-om vrlo često može uzrokovati smanjenje broja crvenih i bijelih krvnih stanica i krvnih pločica (trombocita) u krvi.
English: Frequencies are defined as: 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: Učestalost se definira kao: 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: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Croatian: Bolesnici koji postignu potpuni odgovor mogu nastaviti liječenje tijekom najmanje 2 ciklusa nakon prvog dokaza potpunog odgovora, čak i ako to zahtjeva liječenje u više od
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Croatian: Preporučuje se nošenje rukavica i druge zaštitne odjeće kako bi se spriječio dodir s kožom.
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Croatian: Doziranje pri liječenju progresivnog multiplog mijeloma (bolesnici koji su prethodno primili barem jednu liniju liječenja)
English: Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Croatian: Liječenje bortezomibom vrlo je često povezano s perifernom neuropatijom, koja je pretežno senzorna.
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Croatian: Podaci ispitivanja in vitro, ex-vivoi na životinjskim modelima pokazuju da bortezomib povećava diferencijaciju i aktivnost osteoblasta i inhibira funkciju osteoklasta.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Croatian: Bez obzira na razine β2-mikroglobulina na početku ispitivanja, svi parametri djelotvornosti (vrijeme do progresije i ukupno preživljenje, kao i stopa odgovora) bili su značajno bolji u skupini koja je primala bortezomib.
English: In addition, following a search of the worldwide medical and scientific literature carried out for the period covered by this PSUSA and a number of papers reporting safety information, 35 cases of Thrombotic Microangiopathy (TMA) were retrieved.
Croatian: Dodatno, nakon pregleda svjetske medicinske i znanstvene literature provedenog za razdoblje koje pokriva ova PSUSA i niza radova s izvješćima o sigurnosnim informacijama, nađeno je 35 slučajeva trombotičke mikroangiopatije (TMA).
English: Common Vertigo*
Croatian: Vertigo*
English: After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Croatian: Nakon korekcije za BSA učinak, drugi demografski podaci poput dobi, tjelesne težine i spola nisu imali klinički značajne učinke na klirens bortezomiba.