FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Croatian: Ispitivanja kardiovaskularne sigurnosne farmakologije u majmuna i pasa pokazala su da su intravenske doze koje su približno dva do tri puta veće od preporučene kliničke doze izražene na temelju mg/m2 povezane s povećanjem broja otkucaja srca, smanjenjem kontraktilnosti, hipotenzijom i smrću.
English: White to off-white lyophilized powder or cake.
Croatian: Bijeli do gotovo bijeli liofilizirani prašak ili kolačić.
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Croatian: Bortezomibom posredovana inhibicija proteasoma utječe na stanice raka na više načina, uključujući između ostaloga, iako to nije jedini način, i promjenu regulacijskih proteina koji kontroliraju odvijanje staničnog ciklusa i aktivaciju nuklearnog faktora kappa B (NF-kB).
English: By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Croatian: Prema multivarijantnoj analizi, stopa odgovora nije ovisila o vrsti mijeloma, funkcionalnom stanju, deleciji kromosoma 13 ili broju i vrsti prethodnih liječenja.
English: Of those, 121 cases reported chalazion, blepharitis, meibomianitis, and/or Meibomian gland dysfunction.
Croatian: Među njima, u 121 slučaju prijavljen je halacion, blefaritis, meibomianitis i/ili disfunkcija Meibomove žlijezde.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Croatian: Planom ispitivanja definirana prijevremena analiza (temeljeno na 249 TTP događaja) bila je okidač za prijevremeni završetak ispitivanja djelotvornosti.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Croatian: • prikaz potencijalnih rizika kod primjene uključujući predoziranje, poddoziranje te da je nehotična intratekalna primjena rezultirala smrtnim ishodom
English: Up to 8 cycles of this combination therapy can be administered as long as patients have not progressed and tolerate treatment.
Croatian: Može se primijeniti do 8 ciklusa ovog kombiniranog liječenja sve dok bolesnik ne doživi progresiju i dok podnosi liječenje.
English: Other reported hepatic reactions include increases in liver enzymes, hyperbilirubinaemia, and hepatitis.
Croatian: Druge prijavljene jetrene reakcije uključuju povišenje jetrenih enzima, hiperbilirubinemiju i hepatitis.
English: Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Croatian: Transfuzija trombocita mora se uzeti u obzir kada je klinički prikladna (vidjeti dio 4.2).
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm.
Croatian: Antivirusna profilaksa bila je primijenjena u 137 od 240 bolesnika (57 %) u BzmbR-CAP skupini.
English: Reduction in serum Mprotein populationg n=667
Croatian: Smanjenje serumskog M proteina populacijag n=667
English: Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
Croatian: Bortezomib se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje bortezomibom.
English: If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Croatian: Ako se bortezomib primjenjuje tijekom trudnoće ili ako bolesnica zatrudni za vrijeme primanja ovog lijeka, bolesnicu se mora upozoriti na mogući rizik za fetus.
English: Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Croatian: Bolesnike s oštećenjem bubrega treba pomno pratiti (vidjeti dijelove 4.2 i 5.2).
English: There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group.
Croatian: Postojao je trend prema produženom ukupnom preživljenju u korist BzmbR-CAP skupine; procijenjena stopa 4-godišnjeg preživljenja bila je 53,9 % u R-CHOP skupini i 64,4 % u BzmbR-CAP skupini.
English: The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Croatian: Incidencija periferne neuropatije povećava se u početku liječenja, a primijećeno je da je najveća tijekom 5. ciklusa.
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Croatian: U koncentraciji od 10 μM, bortezomib ne inhibira niti jedan od probranih raznih receptora i proteaza i pokazuje više nego 1500 puta veću selektivnost prema proteasomima nego sljedećem enzimu prema kojem ima afinitet.
English: Most adverse reactions are mild to moderate in nature and are observed throughout treatment.
Croatian: Većina nuspojava je blage do umjerene naravi i bilježe se tijekom cijelog liječenja.
English: Patients diagnosed with PML had prior or concurrent immunosuppressive therapy.
Croatian: Bolesnici kojima je dijagnosticirana PML, prethodno ili konkomitantno su uzimali imunosupresivnu terapiju.
English: Intrathecal administration has resulted in death.
Croatian: Intratekalna primjena dovela je do smrti.
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Croatian: Nema dokaza koji ukazuju da je neophodna prilagodba doze u bolesnika starijih od 65 godina s multiplim mijelomom ili s limfomom plaštenih stanica.
English: There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Croatian: Ukupno je bilo uključeno i procijenjeno na sigurnost 140 bolesnika s ALL ili LL; medijan dobi bio je 10 godina (raspon od 1 do 26).
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Croatian: Talidomid je poznata teratogena djelatna tvar za ljude koja uzrokuje teška po život opasna oštećenja po rođenju.
English: In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Croatian: Dodatno, incidencija perifernih neuropatija stupnja 3 ili više bila je 10 % niža, a stopa prekida primjene zbog perifernih neuropatija bila je 8 % niža za supkutanu skupinu u usporedbi s intravenskom skupinom.
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Croatian: Primarni ishod djelotvornosti bilo je preživljenje bez progresije na temelju ocjene Nezavisnog odbora za procjenu (od engl.
English: If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib SUN you should tell your doctor: - if you think you have hepatitis infection now or have had it in the past.
Croatian: Ako imate limfom plaštenih stanica i uz Bortezomib SUN primate lijek rituksimab morate obavijestiti svog liječnika: - ako mislite da trenutno imate infekciju hepatitisa ili ste je imali u prošlosti.
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Croatian: Primarna mjera ishoda djelotvornosti bila je TTP dok su sekundarne mjere ishoda djelotvornosti bile OS ili ORR (CR+PR), prema kriterijima Europske Skupine za Krv i Transplantaciju Srži (EBMT).
English: In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Croatian: U nekliničkim ispitivanjima bortezomib nije imao učinke na embrionalno/fetalni razvoj štakora i kunića pri najvišim dozama koje su ženke mogle podnijeti.
English: The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Croatian: Put ubikvitin - proteasom igra ključnu ulogu u regulaciji prometa specifičnih proteina i tako održava homeostazu unutar stanica.
English: Cluj-Napoca, Judeţul Cluj România
Croatian: Fabricii nr 124 Cluj-Napoca, Judeţul Cluj
English: • that Bortezomib SUN is to be given only by IV or SC injections; no other route of administration is allowed
Croatian: • Bortezomib SUN se primjenjuje samo putem i.v. ili s.c. injekcije; bilo koji drugi put primjene nije dozvoljen
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Croatian: Budite sigurni da primjenjujete ispravnu dozu za intravenski put primjene (1 mg/ml).
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Croatian: Ukupna najbolja stopa odgovora (CR + PR), na ponovljeno liječenje u 130 bolesnika, bila je 38,5 % (95 % CI: 30,1, 47,4).
English: No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Croatian: Nisu dostupne informacije o mogućim posljedicama ili stopama povlačenja periferne neuropatije u ovom ispitivanju.
English: Proteasomes play an important role in controlling cell function and growth.
Croatian: Proteasomi imaju važnu ulogu u kontroliranju staničnih funkcija i rasta stanica.
English: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Croatian: Suicidalne misli*, poremećaj prilagodbe, delirij, smanjen libido
English: Cases of ileus have been uncommonly reported (see section 4.8).
Croatian: Manje su česti prijavljeni slučajevi ileusa (vidjeti dio 4.8).
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Croatian: - Potvrdite dozu i koncentraciju lijeka u štrcaljki prije primjene (provjerite da je štrcaljka označena za intravensku primjenu).
English: Herpes zoster virus reactivation
Croatian: Reaktivacija virusa herpes zoster
English: Pregnancy and breast-feeding You should not use Bortezomib SUN if you are pregnant, unless clearly necessary.
Croatian: Trudnoća i dojenje Bortezomib SUN se ne smije primjenjivati ako ste trudni, osim ako to nije izričito neophodno.
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone.
Croatian: Slične incidencije ovih događaja u obje skupine, ukazale su na to da se ove nuspojave ne mogu pripisati samom bortezomibu.
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Croatian: Talidomid je kontraindiciran tijekom trudnoće i u žena s reproduktivnim potencijalom osim ako nisu postignuti svi uvjeti talidomidskog programa prevencije trudnoće Celgene.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and
Croatian: U slučaju predoziranja potrebno je pratiti vitalne znakove bolesnika te im pružiti odgovarajuće potporne mjere za održavanje krvnog tlaka (kao što je tekućina, presorni lijekovi i/ili inotropni lijekovi) i tjelesne temperature (vidjeti dijelove 4.2 i 4.4).
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Croatian: Sekundarne mjere ishoda djelotvornosti uključile su posttransplantcijske stope odgovora (CR+nCR, CR+nCR+VGPR+PR), preživljenje bez progresije i ukupno preživljenje.
English: Peri- and postnatal development studies were not conducted.
Croatian: Nisu provedena ispitivanja utjecaja na perinatalni i postnatalni razvoj.
English: What Bortezomib SUN is and what it is used for
Croatian: Što je Bortezomib SUN i za što se koristi
English: Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Croatian: Potrebno je potvrditi normalnu funkciju jetre i s oprezom pristupiti bolesnicima koji uzimaju oralne hipoglikemike (vidjeti dio 4.5).
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Croatian: Bolesnike se mora uputiti da potraže liječnički savjet ako osjete simptome omaglice, ošamućenosti ili nesvjestice.
English: The resulting solution is then either injected into a vein or under the skin.
Croatian: Ta se otopina zatim daje injekcijom ili u venu ili pod kožu.
English: Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - krvni ugrušak u malim krvnim žilama (trombotička mikroangiopatija).
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe).
Croatian: * Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
English: In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Croatian: U BzmbTDx skupini 12 % bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16 % bolesnika u TDx skupini.
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Croatian: Incidencija smrti za vrijeme liječenja bila je 5 % u skupini liječenoj supkutano a 7 % u skupini liječenoj intravenski.
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Croatian: Stotinu i trideset bolesnika (≥ 18 godina starosti) s multiplim mijelomom koji su prethodno imali barem parcijalan odgovor na režim koji je uključivao bortezomib bilo je ponovno liječeno nakon progresije.
English: Rest period
Croatian: Period odmora
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Croatian: Periferna neuropatija stupnja ≥3 pojavila se kod 6 % bolesnika u skupini liječenoj supkutano, u usporedbi sa 16 % u skupini liječenoj intravenski (p=0,0264).
English: ≤ 1.0 x ULN
Croatian: ≤ 1,0 x GGN
English: Patients with risk factors for or existing heart disease should be closely monitored.
Croatian: Bolesnike s čimbenicima rizika za razvoj ili s postojećom bolešću srca mora se pomno pratiti.
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Croatian: Sekundarne mjere ishoda uključile su preživljenje bez progresije i ukupno preživljenje.
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Croatian: Ovo ispitivanje doseglo je svoj primarni cilj, neinferiornost u stopi odgovora (CR+PR) nakon 4 ciklusa samostalno primijenjenog bortezomiba za oba puta primjene, i supkutano i intravenski, 42 % u obje skupine.
English: Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Croatian: Također su uključene nuspojave identificirane u skupini BzmbRCAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
English: - The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: - Rekonstituirana otopina primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Croatian: Autologne transplantate matičnih stanica primilo je 198 (82 %) bolesnika odnosno 208 (87 %) bolesnika u VDDx i BzmbDx skupinama; većina bolesnika prošla je jednu transplantaciju.
English: What Bortezomib SUN is and what it is used for What you need to know before you are given Bortezomib SUN How to use Bortezomib SUN
Croatian: Što je Bortezomib SUN i za što se koristi Što morate znati prije nego što počnete primati Bortezomib SUN
English: Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Croatian: Pokusi su pokazali da je bortezomib citotoksičan za razne vrste stanica raka i da su stanice raka osjetljivije od normalnih stanica na proapoptotičke učinke inhibicije proteasoma.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, 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 bortezomib, znanstveni zaključci CHMP-a su sljedeći:
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
Croatian: • upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom kod transplantiranih bolesnika (Bortezomib SUN plus deksametazon i Bortezomib SUN plus deksametazon i talidomid).
English: Based on this review, chalazion/blepharitis is considered associated with the use of bortezomib.
Croatian: Na temelju ovog pregleda, halacion/blefaritis se smatraju povezanima s primjenom bortezomiba.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Croatian: Kada se primjenjuje talidomid, potrebna je posebna pažnja vezana uz mjere prevencije i testiranje na trudnoću (vidjeti Trudnoća i dojenje u ovom dijelu).
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Croatian: Kinetika inhibicije proteasoma ocjenjivala se in vitroi pokazalo se da se bortezomib razdvaja od proteasoma uz t½ od 20 minuta, pokazujući tako da je inhibicija proteasoma bortezomibom reverzibilna.
English: May be fatal if given by other routes.
Croatian: Primjena drugim putevima primjene može biti smrtonosna.
English: These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Croatian: Ovi su učinci bili primijećeni u bolesnika s multiplim mijelomom koji su imali uznapredovalu osteolitičku bolest i liječili su se bortezomibom.
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Croatian: Periferna neuropatija svih stupnjeva i periferna neuropatija stupnja ≥ 3 bile su uočene u 40 % odnosno 8,5 % bolesnika.
English: - Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Croatian: Nakon što je otopljena, povucite odgovarajuću količinu rekonstituirane otopine prema dozi izračunatoj na temelju bolesnikove površine tijela.
English: Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Croatian: Budite sigurni da primjenjujete ispravnu dozu za supkutani put primjene (2,5 mg/ml).
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Croatian: On je posebno oblikovan da inhibira aktivnost poput kimotripsina 26S proteasoma u stanicama sisavaca.
English: Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
Croatian: I u bolesnika koji su bili refraktorni na zadnje prethodno liječenje i onih koji nisu bili refraktorni, ukupno preživljavanje bilo je značajno dulje i stopa odgovora bila je značajno viša u skupini koja je primala bortezomib.
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Croatian: Nositelji hepatitisa B i bolesnici s hepatitisom B u anamnezi moraju se strogo nadzirati na kliničke i laboratorijske znakove aktivne infekcije HBV-om tijekom i nakon kombiniranog liječenja rituksimabom i bortezomibom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja bortezomiba u svim podskupinama pedijatrijske populacije u multiplom mijelomu i u limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: - When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Croatian: - Kada se Bortezomib SUN primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Croatian: Na osnovi ograničenog doprinosa (7 %) enzima CYP2D6 metabolizmu bortezomiba, ne očekuje se da će fenotip slabog CYP2D6 metabolizatora utjecati na cjelokupnu raspoloživost bortezomiba.
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Croatian: Ukupna incidencija proljeva, gastrointestinalne i abdominalne boli, astenijskih stanja, infekcija gornjih dišnih putova i perifernih neuropatija, bila je 12 % - 15 % niža u skupini supkutane primjene nego u intravenskoj skupini.
English: In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Croatian: U pasa su smanjena srčana kontraktilnost i hipotenzija reagirale na akutnu intervenciju primjene lijekova s pozitivnim inotropnim učinkom ili presornih lijekova.