FrancophonIA/ELRC3.0 huggingface dataset:
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to VELCADE alone.
Croatian: Slične incidencije ovih događaja u obje skupine, ukazale su na to da se ove nuspojave ne mogu pripisati samom lijeku VELCADE.
English: Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Croatian: Liječenje lijekom VELCADE vrlo često može uzrokovati smanjenje broja crvenih i bijelih krvnih stanica i krvnih pločica (trombocita) u krvi.
English: Pregnancy and breast-feeding You should not use VELCADE if you are pregnant, unless clearly necessary.
Croatian: Trudnoća i dojenje VELCADE se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
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-vivo i na životinjskim modelima pokazuju da bortezomib povećava diferencijaciju i aktivnost osteoblasta i inhibira funkciju osteoklasta.
English: • Disorders that affect your lungs, preventing your body from getting enough oxygen.
Croatian: • poremećaji koji djeluju na pluća, i tako onemogućuju dostupnost dovoljne količine kisika vašem tijelu.
English: Time to first response in CR + PR Median
Croatian: Vrijeme do prvog odgovora u CR + PR Medijan
English: 9/l and the absolute neutrophils count should be ≥ 1.0 x 10
Croatian: 9/l, a apsolutni broj neutrofila mora biti ≥ 1,0 x 10
English: • Weight increase
Croatian: • povećanje težine
English: Day 22
Croatian: 22. dan
English: Response parameters as well as TTP remained significantly better for VELCADE independently of age.
Croatian: Parametri odgovora kao i TTP ostali su značajno bolji u skupini koja je primala VELCADE neovisno o dobi.
English: Since dialysis may reduce bortezomib concentrations, VELCADE should be administered after the dialysis procedure (see section 5.2).
Croatian: Budući da dijaliza može smanjiti koncentracije bortezomiba, VELCADE treba primijeniti nakon postupka dijalize (vidjeti dio 5.2).
English: What you need to know before you use VELCADE
Croatian: Što morate znati prije nego počnete primjenjivati VELCADE
English: Incidence of PN (%) All GradePN  Grade 2 PN  Grade 3 PN
Croatian: Incidencija PN (%) Svi stupnjevi PN ≥ Stupanj 2 PN ≥ Stupanj 3 PN
English: Your doctor will work out your dose of VELCADE according to your height and weight (body surface area).
Croatian: Vaš će liječnik izračunati dozu lijeka VELCADE prema vašoj visini i težini (površini tijela).
English: 56.4 mo
Croatian: 56,4 mjeseca
English: Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Croatian: Liječenje lijekom VELCADE vrlo je često povezano s perifernom neuropatijom, koja je pretežno senzorna.
English: Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Croatian: Log rank test prilagođen za čimbenike stratifikacije: ISS stupnjevanje i broj prethodnih linija.
English: • Altered level of consciousness, confusion
Croatian: • promijenjena razina svijesti, smetenost
English: At 10 M 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 M, 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: Weight decreased
Croatian: Smanjena težina
English: • Genital pain, problem having an erection
Croatian: • bol spolnih organa, poteškoće s postizanjem erekcije
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
Croatian: Antivirusna profilaksa bila je primijenjena u 137 od 240 bolesnika (57%) u VcR-CAP skupini.
English: • Changes in or abnormal bowel function
Croatian: • promjene funkcije ili abnormalna funkcija crijeva
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
Croatian: • infekcija vanjskog sloja oka i unutarnje površine kapaka (konjuktivitis)
English: • The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: • Pripremljena otopina primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: Cases of ileus have been uncommonly reported (see section 4.8).
Croatian: Manje često su prijavljeni slučajevi ileusa (vidjeti dio 4.8).
English: The observed final median difference in the OS between the 2 treatment groups was 35 months.
Croatian: Zapažena razlika konačnih medijana ukupnog preživljenja između 2 liječene skupine bila je 35 mjeseci.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Croatian: Stoga se ne preporučuje ovaj kombinirani režim s istodobnom primjenom visokih doza citarabina (2g/m2 na dan) kontinuiranom infuzijom u trajanju od 24 sata.
English: • Platelet counts should be ≥ 70 x 10
Croatian: • Broj trombocita mora biti ≥ 70 x 10
English: Name and address of the manufacturer responsible for batch release Janssen Pharmaceutica NV
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Janssen Pharmaceutica NV
English: • Blood clot in small blood vessels (thrombotic microangiopathy)
Croatian: • krvni ugrušak u malim krvnim žilama (trombotička mikroangiopatija)
English: It is recommended that patients receive 2 cycles of VELCADE following a confirmation of a complete response.
Croatian: Preporučuje se da bolesnici prime još 2 ciklusa liječenja lijekom VELCADE nakon potvrđenog kompletnog odgovora.
English: What VELCADE looks like and contents of the pack VELCADE powder for solution for injection is a white to off-white cake or powder.
Croatian: Kako VELCADE izgleda i sadržaj pakiranja VELCADE prašak za otopinu za injekciju je bijeli do gotovo bijeli kolačić ili prašak.
English: Progressive multiple myeloma
Croatian: Progresivni multipli mijelom
English: The final analysis for OS was performed after a median follow-up of 82 months.
Croatian: Konačna analiza ukupnog preživljenja bila je provedena nakon medijana praćenja od 82 mjeseca.
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/m povezane s povećanjem broja otkucaja srca, smanjenjem kontraktilnosti, hipotenzijom i smrću.
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Croatian: Sekundarni ishod djelotvornosti uključio je posttransplantacijske stope odgovora (CR+nCR, CR+nCR+VGPR+PR), preživljenje bez progresije i ukupno preživljenje.
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: What VELCADE is and what it is used for What you need to know before you use VELCADE How to use VELCADE
Croatian: Što je VELCADE i za što se koristi Što morate znati prije nego počnete primjenjivati VELCADE Kako primjenjivati VELCADE Moguće nuspojave
English: Neuropathic pain and/or peripheral neuropathy
Croatian: Neuropatska bol i/ili periferna neuropatija
English: NA=not applicable, NE=not estimated TTP-Time to Progression
Croatian: NA=nije primjenjivo, NE=nije procijenjeno
English: Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Croatian: Tablica 11: Rezultati djelotvornosti nakon finalnog ažuriranja podataka o preživljenju u ispitivanju VISTA Ishod djelotvornosti
English: VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Croatian: VELCADE je bio primijenjen samo u 1. i 2.bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u bloku 3.
English: Hepatic enzyme abnormality*
Croatian: Abnormalni jetreni enzimi*
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: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Croatian: Suicidne misli*, poremećaj prilagodbe, delirij, smanjen libido
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: 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: • that VELCADE is to be given only by IV or SC injections; no other route of administration is allowed
Croatian: • VELCADE se primjenjuje samo putem i.v. ili s.c. injekcije; bilo koji drugi put primjene nije dozvoljen
English: • Reduction in the number of red blood cells and or white blood cells (see above)
Croatian: • smanjenje broja crvenih i/ili bijelih krvnih stanica (vidjeti iznad)
English: • memory loss, trouble thinking, difficulty with walking or loss of vision.
Croatian: • gubitak memorije, poteškoće pri razmišljanju, poteškoće pri hodu ili gubitak vida.
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 4.4).
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: You will receive 9 cycles (54 weeks).
Croatian: Primit ćete 9 ciklusa (54 tjedna).
English: Leukopenia*, Lymphopenia*
Croatian: Leukopenija*, limfopenija *
English: VELCADE should not be administered intrathecally.
Croatian: VELCADE se ne smije primijeniti intratekalno.
English: Table 12: Efficacy results from study IFM-2005-01
Croatian: Tablica 12: Rezultati djelotvornosti iz ispitivanja IFM-2005-01
English: If VELCADE 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 VELCADE primjenjuje tijekom trudnoće ili ako bolesnica zatrudni za vrijeme primanja ovog lijeka, bolesnicu se mora upozoriti na mogući rizik za fetus.
English: In the VcTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Croatian: U VcTDx skupini 12% bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16% bolesnika u TDx skupini.
English: • If several VELCADE doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Croatian: • Ako se prekine primjena nekoliko doza lijeka VELCADE u jednom ciklusu (≥ 3 doze tijekom primjene dva puta tjedno ili ≥ 2 doze tijekom primjene jedanput na tjedan)
English: Once weekly VELCADE (cycles 5-9)
Croatian: VELCADE jednom tjedno (5.-9. ciklus)
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 primjerenu količinu rekonstituirane otopine prema dozi izračunatoj na temelju bolesnikove površine tijela.
English: Mannitol (E421), nitrogen
Croatian: manitol (E421), dušik
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 vitro i pokazalo se da se bortezomib razdvaja od proteasoma uz t½ od 20 minuta, pokazujući tako da je inhibicija proteasoma bortezomibom reverzibilna.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and VcDx 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 VcDx skupinama; većina bolesnika prošla je jednu transplantaciju.
English: Rash*, Pruritus*, Erythema, Dry skin
Croatian: Osip*, pruritus*, eritem, suha koža
English: (usually on the legs) to large bruise-like patches under the skin or tissue
Croatian: (obično na nogama) odnosno mrlja u obliku modrica pod kožom ili tkivom
English: • If platelet counts ≤ 30 x 10
Croatian: • Ako je broj trombocita ≤ 30 x 10
English: • Sensitivity to light
Croatian: • preosjetljivost na svjetlo
English: Response Evaluable Population n=73
Croatian: Populacija procjenjiva na odgovor n = 73
English: • Itching of the skin, lumps on the skin or dry skin
Croatian: • svrbež kože, kvržice na koži ili suha koža
English: Overall response (CR+CRu+PR)
Croatian: Ukupni odgovor (CR+CRu+PR)
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 VELCADE arm.
Croatian: I u bolesnika koji su bili refraktorni na zadnje prethodno liječenje i onih koji nisu bili refraktorni, ukupno preživljenje bilo je značajno dulje i stopa odgovora bila je značajno viša u skupini koja je primala VELCADE.
English: The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:
Croatian: Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja lijekom VELCADE u trajanju od 21-dan kao intravenske infuzije:
English: 9/l on a VELCADE dosing day (other than day 1)
Croatian: 9/l na dan primjene doze lijeka VELCADE (osim 1. dana)
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Croatian: • neutropenija ≥ stupnja 3 s vrućicom, neutropenija stupnja 4 koja traje duže od 7 dana, broj trombocita < 10 000 stanica/μL
English: The European Medicines Agency has waived the obligation to submit the results of studies with VELCADE 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 je izuzela obvezu podnošenja rezultata ispitivanja lijeka VELCADE u svim podskupinama pedijatrijske populacije u multiplom mijelomu i u limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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 (VELCADE plus dexamethasone, and VELCADE 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 (VELCADE plus deksametazon i VELCADE plus deksametazon i talidomid).
English: TTP, months (95% CI)
Croatian: TTP, mjeseci (95% CI)
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: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Croatian: Samo bočica od 3,5 mg se smije primijeniti supkutano, što je opisano ispod.
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 VELCADE.
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 lijekom VELCADE.
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: • Increased heartbeat, high blood pressure, sweating,
Croatian: • ubrzani otkucaji srca, visoki krvni tlak, znojenje,
English: The majority of the patients in both groups completed treatment, 80% in the VcR-CAP group and 82% in the R-CHOP group.
Croatian: Većina bolesnika u obje skupine završilo je liječenje, 80% u VcR-CAP skupini i 82% u R-CHOP skupini.
English: Patient demographic and baseline disease charateristics were similar between the treatment groups.
Croatian: Demografske karakteristike bolesnika, te osnovne karakteristike bolesti bile su slične među liječenim skupinama.
English: Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za ne navođenje Braillea.
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: #, Different degrees of visual impairment (up to blindness)*
Croatian: #, različiti stupnjevi oštećenja vida (do sljepoće)*
English: Very Common Decreased appetite
Croatian: Vrlo često Smanjeni apetit Često
English: Regardless of 2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the VELCADE arm.
Croatian: Bez obzira na razine 2-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 VELCADE.
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent VELCADE 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 lijeka VELCADE za oba puta primjene, i supkutano i intravenski, 42% u obje skupine.
English: Vc=VELCADE; M=melphalan, P=prednisone
Croatian: Vc = VELCADE; M = melfalan, P = prednizon
English: • A severe reversible brain condition which includes seizures, high blood pressure, headaches,
Croatian: • teško reverzibilno stanje mozga koje uključuje napadaje, visoki krvni tlak, glavobolje, umor,
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: Based on Kaplan-Meier product limit estimates.
Croatian: Temeljeno na Kaplan-Meierovim procjenama.
English: Uncommon Colitis (inc clostridium difficile)*
Croatian: Manje često Kolitis (uključujući clostridium difficile)*
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: Grade ≥ 3 non-haematological toxicities considered to be related to VELCADE
Croatian: Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s lijekom VELCADE
English: Hazard ratio (95% CI) p-value Response rate population e n=668
Croatian: Omjer hazarda (95% CI) p-vrijednost Stopa odgovora populacija e n = 668
English: • Bacterial and viral infections
Croatian: • bakterijske i virusne infekcije
English: A statistically significant benefit (p < 0.001) in favour of the VcR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Croatian: Statistički značajna korist (p < 0,001) za VcR-CAP liječenu skupinu u odnosu na R-CHOP skupinu bila je zapažena za TTP (medijan 30,5 naspram 16,1 mjesec), TNT (medijan 44,5 naspram 24,8 mjeseci) i TFI (medijan 40,6 naspram 20,5 mjeseci).
English: Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Croatian: Potreban je oprez kad se bortezomib kombinira sa supstratima enzima CYP3A4- ili CYP2C19 (vidjeti dio 4.5).
English: 42.9% and 10.4% of patients in the VcR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Croatian: 42,9% i 10,4% bolesnika u VcR-CAP skupini bilo je u dobi unutar raspona 65-74 godina odnosno ≥ 75 godina starosti.
English: (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching
Croatian: (dodira, sluha, okusa, mirisa), poremećaj pažnje, drhtanje, trzanje mišića
English: When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
Croatian: U usporedbi s bolesnicima s normalnom funkcijom jetre, blago oštećenje funkcije jetre nije promijenilo prema dozi normalizirani AUC bortezomiba.
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Croatian: Prosječno poluvrijeme eliminacije (t1/2) bortezomiba nakon višekratnog doziranja kretao se u rasponu od 40-193 sata.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy.
Croatian: Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije s lijekom VELCADE.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Croatian: Na temelju populacijske farmakokinetičke analize klirens bortezomiba povećava se s porastom površine tijela (engl. body surface area, BSA).
English: You should not breast-feed while using VELCADE.
Croatian: Ne smijete dojiti dok primate VELCADE.