FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Velactis can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Velactis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: A third field study involved 228 dairy cows.
Croatian: Treće terensko ispitivanje obuhvatilo je 228 muznih krava.
English: Cabergoline has a long-lasting action on receptors in these cells (called D2 receptors) that block release of the hormone.
Croatian: Kabergolin ima dugotrajan učinak na receptore u tim stanicama (koji se zovu D2 receptori) koji blokiraju otpuštanje hormona.
English: The European Commission granted a marketing authorisation valid throughout the EU for Velactis on 9 December 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Velactis na snazi u Europskoj uniji od 9. prosinca 2015.
English: By blocking prolactin release in this way, milk production is reduced.
Croatian: Blokiranjem otpuštanja prolaktina na taj način smanjuje se proizvodnja mlijeka.
English: Velactis reduced the incidence of milk leakage to 2% compared to 10.7% in the cows treated with placebo.
Croatian: Velactis je smanjio pojavu curenja mlijeka na 2 % u usporedbi s 10,7 % u krava liječenih placebom.
English: Why is Velactis approved?
Croatian: Zašto je Velactis odobren?
English: What is Velactis and what is it used for?
Croatian: Što je Velactis i za što se koristi?
English: It is not intended to provide practical advice on how to use Velactis.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP Velactis.
English: The withdrawal period for meat from dairy cows treated with Velactis is 23 days.
Croatian: Razdoblje karencije za meso muznih krava liječenih VMP-om Velactis iznosi 23 dana.
English: The withdrawal period for milk from dairy cows treated with Velactis is ‘zero' days, which means there is no mandatory waiting time after calving, if the dry period length is 32 days or more.
Croatian: Razdoblje karencije za mlijeko muznih krava liječenih VMP-om Velactis iznosi „nula” dana, što znači da nema obveznog razdoblja čekanja nakon teljenja ako je suhostaj trajao 32 dana ili više.
English: Velactis cabergoline
Croatian: Velactis kabergolin
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Velactis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Velactis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: As Velactis reduces milk production, breastfeeding women should also avoid contact with the product.
Croatian: Budući da VMP Velactis smanjuje proizvodnju mlijeka, dojilje također trebaju izbjegavati kontakt s proizvodom.
English: This is a summary of the European public assessment report (EPAR) for Velactis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarsko-medicinskom proizvodu Velactis.
English: Pregnant women and women attempting to conceive should avoid contact with Velactis.
Croatian: Trudnice i žene koje pokušavaju zanijeti trebaju izbjegavati kontakt s VMP-om Velactis.
English: People who are hypersensitive (allergic) to cabergoline should avoid contact with Velactis.
Croatian: Osobe koje su preosjetljive (alergične) na kabergolin trebaju izbjegavati kontakt s VMP-om Velactis.
English: The most common side effects with Velactis (which may affect up to 1 in 10 cows) are slight injection site reactions (mostly swellings) after injection of the product which may persist for at least 7 days.
Croatian: Najčešće su nuspojave VMP-a Velactis (mogu se javiti u do 1 na 10 krava) blage reakcije na mjestu injekcije (uglavnom oticanje) nakon ubrizgavanja proizvoda koje mogu potrajati najmanje sedam dana.
English: It contains the active substance cabergoline.
Croatian: Sadržava djelatnu tvar kabergolin.
English: In a second field study involving 263 dairy cows the percentage of Velactis-treated cows with milk leakages during a 14-day period after drying-off was 3.9% compared with 17.6% for the cows treated with placebo.
Croatian: U drugom terenskom ispitivanju, koje je obuhvatilo 263 muzne krave, postotak krava liječenih VMPom Velactis kojima je curilo mlijeko tijekom 14-dnevnog razdoblja nakon zasušivanja iznosio je 3,9 % u usporedbi sa 17,6 % u krava liječenih placebom.
English: In an initial field study with 917 cows, Velactis was given to cows free of subclinical mastitis (inflammation of the udder without visible clinical signs) and in the absence of antimicrobial treatment, showed a 5.5% reduction of new udder infections during the dry period compared to cows treated with placebo (the dummy treatment).
Croatian: U početnom terenskom ispitivanju koje je provedeno na 917 krava Velactis je dan kravama koje nisu imale subklinički mastitis (upalu vimena bez vidljivih kliničkih znakova) i koje nisu primale antimikrobnu terapiju te je pokazao smanjenje od 5,5 % novih infekcija vimena tijekom suhostaja u usporedbi s kravama liječenima placebom (prividnim liječenjem).
English: Milk production is stimulated by a hormone, prolactin, released from specialised cells in the pituitary gland (a small gland attached to the brain).
Croatian: Proizvodnju mlijeka potiče hormon prolaktin koji otpuštaju specijalizirane stanice u hipofizi (mala žlijezda koja se nalazi uz mozak).
English: Velactis treated cows showed reduced discomfort on the first day of drying-off as indicated by increased daily lying time.
Croatian: Krave liječenje VMP-om Velactis pokazale su smanjenu nelagodu prvoga dana zasušivanja, na što ukazuje produljeno razdoblje ležanja tijekom dana.
English: Velactis is a medicine used in the herd management programme of dairy cows as an aid to reduce milk production in dairy cows at the start of the dry period (the period when the cow is not milked before calving and start of the next lactation).
Croatian: Velactis je VMP koji se koristi kao pomoć u planiranom upravljanju stadom muznih krava i kao pomoć pri smanjenju proizvodnje mlijeka u muznih krava na početku suhostaja (razdoblja kada se krava ne muze prije teljenja i početka sljedeće laktacije).
English: Velactis is given as a single injection into the muscle within four hours of the last milking on the day of drying off. Velactis is available as a solution for injection in multidose vials of 5 ml, 25 ml or 50 ml.
Croatian: Velactis je dostupan kao otopina za injekciju u višedoznim bočicama od 5 ml, 25 ml ili 50 ml.
English: What are the risks associated with Velactis?
Croatian: Koji su rizici povezani s VMP Velactis?
English: Other information about Velactis?
Croatian: Ostale informacije o VMP-u Velactis
English: How does Velactis work?
Croatian: Kako djeluje Velactis?
English: How is Velactis used?
Croatian: Kako se Velactis koristi?
English: For practical information about using Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP Velactis vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: It is 4 days (8 milkings) after calving when the dry period length is less than 32 days.
Croatian: Ako je suhostaj trajao kraće od 32 dana, razdoblje karencije iznosi četiri dana (osam mužnji) nakon teljenja.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Velactis, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Velactis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: What benefits of Velactis have been shown in studies?
Croatian: Koje su koristi VMP Velactis utvrđene u ispitivanjima?
English: For more information about treatment with Velactis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Velactis vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: • reduce milk leakage at drying off (the point at which the cow is no longer milked),
Croatian: Velactis se koristi za: smanjenje curenja mlijeka tijekom zasušivanja (točka u kojoj se krave više ne muzu), smanjenje rizika od novih infekcija vimena tijekom suhostaja, smanjenje nelagode.
English: • if you think you have hepatitis infection now or have had it in the past.
Croatian: • ako mislite da trenutno imate infekciju hepatitisa ili ste ju imali u prošlosti.
English: Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Croatian: • proljev: u tom slučaju, važno je da pijete više vode nego inače.
English: For dose adjustments, see Table 5 below.
Croatian: Za prilagodbe doza, vidjeti Tablicu 5 ispod.
English: n: ITT patients
Croatian: n: ITT bolesnici
English: What VELCADE is and what it is used for
Croatian: Što je VELCADE i za što se koristi
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Croatian: Osamnaest posto bolesnika postiglo je ili je imalo poboljšan odgovor [MR (11%) ili PR (7%)] uz kombinirano liječenje.
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Croatian: Temeljeno na ocjeni Nezavisnog odbora za procjenu (IRC) (samo radiološki podaci).
English: • Inability to tolerate alcohol consumption
Croatian: • netolerancija na konzumaciju alkohola
English: • Abnormal reaction to blood transfusions
Croatian: • abnormalna reakcija na transfuziju krvi
English: • Haemoglobin ≥ 8 g/dL
Croatian: • Hemoglobin ≥ 8 g/dL
English: White to off-white cake or powder.
Croatian: Bijeli do gotovo bijel kolačić ili prašak.
English: • Partial or total loss of vision
Croatian: • djelomičan ili potpuni gubitak vida
English: Date of first authorisation: 26 April 2004
Croatian: Datum prvog odobrenja: 26. travnja 2004.
English: CI=Confidence Interval
Croatian: CI = Interval pouzdanosti
English: Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Croatian: Dvoje (1%) bolesnika imalo je teške reakcije; 1 slučaj pruritusa i 1 slučaj crvenila.
English: • Inability to produce enough insulin or resistance to normal levels of insulin
Croatian: • nemogućnost stvaranja dovoljno inzulina ili rezistencija na normalne razine inzulina
English: Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
Croatian: Od 669 uključenih bolesnika, 245 (37%) bilo je u dobi od 65 godina ili starije.
English: VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.
Croatian: VELCADE se ne smije primjenjivati kod djece i adolescenata, jer nije poznato kako će lijek utjecati na njih.
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Croatian: Razmotriti smanjenje doze melfalana za 25% u sljedećem ciklusu.
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: • Hormone abnormality which may affect salt and water absorption
Croatian: • poremećaj hormona koji može utjecati na apsorpciju soli i vode
English: • Death
Croatian: • smrt
English: Date of latest renewal: 10 January 2014
Croatian: Datum posljednje obnove odobrenja: 10. siječnja 2014.
English: • Breakdown of muscle fibers leading to other complications
Croatian: • kidanje mišićnih vlakana koje dovodi do drugih komplikacija
English: Other medicines and VELCADE
Croatian: Drugi lijekovi i VELCADE
English: • Hypersensitivity (allergic reaction)
Croatian: • preosjetljivost (alergijska reakcija)
English: No new safety concerns were observed during the study, and in particular VELCADE did not exacerbate target organ damage (heart, kidney and liver).
Croatian: Nisu bili primijećeni novi sigurnosni pokazatelji tijekom ispitivanja, a konkretno VELCADE nije pogoršao oštećenja ciljnih organa (srce, bubreg i jetra).
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the VcDx group.
Croatian: Medijan trajanja liječenja bio je 13 tjedana za skupinu VDDx i 11 tjedana za VcDx skupinu.
English: The safety and efficacy of VELCADE in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Croatian: Sigurnost i djelotvornost lijeka VELCADE u djece do 18 godina starosti nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
English: Modification of starting dose
Croatian: Prilagodba početne doze
English: • Difficulty or problems in sleeping
Croatian: • poteškoće ili problemi sa spavanjem
English: • Heart problems to include heart attack, angina
Croatian: • tegobe sa srcem uključujući srčani udar, angina
English: • Hair loss and abnormal hair texture
Croatian: • gubitak kose i neuobičajena tekstura dlake
English: Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Croatian: Trajanje liječenja (medijan = 17 tjedana) i trajanje praćenja (medijan = 40 mjeseci) bili su usporedivi u obje liječene skupine.
English: Haematological toxicity during a cycle
Croatian: Hematološka toksičnost tijekom ciklusa
English: VELCADE must be reconstituted by a healthcare professional (see section 6.6).
Croatian: VELCADE mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
English: Overall, VELCADE was administered for the treatment of multiple myeloma in 3,974 patients.
Croatian: Sveukupno, VELCADE je primijenjen za liječenje multiplog mijeloma u 3974 bolesnika.
English: Your doctor may give you another medicine to control diarrhoea
Croatian: Liječnik će Vam možda dati još neki lijek da kontrolira proljev
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Croatian: Nemojte voziti niti rukovati alatima ili strojevima ako imate takve nuspojave; čak i ako ih ne osjećate, i dalje morate biti na oprezu.
English: Reduction in serum M-protein population g n=667
Croatian: Smanjenje serumskog M proteina populacija g n = 667
English: Most cases of PML were diagnosed within 12 months of their first dose of VELCADE.
Croatian: Većina slučajeva PMLa bila je dijagnosticirana unutar 12 mjeseci od primjene prve doze lijeka VELCADE.
English: Do not use VELCADE - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Croatian: Nemojte primjenjivati VELCADE - ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate određene teške plućne ili srčane tegobe.
English: • Constipation with or without bloating (can be severe)
Croatian: • zatvor sa ili bez nadutosti (može biti težak)
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
English: Table 8 has been generated using Version 16 of the MedDRA.
Croatian: Temelj za izradu tablice 8 bila je verzija 16 MedDRAe.
English: • Insufficient circulation
Croatian: • nedostatna cirkulacija
English: Median duration of follow up is 11.8 months
Croatian: Medijan trajanja praćenja je 11,8 mjeseci
English: • Skin reactions and disorders (which may be severe and life threatening), skin ulcers
Croatian: • kožne reakcije i poremećaji (koji mogu biti teški i opasni po život), čirevi na koži
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Croatian: U svakoj zemlji članici, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Croatian: Temelj za izradu tablice 7 bila je verzija 14.1 MedDRAe.
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 8 ciklusa.
English: For these dose cohorts, the combined 1-year survival rate was 88.1%.
Croatian: U ovim kohortama prema dozi, kombinirana stopa jednogodišnjeg preživljenja iznosila je 88,1%.
English: Elderly MCL patients
Croatian: Stariji bolesnici s MCL-om
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx group and 52/242 [21%] in VDDx group).
Croatian: Odnosi se na stope odgovora nakon druge transplantacije za ispitanike koji su prošli drugu transplantaciju (42/240 [18% ] u VcDx skupini i 52/242 [21%] u VDDx skupini).
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Croatian: BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onim zabilježenim u odraslih.
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Croatian: Za neklinička ispitivanja kardiovaskularne sigurnosne farmakologije, vidjeti dio 5.3.
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: An effective re-induction multi-agent chemotherapy regimen was administered in 3 blocks.
Croatian: Učinkovito ponovno uvođenje režima kemoterapije s više lijekova bilo je primijenjeno u 3 bloka.
English: • Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
Croatian: • Budd-Chiarijev sindrom (klinički simptomi uzrokovani začepljenjem jetrenih vena)
English: When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Croatian: Kada se VELCADE primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).
English: (CrCL=20-39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Croatian: (CrCL = 20-39 ml/min/1,73 m2, n = 9) i teško (CrCL < 20 ml/min/1,73 m2, n = 3).
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: • Injuries
Croatian: • ozljede
English: • High or low blood pressure
Croatian: • visoki ili niski krvni tlak
English: • Wasting, or loss of body mass
Croatian: • opadanje ili gubitak tjelesne mase
English: VELCADE is for single use only.
Croatian: VELCADE je samo za jednokratnu primjenu.
English: • low numbers of red or white blood cells
Croatian: • snižen broj crvenih ili bijelih krvnih stanica
English: OR; 95% CI; P value
Croatian: OR; 95% CI; P vrijednost
English: • If, after VELCADE has been held, the toxicity does not resolve, as defined above, then VELCADE must be discontinued.
Croatian: • Ako se, nakon prestanka primjene lijeka VELCADE, toksičnost ne povuče, kako je definirano iznad, VELCADE se mora prestati primjenjivati.
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: Prior to initiating a new cycle of therapy:
Croatian: Prije početka novog ciklusa liječenja:
English: Kaplan-Meier estimate.
Croatian: Kaplan-Meierova analiza.
English: Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Croatian: Izloženost lijeku VELCADE (prema dozi normalizirani AUC i Cmax) bila je usporediva unutar svih skupina (vidjeti dio 4.2).
English: The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Croatian: Pripremljena otopina je bistra i bezbojna, s konačnim pH od 4 do 7.
English: Median a response duration
Croatian: Medijan a trajanja odgovora
English: VELCADE should not be used during pregnancy unless the clinical condition of the woman requires treatment with VELCADE.
Croatian: VELCADE se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje lijekom VELCADE.
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: Keep the vial in the outer carton in order to protect from light.
Croatian: Bočicu držite u vanjskom pakiranju radi zaštite od svjetlosti.
English: • Increase of platelets or plasma cells (a type of white cell) in the blood
Croatian: • povećanje krvnih pločica ili plazma stanica (vrsta bijelih krvnih stanica) u krvi
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the VcR-CAP arm and with at least a possible or probable causal relationship to the components of the VcR-CAP arm, are listed in Table 8 below.
Croatian: Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u VcR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine VcR-CAP, navedene su u Tablici 8 ispod.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Croatian: AUCtrajanja omjera geometrijske sredine bila je 0,99; a 90% interval pouzdanosti bio je
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: VELCADE may have a moderate influence on the ability to drive and use machines.
Croatian: VELCADE može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
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: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE 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 lijeka VELCADE, osim ako je korist od liječenja neupitno veća od rizika.