natgillin/translations-raw huggingface dataset:
Patient demographic and baseline disease charateristics were similar between the treatment groups. 
Demografske karakteristike bolesnika, te osnovne karakteristike bolesti bile su slične među liječenim skupinama.
Justification for not including Braille accepted 
Prihvaćeno obrazloženje za ne navođenje Braillea.
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). 
Periferna neuropatija stupnja ≥ 3 pojavila se kod 6% bolesnika u skupini liječenoj supkutano, u usporedbi sa 16% u skupini liječenoj intravenski (p = 0,0264).
#, Different degrees of visual impairment (up to blindness)* 
#, različiti stupnjevi oštećenja vida (do sljepoće)*
Very Common Decreased appetite 
Vrlo često Smanjeni apetit Često
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. 
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.
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. 
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.
Vc=VELCADE; M=melphalan, P=prednisone 
Vc = VELCADE; M = melfalan, P = prednizon
• A severe reversible brain condition which includes seizures, high blood pressure, headaches, 
• teško reverzibilno stanje mozga koje uključuje napadaje, visoki krvni tlak, glavobolje, umor,
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. 
Na osnovi ograničenog doprinosa (7%) enzima CYP2D6 metabolizmu bortezomiba, ne očekuje se da će fenotip slabog CYP2D6 metabolizatora utjecati na cjelokupnu raspoloživost bortezomiba.
Based on Kaplan-Meier product limit estimates. 
Temeljeno na Kaplan-Meierovim procjenama.
Uncommon Colitis (inc clostridium difficile)* 
Manje često Kolitis (uključujući clostridium difficile)*
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively. 
Periferna neuropatija svih stupnjeva i periferna neuropatija stupnja ≥ 3 bile su uočene u 40% odnosno 8,5% bolesnika.
Grade ≥ 3 non-haematological toxicities considered to be related to VELCADE 
Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s lijekom VELCADE
Hazard ratio (95% CI) p-value Response rate population e n=668 
Omjer hazarda (95% CI) p-vrijednost Stopa odgovora populacija e n = 668
• Bacterial and viral infections 
• bakterijske i virusne infekcije
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). 
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).
Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5). 
Potreban je oprez kad se bortezomib kombinira sa supstratima enzima CYP3A4- ili CYP2C19 (vidjeti dio 4.5).
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. 
42,9% i 10,4% bolesnika u VcR-CAP skupini bilo je u dobi unutar raspona 65-74 godina odnosno ≥ 75 godina starosti.
(feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching 
(dodira, sluha, okusa, mirisa), poremećaj pažnje, drhtanje, trzanje mišića
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC. 
U usporedbi s bolesnicima s normalnom funkcijom jetre, blago oštećenje funkcije jetre nije promijenilo prema dozi normalizirani AUC bortezomiba.
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours. 
Prosječno poluvrijeme eliminacije (t1/2) bortezomiba nakon višekratnog doziranja kretao se u rasponu od 40-193 sata.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy. 
Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije s lijekom VELCADE.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA). 
Na temelju populacijske farmakokinetičke analize klirens bortezomiba povećava se s porastom površine tijela (engl. body surface area, BSA).
You should not breast-feed while using VELCADE. 
Ne smijete dojiti dok primate VELCADE.
If you have mantle cell lymphoma and are given the medicine rituximab with VELCADE you should tell your doctor: 
Ako imate limfom plaštenih stanica i uz VELCADE primate lijek rituksimab morate obavijestiti svog liječnika:
A statistically significant survival benefit in favour of the Vc+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including VELCADE-based regimens. 
Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s Vc+M+P (HR = 0,695; p = 0,00043) usprkos naknadnim terapijama koje uključuju liječenje lijekom VELCADE.
A hazard ratio < 1 indicates an advantage for VcR-CAP. 
Omjer hazarda < 1 ukazuje na prednost za VcR-CAP.
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past 
• obamrlost, trnce ili bolove u šakama ili stopalima (neuropatija) u prošlosti
Orthostatic/postural hypotension was not acutely related to bolus infusion of VELCADE. 
Ortostatska/posturalna hipotenzija nije bila akutno povezana s bolus infuzijom lijeka VELCADE.
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8). 
U rijetkim slučajevima prijavljena je akutna difuzna infiltrativna bolest pluća nepoznate etiologije, kao što je pneumonitis, intersticijska pneumonija, infiltracija pluća i akutni respiratorni distres sindrom (ARDS) u bolesnika koji su primali VELCADE (vidjeti dio 4.8).
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 10 
Bolesnici su imali mijelom IgG/IgA/lakih lanaca u 63%/25%/8% slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 10
The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration. 
Ukupno vrijeme čuvanja pripremljenog lijeka ne smije prijeći 8 sati, prije primjene.
• shortness of breath or cough 
• nedostatak zraka ili kašljanje
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations. 
Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m2 primijenjene bolesnicima s multiplim mijelomom (n = 14 u intravenskoj skupini, n = 17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
The solution should be injected subcutaneously, at a 45-90° angle. 
Otopina se mora injicirati supkutano, pod kutom od 45-90°.
Additional adverse drug reactions identified associated with the use of the combination therapy (VcR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%). 
Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (VcR-CAP) bile su infekcija hepatitisom B (< 1%) i ishemija miokarda (1,3%).
In the VcR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group. 
VcR-CAP skupini, 22,5% bolesnika primilo je transfuzije trombocita u usporedbi s 2,9% bolesnika u R-CHOP skupini.
Day 29 rest period 
29. dan period odmora
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01 
Tablica 9: Incidencija periferne neuropatije tijekom uvodnog liječenja u odnosu na toksičnost i prekid liječenja radi periferne neuropatije IFM-2005-01
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for VELCADE in combination with dexamethasone over VELCADE monotherapy. 
Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (omjer hazarda 0,511; 95% CI 0,309-0,845; p = 0,008), TTP (omjer hazarda 0,385; 95% CI 0,212-0,698; p = 0,001) za VELCADE u kombinaciji s deksametazonom nad monoterapijom lijekom VELCADE.
• Weight loss, loss of taste 
• gubitak tjelesne težine, gubitak osjeta okusa
Day 1, 4 
Dan 1, 4
Median survival for the Vc+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group. 
Medijan preživljenja za skupinu koja je primala Vc+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m 
Učinak oštećenja jetre na farmakokinetiku bortezomiba procijenio se u ispitivanju faze I tijekom prvog ciklusa liječenja, uključujući primarno 61 bolesnika s primarno solidnim tumorima i raznim stupnjevima oštećenja jetre u dozama bortezomiba u rasponu od 0,5 do 1,3 mg/m
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the VELCADE containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%). 
Sljedeće nuspojave (stupnja ≥ 3) zabilježene su u većoj incidenciji kod režima liječenja koji sadrži VELCADE u usporedbi s ispitivanjem s povijesnom kontrolom u kojem je osnovni režim davan samostalno: u 1. bloku periferna senzorna neuropatija (3% naspram 0%); ileus (2,1% naspram 0%); hipoksija (8% naspram 2%).
This medicine is for intravenous use only. 
Ovaj lijek je namijenjen samo za intravensku primjenu.
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Vc+M+P treatment. 
U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku studije bilo ponuđeno liječenje Vc+M+P.
Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma. 
U rasponu koncentracije bortezomiba od 0,01 do 1,0 μg/ml, vezanje za proteine ljudske plazme in vitro u prosjeku je iznosilo 82,9%.
In the Phase II study, patients who did not obtain an optimal response to therapy with VELCADE alone were able to receive high-dose dexamethasone in conjunction with VELCADE. 
U ispitivanju faze II, bolesnici koji nisu postigli optimalni terapijski odgovor kod liječenja samo lijekom VELCADE mogli su primiti visoku dozu deksametazona zajedno s lijekom VELCADE.
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly. 
U eksplorativnoj analizi djelotvornosti, stopa odgovora od 67,3% (uključujući CR stopu od 28,6%) prema mjerenju hematološkog odgovora (M-protein) bila je zabilježena u 49 procijenjenih bolesnika liječenih maksimalnim dopuštenim dozama od 1,6 mg/m2 na tjedan i 1,3 mg/m2 dvaput na tjedan.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of VELCADE and pegylated liposomal doxorubicin. 
Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29-57 %, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom lijeka VELCADE i pegiliranog liposomalnog doksorubicina.
Regardless of 
bilo koja
Day 1, 2, 3, 4 
Dan 1, 2, 3, 4
Progression free survival (IRC) Events n (%) 
Preživljenje bez progresije (IRC) Događaji n (%)
Patients who developed orthostatic hypotension on VELCADE (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with VELCADE. 
Bolesnici koji su razvili ortostatsku hipotenziju za vrijeme liječenja lijekom VELCADE (injiciran intravenski) nisu imali znakove ortostatske hipotenzije prije liječenja lijekom VELCADE.
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: 2-microglobulin, albumin, and region. 
Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: 2-mikroglobulinu, albuminu i regiji.
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw 
• artritis, uključujući upalu zglobova na prstima, nožnim prstima i čeljusti
In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8). 
≥ 75 godina, su oba režima, VcR-CAP kao i R-CHOP, podnosili lošije (vidjeti dio 4.8).
VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia). 
Liječenje lijekom VELCADE vrlo je često povezano s hematološkim toksičnostima (trombocitopenija, neutropenija i anemija).
• Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots 
• upala ili krvarenje krvnih žila koja se može javiti u obliku malih crvenih ili ljubičastih točkica
VELCADE might cause tiredness, dizziness, fainting, or blurred vision. 
VELCADE može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/m2 once per week. 
Kad se toksičnost povuče, ponovno uvesti liječenje lijekom VELCADE i smanjiti dozu na 0,7 mg/m2 jedanput tjedno.
Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2). 
Također su zabilježene više incidencije za infekcije sa stupnjem ≥ 3 neutropenije (24% naspram 19% u 1. bloku i 22% naspram 11% u 2. bloku), povišen ALT (17% naspram 8% u 2. bloku), hipokalemija (18% naspram 6% u 1. bloku i 21% naspram 12% u 2. bloku), te hiponatrijemija (12% naspram 5% u 1. bloku i 4% naspram 0 u 2. bloku).
• Bleeding in the brain 
• krvarenje u mozgu
Change VELCADE treatment schedule to 1.3 mg/m2 once per week 
Promijeniti raspored primjene lijeka VELCADE na 1,3 mg/m2 jedanput tjedno
On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za bortezomib, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) bortezomib nepromijenjen, uz predložene izmjene informacija o lijeku.
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively. 
Jednu autolognu transplantaciju matičnih stanica primilo je 105 (81%) bolesnika odnosno 78 (61%) bolesnika u VcTDx i TDx skupini.
• to remind that patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information. 
• kako bi se podsjetilo bolesnike koji primaju VELCADE u kombinaciji s talidomidom da se moraju pridržavati talidomidskog programa prevencije trudnoće, s upućivanjem na SPC za talidomid za dodatne informacije.
• Hiccups, speech disorders 
• štucanje, poremećaj govora
• to report any adverse event, or medication error experienced with the administration of VELCADE 3.5 mg. 
• važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene VELCADE 3,5 mg.
1-year Overall Survival (%) (95% CI) 
1-godišnje opće preživljenje (%) (95% CI)
If you are given VELCADE for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, 
Ako VELCADE primate za multipli mijelom ili limfom plaštenih stanica, odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma: - grčenje mišića, slabost mišića - smetenost, gubitak vida ili smetnje vida, sljepoću, napadaje, glavobolje - nedostatak zraka, oticanje stopala ili promjene broja otkucaja srca, visoki krvni tlak, umor,
As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered VELCADE, regardless of disease status. 
Kao posljedica unaprijed planirane privremene analize, skupini koja je primala deksametazon liječenje je zaustavljeno na preporuku radne skupine koja je pratila ispitivanja i svim je bolesnicima nakon toga ponuđeno liječenje lijekom VELCADE bez obzira na stanje bolesti.
• Psoriasis like skin condition 
• stanje kože kao kod psorijaze
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE at 1.3 mg/m2 and included in Table 7. 
Ove nuspojave temelje se na integriranom setu podataka od 5476 bolesnika od kojih je 3996 bilo liječeno lijekom VELCADE u dozi 1,3 mg/m2 te je uvršteno u Tablicu 7.
No new safety concerns were observed when VELCADE was added to the standard pediatric pre-B cell ALL chemotherapy backbone. 
Nisu zabilježena nova sigurnosna pitanja kada je VELCADE bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with VELCADE. 
Progresivna multifokalna leukoencefalopatija (PML) Vrlo rijetko su bili zabilježeni slučajevi John Cunningham (JC) virusne infekcije nepoznate uzročnosti, koji su rezultirali progresivnom multifokalnom leukoencefalopatijom (PML) i smrću kod bolesnika liječenih lijekom VELCADE.
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with VELCADE. 
Zbog mogućnosti ozbiljnih nuspojava u dojene djece, za vrijeme liječenja lijekom VELCADE potrebno je prekinuti dojenje.
• If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle 
• Ako se primijetilo produljeno trajanje neutropenije 4. stupnja ili trombocitopenije ili trombocitopenija s krvarenjem u prethodnom ciklusu
• Problems with blood clotting 
• problemi sa zgrušnjavanjem krvi
• Ringing in the ears, ear discomfort 
• zvonjava u ušima, nelagoda u uhu
Vc=VELCADE; Dx=dexamethasone; T=thalidomide 
Vc = VELCADE; Dex = deksametazon
The median duration of complete response was 42.1 months in the VcR-CAP group compared with 18 months in the R-CHOP group. 
Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u VcR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours. 
Geometrijska sredina (%CV) klirensa bila je 7,79 (25%) l/h/m volumen distribucije u stanju dinamičke ravnoteže bio je 834 (39%) l/m2, i poluvijek eliminacije bio je
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. VELCADE in combination with dexamethasone) and patients in the comparison group (e.g. VELCADE) are made comparable with respect to confounding factors by individually pairing study subjects. 
Analiza odgovarajućih parova je statistička metoda u kojoj se bolesnici u liječenoj skupini (npr. VELCADE u kombinaciji s deksametazonom) i bolesnici u usporednoj skupini (npr. VELCADE) učine usporedivima s obzirom na zbunjujuće čimbenike, tako da se individualno uparuju ispitanici u ispitivanju.
MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease. 
International Prognostic Index, IPI) ≥ 3, i 76% imalo je stadij IV bolesti.
Antiviral prophylaxis was administered to 26% of the patients in the Vc+M+P arm. 
Antivirusna profilaksa se primijenila u 26% bolesnika u skupini koja je primala Vc+M+P.
• Abnormal protein deposits in your vital organs 
• nenormalno nakupljanje bjelančevina u vitalnim organima
VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor'. 
VELCADE sadrži djelatnu tvar bortezomib, koja se naziva ‘inhibitor proteasoma'.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy: 
Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica Prije započinjanja novog ciklusa liječenja:
Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of VELCADE twice weekly. 
Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 lijeka VELCADE dva puta na tjedan.
• Swelling of body, to include eyes and other parts of the body 
• oticanje tijela, uključujući oči i druge dijelove tijela
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors. 
Bolesnike treba pomno pratiti kada primaju bortezomib u kombinaciji s jakim inhibitorima enzima CYP3A4.
Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma 
Klinička djelotvornost uz supkutanu primjenu lijeka VELCADE u bolesnika s relapsnim/refraktornim multiplim mijelomom
M (9 mg/m P (60 mg/m 
M (9 mg/m P (60 mg/m dan dan
Table 13: Efficacy results from study MMY-3010 
Tablica 13: Rezultati djelotvornosti iz ispitivanja MMY-3010
Median a (95% CI) 
Medijan a (95% CI)
What VELCADE contains - The active substance is bortezomib. 
Što VELCADE sadrži - Djelatna tvar je bortezomib.
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the VcR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (VcR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]). 
Dvije liječene skupine imale su sličnu ukupnu incidenciju događaja krvarenja svih stupnjeva (6,3% u VcR-CAP skupini i 5,0% u R-CHOP skupini) kao i stupnja 3 i višeg za događaje krvarenja (VcR-CAP: 4 bolesnika [1.7%]; R-CHOP: 3 bolesnika [1,2%]).
tiredness, confusion, blindness or other vision problems. 
zbunjenost, sljepoću ili druge probleme s vidom.