FrancophonIA/ELRC3.0 huggingface dataset:
English: A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: 2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors
Croatian: Nominalna p-vrijednost utemeljena na stratificiranom log-rank testu prilagođenom za čimbenike stratifikacije: 2-mikroglobulina, albumina i regije. p-vrijednost za stopu odgovora (CR+PR) iz Cochran Mantel-Haenszelovog hi-kvadrat testa prilagođenog za čimbenike stratifikacije.
English: • Swelling of body, to include around eyes and other parts of the body
Croatian: • oticanje tijela, uključujući područje oko očiju i druge dijelove tijela
English: VELCADE subcutaneous arm
Croatian: VELCADE supkutana skupina
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
Croatian: Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s VcR-CAP u kliničkom ispitivanju
English: • Altered levels of consciousness, confusion, memory impairment or loss
Croatian: • promijenjene razine svijesti, smetenost, oštećenje ili gubitak pamćenja
English: Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Croatian: Medijan ukupnog preživljenja bio je 90,7 mjeseci za VcR-CAP skupinu u usporedbi s 55,7 mjeseci za R-CHOP skupinu (HR=0,66; p=0,001).
English: In the Phase III study patients who received VELCADE subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of VELCADE.
Croatian: U ispitivanju faze III bolesnici koji su primili VELCADE supkutano u odnosu na intravensku primjenu, ukupno su imali 13% manju incidenciju nuspojava stupnja toksičnosti 3 ili više, koje su proizašle iz liječenja i 5% manju incidenciju prekida primjene lijeka VELCADE.
English: Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Croatian: Doza talidomida se povisuje na 100 mg od 3. tjedna 1. ciklusa samo ako se podnosi doza od 50 mg, a na 200 mg od 2. ciklusa nadalje ako se podnosi doza od 100 mg.
English: Overall survival* Events (deaths) n (%) Median (95% CI)
Croatian: Ukupno preživljenje* događaji (smrti) n (%) Medijan (95% CI)
English: Therefore, platelet counts should be monitored prior to each dose of VELCADE.
Croatian: Stoga, broj trombocita potrebno je odrediti prije svake doze lijeka VELCADE.
English: Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Croatian: Bolesnici kod kojih se razvije neuropatska bol povezana s bortezomibom i/ili periferna neuropatija liječit će se prema uputama u tablici 1 (vidjeti dio 4.4).
English: Day 8, 9, 10, 11
Croatian: Dan 8, 9, 10, 11
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Croatian: Nakon sljedećih doza, primijećene srednje vrijednosti maksimalne koncentracije u plazmi bile su u rasponu od 67 do 106 ng/ml kod doze od 1,0 mg/m2 i 89 do 120 ng/ml kod doze od 1,3 mg/m
English: VELCADE powder has to be dissolved before administration.
Croatian: VELCADE prašak za otopinu je potrebno otopiti prije primjene.
English: At least 6 months after prior therapy, VELCADE was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Croatian: Najmanje 6 mjeseci nakon prethodne terapije, započela je primjena lijeka VELCADE uz zadnju toleriranu dozu od 1,3 mg/m2 (n = 93) ili ≤ 1,0 mg/m2 (n = 37) te je primijenjen 1., 4., 8. i 11. dan svaka 3 tjedna do maksimalno 8 ciklusa, bilo kao jedini lijek ili u kombinaciji s deksametazonom u skladu sa standardnim liječenjem.
English: Peripheral neuropathy in combination regimens Multiple Myeloma
Croatian: Periferna neuropatija u kombiniranim režimima
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Croatian: Prosječni volumen distribucije (Vd) bortezomiba kretao se u rasponu od 1659 l do 3294 l nakon jednokratne ili ponovljene intravenske primjene doze od 1,0 mg/m2 ili 1,3 mg/m2 bolesnicima s multiplim mijelomom.
English: In patients developing PRES, VELCADE should be discontinued.
Croatian: U bolesnika u kojih se razvije PRES, mora se prekinuti primjena lijeka VELCADE.
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
Croatian: Rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Croatian: Kratice: SGOT = serumska glutamat oksaloacetat transaminaza; AST = aspartat aminotransferaza; GGN = gornja granica normalnog raspona.
English: Patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Croatian: Bolesnici koji primaju VELCADE u kombinaciji s talidomidom moraju se pridržavati programa za sprječavanje trudnoće.
English: Special handling instructions
Croatian: Posebne upute za rukovanje.
English: TTP, days [95% CI] 1 year survival,
Croatian: TTP, dani [95% CI] 1 godina preživljenja, % [95% CI]
English: • Cancer of the skin
Croatian: • karcinom kože
English: For VELCADE-related neuropathic pain and/or peripheral neuropathy, hold and/or modify VELCADE as outlined in Table 1.
Croatian: Kod neuropatske boli povezane s lijekom VELCADE i/ili periferne neuropatije, pričekajte s primjenom i/ili prilagodite dozu lijeka VELCADE kako je prikazano u Tablici 1.
English: Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Croatian: Manje često Multriformni eritem, urtikarija, akutna febrilna neutrofilna dermatoza, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka, toksična epidermalna nekroliza Stevens-Johnsonov sindrom
English: Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Croatian: Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i VcR-CAP i R-CHOP, stopa ozbiljnih nuspojava u VcR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
English: • Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Croatian: • infekcije, uključujući infekcije mokraćnih putova, gripa, infekcije virusom herpesa, infekcija uha i celulitis
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Croatian: Prilagodbe doze za vrijeme i kod ponovnog uvođenja monoterapije Liječenje lijekom VELCADE mora se prekinuti po javljanju svake nehematološke toksičnosti 3. stupnja ili bilo kakve hematološke toksičnosti 4. stupnja, isključujući neuropatiju, kako je objašnjeno u daljnjem tekstu (vidjeti također dio 4.4).
English: VELCADE combination treatment with dexamethasone In the absence of any direct comparison between VELCADE and VELCADE in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of VELCADE in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the VELCADE monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Croatian: Radi nepostojanja bilo kakve izravne usporedbe između lijeka VELCADE i lijeka VELCADE u kombinaciji s deksametazonom u bolesnika s progresivnim multiplim mijelomom, provedena je statistička analiza odgovarajućih parova, radi usporedbe rezultata nerandomizirane skupine lijeka VELCADE u kombinaciji s deksametazonom (otvoreno ispitivanje faze II, MMY-2045), s rezultatima koji su dobiveni u skupini na monoterapiji lijekom VELCADE iz različitih ispitivanja faze III (M34101-039 [APEX] i DOXIL MMY-3001), u istoj indikaciji.
English: The following medicinal products are administered on day 1 of each VELCADE 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Croatian: Sljedeći lijekovi primjenjuju se 1. dan svakog 3-tjednog ciklusa liječenja lijekom VELCADE kao intravenske infuzije: rituksimab 375 mg/m 2, ciklofosfamid 750 mg/m 2 i doksorubicin 50 mg/m
English: Post-marketing adverse reaction regardless of indication
Croatian: Nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji
English: 43.1 mo
Croatian: 43,1 mjesec
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Croatian: Reaktivacija virusa hepatitisa B (HBV) i infekcija Limfom plaštenih stanica
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Croatian: Demografski podaci i karakteristike bolesti na početku ispitivanja općenito su bile dobro izbalansirane unutar dvije liječene skupine: medijan dobi bolesnika bio je 66 godina, 74% su bili muškarci, 66% su bili bijele rase, a 32% azijskog porijekla, 69% bolesnika imalo je pozitivan aspirat koštane srži i/ili pozitivnu biopsiju koštane srži na limfom plaštenih stanica, 54% bolesnika imalo je skor Internacionalnog indeksa prognoze (od engl.
English: In the Phase III study comparing VELCADE administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Croatian: U ispitivanju faze III uspoređena je intravenska primjena lijeka VELCADE u odnosu na supkutanu primjenu, incidencija periferne neuropatije stupnja ≥ 2 bila je 24% u skupini sa supkutanom primjenom injekcije i 41% u intravenskoj skupini (p = 0,0124).
English: You should tell your doctor if you have any of the following:
Croatian: Ako imate nešto od sljedećeg, morate o tome obavijestiti svog liječnika:
English: The usual starting dose of VELCADE is 1.3 mg/m2 body surface area twice a week.
Croatian: Uobičajena početna doza lijeka VELCADE je 1,3 mg/m2 površine tijela, dva puta tjedno.
English: The Reconstitution, dosing and administration booklet shall contain the following key elements:
Croatian: Brošura o rekonstituciji, doziranju i primjeni lijeka će sadržavati sljedeće ključne elemente:
English: b (95% CI)=0.63 (0.50; 0.79) p-value d < 0.001
Croatian: HR b (95% CI) = 0,63 (0,50; 0,79) p-vrijednost d < 0,001
English: • Rapid breathing
Croatian: • brzo disanje
English: • Lump in the eyelid (chalazion), red and swollen eyelids
Croatian: • kvržica na kapku (halacion), crveni i otečeni kapci
English: Progression Free Survival, months (95% CI)
Croatian: Preživljenje bez progresije, mjeseci (95% CI)
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with VELCADE+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Croatian: U ispitivanju faze III kod bolesnika s prethodno neliječenim multiplim mijelomom, ukupna incidencija reaktivacije virusa herpes zoster bila je češća u bolesnika koji su primali VELCADE+melfalan+prednizon nego u onih koji su primali melfalan+prednizon (14% naspram 4%).
English: Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Croatian: Procjena omjera hazarda temelji se na Coxovom modelu stratificiranom prema IPI riziku i stadiju bolesti.
English: The overall incidence of hepatitis B infections was similar in patients treated with VcR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Croatian: Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s VcR-CAP i liječenih s R-CHOP (0,8% odnosno
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of VELCADE in patients with previously treated light-chain (AL) Amyloidosis.
Croatian: Bolesnici prethodno liječeni zbog amiloidoze lakih lanaca (AL) Provedeno je ispitivanje otvorenog, nerandomiziranog tipa faze I/II da bi se utvrdila sigurnost i djelotvornost primjene lijeka VELCADE u bolesnika prethodno liječenih zbog amiloidoze lakih lanaca (AL).
English: • Swelling of the liver, bleeding from the liver
Croatian: • oticanje jetre, krvarenje iz jetre
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Croatian: Statistički značajna razlika CR+nCR bila je uočena u korist skupine koja je primala VELCADE u kombinaciji s deksametazonom.
English: VELCADE 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: Pripremljena otopina lijeka VELCADE od 3,5 mg se primjenjuje supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Croatian: Liječenje lijekom VELCADE mora se prekinuti dok se simptomi toksičnosti ne povuku do stupnja 2 ili manjeg.
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Croatian: nesvjestica - kašalj i poteškoće s disanjem ili stezanje u prsnom košu.
English: VELCADE should not be given by other routes.
Croatian: VELCADE se ne smije primijeniti drugim putevima primjene.
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the VcR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Croatian: U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), incidencija infekcije virusom herpes zoster bila je 6,7% u VcR-CAP skupini i 1,2% u R-CHOP skupini (vidjeti dio 4.8).
English: Reduce VELCADE to 1.0 mg/m or
Croatian: Smanjiti dozu lijeka VELCADE na 1,0 mg/m ili
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment, and those patients should be closely monitored (see section 4.2, Table 6).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre preporučuje se niža početna doza i te bolesnike treba pomno pratiti (vidjeti dio 4.2, tablica 6).
English: In study LYM-3002 in which VELCADE was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Croatian: U ispitivanju LYM-3002 u kojem je VELCADE primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (R-CAP), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
English: Notable differences in the safety profile of VELCADE administered subcutaneously versus intravenously as single agent
Croatian: Primjetne razlike sigurnosnog profila lijeka VELCADE primijenjenog kao monoterapija supkutano u odnosu na intravensku primjenu
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Croatian: P-vrijednost Cochran Mantel-Haenszelovog hi-kvadrat testa, s IPI i stadijem bolesti kao stratifikacijskim faktorima.
English: • Inject the solution subcutaneously, under a 45-90°angle.
Croatian: • Primijenite injekciju supkutano, pod kutem od 45-90°.
English: Day 1 Day 2 Day 3 Day rest period rest period
Croatian: 3. dan 4. dan period odmora period odmora
English: Both men and women receiving VELCADE must use effective contraception during and for up to 3 months after treatment.
Croatian: I muškarci i žene moraju koristiti djelotvorna kontracepcijska sredstva dok su na liječenju lijekom VELCADE, te do 3 mjeseca nakon liječenja.
English: • Infection or inflammation of the stomach and intentines
Croatian: • infekcija ili upala želuca i crijeva
English: Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Croatian: Stoga ćete prije i za vrijeme liječenja lijekom VELCADE morati ići na redovite kontrole krvi, kako bi se redovito provjerio broj krvnih stanica.
English: Combination with dexamethasone
Croatian: Kombinacija s deksametazonom
English: • Bulging eyes
Croatian: • izbuljene oči
English: In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Croatian: U ispitivanju IFM-2005-01 VELCADE u kombinaciji s deksametazonom [VcDx, n = 240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n = 242].
English: Table 6: Recommended starting dose modification for VELCADE in patients with hepatic impairment
Croatian: Tablica 6: Preporučena prilagodba početne doze lijeka VELCADE u bolesnika s oštećenjem jetre
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
Croatian: Statistički značajna razlika CR+nCR bila je uočena u korist skupine s lijekom VELCADE u kombinaciji s deksametazonom i talidomidom.
English: • If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from
Croatian: • Ako se toksičnost povuče, tj. bolesnik ima apsolutni broj neutrofila ≥ 750 stanica/μL i broj trombocita ≥ 25 000 stanica/μL, VELCADE se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m2 na 1 mg/m2, ili s 1 mg/m na
English: Very Common Musculoskeletal pain* Common
Croatian: Vrlo često Mišićno-koštana bol* Često
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost pripremljene otopine u primjeni je 8 sati na temperaturi do 25°C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
English: Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Croatian: Manje često Mentalni poremećaj*, halucinacije*, psihotični poremećaj*, konfuzija*, nemir
English: Time to progression Events n (%) Median a (95% CI)
Croatian: Vrijeme do progresije događaji n (%) Medijan a (95% CI)
English: Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Croatian: Ozbiljne nuspojave koje su manje često bile prijavljene tijekom liječenja lijekom VELCADE uključuju zatajenje srca, sindrom lize tumora, plućnu hipertenziju, sindrom posteriorne reverzibilne encefalopatije, akutne difuzne infiltrativne plućne poremećaje i rijetku autonomnu neuropatiju.
English: • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Croatian: • Ubrizgajte otopinu lijeka intravenskom bolus injekcijom kroz 3-5 sekundi kroz periferni ili centralni venski kateter u venu.
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Croatian: Meningitis (uključujući bakterijski), infekcija Epstein-Barrovim virusom, genitalni herpes, tonzilitis, mastoiditis, sindrom umora nakon virusa
English: Table 16: Efficacy results from study LYM-3002
Croatian: Tablica 16: Rezultati djelotvornosti iz ispitivanja LYM-3002
English: The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Croatian: Incidencija herpes zostera u skupini bolesnika koja je primala Vc+M+P bila je 17% u onih kojima se nije primijenila antivirusna profilaksa, u usporedbi s 3% bolesnika kojima se primijenila antivirusna profilaksa.
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
Croatian: Stopa odgovora u 8 ciklusa n (%) ORR (CR+PR) p-vrijednost
English: Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Croatian: Abnormalni plinovi u krvi*, abnormalnosti elektrokardiograma (uključujući QT produljenje)*, abnormalan međunarodni normalizirani omjer (INR)*, snižen pH želuca, povećana agregacija trombocita, povišen troponin I, identifikacija virusa i serologija*, abnormalan nalaz urina*
English: If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se rekonstituirana otopina ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja pripremljene otopine do primjene odgovornost su korisnika.
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with VELCADE in clinical trials, and all post-marketing adverse reactions regardless of indication System Organ Class
Croatian: Tablica 7: Nuspojave u bolesnika s multiplim mijelomom liječenih lijekom VELCADE u kliničkim ispitivanjima i nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji Klasifikacija organskih sustava
English: Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre liječenje lijekom VELCADE treba započeti smanjenom dozom od 0,7 mg/m2 po injekciji tijekom prvog ciklusa liječenja, a naknadno povećanje doze na 1,0 mg/m ili daljnje smanjenje doze na 0,5 mg/m 2 može se razmotriti na temelju podnošljivosti liječenja za bolesnika (vidjeti Tablicu 6 i dijelove 4.4 i 5.2).
English: Median PFS by investigator assessment was 30.7 months in the VcR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Croatian: Medijan preživljenja bez progresije prema procjeni ispitivača bio je 30,7 mjeseci u VcR-CAP skupini i 16,1 mjeseci u R-CHOP skupini (omjer hazarda [HR] = 0,51; p < 0,001).
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy
Croatian: Napomena: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Vc
English: • Problems with your ear, bleeding from your ear
Croatian: • tegobe s uhom, krvarenje iz uha
English: • different reconstitution requirements for VELCADE 3.5 mg IV or SC use
Croatian: • različite zahtjeve kod pripreme lijeka VELCADE 3,5 mg za i.v. ili s.c. put primjene
English: 18.3 mo
Croatian: 18,3 mjeseca
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Croatian: Stopa odgovora u 4 ciklusa n (%) ORR (CR+PR) p-vrijednost