natgillin/translations-raw huggingface dataset:
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.
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy VcR-CAP (N=240)
Tablica 10: Incidencija periferne neuropatije u ispitivanju LYM-3002 prema toksičnosti i prekidu liječenja radi periferne neuropatije VcR-CAP (N = 240)
The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Incidencija herpes zostera među bolesnicima u VcR-CAP skupini bila je 10,7% za bolesnike kojima nije bila primijenjena antivirusna profilaksa u usporedbi s 3,6% za bolesnike kojima je primijenjena antivirusna profilaksa (vidjeti dio 4.4).
• Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
• Broj trombocita mora biti ≥ 75 000 stanica/μL u bolesnika s infiltracijom koštane srži i sa sekvestracijom u slezeni
VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Liječenje lijekom VELCADE se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim VELCADE može primijeniti zdravstveni radnik koji je iskusan u primjeni kemoterapije.
Also included are adverse drug reactions identified in the VcR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to VELCADE based on historical data in the multiple myeloma studies.
Također su uključene nuspojave identificirane u skupini VcR-CAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s lijekom VELCADE na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Medijan dobi bolesnika u ispitivanju bio je 57 godina, 55% bili su muškarci i 48% bolesnika imalo je citogenetiku visokog rizika.
VELCADE treatment is commonly associated with orthostatic/postural hypotension.
Liječenje lijekom VELCADE često je povezano s ortostatskom/posturalnom hipotenzijom.
Multiple Myeloma
Multipli mijelom
Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
U bolesnika na terapiji oralnim antidijabeticima koji se liječe lijekom VELCADE može biti potrebno pomno praćenje razine glukoze u krvi i prilagodba doze antidijabetika.
Common Sleep disorders and disturbances*
Poremećaji i smetnje spavanja*
Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Vrlo često Trombocitopenija*, febrilna neutropenija, neutropenija*,
Withhold VELCADE treatment until symptoms of toxicity have resolved.
Prekinuti liječenje lijekom VELCADE dok se simptomi toksičnosti ne povuku.
Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Populacija s terapijskim odgovorom uključuje bolesnike koji su imali mjerljivu bolesti na početku liječenja i primili su najmanje 1 dozu ispitivanog lijeka.
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Posebno naglasite svome liječniku ako koristite lijek koji u svom sastavu ima sljedeće tvari: - ketokonazol, za liječenje gljivičnih infekcija - ritonavir, uzima se za liječenje HIV infekcije - rifampicin, antibiotik za liječenje bakterijskih infekcija - karbamazepin, fenitoin ili fenobarbital za liječenje epilepsije - Gospinu travu (Hypericum perforatum) koja se primjenjuje kod depresije ili drugih stanja - oralne antidijabetike.
Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Uključuje sve radiološke CR+CRu+PR prema IRC neovisno o potvrdi koštanom srži i LDH.
• Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention
• pojačana ili smanjena proizvodnja mokraće (zbog oštećenja bubrega), bolno mokrenje ili krv/bjelančevine u mokraći, zadržavanje tekućine
Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
Poremećaji i smetnje raspoloženja *, anksiozni poremećaj*, poremećaji i smetnje spavanja*
• fainting, dizziness or light-headedness in the past
• nesvjesticu, omaglicu ili ošamućenost u prošlosti
The incidence of all grade peripheral neuropathy with VELCADE administered intravenously was lower in the historical studies with VELCADE administered intravenously than in study MMY-3021.
Incidencija periferene neuropatije svih stupnjeva uz intravensku primjenu lijeka VELCADE bila je niža u prethodnim ispitivanjima s lijekom VELCADE primijenjenim intravenski, nego u ispitivanju MMY-3021.
This medicine is for intravenous or subcutaneous use.
Ovaj lijek je namijenjen za primjenu intravenski ili supkutano.
Therefore, caution should be used during handling and preparation of VELCADE.
Stoga je potreban oprez tijekom rukovanja i pripreme lijeka VELCADE.
You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Imati ćete redovne kontrole krvi prije i tijekom liječenja lijekom VELCADE, kako bi se redovito provjerio broj krvnih stanica.
The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Medijan TTP-a bio je 6,5 mjeseci za bolesnike na monoterapiji lijekom VELCADE u usporedbi s 9,3 mjeseci za bolesnike na kombiniranoj terapiji lijekom VELCADE plus pegilirani liposomalni doksorubicin.
Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Bili su prijavljeni slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) kod bolesnika koji su primali VELCADE.
Discontinuation due to PN (%)
Prekid radi PN (%)
Include all CR+CRu, by IRC, bone marrow and LDH.
Uključuje sve CR + CRu, prema IRC, koštanu srž i LDH.
• Alteration of liver function
• promijenjena funkcija jetre
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno (CrCL ≥ 60 ml/min/1,73 m2, n = 12), blago (CrCL = 40-59 ml/min/1,73 m2, n = 10), umjereno
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Ako primijenite više lijeka VELCADE nego što ste trebali Budući da Vam ovaj lijek daje liječnik ili medicinska sestra, nije vjerojatno da će Vam se primijeniti previše lijeka.
In the Phase III study, treatment with VELCADE led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
U ispitivanju faze III, liječenje lijekom VELCADE značajno je produljilo vrijeme do progresije bolesti i dovelo do značajno produljenog preživljenja te značajno veće stope odgovora u usporedbi s liječenjem deksametazonom (vidjeti tablicu 14) u svih bolesnika, kao i u bolesnika koji su prethodno primili 1 liniju terapije.
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to VELCADE were in the range 65-74 years and ≥ 75 years of age, respectively.
U ispitivanju kod bolesnika s prethodno neliječenim limfomom plaštenih stanica, 42,9% i 10,4% bolesnika izloženih lijeku VELCADE bilo je dobi unutar raspona 65-74 godine odnosno ≥ 75 godina starosti.
The reconstituted solution should be used immediately after preparation.
Rekonstituirana otopina se mora primijeniti odmah nakon pripreme.