FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: When bortezomib is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Croatian: Kada se bortezomib daje zajedno s talidomidom, morate slijediti program namijenjen prevenciji trudnoće za talidomid (vidjeti uputu o lijeku za talidomid).
English: Transfusion reaction, Fractures*, Rigors*, Face injury, Joint injury*, Burns, Laceration, Procedural pain, Radiation injuries*
Croatian: Rijetko reakcije transfuzije, lomovi*, tresavica*, ozljeda lica, ozljeda zgloba*, opekline, laceracija, proceduralna bol, radijacijske ozljede*
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Croatian: Demografske karakteristike bolesnika te karakteristike bolesti na početku liječenja bile su slične među liječenim skupinama.
English: Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Croatian: Melfalan (9 mg/m 2) i prednizon (60 mg/m 2) primjenjuju se kroz usta i daju se na 1., 2., 3. i 4. dan prvog tjedna primjene tijekom svih ciklusa.
English: Patients receiving Bortezomib Hospira in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Croatian: Bolesnici koji primaju Bortezomib Hospira u kombinaciji s talidomidom moraju se pridržavati programa prevencije trudnoće za talidomid.
English: Bortezomib Hospira treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Croatian: Liječenje lijekom Bortezomib Hospira mora se prekinuti u slučaju nastupa bilo koje nehematološke toksičnosti ≥ stupnja 3 povezane s bortezomibom (isključujući neuropatiju) ili hematološke toksičnosti ≥ stupnja 3 (također vidjeti dio 4.4).
English: Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Croatian: Vrlo često trombocitopenija*, febrilna neutropenija, neutropenija*,
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Croatian: Dostupni su ograničeni podaci o ponovljenom liječenju bortezomibom pri relapsu multiplog mijeloma.
English: If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you should tell your doctor:
Croatian: Ako imate limfom plaštenih stanica i uz bortezomib primate lijek rituksimab morate obavijestiti svog liječnika:
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Croatian: Bili su prijavljeni slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) u bolesnika koji su primali bortezomib.
English: Rituximab at 375 mg/m2 , cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Croatian: Rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m2.
English: Day 8 rest period
Croatian: 8. dan period odmora
English: The 1 mg, 2.5 mg, 3 mg and 3.5 mg vial can be administered subcutaneously, as described below.
Croatian: Bočica od 1 mg, 2,5 mg, 3 mg i 3,5 mg smije se primijeniti supkutano, kako je opisano ispod.
English: Patients on oral antidiabetic agents receiving Bortezomib Hospira treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Croatian: U bolesnika na terapiji oralnim antidijabeticima koji se liječe lijekom Bortezomib Hospira može biti potrebno pomno praćenje razine glukoze u krvi i prilagodba doze antidijabetika.
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Croatian: Medijan od 6 ciklusa primili su bolesnici u obje liječene skupine, a 14% ispitanika u BR-CAP skupini i 17% bolesnika u R-CHOP skupini primilo je 2 dodatna ciklusa.
English: Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Croatian: Liječenje bortezomibom često je povezano s ortostatskom/posturalnom hipotenzijom.
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Croatian: Farmakokinetika bortezomiba bila je okarakterizirana nakon primjene intravenske bolusne injekcije dva puta tjedno u dozi od 1,3 mg/m2 u 104 pedijatrijska bolesnika (u dobi od 2-16 godina) s akutnom limfoblastičnom leukemijom (ALL) ili akutnom mijeloidnom leukemijom (AML).
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
Croatian: U otvorenom, randomiziranom ispitivanju neinferiornosti, faze III uspoređena je djelotvornost i sigurnost supkutane primjene bortezomiba, u odnosu na intravensku primjenu.
English: Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Croatian: Bortezomib može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
English: the combined 1-year survival rate was 88.1%.
Croatian: U ovim kohortama prema dozi, kombinirana stopa jednogodišnjeg preživljenja iznosila je 88,1%.
English: You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Croatian: Vam se također može dati zajedno s lijekovima koji se zovu pegilirani liposomalni doksorubicin ili deksametazon.
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
Croatian: U ispitivanju LYM-3002, potpora u vidu faktora stimulacije kolonija primijenjena je na 78% bolesnika u BR-CAP skupini te na 61% bolesnika u R-CHOP skupini.
English: p-value g=0.007
Croatian: p-vrijednost g=0,007
English: The following medicinal products are administered on day 1 of each Bortezomib Hospira 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 na 1. dan svakog 3-tjednog ciklusa liječenja lijekom Bortezomib Hospira kao intravenske infuzije: rituksimab 375 mg/m 2, ciklofosfamid 750 mg/m 2 i doksorubicin
English: Time to progression Events n (%) Median a (95% CI)
Croatian: Vrijeme do progresije Događaji n (%) Medijan a (95% CI)
English: Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Croatian: h Uključuje sve radiološke CR+CRu+PR prema IRC neovisno o potvrdi koštanom srži i LDH.
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a 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: B=bortezomib; Dx=deksametazon; T=talidomid a 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.
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Croatian: Tablica 9: Incidencija periferne neuropatije tijekom uvodnog liječenja u odnosu na toksičnost i prekid liječenja radi periferne neuropatije
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Croatian: g P-vrijednost Cochran Mantel-Haenszelovog hi-kvadrat testa, s IPI i stadijem bolesti kao stratifikacijskim faktorima.
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Croatian: e Koristi se Mantel-Haenszelova procjena zajedničkog omjera izgleda za stratificirane tablice, s IPI rizikom i stadijem bolesti kao stratifikacijskim faktorima.
English: > 1.5 x -3 x ULN Any Reduce Bortezomib Hospira to 0.7 mg/m 2 in the first treatment cycle.
Croatian: > 1,5 x - 3 x GGN bilo koja U prvom ciklusu liječenja smanjiti dozu lijeka Bortezomib Hospira na 0,7 mg/m
English: Therefore, platelet counts should be monitored prior to each dose of Bortezomib Hospira.
Croatian: Stoga, broj trombocita potrebno je odrediti prije svake doze Bortezomiba Hospira.
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-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 BR-CAP skupini i 1,2% u R-CHOP skupini (vidjeti dio 4.8).
English: In the Phase III study comparing bortezomib 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 u kojem je uspoređena intravenska primjena bortezomiba 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: Include all CR+CRu, by IRC, bone marrow and LDH.
Croatian: f Uključuje sve CR + CRu, prema IRC, koštanu srž i LDH.
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Croatian: U ispitivanjima u kojima je bortezomib bio primijenjen kao uvodno liječenje u kombinaciji s deksametazonom (ispitivanje IFM-2005-01) i deksametazonom-talidomidom (ispitivanje MMY3010), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici dolje:
English: > 1.0 x -1.5 x ULN Any
Croatian: ≤ 1,0 x GGN > GGN Nema > 1,0 x - 1,5 x GGN bilo koja Nema
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 u 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: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Croatian: Tablica 15: Sažetak analize djelotvornosti usporedbom supkutane i intravenske primjene bortezomiba Bortezomib intravenska skupina
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Croatian: Talidomid se primjenjuje peroralno, 50 mg dnevno, od 1. do 14. dana i, u slučaju da se podnosi, doza se povisuje na 100 mg tijekom 15.-28. dana, a potom se može dalje povisiti na 200 mg dnevno od 2. ciklusa (vidjeti Tablicu 4).
English: At least 6 months after prior therapy, bortezomib 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 bortezomiba uz zadnju toleriranu dozu od 1,3 mg/m (n=93) ili ≤ 1,0 mg/m2 (n=37) te je primijenjen na 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: Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Croatian: Bortezomib će Vam primijeniti zdravstveni radnik koji ima iskustvo u primjeni citotoksičnih lijekova.
English: • Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg can be administered both intravenously and subcutaneously
Croatian: • Bortezomib Hospira 1 mg, 2,5 mg, 3 mg i 3,5 mg može biti primijenjen intravenski i supkutano
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Croatian: #, dermatitis*, poremećaj dlake*, petehije, ekhimoza, lezije kože, purpura, kožna masa*, psorijaza, hiperhidroza, noćno znojenje, dekubitalni ulkus
English: In the Phase III study patients who received bortezomib 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 bortezomib.
Croatian: U ispitivanju faze III bolesnici koji su primili bortezomib supkutano u odnosu na intravensku primjenu, imali su 13% manju ukupnu incidenciju nuspojava stupnja toksičnosti 3 ili više, koje su proizašle iz liječenja i 5% manju incidenciju prekida primjene bortezomiba.
English: Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib 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 bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib 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 bortezomiba i bortezomiba u kombinaciji s deksametazonom u bolesnika s progresivnim multiplim mijelomom, provedena je statistička analiza odgovarajućih parova, radi usporedbe rezultata nerandomizirane skupine bortezomiba u kombinaciji s deksametazonom (otvoreno ispitivanje faze II, MMY-2045), s rezultatima koji su dobiveni u skupini na monoterapiji bortezomibom iz različitih randomiziranih ispitivanja faze III (M34101-039 [APEX] i DOXIL MMY-3001), u istoj indikaciji.
English: Hypertension*, Hypotension*, Orthostatic hypotension
Croatian: Često hipertenzija*, hipotenzija*, ortostatska hipotenzija
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/m bolesnicima s multiplim mijelomom.
English: Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Croatian: Apsorpcija Nakon intravenske primjene bolus doze od 1,0 mg/m odnosno 1,3 mg/m u 11 bolesnika s multiplim mijelomom čije su vrijednosti klirensa kreatinina bile više od 50 ml/min, srednje vrijednosti maksimalne koncentracije bortezomiba u plazmi nakon prve doze iznosile su 57, odnosno 112 ng/ml.
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Croatian: • savjeti vezani uz put /način primjene za oba puta primjene i.v. i s.c., uključujući potrebu promjene mjesta injiciranja kod s.c. puta primjene
English: The incidence of herpes zoster among patients in the B+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 B+M+P bila je 17% u onih kojima se nije primijenila antivirusna profilaksa, u usporedbi s 3% bolesnika kojima se primijenila antivirusna profilaksa.
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
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: Therefore, patients who experience constipation should be closely monitored.
Croatian: Stoga bolesnike u kojih se pojavi zatvor treba pomno pratiti.
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 bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
Croatian: U ispitivanju faze III u bolesnika s prethodno neliječenim multiplim mijelomom, ukupna incidencija reaktivacije virusa herpes zoster bila je češća u bolesnika koji su primali bortezomib+melfalan+prednizon nego u onih koji su primali melfalan+prednizon (14% naspram 4%).
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Hospira as outlined in Table 1.
Croatian: Kod neuropatske boli povezane s bortezomibom i/ili periferne neuropatije, uskratite i/ili prilagodite dozu lijeka Bortezomib Hospira kako je prikazano u Tablici 1.
English: BR-CAP= bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy
Croatian: BR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin i prednizon; R-CHOP= rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; PN=periferna neuropatija
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: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Croatian: Statistički značajna razlika CR+nCR bila je uočena u korist skupine koja je primala bortezomib u kombinaciji s deksametazonom.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section
Croatian: Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih odgoda primjena ciklusa (vidjeti dio 4.2).
English: What Bortezomib Hospira contains
Croatian: Što Bortezomib Hospira sadrži
English: Based on Log rank test stratified with IPI risk and stage of disease.
Croatian: d Temeljeno na Log rank testu stratificiranom s IPI rizikom i stadijem bolesti.
English: Injection sites should be rotated for successive injections.
Croatian: Mjesto primjene injekcije treba mijenjati za svaku uzastopnu injekciju.
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira 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 Bortezomib Hospira 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: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Croatian: Primarne mjere ishoda djelotvornosti ispitivanja bile su postindukcijske i posttransplantcijske stope odgovora (CR+nCR).
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Croatian: Rekonstituirana otopina ne sadrži konzervanse i treba je primijeniti odmah nakon pripreme.
English: • to report any adverse event, or medication error experienced with the administration ofBortezomib
Croatian: • važnost prijave štetnih događaja ili medikacijskih pogrešaka kod primjene lijeka Bortezomib
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with Bortezomib Hospira.
Croatian: Zbog mogućnosti ozbiljnih nuspojava u dojene djece, za vrijeme liječenja lijekom Bortezomib Hospira potrebno je prekinuti dojenje.
English: Week B (1.3 mg/m
Croatian: Tjedan B (1,3 mg/m
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Hospira dose.
Croatian: • instrument za izračun doze koji omogućava propisivaču lijeka da na osnovu unosa podataka o visini i težni bolesnika izračuna tjelesnu površinu (engl. body surface area, BSA) te tako odredi potrebnu dozu lijeka Bortezomib Hospira
English: Table 3: Posology modifications during subsequent cycles of Bortezomib Hospira therapy in combination with melphalan and prednisone
Croatian: Tablica 3: Prilagodbe doziranja tijekom sljedećih ciklusa liječenja lijekom Bortezomib Hospira u kombinaciji s melfalanom i prednizonom
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the RCHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Croatian: Medijan preživljenja bez progresije prema procjeni ispitivača bio je 30,7 mjeseci u BR-CAP skupini i 16,1 mjeseci u R-CHOP skupini (omjer hazarda [HR]=0,51; p < 0,001).
English: • If platelet counts < 25,000 cells/μL or ANC < 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
Croatian: • Ako je broj trombocita < 25 000 stanica/μl ili apsolutni broj neutrofila < 750 stanica/μl na dan primjene doze lijeka Bortezomiba Hospira (osim 1. dana svakog ciklusa)
English: Day 22
Croatian: i 32. dan.
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: Rijetko 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: In study LYM-3002 in which bortezomib 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 bortezomib primijenjen s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (R-CAP), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici ispod:
English: The active substance is bortezomib.
Croatian: Djelatna tvar je bortezomib.
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
Croatian: Stopa odgovora u 8 ciklusa n (%) ORR (CR+PR) p-vrijednost a
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Croatian: - moždano-krvožilni poremećaji - paraliza, napadaji, padovi, poremećaji pokreta, abnormalnost ili promjena u, ili smanjen osjet
English: In patients developing PRES, Bortezomib Hospira should be discontinued.
Croatian: U bolesnika u kojih se razvije PRES, mora se prekinuti primjena lijeka Bortezomib Hospira.
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Croatian: U ispitivanju IFM-2005-01 bortezomib u kombinaciji s deksametazonom [BDx, n=240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n=242].