FrancophonIA/ELRC3.0 huggingface dataset:
English: After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues.
Croatian: Nakon intravenske primjene tkiva brzo apsorbiraju Methylthioninium chloride Proveblue.
English: How Methylthioninium chloride Proveblue is given
Croatian: Kako primjenjivati Methylthioninium chloride Proveblue
English: Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Croatian: Methylthioninium chloride Proveblue može se razrijediti u 50 ml otopine glukoze za injekcije 50 mg/ml (5%) da bi se izbjegla lokalna bol, osobito u pedijatrijskoj populaciji.
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Croatian: Methylthioninium chloride Proveblue 5 mg/ml otopina za injekciju
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Croatian: Jedna ampula od 10 ml sadrži 50 mg metiltioninijeva klorida.
English: Lamepro B.V Tel: + 31 (0) 76-5600030
Croatian: Tel: + 31 (0) 76-5600030
English: Each ml of solution contains 5 mg methylthioninium chloride.
Croatian: Jedan ml otopine sadrži 5 mg metiltioninijeva klorida.
English: Intravenous use only For slow intravenous injection
Croatian: Za sporu injekciju u venu
English: Each 2 ml ampoule contains 10 mg methylthioninium chloride.
Croatian: Jedna ampula od 2 ml sadrži 10 mg metiltioninijeva klorida.
English: Each box contains a tray with 5 ampoules of 2 ml.
Croatian: Jedna kutija sadrži podložak s 5 ampula od 2 ml.
English: Each box contains a tray with 5 ampoules of 10 ml.
Croatian: Jedna kutija sadrži podložak s 5 ampula od 10 ml.
English: Dysgeusia
Croatian: Vrlo često disgeuzija
English: Tel.: + 48 694 775 205
Croatian: AB Pharm Sp. z o.o. Tel: + 48 694 775 205
English: Each carton contains a tray with 5 ampoules of 10 ml in blister.
Croatian: Jedna kutija sadrži podložak s 5 ampula od 10 ml u blisteru.
English: Lietuva Provepharm SAS
Croatian: Laboratoires ETHYPHARM
English: Methylthioninium chloride Proveblue 5 mg/ml injection methylthioninium chloride
Croatian: Methylthioninium chloride Proveblue 5 mg/ml injekcija metiltioninijev klorid
English: Tel: +33 (0)4 91 08 69 30
Croatian: Provepharm SAS Teл.: + 33 (0)4 91 08 69 30
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection Methylthioninium chloride
Croatian: Methylthioninium chloride Proveblue 5 mg/ml otopina za injekciju metiltioninijev klorid
English: Anaphylactic reactions
Croatian: Nepoznato afazija
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji stanje konfuzije
English: Abdominal pain
Croatian: Često bol u abdomenu
English: Dyspnoea
Croatian: AMPULA
English: Hepatic impairment
Croatian: Nepoznato agitacija
English: Intravenous use only
Croatian: Samo za primjenu u venu
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava anafilaktičke reakcije
English: Tremor
Croatian: Često tremor
English: Tachypnoea
Croatian: Nepoznato tahipneja
English: The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes.
Croatian: Odrasli, djeca starija od 3 mjeseca i starije osobe Uobičajena doza je 1 do 2 mg po kilogramu tjelesne težine, tj. od 0,2 do 0,4 ml po kilogramu i daje se u trajanju od 5 minuta.
English: Aphasia
Croatian: OBLIK
English: ● At the request of the European Medicines Agency;
Croatian: ● na zahtjev Europske agencije za lijekove;
English: Date of first authorisation: 20 July 2015
Croatian: Datum prvog odobrenja: 20. srpnja 2015.
English: • if you think you have hepatitis infection now or have had it in the past.
Croatian: • ako mislite da trenutno imate hepatitis infekciju ili ste ju imali u prošlosti.
English: TTP, months
Croatian: TTP, mjeseci
English: NA=not applicable, NE=not estimated
Croatian: NA=nije primjenjivo, NE=nije procijenjeno
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Budući da Vam ovaj lijek daje liječnik ili medicinska sestra, nije vjerojatno da će Vam se primijeniti previše lijeka.
English: Progression Free Survival, months
Croatian: Preživljenje bez progresije, mjeseci
English: A total of 218 patients were evaluable for response.
Croatian: U ukupno 218 bolesnika bila je moguća procijena odgovora.
English: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Croatian: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Španjolska
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzDx group.
Croatian: Medijan trajanja liječenja bio je 13 tjedana za skupinu VDDx i 11 tjedana za BzDx skupinu.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja pripremljene otopine odgovornost su korisnika.
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Croatian: Konačna analiza za OS koja je provedena nakon medijana praćenja od 8,6 godina nije pokazala značajnu razliku u OS-u između dvije liječene skupine.
English: e Median duration of follow up is 11.8 months
Croatian: e Medijan trajanja praćenja je 11,8 mjeseci
English: 1-year Overall Survival (%)e
Croatian: 1-godišnje opće preživljenje (%)e
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk.
Croatian: Ako se toksičnost ne povuče ili se ponovno pojavi pri najnižoj dozi, mora se razmotriti prestanak primjene bortezomiba, osim ako je korist od liječenja neupitno veća od rizika.
English: Very Common Decreased appetite Common
Croatian: Vrlo često Smanjeni apetit
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Croatian: Većina slučajeva PMLa bila je dijagnosticirana unutar 12 mjeseci od primjene prve doze bortezomiba.
English: • Loss of consciousness
Croatian: • gubitak svijesti
English: Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Croatian: Bortezomib Accord mora rekonstituirati zdravstveni radnik (vidjeti dio 6.6).
English: Cochran Mantel-Haenszel test.
Croatian: p-vrijednosti Cochran Mantel-Haenszelovog testa.
English: Hepatitis B virus (HBV) reactivation and infection
Croatian: Reaktivacija virusa hepatitisa B (HBV) i infekcija
English: Peripheral neuropathy in combination regimens
Croatian: Periferna neuropatija u kombiniranim režimima
English: Reduction in serum M-protein populationg n=667
Croatian: Smanjenje serumskog M proteina populacijag n=667
English: Overall survival*
Croatian: Ukupno preživljenje*
English: BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Croatian: BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onim zabilježenim u odraslih.
English: • Skin reactions and disorders (which may be severe and life threatening), skin ulcers
Croatian: • kožne reakcije i poremećaji (koji mogu biti teški i opasni poživot), čirevi na koži
English: If any of the side effects, gets serious, or if you notice , any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Croatian: Ako se bilo koja nuspojava pogorša ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, potrebno je odmah obavijestiti liječnika ili ljekarnika.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzDx groups respectively; the majority of patients underwent one single transplant procedure.
Croatian: Autologne transplantate matičnih stanica primilo je 198 (82%) bolesnika odnosno 208 (87%) bolesnika u VDDx i BzDx skupinama; većina bolesnika prošla je jednu transplantaciju.
English: When Bortezomib Accord is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Croatian: Kada se Bortezomib Accord primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).
English: rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Bortezomib Accord should not be used in children and adolescents because it is not known how the medicine will affect them.
Croatian: Accord se ne smije primjenjivati kod djece i adolescenata, jer nije poznato kako će lijek utjecati na njih.
English: Your doctor will work out your dose of Bortezomib Accord according to your height and weight (body surface area).
Croatian: Vaš će liječnik izračunati dozu lijeka Bortezomib Accord prema vašoj visini i težini (površini tijela).
English: 2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
Croatian: 2 godine (za Bortezomib Accord 1 mg) 3 godine (za Bortezomib Accord 3,5 mg)
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm.
Croatian: Antivirusna profilaksa bila je primijenjena u 137 od 240 bolesnika (57%) u BzR-CAP skupini.
English: Treatment with Bortezomib Accord can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Croatian: Liječenje lijekom Bortezomib Accord vrlo često može uzrokovati smanjenje broja crvenih i bijelih krvnih stanica i krvnih pločica (trombocita) u krvi.
English: 1 year survival, [95% CI]
Croatian: 1 godina preživljenja, % [95% CI]
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Accord should be administered after the dialysis procedure (see section 5.2).
Croatian: Budući da dijaliza može smanjiti koncentracije bortezomiba, Bortezomib Accord treba primijeniti nakon postupka dijalize (vidjeti dio 5.2).
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than
Croatian: Bolesnici koji postignu potpuni odgovor mogu nastaviti liječenje tijekom najmanje 2 ciklusa nakon prvog dokaza potpunog odgovora, čak i ako to zahtjeva liječenje u više od 8 ciklusa.
English: 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:
Croatian: Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno
English: d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Croatian: d Log rank test prilagođen za čimbenike stratifikacije: ISS stupnjevanje i broj prethodnih linija.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u <datum>.
English: What Bortezomib Accord is and what it is used for
Croatian: Što je Bortezomib Accord i za što se koristi
English: For these dose cohorts, the combined 1-year survival rate was 88.1%.
Croatian: kombinirana stopa jednogodišnjeg preživljenja iznosila je 88,1%.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Croatian: U slučaju predoziranja potrebno je pratiti vitalne znakove bolesnika te im pružiti odgovarajuće potporne mjere za održavanje krvnog tlaka (kao što je tekućina, presorni lijekovi i/ili inotropni lijekovi) i tjelesne temperature (vidjeti dijelove 4.2
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Croatian: Nositelji hepatitisa B i bolesnici s hepatitisom B u anamnezi, moraju se strogo nadzirati na kliničke i laboratorijske znakove aktivne infekcije HBV-om tijekom i nakon kombiniranog liječenja rituksimabom i bortezomibom.
English: A vial is for single use only and the remaining solution must be discarded.
Croatian: Bočica je samo za jednokratnu primjenu a preostalu otopinu treba baciti.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mental cell lymphona.
Croatian: Nema dokaza koji ukazuju da je neophodna prilagodba doze u bolesnika starijih od 65 godina s multiplim mijelomom ili s limfomom plaštenih stanica.
English: N=240 (ITT population) N=242 (ITT population)
Croatian: N=240 (ITT populacija) N=242 (ITT populacija)
English: Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN
Croatian: Incidencija PN (%) Svi stupnjevi PN ≥ Stupanj 2 PN ≥ Stupanj 3 PN Prekid radi PN (%)
English: Sleep disorders and disturbances*
Croatian: Poremećaji i smetnje spavanja*
English: Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Croatian: Bolesnici s već prisutnom teškom neuropatijom mogu se liječiti bortezomibom samo nakon pomne procjene omjera rizika i koristi.
English: A statistically significant benefit (p < 0.001) in favour of the BzR-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).
Croatian: Statistički značajna korist (p < 0,001) za BzR-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).
English: In the BzTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Croatian: U BzTDx skupini 12% bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16% bolesnika u TDx skupini.
English: 42.9% and 10.4% of patients in the BzR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Croatian: 42,9% i 10,4% bolesnika u BzR-CAP skupini bilo je u dobi unutar raspona 65-74 godina odnosno ≥ 75 godina starosti.
English: Congenital, familial and genetic disorders
Croatian: obiteljski i genetski poremećaji
English: Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Croatian: Fòti ùt 56., Budapest, 1047, Mađarska
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients 229
Croatian: Medijanc(95% CI) (mjeseci) Stopa odgovora n: bolesnici procjenjivi na odgovor
English: • advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
Croatian: • uputstva kako smanjiti rizik zamjene pripremljenih intravenskih i supkutanih štrcaljki
English: Also included are adverse drug reactions identified in the BzR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Croatian: Također su uključene nuspojave identificirane u skupini BzRCAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
English: By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Croatian: stopa odgovora nije ovisila o vrsti mijeloma, funkcionalnom stanju, deleciji kromosoma 13 ili broju i vrsti prethodnih liječenja.
English: No new safety concerns were observed when Bortezomib Accord was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Croatian: Nisu zabilježena nova sigurnosna pitanja kada je Bortezomib Accord bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
English: Pruritus*, Dermatitis*, Rash*
Croatian: Pruritus*, dermatitis*, osip*
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Croatian: Ovo ispitivanje doseglo je svoj primarni cilj, neinferiornost u stopi odgovora (CR+PR) nakon 4 ciklusa samostalno primijenjenog bortezomiba za oba puta primjene, i supkutano i intravenski, 42% u obje skupine.
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja bortezomiba u svim podskupinama pedijatrijske populacije u multiplom mijelomu i limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzR-CAP arm and with at least a possible or probable causal relationship to the components of the BzR-CAP arm, are listed in Table 8 below.
Croatian: Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u BzR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BzR
English: Subcutaneous or Intravenous use.
Croatian: Samo za supkutanu ili intravensku primjenu.
English: How to store Bortezomib Accord Contents of the pack and other information
Croatian: Kako čuvati Bortezomib Accord Sadržaj pakiranja i druge informacije
English: You should not use Bortezomib Accord if you are pregnant, unless clearly necessary.
Croatian: Accord se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
English: Spain
Croatian: Mađarska
English: Median survival for the Bz+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Croatian: Medijan preživljenja za skupinu koja je primala Bz+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
English: b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Croatian: Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Croatian: Kada se primjenjuje talidomid, potrebna je posebna pažnja vezano uz mjere prevencije i testiranje na trudnoću (vidjeti dio 4.6).
English: Instructions for reconstitution Bortezomib Accord must be reconstituted by a healthcare professional.
Croatian: Upute za pripremu Bortezomib Accord mora rekonstituirati zdravstveni radnik.
English: In the BzR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Croatian: U BzR-CAP skupini, 22,5% bolesnika primilo je transfuzije trombocita u usporedbi s 2,9% bolesnika u R-CHOP skupini.
English: Response Rate at 4 cycles n (%)
Croatian: Stopa odgovora u 4 ciklusa n (%)
English: TTP, days [95% CI]
Croatian: TTP, dani [95% CI]
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Croatian: Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije s bortezomibom.
English: Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Braillea.
English: Once weekly Bortezomib Accord (cycles 5-9)
Croatian: Bortezomib Accord jednom tjedno (5.-9. ciklus)
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Croatian: Učestalost se definira kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma
Croatian: Prilagodbe doza u kombiniranom liječenju za bolesnike s progresivnim multiplim mijelomom
English: Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Croatian: Preporučuje se šest ciklusa liječenja bortezomibom, iako se bolesnicima za koje je odgovor prvi put zabilježen u 6. ciklusu, mogu dati dva dodatna ciklusa liječenja bortezomibom.
English: Posterior reversible encephalopathy syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Croatian: Posterior reversible encephalopathy syndrome) Bili su prijavljeni slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) kod bolesnika koji su primali bortezomib.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Croatian: Kombinirano liječenje bortezomibom s pegiliranim liposomalnim doksorubicinom (ispitivanje DOXIL-MMY-3001)
English: * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Croatian: * Primarni ishod a OR za stope odgovora temeljeno na Mantel-Haenszel procjeni zajedničkog omjera izlgleda za stratificirane tablice;
English: In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Croatian: ≥ 75 godina, su oba režima, BzR-CAP kao i R-CHOP, podnosili lošije (vidjeti dio 4.8).
English: When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Croatian: Kad se toksičnost povuče, ponovno uvesti liječenje lijekom lijekom Bortezomib Accord i smanjiti dozu na 0,7 mg/m2 jedanput tjedno.
English: • that Bortezomib Accord is to be given only by intravenous or subcutaneous injections; no other route of administration is allowed
Croatian: • Bortezomib Accord se primjenjuje samo putem intravenske ili supkutane injekcije; bilo koji drugi put primjene nije dozvoljen
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Croatian: Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (BzR-CAP) bile su infekcija hepatitisom B (< 1%) i ishemija miokarda (1,3%).
English: Response Rate at 8 cycles n (%)
Croatian: Stopa odgovora u 8 ciklusa n (%)
English: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Croatian: (CrCL ≥ 60 ml/min/1,73 m2, n=12), blago (CrCL=40-59 ml/min/1,73 m2, n=10), umjereno (CrCL=20-39 ml/min/1,73 m2, n=9) i teško (CrCL < 20 ml/min/1,73 m2, n=3).
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Croatian: Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 bortezomiba dva puta na tjedan.
English: Response rate populatione n=668
Croatian: Stopa odgovora populacijae n = 668