FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Croatian: Bolesnike kod kojih se pojavi nova ili im se pogorša postojeća periferna neuropatija mora se neurološki pregledati, a po potrebi im treba promijeniti dozu, vremenski raspored primjene ili promijeniti put primjene na supkutani (vidjeti dio 4.2).
English: ORe (95% CI)=1.688 p-valueg=0.007
Croatian: ORe (95 % CI)=1,688 p-vrijednostg=0,007
English: Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Croatian: Hiperbilirubinemija*, abnormalan nalaz analize proteina*, smanjena težina, povećana težina
English: Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Croatian: Bzmb=bortezomib; Dx=deksametazon CR=Kompletni odgovor; nCR=blizu kompletnog odgovora
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: Nakon intravenske primjene bolus doze od 1,0 mg/m2 odnosno 1,3 mg/m2 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: The duration of overall response was 21.4 months longer in the BzmbR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Croatian: Trajanje ukupnog odgovora bilo je 21,4 mjeseca duže u BzmbR-CAP skupini (medijan 36,5 mjeseci naspram 15,1 mjeseci u R-CHOP skupini).
English: h 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: Dosage adjustments for transplant eligible patients
Croatian: Prilagodbe doze za bolesnike za koje je prikladna transplantacija
English: > 1.0 x - 1.5 x ULN Any
Croatian: > 1,0 x - 1,5 x GGN Bilo koja
English: - If platelet counts < 25,000 cells/μl.
Croatian: Ako je broj trombocita < 25 000 stanica/μl.
English: 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).
Croatian: ≥ 3 (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).
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Croatian: Incidencija periferene neuropatije svih stupnjeva uz intravensku primjenu bortezomiba bila je niža u prethodnim ispitivanjima s bortezomibom primijenjenim intravenski, nego u ispitivanju MMY-3021.
English: c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Croatian: p < 0,0001 c Populacija s terapijskim odgovorom uključuje bolesnike koji su imali mjerljivu bolesti na početku liječenja i primili su najmanje 1 dozu ispitivanog lijeka.
English: In patients developing PRES, bortezomib should be discontinued.
Croatian: U bolesnika u kojih se razvije PRES mora se prekinuti primjena bortezomiba.
English: When compared to patients with normal hepatic function, mild hepatic impairment did not alter dosenormalised bortezomib AUC.
Croatian: U usporedbi s bolesnicima s normalnom funkcijom jetre, blago oštećenje funkcije jetre nije promijenilo prema dozi normalizirani AUC bortezomiba.
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Croatian: Deboronirani metaboliti bortezomiba ne djeluju kao inhibitori 26S proteasoma.
English: Bortezomib intravenous arm
Croatian: Bortezomib intravenska skupina
English: d 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: Bortezomib SUN should not be given by other routes.
Croatian: Bortezomib SUN ne smije se primijeniti drugim putevima primjene.
English: Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Croatian: U ispitivanju u kojem se liječenje bortezomibom primijenilo ponovno kod 130 bolesnika s relapsom multiplog mijeloma, koji su prethodno imali barem parcijalni odgovor na režim liječenja koji je uključivao bortezomib, najčešći štetni događaji svih stupnjeva, koji su se pojavili u barem 25 % bolesnika bili su trombocitopenija (55 %), neuropatija (40 %), anemija (37 %), proljev (35 %) i konstipacija (28 %).
English: Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved.
Croatian: Prekinuti liječenje Bortezomib SUN-om dok se simptomi toksičnosti ne povuku.
English: LIST OF EXCIPIENTS Excipient: mannitol (E421)
Croatian: POPIS POMOĆNIH TVARI Pomoćna tvar: manitol (E421)
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Croatian: Reaktivacija virusa hepatitisa B (HBV) i infekcija
English: Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Croatian: Šest posto bolesnika imalo je nuspojave na mjestu supkutane primjene, uglavnom crvenilo.
English: Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Croatian: Melfalan (9 mg/m2) i prednizon (60 mg/m2) primjenjuju kroz usta i daju se 1., 2., 3. i 4. dana prvog tjedna primjene tijekom svih ciklusa.
English: TTP, days [95% CI]
Croatian: TTP, mjeseci (95 % CI)
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Croatian: Budući da je bortezomib citotoksično sredstvo i može brzo uništiti zloćudne plazma stanice i stanice limfoma plaštenih stanica, mogu se pojaviti komplikacije zbog sindroma lize tumora.
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Croatian: U bolesnika s uznapredovalim mijelomom, težina trombocitopenije bila je povezana s brojem trombocita prije liječenja: kod početnog broja trombocita < 75 000/μl, 90 % od 21 bolesnika imalo je ≤ 25 000/μl trombocita za vrijeme ispitivanja, uključujući njih 14 % s < 10 000/μl; nasuprot tome, kod početnog broja trombocita > 75 000/μl, samo 14 % od 309 bolesnika imalo je ≤ 25 000/μl trombocita za vrijeme ispitivanja.
English: e 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: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Croatian: U ispitivanju kod bolesnika s prethodno neliječenim limfomom plaštenih stanica, 42,9 % i 10,4 % bolesnika izloženih bortezomibu bilo je dobi unutar raspona 65 - 74 godine odnosno ≥ 75 godina starosti.
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Croatian: Stoga je potrebno pomno pratiti bolesnike kad im se daje bortezomib u kombinaciji s jakim inhibitorima enzima CYP3A4 (npr. ketokonazol, ritonavir).
English: 1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
Croatian: 1.3 Rekonstituirana otopina ne sadrži konzervanse i treba ju primijeniti odmah nakon pripreme.
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Croatian: Tablica 1: Preporučene* prilagodbe doziranja kod neuropatije povezane s bortezomibom Težina neuropatije
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: Week Bzmb (1.3 mg/m2) Day 1, 4
Croatian: Tjedan Bzmb (1,3 mg/m2) Dan 1, 4
English: Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Croatian: 42,9 % i 10,4 % bolesnika u sklupini BzmbR-CAP bilo je dobi unutar raspona 65-74 godine odnosno ≥ 75 godina starosti.
English: A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Croatian: Biološka plauzibilnost podupire povezanost između primjene bortezomiba i nastanka halaciona/blefaritisa; teoretski, mijelosupresija povezana s primjenom bortezomiba može olakšati pojavu virusne infekcije kao što je herpes zoster što pospješuje nastanak halaciona.
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
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: Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Croatian: Bolesnici koji primaju bortezomib u kombinaciji s talidomidom moraju se pridržavati programa za sprječavanje trudnoće.
English: # Post-marketing adverse reaction regardless of indication
Croatian: # Nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji
English: Bortezomib SUN 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).
Croatian: Liječenje Bortezomib SUN-om 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: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Croatian: Ako se primijeti promjena boje ili prisutnost čestica, rekonstituirana otopina mora se odbaciti.
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: 1 year survival, [95% CI]
Croatian: 1-godišnje preživljenje, (95 % CI)
English: Reduce Bortezomib SUN to 1.0 mg/m2
Croatian: Smanjiti dozu Bortezomib SUN-a na 1,0 mg/m2
English: France tel. +33 1 41 44 44 50
Croatian: +33 1 41 44 44 50 Italia
English: Change Bortezomib SUN treatment schedule to 1.3 mg/m2 once per week
Croatian: Promijeniti raspored primjene Bortezomib SUN-a na 1,3 mg/m2 jedanput tjedno
English: Age 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: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-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 BzmbR-CAP skupini i 17 % bolesnika u R-CHOP skupini primilo je 2 dodatna ciklusa.
English: b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Croatian: b Procjena omjera hazarda temelji se na Coxovom modelu stratificiranom prema IPI riziku i stadiju bolesti.
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: b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin,
Croatian: Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
English: Thalidomide causes birth defects and foetal death.
Croatian: Talidomid uzrokuje prirođene poremećaje i dovodi do smrti fetusa.
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 uspoređena je 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: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Croatian: Manje često Cushingov sindrom*, hipertireoza*, neadekvatno lučenje antidiuretskog hormona
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Croatian: Otvoreno ispitivanje faze II s jednom skupinom, MMY-2036 (RETRIEVE), bilo je provedeno kako bi se utvrdile djelotvornost i sigurnost ponovljenog liječenja bortezomibom.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4b
Croatian: Dan 1, 2, 3, 4 Dan 8, 9, 10, 112. do 4.b ciklus
English: You will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Croatian: Imati ćete redovne kontrole krvi prije i tijekom liječenja Bortezomib SUN-om kako bi se redovito provjerio broj krvnih stanica.
English: > 1.5 x - 3 x ULN Any
Croatian: > 1,5 x - 3 x GGN Bilo koja
English: Post-marketing adverse reactions not seen in clinical trials are also included.
Croatian: Također su uključene nuspojave zabilježene nakon stavljanja lijeka u promet, a koje nisu bile primijećene u kliničkim ispitivanjima.
English: In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
Croatian: In vitro ispitivanja na mikrosomima ljudske jetre i ljudskim izoenzimima citokroma P450 s ekspresijom cDNK pokazuju da se bortezomib primarno metabolizira oksidacijom putem enzima citokroma P450, 3A4, 2C19 i 1A2.
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Croatian: Prilagodbe doze za vrijeme i kod ponovnog uvođenja kombiniranog liječenja melfalanom i prednizonom
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Croatian: Meningitis (uključujući bakterijski), infekcija EpsteinBarrovim virusom, genitalni herpes, tonzilitis, mastoiditis, sindrom umora nakon virusa
English: Efficacy results are presented in Table 16:
Croatian: Rezultati djelotvornosti prikazani su u Tablici 16:
English: What Bortezomib SUN contains - The active substance is bortezomib.
Croatian: Što sadrži Bortezomib SUN - Djelatna tvar je bortezomib.
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Croatian: Srednji ukupni tjelesni klirens nakon prve doze iznosio je 102 l/h kod doze od 1,0 mg/m2 i 112 l/h kod doze od 1,3 mg/m2, a nakon sljedećih doza kretao se u rasponu od 15 to 32 l/h kod doze od 1,0 mg/m2 i 18 do 32 l/h kod doze od 1,3 mg/m2.
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2).
Croatian: Liječenje bortezomibom mora se prekinuti kad je broj trombocita < 25 000/μl, a u slučaju kombinacije s melfalanom i prednizonom kad je broj trombocita ≤ 30 000/μl (vidjeti dio 4.2).
English: 43.1 mo
Croatian: 43,1 mjeseci
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzmbR-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 BzmbR-CAP skupini te na 61 % bolesnika u R-CHOP skupini.
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 bortezomib 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 bortezomiba u bolesnika prethodno liječenih zbog amiloidoze lakih lanaca (AL).
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Croatian: Dostupni su ograničeni podaci o ponovljenom liječenju bortezomibom pri relapsu mulitiplog mijeloma.
English: Distribution 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: Peripheral neuropathy in combination regimens Multiple myeloma
Croatian: Periferna neuropatija u kombiniranim režimima
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzmbR-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 BzmbR-CAP skupini i 1,2 % u R-CHOP skupini (vidjeti dio 4.8).
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib SUN as outlined in Table 1.
Croatian: Kod neuropatske boli povezane s bortezomibom i/ili periferne neuropatije, pričekajte s primjenom i/ili prilagodite dozu Bortezomib SUN-a kako je prikazano u Tablici 1.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib SUN together with two other medicines; melphalan and prednisone.
Croatian: Ako se prethodno niste liječili od multiplog mijeloma i niste predviđeni za transplantaciju krvotvornih matičnih stanica, Bortezomib SUN ćete primiti u kombinaciji s druga dva lijeka; melfalan i prednizon.
English: The following medicinal products are administered on day 1 of each Bortezomib SUN 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Croatian: Sljedeći lijekovi primjenjuju se 1. dan svakog 3-tjednog ciklusa liječenja Bortezomib SUN-om kao intravenske infuzije: rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m2.
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 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/m2.
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, ukupno su imali 13 % manju incidenciju nuspojava stupnja toksičnosti 3 ili više, koje su proizašle iz liječenja i 5 % manju incidenciju prekida primjene bortezomiba.
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Croatian: Tablica 5: Prilagodbe doza tijekom liječenja za bolesnike s prethodno neliječenim limfomom plaštenih stanica
English: The solution will be clear and colourless, with a final pH of 4 to 7.
Croatian: Otopina će biti bistra i bezbojna s konačnim pH od 4 do 7. pH otopine ne trebate provjeravati.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Ako primite više Bortezomib SUN-a nego što ste trebali Budući da Vam ovaj lijek daje liječnik ili medicinska sestra, nije vjerojatno da ćete dobiti previše lijeka.