FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (table 15).
Croatian: Dodatno, ishodi djelotvornosti povezani sa sekundarnim odgovorom i vremenom do događaja pokazali su dosljedne rezultate za supkutanu i intravensku primjenu (tablica 15).
English: EBMT criteria g All randomised patients with secretory disease
Croatian: EBMT kriteriji g Svi randomizirani bolesnici sa sekrecijskom bolešću.
English: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
Croatian: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Ujedinjeno Kraljevstvo
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in table 8 below.
Croatian: Nuspojave identificirane poput onih s incidencijom ≥ 1%, slične ili veće incidencije u BR-CAP skupini s barem mogućom ili vjerojatnom uzročnom povezanošću s komponentama skupine BRCAP, navedene su u Tablici 8 ispod.
English: • that bortezomib is to be given only by IV or SC injections; no other route of administration is allowed
Croatian: • bortezomib se primjenjuje samo putem i.v. ili s.c. injekcije; bilo koji drugi put primjene nije dozvoljen
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant
Croatian: U populaciji s refraktornom bolešću u ispitivanju faze II, odgovore na liječenje je utvrdilo neovisno ocjenjivačko povjerenstvo, a odgovor se procjenjivao prema kriterijima Europske skupine za presađivanje koštane srži.
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Croatian: Vaš će liječnik izračunati dozu bortezomiba prema vašoj visini i težini (površini tijela).
English: Hazard ratio b
Croatian: Omjer hazarda b
English: Median a
Croatian: Medijan a
English: Peripheral neuropathy in combination regimens Multiple myeloma
Croatian: Periferna neuropatija u kombiniranim režimima Multipli mijelom
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Croatian: BSA-normalizirani klirens bortezomiba u pedijatrijskih bolesnika bio je sličan onom zabilježenom u odraslih.
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Croatian: Ispitivanja kardiovaskularne sigurnosne farmakologije u majmuna i pasa pokazala su da su intravenske doze koje su približno dva do tri puta veće od preporučene kliničke doze izražene na temelju mg/m2 povezane s povećanjem broja otkucaja srca, smanjenjem kontraktilnosti, hipotenzijom i smrću.
English: Do not use bortezomib - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Croatian: Nemojte primjenjivati Bortezomib Fresenius Kabi ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako imate određene teške plućne ili srčane tegobe.
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Croatian: U slučaju pojave novih ili pogoršanja postojećih plućnih simptoma (npr. Kašalj, dispneja), bolesnicima se mora napraviti brza dijagnostička obrada, te ih je potrebno liječiti na odgovarajući način.
English: Once weekly bortezomib (cycles 5-9)
Croatian: Bortezomib jednom tjedno (5.-9. ciklus)
English: Overall complete response (CR+CRu)
Croatian: Ukupni kompletni odgovor (CR+CRu)
English: (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Croatian: ml/min/1,73 m2, n = 9) i teško (CrCL < 20 ml/min/1,73 m2, n = 3).
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Croatian: b Procjena omjera hazarda (HR) temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: β2-mikroglobulinu, albuminu i regiji.
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Croatian: • Potvrdite dozu i koncentraciju lijeka u štrcaljki prije primjene (provjerite da je štrcaljka označena za intravensku primjenu).
English: This medicine is for intravenous or subcutaneous use.
Croatian: Ovaj lijek je namijenjen za intravensku ili supkutanu primjenu.
English: In addition, the incidence of grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Croatian: Dodatno, incidencija perifernih neuropatija stupnja 3 ili više bila je 10% niža, a stopa prekida primjene zbog perifernih neuropatija bila je 8% niža za supkutanu skupinu u usporedbi s intravenskom skupinom.
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 i 4.4).
English: ** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Croatian: **Instrumentalni ADL: odnosi se na pripremu obroka, kupnju namirnica ili odjeće, korištenje telefona, rukovanje novcem, itd; ***ADL samozbrinjavanja: odnosi se na kupanje, oblačenje i svlačenje, hranjenje, odlazak na toalet, uzimanje lijekova i ne odnosi se na bolesnike koji leže nepokretni u krevetu.
English: Pregnancy and breast-feeding You must not use this medicine if you are pregnant, unless clearly necessary.
Croatian: Ovaj lijek se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
English: Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Croatian: U koncentraciji od 10 µM, bortezomib ne inhibira niti jedan od probranih raznih receptora i proteaza i pokazuje više nego 1500 puta veću selektivnost prema proteasomima nego sljedećem enzimu prema kojem ima afinitet.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx 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 BDx skupinama; većina bolesnika prošla je jednu transplantaciju.
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Croatian: Kinetika inhibicije proteasoma ocjenjivala se in vitro i pokazalo se da se bortezomib razdvaja od proteasoma uz t1/2 od 20 minuta, pokazujući tako da je inhibicija proteasoma bortezomibom reverzibilna.
English: Therefore, caution should be used during handling and preparation of bortezomib.
Croatian: Stoga je potreban oprez tijekom rukovanja i pripreme bortezomiba.
English: The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Croatian: Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja bortezomibom u trajanju od 21-dan kao intravenske infuzije:
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe).
Croatian: *Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
English: c p-value d
Croatian: c p-vrijednost d
English: Also included are adverse drug reactions identified in the BR-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 BRCAP 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: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (bortezomib plus dexamethasone, and bortezomib plus dexamethasone and thalidomide).
Croatian: • upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom kod transplantiranih bolesnika (bortezomib plus deksametazon i bortezomib plus deksametazon i talidomid).
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Croatian: Tablica 12: Rezultati djelotvornosti iz ispitivanja IFM-2005-01
English: 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/m weekly and 1.3 mg/m twice-weekly.
Croatian: 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/m na tjedan i 1,3 mg/m dvaput na tjedan.
English: 9/l on a bortezomib dosing day (other than day 1)
Croatian: 9/l na dan primjene doze bortezomiba (osim 1. dana)
English: The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Croatian: Većina bolesnika u obje skupine završilo je liječenje, 80% u BR-CAP skupini i 82% u RCHOP skupini.
English: No new safety concerns were observed when bortezomib was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Croatian: Nisu zabilježena nova sigurnosna pitanja kada je bortezomib bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
English: This medicinal product does not require any special temperature storage condition.
Croatian: Lijek ne zahtijeva čuvanje na određenoj temperaturi.
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Croatian: Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m primijenjene bolesnicima s multiplim mijelomom (n = 14 u intravenskoj skupini, n = 17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
English: Instructions for reconstitution Bortezomib must be reconstituted by a healthcare professional.
Croatian: Upute za pripremu Bortezomib mora rekonstituirati zdravstveni radnik.
English: 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.
Croatian: 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 100 (44%) sati.
English: Consider dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m in subsequent cycles based on patient tolerability.
Croatian: Razmotriti povećanje doze na 1,0 mg/m ili daljnje smanjenje doze na 0,5 mg/m u sljedećim ciklusima na temelju bolesnikova podnošenja liječenja.
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Croatian: Talidomid je kontraindiciran tijekom trudnoće i u žena reproduktivne dobi osim ako nisu postignuti svi uvjeti talidomidskog programa prevencije trudnoće Celgene.
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Croatian: Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s B+M+P (HR = 0,695; p = 0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.
English: Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Croatian: Potreban je oprez kad se bortezomib kombinira sa supstratima enzima CYP3A4 ili CYP2C19 (vidjeti dio 4.5).
English: 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 B+M+P treatment.
Croatian: 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 B+M+P.
English: The solution should be injected subcutaneously, at 45-90° angle.
Croatian: Otopina se mora injicirati supkutano, pod kutom od 45°-90°.
English: The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Croatian: Ukupna najbolja stopa odgovora (CR + PR), na ponovljeno liječenje u 130 bolesnika, bila je 38,5% (95% CI: 30,1, 47,4).
English: Bortezomib treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however bortezomib may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Croatian: Liječenje bortezomibom se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim bortezomib može primijeniti zdravstveni radnik koji je iskusan u primjeni kemoterapije.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Croatian: AUCtrajanja omjera geometrijske sredine bila je 0,99; a 90% interval pouzdanosti bio je 80,18%
English: Thalidomide causes birth defects and foetal death.
Croatian: Talidomid uzrokuje urođene mane i dovodi do smrti fetusa.
English: • Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Croatian: • Nakon što je otopljena, povucite odgovarajuću količinu rekonstituirane otopine prema dozi izračunatoj na temelju bolesnikove površine tijela.
English: Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing
Croatian: Neki od slučajeva uključuju otežano disanje, nedostatak zraka, nedostatak zraka u stanju bez napora, disanje koje postaje plitko, teško ili prestaje, piskanje
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Croatian: ≥ 75 godina, su oba režima, BR-CAP kao i R-CHOP, podnosili lošije (vidjeti dio 4.8).
English: 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 bortezomib in combination with dexamethasone over bortezomib monotherapy.
Croatian: 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 bortezomib u kombinaciji s deksametazonom nad monoterapijom bortezomibom.
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 nakon pomne procjene omjera rizika i koristi.
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Croatian: Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29-57 %, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m of bortezomib twice weekly.
Croatian: Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m bortezomiba dva puta na tjedan.
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m and included in table 7.
Croatian: Ove nuspojave temelje se na integriranom setu podataka od 5476 bolesnika od kojih je 3996 bilo liječeno bortezomibom u dozi 1,3 mg/m2 te je uvršteno u Tablicu 7.
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Croatian: Tablica 10: Incidencija periferne neuropatije u ispitivanju LYM-3002 prema toksičnosti i prekidu liječenja radi periferne neuropatije BR-CAP (N = 240)
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Croatian: Tablica 13: Rezultati djelotvornosti iz ispitivanja MMY-3010
English: The following adverse reactions (grade ≥ 3) were observed at a higher incidence in the bortezomib 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%).
Croatian: Sljedeće nuspojave (stupnja ≥ 3) zabilježene su u većoj incidenciji kod režima liječenja koji sadrži bortezomib 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%).
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Croatian: Jednu autolognu transplantaciju matičnih stanica primilo je 105 (81%) bolesnika odnosno 78 (61%) bolesnika u BTDx i TDx skupini.
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: 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).
English: Withhold bortezomib treatment until symptoms of toxicity have resolved.
Croatian: Prekinuti liječenje bortezomibom dok se simptomi toksičnosti ne povuku.
English: This medicine contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Croatian: Ovaj lijek sadrži djelatnu tvar bortezomib, koja se naziva „inhibitor proteasoma“.
English: When toxicity resolves re-initiate bortezomib treatment and reduce dose to 0.7 mg/m once per week
Croatian: Kad se toksičnost povuče, ponovno uvesti liječenje bortezomibom i smanjiti dozu na 0,7 mg/m jedanput tjedno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1397/001
Croatian: EU/1/19/1397/001
English: Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Croatian: Muškarci i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i 3 mjeseca nakon liječenja.
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Croatian: Dvije liječene skupine imale su sličnu ukupnu incidenciju događaja krvarenja svih stupnjeva (6,3% u BR-CAP skupini i 5,0% u R-CHOP skupini) kao i stupnja 3 i višeg za događaje krvarenja (BR-CAP: 4 bolesnika [1.7%]; R-CHOP: 3 bolesnika [1,2%]).
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Croatian: U BRCAP skupini, 22,5% bolesnika primilo je transfuzije trombocita u usporedbi s 2,9% bolesnika u RCHOP skupini.
English: (95% CI) p-value c a Kaplan-Meier estimate b
Croatian: (95% CI) p-vrijednost c a Kaplan-Meierova analiza.
English: Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Croatian: 1. stupanj s bolovima ili 2. stupanj (umjereni simptomi; ograničavaju instrumentalne aktivnosti svakodnevnog života (ADL od engl.
English: • If prolonged grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Croatian: • Ako se primijetilo produljeno trajanje neutropenije 4. stupnja ili trombocitopenije ili trombocitopenija s krvarenjem u prethodnom ciklusu
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Croatian: • neutropenija ≥ stupnja 3 s vrućicom, neutropenija stupnja 4 koja traje duže od 7 dana, broj trombocita < 10 000 stanica/μL
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Croatian: • poremećaji ili problemi sa spavanjem, znojenje, tjeskoba, promjene raspoloženja,
English: # Postmarketing adverse reaction regardless of indication
Croatian: # Nuspojave nakon stavljanja lijeka u promet, neovisno o indikaciji
English: Patients with moderate or severe hepatic impairment should be started on bortezomib at a reduced dose of 0.7 mg/m per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m may be considered based on patient tolerability (see table 6 and sections 4.4 and 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre liječenje bortezomibom treba započeti smanjenom dozom od 0,7 mg/m po injekciji tijekom prvog ciklusa liječenja, a naknadno povećanje doze na 1,0 mg/m ili daljnje smanjenje doze na 0,5 mg/m može se razmotriti na temelju podnošljivosti liječenja za bolesnika (vidjeti Tablicu 6 i dijelove 4.4 i 5.2).