FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib SUN 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 Bortezomib SUN-om 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: Daily
Croatian: Dnevno
English: Hypotension Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Croatian: Liječenje bortezomibom često je povezano s ortostatskom/posturalnom hipotenzijom.
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 do primjene odgovornost su korisnika.
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/m2 (n=93) ili ≤ 1,0 mg/m2 (n=37) te je primijenjen 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: Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS
Croatian: Krvarenje u uhu, vestibularni neuronitis, nespecificirani poremećaj uha
English: Bortezomib SUN should not be administered intrathecally.
Croatian: Bortezomib SUN se ne smije primijeniti intratekalno.
English: Bortezomib SUN is for single use only.
Croatian: Bortezomib SUN je samo za jednokratnu primjenu.
English: CR+PRf n (%) p-valued
Croatian: CR+PRf n (%) p-vrijednostd
English: Since dialysis may reduce bortezomib concentrations, Bortezomib SUN should be administered after the dialysis procedure (see section 5.2).
Croatian: Budući da dijaliza može smanjiti koncentracije bortezomiba, Bortezomib SUN treba primijeniti nakon postupka dijalize
English: Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Croatian: Poremećaji i smetnje raspoloženja *, anksiozni poremećaj*, poremećaji i smetnje spavanja* Manje često Mentalni poremećaj*, halucinacije*, psihotični poremećaj*, konfuzija*, nemir
English: N=130 (ITT population)
Croatian: N=130 (ITT
English: Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Sun Pharmaceutical Industries Europe B.V.
English: If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se pripremljena otopina ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja do primjene odgovornost su korisnika.
English: For Bortezomib SUN dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Croatian: Za prilagodbe doziranja Bortezomib SUN-a potrebno je slijediti smjernice za promjenu doze opisane za monoterapiju.
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 ispitivanja faze III (M34101-039 [APEX] i DOXIL MMY-3001), u istoj indikaciji.
English: Adverse reactions are listed below by system organ class and frequency grouping.
Croatian: Nuspojave u daljnjem tekstu navedene su prema klasifikaciji organskih sustava i skupini učestalosti.
English: Therefore, patients who experience constipation should be closely monitored.
Croatian: Stoga bolesnike kod kojih se pojavi zatvor treba pomno pratiti.
English: The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Croatian: Primarne mjere ishoda ispitivanja bile su postindukcijske i posttransplantcijske stope odgovora (CR+nCR).
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Croatian: Periferna embolija, limfedem, bljedoća, eritromelalgija, vazodilatacija, diskoloracija vena, venska insuficijencija
English: Injection under the skin is in either the thighs or the abdomen.
Croatian: Potkožna injekcija primjenjuje se u bedro ili trbuh.
English: The usual starting dose of Bortezomib SUN is 1.3 mg/m2 body surface area twice a week.
Croatian: Uobičajena početna doza Bortezomib SUN-a jest 1,3 mg/m2 površine tijela, dva puta tjedno.
English: Time to progression Events n (%) Mediana (95% CI)
Croatian: Vrijeme do progresije Događaji n (%) Medijana (95 % CI)
English: The incidence of herpes zoster among patients in the Bzmb+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 Bzmb+M+P bila je 17 % u onih kojima se nije primijenila antivirusna profilaksa, u usporedbi s 3 % bolesnika kojima se primijenila antivirusna profilaksa.
English: disease.
Croatian: - smrt.
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Croatian: Gastrointestinalno i intracerebralno krvarenje bilo je prijavljeno u vezi s liječenjem bortezomibom.
English: Four treatment cycles of this combination therapy are administered.
Croatian: Primjenjuju se 4 ciklusa ovog kombiniranog liječenja.
English: Haematological toxicity during a cycle - 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: The overall incidence of hepatitis B infections was similar in patients treated with BzmbR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Croatian: Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BzmbR-CAP i liječnih s R-CHOP (0,8 % odnosno
English: Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Croatian: Medijan preživljenja bez progresije prema procjeni ispitivača bio je 30,7 mjeseci u BzmbR-CAP skupini i 16,1 mjeseci u R-CHOP skupini (omjer hazarda [HR]=0,51; p < 0,001).
English: You might receive up to 8 cycles (24 weeks).
Croatian: Možete primiti do 8 ciklusa (24 tjedna).
English: Efficacy results are presented in Table 11:
Croatian: Rezultati djelotvornosti prikazani su u Tablici 11:
English: N=127 (ITT population)
Croatian: N=127 (ITT
English: What you need to know before you are given Bortezomib SUN You should NOT be given Bortezomib SUN - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine
Croatian: Što morate znati prije nego što počnete primati Bortezomib SUN Bortezomib SUN ne smije se primijeniti: - 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: 12.8 mo
Croatian: 12,8 mjeseci
English: Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
Croatian: Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55 08007 Barcelona España tel.
English: Bortezomib SUN therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl.
Croatian: Liječenje Bortezomib SUN-om mora se prekinuti do 2 tjedna, dok bolesnik ne dostigne apsolutni broj neutrofila ≥ 750 stanica/μl i broj trombocita ≥ 25 000 stanica/μl.
English: Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy
Croatian: Važno: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Bzmb
English: Bortezomib SUN will be administered by a health care professional experienced in the use of cytotoxic medicines.
Croatian: Bortezomib SUN će Vam primijeniti zdravstveni radnik koji ima iskustvo u primjeni citotoksičnih lijekova.
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
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,
English: You may also be given Bortezomib SUN together with the medicines pegylated liposomal doxorubicin or dexamethasone: - When Bortezomib SUN is given together with pegylated liposomal doxorubicin, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
Croatian: Bortezomib SUN Vam se također može dati zajedno s lijekovima koji se zovu pegilirani liposomalni doksorubicin ili deksametazon: - Kada se Bortezomib SUN daje zajedno s pegiliranim liposomalnim doksorubicinom, Bortezomib SUN ćete primiti u venu ili potkožno u ciklusu liječenja koji traje 21 dan.
English: During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Croatian: Tijekom kliničkih ispitivanja, hipoglikemija je bila manje često, a hiperglikemija često zabilježena u bolesnika s dijabetesom koji su primali oralne hipoglikemike.
English: You should not breast-feed while using Bortezomib SUN.
Croatian: Ne smijete dojiti dok primate Bortezomib SUN.
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Croatian: Viale Giulio Richard, 1 20143 Milano
English: Aseptic technique must be strictly observed throughout the handling of Bortezomib SUN, since it contains no preservative.
Croatian: Aseptična tehnika mora se strogo poštovati tijekom cijelog postupka rukovanja Bortezomib SUN-om budući da lijek ne sadrži konzervanse.
English: - If, after Bortezomib SUN has been held, the toxicity does not resolve, as defined above, then Bortezomib SUN must be discontinued.
Croatian: SUN-a, toksičnost ne povuče kako je definirano iznad, Bortezomib SUN se mora prestati primjenjivati.
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Croatian: U ispitivanju IFM-2005-01 bortezomib u kombinaciji s deksametazonom [BzmbDx, n=240] bio je uspoređen s vinkristinom-doksorubicinom-deksametazonom [VDDx, n=242].
English: Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Croatian: Mišićni spazmi*, mišićno-koštana bol*, bol u ekstremitetima
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti”.
English: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Croatian: Ozbiljne nuspojave koje su manje često bile prijavljene tijekom liječenja bortezomibom uključuju zatajenje srca, sindrom lize tumora, plućnu hipertenziju, sindrom posteriorne reverzibilne encefalopatije, akutne difuzne infiltrativne plućne poremećaje i rijetku autonomnu neuropatiju.
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m2) and prednisone (60 mg/m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Croatian: Klinička djelotvornost u prethodno neliječenih bolesnika s multiplim mijelomom Prospektivno, međunarodno, randomizirano (1:1) kliničko ispitivanje faze III otvorenog tipa (MMY3002 VISTA) koje je uključilo 682 bolesnika, provedeno je da bi se utvrdilo hoće li bortezomib (1,3 mg/m2 primijenjen intravenskom injekcijom) u kombinaciji s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) rezultirati boljim vremenom do progresije bolesti (TTP od engl. time to progression) u usporedbi s melfalanom (9 mg/m2) i prednizonom (60 mg/m2) u prethodno neliječenih bolesnika s multiplim mijelomom.
English: You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib SUN for information related to these medicines before starting treatment with Bortezomib SUN.
Croatian: Za informacije o svim lijekovima koji se uzimaju zajedno s Bortezomib SUN-om morate pročitati pripadajuću uputu o lijeku, prije započinjanja liječenja Bortezomib SUN-om.
English: Renal complications are frequent in patients with multiple myeloma.
Croatian: Bubrežne komplikacije česte su u bolesnika s multiplim mijelomom.
English: (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching - arthritis, including inflammation of the joints in the fingers, toes, and the jaw - disorders that affect your lungs, preventing your body from getting enough oxygen.
Croatian: (dodira, sluha, okusa, mirisa), poremećaj pažnje, drhtanje, trzanje mišića - artritis, uključujući upalu zglobova na prstima, nožnim prstima i čeljusti - poremećaji koji djeluju na pluća, i tako onemogućuju dostupnost dovoljne količine kisika
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 zbrinuti.
English: • different reconstitution requirements for Bortezomib SUN 3.5 mg IV or SC use
Croatian: • različite zahtjeve kod pripreme Bortezomib SUN-a 3,5 mg za i.v. ili s.c. put primjene
English: Combination therapy with dexamethasone
Croatian: Kombinacija s deksametazonom
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Croatian: U ispitivanjima s bolesnicima s relapsom multiplog mijeloma liječenih bortezomibom i s bolesnicima s prethodno neliječenim limfomom plaštenih stanica liječenih bortezomibom u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzmbR-CAP), jedna od najčešćih hematoloških toksičnosti bila je prolazna trombocitopenija.
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,
English: This medicine is for intravenous or subcutaneous use.
Croatian: Ovaj lijek je namijenjen za primjenu u venu ili potkožno.
English: There is no known specific antidote for bortezomib overdose.
Croatian: Specifičan antidot kod predoziranja bortezomibom nije poznat.
English: You might receive up to 6 cycles (24 weeks).
Croatian: Možete primiti do 6 ciklusa (24 tjedna).
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib SUN treatment cycle.
Croatian: Melfalan i prednizon trebaju se primijeniti oralno 1., 2., 3. i 4. dan prvog tjedna svakog ciklusa liječenja Bortezomib SUN-om.
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Croatian: U ispitivanje su uključena 222 bolesnika s relapsnim/refraktornim multiplim mijelomom koji su bili randomizirani u omjeru 2:1 kako bi primili bortezomib 1,3 mg/m2, bilo supkutano ili intravenski, u 8 ciklusa.
English: Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Croatian: Reakcije koje bi mogle biti posredovane imunokompleksima Manje su često prijavljene reakcije koje bi mogle biti posredovane imunokompleksima, kao što su reakcija tipa serumske bolesti, poliartritis s osipom i proliferativni glomerulonefritis.
English: Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Croatian: Stoga ćete prije i za vrijeme liječenja Bortezomib SUNom morati ići na redovite kontrole krvi kako bi se redovito provjerio broj krvnih stanica.
English: In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Croatian: U ispitivanjima opće toksičnosti u više ciklusa koja su provedena u štakora i majmuna, glavni ciljni organi bili su probavni sustav, što se očitovalo povraćanjem i/ili proljevom; hematopoetska i limfatična tkiva što se očitovalo citopenijama u perifernoj krvi, atrofijom limfnog tkiva i krvotvornom hipocelularnošću koštane srži; periferna neuropatija (primijećena u majmuna, miševa i pasa) koja je uključivala aksone senzornih živaca; i blage promjene na bubrezima.
English: Injection sites should be rotated for successive injections.
Croatian: Za uzastopne injekcije treba mijenjati mjesta primjene injekcije.
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Croatian: Značajne razlike u populaciji bolesnika s limfomom plaštenih stanica kada se usporede s ispitivanjima s bolesnicima s multiplim mijelomom bile su ≥ 5 % viša incidencija hematoloških nuspojava (neutropenija, trombocitopenija, leukopenija, anemija, limfopenija), periferna senzorna neuropatija, hipertenzija, pireksija, pneumonija, stomatitis i poremećaji dlakavosti.
English: Bortezomib may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Croatian: Bortezomib može vrlo često biti povezan s umorom, često s omaglicom, manje često sa sinkopom i često s ortostatskom/posturalnom hipotenzijom ili zamagljenim vidom.
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Croatian: Rizik od sindroma lize tumora postoji u bolesnika s velikom tumorskom masom prije liječenja.
English: Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy.
Croatian: Važno: OR > 1 ukazuje na prednost za uvodno liječenje koje sadrži Bzmb.
English: Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Croatian: Plodnost Nisu provedena ispitivanja utjecaja bortezomiba na plodnost (vidjeti dio 5.3).
English: Neuropathic pain and/or peripheral neuropathy 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 kod 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: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za bortezomib, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) bortezomib nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)*
Croatian: Kornelane lezije*, egzoftalmus, retinitis, skotom, nespecificirani poremećaj oka (uključujući kapak), stečeni dakrioadenitis, fotofobija, fotopsija, optička neuropatija#, različiti stupnjevi oštećenja vida (do
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib SUN (both IV and SC use) required for different body surface areas.
Croatian: • upute za doziranje s primjerima: kako izračunati površinu tijela bolesnika i volumen rekonstituirane otopine Bortezomib SUN-a (za oba puta primjene, i.v. i s.c.) s obzirom na različite tjelesne površine.
English: RR (Post-induction) *CR+nCR
Croatian: RR (Postindukcijska) *CR+nCR
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: 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*,
English: - Injection sites should be rotated for successive injections.
Croatian: - Za uzastopne injekcije treba mijenjati mjesta primjene injekcije.
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: volumen distribucije u stanju dinamičke ravnoteže bio je 834 (39%) l/m2, i poluvijek eliminacije bio je 100 (44%) sati.
English: Bzmb=Bortezomib SUN; 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: Bzmb=Bortezomib SUN; 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.