FrancophonIA/ELRC3.0 huggingface dataset:
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP).
Croatian: Infekcija HBV-om sa smrtonosnim ishodima pojavila se kod 0,8 % (n=2) bolesnika u skupini koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; RCHOP) i u 0,4 % (n=1) bolesnika koji su primali bortezomib u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzmbR-CAP).
English: Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Croatian: U rijetkim je slučajevima zabilježeno zatajenje jetre u bolesnika s ozbiljnim zdravstvenim stanjem koji su istodobno primali bortezomib i konkomitantne lijekove.
English: It is not known whether bortezomib is excreted in human milk.
Croatian: Nije poznato izlučuje li se bortezomib u majčino mlijeko.
English: 1 prior line of therapy
Croatian: 1 linija prethodnog liječenja
English: Common Vision abnormal*
Croatian: Abnormalan vid*
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-valuea
Croatian: Stopa odgovora u 4 ciklusa n (%) ORR (CR+PR) p-vrijednosta
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzmbR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Croatian: U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), postojala je viša incidencija (56,7 % naspram 5,8 %) trombocitopenije stupnja ≥ 3 u skupini liječenoj bortezomibom (BzmbRCAP) u usporedbi sa skupinom koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon [R-CHOP]).
English: Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Croatian: Dispneja*, epistaksa, infekcija gornjih/donjih dišnih puteva*, kašalj*
English: Very common side effects (may affect more than 1 in 10 people) - sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage - reduction in the number of red blood cells and/or white blood cells (see above) - fever - feeling sick (nausea) or vomiting, loss of appetite - constipation with or without bloating (can be severe) - diarrhoea: if this happens, it is important that you drink more water than usual.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - osjetljivost, utrnulost, trnci ili osjećaj žarenja kože ili bol u šakama ili stopalima zbog oštećenja živaca - smanjenje broja crvenih i/ili bijelih krvnih stanica (vidjeti iznad) - vrućica - mučnina ili povraćanje, gubitak apetita - zatvor s ili bez nadutosti (može biti težak) - proljev: u tom slučaju, važno je da pijete više vode nego inače.
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Croatian: Za dodatne informacije vezane uz pegilirani liposomalni doksorubicin, vidjeti odgovarajući Sažetak opisa svojstava lijeka.
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Croatian: Za potvrdu dijagnoze koristi se prikaz mozga, po mogućnosti magnetska rezonanca (MRI, od engl.
English: 10 ml Type 1 tubular colourless glass vial with a grey bromobutyl rubber stopper, sealed with a light green flip off aluminium seal containing 3.5 mg bortezomib.
Croatian: Cjevasta staklena bočica (staklo tip 1) od 10 ml sa sivim brombutilnim gumenim čepom i aluminijskim prstenom sa svijetlozelenom kapicom koja sadrži 3,5 mg bortezomiba.
English: Bzmb (1.3 mg/m2) Day 1, 4
Croatian: Bzmb (1,3 mg/m2) Dan 1, 4
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Croatian: • savjeti vezani uz put /način primjene za oba puta primjene i.v. i s.c., uključujući potrebu promjene mjesta injiciranja kod s.c. puta primjene.
English: United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
Croatian: +40 (264) 501 500 United Kingdom Ranbaxy UK Ltd a Sun Pharma Company
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Croatian: Zatajenje jetre, hepatomegalija, Budd-Chiarijev sindrom, citomegalovirusni hepatitis, krvarenje jetre, kolelitijaza
English: Tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma: - grčenje mišića, slabost mišića - smetenost, gubitak vida ili smetnje vida, sljepoću, napadaje, glavobolje - nedostatak zraka, oticanje stopala ili promjene broja otkucaja srca, visoki krvni tlak, umor,
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
Croatian: Prema planu ispitivanja, bolesnici su mogli primiti deksametazon ako je njihov odgovor na liječenje samo bortezomibom bio slabiji od optimalnog.
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Croatian: Klinička djelotvornost kod prethodno neliječenog limfoma plaštenih stanica (MCL) Ispitivanje LYM-3002 bilo je randomizirano, otvoreno ispitivanje faze III koje je uspoređivalo djelotvornost i sigurnost kombinacije bortezomiba, rituksimaba, ciklofosfamida, doksorubicina i prednizona (BzmbR-CAP; n=243) s onima kombinacije rituksimaba, ciklofosfamida, doksorubicina, vinkristina, i prednizona (R-CHOP; n=244) u odraslih bolesnika s prethodno neliječenim limfomom plaštenih stanica (Stadij II, III ili IV).
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-valuea
Croatian: Stopa odgovora u 8 ciklusa n (%) ORR (CR+PR) p-vrijednosta
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Croatian: Talidomid se primjenjuje oralno, 50 mg dnevno, od 1. do 14. dana i, u slučaju da se podnosi, doza se povisuje na 100 mg tijekom 15. - 28. dana, a potom se može dalje povisiti na 200 mg dnevno od 2. ciklusa (vidjeti Tablicu 4).
English: VDDx=vincristine, doxorubicin, dexamethasone; BzmbDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzmbTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Croatian: VDDx=vinkristin, doksorubicin, deksametazon; BzmbDx=bortezomib, deksametazon; TDx=talidomid, deksametazon; BzmbTDx=bortezomib, doksorubicin, deksametazon; PN=periferna neuropatija Važno: Periferna neuropatija je uključila preferirane termine: periferna neuropatija, periferna motorna neuropatija, periferna senzorna neuropatija i polineuropatija.
English: Hepatic reactions
Croatian: Jetrene reakcije
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Croatian: ciklusa nadalje ako se podnosi doza od 100 mg. b Bolesnicima koji nakon 4 ciklusa postignu najmanje parcijalni odgovor može se dati do 6 ciklusa
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Croatian: Aplazija, gastrointestinalne malformacije, ihtioza
English: Bortezomib SUN is for intravenous or subcutaneous use.
Croatian: Bortezomib SUN je namijenjen za intravensku ili supkutanu primjenu.
English: Once the symptoms of the toxicity have resolved, Bortezomib SUN treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
Croatian: Kad se simptomi toksičnosti povuku, može se ponovno uvesti liječenje Bortezomib SUN-om uz dozu smanjenu za 25 % (1,3 mg/m2 smanjeno na 1,0 mg/m2; 1,0 mg/m2 smanjeno na 0,7 mg/m2).
English: There have been reports of PRES in patients receiving bortezomib.
Croatian: Prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) kod bolesnika koji su primali bortezomib.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Croatian: Vam liječnik može predložiti dodatne preglede i praćenje.
English: If you have not been treated before for mantle cell lymphoma you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Croatian: Ako Vam prethodno nije liječen limfom plaštenih stanica, Bortezomib SUN ćete primiti u venu ili potkožno zajedno s lijekovima rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom.
English: Main efficacy results are presented in Table 13.
Croatian: Glavni rezultati djelotvornosti prikazani su u Tablici 13.
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction Rare
Croatian: Manje često Vaginalno krvarenje, genitalna bol*, erektilna disfunkcija
English: - When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
Croatian: - Kada se Bortezomib SUN daje zajedno s deksametazonom, Bortezomib SUN ćete primiti u venu ili potkožno u ciklusu liječenja koji traje 21 dan.
English: There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Croatian: Ne postoje ispitivanja o primjeni bortezomiba u starijih bolesnika s prethodno neliječenim multiplim mijelomom za koje je prikladna kemoterapija u visokim dozama, s transplantacijom hematopoetskih matičnih stanica.
English: Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Croatian: Primjetne razlike sigurnosnog profila bortezomiba primijenjenog kao monoterapija supkutano u odnosu na intravensku primjenu
English: Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Croatian: Vrlo često Neuropatije*, periferna senzorna neuropatija, disestezija*, neuralgija*
English: A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Croatian: Ispitivanje interakcija lijekova kojim se procjenjivao učinak ketokonazola, jakog CYP3A4 inhibitora na farmakokinetiku bortezomiba (primijenjenog intravenski), pokazalo je prosječno povećanje AUC bortezomiba za 35 % (CI90 % [1,032 do 1,772]) na temelju podataka o 12 bolesnika.
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Croatian: Zloćudna novotvorina, plazmocitna leukemija, karcinom renalnih stanica, izraslina, Mycosis fungoides, dobroćudna novotvorina*
English: The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Croatian: Najčešće prijavljene nuspojave tijekom liječenja bortezomibom jesu mučnina, proljev, zatvor, povraćanje, umor, pireksija, trombocitopenija, anemija, neutropenija, periferna neuropatija (uključujući senzornu), glavobolja, parestezija, smanjeni apetit, dispneja, osip, herpes zoster i mialgija.
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication#
Croatian: Tablica 7: Nuspojave u bolesnika s multiplim mijelomom liječenih bortezomibom u kliničkim ispitivanjima i nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji#
English: BzmbR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Croatian: BzmbR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin i prednizon; R-CHOP= rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; PN=periferna neuropatija Periferna neuropatija uključila je preporučene izraze: periferna senzorna neuropatija, periferna neuropatija, periferna motorna neuropatija i periferna senzorno-motorna neuropatija
English: 20.7 mo
Croatian: 20,7 mjeseci
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.5 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Croatian: CI= interval pouzdanosti; CR=kompletni odgovor; nCR=blizu kompletnog odgovora; ITT=populacija bolesnika s namjerom liječenja; RR=stopa odgovora; Bzmb=bortezomib; BzmbDx=bortezomib, deksametazon; VDDx=vinkristin, doksorubicin, deksametazon; VGPR=vrlo dobar parcijalni odgovor; PR=parcijalni odgovor; OR=omjer izgleda.
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Croatian: Sigurnosni profil bortezomiba u 240 bolesnika s MCL-om liječenih s 1,3 mg/m2 bortezomiba u kombinaciji s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzmbR-CAP), naspram 242 bolesnika liječenih s rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom i prednizonom [R-CHOP] bio je relativno sukladan onom zapaženom u bolesnika s multiplim mijelomom s glavnim razlikama koje su opisane ispod.
English: Table 6: Recommended starting dose modification for Bortezomib SUN in patients with hepatic impairment Grade of hepatic impairment*
Croatian: Tablica 6: Preporučena prilagodba početne doze Bortezomib SUN-a u bolesnika s oštećenjem jetre
English: • to remind that patients receiving Bortezomib SUN in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Croatian: • kako bi se podsjetilo bolesnike koji primaju Bortezomib SUN u kombinaciji s talidomidom da se moraju pridržavati talidomidskog programa prevencije trudnoće, s upućivanjem na
English: Package leaflet: Information for the user Bortezomib SUN 3.5 mg powder for solution for injection bortezomib
Croatian: Uputa o lijeku: Informacije za korisnika Bortezomib SUN 3,5 mg prašak za otopinu za injekciju bortezomib
English: Bortezomib SUN 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Croatian: Bortezomib SUN 3,5 mg prašak za otopinu za injekciju JE ZA SUPKUTANU ILI INTRAVENSKU PRIMJENU.
English: - If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl, Bortezomib SUN may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
Croatian: - Ako se toksičnost povuče, tj. bolesnik ima apsolutni broj neutrofila ≥ 750 stanica/μl i broj trombocita ≥ 25 000 stanica/μl, Bortezomib SUN se može ponovno uvesti u dozi smanjenoj za jednu razinu doze (s 1,3 mg/m2 na 1 mg/m2 ili s 1 mg/m2 na
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Croatian: Tablica 9: Incidencija periferne neuropatije tijekom uvodnog liječenja u odnosu na toksičnost i prekid liječenja radi periferne neuropatije
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Croatian: Klinička djelotvornost kod relapsa ili refraktornog multiplog mijeloma Sigurnost i djelotvornost primjene bortezomiba (primijenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1 - 3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
English: Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Croatian: Hipermagnezijemija*, acidoza, neravnoteža elektrolita*, preopterećenje tekućinom, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, poremećaj metabolizma, nedostatak vitamina B kompleksa, nedostatak vitamina B12, giht, pojačani apetit, netolerancija na alkohol
English: Concomitant medicinal products
Croatian: Istodobno primijenjeni lijekovi
English: 15.0 mo
Croatian: 15,0 mjeseci
English: Common Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Croatian: Edem (uključujući periferni), zimica, reakcija na mjestu injekcije*, malaksalost*
English: Both men and women receiving Bortezomib SUN must use effective contraception during and for up to 3 months after treatment.
Croatian: I muškarci i žene moraju koristiti djelotvorna kontracepcijska sredstva dok su na liječenju Bortezomibom SUN-om te do 3 mjeseca nakon liječenja.
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Croatian: Bolesnici kod kojih je transplantacija matičnih stanica prikladna Dva randomizirana, otvorena, multicentrična ispitivanja faze III (IFM-2005-01, MMY-3010) bila su provedena radi utvrđivanja sigurnosti i djelotvornosti bortezomiba u dvostrukoj ili trostrukoj kombinaciji s drugim kemoterapeuticima, kao uvodno liječenje prije transplantacije matičnih stanica u bolesnika s prethodno neliječenim multiplim mijelomom.
English: Common Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Croatian: Disakuzija (uključujući tinitus)* Manje često Vertigo*, oštećenje sluha (do i uključujući gluhoću)
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 izgleda za stratificirane tablice; pvrijednosti Cochran Mantel-Haenszelovog testa.
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients Overall complete response (CR+CRu)f n(%)
Croatian: Medijanc(95 % CI) (mjeseci) Stopa odgovora n: bolesnici procjenjivi na odgovor
English: *RR (Post-induction) CR+nCR
Croatian: *RR (Postindukcijska) CR+nCR
English: However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Croatian: Međutim, dokazana kemijska i fizikalna stabilnost rekonstituirane otopine je 8 sati na temperaturi od 25 °C kad se prije primjene čuva u originalnoj bočici i/ili štrcaljki.
English: Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Croatian: Kada je klinički prikladna za liječenje trombocitopenije u obzir se mora uzeti transfuzija trombocita.
English: Main efficacy results are presented in Table 12.
Croatian: Glavni rezultati djelotvornosti prikazani su u Tablici 12.
English: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Croatian: Trombociti su bili najniži 11. dana svakog ciklusa liječenja bortezomibom i obično su se povukli do početnog stanja do sljedećeg ciklusa.
English: Unopened vial 18 months.
Croatian: 18 mjeseci.
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzmbTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Croatian: U ispitivanju MMY-3010 uvodno liječenje bortezomibom u kombinaciji s talidomidom i deksametazonom [BzmbTDx, n=130] bilo je uspoređeno s liječenjem talidomidom-deksametazonom [TDx, n=127].
English: Bortezomib SUN powder has to be dissolved before administration.
Croatian: Bortezomib SUN prašak za otopinu potrebno je otopiti prije primjene.
English: • storage precautions for reconstituted solution
Croatian: • čuvanje i mjere opreza rekonstituirane otopine
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Croatian: U bolesnika s B-staničnom ALL s relapsom unutar 18 mjeseci od dijagnoze (n = 27) stopa kompletnog odgovora bila je 67% (95% CI: 46, 84); stopa četveromjesečnog preživljenja bez događaja bila je 44% (95% CI: 26, 62).
English: - If local injection site reactions occur following Bortezomib SUN injection subcutaneously, either a less concentrated Bortezomib SUN solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Croatian: - Ako se nakon supkutane injekcije Bortezomib SUN-a pojave reakcije na mjestu primjene, supkutano se može primijeniti otopina Bortezomib SUN-a manje koncentracije (1 mg/ml umjesto 2,5 mg/ml) ili se preporučuje prijeći na intravensku injekciju.
English: 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Croatian: Medijan OS bio je 30,8 mjeseci (95 % CI; 25,2 - 36,5 mjeseci) za bolesnike na monoterapiji bortezomibom i 33,0 mjeseci (95 % CI; 28,9 - 37,1 mjeseci) za bolesnike na kombiniranom liječenju bortezomibom s pegiliranim liposomalnim doksorubicinom.