FrancophonIA/ELRC3.0 huggingface dataset:
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/m2 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: If Bortezomib Hospira is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Croatian: Ako se Bortezomib Hospira primjenjuje tijekom trudnoće ili ako bolesnica zatrudni za vrijeme primanja ovog lijeka, bolesnicu se mora upozoriti na mogući rizik za fetus.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib Hospira therapy.
Croatian: Također se preporučuje da bolesnici u kojih postoji terapijski odgovor, ali nije postignuta kompletna remisija, prime ukupno 8 ciklusa terapije lijekom Bortezomib Hospira.
English: Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Croatian: Autonomna neuropatija može biti povezana s bortezomibom ili bortezomib može pogoršati podležeće stanje kao što su dijabetička neuropatija ili neuropatija kod amiloidoze.
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Croatian: Cushingov sindrom*, hipertireoza*, neadekvatno lučenje antidiuretskog hormona
English: The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Croatian: Incidencija herpes zostera među bolesnicima u BR-CAP skupini bila je 10,7% za bolesnike kojima nije bila primijenjena antivirusna profilaksa u usporedbi s 3,6% za bolesnike kojima je primijenjena antivirusna profilaksa (vidjeti dio 4.4).
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Croatian: Bolesnicima za koje je odgovor na liječenje prvi put zabilježen u 6. ciklusu primijenjena su dva dodatna ciklusa liječenja.
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: Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
Croatian: Antivirusna profilaksa se primijenila u 26% bolesnika u skupini koja je primala B+M+P.
English: Caution should be exercised when Bortezomib Hospira is combined with CYP3A4or CYP2C19 substrates (see section 4.5).
Croatian: Potreban je oprez kad se Bortezomib Hospira kombinira sa supstratima enzima CYP3A4 ili CYP2C19 (vidjeti dio 4.5).
English: Each pack contains 1 single-use vial.
Croatian: Jedno pakiranje sadrži 1 bočicu za jednokratnu primjenu.
English: tiredness, confusion, blindness or other vision problems.
Croatian: smetenost, sljepoću ili druge probleme s vidom.
English: Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Croatian: Stoga se ne preporučuje istodobna primjena bortezomiba i jakih induktora enzima CYP3A4 (npr. rifampicina, karbamazepina, fenitoina, fenobarbitala i gospine trave), jer djelotvornost može biti smanjena.
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Croatian: Medijan od 6 dana bio je potreban za prolazak nuspojave, a u dvoje bolesnika bila je potrebna promjena doze.
English: • ≥ 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 dulje od 7 dana, broj trombocita < 10 000 stanica/μl
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: 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: Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Croatian: Iako su bolesnici u dobi od ≥ 75 godina podnosili lošije i BR-CAP i R-CHOP, stopa ozbiljnih nuspojava u BR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over
Croatian: Stoga se ne preporučuje ovaj specifični režim s istodobnom primjenom visokih doza citarabina (2 g/m na dan) kontinuiranom infuzijom u trajanju od 24 sata.
English: Reduction in serum M-protein population g n=667
Croatian: Smanjenje serumskog M proteina populacija g n=667 >=90% n (%)
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Croatian: Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih odgađanja primjena ciklusa.
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Croatian: Analiza odgovarajućih parova je statistička metoda u kojoj se bolesnici u liječenoj skupini (npr. bortezomib u kombinaciji s deksametazonom) i bolesnici u usporednoj skupini (npr. bortezomib) učine usporedivima s obzirom na zbunjujuće čimbenike, tako da se individualno uparuju ispitanici u ispitivanju.
English: Bortezomib Hospira may have a moderate influence on the ability to drive and use machines.
Croatian: Bortezomib Hospira može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Confirm the dose and concentration in the syringe prior to use (check that the syringe is markedas intravenous administration).
Croatian: - Potvrdite dozu i koncentraciju lijeka u štrcaljki prije primjene (provjerite da je štrcaljka označena za intravensku primjenu).
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL = 40-59 ml/min/1.73 m2, n=10), Moderate (CrCL = 20
Croatian: Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno (CrCL ≥ 60 ml/min/1,73 m2, n=12), blago (CrCL=40-59 ml/min/1,73 m2, n=10), umjereno (CrCL=20
English: • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Croatian: • Broj trombocita mora biti ≥ 75 000 stanica/μl u bolesnika s infiltracijom koštane srži i sa sekvestracijom u slezeni
English: The median duration of complete response was 42.1 months in the BR-CAP group compared with 18 months in the RCHOP group.
Croatian: Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u BR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Croatian: CR=Kompletni odgovor; CRu=Nepotvrđeni kompletni odgovor; PR=Djelomični odgovor; CI=Interval pouzdanosti, HR=Omjer hazrda; OR=Omjer izgleda; ITT=Populacija s namjerom liječenja
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Croatian: Bolesnici su imali mijelom IgG/IgA/lakih lanaca u 63%/25%/8% slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 10
English: Bortezomib Hospira treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Hospira may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Croatian: Liječenje lijekom Bortezomib Hospira se mora započeti pod nadzorom liječnika koji je iskusan u liječenju bolesnika s rakom, međutim lijek Bortezomib Hospira mogu primjenjivati zdravstveni radnici iskusni u primjeni kemoterapije.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Croatian: Deksametazon je bio primijenjen u kombinaciji s bortezomibom u 83 bolesnika u 1. ciklusu, te u dodatnih 11 bolesnika koji su deksametazon primili tijekom ponovnog liječenja bortezomibom.
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib Hospira only after careful risk/benefit assessment.
Croatian: Bolesnici s već prisutnom teškom neuropatijom mogu se liječiti lijekom Bortezomib Hospira nakon pomne procjene omjera rizika i koristi.
English: SGOT (AST) levels
Croatian: Razine SGOT (AST)
English: The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Croatian: Trajanje ukupnog odgovora bilo je 21,4 mjeseca dulje u BR-CAP skupini (medijan 36,5 mjeseci naspram 15,1 mjeseci u R-CHOP skupini).
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Croatian: Tijekom kliničkog ispitivanja, dvoje bolesnika (od 2) koji su primali visoku dozu citarabina (2 g/m2 na dan) kontinuiranom infuzijom u trajanju od 24 sata s daunorubicinom i bortezomibom zbog relapsa akutne mijeloične leukemije umrla su od ARDS na početku liječenja, a ispitivanje je bilo prekinuto.
English: Response Evaluable Population n=73
Croatian: Populacija u kojoj se odgovor može procijeniti n=73
English: Bortezomib Hospira reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: Rekonstituirana otopina Bortezomib Hospira primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: Six Bortezomib Hospira cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib Hospira cycles may be given.
Croatian: Preporučuje se šest ciklusa liječenja lijekom Bortezomib Hospira, iako se bolesnicima za koje je odgovor prvi put zabilježen u 6. ciklusu, mogu dati dva dodatna ciklusa liječenja lijekom Bortezomib Hospira.
English: Therefore, caution should be used during handling and preparation of Bortezomib Hospira.
Croatian: Stoga je potreban oprez tijekom rukovanja i pripreme lijeka Bortezomib Hospira.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Croatian: Talidomid je poznata za ljude teratogena djelatna tvar koja uzrokuje teška, po život opasna, prirođena oštećenja.
English: Patients should be closely monitored when given Bortezomib Hospira in combination with potent CYP3A4-inhibitors.
Croatian: Bolesnike treba pomno pratiti kada primaju Bortezomib Hospira u kombinaciji s jakim inhibitorima enzima CYP3A4.
English: Common Rash*, Pruritus*, Erythema, Dry skin
Croatian: Često osip*, pruritus*, eritem, suha koža
English: An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Croatian: Omjer izgleda (OR) > 1 ukazuje na prednost za BR-CAP.
English: OR; 95% CI; P value a
Croatian: OR; 95% CI; P vrijednost a
English: What Bortezomib Hospira is and what it is used for
Croatian: Što je Bortezomib Hospira i za što se koristi
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Hospira
Croatian: Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s lijekom Bortezomib Hospira
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 u 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: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Croatian: • upute kako smanjiti rizik zamjene i.v. i s.c. pripremljenih štrcaljki
English: What you need to know before you use Bortezomib Hospira
Croatian: Što morate znati prije nego počnete primjenjivati Bortezomib Hospira
English: If you are given bortezomib for multiple myeloma or mantle cell lymphoma, 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,
Croatian: Ako bortezomib primate za multipli mijelom ili limfom plaštenih stanica, 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 usual starting dose of bortezomib is 1.3 mg/m2 body surface area twice a week.
Croatian: Uobičajena početna doza bortezomiba je 1,3 mg/m2 površine tijela, dva puta tjedno.
English: When toxicity resolves re-initiate Bortezomib Hospira treatment and reduce dose to 0.7 mg/m2 once per week.
Croatian: Kad se toksičnost povuče, ponovno uvesti liječenje lijekom Bortezomib Hospira i smanjiti dozu na 0,7 mg/m jedanput tjedno.
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Croatian: Tablica 10: Incidencija periferne neuropatije u ispitivanju LYM-3002 prema toksičnosti i prekidu liječenja radi periferne neuropatije
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with Bortezomib Hospira at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Croatian: Izloženost bortezomibu povećana je u bolesnika s umjereno ili teško oštećenom jetrom; te bolesnike treba liječiti smanjenim dozama lijeka Bortezomib Hospira i pomno ih pratiti na znakove toksičnosti (vidjeti dijelove 4.2 i 5.2).
English: Other medicines and Bortezomib Hospira 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: Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of bortezomib twice weekly.
Croatian: Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 bortezomiba dva puta na tjedan.
English: The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Croatian: Ukupno vrijeme čuvanja rekonstituiranog lijeka ne smije prijeći 8 sati, prije primjene.
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild,
Croatian: * Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
Croatian: • Broj trombocita mora biti ≥ 100 000 stanica/μl i apsolutni broj neutrofila (ABN) mora biti ≥
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 u kojih se pojavi nova ili im se pogorša postojeća periferna neuropatija mora se neurološki pregledati, a po potrebi im treba promijeniti dozu ili vremenski raspored primjene ili promijeniti put primjene na supkutani (vidjeti dio 4.2).
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Hospira is provided with educational material.
Croatian: Nositelj odobrenja će osigurati dostupnost edukacijskog materijala svim zdravstvenim radnicima koji su uključeni u postupak propisivanja, doziranje, pripremu i primjenu lijeka Bortezomib Hospira.
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Croatian: Rijetko anafilaktički šok, amiloidoza, reakcija tipa III posredovana imunokompleksima
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 na 1. dan svakog ciklusa liječenja bortezomibom u trajanju od 21-dan kao infuzije u venu:
English: Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Croatian: Često hiperbilirubinemija*, abnormalan nalaz analize proteina*, smanjena težina, povećana težina
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% < 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: Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Croatian: Bortezomib se primjenjuje u venu ili potkožno na 1., 4., 8. i 11. dan, nakon čega slijedi ‘period odmora' bez liječenja.
English: Patients in the BTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Croatian: Medijan dobi bolesnika u BTDx odnosno TDx skupini, bio je 57 naspram 56 godina, 99% naspram 98% bolesnika bili su bijele rase, a 58% naspram 54% bili su muškarci.
English: A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Croatian: Ukupno je 74 bolesnika, koje se moglo procijeniti, primilo deksametazon u kombinaciji s bortezomibom.
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Croatian: Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BR-CAP i liječenih s R-CHOP (0,8% odnosno 1,2%).
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Croatian: Budući da je bortezomib citotoksičan lijek i može brzo uništiti zloćudne plazmatske stanice i stanice limfoma plaštenih stanica, mogu se pojaviti komplikacije zbog sindroma lize tumora.
English: Pregnancy and breast-feeding You should not use bortezomib if you are pregnant, unless clearly necessary.
Croatian: Bortezomib se ne smije primjenjivati ako ste trudni, osim ako to nije jasno neophodno.
English: Bortezomib Hospira therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
Croatian: Liječenje lijekom Bortezomib Hospira mora se uskratiti 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: You will have to take regular blood tests before and during your treatment with Bortezomib Hospira, to check your blood cell counts regularly.
Croatian: Imat ćete redovne kontrole krvi prije i tijekom liječenja lijekom Bortezomib Hospira, kako bi se redovito provjerio broj krvnih stanica.
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BR-CAP in a clinical trial.
Croatian: Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s BR-CAP u kliničkom ispitivanju
English: p-value d < 0.001
Croatian: p-vrijednost d < 0,001
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 periferne neuropatije svih stupnjeva uz intravensku primjenu bortezomiba bila je niža u prethodnim ispitivanjima s bortezomibom primijenjenim intravenski, nego u ispitivanju MMY-3021.
English: • to remind that patients receiving Bortezomib Hospira 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 lijek Bortezomib Hospira u kombinaciji s talidomidom da se moraju pridržavati talidomidskog programa prevencije trudnoće, s upućivanjem na SPC za talidomid za dodatne informacije.
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 System Organ Class
Croatian: Tablica 7: Nuspojave u bolesnika s multiplim mijelomom liječenih bortezomibom u kliničkim ispitivanjima i sve nuspojave zabilježene nakon stavljanja lijeka u promet bez obzira na indikaciju Klasifikacija organskih sustava
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Hospira at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m 2 or further dose reduction to 0.5 mg/m 2 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 lijekom Bortezomib Hospira treba započeti smanjenom dozom od 0,7 mg/m2 po injekciji tijekom prvog ciklusa liječenja, a naknadno povećanje doze na 1,0 mg/m 2 ili daljnje smanjenje doze na 0,5 mg/m 2 može se razmotriti na temelju podnošljivosti liječenja za bolesnika (vidjeti Tablicu 6 i dijelove 4.4 i 5.2).
English: The median OS was 30.8 months (95% CI; 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.