FrancophonIA/ELRC3.0 huggingface dataset:
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Hospira (both IV and SC use) required for different body surface areas.
Slovenian: • Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib Hospira (za i.v.
English: In B-ALL patients with relapse 18-36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Slovenian: Pri bolnikih z B-celično ALL in ponovitvijo po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odzivov 79 % (95 % IZ: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73 % (95 % IZ: 54, 85).
English: Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Slovenian: Periferna nevropatija vključuje priporočene termine: periferna senzorična nevropatija, periferna nevropatija, periferna motorična nevropatija in periferna senzomotorična nevropatija.
English: • to report any adverse event, or medication error experienced with the administration of Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
Slovenian: • Pomembnost poročanja o kakršnemkoli neželenem učinku ali napakah pri dajanju zdravila Bortezomib Hospira 1 mg, 2,5 mg, 3 mg in 3,5 mg.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Hospira
Slovenian: Nehematološka toksičnost stopnje ≥ 3 povezana z uporabo zdravila Bortezomib Hospira
English: CR+nCR+VGPR+PR % (95% CI)
Slovenian: CR+nCR+VGPR+PR% (95 % IZ)
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Hospira as outlined in Table 1.
Slovenian: V primeru nevropatske bolečine in/ali periferne nevropatije povezane z bortezomibom ukinite in/ali prilagodite odmerek zdravila Bortezomib Hospira, kot je opisano v preglednici 1.
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
Slovenian: Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z zdravilom Bortezomib v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Slovenian: Po kriterijih Evropske skupine za transplantacijo kostnega mozga (EBMT - European Group for Blood and Marrow Transplantation) je bil primarni opazovani dogodek glede učinkovitosti TTP, sekundarna opazovana dogodka pa OS in ORR (CR+PR).
English: 0.7 mg/m2).
Slovenian: 1 mg/m2 na 0,7 mg/m2).
English: • Weight loss
Slovenian: • izguba teka
English: The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Slovenian: Delež popolnih odzivov pri prvih bolnikih s T-celično ALL (n = 22) je bil 68 % (95 % IZ: 45, 86), delež 4-mesečnega preživetja bolnikov brez dogodkov pa 67 % (95 % IZ: 42, 83).
English: R-CHOP
Slovenian: BR-CAP R-CHOP
English: Therefore, platelet counts should be monitored prior to each dose of Bortezomib Hospira.
Slovenian: Zato je treba pred dajanjem vsakega odmerka zdravila Bortezomib Hospira določiti število trombocitov.
English: If you have not been treated before for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Slovenian: Če vam limfoma plaščnih celic še niso zdravili, boste bortezomib prejeli v veno, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
English: In patients developing PRES, Bortezomib Hospira should be discontinued.
Slovenian: Če se pri bolniku pojavi PRES, je treba zdravljenje z zdravilom Bortezomib Hospira prekiniti.
English: Skin reaction, Jessner's lymphocytic infiltration, Palmar-plantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Slovenian: Redki kožna reakcija, Jessnerjeva limfocitna infiltracija, sindrom palmarno-plantarne eritrodisestezije, podkožna krvavitev, livedo retikularis, zatrdlina kože, papula, fotosenzitivna reakcija, seboreja, hladen znoj, bolezni kože NOS, eritroza, kožna razjeda, bolezni nohtov
English: Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Slovenian: Pogosti herpes zoster (vključno z diseminiranim in očesnim), pljučnica*, herpes simpleks*, glivična okužba*
English: CR+nCR+ PR+MR Median duration Days (months) Time to response CR+PR (days)
Slovenian: Mediano trajanje odziva dnevi (meseci) Čas do odziva CR + PR (dnevi)
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Slovenian: Rekonstituirana raztopina ne vsebuje konzervansov in jo je treba porabiti takoj po pripravi.
English: Bortezomib Hospira should not be administered intrathecally.
Slovenian: Zdravila Bortezomib Hospira se ne sme dajati intratekalno.
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z zmerno ali hudo okvaro jeter pa so se vrednosti srednje, na odmerek normalizirane AUC povečale za 60%.
English: Bortezomib is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Slovenian: Bortezomib se uporablja za zdravljenje limfoma plaščnih celic (redka oblika raka, ki prizadene bezgavke) pri bolnikih, starih 18 let in več, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom, pri bolnikih, pri katerih bolezni še niso zdravili in pri katerih presaditev krvotvornih matičnih celic ni primerna.
English: • different reconstitution requirements for Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg IV or
Slovenian: • Različne zahteve za rekonstitucijo zdravila Bortezomib Hospira 1 mg, 2,5 mg, 3 mg in 3,5 mg pri i.v.
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.
Slovenian: Vključeni so tudi neželeni učinki, ugotovljeni v skupini BR-CAP, ki so na osnovi podatkov študij diseminiranega plazmocitoma in po mnenju raziskovalcev najmanj verjetno ali možno povezani z uporabo bortezomiba.
English: (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
Slovenian: Lahko boste imeli zmanjšano število: krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih), rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi, kot sta utrujenost in bledica, belih krvnih celic in tako bolj dovzetni za okužbe ali gripi podobne simptome.
English: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Slovenian: Število trombocitov je bilo najmanjše 11. dan vsakega cikla zdravljenja z bortezomibom in se je do naslednjega cikla zdravljenja običajno povrnilo na začetno vrednost.
English: • If local injection site reactions occur following Bortezomib Hospira injection subcutaneously, either a less concentrated Bortezomib Hospira solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Slovenian: • Če se po subkutanem injiciranju zdravila Bortezomib Hospira na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila Bortezomib Hospira (1 mg/ml namesto 2,5 mg/ml) ali pa preidete na intravensko dajanje zdravila.
English: • In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: V ciklih 1 do 4 se bortezomib daje dvakrat na teden, 1., 4., 8., 11., 22., 25., 29. in 32. dan.
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.
Slovenian: Med zdravljenjem z bortezomibom so najpogosteje poročali o slabosti, diareji, zaprtju, bruhanju, utrujenosti, pireksiji, trombocitopeniji, anemiji, nevtropeniji, periferni nevropatiji (vključno s senzorično nevropatijo), glavobolu, paresteziji, zmanjšanem teku, dispneji, izpuščaju, virusu herpes zoster in mialgiji.
English: Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upperairway cough syndrome
Slovenian: Redki respiratorna odpoved, sindrom akutne dihalne stiske, apneja, pnevmotoraks, atelektaza, pljučna hipertenzija, hemoptiza, hiperventilacija, ortopneja, pnevmonitis, respiratorna alkaloza, tahipneja, pljučna fibroza, bolezni bronhijev*, hipokapnija*, intersticijska bolezen pljuč, infiltracija pljuč, stiskanje v grlu, suho grlo, zvečana sekrecija iz zgornjih dihal, draženje žrela, sindrom kašlja zgornjih dihalnih poti (UACS - Upper-airway cough syndrome)
English: Response Evaluable Population n=73
Slovenian: Populacija a bolnikov, pri katerih so ocenili odziv n = 73
English: • in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
Slovenian: • v kombinaciji z deksametazonom ali z deksametazonom in talidomidom pri bolnikih, pri katerih bolezni še niso zdravili, in pred kemoterapijo v velikih odmerkih in presaditvijo krvotvornih matičnih celic (uvajalno zdravljenje).
English: CR+nCR+PR % (95% CI)
Slovenian: CR+nCR+PR% (95 % IZ)
English: You might receive up to 8 cycles (24 weeks).
Slovenian: Lahko boste prejeli do 8 ciklov zdravljenja (24 tednov).
English: In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Slovenian: V preskušanju faze III so imeli bolniki, ki so prejemali bortezomib subkutano za 13 % manjšo celokupno pojavnost neželenih učinkov zaradi uporabe zdravila, s stopnjo toksičnosti 3 ali več in za 5 % manjšo pojavnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali bortezomib intravensko.
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.
Slovenian: V preskušanje je bilo vključenih 222 bolnikov s ponovitvijo/diseminiranim plazmocitomom, odpornim na zdravljenje, randomiziranih v razmerju 2:1 na bortezomib, z odmerkom1,3 mg/m2 telesne površine subkutano ali intravensko 8 ciklov zdravljenja.
English: A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors
Slovenian: Razmerje ogroženosti manjša kot 1 kaže prednost zdravljenja z VMP. c nominalna p-vrednost na osnovi stratificiranega log-rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
English: OR e (95% CI)=1.428
Slovenian: (95 % IZ) = 1,428 (0,749;
English: 120 ng/ml for the 1.3 mg/m 2 dose.
Slovenian: do 32 l/h za odmerek 1,3 mg/m
English: Time to next therapy Events n (%) Median a (95% CI)
Slovenian: Čas do naslednjega zdravljenja dogodki n (%) mediana a (95 % IZ)
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered medicinal product in Block 3.
Slovenian: Bolniki so prejeli bortezomib le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
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 (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Slovenian: V preskušanjih z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma in pri bolnikih z nezdravljenim MCL, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BR-CAP), je bil najpogostejši toksični učinek na hematološki sistem prehodna trombocitopenija.
English: Type I glass 5 ml siliconised vial with a rubber stopper and an aluminium seal containing 1 mg bortezomib.
Slovenian: 5 ml steklena silikonizirana viala, steklo tipa I, z zamaškom iz gume in aluminijasto zaporko; vsebuje 1 mg bortezomiba.
English: Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Slovenian: Občasni sindrom akutne dihalne stiske, pljučna embolija, pnevmonitis, pljučna hipertenzija, pljučni edem (vključno z akutnim)
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 (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Slovenian: Pri bolnikih z MCL (preskušanje LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala bortezomib (BR-CAP), večja (56,7 % proti 5,8 %), v primerjavi s skupino, ki bortezomiba ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [RCHOP]).
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Slovenian: Dokazov, ki bi potrdili, da je pri bolnikih z diseminiranim plazmocitomom ali limfomom plaščnih celic, starejših od 65 let, potrebna prilagoditev odmerka, ni.
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Slovenian: Pojavnost periferne nevropatije v preskušanjih bortezomiba pri uvajalnem zdravljenju v kombinaciji z deksametazonom (preskušanje IFM-2005-01) ter deksametazonom in talidomidom (preskušanje MMY-3010) je navedena v spodnji preglednici:
English: Aseptic technique must be strictly observed throughout the handling of Bortezomib Hospira, since it contains no preservative.
Slovenian: MED RAVNANJEM Z ZDRAVILOM BORTEZOMIB HOSPIRA MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Slovenian: 14 % preskušancev iz skupine BR-CAP in 17 % bolnikov iz skupine R-CHOP je prejelo 2 dodatna cikla zdravljenja.
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).
Slovenian: Zdravljenje je treba prekiniti, kadar se bolnik zdravi z zdravilom Bortezomib Hospira in je število trombocitov < 25.000/μl, ali če se bolnik zdravi z bortezomibom v kombinaciji z melfalanom in prednizonom in je število trombocitov ≤ 30.000/μl (glejte poglavje 4.2).
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Slovenian: Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek rifampicina, močnega induktorja encima CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), je na osnovi podatkov 6 bolnikov pokazala povprečno zmanjšanje AUC bortezomiba za 45 %.
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with Bortezomib Hospira.
Slovenian: Reaktivacija in okužba z virusom hepatitisa B (HBV) Pri bolnikih s tveganjem za okužbo s HBV je treba pred uporabo rituksimaba v kombinaciji z zdravilom Bortezomib Hospira vedno opraviti presejalni test na HBV. Prenašalce virusa hepatitisa B in bolnike, ki so že bili okuženi z virusom hepatitisa B, je treba med zdravljenjem in v nadaljevanju zdravljenja z rituksimabom v kombinaciji z zdravilom Bortezomib Hospira skrbno spremljati glede kliničnih in laboratorijskih znakov aktivne okužbe s HBV.
English: You might receive up to 6 cycles (24 weeks).
Slovenian: Lahko boste prejeli do 6 ciklov zdravljenja (24 tednov).
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.
Slovenian: Zato je bila opravljena statistična analiza izenačenih parov, ki je primerjala rezultate nerandomizirane skupine zdravljene z bortezomibom v kombinaciji z deksametazonom (odprto preskušanje faze II; MMY-2045) z rezultati zdravljenja z bortezomibom v različnih preskušanjih faze III (M34101-039 [APEX] in DOXIL MMY-3001) za enako indikacijo.
English: At least 72 hours should elapse between consecutive doses of Bortezomib Hospira.
Slovenian: Med zaporednimi odmerki zdravila Bortezomib Hospira mora preteči vsaj 72 ur.
English: Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Slovenian: Pogosti hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zmanjšana telesna masa, zvečana telesna masa
English: How to use Bortezomib Hospira
Slovenian: Kako uporabljati zdravilo Bortezomib Hospira
English: You will have to take regular blood tests before and during your treatment with Bortezomib Hospira, to check your blood cell counts regularly.
Slovenian: Pred in med zdravljenjem z zdravilom Bortezomib Hospira vam bodo redno pregledovali kri in tako spremljali število krvnih celic.
English: Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Slovenian: Redki hipermagneziemija*, acidoza, motnje elektrolitskega ravnovesja *, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B kompleksa, pomanjkanje vitamina B12, protin, zvečan tek, neprenašanje alkohola
English: Bortezomib Hospira reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Rekonstituirano raztopino zdravila Bortezomib Hospira dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije preko perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml (0,9%) raztopino natrijevega klorida za injiciranje.
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Slovenian: Pri 130 bolnikih je bila celokupna stopnja odziva (CR+PR) 38,5 % (95% IZ:
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Slovenian: • težave s spanjem, znojenje, tesnoba, nihanje razpoloženja, depresivno razpoloženje, nemir ali vznemirjenost, spremembe v duševnem stanju, dezorientiranost
English: n=193
Slovenian: B n = 193
English: • Platelet counts should be ≥ 70 x 10 9/l and the absolute neutrophils count should be ≥ 1.0 x 10 9/l
Slovenian: Neutrophil Count) ≥ 1,0 x 10 9/l.
English: Four treatment cycles of this combination therapy are administered.
Slovenian: Bolnik prejme štiri cikle kombiniranega zdravljenja.
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving Bortezomib Hospira in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Bortezomib Hospira v kombinaciji z zdravili, ki so povezana s pojavom nevropatije (npr. talidomid), je potrebno zgodnje in redno spremljanje pojava simptomov z zdravljenjem povezane nevropatije, opraviti nevrološko oceno ter ustrezno zmanjšati odmerek ali razmisliti o ukinitvi zdravljenja.
English: Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
Slovenian: V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO celic) je bil bortezomib v koncentraciji le 3,125 μg/ml, ki je bila najmanjša ovrednotena koncentracija, pozitiven na klastogeno aktivnost (strukturne kromosomske aberacije).
English: > 1.0 x -1.5 x ULN Any
Slovenian: > 1,5 x 3 x ULN katerakoli
English: Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Slovenian: Pomembne razlike v varnostnem profilu uporabe bortezomiba v monoterapiji subkutano oz. intravensko
English: The active substance is bortezomib.
Slovenian: Učinkovina je bortezomib.
English: and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Slovenian: na 1. dan in 100 mg/m2 prednizona peroralno na 1. do 5. dan 21-dnevnega cikla zdravljenja z bortezomibom.
English: n=128
Slovenian: B n = 128
English: Dosage adjustments for transplant eligible patients For Bortezomib Hospira dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Slovenian: Prilagoditev odmerjanja pri bolnikih, primernih za presaditev Za prilagoditev odmerjanja zdravila Bortezomib Hospira upoštevajte smernice za prilagoditev odmerka pri zdravljenju v obliki monoterapije.