natgillin/translations-raw huggingface dataset:
For dose adjustments, see Table 5 below.
Za prilagajanje odmerkov glejte spodnjo preglednico 5.
Proteasomes play an important role in controlling cell function and growth.
Proteasomi imajo pomembno vlogo pri nadzoru delovanja in rasti celic.
Reduction in serum Mprotein populationg n=667
Zmanjšanje serumskega Mproteina populacijag n=667
Time to first response in CR + PR
Čas do prvega odziva pri CR + PR
Day 8, 11
dan 8, 11
Consider reduction of the melphalan dose by 25% in the next cycle.
V naslednjem krogu zdravljenja razmislite o zmanjšanju odmerka melfalana za 25 %.
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
AST = aspartat-aminotransferaza; ULN (upper limit of the normal range) = zgornja meja razpona normalnih vrednosti.
Peri- and postnatal development studies were not conducted.
Raziskav peri- in postnatalnega obdobja niso opravili.
Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Zaradi te zgodnje zamenjave zdravila je mediana trajanja spremljanja preživelih bolnikov 8,3 meseca.
Patients with risk factors for or existing heart disease should be closely monitored.
Bolnike z dejavniki tveganja za srčno bolezen ali z obstoječo srčno boleznijo je treba skrbno spremljati.
A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
S protokolom določena vmesna analiza (na podlagi 249 TTP-dogodkov) je vodila do predčasne prekinitve študije, kar zadeva ugotavljanje učinkovitosti.
From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Z mikrobiološkega vidika je treba rekonstituirano raztopino porabiti takoj po pripravi.
Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Preglednica 14: Povzetek izidov bolezni v preskušanjih faze III (APEX) in II
a Based on Independent Review Committee (IRC) assessment (radiological data only).
a Na podlagi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Skupen čas shranjevanja rekonstituiranega zdravila pred injiciranjem ne sme biti daljši od 8 ur.
If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Če ste preboleli hepatitis B, vas bo zdravnik skrbno spremljal glede znakov aktivnega hepatitisa B.
The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzmbDx group.
Mediani čas trajanja zdravljenja je bil 13 tednov v skupini VDDx in 11 tednov v skupini BzmbDx.
The educational material shall consist of the following:
Izobraževalno gradivo bo vsebovalo:
The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Mehanizem nastanka tega pojava ni znan, čeprav je deloma lahko posledica avtonomne nevropatije.
Use of gloves and other protective clothing to prevent skin contact is recommended.
Za preprečevanje stika s kožo morate uporabljati rokavice in druga zaščitna oblačila.
Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Stopnja 1 (asimptomatična; izguba refleksa globoke tetive ali parestezija) brez bolečine ali izguba funkcije ni potrebna
Both men and women receiving Bortezomib SUN must use effective contraception during and for up to 3 months after treatment.
Moški in ženske, ki prejemajo zdravilo Bortezomib SUN, morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 3 mesece po njem.
After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Po prilagoditvi glede na BSA, drugi demografski dejavniki kot so starost, telesna masa in spol, niso imeli klinično pomembnega vpliva na očistek bortezomiba.
• Additional risk minimisation measures In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo v vsaki državi članici s pristojnim nacionalnim organom države dogovoril za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce.
The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Cmax je bila po subkutanem dajanju (20,4 ng/ml) nižja kot pri intravenskem (223 ng/ml).
Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Skrbno pretehtajte potencialne koristi zdravljenja glede na tveganja, še posebej v primeru zmerne do resne trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Stopnja geometrične sredine AUClast je bila 0,99 in 90 % intervali zaupanja 80,18-122,80 %.
The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Pediatrična populacija Varnost in učinkovitost bortezomiba pri otrocih, mlajših od 18 let, nista bili dokazani (glejte poglavji 5.1 in 5.2).
Prior to initiating a new cycle of therapy:
Pred začetkom novega kroga zdravljenja:
Complete response (CR) was evaluated at the end of Block 1.
Popolni odgovor (CR-Complete Response) so ocenili na koncu 1. sklopa zdravljenja.
In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
V primeru pojava novih ali poslabšanja obstoječih pljučnih simptomov (npr.: kašelj, dispneja) je potrebna takojšnja diagnostična ocena in uvedba ustreznega zdravljenja bolnika.
Overall, the literature results are suggestive of a possible causal association between bortezomib (and other proteasome inhibitors) and TMA.
Na splošno rezultati iz literature kažejo na možno povezavo med bortezomibom (in drugimi zaviralci proteaze) in TMA.
The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Mediana preživetja vseh bolnikov, vključenih v raziskavo, je bila 17 mesecev (razpon < 1 do 36 mesecev).
The resulting solution is then either injected into a vein or under the skin.
Nastala raztopina se potem injicira v veno ali pod kožo.
e Median duration of follow up is 11.8 months
e Mediano trajanje nadaljevanja zdravljenja je 11,8 meseca.
United Kingdom Ranbaxy UK Ltd a Sun Pharma Company Millington Road 11
United Kingdom Ranbaxy UK Ltd a Sun Pharma Company
The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Končna analiza OS po medianem spremljanju bolnikov 8,6 leta ni pokazala pomembne razlike v OS
Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Pri psih so zaznali tudi majhno podaljšanje korigiranega QT-intervala.
5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median duration Days (months) Time to response CR+PR(days)
5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Mediana trajanja odziva dnevi (meseci)
MARKETING AUTHORISATION NUMBER EU/1/16/1102/001
EU/1/16/1102/001
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznakeEXP.
For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Za predklinična farmakološka preskušanja kardiovaskularne varnosti zdravila glejte poglavje 5.3.
TTP, months
TTP, dnevi
Similar proportions of patients had creatinine clearance ≤30 ml/min (3% in each arm).
Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3 % v vsakem kraku študije).
It is recommended that patients with at least partial response receive 2 additional cycles.
Priporočamo, da bolniki z najmanj delnim odzivom prejmejo 2 dodatna kroga zdravljenja.
No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Podatkov o možnih posledicah ali ozdravitvah periferne nevropatije v tej študiji ni na voljo.
The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Primarna ocena učinkovitosti je bil najboljši potrjeni odziv na ponovno zdravljenje, skladno z EBMTkriteriji.
Table 8 has been generated using Version 16 of the MedDRA.
Preglednica 8 je pripravljena po klasifikaciji MedDRA, različica 16.
The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Rekonstituirana raztopina je bistra in brezbarvna, njen končni pH pa je od 4 do 7.
The duration of a treatment cycle is 21 days (3 weeks).
Trajanje enega kroga zdravljenja je 21 dni (3 tedne).
Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Bolniki z nevtropenijo so izpostavljeni zvečanemu tveganju za okužbe, zato jih je treba spremljati glede pojava znakov in simptomov okužbe ter takoj zdraviti.
In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Sekundarna stopnja odziva in čas do z dogodkom povezane učinkovitosti sta pokazali dosledne rezultate za subkutano in intravensko uporabo (preglednica 15).
Table 11: Efficacy results following the final survival update to VISTA study
Preglednica 11: Rezultati učinkovitosti zdravila po posodobljenih podatkih o končnem preživetju iz študije VISTA
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Poskusi so potrdili, da je bortezomib citotoksičen za številne različne vrste rakavih celic in da so rakave celice bolj občutljive za proapoptotične učinke zavore proteasoma od normalnih.
In addition, following a search of the worldwide medical and scientific literature carried out for the period covered by this PSUSA and a number of papers reporting safety information, 35 cases of Thrombotic Microangiopathy (TMA) were retrieved.
Po pregledu svetovne medicinske in znanstvene literature v obdobju zadevnega PSUR in številnih poročil o varnosti, je bilo dodatno odkrito 35 primerov trombotične mikroangiopatije (TMA).
Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
Bortezomiba ne smete uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z bortezomibom.
Table 7 has been generated using Version 14.1 of the MedDRA.
Preglednica 7 je pripravljena po klasifikaciji MedDRA, različica 14.1.
1.3 The reconstituted product is preservative free and should be used immediately after preparation.
1.3 Rekonstituirana raztopina ne vsebuje konzervansov in jo je treba porabiti takoj po pripravi.
Intrathecal administration has resulted in death.
Intratekalna uporaba se je končala s smrtjo.
In the unlikely event of an overdose, your doctor will monitor you for side effects.
V malo verjetnem primeru prevelikega odmerjanja vas bo vaš zdravnik spremljal glede pojava neželenih učinkov.
Bortezomib is highly selective for the proteasome.
Bortezomib je močno selektiven za proteasom.
Cycle 1
krog 1
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
Psi z zmanjšano kontraktilnostjo srca so se odzvali na učinkovine s pozitivnim inotropnim ali presorskim delovanjem.
In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant Group.
Odziv na zdravljenje v populaciji bolnikov faze II preskušanja, ki so bili odporni na zdravljenje, je ugotavljala neodvisna komisija, ki je uporabila kriterije za odziv Evropske skupine za transplantacijo kostnega mozga (European Bone Marrow Transplant Group).
Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Zastajanje tekočin v telesu je lahko dejavnik tveganja za pojav znakov in simptomov srčnega popuščanja.
Bortezomib may have a moderate influence on the ability to drive and use machines.
Bortezomib ima lahko zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
- The other ingredient is mannitol (E421).
- Drugi sestavini zdravila je manitol (E421).
The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
26S-proteasom je velik beljakovinski kompleks, ki razgradi ubikvitinske beljakovine.
In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Pri redkih bolnikih, ki so imeli hepatitis B, lahko bolezen ponovno izbruhne, z možnim smrtnim izidom.
Posology modification or delay
Prilagoditev ali zakasnitev odmerka
Day 29 Rest period
dan 29 premor
At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz ter je za več kot 1500-krat bolj selektiven za proteasom kot za svoj drugi prednostni encim.
Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
(mediana=17 tednov) in trajanje nadaljnjega spremljanja bolnikov (mediana=40 mesecev) sta bila primerljiva v obeh zdravljenih skupinah.
May be fatal if given by other routes.
Dajanje po drugi poti je lahko smrtno nevarno.
- Haemoglobin ≥ 8 g/dl
- Koncentracija hemoglobina ≥ 8 g/dl.
Acute diffuse infiltrative pulmonary and pericardial disease.
Akutna difuzna infiltracijska bolezen pljuč in perikarda.
Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Zavora 26Sproteasoma preprečuje to ciljano proteolizo in vpliva na več signalnih kaskad v celici ter končno vodi do smrti rakave celice.
Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Pri dveh bolnikih (1 %) so se pojavile hude reakcije - pri enem pruritus in pri drugem rdečica.
Of those, 121 cases reported chalazion, blepharitis, meibomianitis, and/or Meibomian gland dysfunction.
Od teh so v 121 primerih poročali o halaziju, blefaritisu, meibomianitisu in/ali okvari Meibomove žleze.
By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Pri multivariantni analizi stopnja odziva ni bila odvisna od vrste plazmocitoma, stanja fizične zmogljivosti bolnika, delecije kromosoma 13 in števila ali vrste predhodnih zdravljenj.
Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Zdravljenje ortostatske oz. posturalne hipotenzije lahko vključuje tudi prilagoditev odmerjanja antihipertenzivov, rehidracijo bolnika ali dajanje mineralokortikosteroidov in/ali simpatikomimetikov.
Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Bolniki s popolnim odzivom lahko z zdravljenjem nadaljujejo še najmanj dva kroga po prvi ugotovitvi popolnega odziva, tudi če to zahteva zdravljenje, daljše od
The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Celukupna incidenca driske, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12-15 % manjša v subkutani kot v intravenski skupini.
If bortezomib 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.
Če se bortezomib uporablja v času nosečnosti ali če bolnica zanosi med uporabo tega zdravila, jo morate obvestiti o potencialnem tveganju za plod.
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO.
DISPOSAL A vial is for single use only and the remaining solution must be discarded.
ODSTRANJEVANJE ZDRAVILA Viala je namenjena izključno enkratni uporabi, preostalo raztopino morate zavreči.
Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Šest odstotkov bolnikov je imelo lokalne reakcije na mestu subkutanega injiciranja, večinoma rdečico.
Response rate populatione n=668
Stopnja odziva populacijae n = 668
A total of 218 patients were evaluable for response.
Skupaj so odziv na zdravljenje ocenili pri 218 bolnikih.
Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Sekundarna ocena je vključevala čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnja odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Bolnike je treba opozoriti naj v primeru pojava teh simptomov ne vozijo ali upravljajo s stroji (glejte poglavje 4.8).
The teratogenic potential of bortezomib has not been fully investigated.
Teratogenost bortezomiba še ni bila v celoti raziskana.
The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Pot prek kompleksa ubikvitin-proteasom ima pomembno vlogo pri uravnavanju presnove specifičnih beljakovin in tako ohranja homeostazo v celicah.
Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Redki samomorilne misli*, motnje prilagajanja, delirij, zmanjšan libido
In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
V skupini BzmbTDx je imelo 12 % bolnikov citogenetiko visokega tveganja v primerjavi s 16 % v skupini TDx.
The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80 % v skupini BzmbR-CAP in 82 % v skupini R-CHOP.
- Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
DAJANJE ZDRAVILA - Po raztapljanju odvzemite ustrezno količino rekonstituirane raztopine po izračunu odmerka na osnovi bolnikove telesne površine.
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Stopnja 1 z bolečino ali stopnja 2 (zmerni simptomi; omejene instrumentalne osnovne vsakodnevne aktivnosti (ADL)**)
Tel. +48 22 642 07 75
Tel. +48 22 642 07 75 România
Cases resolved in a median of 6 days, dose modification was required in two patients.
Primere so rešili v približno 6 dneh, dvema bolnikoma so morali prilagoditi odmerek zdravila.
The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Primarna ocena učinkovitosti je bilo preživetje brez napredovanja bolezni, ki ga je ocenil neodvisni odbor za pregled (Independent Review Committee-IRC).
Pregnancy and breast-feeding You should not use Bortezomib SUN if you are pregnant, unless clearly necessary.
Nosečnost in dojenje Če ste noseči, zdravila Bortezomib SUN ne smete uporabljati, razen če je nujno potrebno.
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Bzmb+M+P treatment.
Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z Bzmb+M+P.
Bortezomib SUN should not be used in children and adolescents because it is not known how the medicine will affect them.
Otroci in mladostniki Zdravilo Bortezomib SUN se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Bolniki, pri katerih se koncentracija paraproteinov po 8 krogih še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Okrajšave: SGOT = serumska glutamat-oksaloacetat transaminaza
BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Očistek bortezomiba normaliziran na BSA je bil pri pediatričnih bolnikih podoben očistku, ki so ga opazili pri odraslih.
Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
245 (37 %) izmed 669 vključenih bolnikov je bilo starih 65 let ali več.
Neuropathy has been managed with supportive care and other therapies.
Nevropatijo so zdravili s podpornim zdravljenjem in z drugimi načini.
OR; 95% CI; P valuea
OR; 95 % CI; p-vrednosta
Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Podatki, pridobljeni in vitro, ex-vivo in iz živalskih modelov, kažejo, da bortezomib spodbuja diferenciacijo in aktivnost osteoblastov ter zavira osteoklaste.
Patients with pre-existing severe neuropathy may be treated with Bortezomib SUN only after careful risk/benefit assessment.
Bolnike z obstoječo hudo nevropatijo lahko zdravite z zdravilom Bortezomib SUN šele po skrbnem pretehtanju razmerja koristi in tveganj.
In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Pri bolnikih je bilo preveliko odmerjanje (odmerki so bili več kot dvakrat večji od priporočenega) povezano z akutnim pojavom simptomatične hipotenzije in trombocitopenije s smrtnimi izidi.
ORe (95% CI)=1.428 p-valueg=0.275
ORe (95 % CI)=1,428 p-vrednostg=0,275
Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Zdravljenje z bortezomibom je zelo pogosto povezano s periferno nevropatijo, ki je pretežno senzorična.
The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Incidenca smrti med zdravljenjem je bila v subkutani skupini 5 % in v intravenski skupini 7 %.
The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone.
Podobna pojavnost teh neželenih učinkov v obeh zdravljenih skupinah kaže, da ju ni možno pripisati samo uporabi bortezomiba.
Since dialysis may reduce bortezomib concentrations, Bortezomib SUN should be administered after the dialysis procedure (see section 5.2).
Ker lahko dializa zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib SUN injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
V razponu koncentracij bortezomiba od 0,01 do 1,0 μg/ml je bila in vitro vezava na beljakovine povprečno 82,9 % v človeški plazmi.