natgillin/translations-raw huggingface dataset:
This approach yields 7 days plus a safety margin for the 1st study, 10 days plus a safety margin for the 2nd study, and 0.5 days plus a safety margin for the 3rd.
Ta pristop da karenco 7 dni z varnostnim odmikom za prvo raziskavo, 10 dni z varnostnim odmikom za drugo raziskavo in 0,5 dneva z varnostnim odmikom za četrto raziskavo.
Residues were below the MRL values at all points measured.
Zaostanki so bili pod vrednostmi MRL na vseh merjenih točkah.
Member State
DRŽAVAH ČLANICAH
2.2 Calculation of withdrawal periods
2.2 Izračun obdobij karence
All four studies were considered relevant to be used in the establishment for the determination of the withdrawal period.
Za vse štiri študije je bilo ugotovljeno, da so primerne za določevanje karence.
One untreated control animal was slaughtered just before treatment and another one after 14 days.
Ena nezdravljena kontrolna žival je bila zaklana tik pred izvedbo zdravljenja, druga pa po 14 dneh.
Tissue samples were taken from the muscle, perirenal fat, liver, kidney and dose-site muscle.
Vzorci tkiv so bili odvzeti iz mišice, perirenalne maščobe, jeter, ledvic in mišice na mestu nanosa.
For the referral procedure one radiolabelled and three non-radiolabelled residue depletion studies in cattle were submitted.
V posvetovalnem postopku so bile predložene raziskave izločanja zaostankov pri govedu, in sicer ena z radioaktivnimi označevalci in tri z neradioaktivnimi označevalci.
Two untreated control animals were slaughtered the day before treatment and 2 others 23 days after treatment.
Dve nezdravljeni kontrolni živali sta bili zaklani en dan pred zdravljenjem, dve drugi kontrolni živali pa 23 dni po zdravljenju.
Residue concentrations were below the MRL values at all points measured.
Koncentracije zaostankov so bile pod vrednostmi MRL na vseh merjenih točkah.
The CVMP had previously assessed eprinomectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
CVMP je predhodno, skladno z Uredbo Sveta 2377/90, že ovrednotila eprinomektin glede določitve najvišjih mejnih vrednosti zaostankov zdravil (maximum residue limits, MRL).
The CVMP during its meeting of 23 July 2003 decided to start a referral procedure under Article 34 of Council Directive 2001/82/EC for the Eprinex pour-on products containing eprinomectin.
CVMP se je na sestanku 23. julija 2003 odločila, da začne posvetovalni postopek po 34. členu
However animals were only slaughtered at withdrawal times of 10 days or more, therefore, it could not be excluded that the MRL was not exceeded at earlier time points.
Ker so bile živali zaklane 10 ali več dni po preteku karenčnga obdobja, ni možno izključiti, da vrednosti MRL niso bile presežene v neki časovni točki pred zakolom.
Animals were slaughtered on day 10, 17, 24, 34, 44 and 55 after treatment, 5 animals per time point.
Zakol je bil opravljen 10., 17., 24., 34., 44. in 55. dan po zdravljenju, vsakič po pet živali.
However, animals were only slaughtered at withdrawal times of 7 days or more, therefore, it could not be excluded that the MRL was not exceeded at earlier time points.
Ker so bile živali zaklane 7 ali več dni po preteku karenčnega obdobja, ni možno izključiti, da vrednosti MRL niso bile presežene v neki časovni točki pred zakolom.
United Kingdom Merial Ltd Sandringham House Harlow Business Park Harlow
Velika Britanija Merial Ltd Sandringham House Harlow Business Park Harlow
The withdrawal period for milk was consistently set as 0 days.
Karenca za mleko je povsod 0 dni.
Merial GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany
D-85399 Hallbergmoos
The withdrawal period calculated was 15 days for 2 of the studies and 3 days for the 3rd one, based on depletion from liver.
Karenca je bila izračunana na podlagi izločanja zazaostankov iz jeter, in sicer za prvi dve raziskavi 15 dni, za tretjo raziskavo pa 3 dni.
Animals were slaughtered at 0.5, 1, 3, 5 and 7 days after treatment, 5 animals per time point.
Zakol je bil opravljen 0.5., 1., 3., 5. in 7. dan po zdravljenju, vsakič po pet živali.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, NAČINOV DAJANJA,
In the radiolabelled study 14 steers and heifers, aged 8-10 months were administered topically [5-3]Hradiolabelled eprinomectin at a single dose of 0.5 mg/kg bw.
V raziskavi z radioaktivnimi označevalci je bil [5-3]H-radioaktivno označen eprinomektin topikalno nanešen pri 14 kastratih in telicah, starih 8-10 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
Overall, a withdrawal period of 15 days is considered appropriate to ensure depletion of residues below the MRLs.
Končni sklep je, da je karenca 15 dni primerna za zmanjšanje koncentracij zazaostankov pod vrednosti
On 18 June 2003 Germany requested the CVMP to give an opinion under Article 34 of Council Directive 2001/82/EC concerning the divergent decisions taken by the competent national authorities regarding the withdrawal periods for meat and offal when granting the marketing authorisations for Eprinex pour on products.
Veterinary Medicinal Products - Odbor ) za mnenje glede različnih odločitev pristojnih nacionalnih organov o obdobju karence za meso in drobovino v postopkih podeljevanja dovoljenj za promet za kožne polive Eprinex.
The CVMP established a toxicological ADI of 5 µg/kg bw (300 µg/person) for eprinomectin, based on the NOEL of 1.0 mg/kg bw/day for mydriasis and focal neuronal degeneration of the nervous system observed in the 53-week toxicity study in beagle dogs and applying a safety factor of 200.
NOEL 1,0 mg/kg telesne mase za midriazo in degeneracijo nevronskih žarišč v živčevju (določene v
Marker residue concentrations were determined using validated HPLC-fluorescence method with a limit of detection of 1 µg/kg and limit of quantification of 2 µg/kg.
Koncentracije ostankov označevalca so bile določene z validirano HPLC-fluorescenčno metodo, ki je imela mejo zaznavnosti 1 µg/kg in mejo določljivosti 2 µg/kg.
In the third non-radiolabelled study 12 male non-ruminating calves, aged 11 to 13 weeks, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
V tretji raziskavi z neradioaktivnimi označevalci je bil eprinomektin topikalno nanešen pri 12 sesnih teletih, starih od 11 do 13 tednov, v enkratnem odmerku 0,5 mg/kg telesne mase.
Animals were slaughtered at 7, 14, 21 and 28 days after treatment, 3 animals per time point.
Zakol je bil opravljen 7., 14., 21. in 28. dan po zdravljenju, vsakič po tri živali.
The alternative approach yields a withdrawal period of 14 days plus a safety margin, based on depletion from liver, fat and muscle for the 4th study.
Z alternativnim pristopom je bilo na podlagi izločanja zazaostankov iz jeter, maščobe in mišice v četrti raziskavi izračunano karenco 14 dni z varnostnim odmikom.
Plasma and residue levels were higher in non-ruminant calves than in adult cattle and it took longer to reach a maximum level; tissue residue concentrations were highest after 7 days.
Pri sesnih teletih je trajalo dlje, da so koncentracije dosegle najvišjo raven, saj so bile koncentracije zaostankov v tkivih najvišje po 7 dneh.
Residue concentrations in dose-site muscle showed a large variation, the highest concentration was found in a 28-day sample, the latest time point in the study and residue concentrations were higher than in muscle (by a factor of about 3-4).
Najvišja koncentracija je bila ugotovljena v vzorcu 28. dne (zadnji časovni točki v raziskavi)
Cattle and dairy cows
Govedo in molzne krave
P.O.
MRL.
In a non-radiolabelled study 17 male castrate and 17 female beef cattle, aged 17 to 20 months, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
17 pitankah, starih od 17 do 20 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
Lactating and non-lactating cattle
Govedo v laktaciji in govedo izven laktacije
Cattle including lactating cows
Pitano govedo, molzne krave vključno s kravami v laktaciji
In a second non-radiolabelled study 14 male castrate and 13 female cattle, aged 12-19 months, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
kastratih in 13 telicah, starih 12-19 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
Animals were slaughtered on day 1, 3, 7 and 14 after treatment, 3 animals per time point.
1., 3., 7. in 14. dan po izvedenem zdravljenju, vsakič s po tremi živalmi.
Beef and dairy cattle including lactating dairy cattle
Pitano in molzno govedo vključujoč molzno govedo v času laktacije
Date of first authorisation: 20 July 2015
Datum prve odobritve: 20. julij 2015
CI=Confidence Interval
CI=interval zaupanja
Overall survival*
Celokupno preživetje*
Each pack contains 1 vial.
Ena škatla vsebuje eno vialo.
Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
1-year Overall Survival (%)e
1-letno celokupno preživetje (%)e
You may experience a reduction in the number of:
Lahko boste imeli zmanjšanje števila
Progression Free Survival, months
Preživetje brez napredovanja bolezni, meseci
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, ki so jo izvedli po mediani sledenja 8,6 let, ni pokazala nobene pomembne razlike v OS med obema skupinama zdravljenja.
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 faza III
Cochran Mantel-Haenszel test.
Cochran Mantel-Haenszelovega testa.
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Complete response (CR) was evaluated at the end of Block 1.
Popolni odgovor (CR - Complete Response) so ocenili na koncu 1. sklopa zdravljenja.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Španija
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 za oznako EXP:.
Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Trajanje zdravljenja (mediana=17 tednov) in trajanje nadaljnjega spremljanja bolnikov (mediana=40 mesecev) sta bila primerljiva v obeh zdravljenih skupinah.
Both men and women receiving Bortezomib Accord must use effective contraception during and for up to 3 months after treatment.
Moški in ženske, ki prejemajo zdravilo Bortezomib Accord, morajo uporabljati učinkovito kontracepcijo med in do 3 mesece po zdravljenju.
Bortezomib Accord should not be used in children and adolescents because it is not known how the medicine will affect them.
Zdravilo Bortezomib Accord se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN
pojavnost PN (%) vse stopnje PN ≥ stopnja 2 PN ≥ stopnja 3 PN
Reduction in serum M-protein populationg n=667
Zmanjšanje serumskega M-proteina populacijag n=667
e Median duration of follow up is 11.8 months
e Mediano trajanje nadaljevanja zdravljenja je 11,8 mesecev.
a Based on Independent Review Committee (IRC) assessment (radiological data only).
a Na osnovi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
b b d d b b
b b d d
Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Izpostavljenost bortezomibu (AUC in Cmax normalizirana glede na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
Mediana response duration
Medianaa trajanja odziva
The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzDx group.
Mediani čas trajanja zdravljenja je bil 13 tednov v skupini BzDx in 11 tednov v skupini BzDx.
Bz= Bortezomib Accord; M=melphalan, P=prednisone
Bz=Bortezomib Accord ; M=melfalan, P=prednizolon
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).
- if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
- če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju - če imate določene hude težave s pljuči in srcem.
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 posebno v primeru srednje do resne trombocitopenije in ob obstoječih dejavnikih tveganja za krvavitev.
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 in takoj zdraviti.
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk.
Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate premisliti o ukinitvi bortezomiba, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
Day 1, 4
dan 1, 4
Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Bolnike z obstoječo hudo nevropatijo lahko zdravite z bortezomibom šele po skrbnem pretehtanju razmerja koristi in tveganj.
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
(≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
2 leti (za Bortezomib Accord 1 mg) 3 leta (za Bortezomib Accord 3,5 mg)
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
Bolniki s popolnim odgovorom lahko z zdravljenjem nadaljujejo še najmanj dva kroga po prvi ugotovitvi popolnega odgovora, tudi če to zahteva zdravljenje, daljše od 8 krogov.
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction
• Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri zdravljenju in dajanju zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Zato ta režim dajanja s sočasnim visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) ni priporočljiv.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
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 jemanjem tega zdravila, jo morate obvestiti o potencialnem tveganju za plod.
Name and address of the manufacturers responsible for batch release Accord Healthcare Ltd
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Accord Healthcare Ltd
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se rekonstituirane raztopine ne uporabi takoj, je za rok uporabe in pogoje shranjevanja po pripravi odgovoren uporabnik.
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 in je več kot 1500-krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z bortezomibom.
Medianc(95% CI) (months) Response rate n: response-evaluable patients 229
medianac(95% CI) (meseci) Stopnja odziva n: odgovor preiskovanih bolnikov
Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001)
In the BzTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
V skupini BzTDx je imelo 12% bolnikov citogenetiko visokega tveganja v primerjavi s 16% v skupini TDx.
Since dialysis may reduce bortezomib concentrations, Bortezomib Accord should be administered after the dialysis procedure (see section 5.2).
Ker dializa lahko zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib Accord injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
• Hypersensitivity (allergic reaction)
• glivične okužbe • preobčutljivostne (alergijske reakcije)
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 Bz+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 Bz+M+P.
When Bortezomib Accord is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Če jemljete zdravilo Bortezomib Accord skupaj s talidomidom in deksametazonom, traja en krog zdravljenja 28 dni (4 tedne).
The majority of the patients in both groups completed treatment, 80% in the BzR-CAP group and 82% in the R-CHOP group.
Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80% v skupini BzR-CAP in 82% v skupini R-CHOP.
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano dne <datum>
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
** Instrumentalna ADL: zajema pripravo obrokov, nakup živil ali oblačil, uporabo telefona, upravljanje z denarjem, itd; *** Fizična ADL: zajema kopanje, oblačenje in slačenje, hranjenje, uporabo stranišča, jemanje zdravil, ne zajema pa bolnikov priklenjenih na posteljo zaradi bolezni.
Subcutaneous or Intravenous use.
Za subkutano ali intravensko uporabo.
1 year survival, [95% CI]
1-letno preživetje,% [95% CI]
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
b Ocena razmerjetveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
Table 13: Efficacy results from study MMY-3010
Preglednica 13: rezultati učinkovitosti študije MMY-3010 Ocena učinkovitosti
Bortezomib Accord therapy should be withheld for up to 2 weeks until the patient has an ANC
Zdravljenje z Bortezomib Accord je treba prekiniti za največ 2 tedna, dokler nima bolnik
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Sekundarna ocena učinkovitosti je zajemala stopnje odgovora po presaditvi (CR+nCR, CR+nCR+VGPR+PR), Čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
OR; 95% CI; P value a
OR; 95% CI; p vrednost a
• that Bortezomib Accord is to be given only by intravenous or subcutaneous injections; no other route of administration is allowed
• Zdravilo Bortezomib Accord se lahko injicira samo intravensko ali subkutano, nobena druga uporaba ni dovoljena.
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Mediana starost bolnikov v študiji je bila 57 let, 55% je bilo moških in 48% bolnikov je imelo citogenetiko visokega tveganja.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Če ste prejeli večji odmerek zdravila Bortezomib Accord, kot bi smeli To zdravilo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
d Log- rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
Table 12: Efficacy results from study IFM-2005-01
Preglednica 12: rezultati učinkovitosti študije IFM-2005-01 Ocena učinkovitosti
Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Še posebna previdnost je potrebna, kadar se daje bortezomib v kombinaciji s substrati encima CYP3A4 ali CYP2C19 (glejte poglavje4.5).
Response Evaluable Population n=73
Odgovor preiskovane populacije n=73
A statistically significant benefit (p < 0.001) in favour of the BzR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Opazili so statistično značilno korist (p < 0,001) v skupini BzR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 mesecev), TNT (mediana 44,5 proti 24,8 mesecev) in TFI (mediana 40,6 proti 20,5 mesecev).
Median survival for the Bz+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Mediana preživetja v tretirani skupini Bz+M+P je bila 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Farmakološka preskušanja kardiovaskularne varnosti zdravila pri opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat višji od priporočenega kliničnega odmerka (v mg/m2), in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
je bila diagnosticirana v 12 mesecih po prvem odmerku bortezomiba.