natgillin/translations-raw huggingface dataset:
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124). 
V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije 2. stopnje v skupini, ki je prejemala zdravilo subkutano, 24 %, v skupini, ki je prejemala zdravilo intravensko, pa 41 % (p=0,0124).
** 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;
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial 
prašek za raztopino za injiciranje 1 viala
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP). 
Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8 % (n=2) bolnikov v skupini, ki ni prejemala bortezomiba (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP), in pri 0,4 % (n=1) bolnikov v skupini, ki je prejemala bortezomib v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina BzmbR-CAP).
Bortezomib is a proteasome inhibitor. 
Mehanizem delovanja Bortezomib je zaviralec proteasoma.
Main efficacy results are presented in Table 13. 
Glavni rezultati so zbrani v preglednici 13.
What Bortezomib SUN contains - The active substance is bortezomib. 
Kaj vsebuje zdravilo Bortezomib SUN - Učinkovina je bortezomib.
Neuropathic pain and/or peripheral neuropathy Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4). 
Nevropatična bolečina in/ali periferna nevropatija Bolnike, ki imajo nevropatično bolečino in/ali periferno nevropatijo v povezavi z jemanjem bortezomiba, zdravite v skladu s preglednico 1 (glejte poglavje 4.4).
For Bortezomib SUN dosage adjustments, dose modification guidelines described for monotherapy should be followed. 
Za prilagoditev odmerjanja zdravila Bortezomib SUN je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors. 
g Vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.
For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics. 
Za dodatne informacije o pegiliranem liposomskem doksorubicinu glejte povzetek glavnih značilnosti tega zdravila.
Bortezomib is metabolised by liver enzymes. 
Bortezomib se presnavlja z jetrnimi encimi.
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. 
V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO-celic) je bil bortezomib v koncentraciji samo 3,125 μg/ml, ki je bila najnižja ovrednotena koncentracija,
20.7 mo 
20,7 meseca
LIST OF EXCIPIENTS Excipient: mannitol (E421) 
SEZNAM POMOŽNIH SNOVI Pomožna snov: manitol (E421).
ORe (95% CI)=1.688 p-valueg=0.007 
ORe (95 % CI)=1,688
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2). 
Vpliv hude okvare ledvic na farmakokinetiko bortezomiba pri bolnikih, ki se še ne zdravijo z dializo (CrCL< 20 ml/min/1,73 m2), ni znan.
This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups. 
V študiji je bil dosežen primarni cilj neinferiornosti, 42 % stopnja odziva (CR+PR) po 4 krogih zdravljenja z bortezomibom v monoterapiji pri subkutani in intravenski uporabi.
4.63 (2.61, 8.22); < 0.001a 3.46 (1.90, 6.27); < 0.001a 
4,63 (2,61; 8,22); < 0,001a
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for 
Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74 % je bilo moških, 66 % je bilo belcev in 32 % azijcev,
• different reconstitution requirements for Bortezomib SUN 3.5 mg IV or SC use 
• Različne zahteve za rekonstitucijo zdravila Bortezomib SUN 3,5 mg pri i.v.
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2. 
Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m2 so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome 
Redki meningitis (vključno z bakterijskim), okužba z virusom Epstein-Barr, genitalni herpes, tonzilitis, mastoiditis,
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. 
V študiji z bortezomibom pri bolnikih, pri katerih limfom plaščnih celic še ni bil zdravljen, je bilo 42,9 % bolnikov, starih 65-74 let, in 10,4 % bolnikov, starih ≥ 75 let.
• potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death 
• Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju,
1-year Overall Survival (%)e 
1-letno celokupno preživetje (%)e (95 % CI)
There is no known specific antidote for bortezomib overdose. 
Specifični antidot za bortezomib ni znan.
Main efficacy results are presented in Table 12. 
Glavni rezultati so zbrani v preglednici 12.
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); 
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do
Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice. 
Glede na lokalne smernice se za hematološke toksičnosti lahko daje granulocitne kolonije spodbujajoče faktorje.
Treatment with Bortezomib SUN can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. 
- težave s kašljem in dihanjem ali tiščanje v prsih Zdravljenje z zdravilom Bortezomib SUN lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
RECONSTITUTION FOR INTRAVENOUS INJECTION 
REKONSTITUCIJA ZA INTRAVENSKO INJICIRANJE
Bortezomib SUN should not be administered intrathecally. 
Zdravila Bortezomib SUN se ne sme dajati intratekalno.
When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide). 
Če jemljete zdravilo Bortezomib SUN v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
This 4-week period is considered a treatment cycle. 
To 4-tedensko obdobje predstavlja en krog zdravljenja.
Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za bortezmib, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Combination therapy with melphalan and prednisone Bortezomib SUN is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2. 
Zdravilo Bortezomib SUN se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group. 
Opazili so statistično značilno razliko v CR+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
Injection sites should be rotated for successive injections. 
Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
What Bortezomib SUN looks like and contents of the pack Bortezomib SUN 3.5 mg powder for solution for injection is a white to off-white powder or cake. 
Izgled zdravila Bortezomib SUN in vsebina pakiranja Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis. 
Diagnozo potrdimo s slikovnimi preiskavami možganov, najbolje z magnetnoresonančnim slikanjem (MRIMagnetic Resonance Imaging).
You will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly. 
Pred in med zdravljenjem z zdravilom Bortezomib SUN vam bodo redno pregledovali kri in tako spremljali število krvnih celic.
Intravenous use: Add 3.5 ml 0.9% sodium chloride to make 1 mg/ml final concentration. 
Intravenska uporaba: dodajte 3,5 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN 
Nehematološka toksičnost stopnje ≥ 3, povezana z uporabo zdravila Bortezomib SUN
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
Response parameters as well as TTP remained significantly better for bortezomib independently of age. 
Parametri odziva na zdravljenje, kot tudi čas do napredovanja bolezni (time to progression, TTP) so bili, neodvisno od starosti, pri zdravljenju z bortezomibom statistično značilno boljši.
d Based on Log rank test stratified with IPI risk and stage of disease. 
d Na podlagi log-rank testa, stratificiranega z IPI-tveganjem in stadijem bolezni.
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients. 
Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), je na podlagi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35 % (CI 90 % (1.032 do 1.772)).
Patient demographic and baseline disease characteristics were similar between the treatment groups. 
Bolniki v obeh skupinah so imeli podobne demografske in bolezenske značilnosti.
Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively. 
V skupini BzmbR-CAP je bilo 42,9 % bolnikov starih 65-74 let in 10,4 % bolnikov starih ≥ 75 let.
The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below. 
Kot je navedeno spodaj, se lahko daje subkutano samo 3,5 mg viala.
The following medicinal products are administered on day 1 of each Bortezomib SUN 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2. 
Zdravila, ki se dajejo v obliki intravenske infuzije na 1. dan vsakega 3-tedenskega kroga zdravljenja z zdravilom Bortezomib SUN, so: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2 doksorubicina.
Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems. 
Kot del diferencialne diagnoze težav CŽS je pri bolnikih treba redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment. 
Med zdravljenjem z bortezomibom so poročali o akutnem razvoju ali poslabšanju kongestivnega srčnega popuščanja in/ali novim pojavom zmanjšanja iztisne frakcije levega prekata.
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./ 
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
1.4 mo 
1,4 meseca
A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]). 
V farmakokinetični študiji varnosti in učinkovitosti faze II, z enim krakom, ki jo je izvedla Skupina za otroško onkologijo (COG- Children's Oncology Group) so ocenili delovanje bortezomiba, ki so Ga dodali k ponovno uvedeni indukcijski kemoterapiji z več zdravili pri pediatričnih in mladih odraslih bolnikih z limfatičnimi malignomi (s pre-B-celično akutno limfoblastno levkemijo [ALL], T-celično
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. 
V študijo je bilo vključenih 222 bolnikov z relapsom/diseminiranim plazmocitomom, odpornim na zdravljenje, randomiziranih 2:1 na bortezomib v odmerku 1,3 mg/m2 telesne površine subkutano ali intravensko 8 krogov zdravljenja.
d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=not applicable, NE=not estimated TTP-Time to Progression 
c Populacija oz. skupina bolnikov, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek raziskovalnega zdravila d P-vrednost iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=ne velja za ta primer, NE=odziva ni bilo mogoče oceniti TTP=čas do napredovanja bolezni CI=interval zaupanja
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys. 
V raziskavah splošne toksičnosti z več krogi zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali drisko ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev in blagimi spremembami ledvic.
In patients developing PRES, bortezomib should be discontinued. 
Če se pri bolniku razvije PML, je treba zdravljenje z bortezomibom prekiniti.
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting. 
ki prejemajo zdravila, za katera je znano, da so povezana s pojavom hipotenzije, ali pri tistih, ki so dehidrirani zaradi ponavljajoče se driske ali bruhanja, svetujemo previdnost.
Special populations 
populacija)
Mediana response duration 
Medianaa trajanja odziva CRf
Electrocardiogram investigations 
Elektrokardiogram (EKG)
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR). 
Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi zdravljenja in po presaditvi (CR+nCR).
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone. 
V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo optimalnega odziva na zdravljenje z bortezomibom v monoterapiji.
An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks. 
Bolnikom so uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy. 
Med zdravljenjem z bortezomibom so občasno poročali o resnih neželenih učinkih - srčno popuščanje, sindrom razpada tumorja, pljučna hipertenzija, sindrom reverzne posteriorne encefalopatije, akutna difuzna infiltracijska pljučna stanja - in redko o avtonomni nevropatiji.
Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide. 
Bolniki, ki prejemajo bortezomib v kombinaciji s talidomidom, morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2). 
Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev (glejte poglavje 4.2).
Such changes may be reversible upon discontinuation of bortezomib (see section 4.8). 
Po prekinitvi zdravljenja z bortezomibom so te spremembe lahko reverzibilne (glejte poglavje 4.8).
There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group. 
Ocenjena stopnja 4-letnega preživetja je bila v skupini R-CHOP 53,9 % in v skupini BzmbR-CAP
Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area). 
Zdravnik bo določil odmerek na podlagi vaše telesne višine in mase (telesne površine).
Haematological toxicity during a cycle - If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle 
Hematološka toksičnost med zdravljenjem - Če je bila v prejšnjem krogu zdravljenja opažena dolgotrajna nevtropenija 4. stopnje, trombocitopenija ali trombocitopenija in
Bilirubin level 
Koncentracija bilirubina
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib SUN as outlined in Table 1. 
V primeru nevropatske bolečine in/ali periferne nevropatije, povezane z bortezomibom, zakasnite in/ali prilagodite odmerek zdravila Bortezomib SUN, kot je opisano v preglednici 1.
There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established. 
Vzroka za podaljšanje QT-intervala niso ugotovili.
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzmbTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127]. 
V študiji MMY-3010 so primerjali uvajalno zdravljenje z bortezomibom v kombinaciji s talidomidom in deksametazonom [BzmbTDx, n=130] s kombinacijo talidomid-deksametazon [TDx, n=127].
MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV 
69 % bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76 % bolnikov je bilo v IV. stadiju bolezni.
In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed. 
V 6-mesečni raziskavi na podganah so opažali degenerativne učinke tako na testise kot na ovarije, zato je verjetno, da bi bortezomib lahko vplival na plodnost samic ali samcev.
- Platelet counts should be ≥ 100,000 cells/μl and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μl 
- Število trombocitov mora biti ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients. 
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m2) farmakokinetika bortezomiba ni spremenjena, zato pri njih ni treba prilagajati odmerka.
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: 
Pojavnost periferne nevropatije v preskušanjih bortezomiba pri uvajalnem zdravljenju v kombinaciji z deksametazonom (študija IFM-2005-01) ter deksametazonom in talidomidom (študija MMY-3010) je navedena v spodnji preglednici:
• to report any adverse event, or medication error experienced with the administration of Bortezomib SUN 3.5 mg. 
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila Bortezomib SUN 3,5 mg.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells. 
naj se posvetujejo z zdravnikom, če imajo simptome omotice, vrtoglavice ali napade nezavesti.
18.3 mo 
18,3 meseca
Each carton of Bortezomib SUN 3.5 mg powder for solution for injection contains a clear glass 10 ml vial closed with a light green aluminium cap, in a transparent blister pack. 
Ena škatla zdravila Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje vsebuje prozorno stekleno 10 ml vialo s svetlo zeleno aluminijasto zaporko v prozornem pretisnem omotu.
The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study. 
Povprečna vrednost najnižjega izmerjenega števila trombocitov je v študijah diseminiranega plazmocitoma z uporabo ene učinkovine znašala približno 40 % in v študiji MCL 50 % začetne vrednosti.
T 100 mga 
T 100 mga na dan na dan